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A Summary of Daniel P. Carpenter’s “Reputation and Power” – A Titanic Book on the History of the FDA

A Summary of Daniel P. Carpenter’s “Reputation and Power” – A Titanic Book on the History of the FDA

Willy Chertman
Edited by Dan Elton


Note from the Editor: In a conversation on Clubhouse that I hosted, entitled “Is the FDA moving too slowly with vaccine approvals?”, Willy Chertman articulated a number of nuanced points about the FDA. He had recently finished reading Reputation and Power, an 856-page book on the history of the FDA. I asked Willy to organize his notes on the book so that the USTP membership could learn his key takeaways from the book and learn more about the history and role of the FDA. Willy graciously accepted my request. I have edited his notes somewhat for length and made some minor copyedits. A few key takeaways are bolded.

– Daniel C. Elton, Director of Scholarship, United States Transhumanist Party, April 2, 2021


Reputation and Power book cover


Reputation and Power

Organizational Image and Pharmaceutical Regulation at the FDA
by Daniel P. Carpenter
856 pgs. Princeton University Press, 2010

 

Reputation and Power is a very deep dive into the history of the FDA and the reputational universe that it inhabits and creates. The gist of the book is that reputation management is the best lens to understand the FDA, not “public interest” versus “regulatory capture”. The political and regulatory power of the FDA is bound up inextricably with how Congress, the pharmaceutical industry, academic medicine, and consumer-protection groups view it. By virtue of the size of the market it regulates and its pre-market approval power, the FDA is likely the most powerful regulatory agency in the world. 

Because of the length of the book and the variety of topics it covers, I’ve split this book summary into two parts. The first half covers the history of the FDA and the second half covers the themes and lessons I learned from the book. Though Carpenter covers up to about 2010, time constraints meant that this summary only covers up to 1992. Hopefully future posts will cover the remaining material.

Origins

The origin story of the FDA in popular political mythology begins with thalidomide, but Carpenter does an excellent job showing how the FDA started as an obscure branch of the USDA, originating with the Pure Food and Drug Act of 1906. In the early 1900’s the FDA had nothing but the ability to confiscate dangerous drugs or compounds from the market.  Later, in a pattern that will repeat itself, forces within and without the FDA made good use of the dictum “Never let a crisis go to waste.” 

The context is that the early 1900s were a stupendous time to be a patent medicine salesman– a synonym for charlatan. Apart from aspirin, it’s not clear that any patent medicine of that time ever turned out to be effective. Medicines to lull your baby to sleep relied on opium or alcohol, and sulfonamide antibiotics were not invented until the 1930s, and even then their manufacturing process was initially unreliable . Yet the patent medicine trade was booming. In an interesting historical irony, John D Rockefeller, through his foundation’s funding of the Flexner Report, which birthed medical education as we know it, ended the traveling medicine salesman/huckster-doctor profession – which his own father had been in. 

The Pure Food and Drug Act of 1908 required accurate labeling of products and also gave the FDA the power to seize and destroy products that violated the law. Importantly, this did not give the FDA the power of pre-market approval, which is its most important power today. Though the FDA was prohibited from directly lobbying for more authority, many in the agency and their Progressive congressional allies believed the FDA was weak and underfunded relative to the growing pharmaceutical industry it was supposed to regulate. In 1935, New York Senator Copeland had tried to pass legislation that would strengthen the FDA, aided by women’s political organizations and the Consumers Research group, but his attempt had failed in the House. 

There had been previous small-scale pharmaceutical disasters, but the Sulfonamide Elixir stood out for scale and the media attention that it garnered. The leading role that the FDA eventually took in handling the disaster, as well as the relationship with the media that it cultivated, also made this disaster special.  This is the beginning of the sidelining of the American Medical Association (AMA), which had previously been one of the centers of organized medical power. 

People became seriously ill from its consumption, and by late October 1937, at least seventy-three of these had died. The FDA, assisted by state and local health officials and the American Medical Association, commenced an effort to secure as much of the compound as possible before any more was consumed.

The media ran stories of heroic FDA officials working late into the night trying to confiscate a dangerous drug, and the story re-surfaced whenever another death was reported. The cherry on top of this story was a report released by the Secretary of Agriculture, the Campbell-Wallace Report:

‘A few simple and inexpensive tests,’ the sort that would be performed by the company before marketing and analyzed in a pre-market review process by the FDA, would quickly have evinced the elixir’s “toxic properties.” Translation: with a pre-market review process, none of this would have happened.

In February 1938, Copeland’s S.3073 was again considered in the Senate. Women’s groups and public-health leagues now lobbied intensively for its passage, and their rhetoric made clear the centrality of the Wallace report in the new deliberations. 

Contrary to the theory of regulatory capture, large pharmaceutical firms, who might have expected to benefit from a regulatory moat, did not advocate for the 1938 Food, Drug, and Cosmetic Act. Instead, it was Progressive politicians pressured by consumer protection groups, women’s groups, and forces within the FDA that advocated for it. 

The 1938 Food, Drug, and Cosmetic Act gave birth to modern pharmaceutical regulation: The four enumerated powers—(1) pre-market review and notification, (2) prohibition (or withdrawal authority), (3) labeling regulation, and (4) compulsory disclosure of all drug contents (active and inactive)—have become assumed and core legal features of pharmaceutical markets 

While the 1938 act did not contain an efficacy provision, Carpenter shows how this was effectively smuggled into drug regulation anyways, with officials saying: 

It has been emphasized that there is no arbitrary standard of safety; it is a relative matter in which the toxicity of the drug must be weighed against the therapeutic benefits which its use will bring about.

In the 1940’s and 1950’s the FDA gradually raised the standards for drug approval, and its Division of Pharmacology drew many talented pharmacologists from academia. Throughout the FDA-cultivated “reputational ambiguity”.

The simultaneous ambiguity and fear-provoking stance of investigational regulation was, in part, FDA officials’ manner of expressing and maintaining the agency’s gatekeeping role, even as they did not fully comprehend… 

Though a Randomized Controlled Trial was not yet an explicit requirement for drug approval, the FDA gradually raised the bar on the required toxicity, stability, and drug metabolism studies. As pharmacology refined its methodology, the FDA required more and more from drug companies, viewed amateur physician-directed trials with more suspicion, and by being the central gatekeeper of pharma, made the whole field more rigorous and scientific. 

The FDA used a variety of carrots in addition to the “stick” of gatekeeper:

From the beginnings of the Eisenhower administration and probably earlier, FDA officials acted intentionally, strategically, and with foresight to establish numerous committees of liaison to the professions. Agency officials established not just medically specialized “advisory committees” of the sort that became institutionalized in the late twentieth and twenty-first centuries, but also more temporary committees that helped the FDA recruit and retain allies and consultants. 

The Administration cultivated relationships with academic luminaries in pharmacology, and many of their promising students became part of it. Dr. Frances Kelsey, a Professor of Pharmacology at South Dakota State University who had done important research on the teratogenic effects of drugs on animal fetuses, was an archetypical example. She had come highly recommended to the agency, and though she developed a reputation as being a more exacting drug reviewer than most, the agency as a whole had become more cautious over the decades. 

Thalidomide

Thalidomide, marketed as Contergan in Europe, was being widely used there as a sedative, and the company (Merrell) submitted a drug application to the FDA. Kelsey held up the application due to safety concerns, even in the face of vigorous company complaint, and was vindicated when it was later tied to an outbreak of birth defects in Europe. 

This might have remained the stuff of obscure industry history if the antitrust subcommittee led by Senator Estes Kefauver had not leaked the details of the story to the reporter Morton Mintz. Kefauver, who had been leading high-profile hearings on the “drug industry” and had been trying to shorten their drug patent periods as well as incentivize generic drug prescription, gave Morton Mintz key data about the Thalidomide saga as well as Frances Kelsey’s role in it. 

1962 Amendments and After…

The Drug Amendments of 1962 were opposed by the Pharmaceutical Manufacturers Association, but the FDA’s star was ascendant with the Thalidomide crisis having shown its worth. 

At their core, the Amendments contained three provisions governing pharmaceutical regulation (table 4.1). They first required affirmative evidence of “effectiveness” and “safety,” evidence in the form of “adequate and well-controlled investigations,” before any “new drug” could enter into interstate commerce. Second, they required designation of a medicine as an Investigational New Drug during its period of experimentation (and submission of the IND to the agency), and empowered the Administration to nullify this status (and hence development of the drug) if research protections for patients were not being observed, if the clinical trial protocol was not sufficiently rigorous, if pregnant women were being exposed to teratogens, or if any evidence of research as commercialization emerged. Third, they required the Administration to lay out and enforce new procedures to protect the interests and rights of patients in medical research. 

The impact of the law was significant: Before 1960, there are no references to phased trials in the American and European medical literature, and there is no reference to a “Phase 3” study in Western medical literature before 1964. In the early 1960s, reports of “Phase 1” and “Phase 2” experiments appear haltingly, then rapidly near the end of the decade (table 4.2). What is more, American researchers and doctors began to reflect systematically on the relationship between earlier phases and later phases. 

In the 1960’s, as the FDA continued to gain in power, it met with some moderate resistance from organized medicine. These incidents illustrate the reputational politics that the FDA is sensitive to: when comments by Frances Kelsey at a medical conference were taken to indicate that patients always had to be informed that they might receive a placebo, a leading clinical trialist at Harvard, Henry Beecher, wrote to the FDA Commissioner. In another incident, the FDA’s General Counsel William Goodrich implied that medical journals might be liable for misleading advertisements, which prompted a prominent Cornell pharmacologist Walter Modell, who had previously been an ally of the FDA, to publicly rebuke them. 

In both cases, to varying degrees, those statements were publicly walked back by the FDA.

Sometimes public dissent against the FDA could damage one’s career, even for the most credentialed academic, as Louis Lasagna’s advocacy for combination antibiotics demonstrated: 

Lasagna’s advocacy for Panalba was risky and vocal, and it marked the beginning of a steady decline in his status among medical academicians. Lasagna’s name was golden in the 1950s, when he had authored pathbreaking papers on the placebo response and clinical trial design, when he had founded the nation’s first clinical pharmacology department at Johns Hopkins, and when he had testified in support of efficacy standards at the Kefauver hearings in 1960. 

…The diverging paths of Louis Goodman and Louis Lasagna marked the splintering audiences of the Food and Drug Administration as well as the agency’s enduring scientific legitimacy. In the status-conscious world of academic medicine, Louis Lasagna never fully recovered from the Panalba battle. 

An important feature of FDA history in the 60’s and 70’s was the congressional hearing. Because of changes in how congressional committee chairs were chosen, congressional hearings became more important in this period. The obligation of FDA officials to appear before Congress when requested and to testify was an important check on its power and a venue where its public reputation was maintained. 

Criticism from an industry-friendly senator could strengthen the FDA’s image as pharma policeman while an FDA whistleblower like John Nestor testifying to its regulatory inadequacy could force less accommodation with the drug industry by effectively shaming the FDA into more stringency. 

Congressional hearings seemed, at least in the 1970s, to be the strongest check on FDA behavior. When Senator Gaylord Nelson read The Doctor’s Case Against the Pill, and started hearings into the FDA’s approval of it, and its widespread use, the end result was, after much criticism from prestigious physicians, scientists, and consumer safety advocates, the creation of the patient-package-insert. (see chapter 9)

An illustration of how the FDA sought to collaborate with other scientific institutions can be seen in how it dealt with medications that had been approved before 1962 and the formal recognition of an efficacy standard. Thousands of drugs had been approved in the 1940s and 1950s on the basis of evidence that were wholly inadequate by 1962 FDA standards. These drugs had now been incorporated into clinical practice for many years, and so any FDA action on them would be seen as doubly intrusive by physicians. To strengthen their position and reduce their workload, the FDA collaborated with the National Academy of Sciences to evaluate these old drugs.

1970s

The 1970s probably marks the peak of the FDA’s power, as a series of court decisions endowed the Administration with the authority to issue rules with “the force of law” and creating “a presumption in favor of agencies that claimed legislative rulemaking authority”. When the FDA does not want to create formal rules, which require an elaborate process, it also uses “nonbinding” guidance documents which are, in reality, quite binding: 

Because the Administration has the ultimate say over whether and when a new drug will be marketed, its mere suggestions and intimations induce compliance even where they are not backed by legal authority. The agency’s use of Federal Register policy statements and “guidance documents” (nonbinding statements of policy that are not customarily published in the Federal Register but are published under the auspices of the FDA itself) permits its officials to avoid the more costly and elaborate process of formal rulemaking, while still gaining acquiescence with its regulatory wishes. 

With its arsenal of new authorities and the powers that flowed from them, the Administration began in the 1960s and 1970s to exercise vast sway over the medical marketplace. Familiar over-the-counter remedies and doctor-prescribed pills vanished. The place of the general practitioner in drug development waned to the point of disappearance, as companies could no longer rely upon doctors’ casual observations or observations of patient histories to buttress claims of safety and effectiveness. 

Though there were occasional media critiques of the FDA in the late 1960s, the 1970s and 1980s were really the beginning of a sustained critique of the FDA from the right. This came from many quarters: business-friendly publications like the Wall Street Journal, prominent economists like Sam Peltzman who were quantitatively assessing regulatory impact on innovation in various industries, and industry organizations. In 1974, the American Enterprise Institute played a key role by launching the AEI Center for Health Policy Research, which brought together pharmacologists, industry officials, and economists. The “drug lag”, coined in 1972, was the time between a drug being introduced in Europe vs the US, and along with the cost-benefit analysis of regulation, was a key critique of the administration. A sign of the success of these critiques was that while top FDA officials publicly rejected the premise of the drug lag, inside the administration, increased attention was paid to the drugs that had already been approved in peer countries. 

Even as libertarian-aligned think tanks, academics, and newspapers criticized the FDA for being too cautious, the opposite critique was sustained by consumer-protection groups throughout this period.

No voice more cogently or passionately articulated the case for rigorous drug safety standards than that of physician-activist Sidney Wolfe, and no arrangement better amplified the concerns of Wolfe and his allies than the committee systems of the U.S. House and Senate. Wolfe helped to found the Health Research Group, a subsidiary of Ralph Nader’s Public Citizen, in 1971. 

Wolfe had no formal role in the Administration, but by careful use of administrative procedures like FOIA requests and citizen petitions, combined with journalist connections, he could push the FDA into action when it was reluctant. The whole section on him is worth excerpting:

Wolfe’s principal weapon was his threat to the Administration’s consumer protection image. The credibility of this threat depended on a set of strategies by which Wolfe and his organization could embarrass the agency, extract data from it, influence the FDA’s decision agenda, or (less commonly) induce courts to force the agency to take a given action.

First, he was adept at using administrative procedures refined in the 1970s, including Freedom of Information Act (FOIA) requests and citizens’ petitions, to pry important drug safety and procedural information out of the agency, or to place contentious and uncomfortable items on the Administration’s agenda. Second, Wolfe exploited the public comment period of the FDA’s advisory committee meetings on drugs, an opportunity that offered a public venue albeit with brief appearances. Third, Wolfe appeared regularly at congressional committee hearings as an invited guest, and his ties to committee chairs and their staff gave him indirect access to committee powers (replete with tools for discovery). In the 1970s and 1980s, Wolfe worked partially in tandem with subcommittee chairmen ranging from Lawrence Fountain, Henry Waxman, and Ted Weiss in the House to Senators Edward Kennedy and Abraham Ribicoff. 

Fourth, Wolfe maintained ties to journalists over a period of several decades (Morton Mintz, Christine Russell, Philip Hilts, and others). He used these journalists to publicize actions (such as the taking of surveys of FDA medical officers) that would otherwise not have received much public attention. Finally, Wolfe and his organization shrewdly used lawsuits and the threat of legal action to induce rulemaking and jar the agency into action. The strategies of administrative maneuvering, advisory committee testimony, appearances at congressional hearings, and media access became much more pivotal to Wolfe’s leverage over the FDA after 1979, when a federal judge limited the right of Nader’s group to sue agencies on behalf of the general public. 

A clear demonstration of the conservative sentiment of the times was the backlash against the FDA when it attempted to regulate supplements more stringently:

In August 1973, the Administration published fourteen final regulations and five proposed rules that governed the labeling of foods and food supplements. 

Led by Wisconsin Senator William Proxmire, Congress in 1976 passed an amendment to the 1938 Act which extended the “generally recognized as safe” (GRAS) exemption for vitamins and minerals to dietary supplements. The “Proxmire Amendment” prevents the Administration from restricting the potency of a vitamin or mineral supplement based on either of two criteria: (1) food misbranding charges or (2) on the premise that the supplement would qualify as a drug if it surpassed the agency’s desired level of potency. For almost two decades, FDA officials largely backed off from rule-making on supplements.

In the late 1990s, the FDA again attempted to regulate supplements and faced a similar legislative rebuke. 

Overall, though the FDA faced some setbacks when it attempted to regulate supplements, it survived the conservative turn in the 1980s with its power and reputation mostly intact, an impressive achievement for such a powerful regulatory agency. In some ways, the criticism from the libertarian perspective may have strengthened the FDA’s reputational position:

[I]t would be wrong to conclude that the persistence of criticism and scrutiny has undermined the agency’s reputation and power. It is certainly plausible that criticism has depleted morale, and on occasion publicity and hearings have weakened its leadership. 

For those who have paid attention to the increasing polarization of US politics over the last 20 years, this may sound familiar – criticism from your enemies can be a reliable signal to your allies that you’re on their side. In a similar way, pharma and libertarian criticism of the FDA may strengthen its reputational position in the views of consumer-protection groups and allied groups.

