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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.

A List of Possible FDA Reforms – Compilation by Dan Elton

A List of Possible FDA Reforms – Compilation by Dan Elton

Daniel C. Elton, Ph.D.


I have ranked these according to my own perception of which have the most support among DC bureaucrats and members of congress.

  • Improving transparency. During the COVID-19 pandemic the public has been kept in the dark regarding how key decisions were made, such as the decision to issue an EUA for hydroxychloroquine, the decisions that pushed Pfizer’s EUA from early November to late December, and the decision to require additional Phase III data from AstraZeneca which delayed their EUA by at least 3-4 months. Currently the FDA keeps much of the information relevant to decision making confidential. In theory Freedom of Information Act (FOIA) requests can be used to obtain some information, but in practice FOIAs are slow-walked, may require litigation, and take years to resolve. There are many possible ways to increase transparency at the FDA, some of which are outlined in this recent article in STAT News. 18 specific recommendations can be found in this journal article from 2018. One of people referenced as a top candidate for FDA Commissioner, Joshua M. Sharfstein, is a poor choice when it comes to implementing other reforms but has been a leading voice calling for more transparency.
  • Reciprocity. If a drug/medication is approved by a regulatory agency in a different country which has equivalent standards to the FDA (for instance agencies in the UK or Japan, the European Medicines Agency (EMA), or Health Canada), it should automatically be approved by the FDA (and vice versa). Reciprocity would save both taxpayers and companies a lot of time and money. Imagine if the AstraZeneca vaccine had been approved on January 1st, a few days after the UK approved it. It’s easy to see that tens of thousands of lives would have been saved, especially when you consider it would have been given to the most at-risk first!  In 2015 Senators Mike Lee and Ted Cruz introduced the RESULT Act, which is primarily focused on implementing reciprocity.
  • Making the agency independent from the executive branch. It’s hard to insulate the FDA from political concerns as long as Congress controls the FDA’s purse, but it could at least be removed from direct interference from the executive branch by making it an independent agency like the FCC or Federal Reserve. There seems to be wide support behind this idea right now and recently four former FDA commissioners all endorsed this idea in an interview.
  • Rolling reviews. It should not take 3-4 weeks from the submission of an EUA application until a decision is made, especially when thousands are dying every day while waiting for vaccines. 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, the FDA “could have done the approval in 24-48 hours without cutting any corners”. Likewise, the approval of drugs and therapies after Phase III trials have reached an endpoint should not take 6 – 18 months. While the FDA does engage in a back and forth with companies prior to when they submit their paperwork for an EUA or approval, they do not use rolling reviews. Due to their rolling review systems other countries like the UK were able issue EUAs for COVID-19 vaccines faster than the FDA. Rolling reviews should be the norm, and the submission and analysis of trial data should made as streamlined and as efficient as possible without compromising the integrity of the analysis.
  • Tiered approvals. Doctors who want to provide new drugs to at-risk patients currently have to wait 5-10 years for lengthy Phase III trials to conclude and then another 6 – 18 months for the FDA to carry out their review of the trial data. Tiered approvals would allow a lower level of approval after just Phases I and II, freeing up treatments to those who need them most. The centrist Niskanen center has a white paper which suggests four levels of approval (see also their op-ed in The Hill).
  • Expansion of Right-to-Try. Federal right-to-try legislation was passed in 2018. However, it is very restrictive, and patients need to have met a number of strict requirements before they can try new medications and treatments, greatly limiting its utility.
  • Treating aging as a disease. Currently it is illegal to market an FDA-approved product as a treatment for aging. Even though aging is a harmful biological process, it is not considered a legitimate “indication” for a drug or therapy by the FDA. In other words, the FDA doesn’t view aging as a “disease” and therefore anti-aging treatments fall outside their mandate. Some specific aspects of aging are also not considered as legitimate indications. The FDA is currently operating in an inconsistent way as some conditions which are due to the aging process can are considered legitimate targets, such as osteoporosis and menopause, but others, like sarcopenia (age-related muscle loss /frailty), are not.  Many experts, including David Sinclair, have spoken out about this issue. Some companies have found ways to get around the FDA’s restrictions, such as by using certain metabolic markers to track the degree of damage from aging. However, the impossibility of getting FDA approval for therapies that directly slow down or repair the damages from aging greatly dis-incentivizes industry R&D investment in this area.  Fortunately, with advanced gene and stem-cell therapies on the horizon, the Congress and the FDA have already taken a few steps towards being able to review and approve anti-aging drugs and therapies. The 21st-Century CURES Act, for instance, mandated the creation of the Regenerative Medicine Advanced Therapy designation at the FDA.
  • Challenge trials in emergency situations. Many people, including a group of legislators, lobbied the FDA to give companies the go-ahead to do challenge trials, but there was no action. Thousands of volunteers for COVID-19 challenge trials signed up with 1daysooner.org but were unable to participate as they had wished to. As a result, data on vaccine efficacy was obtained much slower than it could have been.
  • Use of the proactionary principle for all drug & therapy approvals. The FDA should publish a transparent, quantitative, scientifically informed, and structured cost-benefit analysis for each regulatory action performed, which estimates the expected quality-adjusted life years (QALYs) saved versus risk of QALYs lost for both the action and inaction. The analysis should be made public, ideally sometime before the decision goes into effect. Crucially, the analysis should enumerate the risks and benefits of granting an approval and the risks and benefits of not granting it. See Max More’s overview of the proactionary principle and his chapter in The Transhumanist Reader, where he presents not just a principle but an entire framework for rational decision making. The key reform here is to make it mandatory that decision making at the FDA be highly structured and quantitative so it under less sway from political concerns and cognitive biases. If such a framework for rational decision making was in place it’s unlikely the FDA would have decided to delay Pfizer’s Emergency Use Authorization (EUA) from early November to December 11th, a decision which cost tens of thousands of American lives.
  • Free to Choose Medicine with a Trade-off Evaluation Database.  In brief, Free to Choose Medicine would create an additional track after Phases I and II to allow doctors to prescribe new therapies to at-risk patients who are unable or unwilling to participate in a Phase III trial. Patients in the Free-to-Choose Track would be mandated to submit data to a trade-off evaluation database, creating a trove of valuable real-world data (this could be genetic, biomarker, and adverse events data, for instance).  See this excellent podcast interview with Bart Madden for more information. 

Figure from Bart Madden, “Free to Choose Medicine“, The Heartland Institute

 

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. 

U.S. Transhumanist Party Reform Summit – Public Session – November 29, 2020

U.S. Transhumanist Party Reform Summit – Public Session – November 29, 2020

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Gennady Stolyarov II
David Shumaker
Charlie Kam
Dan Elton
Pavel Ilin
Art Ramon Garcia, Jr.
David Wood
Chris Monteiro
Edward Hudgins
Alexandria Black
Jason Geringer
Osinakachi Akuma Kalu


On Sunday, November 29, 2020, at 1 p.m. U.S. Pacific Time, the U.S. Transhumanist Party held the Public Session of its Reform Summit as its Virtual Enlightenment Salon for that week. During the Reform Summit, USTP Officers and several trusted members discussed some of the outcomes of a previous closed Executive Session and potential ideas to put forward before the membership. Member input was also solicited via the YouTube chat on the following issues:

1. Community Resilience / Preventing Troublemakers
2. Organization / Structure
3. Financial Matters (if Any)

The USTP Reform Summit was highly productive, and important reforms to the U.S. Transhumanist Party Constitution are expected to be proposed during December 2020 based on the input provided by USTP Officers and members in the course of the conversations.

