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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.

Persecution of Science: A Lesson from the 20th Century – Article by Benjamin Locke

Persecution of Science: A Lesson from the 20th Century – Article by Benjamin Locke

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Benjamin Locke


Editor’s Note: The United States Transhumanist Party publishes this guest submission by Benjamin Locke to bring attention to the important issues it raises regarding how irrational prejudice against science, as well as against human beings based on circumstantial attributes more generally, can be prevented and diminished, to avert the kind of terrible toll that transpired in the mid-20th century from being inflicted again.

~ Gennady Stolyarov II, Chairman, United States Transhumanist Party,
July 18, 2020


Throughout the course of human history, there has been a struggle between rationality and antiscience. This struggle also grips the United States. The U.S. Transhumanist Party is a rarity in the American political atmosphere. There is admiration for seeing an American political party dedicated to reason, scientific advancements, and improving life for all of humanity. So, I started wondering: what would happen if parties like us were too afraid to exist? What would happen if people dedicated to reason and science were too afraid to speak? I found my answer in one of the most infamous, cruelest governments ever to taint the face of Earth.

During the reign of the Nazi Fascists, there was a mass scientific exodus from Germany because the Nazis valued nationalism and “racial pride” over brilliant minds like Albert Einstein, Hans Bethe, Leo Szilard, and many others who fled to the United States. Two years before the Nazis consolidated power in 1933, a journalist asked Adolf Hitler who would be the brains of Germany if the Nazis took over. Hitler responded: “I’ll be the brains!” By 1945, Hitler’s “brains” deepened Germany into a system of hate and genocide. He pushed Europe into a brutal world war, and he oversaw the largest persecution of logic and reason. 

Many people wonder: “Why wasn’t an atrocity like the Holocaust prevented?” While many are quick to solely place blame on the actions of Hitler and his unfortunately large amount of monstrous followers, a large portion of the blame falls on those who remained silent and indifferent. In the spring of 1933, a few protested the expulsion of great scientists (like Max Born, James Franck, and many more) from Gottingen University. Even famous scientists like Werner Heisenberg voiced dissent. Despite the calls for reason, Hitler and his companions were deafened by their own tune of hate. 

By the end of 1945, when the hatred of the Nazis was finally stomped out by the Allies, 6 million Jews and 5 – 6 million members of other groups had been murdered. We will never know the number of future Albert Einsteins, Hans Bethes, and Leo Szilards buried because of systematic hatred. 

So that raises the question: why were high-ranking Germans so blinded by antiscience and racism that they could not see reason? When World War One concluded, the once-powerful German Empire was replaced by a weak nation called the Weimar Republic. It was a nation which, many claimed, was unnecessarily weakened by the victorious powers of the First World War through articles like the Treaty of Versailles (signed 1919). This infuriated World War One veterans (Hitler himself was one) and many patriotic Germans. A wave of fervent nationalism arose and demanded an answer to Germany’s failures. This is why groups like the Nazis assembled in 1920. Instead of utilizing reason and using it as a tool to rebuild their national pride, they settled on scapegoats and pseudoscience. The Jews were quickly targeted. Their shops were vandalized, they were beaten in the streets, and German doctrine declared them “subhuman”. By 1933, the Nazis were so entrenched in their hatred that their misguided beliefs became their reason. 

Some may argue that Hitler’s Nazi Party is the reason why Germany rose out of a broken and impoverished nation like the Weimar Republic. However, in the span of less than 20 years, Germany went from the forefront of the scientific world back to a devastated, impoverished nation… a nation in a worse state than that after the infamous signing of the Treaty of Versailles. 

We have to wonder: What if the flames of bitter hate were stomped out early before it blazed into an uncontrollable forest fire? What would happen if Germany had, instead of persecuting their most brilliant minds, let them live and work? How much further would science be today? What responsibilities do we, as Americans dedicated to defending life, liberty, and the pursuit of happiness, hold so a terrible system of hatred never burns down our country? 