AIDS and Cancer

The “drug lag” criticism was a long-lasting and effective critique of the FDA, but Carpenter seems to argue that the most significant reforms of the FDA were really brought about by inter-agency squabbles over cancer drugs and the moral outcry of the HIV epidemic. The interactions of AIDS activists and the FDA are probably more well-known than the turf battle between the National Cancer Institute (NCI) and the FDA, but it appears that the latter may have been more influential.

NCI-supported investigators were developing combination chemotherapies that were very promising, modeled after the lucky discovery of platinum’s anticancer potential by physicist Barnett Rosenberg. From 1975 to 1977 Robert S. K. Young, an FDA medical reviewer, repeatedly took issue with the study protocols of combination chemotherapy trials and halted several trials. A prominent MD Anderson oncologist, Emil Freireich, retaliated by reading out a list of complaints about FDA interference into NCI-funded trials at an important meeting of President Ford’s Cancer panel. Benno Schmidt, the chairman of the panel and a prominent official in Ford’s Administration, agreed with him. Young’s supervisor William Gyarfas stuck by his subordinate. 

Young overreached when in a 1977 Advisory Committee he attempted to more aggressively regulate the clinical trials of combination chemotherapy and effectively eliminate dosage variation in chemotherapy without preclinical studies. The Committee voted against his proposal, and this caught the attention of Richard Crout, then-head of the Bureau of Drugs. Crout met with the head of NCI and basically admitted his subordinate had overreached, and they worked on a series of protocols to relax FDA restrictions for terminally ill patients. 

While this might have been the end of the bureaucratic conflict, the NCI had decided to escalate: 

House Health Subcommittee chairman Paul Grant Rogers (D-FL) released a December 3, 1976 letter from the American Cancer Society calling for full “NCI control over the testing of new anticancer drugs, instead of FDA control” for nonprofit research sponsors. This transfer of power would be accomplished, as ACS representative Nathaniel Polster hoped, by amendments to the National Cancer Act. While NCI officials were largely silent about the ACS proposal, M. D. Anderson’s Freireich was not. He openly called for deep “structural changes” so that the “FDA can never again shut [down cancer research].” 

This would be a huge escalation. If the NCI succeeded in wresting control over regulation of a specific disease, it would set a precedent for continued piecemeal diminishment of FDA authority: 

And to Administration officials concerned about the maintenance of their authority over clinical trials, the ACS-NCI proposal raised the specter of debilitation by precedent. Once an exception for one category of illness was carved out of the FDA’s power over clinical research, it was feared, demands from representatives of other diseases would soon follow. As if to confirm the FDA’s premonitions, Solomon Garb of the Citizens’ Committee for the Conquest of Cancer seized upon the NCI-FDA dispute and called for ending FDA power over any clinical trial in which patients have “poor prognoses.” Garb’s remarks introduced a different and more formidable voice to the growing chorus of criticism, in part because the Citizens’ Committee was an amalgam of union, scientific, corporate, scientific, and civic leaders… 

This proposal didn’t come from a fringe libertarian or anti-government organization but from respected sources. The NCI and the FDA eventually came to agreement: 

DeVita and Crout settled on a new procedure whereby “stop orders” for NCI-sponsored trials for terminally ill patients could be issued only by the Bureau of Drugs chief (Crout himself at the time) or the deputy chief (Marion Finkel, at the time). The two groups later agreed to use the nation’s forty comprehensive cancer centers to mediate the surveillance of research protocols. The new arrangement embedded meaningful victories for both sides. For the Institute, the new procedures effectively bypassed Robert Young and, more notably, William Gyarfas, Director of the Oncology Drugs Division. NCI officials and their grantees would now deal more directly with Crout and Finkel, who were more trusted within oncology networks. And the Institute’s détente with the FDA helped it to buttress claims that it was being “dominated”… 

The Administration would retain full control over cancer trials. The NCI would now officially acknowledge and defer to the IND regulations, and in so doing it would develop a “Master Plan” of drug development… 

By January 1979, the dispute had issued in a document with odd legal status but firm organizational commitments (figure 6.1). An informal procedure for resolving FDA-NCI disputes appears to have been worked out in April 1979. The procedure entailed four steps: (1) first devolving disputes to the lowest managerial level deemed suitable for negotiation—the Associate Director of the Bureau of Drugs (at that time, Finkel) and the Director of the NCI’s Cancer Treatment Division (DeVita), then (2) to negotiations between the Bureau of Drugs head (Crout) and the NCI Director, then (3) to negotiations between the FDA Commissioner and NIH head, and (4) finally, determination by FDA Commissioner himself if none of these previous options produced a resolution. The memorandum bound neither agency legally. It was rather an informal institution founded in a political equilibrium, a mutual wish to avoid the spectacle of open, public conflict among two agencies whose reputations generally benefited from being out of the public eye. 

While the NCI and FDA struggle would lead to a durable compromise between the two agencies, the Laetrile saga would come closest to threatening FDA power, and yet ultimately affirm it. From a libertarian perspective it is darkly amusing that the drug that came closest to breaking the FDA’s stranglehold was the charismatic but ultimately useless drug Laetrile. 

Laetrile had been developed by an Ernst Krebs (of no relation to the Krebs cycle) who had failed out of medical school and whose father, incidentally, was also a conman physician. At various times its supporters described it as vitamin B17, as a relative of cyanide, and as amygdalin. NCI scientist Dean Burk had developed a molecular model that was supposed to demonstrate Laetrile’s anti-tumor activity and a San Francisco foundation applied to the FDA for an IND for experimentation. 

Their IND was ultimately rejected by the FDA, which cited problems with the sponsors and monitors of the trial and its design. The key difference between the FDA’s rejection of Laetrile and its previous policing of quack medicines was the FDA exerting its power on the IND stage. This was a rhetorically powerful difference. 

What most bothered many Laetrile supporters and their distant sympathizers was not the absence of Laetrile from the drug marketplace, but the absence of a permit for testing. Appropriating the juridical metaphor of a “fair trial,” they linked a populist ethic of self-medication to issues of justice and to more progressive norms of academic and intellectual freedom, the liberty of research and exploration of ideas. … By pressing the case for a total ban, by publicizing its seizures, and by assisting with state and federal prosecutions of Laetrile distributors, the Administration had resurrected a face that had been nearly invisible since the 1950s: the FDA as police. 

Newspapers ran headlines criticizing the FDA for overreach. Organizations for therapeutic freedom sprung up across the country and a bill sponsored by Representative Steve Symms that would repeal the efficacy provisions of the 1962 amendments attracted over 100 sponsors. Several states passed laws legalizing Laetrile. The anti-FDA sentiment was nearly mainstream: Time Magazine, The Wall Street Journal, and the New York Times all ran editorials with some support for Laetrile proponents, or at least criticized the FDA’s overreach. 

From the FDA’s perspective, several court cases were going in an unwelcome direction. Lower courts had issued an injunction against seizure of Laetrile, had decided that the FDA had the duty of showing lack of safety, not the sponsor affirmative proof of safety, and that the FDA had not exercised due process in its Laetrile ban. Since the regulatory power of the FDA was inextricably bound up with its flexible ability to issue rules and the affirmative requirement of drug sponsors to show safety and efficacy, these rulings were a threat to the FDA. In recognition of this enormous pressure, the FDA Commissioner did two contradictory things: one, he affirmed his agency’s judgement that Laetrile was ineffective and dangerous; two, he granted an IND to the NCI for Laetrile. In a PR coup for the Laetrile camp, they also testified before Congress to the Health and Scientific Research Subcommittee. The ability of the agency to offer different faces to different audiences is a recurring theme of Carpenter’s, who views it as key to the FDA’s long-term success. 

In June 1979, in Rutherford vs United States, The Supreme Court reversed the Tenth Circuit, which had previously ruled that the FDA could not regulate drugs given to terminally ill patients. It was a powerful affirmation of the FDA’s regulatory authority. Though at this point the FDA could have likely dropped the Laetrile IND for any number of reasons, the FDA issued a conditional approval for Laetrile’s IND, which was set to be tested at rigorous NCI-affiliated institutions that the FDA trusted. 

The Supreme Court decision, followed by the very public death of actor Steve McQueen, who had pursued a number of alternative medicine therapies including Laetrile after a mesothelioma diagnosis, led to the gradual decline of Laetrile’s political power. The FDA post-Laetrile had its legal power affirmed over every part of medicine: terminally ill patients, cancer patients, whether a given drug was even a legitimate experimental drug, etc.

AIDS

Part of the 1988 ACT-UP protest for greater access to HIV-AIDS drugs that was held outside the FDA. Source: FDA/ Creative Commons.

Like the NCI and FDA power struggle, the AIDS crisis resulted in substantial concessions by the FDA. Unlike the former, the AIDS crisis played out much more publicly, and instead of bureaucratic warfare, the battle was a reputational one. The primary strategy of AIDS activists was to attack the FDA’s good name– instead of a public health agency and “protector of the American consumer” they sought to cast it as a villain who was killing AIDS patients through its slow and inflexible procedures. Until the 1990s AIDS was a slow death sentence, and in the early 1980s it was still poorly understood, with an official announcement by HHS Secretary Margaret Heckler that AIDS was caused by HIV occurring only in 1984. Retroviruses had only been discovered in 1970, and there were no targeted therapies for them until the HIV antiretrovirals. 

An important advantage that AIDS activists had was that decades of organizing had left the gay community with many highly effective and experienced community activists. Many of them went on to form important groups: the most prominent of them were Gay Men’s Health Crisis, AIDS Foundation, Project Inform, and ACT-UP. Gay men were also highly concentrated in urban centers and in some places, like San Francisco, had achieved some degree of political power. Nancy Pelosi, a rising star in the Democratic Party, was sympathetic to many gay activist groups and a Congresswoman. All of these resources would eventually be mobilized against the FDA.

A key event was the story of HPA-23 and Rock Hudson. Rock Hudson, a movie star who had been diagnosed with AIDS in 1984, died of AIDS in 1985. Newsweek reported that before his death he had traveled to Paris to receive an experimental HIV treatment, HPA-23, which was being given there, though under poorly controlled conditions and with little good evidence. The FDA had banned even its experimental use in the US because of severe liver toxicity concerns; it then reversed course and allowed testing in 1985, likely due to the Newsweek story. Well-done trials in 1986 in the US later demonstrated severe toxicity and no efficacy, vindicating the FDA’s earlier caution. 

The first effective treatment for HIV was azidothymidine (AZT), which was being developed by Wellcome, a reputable drug company that had substantial experience with the FDA. To the FDA’s credit, the AZT path to approval was remarkably quick: the company first started investigating AZT in June 1984 for possible HIV activity in-vitro; notified the FDA in April 1985, submitted an IND in June 1985, the FDA approved it in a week, and the first clinical trial (Phase 1) began in July 1985. 

Phase 2 trials which had begun in February 1986 were halted early in September 1986 due to clear signs of treatment success, and AZT was officially submitted to the FDA for approval in December 1986. Eileen Cooper, a rising young star at the FDA, was in charge of reviewing it, and had been reviewing the AZT data for months before the official submission date. Even before the most militant AIDS activists had begun pressuring the FDA, she had been discussing with others on ways to speed and streamline the approval process. 

She took two important steps. First, in September 1986 she had released AZT for compassionate use to 4000+ AIDS patients, which likely saved many lives. Second, she sought the support of the FDA’s Advisory Committee on Ineffective Drug Products in a January 1987 meeting, which would symbolically back up the FDA’s decision to approve AZT on the basis of a single prematurely ended clinical trial. This would achieve two contradictory goals: the rapid release of a likely effective drug to suffering patients; and satisfy the consumer-protection and public-health voices that generally urged caution.

Thus, even before much of the publicized anti-FDA activism, the FDA had demonstrated flexibility and speed in approving AZT. However Larry Kramer, a prominent playwright and activist in the gay community, viewed this as grossly inadequate, and penned a 1987 essay in the NYTimes attacking the FDA. Carpenter is skeptical of Kramer’s specific claims: 

Kramer’s essay is shot through with inaccuracy and hyperbole. Of the therapies he mentions, only ddC (zalcitabine) emerged as a recognizably and broadly effective treatment for HIV/AIDS in the ensuing two decades—and its development had been accelerated by the Administration at the very time that AIDS activists were expressing strong doubts about it. Furthermore, many who perceived organizational problems at the agency—including journalists at the New York Times but also the George H. W. Bush administration—saw less a malady of bureaucracy and more a deficiency of resources. Like other AIDS activists, moreover, Kramer was equating the FDA with the Reagan administration when in fact much of Reagan’s and his administration’s ignorance of or indifference to AIDS was unrelated to FDA policy or regulations… Yet for all of its shortcomings and simplifications, and indeed because of them, Kramer’s essay was politically effective because it projected a simple, accessible, and forceful threat to the FDA’s reputation. Like much of the portraiture emerging from AIDS activists, it recast the Administration in terms and symbols diametrically opposed to those fashioned by Young, Cooper, and Tabor in the review and approval of AZT. In some ways, the FDA was being cast as a generalized but faceless bureaucracy, as an inefficient, an “intransigent,” “callous,” and inaccessible organization. In other ways, it was the Administration’s very gatekeeping power—over drugs themselves (the NDA process) and over clinical trials (IND approvals)—that was under attack. By serving as a “bottleneck,” a public health agency dedicated to consumer protection was lengthening the “roll-call of death.” Instead of raising genuine and substantive issues regarding clinical trial design with AIDS drugs, the Administration was in Kramer’s depiction imposing classic “red-tape” constraints upon medical research, nitpicking research protocols, shuffling words and sentences.  

Beyond criticizing the FDA, local activists and physicians also directly subverted the traditional placebo-controlled trials: 

Doctors would lie about their patients’ previous disease status to secure patient enrollment in a trial. Activist physicians and health-care workers would examine a pill to expose its placebo content. Once a placebo was identified, activists and patients would substitute the genuine treatment for the research subject, using supplies procured underground. 

In California activist Martin Delaney ran an unofficial trial with “Compound Q”, distributing it to patients that had failed to respond to other drugs and bypassing the FDA entirely. Part of the project’s explicit aim was to push the FDA harder against its traditional approach to drug development. 

Activists like Delaney and Kramer also personalized their criticism of the FDA by singling out Ellen Cooper, the medical reviewer for AZT (and the FDA’s unofficial point-person for HIV drugs), attacking her in the New York Times and in ACT-UP manuals. The peak of activist militancy was probably the October 1988 Rockville demonstration against the FDA. More than 1000 activists gathered in front of the FDA and displayed a banner that read, “Federal Death Administration”. Of note, these protests occurred after the AZT approval. Media coverage followed the protest, and the FDA responded by hosting a press release which effectively restated the new procedures that Ellen Cooper had developed for AZT. This announcement made newspaper headlines, though activists viewed it as a publicity stunt, not as a substantive change. 

The most substantive change was probably the “Subpart E” regulation, which would allow for the possibility of a single expanded Phase 2 Trial sufficing to prove safety and efficacy for certain debilitating diseases. Again, this formalized the process that AZT had undergone, and this and other changes had actually been foreshadowed by the FDA’s behavior with cancer therapeutics. This is a recurring observation by Carpenter – phase shifts in FDA behavior are usually preceded by more subtle but similar behavior years or decades before. AZT had sped through the FDA approval process faster than any drug before – but it followed the template of cancer drugs before it. Continuity, not revolution, is the running theme of the FDA’s history. 

ACT-UP was very strategic: some elements of conservative politics had long wished for a repeal of the 1962 Kefauver-Harris Amendments, but ACT-UP made sure to maintain “organizational and rhetorical distance” from those groups, which likely preserved their credibility with other forces. ACT-UP overplayed their hand in 1991. With the looming threat of another protest, ACT-UP demanded a 30-day review of DDI, which was undergoing the reformed approval process that incorporated surrogate endpoints (CD4 counts) and a historical controls of the patient’s previous history. Though they received a letter from the FDA Commissioner in response, the approval took more than 30 days, and so ACT-UP staged another protest. It was a dud in comparison to the 1988 protest, with many fewer protesters and little media attention. 

This was likely because the FDA had neutralized much of the group’s criticisms by moving quite quickly with approvals and liberally allowing treatment INDs (which allow “compassionate use” of drugs outside of trial settings). The FDA had also begun reaching out to less militant AIDS groups and invited activists into Advisory Committee meetings. In a move reminiscent of how the FDA recruited prestigious academics in the 1950s and 1960s, the FDA waved the “carrot” of being a (partial) insider to neutralize opposition. Another factor may have been a changing media narrative that argued (apparently without evidence) that Reagan-era cuts were the reason for FDA slowness, which exonerated the FDA of blame.

The unofficial buyer’s clubs popularized in film were treated deferentially by the FDA in comparison to Laetrile sellers decades before. It tread lightly, likely in fear of invoking the “FDA as policeman” image. 

Something inconvenient for the libertarian and AIDS activist critique of the FDA was the “medical reversal” on the DDC/DDI/AZT combination therapy. After DDC and DDI were approved in 1992 on the basis of surrogate endpoints showing boosted T-cell counts, follow-up studies failed to show benefit relative to AZT alone, and the combination was more toxic than AZT alone. This led to an internal debate in the AIDS-treatment-activist sphere. Here is one account, from Treatment Action Group, an organization that successfully pushed for stricter AIDS drug standards instead of continued loosening of regulatory standards. For a book-length treatment on the loosening of regulatory standards in the cancer world, and the consequences that followed, read “Malignant” by Vinay Prasad. 

