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Pfizer RSV Vaccine for Infants Has ‘Generally Favorable’ Safety Data, FDA Staff Say
U.S. Food and Drug Administration staff on Tuesday said Pfizer’s vaccine that protects infants from respiratory syncytial virus has “generally favorable” safety data.
The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot.
The advisors will vote on whether Pfizer’s late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the advice of its advisory committees but is not required to do so.
Most of the more than 3,000 mothers who received the shot in a phase three trial experienced mild to moderate adverse reactions, according to the FDA staff’s review of data. A higher number of premature births occurred among mothers who took the vaccine compared to those who received a placebo, according to the staff review. But they said that difference does not appear to be statistically significant.
Universal Flu Vaccine Based on mRNA Tech to Be Tested by National Institutes of Health
Patients are now enrolling in an early-stage clinical trial to test a universal flu vaccine based on messenger RNA technology, the National Institutes of Health announced Monday.
Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year.
Messenger RNA, or mRNA, is the technology behind Moderna’s and Pfizer’s widely used COVID vaccines. NIH played a crucial role in developing the mRNA platform used by Moderna.
The universal shot was developed by researchers at the National Institute of Allergy and Infectious Diseases. The clinical trial is enrolling volunteers at Duke University in Durham, North Carolina.
New Mpox Cluster in Fully Vaccinated People Has NYC Ties, CDC Warns
The global outbreak of the disease formerly known as monkeypox appeared to be dying down — but the CDC warned Monday of a concerning new cluster with ties to New York City.
Between April 17 and May 5, doctors reported 13 confirmed or probable cases of mpox to public health authorities in Chicago. All the cases were in men, all had symptoms — and nine of the 13 were previously vaccinated with two doses of the JYNNEOS vaccine.
“Travel history was available for 9 cases; 4 recently traveled (New York City, New Orleans, and Mexico),” the CDC said in an update issued via its Health Alert Network. None of the 13 were sick enough to be hospitalized.
The Decline of Science at the FDA Has Become Unmanageable
Before 1962, U.S. federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings revealing widespread false advertising of drugs — along with the thalidomide safety disaster — spurred Congress into action.
From then on, approval of a New Drug Application (NDA) by the U.S. Food and Drug Administration required proof of “substantial evidence” of effectiveness. This proof was defined as results from “adequate and well-controlled investigations, including clinical investigations,” with such evidence also required to advertise claims of safety and effectiveness. A National Academy of Sciences review underscored the need for these mandates, finding over 30% of pre-1962 marketed drugs to be ineffective.
However, as Peter Doshi reports in The BMJ, the FDA subverted the legal standard for effectiveness in its 2019 approval of Recarbrio, a fixed dose combination of imipenem, cilastatin, and relebactam. While the FDA has previously approved products with marginal evidence of effectiveness, approval of the Recarbrio NDA was shocking given its lack of substantial evidence of effectiveness and the complete absence of adequate and well-controlled clinical investigations on the actual indication of interest.
What accounts for this descent into cargo cult science? Much of the blame must go to the FDA’s reliance on industry-paid user fees. Over the past three decades, the proportion of the FDA’s annual drug budget made up of such fees has risen from less than 10% (fiscal year 1994) to more than two-thirds (fiscal year 2023).
Wyden Blasts Big Pharma for Tax Ploys and Lack of Cooperation in Probe
In 2017, a law passed during the administration of former president Donald Trump dropped the corporate tax rate for companies in the United States from 35% to 21%. But in reality, Big Pharma companies are paying much less, according to a report from Senate Finance Committee chairman Ron Wyden (D-Oregon).
Data from 2020 show that the country’s seven largest pharmaceutical companies paid an average rate of 11.6% that year. The number was down from 19.6% in 2016, before the law was enacted, according to the senator.
Drugmakers are pulling this off by reporting that 75% of their profits came from overseas, according to the committee’s most recent update of its ongoing investigation into pharma tax practices.
Drugmakers get a large portion of their sales — and profits — from the lucrative United States pharmaceutical market. But they often run those profits through their foreign subsidiaries based in low-tax countries.
Why Is a Curable Disease Still Allowed to Kill Millions?
From the 1940s to 1960s, eight separate classes of anti-tuberculosis (TB) drugs were synthesized to fight the disease. But then no new drugs were developed to fight TB until 2012.
As tuberculosis became less of a problem in rich countries with robust healthcare systems, the profit incentives changed, making TB less of a priority for pharmaceutical companies even as it continued to be a huge problem for humanity. As journalist Tina Rosenberg once noted about another infectious disease, “Probably the worst thing that ever happened to malaria in poor countries was its eradication in rich ones.”
In 2012, a new drug appeared at last: bedaquiline, which has become a critical component in multidrug-resistant tuberculosis (MDR-TB) treatment cocktails. Most of the research dollars that went into the development of bedaquiline came from the public in many countries — taxpayers invested far more in bedaquiline research and trials than pharmaceutical corporations did — and yet the drug is owned and distributed entirely by a private corporation, Johnson & Johnson.
Its patent expires just two months from now, but the company is attempting to “evergreen” its monopoly by slightly adjusting the drug’s formulation, enabling Johnson & Johnson to enforce secondary patents and extend its control of bedaquiline in most countries with a high TB burden. This would be good news for Johnson & Johnson, I suppose, but bad news for almost everyone else on the planet.
AstraZeneca to Leave Leading U.S. Drug Lobby Group
AstraZeneca (AZN.L) has decided to leave the main U.S. drug lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), and pursue other ways of engaging in advocacy at the state and federal level, the company said.
The news, first reported by Politico, marks the trade body’s third major departure in six months. AstraZeneca’s exit follows those of AbbVie, maker of blockbuster arthritis drug Humira, and Teva, a leading manufacturer of generic drugs.
AstraZeneca will redirect the funds previously used on its PhRMA membership to continue U.S. advocacy efforts with state and federal policymakers, its statement read.
The U.S. is the largest national market for all big pharma companies. Drugmakers suffered a rare defeat last year in failing to stop the Inflation Reduction Act, which allows the government to negotiate prices on certain drugs.
Philips Says Most Recalled Devices Unlikely to Harm Health
Royal Philips NV said new tests on its recalled sleep apnea products showed the vast majority of the devices are unlikely to cause considerable health damage to patients.
Exposure to degraded foam in 95% of the breathing apparatuses is “unlikely to result in an appreciable harm to health in patients,” the Netherlands-based health company said Tuesday, citing its test results. Philips initiated its first recall of potentially faulty sleep apnea products in June 2021, with the U.S. Food & Drug Administration also labeling those as a Class 1 issue, the most serious type.
Plans for U.K. ‘Genomics Transformation’ Aim to Act on Lessons of COVID
Health officials in the U.K. have drawn up plans for a “genomics transformation” that aims to detect and deal with outbreaks of infectious diseases faster and more effectively in the light of the COVID pandemic.
The U.K. Health Security Agency (UKHSA) now aims to build on the lessons of the pandemic by embedding genomics into routine public health practice. The move intends to bolster surveillance for outbreaks, drive down cases of infections such as TB, measles, hepatitis C and HIV/Aids, and predict the course of future threats, such as avian flu and diseases borne by mosquitoes and ticks as they gain ground in a warming climate.
The boost for genomics is central to the UKHSA’s 10-year science strategy released on Tuesday. Among the plans, which cover infections, radiation protection, the health impact of the climate crisis and vaccine development, is a commitment to the “100 Days Mission”, which aims to have diagnostic tests, drugs and vaccines ready to deploy within 100 days of a new pandemic threat emerging.