Read USTP Chairman Gennady Stolyarov II’s Fourth Anniversary Message.

Join the USTP for free, no matter where you reside.

Become a Foreign Ambassador for the U.S. Transhumanist Party.

U.S. Transhumanist Party Chairman’s Fourth Anniversary Message

U.S. Transhumanist Party Chairman’s Fourth Anniversary Message

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Gennady Stolyarov II


Gennady Stolyarov II, Chairman, United States Transhumanist Party
Gennady Stolyarov II, Chairman, United States Transhumanist Party

The fourth year of my Chairmanship of the U.S. Transhumanist Party has been a test of leadership unlike any I expected to face. Working to advance a small but determined transpartisan organization during a deadly global pandemic and a time of unprecedented (for the modern era) political division and toxicity is not an undertaking for the faint of heart. Indeed, the worst is still not behind us, despite science and technology again coming to the rescue with the rapid development of safe, effective vaccines for COVID-19 in a timeframe unmatched in all of human history by its rapidity. This is clearly an achievement for contemporary biomedical research, and it illustrates again the aspects of human endeavor that will hopefully extricate ourselves from humankind’s dire crisis within a few months’ time. Other aspects of this crisis – the immense and utterly counterproductive societal rifts that it has created, the economic and psychological strain it has imposed upon people, the material disruptions to our civilization that will take heroic efforts to mend – may be longer-lasting. The tension of these influences has made crafting this Chairman’s Message my most difficult effort by far compared to prior years – as it was necessary to both acknowledge the dire predicament that humankind is currently mired in, and to outline possible ways out through our direct actions. However, I hope that this message, which I began to write on November 17, 2020, the actual four-year anniversary of my selection as USTP Chairman, will clearly outline the various dimensions of my thinking regarding the present situation and future prospects.

This pandemic fortified my confidence in science and technology while greatly diminishing it with regard to contemporary human societies and American society especially. As I explained in my presentation at the Vanguard Scientific Instruments in Management (VSIM) 2020 virtual conference on July 29, 2020 (video recording forthcoming), the great crisis of 2020 is essentially manmade. While COVID-19 results from a naturally occurring virus and is highly dangerous, systemic human failures transformed the pandemic into a major worldwide crisis. These human failures exposed the severe vulnerabilities in contemporary societies against relatively simple threats. Societies have turned inward, degenerating into tribal, factional conflict, instead of fighting the common enemies of death and disease. Science has become politicized in a deleterious, tribal way, and the politicized versions have anything but the hallmarks of true science – traits such as openness to empirical evidence, systematic testing of hypotheses, willingness to acknowledge evidence that challenges a prior hypothesis and to refine one’s hypotheses accordingly. Neither the “red tribe” nor the “blue tribe” are logically consistent or open to evidence, instead choosing to cherry-pick tidbits from science that happen to support their preconceived agendas. Because of American influence throughout the globe, the entire world suffers from American political toxicity. Worse, the material and psychological stresses of the pandemic are pushing some people over the brink into destructive madness. Mainstream propaganda with ulterior motives amplifies this tendency, prompting unstable personalities toward violence. Although the scientific means to overcome this pandemic are already here with us, persistent cultural, attitudinal, and institutional failures may lead to delayed application of the remedies and thus the needless deaths of tens of thousands more Americans – and certainly the needless suffering of millions.

It is no surprise that, given the pervasiveness of American societal failure in 2020, aspects of the toxic tendencies involved attempted to seep even into the organization which has sought to be a small but bold and high-minded bastion of resistance to these ills. Much time and energy has unfortunately been expended to fend off the destructive behaviors of a small number of detractors who sought, despite my staunch resistance, to import the rancorousness of mainstream politics into the USTP. And yet, in spite of this, while the USTP has needed to pivot and adjust in multiple respects, the creative output of this organization has been phenomenal despite an environment of ubiquitous world crisis. My initial – rather unrealized – strategic inclination in the midst of this pandemic had been to chart a course of careful maintenance of what was and a more relaxed and deliberative pace of activity to enable us all to focus on immediate needs in adjusting to the pandemic. Similarly to how I personally resolved to avoid major life changes while the pandemic raged, my aim for the USTP had been primarily one of preservation – and yet these times require one to keep adjusting. The ultimate result has, notwithstanding my initial inclination, been major acceleration of activity in many areas – often too rapid to even systematically publish updates about. While we have recently exceeded 3,000 members and are still working to integrate all of the members from our merger with the Longevity Party United States in February 2020, we have consistently produced output on a scale worthy of an organization with several orders of magnitude more resources at its disposal. This could not have been done successfully without the dedicated core of Officers, Advisors, and members who have maintained a steadfast commitment to the USTP during these troubled times. These individuals have always greatly outnumbered the troublemakers, and it is for them primarily that the USTP exists and persists no matter what obstacles it faces.

The Virtual Enlightenment Salons, of which we have already held 30 every Sunday since May 2020, have been an immense feat of the U.S. Transhumanist Party, brought about by our Officers’ rapid adaptation to the circumstances of the pandemic and the opportunities created by the consequent higher level of utilization of videoconferencing and streaming technologies. Whereas the logistics for our USTP Primary debates in 2019 were complex and cumbersome, the Virtual Enlightenment Salons are able to be carried out far more reliably and with superior production quality. The audience of these gatherings is dedicated, vibrant, and insightful, as the comments accompanying the Virtual Enlightenment Salon videos illustrate. Special thanks are due to David Shumaker, the USTP Director of Applied Innovation, for hosting the Zoom sessions for the panelists, and to Pavel Ilin, USTP Secretary, and Art Ramon Garcia, Jr., USTP Director of Visual Art, for their work on streaming the salons to YouTube – and also to Art Ramon Garcia for his polished graphics that convey both the dignity and the mindsets of exploration, expansion, and discovery that characterize the Virtual Enlightenment Salons. If anyone had told me a year ago that I would be involved in not a mere handful, but thirty Enlightenment Salons in 2020, I would have been hard-pressed to believe this – and yet this is an illustration of how technological progress and, more importantly, technological utilization, can enable exponential and not just linear growth in valuable output.

In addition, the U.S. Transhumanist Party has been at the forefront of developing constructive policy options for addressing the ongoing pandemic. Shortly after the disruption from the pandemic set in, the members of the USTP got to work, developing 21 Platform sections, outlining a comprehensive, multifaceted approach toward defeating COVID-19, preventing future pandemics, and prioritizing medical innovation – particularly in anti-aging research – to greatly lower the toll of infectious diseases even in those who contract them. If only these ideas had been taken into account by mainstream politicians and implemented in early April 2020, likely tens of thousands of American lives would have been saved – through rapid construction of hospitals, training of a rapid-response corps of medical personnel, removal of barriers to vaccine deployment, improved general education on pandemics, and the rapid, decentralized production of supplies of every sort needed to assist people in their protective efforts. Many of these 21 proposals can still be implemented today to great effect and could help accelerate the arrival of our victory against COVID-19. The USTP encourages all of its members and others among the general public to advocate for these measures.