1992

A less visible but likely more important event in FDA history was the Lasagna Committee, which was announced in 1988, and gathered many of the FDA’s critics. 

Rhetorically, Administration personnel claimed from the late 1980s onward (with great plausibility) that drug review delays were primarily a matter of staffing. Internally, FDA leaders looked at the oncology drug division as an exemplar of what quick NDA review could look like, as many of its reviews were completed in less than a year. Oncology drug reviewers were quietly transferred to the anti-viral division, and new medical reviewers were hired. In the late 1980s and early 1990s, drug review times for new molecular entities – perhaps the single most important quantitative measure on which the Administration was judged in pharmaceutical politics – began to decline appreciably

In 1992 FDA Commissioner David Kessler, patient advocates, pharma industry representatives, congressional committee chairs, and President Bush’s staff agreed to the Prescription Drug User Fee Act, which informally bound the FDA to review time goals and effectively taxed drug companies per drug application. To the degree that FDA staffing was the rate-limiting step on drug approval, this would speed approval, but critics said it eroded the FDA’s willingness to push back against shoddy drugs. I am not sure how to evaluate that claim, but I don’t understand the mechanistic claim – the user fees tied the FDA to a review timeline, but it didn’t mandate approval or penalize rejection. Carpenter writes that it might have eroded FDA culture by tying it financially to pharma, but this seems somewhat implausible, because it did not tie funding to any drug in particular, or any particular target of “X% of drugs must be approved”. 

FDA in the 2000s

Briefly, the FDA in the 2000s has been described as becoming increasingly lax on drug approval, particularly in cancer. This is covered in-depth in Malignant by Vinay Prasad. The Vioxx scandal, in which Merck was viewed as having concealed the fact that patients taking Vioxx were experiencing higher rates of cardiovascular complications, and in which the FDA seemed to take quite a long time to remove Vioxx from the market, also damaged the FDA’s reputation. In 2004 the FDA was widely viewed as having ignored science for political reasons when it kept Plan B (emergency contraception) prescription-only instead of making it OTC. Here is one perspective on that.

Scott Gottlieb, who had been a high-level FDA official before being Commissioner but also worked for the AEI (the leading think tank criticizing the FDA), had been anticipated to be a highly de-regulatory FDA Commissioner. I can’t find sources for this claim, but my impression is that Gottlieb has generally acquired a good bipartisan reputation and did not oversee a radical shift in FDA direction. He also won praise for moving somewhat aggressively against flavored vapes, which are widely viewed (rightly or wrongly) as a growing public health threat. 

Lessons Learned

Approval is Final

Because approval of a drug is so symbolically powerful, and effectively stakes the FDA’s reputation to a given drug, the FDA only does so very deliberately. It is a social technology that reduces the immense complexity of an IND application (consisting of clinical trials, endless manufacturing and absorption data, etc.) into a binary YES/NO that physicians and nurses can rely upon. Reversing a decision is reputationally damaging, and the FDA has occasionally faced criticism from consumer-protection groups and even internal FDA employees that it is too unwilling to withdraw unsafe drugs from the market. This is problematic when drugs are approved based on surrogate endpoints instead of clinical endpoints, or when safety problems emerge after approval, as with Vioxx. 

Carpenter comments on this: 

It is interesting in light of these conflicts that, in the wake of the Vioxx tragedy of October 2004, higher FDA officials (including many long-term careerists) engaged in an organizationally motivated embrace of the status quo by defending randomized controlled trials and by disparaging pharmacoepidemiology. For different reasons, Deputy Commissioner Scott Gottlieb, CDER officials Sandra Kweder, Robert Temple, and others did not want to cede more control of the pharmaceutical market to David Graham and his colleagues at ODS. Yet it was also an extension of the familiar, an area where the agency had already developed capacity. Clinical trials have advantages when they are randomized and placebo-controlled. They also have drawbacks. Often tests are done on homogeneous patient populations, among patients who differ in many ways from the patients who will utilize the drugs in clinical situations. Clinical trials usually have an endpoint, and can often be too brief to allow analysts to detect whether the drug is inducing adverse events, particularly for toxicity, hepatotoxicity (or liver damage), and cardiovascular outcomes. 

On Pressuring the FDA through Reputation

The FDA is responsive to both reputational and political pressure. The former is best thought of as arguing with the FDA on its own ground, which can be done from multiple perspectives. Patient advocacy groups can push the FDA to approve cancer drugs on less evidence; “thought-leader” physicians can sing the praises of an innovative drug and call the FDA slow; FDA whistleblowers can testify before Congress that the FDA is too deferential to pharma; consumer-protection groups can call the FDA’s approval based on a surrogate endpoint “reckless”. All these approaches seek to push the FDA in one direction or another, but fundamentally accept the legitimacy of the FDA and especially in the case of those pushing for more regulatory caution, hearken back to some idealized version of the FDA as a rhetorical device. In the early 2000’s, as the FDA was perceived to have relaxed its regulatory standards, especially on cancer, this occurs more often, with long-time FDA critics like Sydney Wolfe unfavorably compared the current FDA to the old FDA.

A recent example of reputational pressure was Eric Topol’s open letter to the FDA in October 2020 that criticized the emergency approvals of convalescent plasma, hydroxychloroquine, and remdemisvir, and pressured the FDA Commissioner to delay approval of a Covid-19 vaccine. Though many have criticized his actions, its method is illustrative: Topol, who has immense reputational power in academic medicine through decades of leading large clinical trials, publicly attacking Merck during the Vioxx scandal, and having critiqued the FDA in the past for its lack of action on Vioxx, was well-positioned to push the FDA to be more cautious. In addition, the emergency approvals Topol criticized (with the possible exception of Remdemisvir, and maybe Convalescent Plasma if you play with subgroup analysis….) seemed to have been regulatory bets that did not pan out, which left the FDA in a weak position. The politicization of hydroxychloroquine in particular made Topol’s arguments extremely appealing among the reputational audience (large medical journals, elite media, etc.) that the FDA caters to, which all dislike Trump. The combination of a weakened FDA and a strong attacker were the likely reasons for Topol’s success (and in the view of Alex Tabarrok and many others, the rest of the US’s disaster, since any delay in vaccine approvals likely cost many lives). Here an in-depth read on this. 

The pro-regulatory counter to the previous paragraph is that vaccine approval was only an obviously good idea in retrospect and that vaccine hesitancy would rise with a rushed process. I think both of those claims are wrong, and I think Ezra Klein argues this well in a recent piece. 

Political Pressure

Political pressure takes the form of more direct action: Congressional committees can ask FDA officials to justify their actions and have public hearings that embarrass an agency that prefers less public attention. They can threaten FDA funding and if they’re playing hardball, threaten legislative action that directly alters FDA authority.  

The challenges to FDA practice which resulted in sustained reform are those that combine both approaches, along with policy solutions that can be proposed at the right political moment. Conservative think tanks had long wished to tie some FDA funding to drug approvals and hold the FDA to a deadline and when conservatives made sustained and substantial gains in the 1980s and 1990s, the FDA, first informally and then through legislative change, moved in that direction. 

Sustained media attention also seems to be important for pushing the FDA, but is not essential. The NCI-FDA disputes were not as high-profile as the 1980s AIDS activism but effected reform that was just as important.

An important but vague “audience” that the FDA defers to is the medical community as a whole. This might be thought of as the “elite consensus” in medicine. By directly incorporating respected medical scientists and doctors onto Advisory Committees, the FDA accedes to this audience but also partially neutralizes it. Pharmaceutical companies seek to use this in their favor as well by recruiting big-name academic stars to head clinical trials or research divisions and thereby “borrow” some of their reputation. A sustained critique of the FDA from these directions would also likely be a powerful pressure. For instance, if Advisory Committees repeatedly disagreed with the FDA in one direction, they could likely shame it into changing course.

Theoretically this might be strengthened if a sitting Congressman/woman then called a hearing to directly ask FDA officials about controversial decisions or if sympathetic media ran pieces highlighting this discrepancy. This would be a direct reputational attack on the FDA and a veiled political threat because it would raise the specter of legislative reform of the FDA with enough political attention.

Regulatory Caution is Often Proven Right

As disappointing and non-contrarian as it is to agree with a large, slow-moving government bureaucracy, my impressionistic summary of Reputation and Power along with background knowledge from Ending Medical Reversal and Malignant is that the FDA has usually been proven right in its caution. Approvals based on surrogate endpoints sometimes work, but in Malignant Vinay Prasad makes a strong argument that this often doesn’t speed approvals and that a substantial number of drugs approved on surrogate endpoints are never properly followed up on. Low regulatory standards in cancer drugs have led to a proliferation of low-value treatments approved on the basis of surrogate endpoints that don’t predict clinical (a.k.a. useful) endpoints and that may not actually provide any benefit outside of carefully selected clinical-trial participants. (Editorial Note: For a counterargument, see this post and linked SSRN article on “Type II” errors at the FDA). 

A full argument that strict regulation is required for medical innovation is too long for this paper, but Ending Medical Reversal is an excellent argument along these lines. Here is a summary of it. I fully agree with Cowen and Tabarrok that the FDA was far too slow during COVID-19, but I think the libertarian critique of the FDA (usually) goes too far. 

The FDA is More Powerful Than You Think

– Apart from holding pre-market approval power over a drug, the FDA also intensely regulates drug experimentation in the first place. It also regulates drug labeling. By virtue of regulating a drug’s intended use (which has substantial effects on insurance coverage) it also informally regulates medical practice in general. And in a decentralized fashion, by being able to disqualify Institutional Review Boards (IRBs), it also regulates clinical research on a fine-grained level.

This IRB-mediated power means the FDA can effectively ban individual physicians or entire institutions from research. 

To the degree that overly-cautious IRB’s (who are in turn fearful of FDA attention) constrained Human Challenge Trials, this seems like an under-appreciated cost of the FDA and one that has not previously faced any sustained challenge. The lack of a constituency that is visibly harmed by overly cautious IRBs makes developing political pressure on this more challenging, but this seems valuable. 

The FDA and COVID-19 Vaccines

As a thought exercise, it is worth considering what a successful attack against Topol on the vaccine delay question might have entailed. Academic stars in medicine that argued for faster vaccine approval, in contradiction to Topol, would have been rhetorically effective. A less politically polarized COVID-19 response in general would have neutralized the specific anti-Trump claims that Topol made. 

Not being in an election year and so proximal to November 2 would have removed the incentive for anti-Trump individuals and institutions to view an early vaccine approval as a Trump victory and likely alleviated some concerns that the vaccines were being “rushed through.” Elite media that favored faster approval and that continually raised vaccine approval salience would not have so favorably amplified Topol’s open letter. 

There were some prestigious names contra Topol on vaccines like Walid Gellad but few or none with Topol’s star-power and connections. The prominent economists who pushed for faster approval were all, fairly or not, associated with a deregulatory perspective, which likely made their arguments less credible to the FDA. If the FDA had not burned their credibility on hydroxychloroquine early on, they would have been less vulnerable to Topol’s reputational attack. The somewhat Rationalist-aligned academics and institutions that consistently pushed for vaccine approval and human challenge trials have no cachet in the medical community, and so cannot effectively engage in this reputational battle as insiders. 

Willy Chertman is a 4th-year medical student at University of Miami who studied biology and political science as an undergraduate at the University of Miami. When not in school, he reads and tweets about medical research and health policy at @willyintheworld and on substack at https://willyreads.substack.com.

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. If you like his content, check out his website and subscribe to his newsletter on Substack.

To Maryland Governor Larry Hogan: Liberate Vaccine Doses from the FDA! – Article by Dan Elton and Edward Hudgins

To Maryland Governor Larry Hogan: Liberate Vaccine Doses from the FDA! – Article by Dan Elton and Edward Hudgins

Daniel C. Elton, Ph.D.
Edward Hudgins, Ph.D.


Note from the Authors: This was an op-ed we wrote in the first week of February 2021. Unfortunately, no newspaper wanted to publish it. We first submitted it to the Baltimore Sun, which promptly turned it down. We then submitted it to the Capitol Gazette, The Washington Times, and The Washington Examiner but never heard back from any of them. Sadly, this op-ed is just as relevant today as when we first wrote it almost two months ago. Since it was written, the evidence for the safety and efficacy of the AstraZeneca vaccine has only gotten stronger. An observational study of millions of people in Scotland published in early March found that a single dose of the AstraZeneca vaccine offers ~94% protection against hospitalization, outperforming Pfizer’s vaccine, which offered ~85% protection. Last week AstraZeneca reached an endpoint in the Phase III trial in the United States that the FDA requested, finding an efficacy of 76%, very similar to the previous Phase III trial result (70%). Despite all this, there has been no action from the FDA,and millions of AstraZeneca doses remain languishing in factories in Baltimore, Maryland and West Chester, Ohio as thousands of American taxpayers that are desperate for them die every day.

~ Daniel C. Elton and Edward Hudgins, March 31, 2021


If Maryland Governor Larry Hogan acts immediately and decisively, he can save thousands of Marylanders from suffering and death from COVID-19. A facility in Baltimore produces the very effective AstraZeneca vaccine and has stockpiled millions of doses. But the U.S. Food and Drug Administration, headquartered in suburban Maryland, which must certify all vaccines and medical treatments before patients can reap their benefits, is holding those doses hostage to its antiquated, bureaucratic red tape. Hogan should act now to liberate the vaccine to save the lives of Marylanders.

Over a year into the pandemic, over 8,200 Marylanders have died, and some 410,000 have suffered from COVID-19. Marylanders have suffered from a chronic shortage of the FDA-approved Pfizer and Moderna vaccines. AstraZeneca is approved in the E.U. and 19 other countries. So as our morgues fill up, what’s the FDA’s excuse for delay?

The AstraZeneca vaccine has passed Phase I and Phase II efficacy trials, which were published in the medical journal The Lancet in July and November 2020. A Phase III peer-reviewed study that was conducted in three other countries indicates the vaccine has an efficacy of 70 percent, ranging from 62 percent to 90 percent with different dosages. Most importantly, the vaccine showed a 100-percent efficacy at preventing COVID-19 hospitalizations and deaths. The AstraZeneca vaccine was also the first shown in a scientific study to reduce transmission. And unlike the two already-approved vaccines, it requires only regular rather than ultra-cold refrigeration. It has been given to over one million people in the U.K. without safety issues detected, yet FDA has requested that AstraZeneca redo most of their Phase III trials using patients from the U.S.

Some media outlets have reported that AstraZeneca’s vaccine “may not work” in the elderly. Unfortunately, AstraZeneca’s Phase III data published so far does not allow for efficacy to be determined for those older than 65. However, Phase I & II trials showed a similar immune response after the second dose across all age groups, including those over 65, so there are good reasons to believe the efficacy should be similar for the elderly. Even if the efficacy is much lower, because the elderly are at such high risk it still makes sense to give them the vaccine in order to save lives. This was shown clearly by Oxford bioethicists Jonathan Pugh and Julian Savulescu, who ran some numbers to show the grave consequences of denying the vaccine to the elderly. It is also true that recent results show the AstraZeneca vaccine is not very effective against the South African variant at preventing mild forms of COVID-19. However, the current study only addressed mild illness and AstraZeneca’s vaccine gives a similar immune response to Pfizer’s vaccine, which has been shown to protect strongly against hospitalization from the South African variant. The World Health Organization recently released guidance recommending the rollout of the vaccine not be halted due to this finding and that the vaccine be given to all age groups. 

The U.S. government has already contracted for 300 million doses of the vaccine, costing taxpayers over $1 billion. Yet with thousands dying daily and many more suffering from COVID-19 across the county, the FDA projects they won’t approve the vaccine until late April.  

Since FDA won’t certify the AstraZeneca vaccine immediately, Governor Hogan should act. He might invoke emergency authority to simply take possession of enough of the AstraZeneca vaccine supply in the Baltimore factory producing it to meet Maryland’s needs. But this would likely be unnecessary. He should request that the facility release the vaccine and inform them that the state will likely be able to guarantee no adverse repercussions from the FDA. After all, during the past decade over 40 states passed “Right To Try” laws that allowed terminally ill patients to access safe treatments not certified by FDA for efficacy. The only “repercussion”: in 2018 Congress passed bipartisan legislation, signed by President Trump, recognizing the state’s authority to do so. 

But in parallel, Hogan should call on President Biden to issue an executive order suspending the need for final FDA certification in this exceptional case.

Or Biden, backed strongly by the Maryland Congressional delegation, could request Congress pass emergency legislation creating a Free To Choose Medicine track parallel to FDA’s normal, slow certification process, on which COVID vaccines, tested safe and promising in Phase II or III trials, could be accessed by individuals, with informed consent. Such a track was created in 1992 for AIDS treatments, saving the lives of thousands of sufferers.

Or Biden could request Congress pass a reciprocity law certifying for the use of Americans any COVID treatment approved  in other advanced countries. Rep. Chip Roy (TX-21) and Sen. Ted Cruz, (R-TX) have introduced legislation allowing for reciprocal approval of drugs approved in other trusted countries. This proposal could be focused to allow access to COVID vaccines.

Since AstraZeneca is produced in Maryland and the FDA headquarters is also in Maryland, Hogan is in an ideal position to be the hero, shake things up, and break the bureaucratic walls separating citizens from a lifesaving medication.

