Regulatory capture

The MHRA held no safety data on the Covid vaccine it approved as it was a different product to the one used in the trial. But Hugo Keith KC fumbled his question to June Raine at the Covid Inquiry and let her off the hook.

Internal emails show that the US Food and Drug Administration informs employees leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency. Peter Doshi reports During his final three years at the US Food and Drug Administration the physician scientist Doran Fink’s work focused on reviewing covid-19 vaccines. But a decade after joining the agency Fink had accepted a job with Moderna, the covid vaccine manufacturer, and was undergoing mandatory FDA exit requirements. As he left for the private sector, the FDA’s ethics programme staff emailed him guidelines on post-employment restrictions, “tailored to your situation.” The email, obtained by The BMJ under a freedom of information request, explained that, although US law prohibits a variety of types of lobbying contact,1 “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’” The legal ability to work “behind the scenes” is enshrined in federal regulations2 and highlights a “critical, critical loophole” in US revolving door policy, says a leading consumer advocate. Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told The BMJ that the rules forbid various forms of direct lobbying contact but permit lobbying activity that is indirect. “So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman explained. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and …

Peter Doshi Investigates

We have all long been aware of the reluctance of mainstream news outlets to question any aspect of the Covid vaccination programme. It should be a matter of gravest concern for us all

On August 23, 2021, the US Food and Drug Administration (FDA) granted approval (or licensure) to the first ever COVID-19 mRNA gene therapy product by Pfizer/BioNTech, which from the onset was misbranded as a ‘vaccine.’ The Acting FDA Commissioner Janet Woodcock, M.D., said at the time: “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

NTD’s Lee Hall sits down with Hedley Rees, Managing Director of Pharmaflow, who has worked in the pharmaceutical industry for over 40 years.

According to documents obtained by Children’s Health Defense, reports of injuries and deaths following COVID-19 vaccines — including a child injured by the Pfizer vaccine during a clinical trial and a fatal vaccine-induced case of myocarditis — reached NIH researchers, Dr. Anthony Fauci and others in 2021 and 2022.

In 2017, the US Food and Drug Administration (FDA) entered into a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation. Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,”

Pharma funding inevitably means lack of neutrality

Regulatory capture is a theory that regulatory agencies may be dominated by the interests they regulate and not by the public interest.

Pharma funding inevitably means lack of neutrality

In light of the EU’s Covid-19 response, it is clear that the actual emphasis is likely to be placed on mRNA.

#1 on AMAZON, and a NEW YORK TIMES, WALL STREET JOURNAL…

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Billionaire Warren Buffett says leaders aren't always making rational decisions, and companies too often copy one another without critical thinking. Here's why the concept he calls "institutional imperative" is important.

A Freedom of Information request to the Australian drugs regulator that approved the Pfizer vaccine confirms that they have never seen the study data.

In an interview with former BlackRock advisor Edward Dowd on “RFK Jr. The Defender Podcast,” Robert F. Kennedy, Jr. and Dowd discussed why they believe COVID vaccine makers committed fraud, and government agencies know it.

The Centers for Disease Control and Prevention (CDC) has a track record of trying to hide its communications with representatives of pharmaceutical companies. ICAN has sued the agency in the past for this very conduct. Apparently, CDC has not learned its lesson because it is now trying to hide emails between Dr. Amanda Cohn, the former Executive Secretary of CDC’s Advisory Committee on Immunization Practices, and pharmaceutical companies.

FDA Assigned Pfizer’s COVID Vaccine a License Number Months Prior to Actually Licensing It

On December 16, 2020, ICAN submitted a Freedom of Information Act (FOIA) request to the Centers for Disease Control and Prevention (CDC) which resulted in the production of an email showing the cozy relationship between Pfizer and the CDC official now heading up its COVID-19 Vaccine Task Force.

EXCLUSIVE: Freedom of Information requests reveal that the UK medical regulator, like its Australian counterpart, never inspected the Pfizer vaccine study data.

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate. In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold—from around $29m in 1993 to $884m in 2016.1 In Europe, industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is 89%.2 In 2005 in the UK, the House of Commons’ health committee evaluated the influence of the drug industry on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA).3 The committee was concerned that industry funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” But nearly two decades on, little has changed, and industry funding of drug regulators has become the international norm. The BMJ asked six leading regulators, in Australia, Canada, Europe, Japan, the UK, and US, a series of questions about their funding, transparency in their decision making (and of data), and the rate at which new drugs are approved. We found that industry money permeates the globe’s leading regulators, raising questions about …

After holding oversight roles for covid vaccines, two regulators from the US Food and Drug Administration went to work for Moderna. Peter Doshi reports The physician-scientist Doran Fink worked his way up at the Food and Drug Administration, with a focus on the regulation of vaccines. Starting as a clinical reviewer in 2010, he was promoted to lead medical officer in the FDA’s Office of Vaccines Research and Review, overseeing a small team of medical officers responsible for infectious diseases and related biological products. During the covid-19 pandemic Fink took on a public role, appearing in numerous FDA and Centers for Disease Control and Prevention advisory committee meetings to discuss covid vaccines and serving on the senior leadership team for covid vaccine review and policy activities. Part of his role was to engage vaccine manufacturers to advise on the development of vaccines during the pandemic. In mid-2020 Fink announced the FDA’s expectations for any covid vaccine that the agency would consider authorising, and he took part in the ultimate decision to license the Pfizer and Moderna vaccines. Fink’s LinkedIn profile states that he finished his role at the FDA in December 2022. Two months later he was working at Moderna, heading the translational medicine and early clinical development programme in infectious diseases. He is one of two regulators The BMJ has found to have recently moved to Moderna from the FDA’s Office of Vaccines Research and Review. Concerns about a “revolving door”—movement of people between the government and the private sector—have persisted for decades, with public confidence in the balance over the integrity of government decision making.1–3 Craig Holman, who serves as government affairs lobbyist for the consumer advocacy organisation Public Citizen, says that government service is fundamentally different from private sector work. Those in the public …

Former TGA boss appointed to the board of Medicines Australia, hoping to advance "mRNA technology framework" in Australia.