 

The United States Transhumanist Party and the Politics of Abundance – Essay by Gennady Stolyarov II in “The Transhumanism Handbook”

The United States Transhumanist Party and the Politics of Abundance – Essay by Gennady Stolyarov II in “The Transhumanism Handbook”

Gennady Stolyarov II


U.S. Transhumanist Party / Transhuman Party Chairman Gennady Stolyarov II’s essay “The United States Transhumanist Party and the Politics of Abundance” is available in the newly published master compilation, The Transhumanism Handbook, edited by Newton Lee, the California Transhumanist Party Chairman and U.S. Transhumanist Party Education and Media Advisor, and published by Springer Nature. This book is a milestone publication in transhumanist thought, and the U.S. Transhumanist Party / Transhuman Party encourages everyone to purchase it and read it in full. Fortunately, Mr. Stolyarov is able to share his own chapter – 60 pages within the book – for free download here: https://transhumanist-party.org/wp-content/uploads/2019/07/Stolyarov_USTP_Politics_of_Abundance.pdf.

Read “The United States Transhumanist Party and the Politics of Abundance” for a detailed explanation of the premises behind transhumanist politics and what the U.S. Transhumanist Party stands for. This essay is current through year-end 2018, and various other significant developments have occurred since then. However, this essay should give readers a strong impression of the USTP’s values, operating procedures, areas of focus, and aspirations for the future.

Abstract: “The depredations of contemporary politics and the majority of our era’s societal problems stem from the scarcity of material resources and time. However, numerous emerging technologies on the horizon promise to dramatically lift the present-day constraints of scarcity. The United States Transhumanist Party, in advocating the accelerated development of these technologies and seeking to influence public opinion to embrace them, is forging a new political paradigm rooted in abundance, rather than scarcity. This new approach is simultaneously more ambitious and more civil than the status quo. Here I illustrate the distinguishing features of the Transhumanist Party’s mode of operation, achievements, and plans for the future.”

Purchase the Transhumanism Handbook on Amazon here.

Become a member of the U.S. Transhumanist Party / Transhuman Party for free, no matter where you reside. Click here.

Click on the image of the first page above to read the essay in full. 

James Hughes’ Problems of Transhumanism: A Review (Intro + Part 1) – Article by Ojochogwu Abdul

James Hughes’ Problems of Transhumanism: A Review (Intro + Part 1) – Article by Ojochogwu Abdul

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Ojochogwu Abdul


Part 1 | Part 2 | Part 3 | Part 4 | Part 5

Introduction

In 2010, James Hughes, Executive Director of the Institute for Ethics and Emerging Technologies (IEET), having then just stepped down from the Board of Directors of the World Transhumanist Association (presently known as Humanity+), took up an interesting challenge during the Spring of that year to reflect on the current state of transhumanist thought and determine what the questions were that the transhumanist movement needed to answer in order to move forward. Introducing a series of articles with which he hoped to navigate through a number of heady ideas and issues concerning transhumanism, Hughes opens by posing: “What are the current unresolved issues in transhumanist thought? Which of these issues are peculiar to transhumanist philosophy and the transhumanist movement, and which are more actually general problems of Enlightenment thought?” Further, he queried, “Which of these are simply inevitable differences of opinion among the more or less like-minded, and which need a decisive resolution to avoid tragic errors of the past?”

Some clarification is made by Hughes on the “Enlightenment” as referring to a wide variety of thinkers and movements beginning in the seventeenth century, continuing through the early nineteenth century, and centered in Britain, France, Germany, and as increasingly demonstrated by recent scholarship, manifesting on a global dimension with significant contributions from thinkers and movements across Europe, North America, and the Caribbean. Hughes points out further the relevance of these thinkers and movements in terms of their endeavour in broadly emphasizing the capacity of individuals for achieving social and technological progress through application of critical reason to investigate nature, establish new forms and institutions of governance, and transcend such stagnating (or even retrogressive) forces as superstition and authoritarianism.

The engagement Hughes then sets for himself as he proceeded forward were a set of reflections which he was to structure around two general questions:

  1. An attempt to parse out which unresolved problems transhumanism has inherited from the Enlightenment; and
  2. How transhumanist technological utopianism has both inspired and delayed scientific and political progress over the last 300 years.