Out of all of the priorities I had set forth in my Third Anniversary Message one year ago, the goal of building alliances with like-minded organization has been the most successfully realized. This has been a year of forging ties with other future-oriented organizations throughout the world, including the Transdisciplinary Agora for Future Discussions (TAFFD’s), whose Future Africa Conference in April 2020 was highly attended by USTP members and Officers; the World Talent Economy Forum (WTEF), which has hosted numerous interviews with USTP representatives and candidates; the Human Achievement Alliance, which espouses the same essential broadly techno-optimistic vision that the USTP seeks to advance; the Ogba Educational Clinic, which aims to bring knowledge of programming and artificial intelligence to students in Nigeria, Steele Archer’s Debt Nation and Archer Report programs, and many others. The hundreds of conversations, interviews, meetings, forums, and posts exchanged among our organizations are truly enabling a distributed, worldwide network of transhumanist and futurist thought to emerge. The resulting proliferation of rational discourse and innovation is greater than any one organization can contain – and indeed, ideally, can transform humankind as a whole significantly for the better.

Of course, no analysis of 2020 can be complete without commentary on the election season in the United States and its outcomes. While the 2020 election has shown that American politics has a long way to go in order to climb out of its abyss, it also featured several noteworthy accomplishments and reasons for hope.

Vote Results – 2020 Elections

Kam-Parrish 2020 Presidential Campaign

Thus far we are aware of 51 write-in votes having been cast for Charlie Kam and Liz Parrish. Preliminary member-reported totals are found here and will be updated as additional information is received, including when any state which counts write-in votes publishes its results. We are pleased by the dedication of our members who chose to vote their consciences in the states that allowed write-ins, and who moreover proactively reported those votes to us per our request. Anyone who still has not done so can contact us at ustranshumanistparty@protonmail.com in order to be counted as having voted for Charlie Kam and Liz Parrish. We want every write-in vote for our candidates to be recognized!

Considering the turn of events that led Charlie Kam to become our candidate in June 2020, at quite a late stage in the election season, the U.S. Transhumanist Party appreciates what has been achieved in the subsequent 4.5 months. Despite the detailed ballot-access plan that the USTP developed internally in January 2020, the ravages and risks of the COVID-19 pandemic made any petitioning for ballot access and in-person campaigning impractical (we are life-extensionists, after all, and preservation of healthy longevity is our foremost priority). Notwithstanding this pandemic-imposed constraint, both Charlie Kam and his Vice-Presidential running mate, Liz Parrish, served as outstanding ambassadors for the USTP and were indeed our best candidates yet. In the course of many external interviews as well as appearances at the U.S. Transhumanist Party’s weekly Virtual Enlightenment Salons, Charlie Kam and Liz Parrish illustrated a new approach to politics – one based on substantive discussion of issues and policies, a focus on the need for technological innovation to improve the lives of all, and an appeal to the aspirations that unite us rather than the mainstream politicians’ focus on division. As we have emphasized time and again, the primary purpose of Transhumanist campaigns at this stage of our evolution is one of educating the public about the ideas and goals of transhumanism. In this regard, the Kam-Parrish 2020 campaign succeeded, and I am proud to have contributed my time and support to its activities. Charlie Kam and Liz Parrish will remain prominent and eloquent ambassadors for the USTP, and we hope that our future candidates will be able to live up to the examples that they set of high-mindedness, civility, integrity, techno-optimism, and dedication to longevity advocacy.

For a wonderful illustration of the tone of the Kam-Parrish 2020 campaign and the hopeful outlook with which it concluded, watch the final joint interview of Charlie Kam, Liz Parrish, and myself by our ally in Malaysia, Sharif Uddin Ahmed Rana of the World Talent Economy Forum, conducted on November 2, 2020, the day before the U.S. general election.

A glimpse into a parallel universe, courtesy of Charlie Kam
A glimpse into a wondrous parallel universe, courtesy of Charlie Kam

Local Campaigns

Daniel Twedt – City Council, Thousand Oaks, California

U.S. Transhumanist Party member Dan Twedt ran for City Council in Thousand Oaks, California, and gained 3.437 votes, or 3% of the total. During his campaign, he spread awareness of the U.S. Transhumanist Party in local newspapers. An excerpt from the Acorn Newspaper in Thousand Oaks characterized Mr. Twedt as “a member of the Transhumanist Party” with “a platform tied to technology and the environment.” Mr. Twedt was cited as expressing the view that “government needs be way more open-source, way more transparent”. Mr. Twedt plans to run again in 2022, and we encourage his continued activities within the USTP, such as his regular participation in our weekly Virtual Enlightenment Salons, and his public outreach when campaigning.

Gennady Stolyarov II – Board of Trustees, Indian Hills General Improvement District, Douglas County, Nevada

My second attempt to run for the Board of Trustees of the Indian Hills General Improvement District was unfortunately thwarted by the occurrence of a primary in June 2020, in the midst of a pandemic. Because of physical-distancing restrictions as well as general concern for health and safety, I decided to campaign using solely virtual means, including holding a Virtual Town Hall via Zoom on May 9, 2020. Nonetheless, there remains a technological gap in the area, and it appears that many residents simply do not get their local news or gain awareness of candidates and issues via electronic means. Moreover, a wave of anti-development sentiment has unfortunately swept Douglas County, resulting in the election of three anti-growth Republican County Commissioners who have vowed to put limits on new construction and residential housing in the name of “keeping Douglas County rural” – which essentially means keeping it unaffordable for those who did not purchase homes there a long time ago. Perhaps these sentiments also translated into voters’ choices for the Board of Trustees of the General Improvement District, and my open and unabashed advocacy of more residential development and more technological utilization certainly clashed with this reactionary mentality. However, I will never apologize for standing on principle and supporting progress in material standards of living, even if it clashes with some people’s attempts to freeze a particular status quo in place. I also remain hopeful that ongoing new construction in the area will continue and help reduce the cost of housing and improve the quality of the infrastructure despite the anti-development partisans’ objections.

The presence of five candidates on the ballot triggered the primary, and one of the candidates who advanced finished with only 17 votes ahead of me (270 votes to my 253). Subsequently, that candidate indicated that he would not accept the office of Board Member if he were elected, effectively leaving three candidates to compete in the general election. This turn of events underscores the importance of candidates being committed to the responsibilities involved in the offices for which they run. Candidates should run only if they are determined to follow through all the way and carry out the duties of the office if they are elected to it. Had the aforementioned candidate decided against running for office to begin with, given his uncertainty about accepting it, then there would not have been a primary, and I would have had about 4.5 additional months to campaign and communicate a rational, transpartisan, and future-friendly approach to the residents.  Still, receiving 253 votes out of 1216 ballots cast during a low-turnout primary means that I have successfully reached 20.8% or more than one-fifth of the voting residents. The challenge for future campaigns will be to determine by what channels information spreads in these local elections. There had not been any significant media coverage of the other candidates, and extremely little information was discoverable about them online prior to the primary. Therefore, how were they able to gain recognition and votes during a pandemic in which physical distancing was mandated for the vast majority of the campaign season? Discovering how information can effectively propagate through “offline” channels may lead to insights regarding how more generally to communicate awareness of transhumanist ideas to the broader public.

Ballot Initiatives in Nevada and California – Outcomes as Compared to USTP Recommendations

In Nevada, the recommendations of the USTP and Nevada Transhumanist Party (NTP) prevailed among voters on Ballot Question 2, the Marriage Regardless of Gender Amendment, which passed with a vote of 62.4% in favor, and Ballot Question 3, the State Board of Pardons Commissioners Amendment, which passed with a vote of 61.2% in favor. However, Nevada voters also chose to adopt the two ballot questions that were opposed by the USTP and NTP – Ballot Question 4 (64.1% of voters in favor), which would enshrine in the Nevada Constitution a list of voter rights based on the current, soon-to-be-obsolete paper-based voting system, and Ballot Question 5 – the Renewable Energy Standards Initiative (57.9% of voters in favor). Although the USTP and NTP hope that more than 50 percent of energy sold to consumers could indeed come from renewable sources by 2030, the USTP and NTP wish for this to be achieved through voluntary methods of technical progress and increasing affordability of renewable energy, not through mandates that (if they supersede the pace of technological advancement) would simply raise energy costs for ordinary consumers. Still, the USTP and NTP do not consider the passage of Ballot Questions 4 and 5 to be significant obstacles to the progress of transhumanism and emerging technologies as such; we would have preferred different outcomes, but our efforts will not be materially affected by the results of these votes.