If you agree that Hogan should act now, please sign this petition on Change.org:
Larry Hogan : Liberate the AstraZeneca vaccine from the FDA!

Ed Hudgins is founder of the Human Achievement Alliance and a science policy researcher.  He can be reached at ehudgins@humanachievementalliance.org. Dan Elton is  Director of Scholarship at the US Transhumanist Party.  You can reach him via direct message on Twitter (@moreisdifferent).

USTP Director of Scholarship Dan Elton’s Letter to the FDA’s Vaccine Committee Meeting on the Emergency Use Authorization of the Johnson & Johnson Vaccine

USTP Director of Scholarship Dan Elton’s Letter to the FDA’s Vaccine Committee Meeting on the Emergency Use Authorization of the Johnson & Johnson Vaccine

 

Daniel C. Elton, Ph.D.


The public can comment on the FDA’s committee meeting tomorrow (February 26th) to discuss the Emergency Use Authorization for the Johnson & Johnson / Janssen vaccine candidate. Members of the public can submit comments via an online system here or via the mail. Attached is my letter. The main theme is transparency.  

 

To the VRBP Advisory Committee:

I am writing to request the FDA exhibit full transparency and show their cost-benefit calculations which justified such a long delay in approving the J&J/Janssen vaccine. Taxpayers deserve decisions that are made on the basis of rational cost-benefit analysis informed by the best science and data available. There is an incredible fog around key decisions that have greatly affected Americans during the COVID-19 pandemic – such as the FDA’s decisions that made it hard for at-home tests to be approved, HHS & FDA decisions not to pursue or support human challenge trials, and the FDA’s deadly decision to delay approvals of life-saving vaccines, most shockingly the AstraZeneca vaccine. With 2,000 – 3,000 Americans dying every day and millions of Americans desperate for life-saving vaccines (as evidenced by long lines across the country) it is only fair that taxpayers know the reasons for the FDA’s delays.

In a relentless pursuit of safety the FDA has ironically ignored the greatest safety concern to the American people – the SARS-CoV2 virus, and many have died needlessly as a result. Beyond normal expected utility based utilitarian calculations, the proactionary principle(s), developed by philosopher Max More and extended by Steve Fuller and others provide a good blueprint for conducting rational cost benefit analysis. It is my belief that the procedures the FDA have used to decide if and when to approve this vaccine have not utilized even the most rudimentary cost-benefit analyses, and lives have been lost as a result. I am open to changing my mind, however, if the FDA can produce a cost-benefit calculation that informed their decision making.

The interim Phase III collection period for the Janssen vaccine ended January 22 and they submitted their EUA application on February 4th. The American people have had to wait 22+ days for the EUA to be granted. Between February 4th – 26th, around 52,500 Americans will have lost their lives to COVID-19 (extrapolating the death rate forward 2 days from February 24th). In that time, countless others will have suffered under the ravages of the disease and the numerous sequela of “long COVID”. Even among those who have been lucky enough not to have their bodies invaded by the virus, most have suffered brutal economic and psychological effects from the pandemic.

As economist Tyler Cowen points out, it is a fallacy to think that manufacturing is the main bottleneck to getting life-saving vaccines to American people. Millions of doses of both the Pfizer and Moderna vaccines were available when the FDA finally approved them, showing that FDA approval was a larger constraint than manufacturing. While J&J may not have as many vaccines produced by February 26th as Moderna & Pfizer did at their EUA, if an expectation of an earlier EUA had been set by the FDA the company would have had a stronger incentive to ramp up production. It is incorrect to view the manufacturing and approval as independent – both are linked, with the timeframe set for one affecting the timeframe for the other. In economic terms, the elasticity of manufacturing to demand is not zero. Production of J&J’s vaccine began long ago so they could provide vaccines for their Phase I/IIa trial which began on July 22, 2020. While the company has faced production setbacks, a GSA report (GAO-21-265) estimates they will have 2 million doses available on February 26th.

The government of South Africa announced on February 10th that they would start administering the J&J vaccine to frontline health care workers. Now imagine if the FDA had made the J&J vaccine available just two weeks prior and assume that 2 million doses could therefore be distributed two weeks earlier as a result. At the current monthly rate of deaths, the average american has a 1/9,410 chance of dying from COVID-19 every 2 weeks. The risk of dying from the J&J vaccine, by contrast, based on the Phase I/II data and our prior knowledge about similar vaccines, is at most 1/1,000,000 (likely an overestimate). Assuming the vaccine is 100% effective at preventing death from COVID-19 (a safe assumption based on the current science), delivery of 2 million J&J vaccines 2 weeks earlier could save 212 lives and reduce suffering in many more. However, this number is obviously an underestimate because the vaccines will be distributed to the elderly and those with pre-existing conditions first, who have a 10x – 100x higher chance of dying from COVID-19 than the average American. So, the true number of lives that would have been saved is in the ballpark range 2,120-20,120.

The FDA’s decision to delay approval of the AstraZeneca vaccine by demanding additional American Phase III trial participants represents an even more egregious decision which surely cost thousands of Americans their lives. To be respectful of the purpose of the meeting at hand, however, I have restricted my discussion here to the J&J vaccine alone.

I ask that the FDA produce a cost-benefit analysis and clearly explain the reasons for the following decisions:

  • The reason the FDA did not allow the J&J vaccine to be made available via the FDA’s Expanded Access Program after excellent Phase I/II safety & immunogenicity data was published The Lancet on January 13th, 2021. (side note: see this article in STAT)
  • The reason the FDA did not recommend and/or advocate that those with a high risk of dying from COVID-19 obtain the J&J vaccine via the Right-to-Try pathway prior to EUA.
  • The reason the FDA, in October, created a requirement for a median 2 month follow up period in Phase III trials.
  • The reason the FDA decided not to recommend J&J use challenge trials to demonstrate the efficacy of their vaccine in a faster manner.
  • The reason the FDA decided not to allow pre-distribution of the J&J vaccine prior to EUA to speed up distribution.
  • The reason the FDA did not implement rolling reviews for the J&J vaccine.
  • The reason the FDA decided it needed 22 days to review J&J’s EUA application.

For each point, a cost-benefit calculation should be provided including a list of costs and benefits to the action vs the opposite action, ideally expressed in terms of quality-adjusted life years (QALYs) saved or lost.

Finally, I ask that in their communications and messaging the FDA focus on the efficacy of the J&J vaccine against hospitalization and death, especially against the South African variant, so Americans are informed first and foremost about the most important benefits of this vaccine.

Respectfully,
Daniel C. Elton, Ph.D.

 

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. If you like his content, check out his website and subscribe to his newsletter on Substack.

A Polite List of Requests to the FDA – Article by Dan Elton

A Polite List of Requests to the FDA – Article by Dan Elton

Daniel C. Elton, Ph.D.


A List of Requests to President Joseph R. Biden, Jr.,
HHS, FDA, and Congress: 

Approve the following vaccines for emergency use immediately: 


Give people the right to try the following vaccines: 

Seriously study and consider these actions: 

  • Allow hospitals and pharmacies to start stockpiling unapproved vaccines so they can be rapidly disseminated upon approval. 
  • Allow Moderna to give fractional doses. Data from Moderna’s clinical trials have illustrated that people between ages of 18 and 55 who received two 50-microgram doses showed an identical immune response to the standard of two 100-microgram doses.
  • Allow all age groups to get the vaccine. Research published in the journal Science indicates that as of October 2020, “individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one”. Thus, targeting vaccines at these groups may accelerate the end of the pandemic and save more lives than continuing to restrict the vaccines to the elderly and vulnerable.
  • Consider making “First Doses First” national policy.


The FDA has not moved fast enough given the gravity of the situation we face. Consider the following: 

  • Pfizer sent its paperwork to the FDA on November 22, 2020, but rather than immediately convening its panel of experts, the FDA scheduled a review meeting for December 10. During that three-week wait, 27,000 Americans died of COVID-19. According to Dr. Marty Makary, a professor of public health policy at the Johns Hopkins Bloomberg School of Public Health who has conducted over a hundred clinical studies during his career, the FDA “could have done the approval in 24-48 hours without cutting any corners”.  The slow rollout that followed after the FDA approved the vaccine on December 11 was not due to delays in production – Pfizer had millions of doses produced and sitting in cold storage at the time of the approval. 
  • While Americans were waiting for the Pfizer vaccine that millions of their taxpayer dollars had been invested in, the FDA went dark for 4 days during the Thanksgiving holiday, with almost all of its 17,000 employees taking that time off, including those working on critical COVID-19-related work. 
  • Moderna sent its paperwork to the FDA on November 30, 2020. As with the Pfizer vaccine, the FDA needlessly delayed the approval by scheduling the review meeting for December 17. 
  • The FDA’s equivalents in the EU, Canada, Switzerland, UK, Israel, and Singapore all use rolling reviews, evaluating data as it becomes available for the sake of efficiency. The FDA does not. 
  • The Sputnik V vaccine was approved September 4, 2020, over 150 days ago. In a paper in The Lancet, phase III results indicate it has an effectiveness of 91.6% and excellent safety profile. 
  • China began administering the CanSino Biologica vaccine to its military in June after Phase I and Phase II clinical trials established safety and immune response. (The phase II results were published in The Lancet on July 20th, 2020). China approved the vaccine for their public on December 24, 2020. 


Here’s what public-health experts are saying:
 


“The F.D.A. needs to catch up to the science… They are inadvertently killing people by not following the science.” – Michael Mina, Epidemiologist, Immunologist, Physician, Harvard Medical School.

“We’ve gone from ‘Operation Warp Speed’ to develop a vaccine to ‘Operation Turtle Speed’ to review it… The FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine.  It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute.”Marty Makary, M.D., a professor of health policy at the Johns Hopkins University School of Medicine. 

I do think we’ve been too conservative… companies that potentially make public health diagnostic tests did not feel that there was, for example, a pathway to get those approved at the F.D.A.”Vivek Murphy, President Biden’s nominee for Surgeon General.

“We’ve already bought 300 million doses of the AstraZeneca-Oxford vaccine. We’ve paid for it — over a billion dollars — so let’s use it… I know we have some of that vaccine stockpiled.”Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and the lead developer of a COVID-19 vaccine being produced in India.


More quotes from notable public figures: 

“For years the FDA was focused on, don’t repeat thalidomide. Drugs must be safe. AIDS forced a hard reckoning. The people who are dying while you wait matter. But this is a third, even harder conceptual change. Stopping the spread of the disease matters. And the FDA does not have the years it took to make the AIDS change of mindset.”John Cochrane, Senior Fellow at the Hoover Institution. 

The new strains spread quickly. The speed of our countermeasures will decide our fate. What feels like reasonable delays in our normal experience of time — a few weeks here for Congress to debate a bill, a few weeks there for the F.D.A. to hold meetings — could lead to the kind of explosive infections that overwhelm our hospitals and fill our morgues.”Ezra Klein, co-founder of Vox.

“The US failure to authorize the AstraZeneca vaccine in the midst of a pandemic when thousands are dying daily and a factory in Baltimore is warmed up and ready to run is a tragedy and dereliction of duty of epic proportions. The AZ vaccine should be given an EUA immediately and made available in pharmacies for anyone who wants it while continuing to prioritize Moderna and Pfizer for the elderly and essential workers.”Alex Tabarrok, Bartley J. Madden Chair in Economics, George Mason University. 

“It’s amazing that not only is this vaccine (AstraZeneca) not approved, there’s no political pressure to approve it.”Matthew Yglesias, author of One Billion Americans: The Case for Thinking Bigger.

“The UK has authorized #AstraZeneca vaccine for #CV19 but #FDA won’t “because of questions about its efficacy among older people.”
Then authorize its use for younger people!
Dear FDA: Get out of the way!
Over 7,000 Americans died of CV19 in the past two days!
You are murdering us!”
– @Robert Zubrin on Twitter, author of The Case for Mars and The Case for Space.

Further reading: 

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. 

How We Can Judge the Safety and Efficacy of New Vaccines Prior to Phase III Data and Why We Must – Article by Dan Elton

How We Can Judge the Safety and Efficacy of New Vaccines Prior to Phase III Data and Why We Must – Article by Dan Elton

Daniel C. Elton, Ph.D.


A common refrain we hear from public intellectuals about vaccines prior to Phase III data is “we don’t know anything about the safety or efficacy of vaccine X”. This attitude is both false and misleading to the public, instilling uncertainty and fear about vaccines. To see why it is false, consider if a normal vaccine safety study was done, but by coincidence all of the vaccines were given in hospital rooms that were painted blue. Could we conclude on the basis of such a study whether the vaccine would be safe if administered in rooms painted red? Yes, we can, and we should. We can utilize two forms of reasoning to conclude that the vaccine is safe if given in red rooms, even though we have no data on the matter.

The first form of reasoning roughly approximates the way an ideal Bayesian statistical reasoner would function to compute what is called a “prior probability distribution”. Under this form of reasoning, we consider the millions of doses of similar vaccines (called the “reference class”) that have been administered. For instance, we might consider the vaccines developed for very similar coronaviruses like SARS and MERS.  We note that if the color of paint did affect the safety of those vaccines, this would have likely been detected over the course of prior studies and over the course of millions of doses given previously. Of course, there is a chance the correlation might have been missed. To figure out how big that is, we can go a level deeper and consider a reference class of “things people might notice or fail to notice in medical studies”. We can conclude that for prior vaccines, if such correlations existed they would generally be picked up. On the basis of this and the fact that no such correlation was ever discovered in the reference class of prior vaccines we can conclude that the probability of vaccines like the COVID-19 vaccine being dependent on the color of paint is very small. 

The second type of reasoning, which happens to be much more straightforward in this situation, is what the physicist David Deutsch calls “reasoning from our best explanation of the world”. According to the philosopher of science Karl Popper, we should reason using our explanatory theories of the world which have survived the most rounds of attempted falsification, and which have the highest degree of falsifiability (this rules out non-testable explanations like “vaccines work via invisible ghosts”). In more prosaic terms, this simply means reasoning using the best scientific theories which make predictions in the domain under consideration. We note that our best theories of vaccine function do not anywhere depend on the color of paint in the room. Instead they depend on things like T-cells, binding affinities of molecules, the concentrations of certain molecules in the body, etc. So, we decide that the vaccine is safe regardless of the color of paint in the room where it is administered. 

Both of these forms of reasoning are valid and both are foundational to science, rationality, and human progress. Both of these types of reasoning can be used to say that vaccines under development are likely to be safe and effective before any data comes in. It’s why a reporter who interviewed numerous top scientists reported that they all told him that “they expected the vaccines were safe and effective all along.” Yet instead of proudly sharing this important knowledge with the public, we rarely hear scientists say publicly that they expect the vaccines are safe and efficacious. Instead, they hedge, saying “we have to wait until the data comes in”. This is unethical both on Kantian grounds (they are lying) and on consequentialist grounds, because it leads to undue caution and the public being afraid of vaccines. 

Unfortunately, there is little incentive for scientists to tell the truth about what the likely risks and benefits are with new vaccines before full Phase III data is published. If, for instance, one or two people suffer severe side effects in a Phase III trial (which is rare, but has happened) a scientist who said they suspected it was “very safe” might receive harsh criticism for making a premature assessment. On the other hand, the same scientist will get no pushback for saying “we need to wait for data to make a judgement”. Indeed, they are likely to even be praised for exhibiting the virtues of “caution, prudence, and scientific skepticism”. Moreover, under no scenario should someone be allowed to get a vaccine until the full data comes in, even though it’s fine to allow people to sign up for studies where they have a 50-50 chance of getting the vaccine. Not very consistent, eh?

As US Transhumanist Party Chairman Gennady Stolyarov II has described in detail in an an earlier publication on this site, all of this is the result of a deeply flawed and deadly ethical principle called the precautionary principle, which unfortunately many people have fallen under the sway of. The principle originates in the environmentalist movement but is widely applied in medicine, and was instrumental in decisions such as the Bush administration’s ban on stem-cell research and decisions to ban life-saving GMO technologies such as golden rice. It has been formulated to varying degrees in several different ways. The United Nations World Charter for Nature (1982) issued one version of the principle, stating: 

Activities which are likely to pose a significant risk to nature shall be preceded by an exhaustive examination; their proponents shall demonstrate that expected benefits outweigh potential damage to nature, and where potential adverse effects are not fully understood, the activities should not proceed. 

The principle starts off OK but dives into serious error in the last line. The issue is that the precautionary principle only focuses on the potential adverse effects of proceeding and ignores the potential adverse effects of not proceeding, i.e., the effects of delay. As should now be clear in the case of the COVID-19 vaccines, not proceeding can sometimes be much more deadly than proceeding! There is often a high but unclear risk to not proceeding, and a low but unclear risk to not proceeding. (Picture two probability distributions, both wide (unclear) but one with a mean that is distinctly higher than the other). That’s where the precautionary principle throws expected utility theory (cost-benefit analysis) out and says we cannot proceed. The Nobel Prize-winning physicist Freeman Dyson stated the issue as follows: 

The Precautionary Principle says that if some course of action carries even a remote chance of irreparable damage to the ecology, then you shouldn’t do it, no matter how great the possible advantages of the action may be. You are not allowed to balance costs against benefits when deciding what to do.” — Freeman Dyson, Report from the 2001 World Economic Forum

Imagine an alternative world in which our society and government was not under the sway of the precautionary principle. In this alternative world, scientists would give their truthful assessment of new vaccines to the public, stating that they are likely safe and effective, using one or both of the reasoning methods mentioned above. In such a world, given the clear potential harms of inaction, the public would be allowed to purchase new vaccines if they wanted, if the companies manufacturing them were comfortable doing so, and if they were fully informed prior to their decision that they were taking an unapproved product that carries potential risks but also potential benefits. Initially, only a few people would purchase the vaccines, perhaps on the basis of Phase I results. These would be folks like those who injected themselves with a DIY vaccine over the summer, and the tens of thousands who were willing to participate in clinical trials as early as last spring. Companies would be incentivized to survey those who took the vaccine and collect self-reported data on their outcomes, which is very cheap and easy to do. After a few months going by without any of those people keeling over and dying, and with very few (likely none) of those people getting hospitalized for COVID-19, more people would feel comfortable getting the vaccine. Things would quickly snowball, with more and more people becoming willing to get the vaccine. During this time the distribution system would have been stood up and become operational, with on-site stockpiles building up ahead of the FDA’s Emergency Use Authorization (currently, the FDA does not allow hospitals to stockpile unapproved vaccines ahead of their EUA). To present this case in its strongest form, in a future post I plan to estimate how many lives would have been saved, assuming many vaccines had become available to those who wanted them last March or August. However, I hope it’s easy to see that thousands of lives would have been saved in this alternative world.  

