Authors note: For clarity, the acronyms above describe the Center for Disease Control (CDC, USA), the Federal Drug Administration (FDA, USA) the European Medicines Agency (EMA, EU) and the Medicines and Healthcare Products Regulatory Agency (MHRA,UK)
For a regulatory body to functional effectively, irrelevant of the industry it serves, three key components are essential.
- The assurance that any funding received by the regulatory body does not originate from any of the companies the body is appointed to regulate, and
- that the staff that occupy decision making positions within the body have no ties to any of the companies within the industry, and no vested interest in the financial futures of any of these businesses.
- To ensure the above are put into working practice, transparency is required with regard the inner workings, structures and finances of the regulator.
While most industries at least attempt to adhere to the above,, healthcare is the notable exception. Pharmaceutical companies have, over the course of decades, exerted, bought, funded and lobbied their way into every corner of healthcare, the educational institutions that underpin it and the bodies that seek to regulate it.
Pharma in effect, now dictates public health, a fact the Covid pandemic has made abundantly clear.
Take the unethical practice of ghostwriting as a simple example. It is common practice for pharma to engage the services of PR firms for the purposes of ghostwriting medical studies to shape pharmaceutical prescribing. Although everyone is aware of this egregious abuse of the system, the practice continues unabated.
For those interested in finding out more about the full extent of pharma’s reach into healthcare I highly recommend a book entitled Ghost Managed Medicine by Sergio Sismondo. The link is to a free PDF of the publication.
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, paving the way for pharma to ingratiate itself with regulators.
Net PDUFA fees collected have increased 30 fold, from around $29m in 1993 to $884m in 2016. In Europe, in 1995. industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA). By 2010 that had risen to 75% and today it represents 89% of their funding.
The CDC and FDA
The CDC owns over 20 vaccine patents and sells over 4.6 billion dollars worth of vaccines every year. How did an institution that is publicly funded, supposedly impartial and not involved in the commercial dealings of pharma arrive at this point? Sit back, take a breath, and expect to be dumbfounded as we explore the anything but impartial Center for Disease Control and the other regulatory bodies that control healthcare across the globe.
Pharmaceutical industries have completely coopted and corrupted public health and your safety. This article will expose the depth of their influence and while it only focuses on four regulators, it should come as no surprise that any acronym (WHO for instance) involved in regulatory public health has suffered a similar fate.
The CDC has, until now, for the most part managed to operate under the radar, with vaccine approvals, drug approvals and other day to day business taking place in a vacuum of press interest. Drugs don’t sell newspapers and neither do the boring politics of the mechanics behind how these drugs appear on our pharmacy shelves. For decades, the CDC and FDA have operated in this vacuum, regulatory bodies with no accountability, other than to themselves.
The Covid pandemic changed that.
As early as February of 2020, cracks began to appear in the CDC’s public facing advice on the pandemic in relation to masks. Wear them, don’t wear them. Healthcare providers were told they were required and when stock of N95’s started to dry up, the CDC advised health care workers they were no longer needed. Months later, after acknowledging the virus was airborne, masks were once again, back in vogue.
It was the first in a long list of conflicting advice the CDC would issue on the Covid pandemic that was at odds with recognized medical advice.
Over the course of the pandemic. the CDC would publish lie after lie, all in support of a public narrative underwritten by pharma. the major beneficiaries of the CDC’s advice. For commercially driven companies (read pharma), the pandemic was about one thing, and only thing. Maximizing profits on a global scale, an opportunity never before presented. To claim that during the pandemic, the CDC was driven to protect public health or by any other altruistic motive is the equivalent of believing in Santa Claus.
Conflicts of Interest (COI’s)
To reiterate again, and for the sake of clarity, the main directive of these regulators and their raison d’etre is the pursuance of public health and the safety of patients. This involves offering health advice and ensuring medical products, pharmaceutical or otherwise, are fit for purpose and do not pose a risk to the public. It is the reason why they were created and it is the reason they require oversight, as will become abundantly clear in this article. They are compromised at every level and are no longer able to offer independent advice that is motivated only by the interests of the patient.
In the early days of the Covid pandemic, the CDC appointed Weber Shandwick to oversee its Covid vaccine PR. This is the same PR company that manages PR for both Moderna and Pfizer. This should have immediately sounded conflict of interest bells, loudly. It was and remains, in all aspects, a brazen reminder of just how out of touch the CDC has become in terms of their original founding mission. You can read more on this in an article published by the Daily Mail.