In California, the outcome of the ballot propositions was even more aligned with the USTP’s recommendations, illustrating that on many issues, the USTP has tapped into the outlooks and priorities of many voters who do not strictly adhere to partisan ideologies. On eight out of ten or 80% of ballot propositions on which the USTP made a recommendation in a particular direction, the majority of California voters also favored that course of action.

California Proposition 14 – Stem Cell Research Institute Bond Initiative

USTP Position: Support

Outcome: Passed with 51.09% in favor

The passage of California Proposition 14 is perhaps the most significant victory for transhumanists, as it makes available $5.5 billion in new funds for potentially life-saving stem-cell research initiatives.

California Proposition 15 – Tax on Commercial and Industrial Properties for Education and Local Government Funding Initiative

USTP Position: Oppose

Outcome: Failed with 51.97% in opposition

Most California voters agreed with the USTP on the undesirability of further increases of property taxes – one of the least equitable and least convenient forms of taxation.

California Proposition 16 – Repeal Proposition 209 Affirmative Action Amendment

USTP Position: Oppose

Outcome: Failed with 57.19% in opposition

Most California voters agreed with the USTP that the imposition of racial preferences in public employment and education is inherently unjust and anathema to a society that values individual rights and individual attributes of character over people’s circumstances of birth.

California Proposition 17 – Voting Rights Restoration for Persons on Parole Amendment

USTP Position: Support

Outcome: Passed with 58.57% in favor

Most California voters agreed with the USTP that there is no reason to deprive the essential right to vote from individuals who have completed their prison sentences.

California Proposition 18 – Primary Voting for 17-Year-Olds Amendment

USTP Position: Support

Outcome: Failed with 56.01% in opposition

This was an issue on which the majority of California voters differed from the USTP’s recommendations. Perhaps the attitudinal climate has not yet matured to the point of accepting that a person’s individual understanding of the political system and the issues involved should be the determinant of eligibility to vote – rather than an arbitrary dividing line such as that of age. However, there will be opportunities to continue articulating these principles in the years to come.

California Proposition 20 – Criminal Sentencing, Parole, and DNA Collection Initiative

USTP Position: Oppose

Outcome: Failed with 61.73% in opposition

Most California voters agreed with the USTP regarding the undesirability of measures that would significantly increase the population in prison for relatively minor criminal offenses, such as petty thefts and various nonviolent crimes. Such crimes are better addressed through restitution than through imprisonment.

California Proposition 21 – Local Rent Control Initiative

USTP Position: Oppose

Outcome: Failed with 59.84% in opposition

Most California voters agreed with the USTP in rejecting rent control. In the absence of new construction, rent control creates undesirable incentives that harm tenants of rent-controlled buildings directly and indirectly. Everyone should hope that California will instead loosen the many onerous restrictions on new housing development, which have contributed to a dire shortage of available housing and an essentially complete lack of housing affordability in that state.

California Proposition 22 – App-Based Drivers as Contractors and Labor Policies Initiative

USTP Position: Support

Outcome: Passed with 58.59% in favor

The USTP is relieved that most California voters supported saving the ridesharing business model on transportation network companies by rejecting the presumptive classification of their drivers as employees – a classification that the drivers themselves would find onerous and restrictive. As the USTP stated in its analysis, “It is clear that classifying ridesharing services’ drivers as employees is intended as protectionism for legacy taxicab companies, whose business model has often resulted in sub-optimal treatment of consumers and thus led to widespread consumer frustration. On the other hand, most consumers have expressed overwhelming satisfaction with ridesharing services. California Ballot Proposition 22 restores the more reasonable classification of ridesharing services’ drivers as independent contractors while affording them basic protections regarding their earnings, healthcare, and vehicle insurance.”

California Proposition 23 – Dialysis Clinic Requirements Initiative

USTP Position: Oppose

Outcome: Failed with 63.45% in opposition

Most California voters agreed with the USTP in opposing the requirement for at least one licensed physician be on site during treatment at outpatient kidney dialysis clinics. Voters recognized that, because of the dire shortage of available physicians, especially during the COVID-19 pandemic, this requirement would mean that many dialysis clinics would be unable to operate or offer life-serving services to patients who require dialysis.

California Proposition 25 – Replace Cash Bail with Risk Assessments Referendum          

USTP Position: Support

Outcome: Failed with 56.40% in opposition

This was another issue on which the majority of California voters differed from the USTP recommendation. The failure of Ballot Proposition 25 likely means that California will keep its previous system of cash bail instead of abolishing the requirement of cash bail and replacing it with a system of risk assessments for each accused individual. Per the USTP’s position statement, “A person who goes to trial and is exonerated for the alleged offense should not be made any poorer as a result, yet the system of cash bail channels many people in already precarious financial situations into arrangements which lead exactly to such impoverishment.” Unfortunately, it appears that the cash bail system will still persist in California for some time. Nonetheless, this situation is not expected to pose a material obstacle to the attainment of the vast majority of transhumanist goals.

Future Initiatives

With the 2020 election behind us, the U.S. Transhumanist Party’s focus will be on effectively scaling up its operations, maintaining broad unity of purpose and constructive conduct within the transhumanist movement, and participating in wider public discourse on the issues where science and technology can positively affect outcomes.

Working Groups: The USTP is beginning to set up small, focused, project-oriented working groups, each of which will produce a particular set of deliverables – be it a white paper on a policy topic, a computer game on life extension, a survey of members, upgrades to the USTP’s voting system, new graphical assets, or a variety of other possibilities. Some working groups may have an ongoing role, such as providing responses to current events or emerging issues within the transhumanist community. In particular, it will be important to form a working group on legislative tracking and advocacy in order to be able to effectively monitor and respond to proposed legislation at both state and federal levels. Volunteers for future working groups will be welcomed and actively solicited, as long as they exhibit integrity and sincerity of intention.

Member Education and Tiered Membership: The USTP continues to seek ways to reward its most dedicated and knowledgeable members, who should have a stronger influence over the outcomes of our votes. Membership of a more prestigious tier could be the result of passing a future set of online learning units on the USTP Platform, Transhumanist Bill of Rights, and other key documents.

Candidate Education and Eligibility Criteria: The USTP will endeavor to enhance the respectability and transhumanist alignment of the candidates who seek its endorsement by creating more extensive upfront candidate eligibility criteria which will focus on respectability of conduct, a history of dedication to transhumanist ideas, and a spirit of ambassadorship from the candidates, instead of ulterior non-transhumanist motives or personal political ambition. Candidates should be willing to use their pre-existing personal merits and position to promote the ideas of transhumanism, rather than seeing the USTP as a vessel for any alternative, non-transhumanist agenda or personal motive.