By addressing these questions, Hughes proposed to challenge a prevailing anti-utopian sentiment and hopefully furnish awareness of the way that dynamic optimism about transcendent possibilities motivated scientific innovation and democratic reform through the work of such thinkers and proto-transhumanists like the Marquis de Condorcet, Joseph Priestley, and J.B.S. Haldane. Indeed, for Hughes, transhumanism and techno-utopianism are part of the family of Enlightenment philosophies, both of which could be traced back to the original Enlightenment thinkers 300 years ago. The ideological conflicts within transhumanism today are, therefore, as Hughes would argue, to be understood by transhumanists as but the product of some 300-year-old conflicts within the Enlightenment itself.

The outcome of this effort, thankfully undertaken by Hughes, was a series of six essays grappling with diverse transhumanism-related issues ranging from problems surrounding the unsustainable autonomy of reason/rationality, and the belief in progress in contrast with rational uncertainty, to matters of deism, atheism and naturalist theology, from liberal democracy and technological absolutism to moral universalism and relativism, and from ideas concerning liberal individualism to the (threat of) erosion of personal identity.

Hughes titled this series of essays “Problems of Transhumanism”, each with its distinctive sub-title. And if one thing at least is to be appreciated from reading these articles, it is, in my modest opinion, the success with which they present the modern transhumanist project as bearing within its character and objective “the unfinished internal contradictions of the Enlightenment tradition.” The author, of course, emphasizes from the onset a yet important motive to his attempt which was to make clear which criticisms of transhumanism are internal contradictions, and which proceed from “external, non-Enlightenment predicates.”

Over the next week or so, I’ll be doing a review of these articles serially, starting with Part 1 below, while also incorporating some relevant views from a number of other thinkers as may be necessary, to aid commentary or analysis of Hughes’ arguments. This exercise, on my part, is essentially intended and hopefully geared to serve as an expository approach towards highlighting the contemporary philosophy and cultural movement of transhumanism whilst encouraging further discourse on the subject.

I invite and would be glad to have as many that may be interested in working through these ideas and issues with me, even as I endeavour, with these series of articles, to open conversations about them.

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How Humans Learned to Stop Worrying and Love Death – Article by Jaeson Booker

How Humans Learned to Stop Worrying and Love Death – Article by Jaeson Booker

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Jaeson Booker


Okay, for this, we have to go back. Way, way back. Before we made history, before we made civilization, before we humans did a lot of things. We may not have even been fully human at the time this happened. But at some point, we became self-aware. This process probably took some time, I doubt it was an “AH-HA!” moment that suddenly changed everything. But we then had the ability to comprehend ourselves: to view ourselves as an independent entity, separate from others, and could reflect on this. And, amid all of this self-revelation, with so many new existential possibilities, we got mauled by a second revelation: we saw other people dying. They got old, they got sick, they stopped moving, and then other animals and bugs started eating them (or, perhaps, we were the ones doing the eating; see “Cannibalism Normal for Early Humans?” by John Roach, National Geographic News, April 10, 2003). And we acknowledged that they were like us, that we one day would meet the same fate.

Well… that sucks. All of this possibility, all of these questions, a whole world to explore, and it turns out we’ll cease to exist before we get to experience even a small fraction of it. Damn. Well… what can be done of it? This question, as soon as humans figured out more advanced communication, was probably many times on their minds. From here, there seem to be three routes.

The first and most depressing, yet also the most pragmatic at the time: accept it and enjoy the time you have. “S**t happens. There ain’t nothin’ you can do about it.” This prospect was probably hard for many to face, causing them to try not to think about it instead (a habit many people still have today). But at the same time, it was probably the only realistic-seeming prospect for some time. Death happens. What can be done of it? No use feeling bad about something that can’t be controlled. Are you going to throw a fit every time it rains?