Weber Shandwick employees are embedded at the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), the CDC group that implements vaccine programs and oversees the work of the CDC Advisory Committee on Immunization Practices (ACIP).
Weber Shandwick is one of the largest and most influential PR companies in the industry and commands a lot of clout, both politically and legally. Given their reach, who would question the CDC’s decision? Definitely not MSM, as this would have been considered business suicide. As a result, this conflict of interest was only exposed in 2022 by independent journalists with Weber Shandwick vociferously defending their position and uttering assurances of impartiality.
Meanwhile, at the FDA, generally regarded as the world’s premier regulator, nine out of 10 of its past commissioners between 2006 and 2019 went on to secure roles linked with pharmaceutical companies, and its 11th and most recent, Stephen Hahn, is working for Flagship Pioneering, a company that acts as an incubator for new biopharmaceutical companies.
Just how deep does the corruption go? An article produced at the behest of the British Medical Journal (BMJ) in 2022, highlights the extent of the rot. This is a table from the article referenced.
Australia has the highest proportion of budget from industry fees (96%) and in 2020-2021 approved more than nine of every 10 drug company applications. Australia’s Therapeutic Goods Administration (TGA) firmly denies that its almost exclusive reliance on pharmaceutical industry funding is a conflict of interest. In response to a query, the agency said,
“All fees and charges are prescribed in our legislation. To provide transparency, the TGA fees and charges are published on the TGA website.”
This response serves only to underline the complete and utter capitulation of healthcare regulation to the monetary onslaught of pharmaceutical companies. The victims in this are the public. Sociologist Donald Light of Rowan University in New Jersey, US, who has spent decades studying drug regulation, has the following to say;
“Like the FDA, the TGA (Australia’s Therapeutic Goods Association) was founded to be an independent institute. However, being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.”
The FDA, by far the most well funded regulator, reports that 65% of its funding for the evaluation of drugs comes from industry user fees (see table above) and over the years user fees have expanded to generic drugs, biosimilars, and other medical devices. The EU and the UK post figures of 85% and 89% respectively.
What clearly emerges from the table above is that none of the global health care regulators is able to offer any form of independent, unbiased reviews on medication and health related medical devices. The problem, however, doesn’t simply end there.
Employing personal with clearly defined conflicts of interest
Australia and Japan lead the pack, with 50% and 70% of staff respectively involved in regulatory decisions relating to Covid-19 vaccines declaring financial conflicts of interest. America comes in at <10% and the UK at 35%. While I would tend to question the figures from the U.S., Canada and Europe appear even more suspect, reporting figures of 0 and 3% respectively.
It should be noted that the regulators themselves control how these conflicts of interest are reported, and will often gloss over conflicts they deem not to be relevant.
These figures highlight a very real problem that exists within the industry, which again, has its root in the pharmaceutical industry’s reach. It is almost impossible to find staff and medical professionals that have not been exposed to pharma, whether directly through employment, or indirectly, via grants for research projects at Universities and beyond.
Pharma has entwined itself, almost inseparably, with healthcare. This is true of every country across the globe. Trillions in global revenue ensure the pharma behemoth is able to wield its influence wherever it chooses, not merely with regulators, but in political and government circles, utilizing lobbyists wielding an endless supply of cash. Cash made off the backs of the public. It is ironic that we are in fact paying for whip that beats us.
Globally, pharma is one of the most most powerful financial forces in the market and projected revenues for 2023 for the Drug, Cosmetic & Toiletry Industry in the US alone, stand at $1.202.2B, in 4th place, surpassed only by Hospitals, Health and Medical Insurance and Commercial Banking. Health is rapidly becoming the most lucrative industry in the world, placing patients directly in harms way.
These clear and distinct conflicts of interest serve only to weaken public trust in the very institutions created to protect them. Patients can longer accept that decisions concerning approved medications and advice issued regarding the use of these medicines is made and offered in their best interests. Profit, financial gain and pharma based allegiances now drive regulatory decisions made across the globe.
The problems don’t however stop with the regulators. Advisory panels, selected to advise regulators with expert, independent advice, are also largely compromised. A BMJ investigation in 2021 found several expert advisers for covid-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers, ties the regulators themselves deemed to be acceptable.
A large study that investigated the impact of COI’s among FDA advisory committee members over 15 years found that those with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor’s product, and that people who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor’s product.