Candidates for Non-Presidential Offices: The USTP continues to seek out promising candidates for local and state-level offices and has already identified several promising individuals who may be able to effectively promote the ideas of transhumanism during the next midterm elections in 2022 or possibly even earlier.  One question that the USTP will place before its members for consideration is the matter of whether or not affiliations with other political parties should restrict the USTP from endorsing a particular candidate if that candidate explicitly expresses support for transhumanism and/or life extension. The USTP welcomes diverse member perspectives regarding where the boundary should be drawn so that we preserve our distinctive organizational identity while recognizing any techno-positive efforts that advance our vision in the U.S. political arena.

Focus on Ballot Initiatives: One of the USTP’s great strengths is the analytical talent present within it. Almost every state places several questions on the ballot for voters to decide upon directly. The impact of these ballot initiatives is often more significant and more accurately foreseeable than the outcomes arising from the identity of a given elected official. If the USTP can provide recommendations on every ballot initiative in a given election, this will greatly enhance its credibility as a source of reliable policy analysis for large numbers of people. Many of our views are already aligned with large populations of independent voters; they just have to discover us and have ample content from the USTP that they could rely upon in regard to policy questions of interest to them.

Ballot-Access Collaboration with Other Political Parties: Lowering barriers to entry in elections at every level is a common aim shared by the USTP and other political parties with the exception of the Democrats and Republicans. As evidenced by our highly constructive Virtual Enlightenment Salon with Spike Cohen on September 13, 2020, there is an opportunity for concerted efforts among representatives of multiple political parties to assist one another in advocating for greatly lowered ballot-access thresholds and perhaps even coordinate the circulation of petitions once the present pandemic is behind us.

Anti-Troll Campaign: The USTP has not forgotten the importance of effectively responding to trolls and detractors within the transhumanist community who inflict a greater toll upon it than any external critic or adversary. We encourage our members to contribute resources to the anti-troll campaigns, such as tasteful images that can be posted to counter comments and crude “memes” that trolls sometimes deploy. Be both creative and dignified! It is possible to do so and also to amuse and entertain well-intentioned audiences. Show that we can be better than the trolls even in their media of choice!

The above-listed areas are not exhaustive of the endeavors that the USTP intends to pursue. Indeed, our Virtual Enlightenment Salon this coming Sunday, November 29, 2020, will be the Public Session of our U.S. Transhumanist Party Reform Summit, where additional ideas will be both presented to and solicited from our members.

Conclusion

As I have often expressed this year, the future can be bright indeed, if only we can overcome the extreme predicament of the present. No set of ideas prevails automatically or inexorably. The key to success is perseverance, even and especially in the face of adversity and doubt from some. Those who waver and continually change course will never reach any particular desirable destination. While this pandemic has been a strenuous period for all – including perhaps the majority of us in the transhumanist movement – it has only fortified my determination to make the U.S. Transhumanist Party a lasting and ever-expanding success. Since becoming Chairman of the USTP more than four years ago, I have come to recognize clearly the indispensability of this organization to the advancement of transhumanism more broadly, as the USTP has become the nexus of conversations, collaborations, and meetings of great minds who might otherwise never have come into contact. Moreover, the USTP openly and proudly embraces transhumanism without downplaying it or giving lip service to techno-pessimist criticisms. Of course, the success of the transhumanist vision is crucial to the success of humanity as a whole – making a key difference in which path our species takes. Do we reach toward the stars, toward indefinite longevity, toward sustainable superabundance – or do we allow the cascade of present crises to plunge us into the abyss of a new Dark Age? These are outcomes over which we can have control, and the locus of control begins with the transhumanist movement itself. This year more than ever, I urge unity and steadfastness of purpose. Do not allow petty personality conflicts, lack of self-control, and factionalism derail potentially the most pivotal ideas, aspirations, and projects in human history. Support the people who build and uplift, rather than those who destroy and tear down. All those who earnestly seek to advance the well-being of humans through the progress of science and technology – and who are willing to behave civilly while doing so – are welcome to contribute to the endeavors of the U.S. Transhumanist Party and help take our organization to the next level.

U.S. Transhumanist Party Condemns Unjustified Shootings and Crowd Violence in Wisconsin and Washington, D.C., Calls for Unity for a Brighter Future

U.S. Transhumanist Party Condemns Unjustified Shootings and Crowd Violence in Wisconsin and Washington, D.C., Calls for Unity for a Brighter Future

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August 29, 2020 – The United States Transhumanist Party (USTP) expressed alarm at the troubling and saddening events in Kenosha, Wisconsin, which began with the tragic and unjustified shooting on August 23 by police of Jacob Blake, an unarmed black man, multiple times in the back. Violence was escalated in subsequent days by looters who robbed and destroyed numerous peaceful businesses, and also by a lone individual who killed two protesters. During the night of August 27, 2020, while returning from the Republican National Convention in Washington, D.C., Kentucky Senator Rand Paul, a long-time advocate critic of police shootings and advocate of police reform, was violently assaulted along with his wife, by a crowd of about 100 protesters who threatened his life and attempted to push through the police who were escorting him and to violently lunge at him.

Opposition to racism and other circumstantial discrimination, as well as the unequivocal condemnation of violence resulting from such attitudes, has been a cornerstone of the USTP Platform since its inception. Section II of the USTP Platform, adopted by its members during the first USTP Platform vote held on January 15-21, 2017, and subsequently amended during November 11-17, 2017, reads, “The United States Transhumanist Party supports all acceptance, tolerance, and inclusivity of individuals and groups of all races, genders, classes, religions, creeds, and ideologies. Accordingly, the United States Transhumanist Party condemns any hostile discrimination or legal restrictions on the basis of national origin, skin color, birthplace, ancestry, gender identity, or any manner of circumstantial attribute tied to a person’s lineage or accident of birth. Furthermore, the United States Transhumanist Party strongly opposes any efforts to enforce said restrictions regardless of cause or motivation thereof. Additionally, any institution that uses violence, suppression of free speech, or other unconstitutional or otherwise illegal methods will be disavowed and condemned by the United States Transhumanist Party, with an efficient, non-violent alternative to said institution being offered to achieve its goals if they align with the Party’s interests.”

The USTP has also long stood against police brutality and excessive use of force. During a vote held during March 26 – April 1, 2017, the USTP members adopted Section XXI of the USTP Platform, which reads, “The United States Transhumanist Party supports a concerted effort by governments and by public opinion to eradicate police brutality against peaceful citizens, such that violent force is only utilized against individuals who actually pose an imminent threat to human lives.”

The text of Section XXI was originally authored in 2015 by USTP Chairman Gennady Stolyarov II, who remarked, “Police brutality has long been a personal issue for me. In June 2009, I was peacefully exercising in the fitness center of my apartment complex at the time, when two police officers barged in with guns pointed at me, in response to an alarm triggered by an unknown individual, which summoned them automatically. This situation was the closest I had ever come to death and thus was the moment in my life where I as a transhumanist faced the greatest threat and the greatest injustice. I managed to successfully narrate my every move to the police and de-escalate the situation over the course of a minute during which guns were pointed at me. But I sometimes wonder what my fate would have been had I lacked the presence of mind to cooperate, or had I looked different or been less readily able to prove that I had a key to the facility. The next day I learned from the assistant manager of the apartment complex that the police had treated him the same way. It became apparent to me that threatening and deploying lethal force against unarmed individuals has become a default modus operandi for American police – a practice that verges dangerously close to a bias for shooting first, asking questions later. We can also expect that every organization will have its ‘bad apples’ – individuals without moral restraint, who are also often prone to racial stereotyping. Combining violence-prone training with violence-prone mentalities of the few but still highly damaging racially biased police officers leads to a situation where many black Americans have suffered disproportionately from these unjust killings – but many Americans of all backgrounds have paid this heavy toll as well. No unarmed, non-violent, or non-lethally-violent person – of any skin color – should ever be killed, injured, or threatened with such undeserved punishments by police.  No other country with even a quasi-representative form of government has anywhere near the rate of police killings that are widespread in the United States. It is evident that police training and protocols regarding the use of force need urgent reform, and far less violent options that are routinely practiced in Europe, Canada, and Japan should be implemented in the United States.”