The second, and easiest to adopt: telling yourself it’s not true. Acknowledging you and everyone you love won’t exist one day is a tough pill to swallow, a pill many don’t want to take. But if nothing can be done about it, the only way around the pill is either ignoring death or believing differently. Over time, believing differently got easier and easier. It probably wasn’t done intentionally, but any idea we might not die when we shed our mortal coil probably spread faster than smallpox. Flowers came back every spring, after ‘dying’: where did you go? Trees went stark and bare, but came back to full health in the spring. How do we know this doesn’t happen to humans? Perhaps we were in our winter, and one day, human spring would come, and all the dead humans would sprout back up like daisies.

Over time, the resurrection pill probably went from easy-to-swallow to a-bit-more-difficult-to-swallow. Generations passed, with the stories being told, but human spring never came. We understood that seeds were the reason plants came back, and that it wasn’t an actual resurrection after all. And if you chopped-down a tree, it didn’t turn green next year. This is all speculation, of course, but at some point humans invented a concept that fixed this: the soul pill.

Ah, the soul, man’s best friend. Suddenly the body had nothing to do with all of those things people really cared about. All of those things humans tied so closely with their identity: emotions, reason, consciousness itself, all of these things the soul had covered for us. You could get pierced by a sword, fall off a cliff, be burned in a forest fire, but none of these perils could kill a soul. Whatever happened, no matter how bad things got, you were, ultimately, okay – because your soul would live on. To quote the Iron Giant: “Souls don’t die”.  Ah, death, thou shalt die at last.

But after a while, things started to change. We were starting to learn a lot, and a bunch of the earlier myths were turning-out to be false. Lightning wasn’t the wrath of any deity, the sky didn’t lead to any spirit world, humans weren’t created by anything but instead evolved, and a whole lot of the things we associated with “the soul” could be explained by a thing called a brain. Worse still, when this brain was changed, so did our personality. (See the Wikipedia entry on Phineas Gage.) This was depressing for many who saw the signs. And that soul pill, once so easy to swallow, was becoming harder and harder to get all the way down.

Which brings us to where you walked in. Many of us are still having issues with that soul pill, but many still don’t want to swallow that “we’re all gonna cease to exist” pill. For those who rejected the soul pill, many instantly grabbed a glass of water and hurriedly swallowed the other pill. They were proud of swallowing that tough pill, and annoyed with those struggling with the soul pill for not being brave-enough to do what they did. They found new ways to discover meaning, despite knowing they would die. Death was natural. Population had to be kept under control. They could live on through other means: their children, their legacy, the people they helped. The last thing these tough-pill-swallowers wanted to do was regurgitate something that had been so hard to get down in the first place. Which is why both types of pill-takers really hate the third pill.

The third pill: actually doing something about it. This solution had started around the time of the other two, but after a brief flare-up of popularity, had quickly died down due to failing to produce any results. Magic, the philosopher’s stone (the dream of the alchemists), blood sacrifices, breathing the air of virgins, and cannibalization of the young: these were all very embarrassing failures of this pill. After these blunders, no one really wanted anything to do with it anymore. And this is how things stayed for a long time. But even though the mentality toward this solution has stayed relatively the same for a long time, it’s potential was slowly changing. We were starting to understand how the body worked, and improve people’s health. We learned we were made up of these tiny things called cells, and that those cells were manufactured using even smaller things called DNA and RNA. And with all of this new-found knowledge, many were starting to wonder if discarding the third pill might have been a bit premature.

Up until very recently, the response has not been very nice to advocates of the Do-Something-About-It pill. And even today, there are many who call such advocates insane, immoral, greedy, and anything else you that’s meant to sound bad or misguided. The advocates of the soul-pill and the tough-pill could finally agree that this other pill had to go. Religions declared such aspirations evil and against God’s will. Scientists worked hard to separate themselves from these advocates as much as possible, not wanting to be lumped in with what sounded to many like some sort of icky cult.

