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TOTM Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly . . .
Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly agree to amendments to the International Health Regulations (IHRs), which are intended to “prevent, protect against, prepare, control and provide a public health response to the international spread of diseases.” Ministers will also be asked to approve the text of a new World Health Organization (WHO) convention to combat future pandemics.
While there is a need to coordinate the detection of and response to potential pandemics, it is not clear what role, if any, the WHO should have. Perhaps more importantly, it is uncertain what policies should be put in place (and by whom) to prevent, limit, and respond to any future pandemic. The U.S. government should encourage the WHO to delay both changes to the IHRs and the introduction of a new treaty until several issues are satisfactorily resolved.
Read the full piece here.
TOTM Although it was overshadowed by the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) year-end release of the 2023 merger guidelines, one should also note . . .
Although it was overshadowed by the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) year-end release of the 2023 merger guidelines, one should also note the abrupt end of the FTC v. Illumina/Grail saga. The saga finished with the FTC’s Dec. 18 press release announcing that Illumina decided on Dec.17 to divest itself of its recently reacquired Grail cancer blood-testing subsidiary.
The press release crowed that the 5th U.S. Circuit Court of Appeals “issued an opinion in the case finding that there was substantial evidence supporting the Commission’s ruling that the deal was anticompetitive.”
TOTM This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain . . .
This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. Yet from a risk perspective, the standards are quite different; by shifting risk taking from regulator to patient, physician, and payer, this creates problems. The second problem is more practical and is generally considered the most significant problem with accelerated approval. Some companies that have received accelerated approval for their products have not done confirmatory studies, as required by their agreement with FDA. This leads to distrust of these companies and their products, and threatens to undermine the accelerated-approval program. The third problem is the issue of approving medicines with marginal benefits.
Popular Media Sometimes Congress does something right, and one example is the Bayh-Dole Act of 1980. This bipartisan patent law is widely recognized as one of the great legislative . . .
Sometimes Congress does something right, and one example is the Bayh-Dole Act of 1980. This bipartisan patent law is widely recognized as one of the great legislative achievements of the past 60 years. It has massively boosted innovation and economic growth by incentivizing researchers and universities to commercialize their new inventions by, paradoxically, removing them from public control by the government. The Biden administration has now announced a plan to twist this law to reimpose government control over these inventions in the form of price controls. This proposal would kill this “golden goose” of innovation.
TOTM In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s . . .
In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s efficacy. Allowing HIV patients to take investigational treatments meant that research into rarer conditions—which previously would never have been profitable—might now be financially worthwhile.
This post estimates the benefits of accelerated approval and how oncology medicines have become the treatment category with the most accelerated approvals.
Scholarship Abstract We study here what can be learned from our experience with COVID-19 vaccination for an initially naïve population, that can inform planning for vaccination . . .
We study here what can be learned from our experience with COVID-19 vaccination for an initially naïve population, that can inform planning for vaccination against the next novel, highly transmissible pathogen. We focus on the first two pandemic years (wild strain through Delta), because after the Omicron wave in early 2022, few people were still SARS-CoV-2-naïve. Almost all were vaccinated, infected, or often both. We review the evidence on COVID-19 vaccine effectiveness (VE), waning effectiveness over time, and what we should expect about VE and waning from a future pathogen. As a basis for our analysis, we conducted a PRISMA-compliant review of all studies on PubMed through August 15, 2022 reporting VE against four endpoints: any infection, symptomatic infection, hospitalization, and death, for the four principal vaccines used in developed Western countries (BNT162b2, mRNA1273, Ad26.CoV2.S, and ChAdOx1-S). The mRNA vaccines (BNT162b2, mRNA1273) had high initial VE against all endpoints but protection waned after approximately six months, with BNT162b2 declining faster than mRNA1273. Both mRNA vaccines initially outperformed the viral vector vaccines. A third “booster” dose, roughly six months after the primary doses, substantially reduced symptomatic infection, severe disease, and mortality, and in hindsight should be seen as part of the normal vaccination schedule
TOTM This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, . . .
This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, how disasters drove its expansion and regulatory oversight, and how the epidemic of the human immunodeficiency virus (HIV) changed the approval processes.
TOTM Lina M. Khan was sworn in as chair of the Federal Trade Commission (FTC) on June 15, 2021. On July 9 of that year, the . . .
Lina M. Khan was sworn in as chair of the Federal Trade Commission (FTC) on June 15, 2021. On July 9 of that year, the FTC withdrew the commission’s 2015 “Statement of Enforcement Principles Regarding ‘Unfair Methods of Competition’ Under Section 5 of the FTC Act.” That three-week lag was, in practical terms, nothing. Even ignoring the many practical/ministerial/managerial things that come with assuming the chair, there’s a certain amount of process required of policy decisions at the commission.
As many noted at the time, rescinding the 2015 statement, “absent any new guidance about how the Commission interprets its authority,” did little to signal the commission’s new view of its authority. That is, apart from the vague signal that a far more expansive statement was forthcoming and, of course, a not-so-tepid statement that…
TOTM I can hardly believe it, but I’ve read that a famous old bit by Henny Youngman has been purged from Florida textbooks, apparently because it was . . .
I can hardly believe it, but I’ve read that a famous old bit by Henny Youngman has been purged from Florida textbooks, apparently because it was deemed offensive to those who wrote, told, and laughed at the joke. I won’t tell it here, but you can look it up. And if you’re a reader of a certain age, you’ll know it as soon as I note that it’s at the heart of the U.S. Justice Department’s (DOJ) antitrust case against Google.