For more on the transhumanist alternative to the precautionary principle, the proactionary principle, see Max More’s excellent book chapter as well as the Wikipedia article and references therein.

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. 

Reject the Deadly Precautionary Principle: Approve All COVID-19 Vaccines Immediately! – Article by Gennady Stolyarov II

Reject the Deadly Precautionary Principle: Approve All COVID-19 Vaccines Immediately! – Article by Gennady Stolyarov II

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Gennady Stolyarov II


It should be a mild relief that vaccination efforts against COVID-19 are finally beginning in the United States, but they are beginning eleven months too late, while the pandemic surrounds us and most of us must wait months longer to receive vaccinations. Over 300,000 Americans have already died needlessly and preventably from COVID-19; hundreds of thousands more are likely to die in the coming months, even though the exact same vaccine from Moderna that is even today still undergoing Food and Drug Administration (FDA) review already existed in its current form by January 13, 2020. As David Wallace-Wells writes in New York Magzine, in an article entitled “We Had the Vaccine the Whole Time” (dated December 7, 2020):

You may be surprised to learn that of the trio of long-awaited coronavirus vaccines, the most promising, Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public in an act of scientific and humanitarian generosity that resulted in China’s Yong-Zhen Zhang’s being temporarily forced out of his lab. In Massachusetts, the Moderna vaccine design took all of one weekend. It was completed before China had even acknowledged that the disease could be transmitted from human to human, more than a week before the first confirmed coronavirus case in the United States. By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial. This is — as the country and the world are rightly celebrating — the fastest timeline of development in the history of vaccines. It also means that for the entire span of the pandemic in this country, which has already killed more than 250,000 Americans, we had the tools we needed to prevent it.

As has been demonstrated time and again during this pandemic, scientists and doctors have been the true heroes in their rapid and immensely creative responses, whereas institutions and their processes have failed massively, and our egregiously broken society and culture have precipitated abysmal mass-scale reactions and behaviors as well. But the major reason why now almost 300,000 Americans died who did not need to die at all, is the Precautionary Principle – a cornerstone of contemporary “bioethics” which is, in fact, deeply unethical. The Precautionary Principle is the fundamental reason why new medical treatments, including vaccines, are required in the United States to undergo extensive safety and efficacy testing before they are allowed to be provided to patients, even willing patients who may knowingly accept the risks of experimental medicines. Essentially, unless safety and efficacy can be rigorously demonstrated first, along with a sufficient lack of adverse consequences, adherents of the Precautionary Principle believe that no action should be taken to implement an innovation. Those who espouse the Precautionary Principle completely ignore, of course, the costs and risks of inaction – which, in the case of a global pandemic, can be measured in more than 1.62 million lives worldwide, but which have also resulted in far greater numbers of deaths from more “routine” otherwise terminal illnesses, whose victims might have been saved by new treatments whose approval the FDA delayed, sometimes for a decade or more while billions of dollars were spent on hyper-expensive efficacy testing.

While laudable efforts were made in the United States to greatly accelerate the review timeframe for COVID-19 vaccines – hence the now well-known “Operation Warp Speed” – those efforts did not come in time for the hundreds of thousands who died and the hundreds of millions who now live in fear of death every day as the pandemic’s spread has become all-encompassing. Cutting the approval timeline from the typical unconscionable 4-5 years to 9 months is an improvement, but not nearly enough. Much more should have been done right away. Approval for the vaccines should have been granted as soon as they were developed, and instead of putting review roadblocks in the way, governments should have actively aided in vaccine production and distribution of all serious candidate vaccines from day one.

While New York Magazine’s David Wallace-Wells made the seemingly obligatory (during this tragically precautionary era) disclaimer that “To be clear, I don’t want to suggest that Moderna should have been allowed to roll out its vaccine in February or even in May, when interim results from its Phase I trial demonstrated its basic safety” (and Wallace-Wells still faced considerable vitriol for the quite modest observations he sought to make) – I do want to suggest exactly that. Indeed, I would go further and insist that it was a moral imperative to approve and facilitate the mass production and distribution of vaccines such as Moderna’s mRNA-1273 to willing members of the general population as soon as those vaccines were available.

Transhumanists reject the Precautionary Principle and instead follow the Proactionary Principle, which, per the description of Max More (Extropy Institute, 2004), “urges all parties to actively take into account all the consequences of an activity – good as well as bad – while apportioning precautionary measures to the real threats we face, in the context of an appreciation of the crucial role played by technological innovation and humanity’s evolving ability to adapt to and remedy any undesirable side-effects.” The Proactionary Principle does not ignore the potential for adverse consequences of an activity, but recognizes that there are situations when the benefits can greatly outweigh any potential adverse effects.

Imagine how, in an alternate history, a Transhumanist administration would have dealt with the COVID-19 crisis. Suppose, for instance, that Zoltan Istvan had been elected President in 2016 and thus was the President who faced the COVID-19 pandemic in 2020. Or suppose that Charlie Kam, the U.S. Transhumanist Party (USTP) Presidential nominee in 2020, had held the country’s highest executive office. The U.S. Transhumanist Party Platform contains 21 sections specifically addressing COVID-19 responses – proposals that were adopted by USTP members in late March 2020, and would have saved most of the lives of the COVID-19 victims had they been expeditiously implemented by governments. These proposals, indeed, are applications of the Proactionary Principle to the COVID-19 pandemic. Section CIII of the USTP Platform specifically states that “The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable.”

This is exactly what would have been done by a Transhumanist administration with the Moderna, Pfizer, AstraZeneca, and any other vaccines, including do-it-yourself experiments such as that undertaken by Josiah Zayner. The Transhumanist administration would have asked the vaccine developer one question: “Do you intend to apply this candidate vaccine in an ethical manner when offering it to the general public?” After giving an affirmative answer to that question, the vaccine developer would have the full legal right to test, give away, or sell its product to any volunteers capable of giving informed consent – provided that the recipients understood that the vaccine was experimental and had not passed the typical safety and/or efficacy tests. Receiving any vaccine would always remain entirely voluntary. Individuals who were uncertain or concerned about side effects – or even motivated by pseudoscientific, anti-scientific, or religious objections – would maintain the right not to get vaccinated. However, those who chose to get vaccinated would be shown clearly and quickly to have far lower incidence of COVID-19, and the statistical disparity in infection rates between the vaccinated and the un-vaccinated would grow too large in just a few months for reasonable people to ignore. Those who become vaccinated would be free to lead their everyday lives and participate in economic activities as usual, and massive disruptions to the economy and to people’s livelihoods would have been completely avoidable. The multifaceted advantages of vaccination under this approach would become abundantly clear in a relatively short time.

Testing would not be eliminated by the Transhumanist administration. Indeed, it would be accelerated and fully funded via the $100 billion emergency package (and likely via other resources as well), so that vaccine developers would need to pay absolutely nothing out of pocket for any compliance with testing protocols. However, testing would occur in parallel with mass distribution of the vaccines, and as much data as possible would be collected from vaccine recipients in the general population, to greatly augment the samples of tested patients. If any specific side effects manifested themselves in a statistically significant portion of the population, protocols for administering the vaccine would be adjusted in real time. For example, if a specific group of people were found to be particularly vulnerable to certain side effects, members of that group would quickly receive additional disclosures and warnings and would be able to make informed decisions in light of this information.

Could there conceivably be adverse side effects or even deaths of certain patients under this approach of mass distribution in parallel with testing? Of course, that is a possibility. However, the scale of such side effects and deaths would surely be orders of magnitude less than the all-encompassing devastation that the current sequential review-and-approval process has allowed to happen. So far nobody has died specifically from any COVID-19 vaccine. At least 1.62 million people in the world have died from COVID-19. Numerous others have died because of the fallout of the restrictive measures taken to contain the spread of COVID-19. Even if the vaccines had been far more dangerous than they actually are, it is absolutely impossible for them to have caused anywhere near the death toll inflicted by the disease itself and the societal havoc that it and responses to it have wreaked. This basic insight, whose evidence is all around us, is precisely what the Precautionary Principle misses. By placing all of the burden of proof on the innovation, the Precautionary Principle gives a free pass to the wantonly murderous status quo. Inaction is not safety. Inaction is quite frequently the greatest danger – and at no time is that truer than during a global pandemic. If we do nothing, any of a vast array of perils will befall us rather quickly.

The United States has already lost more people to COVID-19 than it had to all but one of its historical wars. The novel coronavirus is the enemy here to be sure, but the Precautionary Principle is an even more pernicious and insidious foe. The Precautionary Principle is responsible for the hundreds of thousands of American dead just as much as the novel coronavirus itself, since it prevented an implementation of an existing off-the-shelf solution that could have saved the vast majority of their lives. Every war in history has resulted in unacceptable death tolls because of fundamentally flawed premises – ideas and practices that brought about the war because people accepted them as commonplace and justified. Slavery, religious intolerance, jingoistic nationalism, and totalitarianism have all stemmed from deep moral errors that caused colossal loss of life – and fortunately most of humanity has recognized the great evil that these notions entail and has resoundingly rejected them. The Precautionary Principle, when implemented in institutions that have the power to make life-or-death decisions, is in that same league of moral errors; it will be remembered decades and centuries hence as the greatest destroyer of lives in our epoch.

How much senseless loss of life needs to occur before we recognize that our institutions, based on the Precautionary Principle, are wantonly negligent in allowing our fellow humans to die and are still withholding life-saving solutions from them? It is time to reject the Precautionary Principle once and for all and to institute the truly humane policy of allowing all rationally capable individuals to assess the risks and benefits of emerging medical treatments for themselves. This would not only save colossal numbers of lives in the immediate term, but also greatly accelerate medical discovery and technological progress – since innovators would be able to obtain data rapidly and iterate upon their approaches. The arrival of cures for cancer, dementia, diabetes, and biological aging itself will depend on how free medical innovators are to offer their treatments and how free patients are to accept them. Extensive and expensive pre-distribution review processes kill many more people than they save. End them now!

Gennady Stolyarov II is the Chairman of the United States Transhumanist Party. 

Breaking the Bottleneck: A Synergy of Technology and Medicine – Article by Zach Richardson

Breaking the Bottleneck: A Synergy of Technology and Medicine – Article by Zach Richardson

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Zach Richardson


In March of 2019, I began to have a very strange problem. I was breathing normally, but felt like I was suffocating. The problem became much worse when lying down, but seemed to come and go arbitrarily. Some days it would be really bad, and on others I didn’t even notice it. This happened twice in a week, and I checked with a doctor. He assured me I had anxiety and gave me a prescription for some anxiolytic medicine. I couldn’t breathe, and his solution was Xanax. I stupidly trusted him.

In May 2019, I ended up in the hospital. My body was turning yellow, and my liver, kidneys, and heart were failing. The cause was idiopathic; none of the 7 specialists knew why I was having congestive heart failure. A couple of drugs were tried, but in the end the only solution they said would save my life was the implantation of a mechanical device that would help my heart pump: a Ventricular Assist Device, or VAD.

I was lucky enough to be selected as a perfect candidate for a clinical trial, partially due to being particularly young for having Congestive Heart Failure (CHF). A new version of an already cutting-edge technology would be tested on my body, and the results would be recorded for their study. The machine they implanted was called the Heartmate 3, and it saved my life.

The VAD is currently used either as “bridge” or “destination” therapy, with “bridge” meaning that it is used only temporarily until one can get a heart transplant, and “destination” meaning that one is ineligible for transplant at all, and will have the VAD for the rest of one’s life. Some of the contraindications for VAD implantation being bridge therapy include being obese or over 65 years of age. Luckily, I am not either of those two, and therefore am eligible for a transplant. However, there are two factors that are going to lead to it likely being an extremely long time before a donor heart is available. One is that I am a larger man, standing at 6 feet tall, meaning I require a larger-than-average heart. The other is that I have Type O blood, which is the hardest from the standpoint of receiving an organ donation.

This puts me in a very interesting situation, where I am a young man who may have many years still ahead of him with an implanted device. It may be 7 years from now when I get the call for transplant, or it may be tomorrow. If it happens 7 years from now, there may be therapies that will have been developed that would allow me to regrow my heart, or clone one from my stem cells, and thereby avoid having to be on a cocktail of immunosuppressants indefinitely. Unfortunately, even Athersys only has CHF treatments in the preclinical stage, which means I may have to wait a while. I intensely wish those trials weren’t being constrained like they are.

Having set significant life extension towards the very top of my hierarchy of values, I am extremely grateful that I live in a society where these technologies are available to me. I have a highly personal interest in seeing a society of scientists and biomedical engineers emerge to help develop these technologies! However, part of my situation was just me getting lucky: I had the treatment I needed approved just months before receiving it, and happened to have top-notch insurance.

One unfortunate side effect of having a centralized regulatory system is that the Food and Drug Administration (FDA) is only held responsible for what are known as “Type I Errors”. A Type I error is where the FDA passes an unsafe drug or treatment, leading to harm to an individual or group. Unfortunately, this means that FDA officials do not seem to care at all about “Type II Errors”, where they do not pass a life-saving treatment or drug in time to save someone’s life. The FDA is so terrified of having another Vioxx incident, that FDA officials are overly cautious in approving the use of radically innovative and breakthrough technologies. The fact that these technologies carry some risk is something of no worry to someone who is going to die if they don’t get the treatment. It is much harder to blame the FDA for being too safe than it is to blame them for being reckless.

This is why I am proud to be a member of the U.S. Transhumanist Party (USTP), where science and technology are put at the forefront of American politics. The current bottleneck those like me with CHF face is regulatory hurdles. Article VI, Section VI, of the USTP Constitution states: “The United States Transhumanist Party upholds morphological freedom—the right to do with one’s physical attributes or intelligence whatever one wants so long as it does not directly harm others.” Right now what I and others with CHF would like to do is to get a stem-cell heart. We are being hindered not by direct legislation restricting morphological freedom, but by the far more pernicious hindrance of excessive regulatory burden. The treatments we want are being developed exponentially slower than they could be, because each step of the way has to adhere to draconian testing standards. This means a lot of Type II errors are being committed. We are not being told, “You cannot get this treatment.” Providers are being told, “You cannot provide this treatment.”

In my ideal world, regulatory agencies would work more like Underwriters Laboratories or Quality Assurance International. Leaving regulatory activity to the market, far from the fearmongering of producing dangerous and shoddy drugs and treatments, would instead invigorate the institutions as they would compete to certify the best products and treatments for consumers, since their names and reputations would be on the line.

I believe there needs to be a much stronger focus in regulatory institutions toward the elimination of Type II Errors, because there are a lot of sick people going untreated.

Zach Richardson is a Certified Supply Chain Professional and small-business co-owner producing respirator-style masks to help stem the tide of COVID-19’s spread. His website is isgmanufacturing.com. He is a member of the U.S. Transhumanist Party.

Results of Platform Vote #8 and Adopted Sections on COVID-19 Responses

Results of Platform Vote #8 and Adopted Sections on COVID-19 Responses

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Gennady Stolyarov II


The U.S. Transhumanist Party conducted its fourteenth vote of the members and the eighth vote on its platform planks between March 25 and March 28, 2020. Official ballot options can be found here.

Detailed results of the voting have been tabulated here. In two instances, where no majority was reached in the first round of voting, options were selected based on the ranked-preference method with instant runoffs.

As a result, the following new or amended sections of Article VI of the U.S. Transhumanist Party Constitution were adopted.

These sections are also compiled in a special area of the USTP Platform pertaining to COVID-19 responses.

Watch U.S. Transhumanist Party Chairman Gennady Stolyarov II and Vice-Chairman J. Ben Zion discuss the results of the vote on the Debt Nation show with Steele Archer here.

It is time to reorient the economy and society toward pursuit of public health and longevity. We are already effectively on a war footing, so let us take the war on the offensive against death and disease. Either the world will succumb to this pandemic, or we can turn around the situation to step fully into the Transhuman Era. The U.S. Transhumanist Party is proud to put forward these proactive ideas for winning this war.


Section XCVIII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party advocates for rapid construction of hospitals to begin immediately throughout the United States, with one new hospital constructed for every 50,000 in population. Rapid construction techniques, pioneered in China during the COVID-19 outbreak, should be utilized in the United States to build new hospitals in 10 days or less. However, unlike the rapidly constructed Chinese hospitals, the new hospitals constructed in the United States should become permanent.