So, the swallowers of the first two pills march forward, parading ideas of death and aging being natural, that seeking anything else is wrong and selfish, and we should just accept our situation. It is these two pills that have enabled people to justify a holocaust that is occurring every day – a holocaust that will one day claim us all, unless the third pill is ever swallowed and digested properly by humanity. Aging has killed more than all wars, famines, and plagues combined, yet most march onward, without making any attempts to halt it. Governments invest in fighting cancer, heart disease, and countless other ailments—ignoring the underlying cause of most of these problems, which is aging itself. Every year, there are drives for charities to fight different cancers, entire months and hues devoted to some (See “Pink porta-potty fundraiser aimed at flushing breast cancer“, CBC News, October 2, 2017), yet none toward combating aging. People stake trillions of dollars toward remedies to make them look younger, but almost none to aiding the effort of actually making them younger. They plan out their wills, their life insurance, and their funerals, but ignore opportunities to preserve themselves (for instance, cryopreservation, as offered by the Alcor Life Extension Foundation or the Cryonics Institute) for a chance to keep living, even if it is more affordable than they think.

But, despite the opposition, this solution has been making progress. We have seen progress in stem cells (“Anti-aging stem cell treatment proves successful in early human trials” by Rich Haridy, New Atlas, October 23, 2017 ), biotechnology (“A Silicon Valley scientist and entrepreneur who invented a drug to explode double chins is now working on a cure for aging” by Nikhil Swaminathan, Quartz, January 6, 2017), and machine learning used to better understand the aging process and how to treat it (“Artificial Intelligence uncovers anti-aging plant extracts” – Press Release by Insilico Medicine, October 31, 2017). The third pill is getting more and more enticing. Many older people, having swallowed one of the first two pills decades ago, have no desire to change their existential outlook now. But many younger ones, those who have not yet chosen a pill, and finding the other two inadequate, are starting to wonder if the third pill is for them. Time will tell which pill will ultimately win out, if any, but for now, for the first time ever in human history, the Do-Something-About-It Pill has an actual chance to shine and show what it is truly capable of.

Jaeson Booker is a software development engineer who has worked as a journalist. He earned a Bachelor of Arts (BA) degree in Political Science from Salisbury University, a Bachelor of Applied Science (BASc) degree in Molecular Biology from the Texas A&M Univerisity in Corpus Christi, and a Master of Business Administration (MBA) degree from Wilmington University.

The Discovery Doctrine in International Law, with Respect to the Islands of La Encarnacion and San Juan Bautista – Article by Stan Vaughan

The Discovery Doctrine in International Law, with Respect to the Islands of La Encarnacion and San Juan Bautista – Article by Stan Vaughan

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Stan Vaughan


Editor’s Note: In accord with Article III, Section XXII of the U.S. Transhumanist Party Constitution, which states that “The United States Transhumanist Party supports efforts at political, economic, and cultural experimentation in the form of seasteads and micronations”, the U.S. Transhumanist Party has published this guest article by Stan Vaughan, explaining the historical basis in international law for the claims by the Kingdom of Ourania on the uninhabited Pacific Islands of La Encarnacion and San Juan Bautista. Find out more about the Kingdom of Ourania here and read here about the State Visit made by King Immanuel X of Ourania to the Republic of Molossia on June 17, 2017. The arguments made herein by Mr. Vaughan are his own analysis, and members of the U.S. Transhumanist Party are encouraged to study it, review the relevant history, and form their own views and perspectives on it. The United States Transhumanist Party does, however, wish Mr. Vaughan the best in forwarding the recognition and development of the Kingdom of Ourania, which may, if successful, lead to innovations in seasteading and construction of floating cities. We anticipate publishing future updates regarding the Kingdom of Ourania as they become available.

~ Gennady Stolyarov II, Chairman, United States Transhumanist Party, July 2, 2017

Flag of the Kingdom of Ourania

Public international law seems to recognize five ways to acquire insular areas. These are 1) cession, 2) occupation, 3) accretion, 4) subjugation, and 5) prescription. [Raphael Perl, The Falkland Islands Dispute in International Law and Politics: A Documentary Sourcebook (New York: Oceana Publications, Inc., 1983) (hereinafter cited as Perl) 12-13.]

This essay discusses how international law applies to the islands of La Encarnacion (a.k.a. Ducie) and San Juan Bautista (a.k.a. Henderson) in the South Pacific Ocean.