“It is evident that police training and protocols regarding the use of force need urgent reform, and far less violent options that are routinely practiced in Europe, Canada, and Japan should be implemented in the United States.”
~ Gennady Stolyarov II, Chairman, United States Transhumanist Party

The USTP Platform advocates for numerous other measures to quell police brutality, including Section XXXIV (sousveillance / body cameras), Section LXXXIX (prohibition against police being equipped with military-grade hardware), Section XC (requirement for police to be equipped with and mostly use rubber bullets), Section LIX (requirement for outside investigations of police misconduct), Section LX (prohibition of collusion among law-enforcement entities to cover up police misbehavior), Section LXXXVI (improved reporting of police misconduct), and various additional approaches to achieve police accountability. Had these measures and others – such as banning no-knock raids, banning chokeholds, implementing mandatory de-escalation protocols and interventions by police officers who observe wrongdoing by their colleagues, and ending qualified immunity for police officers accused of misconduct – been implemented in the United States, many victims of police killings – including Tamir Rice, George Floyd, Breonna Taylor, and USTP member Duncan Socrates Lemp, who was killed by a SWAT team during a no-knock raid in Potomac, Maryland, on March 12, 2020 – would likely have been alive today.

Moreover, Section VI of the USTP Platform champions morphological freedom, defined as “the right to do with one’s physical attributes or intelligence whatever one wants so long as it does not directly harm others” and entailing “the duty to treat all sapients as individuals instead of categorizing them into arbitrary subgroups or demographics”. Discussing the implications of morphological freedom, Art Ramon Garcia, Jr., the USTP Director of Visual Art, articulated the hope that it will “make white supremacy irrelevant” and likewise obliterate the remnants of every other form of irrational prejudice based on a person’s origins, “morphological freedom in an age of genetic engineering […] will allow anyone to become anything.”

“Morphological freedom will make white supremacy irrelevant. Morphological freedom in an age of genetic engineering will allow anyone to become anything.”      ~ Art Ramon Garcia, Jr., Director of Visual Art, United States  Transhumanist Party

Tom Ross, the USTP Director of Sentient Rights Advocacy, condemned the violence in Kenosha and explained that “These [shootings] are racist. A white man walked right by cops with an assault rifle strapped to him and Jacob Blake was simply walking away.” Mr. Ross pointed to two of the USTP’s three Core Ideals being in conflict with these violent events.

The USTP’s Core Ideal 2 states, “The Transhumanist Party supports a cultural, societal, and political atmosphere informed and animated by reason, science, and secular values.”

Mr. Ross remarked regarding the police shooting of Mr. Blake, “The actions of the police are not reasonable. They are fueled by systemic racism which the U.S. has been mired in for two plus centuries. We also recognize that the current Executive Branch of the government is fomenting this violence by ignoring the overwhelming call for tolerance and equal justice for African-Americans and other minorities. We recognize that this current President is desperate to stay in office by whatever means necessary to avoid charges and possible imprisonment if defeated. He is attempting to do so by fanning the flames of civil unrest and emboldening racist actions in our Law Enforcement. The USTP absolutely recognizes that these actions and personalities are the exception that proves the rule, and we do not promote defunding the Police entirely; rather we think Police Departments are overburdened by activities that other civil social operations should handle, and funding should be redirected. But let’s call it what it is, racism and an abuse of power.”

The USTP’s Core Ideal 3 states, “The Transhumanist Party supports efforts to use science, technology, and rational discourse to reduce and eliminate various existential risks to the human species.”

Mr. Ross pointed to how the downward spiral of violence can endanger the prospects of humanity. “One of the clear existential threats to our species is the sensationalization of such violence. Today’s media technology is used too often to share discord, and our news services understand that sensational stories with ‘graphic content’ are ways to increase ‘likes’ and ‘views’, which directly affects their ratings and revenue. Media plays on the basest instincts in humanity and profits on this greatly. The ‘Human Condition’ has been made to be a negative attribute because of this machine of sensationalism. ‘If it bleeds it leads’ is the principle on which this machine operates. Although we recognize that this ship will not be easily turned, the USTP strives to find trimtabs in our society that can make the small and necessary changes in their own communities to right the ship of state.”

 

“One of the clear existential threats to our species is the sensationalization of such violence. Today’s media technology is used too often to share discord, and our news services understand that sensational stories with ‘graphic content’ are ways to increase ‘likes’ and ‘views’, which directly affects their ratings and revenue. Media plays on the basest instincts in humanity and profits on this greatly.” ~ Tom Ross, Director of Sentient Rights Advocacy, United States Transhumanist Party

At the same time, the USTP emphasized that more violence is never the answer to the problem of unjustified violence. “The businesses in Kenosha, Wisconsin, and the many peaceful civilians whose lives have been disrupted and who have been met with threats and injury, had no involvement in the tragic shooting of Jacob Blake or the many other victims of police misconduct,” Chairman Stolyarov stated. “Efforts should be focused toward reforming unjust protocols and institutions, not lashing out against innocent third parties who might quite likely have been potential allies in the task of reform. The path offered by the U.S. Transhumanist Party is to deliberate about how science, technology, and rational discourse – and their ethical and effective implementation through well-thought-out policies – can right these wrongs in a lasting manner, enabling racism, police brutality, and opportunistic looting alike to all become relegated to the dustbin of history by a society whose members come to know better. We express our support for those who, through peaceful and constructive action, are seeking solutions to this feedback loop of recurring and mutually escalating tragedies. All persons of conscience who wish to improve the situation must desist from initiating violence in any form and must turn their attention toward building instead of destroying.”

Tom Ross also criticized the violent attacks on Senator Rand Paul by the crowd in Washington D.C., “Regardless of our personal political bents or positions on this issue, our central motive must be to stand against all forms of violence. As a Transhumanist, I consider physical violence to be a primitive action that is motivated by fear and perpetuates a mob mentality. To protest police brutality with brutality is not only counterproductive but gives bad actors more justification for it. This is not a binary issue between Democrats and Republicans, Right and Left; it is a nuanced and multifaceted issue that requires a holistic approach. Senator Rand Paul is a proponent of criminal-justice reform, and so the protesters who attacked him have, well, lunged at Peter to scare Paul.”

Chairman Stolyarov concurred. He remarked, “A mob of people threatened the life of a Senator who, by all reasonable understandings, has been a leading proponent of curbing police brutality and eliminating abuse from the criminal-justice system. If we are to stand against the unjust violence perpetrated against Jacob Blake and others, then we must also stand against this purely counterproductive conduct. Injustice does not give license to perpetrate further injustice. Two wrongs – or thousands of wrongs – cannot ever make a right. Only de-escalation and a return to rational discourse, focusing on systemic and technologically powered reforms, can chart a way out of the present crisis.”