The United States Transhumanist Party advocates for immediately waiving any zoning restrictions and building codes that would in any manner delay, prevent, or interfere with such rapid construction of hospitals.

Architectural designs for the rapidly constructed hospitals should:
(i) Be prepared and updated as new and superior building techniques and technologies are developed;
(ii) Include plans for multi-purpose facilities for patient care and research, or protocols for how to flexibly convert patient-care facilities into research facilities and vice versa as the need arises; and
(iii) Include separate entrances and generally separate facilities for patients infected with COVID-19 and all other patients, so as to effectively prevent the spread of COVID-19 to hospital visitors who do not have it.

Once the new permanent hospitals have been established, the United States Transhumanist Party supports a mandate for these hospitals to remain open to patients and fully staffed in perpetuity, regardless of profitability or patient influx. After the COVID-19 outbreak subsides, the new hospitals would provide major additional capacity to respond to epidemics and also conduct research on fighting diseases, including biological aging.

After the construction of the new hospitals, the United States Transhumanist Party supports an indefinite obligation for the U.S. federal government to indefinitely remedy any shortfall in funds to a new hospital in order to prevent its closure. Any hospital receiving such federal assistance shall be limited in the charges it may impose for its services to 110% of the cost of providing such services.

The United States Transhumanist Party supports the construction and retrofit of buildings adjacent to the hospitals, which could be used for any of a variety of unrelated purposes in normal times, but which could rapidly be converted into hospital space in times of pandemics by means of features that enable easy customizability, modularity, and accessibility to patients and medical personnel.

The United States Transhumanist Party views a vast and permanent expansion of hospital capacity as a necessary component of a permanent reorientation of the economy and broader society toward the pursuit of improved public health and widespread life extension. The COVID-19 pandemic has illustrated the extent of the disruption and suffering that can occur if these goals are not made explicit and not supported by guaranteed allocations of resources immune from macroeconomic vicissitudes.

Section XCIX [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports for an immediate, universal, unconditional basic income of at least $1000 per month to be provided to every United States citizen for the duration of the COVID-19 outbreak and its immediate aftermath, without regard for individuals’ means or other sources of income. The priority for this program should be to prevent massive and irreparable economic disruptions to the lives of Americans in the wake of the COVID-19 epidemic.

Section C [Adopted by a vote of the members during March 25-28, 2020]: In recognition of the severe, sudden, and often all-encompassing adverse economic impacts resulting from governmental measures taken to limit the spread of the COVID-19 epidemic, and in the conviction that the principles of justice require that governmental policies – even if necessary, unavoidable, or beneficial on balance – not damage innocent parties without just compensation, the United States Transhumanist Party advocates for the United States federal government to take the following actions:

(i) Fully compensate all adversely affected businesses for all loss of income and property resulting from governmental measures taken to contain the COVID-19 epidemic. The United States Transhumanist Party holds that any businesses receiving such compensation should be
    (a) Prohibited from engaging in buybacks of their own stocks; and
    (b) Prohibited from increasing executive pay if that pay currently exceeds $500,000 per executive per year.

(ii) Fully compensate all individuals who lost their jobs or self-employment income, or suffered a reduction in working hours, as a result of governmental measures taken to contain the COVID-19 epidemic. This compensation shall be in addition to, and not a substitute for, the universal basic income received by those individuals.

Section CI [Adopted by a vote of the members during March 25-28, 2020]: In recognition that the recent screening bottlenecks at United States airports create situations of unacceptable crowding which further contribute to the spread of the COVID-19 epidemic, the United States Transhumanist Party advocates for immediate admittance through security checkpoints of the vast majority travelers currently waiting at airports in the United States. Such travelers may be required to subsequently undergo health screenings at other facilities within the United States within a certain period of time, as long as such screenings do not involuntarily place the individuals being screened in close physical proximity to one another.

Section CII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the recall of all United States military personnel from overseas stations as soon as possible and their deployment for the purpose of rapid hospital construction in the United States, as well as for providing rapid emergency aid and essential infrastructure improvements. Continued military presence abroad only unnecessarily exposes American troops to the risk of infection, while the expertise of American military personnel in crisis response is urgently needed within American borders.

Section CIII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable. The United States Transhumanist Party advocates for government funding and ownership of any cure for COVID-19, to be distributed free of charge to those infected with the virus.

Section CIV [Adopted by a vote of the members during March 25-28, 2020]: Because biological aging is the number-one risk factor for mortality and severe complications from COVID-19 infections, as well as infections of virtually every sort, the United States Transhumanist Party emphasizes the importance of reversing biological aging as rapidly as possible and thereby protecting more lives from future pandemics. Accordingly, the United States Transhumanist Party advocates for a permanent, annual $100 billion funding package for anti-aging research, to be immediately distributed to leading research organizations in the field which have in the past specifically identified the defeat and reversal of biological aging as their goals.

Section CV [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party advocates for the immediate institution of a program of micropayments to everyone participating in citizen-science initiatives, such as Foldit, with the specific aim of developing cures or vaccines for COVID-19. Micropayments should be proportional to the amount of time and/or computing power spent contributing to any given initiative, with additional bounties provided for results with meaningful practical applications.

Section CVI [Adopted by a vote of the members during March 25-28, 2020]: In response to the dire shortage of ventilator components and other crucial equipment in hospitals treating COVID-19 patients, the United States Transhumanist Party advocates for the rapid 3D-printing of additional components through both private and governmental initiatives, as well as the deployment of on-site 3D-printers in every hospital and medical clinic to enable the future production of such components on demand. Immediate bounties should be offered by federal, state, and local government to individuals and businesses capable of producing such components. Policy initiatives should empower individuals and communities to explore the suitability of alternative manufacturing processes to produce needed parts and equipment to deal with the crisis.

Section CVII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party advocates for an immediate allowance for remote learning to satisfy the completion or graduation requirements of all K-12 schools and all publicly funded colleges and universities indefinitely going forward. Not only is physical proximity not necessary for effective learning in light of rapidly advancing technologies allowing immersive interaction at a distance, but the encouragement of remote learning also allows individuals more flexibility in advancing at their own pace and focusing on subjects and skill sets which result in the greatest fulfillment and most improved life prospects. The United States Transhumanist Party advocates for the maximal adoption of diverse homeschooling approaches throughout the United States, suited to the individual aptitudes, preferences, and learning styles of students.

The United States Transhumanist Party also supports refocusing the education system on producing the goods and services necessary to maintain United States independence, including vocational studies in electricity, metalwork, ceramics, auto mechanics, graphic arts, and coding in the classroom.

Section CVIII [Adopted by a vote of the members during March 25-28, 2020]: In recognition that unsanitary living conditions are a primary cause of the spread of COVID-19 and other infectious diseases, the United States Transhumanist Party supports the immediate and mandatory housing of the homeless, achieved by means of the rapid construction of tiny homes, including 3D-printed homes, without regard for building codes or zoning regulations, which must be immediately waived to allow such construction.

Every homeless individual discovered by local authorities would be required to move into a separate small home free of monetary cost and would be granted free conditional title to the home. The conditions of the title would be that the new homeowner would be obligated to perform litter-cleanup and other community-service duties for a specified time period per day under supervision, until and unless he or she is able to find different or better housing independently. The new housing communities would be subject to actively enforced covenants and restrictions prohibiting alcohol and recreational drugs. Such prohibitions will have the side benefit of transitioning the homeless toward meaningful social participation and useful work.

Section CIX [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports establishing a rapid three-month training and certification program for hundreds of thousands medical personnel specifically for responding to the COVID-19 outbreak and other pandemics. While the newly trained medical practitioners would not be full-fledged medical doctors, they would be provided with fundamental knowledge of epidemiology, first aid, sanitary practices, and patient care, including the operation of the devices used to assist severely ill patients. This would greatly supplement the available personnel to respond effectively to the COVID-19 outbreak and also anticipate future pandemics. The new COVID-19 medical responders would be compensated generously and selected from among high-performing students and other populations with demonstrated competence and aptitude for learning. For any first responders with student loans, those loans would be forgiven in exchange for a commitment to serve until the COVID-19 pandemic is eradicated. Those medical responders who remain in their positions afterward will receive continuous training on effective pandemic response so as to be in a superior position to anticipate, prevent, and mitigate future outbreaks.

Section CX [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the immediate deployment of as many COVID-19 diagnostic tests as possible to the general population, with the aim of achieving universal testing of every American, even those without symptoms, free of charge. Universal testing is necessary to understand the true prevalence of COVID-19 infections and the proportion of serious cases and fatalities relative to actual total cases, not merely reported cases. This would enable a true understanding of the extent of the epidemic’s spread as well as how the rates of serious complications and death compare to the common cold and influenza. The United States Transhumanist Party supports generous aid to both private and governmental research teams working in parallel on developing effective testing kits and approaches, particularly those which do not require large numbers of people to congregate.

The United States Transhumanist Party also advocates for COVID-19 testing kits to be developed that could result in tests being self-administered by individuals in their own homes and then mailed to laboratories for evaluation. This would minimize the physical contact of individuals being tested with medical practitioners and other patients.

Section CXI [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party advocates for the establishment of facilities, such as warehouses, where essential supplies would be temporarily stored in large quantities in case of emergencies such as COVID-19. Distributors would supply to these warehouses a large surplus of essential goods, and hospitals, medical research facilities, pharmaceutical companies, and other medical organizations would get their normal supplies, including masks, soap, hand-sanitizer, and common device components, from there in the event of any shortages. In case of an epidemic, there will be enough supplies on hand to provide such institutions for a prolonged period of time.

The essential supplies stored by such facilities would include ready-made hazmat suits that could be distributed to both medical practitioners and the population at large in the event of a highly contagious disease outbreak, along with clear and layperson-friendly instructions of how to put on and use the hazmat suits effectively.

Section CXII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party holds that, as a proactive measure, the United States should spearhead an initiative to collaborate with other wealthy nations, or by means of the World Health Organization (WHO), to set up a financial and material package of supplies and infrastructure to be deployed anywhere in the world in case a pathogen is found that needs to rapidly be contained in a foreign nation. This could be particularly important if the origin country is one that cannot itself manage to contain the outbreak due to poverty or lack of resources. This could help prevent a pathogen from ever coming to the United States.

A committee or part of an existing office should research and collaborate with other nations to learn and establish best or improved practices and update emergency plans accordingly. Likewise such collaborative efforts could establish which practices are not effective and remove those accordingly.

Section CXIII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports efforts by the federal government to begin an initiative in collaboration with businesses to create packages of emergency medical supplies, akin to a first-aid kit box, for civilians to buy for an affordable price, and offered for free to those who fall below the poverty line. Such a package could include advanced face masks, hand-sanitizer, soap, latex gloves, and other important items for effective epidemic response. The kit should come with clear instructions on how and when to use it, as well as instructions regarding self-quarantining and the express notice that the kit should not be re-sold, because the health and safety of everyone depends on the maximum number of people participating. This advance provision of response kits would have the effects of lowering the pressure on supply when there is an emergency and enabling people to be better prepared from the start, thus immediately limiting the spread of a pathogen.

Section CXIV [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the inclusion of education on epidemic crises in the curricula of schools. Science-based instruction on key attributes of epidemics and pandemics, historical instances, and effective responses could be incorporated within related courses, such as biology.

Section CXV [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the immediate and complete repeal of all “certificate of need” laws, which currently, in many jurisdictions, prohibit the construction of new hospitals or the expansion of capacity of existing hospitals, unless “need” is demonstrated using arbitrary criteria overseen by incumbents within the hospital industry. “Certificate of need” laws are entirely deleterious and have no redeeming features of any sort. They constitute pure protectionism for the incomes of incumbents, at the expense of available and affordable health care, especially in times of increased strain, such as pandemics.

Section CXVI [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the development of vaccines under conditions that do not afford patents to the developers but instead compensate the developers in the form of bounties for safe, effective vaccines and their rapid production and deployment. Patents, as grants of exclusive monopoly privilege for as long as twenty years, operate to limit the supply of a vaccine and render it artificially expensive. Bounties and other forms of compensation based on production and distribution of vaccines would be better aligned with the urgent public interest in those vaccines’ rapid availability to the general population.

Section CXVII [Adopted by a vote of the members during March 25-28, 2020]: The United States Transhumanist Party supports the deployment of robots and automated systems wherever possible to assist COVID-19 patients and individuals who are at greater risk for serious complications from COVID-19. These systems could include autonomous vehicles, food-delivery robots and drones, and production robots in as many industries as possible to reduce the human presence in factories while continuing to manufacture many goods necessary for human life and well-being.

Section CXVIII [Adopted by a vote of the members during March 25-28, 2020]: Given the extreme delays, bottlenecks, and expenses created by the mandatory approval processes on the Food and Drug Administration (FDA), the United States Transhumanist Party supports abolishing the FDA and replacing it with a Radical Life Extension Administration (RLEA), whose mandate would be to prioritize the rapid development of potential disease cures, treatments, and vaccines – including any possible cures or vaccines for COVID-19, as well as treatments to mitigate and reverse the disease of biological aging, the major risk factor for COVID-19. The RLEA would allow the marketing and collection of patient data on any potential cure, treatment, or vaccine which has passed affordable safety testing at a reasonably acceptable threshold.

Official Ballot Options for Platform Vote #8 on COVID-19 Response

Official Ballot Options for Platform Vote #8 on COVID-19 Response

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The 3-day electronic voting period on the eighth set of proposed platform planks of the U.S. Transhumanist Party in response to the COVID-19 crisis (21 potential planks in total) will occur from 1:01 p.m. U.S. Pacific Time on March 25, 2020, to 1:01 p.m.  U.S. Pacific Time on March 28, 2020. All members of the U.S. Transhumanist Party (USTP) who have applied before 1:01 p.m. on March 25, 2020, will be eligible to vote, as long as they have expressed agreement with the three Core Ideals of the USTP or have otherwise been rendered eligible to vote at the discretion of the Chairman.

All members who are eligible to vote will be sent a link to an electronic submission form whereby they will be able to cast their ballot.

When you are voting, it is strongly recommended that you keep this page of official ballot options and the submission form open simultaneously in different windows so that you can reference the relevant options as you vote on them. Due to space limitations, the submission form does not list the entire text of all the options.

It is also recommended that you set aside at least thirty minutes to consider and vote on all of the options and read their text closely, as some of the options contain minor variations upon other options. 

For some questions, electronic voting is  conducted by a ranked-preference method on individual articles where more options are possible than would be accommodated by a simple “Yes” or “No” vote. Members should keep in mind that the ranked-preference method eliminates the incentives for strategic voting – so members are encouraged to vote for the options that reflect their individual preferences as closely as possible, without regard for how other members might vote.

Results of the voting will be tabulated during late March 2020, with the intent to announce the results approximately 2-3 days after all votes have been submitted.

NOTE: The titles of the questions and potential Sections are descriptive and informational only and will not appear in the final adopted platform planks (which will be incorporated into Article VI of the U.S. Transhumanist Party Constitution). They are intended as concise guides to the subject matter of the questions and potential Sections. Likewise, the letters assigned to Sections within this ballot will not reflect the numbering of the final adopted provisions, which will depend on which Sections are selected by the membership.

NOTE II: The inclusion of any proposals on this ballot does not indicate any manner of endorsement for those proposals by the U.S. Transhumanist Party at this time – except to place those proposals before the members to determine the will of the members with regard to whether or not the U.S. Transhumanist Party Platform should incorporate any given proposal.


Voter Identification

E-mail address

Provide the same e-mail address you used to register for U.S. Transhumanist Party membership. Your ballot will be cross-referenced to our membership rolls, and only ballots with matching e-mail addresses will be counted.

What is your name?

At minimum, first and last name are required, unless you are publicly known by a single-name pseudonym which is not itself a common name. Your identity will not be publicly disclosed by the Transhumanist Party, unless you choose and/or authorize its disclosure. The nature of the selections made by the members may be disclosed, but, if they are, each individual vote will not be associated with the identity of the voter but rather will be presented in an anonymized manner.

Navigate the Options

Proposed Platform Sections

Question I. Section E8-A. Rapid Construction of Hospitals
Question II. Section E8-A. Rapid Construction of Hospitals – Ancillary Provisions
Question III. Section E8-B. Emergency Universal Basic Income
Question IV. Section E8-C. Full Compensation of Affected Businesses and Workers
Question V. Section E8-C. Full Compensation of Affected Businesses and Workers – Ancillary Provisions
Question VI. Section E8-D. Elimination of Bottlenecks at Airports
Question VII. Section E8-E. Rapid Domestic Deployment of Military Personnel from Overseas
Question VIII. Section E8-F. Rapid Research into Cures for COVID-19, Common Cold, and Influenza
Question IX. Section E8-G. Emergency Funding Package for Anti-Aging Research
Question X. Section E8-H. Micropayments for Citizen-Science Initiatives
Question XI. Section E8-I. Rapid 3D-Printing of Ventilator Components and Other Crucial Medical Equipment
Question XII. Section E8-J. Refocusing of the Education System toward Remote Learning
Question XIII. Section E8-J. Refocusing of the Education System toward Remote Learning – Ancillary Provision
Question XIV. Section E8-K. Mandatory Free Housing of the Homeless
Question XV. Section E8-L. Rapid Training for Medical Personnel
Question XVI. Section E8-M. Universal Free COVID-19 Testing
Question XVII. Section E8-M. Universal Free COVID-19 Testing – Ancillary Provision
Question XVIII. Section E8-N. Establishment of Facilities to Store Essential Supplies
Question XIX. Section E8-N. Establishment of Facilities to Store Essential Supplies – Ancillary Provision
Question XX. Section E8-O. Collaboration with Other Nations on Pandemic Response
Question XXI. Section E8-P. Creation of Packages of Emergency Medical Supplies
Question XXII. Section E8-Q. Educational Programs on Epidemics
Question XXIII. Section E8-R. Repeal of “Certificate of Need” Laws
Question XXIV. Section E8-S. Patentless Development of Vaccines
Question XXV. Section E8-T. Utilization of Robots to Assist Patients and Vulnerable Individuals
Question XXVI. Section E8-U. Abolition of the Food and Drug Administration and Its Replacement with a Radical Life Extension Administration

Proposed Platform Sections

Question I. Section E8-A. Rapid Construction of Hospitals

Rank-order the Section E8-A Options that you support. Choose “1” for your most highly favored option, “2” for your second-most highly favored option, etc. You may include the option for “No Section of this sort” in your rank-ordering, and it does not need to be your most favored option if you do so. (For instance, some voters might favor some options but think that no language is preferable to some of the other options.)