The Covid Vaccine debacle
No where is this conflict more evident than in the approval, distribution and advice offered to the general public on Covid vaccines.
The CDC, in particular, and not surprisingly, given its embedded PR influence, was guilty of repeatedly issuing advice that had no basis in science and simply adhered to the pharma based narrative of the pandemic. Sell the vaccine! At any cost. In keeping with this narrative, the CDC issued the following advice, often underwritten by their director, Rachel Walensky.
- The vaccines prevented transmission (false)
- The vaccines prevented you catching the virus (false)
- Vaccinating yourself offered protection to those most vulnerable (false)
- The vaccines were both safe and effective (false)
- Children, despite their almost negligible risk, should be vaccinated (false)
The Covid vaccines were awarded Emergency Use Authorization within months of development and despite woefully inadequate clinical trials, the manufacturers were indemnified against any and all claims arising from their use. Subsequent boosters, while differing in formulation, where approved with NO CLINICAL trials.
Then there is the issue of profit. The Moderna vaccine is part owned by the National Institute for Health (NIH) and is more of a collaborative effort between government and Moderna, than an outright product of Moderna.
Moderna received almost a billion dollars from BARDA (Biomedical Advanced Research and Development Authority, part of HHS), all of which flows from the U.S. taxpayer. On top of that, Moderna cut a deal worth more than $1.5 billion with the federal government for an initial 100 million doses of the vaccine, enriching Moderna’s top level management to the tune of nearly 100 million dollars.
Despite this, Moderna recently announced plans to start charging for their Covid vaccine. The price? Between $110 to $130. Remember, you, as an American taxpayer, funded the development of this vaccine. I mention this simple act of profiteering to underscore why pharma can never be trusted with the wellbeing of the public.
The FDA has also recently come under fire, its unanimous approval of mRNA Covid vaccines for the 0-4 age group offering an object lesson in why patient safety is furthermost from their minds. Let’s examine more closely some of the information emerging from the FDA’s meeting with Pfizer and Moderna.
- In the FDA open meeting, none of the members pointed out that a two months follow-up is totally inadequate for assessing safety. Nor did any of the members question the use of an antibody level as a measure of the vaccine’s success. There is no established specific level of antibody which we know provides protection against Covid. How then can this be used as a useful measure? For young children, much of their reduced risk from Covid arises from their superior innate immunity.
- Pfizer’s submission again serves as a case study of the most extreme data manipulation and bad science ever presented to the FDA. The study was approved on the basis of 4,500 participants 3,000 of whom did not make it to the end of the trial. This fact alone is sufficient to render the study results null and void.
- Pfizer researchers found that there were 30% more Covid cases in the vaccine arm in the three weeks after first dose, so they willfully ignored that data. They also ignored the data after the second dose where there was no benefit shown. They then ignored a full week after the third dose too. In total 97% of the Covid cases in the trial were ignored.
- To finally justify the vaccine, Pfizer focused on 7 cases in the placebo arm more than a week after vaccination and 3 in the vaccine arm. On the basis of these tiny numbers over a very contracted period, Pfizer claimed efficacy.
- Overall, there was no reduction in Covid (the difference across the whole trial was not statistically significant even for a particular sub group); more severe Covid in the vaccine group and one hospitalization in the vaccine group. Safety was only monitored for 6 weeks before Pfizer decided to vaccinate the children in the placebo group showing a total disregard for a meaningful collection of true safety data. Three children who presented with a serious fever and all were in the vaccine group.
- Moderna also received approval, despite their vaccine being restricted in many countries to the over 30 age group. They offered up a 189 page document justifying their vaccine’s efficacy, a document that was only made available to the committee two days before it convened.
Unbelievably, this study achieved ethical approval despite the lack of long term safety data with these novel treatments in an age group that is at negligible risk of serious disease or death from the virus. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend the products for emergency use authorization (EUA).
This FDA decision failed in every aspect to consider the safety of this vulnerable patient population. No case was ever made to justify the risk/benefit relationship of advocating vaccination for a vaccine with known serious adverse effects to a demographic with almost no known risk for Covid or its variants. Additionally, approving these vaccines under the EUA guidelines was an egregious abuse of the EUA system, designed for mitigating extreme risk and loss of life.
Where, if the FDA is of a mind to explain itself, does Covid or rather the variants we now face, pose an extreme risk to the health of children? With no oversight, no explanations for this medical travesty will be forthcoming from the FDA, until such time as committee’s are appointed to investigate their rationale.