Pavel Ilin, Secretary of the U.S. Transhumanist Party, emphasized the need to refocus the conversation toward shared goals that include everyone. “As transhumanists we are trying to overcome a built-in brutal evolutionary heritage by building an environment of inclusion and dialogue. We try to transcend division between ‘us’ and ‘them’ by creating a larger concept of WE in which every sentient form of life is included, protected, and celebrated. There are no ‘Others’, only ‘we’. Murder is an extreme form of othering which cannot be undone. The life of each sentient entity is sacred. We are often talking about curing aging and living indefinitely long. But death from aging is no different fundamentally than death from a gun. No one should lose life involuntarily. No one should have a right to take it away.”

“Murder is an extreme form of othering which cannot be undone. The life of each sentient entity is sacred. We are often talking about curing aging and living indefinitely long. But death from aging is no different fundamentally than death from a gun. No one should lose life involuntarily. No one should have a right to take it away.” ~ Pavel Ilin, Secretary, United States Transhumanist Party

Liz Parrish, the U.S. Vice-Presidential candidate endorsed by the USTP, called on all Americans to transcend violence and join the effort to build a brighter future for all. She stated:

“We must build a future founded in the principles that every American can agree with by stating the obvious; we are all in this together. We need each other.  We must deny drowning in party-line negativity, condemn violence, and use these current events as fuel to create positive change. We can bring this country back together over principles that we can all agree on — health, freedom, liberty, and justice.

“As a country, we will unite to create a future through science and technological advancement— eradicate disease and thereby increase human health-span and create technological developments that can reach every adult and child.  We will lead by rational conversation, compassion, and connection.

“We must deny drowning in party-line negativity, condemn violence, and use these current events as fuel to create positive change. We can bring this country back together over principles that we can all agree on — health, freedom, liberty, and justice.” ~ Liz Parrish, U.S. Vice-Presidential Candidate, United States Transhumanist Party

“Regardless of religion and identity, everyone is invited to build this future with us—a future without the abuse of power, unequal resources, and unfair treatment. We must overcome our brutality and greed to make these next advancements. The future awaits us as a logical, feeling, and intelligent species.  And in this newfound peace, we will create new advancements and connections to expand our reach beyond the stars.”

Join us in restoring a shared vision of a brighter future. Become a member of the U.S. Transhumanist Party for free in less than a minute, no matter where you reside. 

U.S. Transhumanist Party Public-Service Announcement by Casey Cockrell

U.S. Transhumanist Party Public-Service Announcement by Casey Cockrell

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Casey Cockrell


The U.S. Transhumanist Party / Transhuman Party is pleased to feature this public-service announcement created by our member Casey Cockrell. You can view it on YouTube here

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Become a member of the U.S. Transhumanist Party for free, no matter where you reside. Apply here in less than a minute.

 

 

Transhumanist Ideas for Reforming Political Processes and Improving Government Accountability – Presentation by Gennady Stolyarov II

Transhumanist Ideas for Reforming Political Processes and Improving Government Accountability – Presentation by Gennady Stolyarov II

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Gennady Stolyarov II


On February 13, 2019, Gennady Stolyarov II, Chairman of the U.S. Transhumanist Party / Transhuman Party, spoke to the Young Americans for Liberty Chapter at the University of Nevada, Reno (UNR) in a wide-ranging discussion on the intersection of technology and politics and the types of reforms that could pave the way to the new technological era of major progress and radical abundance. Watch Mr. Stolyarov’s presentation on YouTube here.

Mr. Stolyarov discussed policy positions from the U.S. Transhumanist Party Platform, such as support for ranked-preference voting, greatly lowered ballot-access thresholds, simultaneous nationwide primaries, shorter campaign seasons, AI-assisted redistricting, germaneness rules for legislation, minimum consideration timeframes for amendments, and the general desirable shift in the balance away from special-interest lobbies and toward intelligent laypersons.

See Mr. Stolyarov’s presentation slides here.

Become a member of the U.S. Transhumanist Party for free, no matter where you reside. Apply here in less than a minute.

Watch Mr. Stolyarov’s interview of Ray Kurzweil at RAAD Fest 2018.

Watch the presentation by Gennady Stolyarov II at RAAD Fest 2018, entitled, “The U.S. Transhumanist Party: Four Years of Advocating for the Future”.

The Imperative to Build a Transhumanist Society – Article by C. H. Antony

The Imperative to Build a Transhumanist Society – Article by C. H. Antony

logo_bgC. H. Antony


Editor’s Note: The U.S. Transhumanist Party publishes this article by member C. H. Antony as a reminder that the aspirations of the transhumanist movement and the imperative to develop technologies to instantiate it are personal to many of us. Delays in achieving our vision come at the cost of innocent lives. In Section XXII of its Platform, “The United States Transhumanist Party supports efforts at political, economic, and cultural experimentation in the form of seasteads and micronations.” To what extent can such experimentation be explicitly transhumanist in nature? To what extent can the U.S. Transhumanist Party collaborate and its members contribute their efforts to advance emerging efforts to create seasteads and micronations – such as Blue Frontiers? Do members agree with Mr. Antony’s critique of the U.S. Transhumanist Party’s predominant approach, which is aimed at incrementally reforming existing political systems? Comments from various perspectives are welcome.

~ Gennady Stolyarov II, Chairman, United States Transhumanist Party, December 17, 2018


        Amanda Y. Bowers

         September 25th, 1984 – December 8th, 2018

My wife had been sick for a long time. Off and on she suffered peculiar gastrointestinal problems and was given a different reason every time. Finally, in 2015, Amanda was diagnosed with celiac sprue symptomatically, though she presented no protein markers. We were told that is sometimes the case and began a gluten-free diet and some important lifestyle changes we hoped would alleviate her suffering. As time went on, we believed every other GI problem to be easily explained by some cross-contamination or hidden filler in something. We had no idea that she was suffering from colorectal cancer that was slowly reaching a critical point. In July of 2018 her left ureter collapsed, and she was sent home with the explanation that she had passed a kidney stone. I came home from a trip to find her more ill than when I had left and brought her back in and had to fight for her admission and testing. The results were inconclusive, the prevailing theory being a progression of Celiac Disease to Crohn’s Disease. She was sent home on a steroidal regiment. Before we could follow up with the GI issues, we found ourselves back in the hospital, where they refused to do imaging and her bowel ruptured right there in front of them. But again she was sent home after the pain meds she was on quieted things down. I brought her back the very next day after begging a hospitalist we hit off with to grease the wheels a little. The result was emergency surgery and an ileostomy. Three days later, after narrowly surviving the rupture and sepsis, she was diagnosed with colon cancer. A week later, as her pleural tissues filled with fluid, and they determined the cancer to be at Stage 4. The last 5 months had been a breakneck race against a clock we couldn’t see. She endured 4 rounds of chemo, a pericardial effusion that she was again sent home with to die, and finally, her lungs began filling with fluid. On Tuesday last week, she came home on hospice; she died that Saturday night.

The longer history of this is filled with misdiagnosis, marginalization, even accusations of attempting to fraudulently obtain opioids. The local hospital corporation, the Veterans’ Administration (VA), all the affiliated specialists – they all guessed and missed. This is an all-too-common story. Cancer is nearly epidemic in our country; patients get passed around and dumped here and there, and diagnoses are rarely found before their deaths. My wife, Amanda, leaves behind two young children and a distraught husband. Her life thus far was rife with struggle and abuse; we had only a short time together for that to abate before she died in the most horrific manner I’ve ever witnessed. It has to stop.