If you choose “Abstain”, then do not rank-order any options, as you will be considered to have skipped this question.

Option E8-A-1. [Proposal for Rapid Construction of Permanent Hospitals] The United States Transhumanist Party advocates for rapid construction of hospitals to begin immediately throughout the United States, with one new hospital constructed for every 50,000 in population. Rapid construction techniques, pioneered in China during the COVID-19 outbreak, should be utilized in the United States to build new hospitals in 10 days or less. However, unlike the rapidly constructed Chinese hospitals, the new hospitals constructed in the United States should become permanent.

The United States Transhumanist Party advocates for immediately waiving any zoning restrictions and building codes that would in any manner delay, prevent, or interfere with such rapid construction of hospitals.

Once the new permanent hospitals have been established, the United States Transhumanist Party supports a mandate for these hospitals to remain open to patients and fully staffed in perpetuity, regardless of profitability or patient influx. After the COVID-19 outbreak subsides, the new hospitals would provide major additional capacity to respond to epidemics and also conduct research on fighting diseases, including biological aging.

After the construction of the new hospitals, the United States Transhumanist Party supports an indefinite obligation for the U.S. federal government to indefinitely remedy any shortfall in funds to a new hospital in order to prevent its closure. Any hospital receiving such federal assistance shall be limited in the charges it may impose for its services to 110% of the cost of providing such services.

The United States Transhumanist Party views a vast and permanent expansion of hospital capacity as a necessary component of a permanent reorientation of the economy and broader society toward the pursuit of improved public health and widespread life extension. The COVID-19 pandemic has illustrated the extent of the disruption and suffering that can occur if these goals are not made explicit and not supported by guaranteed allocations of resources immune from macroeconomic vicissitudes.

Option E8-A-2. [Proposal by Marlin Adams for Rapid Construction of Temporary Hospitals]

The United States Transhumanist Party advocates for rapid construction of temporary hospitals to begin immediately throughout the United States, with one new hospital constructed for every 50,000 in population. Rapid construction techniques, pioneered in China during the COVID-19 outbreak, should be utilized in the United States to build new hospitals in 10 days or less.

The United States Transhumanist Party advocates for immediately waiving any zoning restrictions and building codes that would in any manner delay, prevent, or interfere with such rapid construction of hospitals.

☐ Option E8-A-NO. No Section of this sort.

Question II. Section E8-A. Rapid Construction of Hospitals – Ancillary Provisions 

If Section E8-A regarding the rapid construction of hospitals is adopted as part of the U.S. Transhumanist Party Platform, shall any of the following ancillary provisions be appended to that Section?

Select all the options you support. (You can select multiple options for this question.)  Any option receiving the majority of votes cast will be included in the ultimately adopted plank, unless Option E8-A-NO prevails in the vote on Question I above. If you do not favor any of the options below, then you may leave this question blank.

☐ Ancillary Provision E8-A-i. [Based on Proposal by Martin van der Kroon] Architectural designs for the rapidly constructed hospitals should be prepared and updated as new and superior building techniques and technologies are developed.

Ancillary Provision E8-A-ii. [Based on Proposal by Jason Geringer] Architectural designs for the rapidly constructed hospitals should include plans for multi-purpose facilities for patient care and research, or protocols for how to flexibly convert patient-care facilities into research facilities and vice versa as the need arises.

☐ Ancillary Provision E8-A-iii. [Based on Proposal by Sylvester Geldtmeijer] Architectural designs for the rapidly constructed hospitals should include separate entrances and generally separate facilities for patients infected with COVID-19 and all other patients, so as to effectively prevent the spread of COVID-19 to hospital visitors who do not have it.

☐ Ancillary Provision E8-A-iv. [Based on Proposal by Sylvester Geldtmeijer] The United States Transhumanist Party supports the construction and retrofit of buildings adjacent to the hospitals, which could be used for any of a variety of unrelated purposes in normal times, but which could rapidly be converted into hospital space in times of pandemics by means of features that enable easy customizability, modularity, and accessibility to patients and medical personnel.

☐ Ancillary Provision E8-A-v. [Based on Proposal by Martin van der Kroon] While many unoccupied sites could be used as locations for the new hospitals, burial sites, especially native burial grounds, and other areas that have cultural or historical sensitive backgrounds should be avoided if possible. This is to prevent depriving native minorities of their ancestral legacies, as well as possible litigation afterward, which could lead to forceful closure of a hospital or medical facility after the emergency has subsided, leaving the situation with two losing sides.

Question III. Section E8-B. Emergency Universal Basic Income

Rank-order the Section E8-B Options that you support. Choose “1” for your most highly favored option, “2” for your second-most highly favored option, etc. You may include the option for “No Section of this sort” in your rank-ordering, and it does not need to be your most favored option if you do so. (For instance, some voters might favor some options but think that no language is preferable to some of the other options.)

If you choose “Abstain”, then do not rank-order any options, as you will be considered to have skipped this question.

☐ Option E8-B-1. The United States Transhumanist Party supports for an immediate, universal, unconditional basic income of at least $1000 per month to be provided to every United States citizen for the duration of the COVID-19 outbreak, without regard for individuals’ means or other sources of income. The priority for this program should be to prevent massive and irreparable economic disruptions to the lives of Americans in the wake of the COVID-19 epidemic.

☐ Option E8-B-2. [Based on Suggestion by Marlin Adams to Extend UBI to the Immediate Aftermath of the Outbreak] The United States Transhumanist Party supports for an immediate, universal, unconditional basic income of at least $1000 per month to be provided to every United States citizen for the duration of the COVID-19 outbreak and its immediate aftermath, without regard for individuals’ means or other sources of income. The priority for this program should be to prevent massive and irreparable economic disruptions to the lives of Americans in the wake of the COVID-19 epidemic.

☐ Option E8-B-NO. No Section of this sort.

Question IV. Section E8-C. Full Compensation of Affected Businesses and Workers

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

In recognition of the severe, sudden, and often all-encompassing adverse economic impacts resulting from governmental measures taken to limit the spread of the COVID-19 epidemic, and in the conviction that the principles of justice require that governmental policies – even if necessary, unavoidable, or beneficial on balance – not damage innocent parties without just compensation, the United States Transhumanist Party advocates for the United States federal government to take the following actions:

(i) Fully compensate all adversely affected businesses for all loss of income and property resulting from governmental measures taken to contain the COVID-19 epidemic; and

(ii) Fully compensate all individuals who lost their jobs or self-employment income, or suffered a reduction in working hours, as a result of governmental measures taken to contain the COVID-19 epidemic. This compensation shall be in addition to, and not a substitute for, the universal basic income received by those individuals.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question V. Section E8-C. Full Compensation of Affected Businesses and Workers – Ancillary Provisions

If Section E8-C regarding the full compensation of affected businesses and workers is adopted as part of the U.S. Transhumanist Party Platform, shall any of the following ancillary provisions be appended to that Section?

Select all the options you support. (You can select multiple options for this question.)  Any option receiving the majority of votes cast will be included in the ultimately adopted plank, unless Option E8-A-NO prevails in the vote on Question I above. If you do not favor any of the options below, then you may leave this question blank.

☐ Ancillary Provision E8-C-i. [Based on Proposal by Jason Geringer] The United States Transhumanist Party holds that any businesses receiving such compensation should be prohibited from engaging in buybacks of their own stocks.

☐ Ancillary Provision E8-C-ii. The United States Transhumanist Party holds that any businesses receiving such compensation should be prohibited from increasing executive pay if that pay currently exceeds $500,000 per executive per year.

Question VI. Section E8-D. Elimination of Bottlenecks at Airports

Rank-order the Section E8-D Options that you support. Choose “1” for your most highly favored option, “2” for your second-most highly favored option, etc. You may include the option for “No Section of this sort” in your rank-ordering, and it does not need to be your most favored option if you do so. (For instance, some voters might favor some options but think that no language is preferable to some of the other options.)

If you choose “Abstain”, then do not rank-order any options, as you will be considered to have skipped this question.

☐ Option E8-D-1. In recognition that the recent screening bottlenecks at United States airports create situations of unacceptable crowding which further contribute to the spread of the COVID-19 epidemic, the United States Transhumanist Party advocates for immediate and unconditional admittance through security checkpoints of all travelers currently waiting at airports in the United States. Such travelers may be required to subsequently undergo health screenings at other facilities within the United States within a certain period of time, as long as such screenings do not involuntarily place the individuals being screened in close physical proximity to one another.

☐ Option E8-D-2. [Based on Proposal by Ophelia_Drowned to Remove Unconditional Admittance, Replace It with Admittance of the Vast Majority] In recognition that the recent screening bottlenecks at United States airports create situations of unacceptable crowding which further contribute to the spread of the COVID-19 epidemic, the United States Transhumanist Party advocates for immediate admittance through security checkpoints of the vast majority travelers currently waiting at airports in the United States. Such travelers may be required to subsequently undergo health screenings at other facilities within the United States within a certain period of time, as long as such screenings do not involuntarily place the individuals being screened in close physical proximity to one another.

☐ Option E8-D-NO. No Section of this sort.

Question VII. Section E8-E. Rapid Domestic Deployment of Military Personnel from Overseas

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the recall of all United States military personnel from overseas stations as soon as possible and their deployment for the purpose of rapid hospital construction in the United States, as well as for providing rapid emergency aid and essential infrastructure improvements. Continued military presence abroad only unnecessarily exposes American troops to the risk of infection, while the expertise of American military personnel in crisis response is urgently needed within American borders.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question VIII. Section E8-F. Rapid Research into Cures for COVID-19, Common Cold, and Influenza

Rank-order the Section E8-F Options that you support. Choose “1” for your most highly favored option, “2” for your second-most highly favored option, etc. You may include the option for “No Section of this sort” in your rank-ordering, and it does not need to be your most favored option if you do so. (For instance, some voters might favor some options but think that no language is preferable to some of the other options.)

If you choose “Abstain”, then do not rank-order any options, as you will be considered to have skipped this question.

☐ Option E8-F-1. The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable.

☐ Option E8-F-2. [Based on Suggestion by Marlin Adams for Government Funding and Ownership of the Cure and Its Free Distribution] The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable. The United States Transhumanist Party advocates for government funding and ownership of any cure for COVID-19, to be distributed free of charge to those infected with the virus.

☐ Option E8-F-3. [Option Mentioning Free Distribution of the Cure for COVID-19 But No Mention of Nature of Ownership] The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable. The United States Transhumanist Party advocates for any cure for COVID-19 to be distributed free of charge to those infected with the virus.

☐ Option E8F-NO. No Section of this sort.

Question IX. Section E8-G. Emergency Funding Package for Anti-Aging Research

Rank-order the Section E8-G Options that you support. Choose “1” for your most highly favored option, “2” for your second-most highly favored option, etc. You may include the option for “No Section of this sort” in your rank-ordering, and it does not need to be your most favored option if you do so. (For instance, some voters might favor some options but think that no language is preferable to some of the other options.)

If you choose “Abstain”, then do not rank-order any options, as you will be considered to have skipped this question.

☐ Option E8-G-1. Because biological aging is the number-one risk factor for mortality and severe complications from COVID-19 infections, as well as infections of virtually every sort, the United States Transhumanist Party emphasizes the importance of reversing biological aging as rapidly as possible and thereby protecting more lives from future pandemics. Accordingly, the United States Transhumanist Party advocates for an emergency $100 billion funding package for anti-aging research, to be immediately distributed to leading research organizations in the field which have in the past specifically identified the defeat and reversal of biological aging as their goals.

☐ Option E8-G-2. [Suggestion by Mike DiVerde for a Permanent, Annual $100 Billion Funding Package.]  Because biological aging is the number-one risk factor for mortality and severe complications from COVID-19 infections, as well as infections of virtually every sort, the United States Transhumanist Party emphasizes the importance of reversing biological aging as rapidly as possible and thereby protecting more lives from future pandemics. Accordingly, the United States Transhumanist Party advocates for a permanent, annual $100 billion funding package for anti-aging research, to be immediately distributed to leading research organizations in the field which have in the past specifically identified the defeat and reversal of biological aging as their goals.

☐ Option E8-G-NO. No Section of this sort.

Question X. Section E8-H. Micropayments for Citizen-Science Initiatives

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party advocates for the immediate institution of a program of micropayments to everyone participating in citizen-science initiatives, such as Foldit, with the specific aim of developing cures or vaccines for COVID-19. Micropayments should be proportional to the amount of time and/or computing power spent contributing to any given initiative, with additional bounties provided for results with meaningful practical applications.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XI. Section E8-I. Rapid 3D-Printing of Ventilator Components and Other Crucial Medical Equipment

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

In response to the dire shortage of ventilator components and other crucial equipment in hospitals treating COVID-19 patients, the United States Transhumanist Party advocates for the rapid 3D-printing of additional components through both private and governmental initiatives, as well as the deployment of on-site 3D-printers in every hospital and medical clinic to enable the future production of such components on demand. Immediate bounties should be offered by federal, state, and local government to individuals and businesses capable of producing such components. Policy initiatives should empower individuals and communities to explore the suitability of alternative manufacturing processes to produce needed parts and equipment to deal with the crisis.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XII. Section E8-J. Refocusing of the Education System toward Remote Learning

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party advocates for an immediate allowance for remote learning to satisfy the completion or graduation requirements of all K-12 schools and all publicly funded colleges and universities indefinitely going forward. Not only is physical proximity not necessary for effective learning in light of rapidly advancing technologies allowing immersive interaction at a distance, but the encouragement of remote learning also allows individuals more flexibility in advancing at their own pace and focusing on subjects and skill sets which result in the greatest fulfillment and most improved life prospects. The United States Transhumanist Party advocates for the maximal adoption of diverse homeschooling approaches throughout the United States, suited to the individual aptitudes, preferences, and learning styles of students.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XIII. Section E8-J. Refocusing of the Education System toward Remote Learning – Ancillary Provision

If Section E8-J regarding refocusing the education system toward remote learning is adopted as part of the U.S. Transhumanist Party Platform, shall the following ancillary provision be appended to that Section?

The United States Transhumanist Party also supports refocusing the education system on producing the goods and services necessary to maintain United States independence, including vocational studies in electricity, metalwork, ceramics, auto mechanics, graphic arts, and coding in the classroom.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XIV. Section E8-K. Mandatory Free Housing of the Homeless

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

In recognition that unsanitary living conditions are a primary cause of the spread of COVID-19 and other infectious diseases, the United States Transhumanist Party supports the immediate and mandatory housing of the homeless, achieved by means of the rapid construction of tiny homes, including 3D-printed homes, without regard for building codes or zoning regulations, which must be immediately waived to allow such construction.

Every homeless individual discovered by local authorities would be required to move into a separate small home free of monetary cost and would be granted free conditional title to the home. The conditions of the title would be that the new homeowner would be obligated to perform litter-cleanup and other community-service duties for a specified time period per day under supervision, until and unless he or she is able to find different or better housing independently. The new housing communities would be subject to actively enforced covenants and restrictions prohibiting alcohol and recreational drugs. Such prohibitions will have the side benefit of transitioning the homeless toward meaningful social participation and useful work.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XV. Section E8-L. Rapid Training for Medical Personnel

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports establishing a rapid three-month training and certification program for hundreds of thousands medical personnel specifically for responding to the COVID-19 outbreak and other pandemics. While the newly trained medical practitioners would not be full-fledged medical doctors, they would be provided with fundamental knowledge of epidemiology, first aid, sanitary practices, and patient care, including the operation of the devices used to assist severely ill patients. This would greatly supplement the available personnel to respond effectively to the COVID-19 outbreak and also anticipate future pandemics. The new COVID-19 medical responders would be compensated generously and selected from among high-performing students and other populations with demonstrated competence and aptitude for learning. For any first responders with student loans, those loans would be forgiven in exchange for a commitment to serve until the COVID-19 pandemic is eradicated. Those medical responders who remain in their positions afterward will receive continuous training on effective pandemic response so as to be in a superior position to anticipate, prevent, and mitigate future outbreaks.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XVI. Section E8-M. Universal Free COVID-19 Testing

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the immediate deployment of as many COVID-19 diagnostic tests as possible to the general population, with the aim of achieving universal testing of every American, even those without symptoms, free of charge. Universal testing is necessary to understand the true prevalence of COVID-19 infections and the proportion of serious cases and fatalities relative to actual total cases, not merely reported cases. This would enable a true understanding of the extent of the epidemic’s spread as well as how the rates of serious complications and death compare to the common cold and influenza. The United States Transhumanist Party supports generous aid to both private and governmental research teams working in parallel on developing effective testing kits and approaches, particularly those which do not require large numbers of people to congregate.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XVII. Section E8-M. Universal Free COVID-19 Testing – Ancillary Provision

If Section E8-M regarding universal free COVID-19 testing is adopted as part of the U.S. Transhumanist Party Platform, shall the following ancillary provision be appended to that Section?