La Encarnacion

The island of La Encarnacion (a.k.a. Ducie) was discovered by a Spanish expedition led by Portuguese sailor Pedro Fernandes de Queirós on 26 January 1606, during an expedition that began in Callao, Peru. Supported by Pope Clement VIII and Philip III of Spain, Queirós was given the command of the San Pedro, San Pablo, and Zabra. The fleet was nicknamed Los Tres Reyes Magos (“The Three Wise Men”).  La Encarnacion (a.k.a. Ducie Island) was the first of eighteen discoveries on the trip. Queirós temporarily named it Luna Puesta, then finally settled on La Encarnacion.

The island was rediscovered by Edward Edwards, captain of HMS Pandora, who was sent in 1790 to capture the mutineers of HMS Bounty. He re-named the island Ducie in honour of Francis Reynolds-Moreton, 3rd Baron Ducie.

On March 10, 1867 it was claimed by US Captain John Daggett of Massachusetts for the United States under the Guano Islands Act (enacted August 18, 1856).

The State Department (William Seward, Secretary of State) considered later in 1867 that the claim would remain dormant or only in abeyance until such time as US citizenship of Captain Daggett was proved, which was done, reviving the dormant US claim.

San Juan Bautista

Pedro Fernandes de Queirós, leading the same Spanish expedition that discovered La Encarnacion, was also the first European to discover another uninhabited island on 29 January 1606. De Queirós named this island San Juan Bautista.

Captain Henderson of the British East India Company ship Hercules re-discovered the island on 17 January 1819 and re-named it Henderson Island.

Claim by the United Kingdom and the Implications of the Discovery Doctrine

In 1877, the islands were purportedly included under the protection of the United Kingdom by an Order in Council that claimed jurisdiction over all previously unclaimed Pacific Islands.

However, La Encarnacion and San Juan Bautista were not unclaimed islands, both having been claimed by Spain in 1606. Such claims were recognized via the Treaty of Utrecht (1713), Treaty of Paris (1763), Nootka Convention (1790), Treaty of Madrid (1814), and the First Hague Convention (1899).

The Discovery Doctrine is a concept of public international law expounded by the United States Supreme Court in a series of decisions, most notably Johnson v. M’Intosh in 1823. Chief Justice John Marshall justified the way in which colonial powers laid claim to lands. Here we will not dispute the controversial aspects of the doctrine concerning inhabited lands, but focus on the uncontroversial aspects of terra nullis (discovery of uninhabited land).

Marshall found that ownership of land comes into existence by virtue of discovery of that land, a rule that had been observed by all European countries.

At the time of the 1776 Declaration of Independence, discovery of terra nullis gave the discovering sovereign absolute title to the newly discovered land. This was amended in 1790 by the United Kingdom / Spain Nootka Convention, which said that, thereafter, newly discovered lands must also be occupied as well. However this treaty did not in any way affect previous discoveries and claims.

Sovereignty could effect cession in a treaty between ceding and acquiring sovereigns, and at no time in history has Spain ever ceded its sovereignty over La Encarnacion and San Juan Bautista to the United Kingdom, which specifically acknowledged Spanish sovereignty to these two islands in both 1744 and 1787, as will be discussed herein later.

Thus, prior to either the purported Edwards 1791 “rediscovery” or the 1819 Henderson “rediscovery”, both islands had been shown on the 1787 King of England Samuel Dunn/Thomas Kitchen map (shown below) as the Spanish possessions La Encarnacion and San Juan Bautista, both previously recognized by the discovery doctrine in international law as belonging to Spain. Thus the 1877 British Order of Council extending British purported sovereignty over all unclaimed islands has no basis in international law, which also says that the purported 1902 “annexations” of these islands are illegal under de jure international laws.

Spain, the United Kingdom, as well as the United States all are parties to the 1899 First Hague Convention, which prohibits and considers such annexations as unlawful.

Further, all three recognize the aforementioned discovery doctrine, George II having recognized in 1744 the islands as having been discovered by Spain, and George III in 1787 having recognized such discoveries by Spain under the names La Encarnacion and San Juan Bautista.