By that time, too many young children will have been exposed to unnecessary risk.
Efforts at self regulation
In September of 2022, the MHRA, England’s medicine’s regulatory body announced it was introducing a new, single code of practice for all its scientific advisory committees, to ensure that experts providing it with advice would be independent and impartial, and that processes in place to manage conflicts of interest would be robust, consistent and clear to all.
While the intent was laudable, some argued that this was merely a kneejerk response to growing criticism leveled at the regulator on the topic of vaccine approvals during the pandemic and clear conflicts of interest for individuals on advisory committees dealing with vaccine and drug and device approval. By preempting public and parliamentary scrutiny, the real intent and timing of the document may very well have been to avoid or deflect independent oversight.
You can read the full 28 page document drawn up after public consultation and published on the 8th of September 2022, here and it should be noted that this Code covers any and all advisory committees engaged in the field of healthcare within the United Kingdom. The question that now remains is can the MHRA be trusted to rigorously enforce this document’s stated objectives? History suggest not.
In 2018, then Health Secretary Jeremy Hunt commissioned the Independent Medicines and Medical Devices Safety Review chaired by Baroness Cumberledge. Its purpose was to investigate harms caused by two pregnancy drugs and one device. Primodos, Sodium Valproate and Vaginal Mesh Implants.
When Baroness Cumberledge spoke about her work in 2019 she said,
“We have more evidence to hear before we write our report. But there are some emerging themes. The lack of proper warning about risks; the lack of informed consent; a system whose first inclination is to deny that there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response, the dismissiveness and the arrogance of some (and I stress only some) in the medical profession; the byzantine complexity of a regulatory system that few within it seem to fully understand let alone patients and the public; the fight for diagnosis and support when things have gone wrong and the inadequate resources available.”
Her report, published in July of 2020 called for,
“overhauling adverse event reporting” and an “overhaul of the culture in the MHRA…to ensure that the patient perspective and the public interest always takes precedence over the interests of industry. Patients must be central to the workings of the MHRA” and that “the MHRA should be subject to binding timescales for decisions on risk management.”
One concluding recommendation was for a Patient Safety Commissioner, – with statutory powers, to talk and act from the perspective of the patient, to encourage the system to do what needs to be done and hold it to account. In short, oversight.
Has the EMA faired any better?
Has Europe learned from the mistakes of its older and more established Western colleagues? It would appear not. Initially, in the newly formed European Union, the granting of a marketing authorization (MA) was the responsibility of each Member State. Then, in 1993 a regulation, later replaced by a regularly amended 2004 regulation, established an evaluation agency to centralize the approval of new drugs for the EU. Is is referred to as the European Medicines Agency or EMA.
The EMA consists of a Management Board of 36 members, most of whom represent the Member States (most often the director or president of their national agency). The Management Board appoints an Executive Director, who is supported by seven expert committees.
As shown in the preceding table, 85.70% of the agency’s operating budget (346 million euros) in 2021 came from fees paid by the pharmaceutical industry and only 14.30% from public funding from the European Union. While ostensibly a public body and as an agency of the European Commission, the EMA’s obligations in terms of transparency and access to documents derive from directives stipulating that;
“any document held by the EMA in the course of its activities is in fact a public document.“
The journal Prescrire highlighted the fact that the EMA refuses to communicate many documents, and that those that are transmitted are largely redacted. The EMA’s lack of transparency was further denounced when it refused to tell Members of Parliament the basis on which it had selected the laboratories that produced the Covid vaccines the actual amounts paid for them.
In terms of staff and conflicts of interest, the EMA fares no better than it’s counterparts globally. Clear conflicts are, in point of fact, more pronounced.
Italian Guido Rasi was appointed as director of the EMA in 2011, then forced to resign by the European Justice for an undeclared conflict of interest, before later being reappointed as director of the EMA again in 2015.
His predecessor, Executive Director, Thomas Lönngren, joined the board of directors of NDA Ltd, a lobbying company serving pharmaceutical companies, which recruited him as a “leading influencer, the day after his departure from the EMA in 2011. The current director, Emer Cooke, spent seven years at EFPIA, the main lobby of the pharmaceutical industry in the European Union, which organizes meetings in the European Parliament with representatives of GSK, Roche, Novartis, Pfizer and others.
So, three strikes then, on all counts of impartiality, independence and transparency.