The United States Transhumanist Party also advocates for COVID-19 testing kits to be developed that could result in tests being self-administered by individuals in their own homes and then mailed to laboratories for evaluation. This would minimize the physical contact of individuals being tested with medical practitioners and other patients.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XVIII. Section E8-N. Establishment of Facilities to Store Essential Supplies

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party advocates for the establishment of facilities, such as warehouses, where essential supplies would be temporarily stored in large quantities in case of emergencies such as COVID-19. Distributors would supply to these warehouses a large surplus of essential goods, and hospitals, medical research facilities, pharmaceutical companies, and other medical organizations would get their normal supplies, including masks, soap, hand-sanitizer, and common device components, from there in the event of any shortages. In case of an epidemic, there will be enough supplies on hand to provide such institutions for a prolonged period of time.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XIX. Section E8-N. Establishment of Facilities to Store Essential Supplies – Ancillary Provision

If Section E8-N regarding establishment of facilities to store essential supplies is adopted as part of the U.S. Transhumanist Party Platform, shall the following ancillary provision be appended to that Section?

The essential supplies stored by such facilities would include ready-made hazmat suits that could be distributed to both medical practitioners and the population at large in the event of a highly contagious disease outbreak, along with clear and layperson-friendly instructions of how to put on and use the hazmat suits effectively.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XX. Section E8-O. Collaboration with Other Nations on Pandemic Response

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party holds that, as a pro-active measure, the United States should spearhead an initiative to collaborate with other wealthy nations, or by means of the World Health Organization (WHO), to set up a financial and material package of supplies and infrastructure to be deployed anywhere in the world in case a pathogen is found that needs to rapidly be contained in a foreign nation. This could be particularly important if the origin country is one that cannot itself manage to contain the outbreak due to poverty or lack of resources. This could help prevent a pathogen from ever coming to the United States.

A committee or part of an existing office should research and collaborate with other nations to learn and establish best or improved practices and update emergency plans accordingly. Likewise such collaborative efforts could establish which practices are not effective and remove those accordingly.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXI. Section E8-P. Creation of Packages of Emergency Medical Supplies

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports efforts by the federal government to begin an initiative in collaboration with businesses to create packages of emergency medical supplies, akin to a first-aid kit box, for civilians to buy for an affordable price, and offered for free to those who fall below the poverty line. Such a package could include advanced face masks, hand-sanitizer, soap, latex gloves, and other important items for effective epidemic response. The kit should come with clear instructions on how and when to use it, as well as instructions regarding self-quarantining and the express notice that the kit should not be re-sold, because the health and safety of everyone depends on the maximum number of people participating. This advance provision of response kits would have the effects of lowering the pressure on supply when there is an emergency and enabling people to be better prepared from the start, thus immediately limiting the spread of a pathogen.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXII. Section E8-Q. Educational Programs on Epidemics

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the inclusion of education on epidemic crises in the curricula of schools. Science-based instruction on key attributes of epidemics and pandemics, historical instances, and effective responses could be incorporated within related courses, such as biology.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXIII. Section E8-R. Repeal of “Certificate of Need” Laws

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the immediate and complete repeal of all “certificate of need” laws, which currently, in many jurisdictions, prohibit the construction of new hospitals or the expansion of capacity of existing hospitals, unless “need” is demonstrated using arbitrary criteria overseen by incumbents within the hospital industry. “Certificate of need” laws are entirely deleterious and have no redeeming features of any sort. They constitute pure protectionism for the incomes of incumbents, at the expense of available and affordable health care, especially in times of increased strain, such as pandemics.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXIV. Section E8-S. Patentless Development of Vaccines

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the development of vaccines under conditions that do not afford patents to the developers but instead compensate the developers in the form of bounties for safe, effective vaccines and their rapid production and deployment. Patents, as grants of exclusive monopoly privilege for as long as twenty years, operate to limit the supply of a vaccine and render it artificially expensive. Bounties and other forms of compensation based on production and distribution of vaccines would be better aligned with the urgent public interest in those vaccines’ rapid availability to the general population.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXV. Section E8-T. Utilization of Robots to Assist Patients and Vulnerable Individuals

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

The United States Transhumanist Party supports the deployment of robots and automated systems wherever possible to assist COVID-19 patients and individuals who are at greater risk for serious complications from COVID-19. These systems could include autonomous vehicles, food-delivery robots and drones, and production robots in as many industries as possible to reduce the human presence in factories while continuing to manufacture many goods necessary for human life and well-being.

Select one of the following options.

 Yes.

 No.

 Abstain.

Question XXVI. Section E8-U. Abolition of the Food and Drug Administration and Its Replacement with a Radical Life Extension Administration

Shall the following language be adopted as a new Section within the U.S. Transhumanist Party Platform?

Given the extreme delays, bottlenecks, and expenses created by the mandatory approval processes on the Food and Drug Administration (FDA), the United States Transhumanist Party supports abolishing the FDA and replacing it with a Radical Life Extension Administration (RLEA), whose mandate would be to prioritize the rapid development of potential disease cures, treatments, and vaccines – including any possible cures or vaccines for COVID-19, as well as treatments to mitigate and reverse the disease of biological aging, the major risk factor for COVID-19. The RLEA would allow the marketing and collection of patient data on any potential cure, treatment, or vaccine which has passed affordable safety testing at a reasonably acceptable threshold.

Select one of the following options.

 Yes.

 No.

 Abstain.

 

The Rise of Oisin Biotechnologies – Interview with Gary Hudson, CEO of Oisin Biotechnologies, by Ariel VA Feinerman

The Rise of Oisin Biotechnologies – Interview with Gary Hudson, CEO of Oisin Biotechnologies, by Ariel VA Feinerman

Ariel VA Feinerman
Gary Hudson


Gary Hudson

Preface

What is ageing? We can define ageing as a process of accumulation of the damage which is just a side-effect of normal metabolism. While researchers still poorly understand how metabolic processes cause damage accumulation, and how accumulated damage cause pathology, the damage itself — the structural difference between old tissue and young tissue — is categorized and understood pretty well. By repairing damage and restoring the previous undamaged — young — state of an organism, we can really rejuvenate it! Sounds very promising, and so it is. And for some types of damage (for example, for senescent cells) it is already proved to work!

Today in our virtual studio somewhere between cold rainy Saint-Petersburg and warm rainy Seattle, we meet Gary Hudson!

He has been involved in private space flight development for over 40 years. Hudson is best known as the founder of Rotary Rocket Company, which in spending ~$30 Million attempted to build a unique single stage to orbit launch vehicle known as the Roton. He helped found Transformational Space T/Space in 2004 and AirLaunch LLC which was awarded the DARPA/USAF FALCON project in 2003.

Previous projects included designs of the Phoenix SSTO, the Percheron, and other rockets, founder of Pacific American Launch Systems, and various consulting projects. Currently, he is the President and CEO of the Space Studies Institute.

Now Hudson brings his excellent engineering skills into rejuvenation biotechnology! He is a founding partner of Oisin Biotechnologies, who are developing a liposomally delivered DNA therapy for the removal of senescent cells from the body. Hudson provided an initial seed donation to help fund the creation of the Methuselah Foundation and SENS Research Foundation.

Interview

Feinerman: Hello, Mr Gary Hudson!

Hudson: Thanks for inviting us to this interview!

Feinerman: You have recently visited an amazing Undoing Aging 2018 conference, which took place in Berlin, 15–17 March, where your colleague, Matthew Scholz, was a speaker. What is your impression?

Hudson: It was a great conference with several important presentations. It put me in mind of the early SENS conferences in Cambridge, UK, which I helped to sponsor. I understand it will now become an annual event. Our CSO Dr. John Lewis also gave an important summary of our work to date.

Feinerman: Will Oisin’s presentations from conference be available for general public?

Hudson: I believe that the SENS Foundation will be posting them but I don’t have details about the timing.

FeinermanYour last interview was in July 2017, more than half a year ago. What has been accomplished?

Hudson: We have conducted many pre-clinical mouse experiments on both cancer and senescent cell removal. All have been successful and produce very remarkable results. We’ve also conducted a pilot toxicity and safety trial on non-human primates. The results of that trial were also successful and encourage us to proceed to human safety trials as soon as regulatory authorities approve them. We have also spun-out a cancer-focused company, Oisin Oncology, and raised a seed round for that venture.

Feinerman: Great to hear! However, when can we see some papers? People usually trust papers more than mere interviews or press releases. Of course, papers need many efforts not related to research but they will allow you attract more attention from general public, researchers, and investors.

Hudson: Papers are being prepared now for submission to major journals, but that process takes time, especially the peer review. For the moment, most of our data is only available to investors and partners in pharma and the biotech industry.

Feinerman: You planned human clinical trials, have you carried them out?

Hudson: It takes quite some time to organize a human trial and to get it approved. Before one can be conducted, we have to set up so-called “GMP (Good Manufacturing Practice) manufacture of our therapeutic, and then we have to conduct “GLP (Good Laboratory Practice) Tox” studies in two different species. Once that is all completed later this year, then we can begin a human safety trial, or a “Phase 1” trial. All this takes time, but we hope that first safety trials in oncology indications might begin this year, or in early 2019.

Feinerman: Does that mean we have a race between Unity Biotechnology and Oisin and you have all chances to win the race?

Hudson: I don’t see it as a race or a competition. I believe that future anti-aging treatment will require multiple complimentary approaches.

Feinerman: When we can expect your therapy available in the clinic?

Hudson: It’s very difficult to predict. I believe that our cancer treatment will make it to the clinic first, and that could happen in less than five years. Since the FDA doesn’t regard ageing as an indication, it may take longer for our SENSOlytic™ treatment to reach the public, since the regulatory environment will need to change.

Feinerman: As Michael Rae has said, we need not to wait when ageing will be recognised as a disease. You can mark your senolytics as a therapy for specific ageing pathology like fibrosis or chronic inflammation in the same way as Unity does.

Hudson: This is certainly true and is part of our strategy, but many of those endpoints are more difficult to ascertain than oncology endpoints. Additionally, going after oncology approvals can be faster and easier to get to clinic. But we will push forward on several fronts as funding permits.

Feinerman: In your previous interview you have said that you make some tweaks to both the promoter side and the effector side of the constructs that will provide even more interesting and useful extensions to the basic capability, but you can’t discuss those for IP reasons. Can you now say about them?

Hudson: I still can’t say too much about them, but we have conducted animal trials on some of these “tweaks” and they work quite well. The downside to the matter is that every “tweak” requires new trials, and our goal is to get something to the clinic as soon as possible, so many of the improvements will have to wait. Progress is limited based on available funds and personnel resources, of course, but we will move as quickly as we can.

Feinerman: Do you use any CAD software to design your constructs? Are you going to make them public so independent engineers will be able to help you identify new useful pairs of promoters and effectors? Your technology is so powerful that Open Source approach would be very helpful!

Hudson: No, the design of the current constructs are very straightforward and simple. As our patents are issued, their design will become public. If people wish to design their own constructs for particular applications they may contact us for collaboration, though we do have several collaborations active at the moment so we may already be working on similar ideas.

Feinerman: What do you think on targeting your machinery on cells with abnormal telomerase activity to kill cancer? Can you use several conditions — like in programming — several promoters to be more specific?

Hudson: If we targeted telomerase we’d also kill stem cells, just like the side effects of much of conventional chemotherapy. That’s probably not a good idea. But multiple promoters, or synthetic promoters, might be used to achieve the aims of killing only cancer cells. Our initial therapeutic will likely just employ p53 promoter targeting, since we have good data that works.

Feinerman: Yeah, the same issue as when we remove or break telomerase gene: there would be nice to do this only in compromised tissue, but as researchers say it is very difficult to make the removal selective. However, it is not a problem with ALT genes, which cause 15–20% of cancers. Are you going to collaborate with the OncoSENS lab? Also killing cells actively expressing telomerase will be very useful in WILT implementation.

Hudson: We’ve had conversations with the SENS Foundation about OncoSENS and cooperated in a preliminary fashion, but I don’t believe it is currently a research priority for them. We already have enough projects to keep us busy for some time, too!

Feinerman: Now you use only suicide gene as an effector, do you plan to use other genes? For example to enhance the cells, give them ability to produce new enzymes, or temporarily shut down telomerase to help anti-cancer therapy to be more effective.

Hudson: We believe we can express any gene under the control of any promoter we wish to use, so the possibilities are almost endless.

Feinerman: Now we know that epigenetic changes (shift) play a huge role in ageing. Even though there is no consensus among researchers whether they are a cause or a consequence of ageing, experiments show that temporal expression of OSKM transcription factors may have some health benefits by restoring “young” epigenetic profiles. You can remember the Belmonte work, for example. However, the problem in their work is that they used transgenic mice and express OSKM in every their cell. If you temporarily express OSKM in an “old” cell, that is OK, you can “rejuvenate” such a cell. While if you express OSKM in a stem cell which is already biologically “young”, you can force the cell into iPSC, which is a way to cancer. Using your machinery we can target only cells which have “old” expression profiles, and involving normal mice! Such a work will be much “cleaner” and safer than Belmonte’s work.

Hudson: With respect to your comments about reprogramming, Oisin is currently working with a university group on exactly this approach, but I can’t say more at this time. We also believe that first you have to clear existing senescent cells, then you can reprogram successfully.

Feinerman: How many resources, finances, and personnel do you need to move as quickly as possible? Do you have open positions? Maybe, some of our readers have enough finances or experience.

Hudson: We could effectively spend tens of millions or dollar or more, very easily, but it isn’t realistic to assume we could raise that amount — and if we did, we’d lose control of Oisin’s ageing focus, since investors would most likely want us to aim at quick returns. We are always interested in talking with “mission minded” investors, however. As for hiring, we have to do that slowly and judiciously, since labour is one of the biggest costs to a start-up company, and over-hiring can sink a project quickly. We already have more potential hires than we can bring on-board.

Feinerman: Now cryptocurrencies and blockchain technologies allow completely new and efficient ways for investments. We can see this as various no-name companies easily rise tens of millions dollars via ICOs for clearly doubtful projects. Would you like to make an ICO? Oisin shows real progress and can easily rise big sums! People say that they will be glad to buy your tokens if you issue them. You have said that you prefer to work with “mission minded” investors. There are thousands people out there who can invest from $1,000 to $100,000 in cryptocurrencies and who believe that radical extension of healthy life is possible!

If you are worried about legal issues, you can use various cryptocurrency investment funds who act like proxies between holders of cryptocurrencies and companies.

Hudson: We have investigated several of these financing options, but we are not expert in this area, so we have been reluctant to move too quickly. But we continue to have conversations with relevant parties. There is a lot of regulatory uncertainty surrounding ICOs, however, so we must move cautiously.

Feinerman: Now we know enough about ageing to defeat our main enemy. Do you agree that first comprehensive rejuvenation panel is not a scientific problem and even not an engineering problem, but a problem of engineering management?

Hudson: I wouldn’t say that there is no science left to do, but as an engineer myself I naturally agree that proper engineering management and program management skills must be brought to bear on the problem of ageing.

Feinerman: One person has said, we get what we ask for. Can we now aim high and publicly claim that our main goal is not additional five years of life but LEV — Longevity Escape Velocity and finally unlimited healthy life?

Hudson: This is a difficult “public relations” problem. Most investors, the scientific community, and the public are not yet ready to embrace the notion of longevity escape velocity. Thus at Oisin we do pitch health span as a primary goal. But personally I don’t believe that you can obtain health span improvements without making significant progress towards LEV. So in the end, I think we get LEV by targeting health span, and we reduce the controversy by doing so.

Feinerman: Some people ask me how to buy your stocks or invest in Oisin. What can you say?

Hudson: We do have a number of private investors (angel investors) who are “mission minded” or “mission focused” and we welcome discussions with qualified investors and firms who share our vision for dealing with ageing and cancer. Accredited investor candidates may contact us at info@oisinbio.com

Feinerman: David Gobel claims that “By advancing tissue engineering and regenerative medicine, we want to create a world where 90-year olds can be as healthy as 50-year olds by 2030.” And I secretly hope that 40 will become new 30 or even 20 by 2030! Can we achieve that — in principle?

Hudson: I certainly hope so! In 2030 I’ll be 80, so I’m looking forward to feeling like I’m 40…

Feinerman: Thank you very much for your amazing answers! That was a real pleasure to talk with such a great man like you. I hope we all will succeed in our goal and will have hundreds, thousands, and — who knows? — maybe even millions years of healthy life!

Hudson: It is kind of you to say so, but I only consider myself fortunate to be working with the really great men and women in the anti-aging community who are doing the real work. I’m only trying to facilitate their efforts and get treatments to the clinic as fast as possible. I don’t know what will be possible in the long term, but anything will be better than letting nature run its course, producing sickness and declining functional health.

Ariel VA Feinerman is a researcher, author, and photographer, who believes that people should not die from diseases and ageing, and whose main goal is to improve human health and achieve immortality.

Message from Ariel VA Feinerman: If you like my work, any help will be appreciated!

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