Thomas Kitchin (or Thomas Kitchen (1718–1784)) was an English engraver and cartographer, who became hydrographer to the king. The 1787 Samuel Dunn “A General Map of the World” shows La Encarnacion and San Juan Bautista, as does the 1744 map by Emmanuel Bowen (cartographer to UK King George II and father-in-law to Thomas Kitchin, his apprentice) at correct latitudes south of Tropic of Capricorn and correct longitudes.

Above, the 1744 King George II map of the world with the islands of La Encarnacion and San Juan Bautista at correct latitude south of Tropic of Capricorn and at correct longitude as well, and among those marked as “islands discovered by de Quiros of Spain”.

Above the 1787 King George III map of the world lists La Encarnacion and San Juan Bautista by their actual Spanish names, an acknowledgement of their absolute title by Spain 4 years before the so-called re-discovery of La Encarnacion as Ducie 1791 or the 1819 re-discovery as Henderson instead of San Juan Bautista.

In correspondence from the British Foreign and Commonwealth Office dated 29 March 2017 and postmarked 13 April 2017, the United Kingdom does not dispute the above facts.

Thus, there is no such island as “Ducie” island – only the previously claimed by Spain La Encarnacion Island. There is no such island as “Henderson” island, only the previously claimed by Spain San Juan Bautista Island.

Before the 18th century, discovery alone was sufficient to acquire absolute title to a terra nullis (A. Keller, O. Lissitzyn, & F. Mann, Creation of Rights of Sovereignty 1400-1801 (1938)).

See also William E. Hall, “Discovery gave not merely inchoate title but an absolute title” (International Law 126-127, 214-215, 8th edition, 1924).

International Law Regarding So-Called Annexations

Direct Annexation, by the end of the Napoleonic period, ceased to be recognized in international law as an accepted means of territorial acquisition. Thus, as in the case of La Encarnacion and San Juan Bautista Islands in the South Pacific, the purported annexations (and renaming of the islands), which the United Kingdom proclaimed in 1902, not only violated this principle, but was further illegal by the First Hague Convention of 1899, which had been signed 29 July1900 already by the UK, USA, and Spain. The UK had not acquired these islands by any treaty or cession from Spain, and as earlier pointed out, had already under King George II and King George III by their names and locations recognized their discovery by Spain and thus absolute title from 1606.

In 1948, Emilio Pastor Santos, a researcher of the Spanish National Research Council, claimed there was a historical basis that many islands in the Pacific, formerly parts of either the Viceroyalty of New Spain, or the Viceroyalty of Peru, actually still belonged to Spain and “continue legally under Spanish sovereignty.” These include “a number of small islands in Micronesia (Kapingamarangi or CoroaMapia or GüedesOcea or Matador, and  Rongerik or Pescadores). […]This is because the text of the German–Spanish Treaty of 1899 which transferred sovereignty of certain Spanish possessions in the Pacific to Germany, namely the Northern Mariana Islands (except Guam) and the Caroline Islands (including Palau), failed to include these smaller islands.”  (Wikipedia, “Mapia Atoll”)

On 12 January 1949, after presentation of the research to the Council of Ministers of Spain, the Spanish Foreign Minster declared this as de jure, and the Cabinet of Diplomatic Information of the Ministry of Foreign Affairs declared as follows: “The Ministry recognizes that it is a certain fact and historic truth that Spain reserves a series of rights certain groups of islands as not having been ceded by Spain.”

This situation resulted in the Kingdom of Ourania contacting Spain and acquiring a number of islands formerly either part of the Viceroyalty of New Spain or the Viceroyalty of Peru, but with the proviso they can never be re-assigned to the United Kingdom at any time in the future, unless the UK first returns Gibraltar and restores the territorial integrity of Spain concerning Gibraltar.

Stan Vaughan is a chess champion who resides in Southern Nevada. He ran for State Assembly District 15 as a Republican in 2016. He now represents the Kingdom of Ourania in its efforts to attain international recognition and form a floating city in the vicinity of the claimed islands of San Juan Bautista and La Encarnacion.  