Many investors have sniffed at the idea of breakaway nations, never quite biting in. But I believe it is now critical. The system of cronyism and lobbying that retards advancement and availability of medical science will not be remedied in this or any other nation. We must do it ourselves. My wife died because of this system. Her cancer was not a mutation of her own genes, nor inherited. It was most likely environmental, and most likely caused by the contaminated water on the bases where she was stationed. There will never be enough accountability to atone for this. We are soaked in contaminants we don’t understand and can’t remove from our daily lives. It’s time to take what we do know and start over.

Jeff Bezos recently expressed interest in seastead nations. Imagine if we could have the likes of Elon Musk, Jeff Bezos, Richard Branson, and others backing a transhumanist colony? What opportunity for human advancement we would have! The good people at Blue Frontiers are doing their best, but they need more backing and interest. We need a more solid plan; we can’t simply say what we will do; we must show and sell. It’s not enough to simply say “solar”, “materials science”, “sapioponics”; we have to design it and sell the design, down to the last bolt. And we need to sell it to the men who currently captain our industry, make it appealing and beneficial to them as well. Our wants are simple: freedom – the freedom to live without disease or fear in any form we choose, the freedom to never know hunger or disparity, the freedom to explore each of our individual potentials. But we will not have this freedom in America. Freedom here is truly an illusion.

To borrow heavily from greater minds than mine, we of good conscience cannot abide this culture of blinders and muzzles. We can do better and we must. Should great minds like Elon Musk, Bezos, Sir Branson, Ray Kurzweil, and so on come together and help become the architects of the future, we may yet survive the filthy politics of our current condition. I fear that no matter the achievement, it will be boxed up and slow-rolled for as long as politically possible. We can speculate forever the motivations of our various political parties as to why we are so far behind when we know how to be so far ahead; I do not intend to argue these points anymore. Instead, we must ignore the Luddites and move ahead on our own in the hopes that, through our example, the rest of humanity will eventually follow.

The meat of it is that we must acquire sufficient land and sovereignty to live as we wish, invite the industry and economy that we choose to utilize, and encourage the availability of advancements that are necessary to transcend this mortality and banality. We require financiers, captains of industry who want this future as much as we do, a nation attractive to the sciences and technology that we need in our endeavor, UN representation to protect our sovereignty as we pursue our human birthright, and a well thought-out design ethic to ensure no individual is encroached up on by another. We must not only design our nation, but the very infrastructure with purposeful intent.

To put the finest point on it that I can, I submit the following as the most humble beginning of a Transhumanist Nation:

  • A carefully laid-out infrastructure and topography conducive to peaceful coexistence among the population. One idea is a city-center of commerce and industry, surrounded by suburbs for families and recreation, and outskirt establishments for research and development.
  • The layout would prevent the tendencies for crime and predation that emerge when humans are forced to live in close quarters and congestion. Tunnel systems, electric vehicles, solar and other alternative energies, new forms of currency and trade, methods of education will all be prototyped and heavily utilized as a proof of concept for the rest of the world. The stress of daily living can be mitigated further with the adoption of universal basic income, uninfringed property rights, and universal, state-of-the-art medical-care access.
  • The presence of Amazon, Tesla, Neuralink, Virgin, and Google and all their various useful subsidiaries as our primary industry and commerce. This would serve as an enticement for the funding necessary to establish a new nation, no doubt purchased from another nation that may be willing to benefit from the vast technological advancement of a Transhumanist Society. The sponsoring corporations will be free to innovate and advance so long as doing so is in line with Transhumanist ideals and sensibilities.
  • Recruitment of Researchers and Medical Professionals germane to our intent and ideals.
  • Recruitment of Scholars and Philosophers, Artists and Artisans, Educators, and anyone else who believes that we can be more than the sum of our parts.

We need to achieve a society driven by life and betterment, not this crippling stagnation that sees millions die as the pace is slowed to one comfortable for limited minds and ambitions. Again, I cite Blue Frontiers as a group actively trying for this; I suggest we back them vigorously and attempt to build a purposeful society as soon as possible.

The United States Transhumanist Party has already brilliantly laid out the groundwork for this society in its Transhumanist Bill of Rights and Party Platform. We have the foundation of a great nation in our hands, but the status quo will never allow it. Power, such as it is, is too seductive a drug. Were we to gather our resources, both financial and human, I believe we could engineer a new, greater society of free minds and exchange, one where our coming Singularity propels us to heights we can only imagine. But we must come together. My wife was only 34 years old at the time of her death – a young mother, a veteran, a brilliant mind. As a paid intern, she coauthored a USGS study regarding asteroid mining, because she did the math for the researchers – a feat that required her to learn chemistry and new physics on the fly, all while finishing her own degree work. And now she is gone – just like that.

No More.

Let us begin now. Let us come together and create an opportunity, rather than wait for it to present itself. With the deepest respect to this party and its leadership, I believe that we are wasting our precious time attempting to participate in the American political system. I propose we open discussions with Blue Frontiers, Amazon, Virgin, Tesla, and other innovative organizations and begin the process – before more lives are lost.

C. H. Antony is a member of the U.S. Transhumanist Party. He may be contacted here

Transhumanism: Contemporary Issues – Presentation by Gennady Stolyarov II at VSIM:17 Conference in Ravda, Bulgaria

Transhumanism: Contemporary Issues – Presentation by Gennady Stolyarov II at VSIM:17 Conference in Ravda, Bulgaria

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Gennady Stolyarov II


Gennady Stolyarov II, Chairman of the U.S. Transhumanist Party, outlines common differences in perspectives in three key areas of contemporary transhumanist discourse: artificial intelligence, religion, and privacy. Mr. Stolyarov follows his presentation of each issue with the U.S. Transhumanist Party’s official stances, which endeavor to resolve commonplace debates and find new common ground in these areas. Watch the video of Mr. Stolyarov’s presentation here.

This presentation was delivered by Mr. Stolyarov on September 14, 2017, virtually to the Vanguard Scientific Instruments in Management 2017 (VSIM:17) Conference in Ravda, Bulgaria. Mr. Stolyarov was introduced by Professor Angel Marchev, Sr. –  the organizer of the conference and the U.S. Transhumanist Party’s Ambassador to Bulgaria.

After his presentation, Mr. Stolyarov answered questions from the audience on the subjects of the political orientation of transhumanism, what the institutional norms of a transhuman society would look like, and how best to advance transhumanist ideas.

Download and view the slides of Mr. Stolyarov’s presentation (with hyperlinks) here.

Listen to the Transhumanist March (March #12, Op. 78), composed by Mr. Stolyarov in 2014, here.

Become a member of the U.S. Transhumanist Party for free, no matter where you reside. Fill out our Membership Application Form here.

Become a Foreign Ambassador for the U.S. Transhumanist Party. Apply here.

Dr. José Cordeiro Interviewed by Singularity Weblog at the International Longevity and Cryopreservation Summit in Madrid, Spain

Dr. José Cordeiro Interviewed by Singularity Weblog at the International Longevity and Cryopreservation Summit in Madrid, Spain

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José Luis Cordeiro


The U.S. Transhumanist Party’s Technology Advisor, José Cordeiro, MBA, Ph.D., was interviewed by Nikola Danaylov of Singularity Weblog at the International Longevity and Cryopreservation Summit in Madrid, Spain, which was organized by Dr. Cordeiro and was held during May 25-27, 2017.

Listen to the audio interview below, download it, or see the original Singularity Weblog page hosting it.

Watch the video of the interview below or on its YouTube page.

The interview ventures into transhumanism, life extension, cryonics, and the political and cultural challenges that need to be overcome in order to achieve a world of indefinite lifespans, where technological transformations of the human condition would be broadly accepted.

Find out more about Dr. Cordeiro here.