U.S. Transhumanist Party Discussion Panel on Life Extension – February 18, 2017

U.S. Transhumanist Party Discussion Panel on Life Extension – February 18, 2017

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Gennady Stolyarov II


Listen to and download the audio recording of this panel discussion at http://rationalargumentator.com/USTP_Life_Extension_Panel.mp3 (right-click to download).

For its second expert panel, the U.S. Transhumanist Party invited Bill Andrews, Aubrey de Grey, Ira Pastor, and Ilia Stambler to discuss life extension and the quest to reverse biological aging through science and technology.

This two-hour panel discussion, moderated by Chairman Gennady Stolyarov II, took place on Saturday, February 18, 2017, at 10 a.m. U.S. Pacific Time. In this interactive venue, many opportunities for fresh discourse arose on the possibility of achieving dramatically greater longevity within our lifetimes. The substance of the discussion begins at 4:25 in the recording.

Questions the panelists considered include the following:

(i) How would you characterize the current state of efforts to reverse senescence / lengthen human lifespans?
(ii) How does progress in the areas of research you have delved into compare to your expectations approximately 10 to 15 years ago?
(iii) What are the most significant challenges and obstacles that you perceive to exist in the way of achieving serious reversal of biological aging?
(iv) What key technologies and methods of delivering treatments to patients would need to be developed in order for longevity escape velocity to be affordably achieved society-wide?
(v) What political reforms and societal / attitudinal changes would you advocate to accelerate the arrival of effective treatments to reverse biological aging and lengthen lifespans?
(vi) Are you concerned about any current political trends and how they might affect the progress of research into combating biological aging?
(vii) What can laypersons who are sympathetic to your goals do in order to hasten their realization? How can the effort to defeat aging become as popular and widely supported as efforts to defeat cancer and ALS are today?
(viii) What lessons can the history of anti-aging research offer to those who seek to advocate and help achieve effective scientific breakthroughs in this area in the coming years and decades?

References

Genetic stabilization of transthyretin, cerebrovascular disease, and life expectancy” – Paper by Louise S. Hornstrup, Ruth Frikke-Schmidt, Børge G. Nordestgaard and Anne Tybjærg-Hansen. Arteriosclerosis, Thrombosis, and Vascular Biology. 2013;33:1441-1447, Originally published May 15, 2013.

Recognizing Degenerative Aging as a Treatable Medical Condition: Methodology and Policy” – Paper by Ilia Stambler. Aging and Disease.

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Panelists

Dr. Bill Andrews is the President and CEO of Sierra Sciences – http://www.sierrasci.com/. As a scientist, athlete, and executive, he continually pushes the envelope and challenges convention. In his 35-year biotech career, he has focused the last 23 years on finding ways to extend the human lifespan and healthspan through telomere maintenance. As one of the principal discoverers of both the RNA and protein components of human telomerase, Dr. Andrews was awarded 2nd place as “National Inventor of the Year” in 1997.

Dr. Aubrey de Grey is the biomedical gerontologist who researched the idea for and founded SENS Research Foundation – http://www.sens.org/. He received his BA in Computer Science and Ph.D. in Biology from the University of Cambridge in 1985 and 2000, respectively. Dr. de Grey is Editor-in-Chief of Rejuvenation Research, is a Fellow of both the Gerontological Society of America and the American Aging Association, and sits on the editorial and scientific advisory boards of numerous journals and organizations.

Ira Pastor has 30 years of experience across multiple sectors of the pharmaceutical industry, including pharmaceutical commercialization, biotech drug development, managed care, distribution, OTC, and retail. He is the CEO of BioQuark, Inc. – http://www.bioquark.com/ – and Executive Chairman of ReAnima Advanced Biosciences – https://reanima.tech/.

Dr. Ilia Stambler is a researcher at Bar Ilan University, Israel. His research focuses on the historical and social implications of aging and life-extension research. He is the author of A History of Life-extensionism in the Twentieth Century – www.longevityhistory.com. He is actively involved in advocacy for aging and longevity research – www.longevityforall.org.