Editor’s Note: This article is a reprint. It was originally published October 3, 2018.
I've written many articles highlighting the bias created by funding and the dangers of basing health decisions on industry-funded science. Independent, unbiased research is absolutely crucial for getting to the truth; without it science becomes little more than an extension of marketing, and hence useless.
So, what's happening at Cochrane right now is nothing short of tragic.1,2,3 Cochrane (an international network of scientists that promotes evidence-based medicine), formerly known as the Cochrane Collaboration, has been the gold standard for independent scientific meta-reviews, and the organization's reputation has managed to stay remarkably unblemished — until now.
Cochrane Implodes Amid Accusations of Bias
Cochrane publishes hundreds of scientific reviews each year, looking at what works and what doesn't. For example, Cochrane has repeatedly found that flu vaccinations are ineffective and have no appreciable effect on hospitalizations and mortality.4,5,6,7,8
Considering the flimsy evidence underpinning recommendations for the human papilloma virus (HPV) vaccine, it was therefore surprising when Cochrane published such a strongly favorable review of the vaccine.
The review,9 published May 9, 2018, looked at 26 studies, concluding “There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and women who are vaccinated between 15 and 26 years of age,” and that “The risk of serious adverse events is similar in HPV and control vaccines.”
Two months later, Peter Gøtzsche along with Cochrane-affiliated researchers Lars Jørgensen and Tom Jefferson, published a scathing critique of the HPV review in BMJ Evidence-Based Medicine,10 pointing out methodological flaws and conflicts of interest.
Gøtzsche, a Danish physician-researcher and outspoken critic of the drug industry (as his book, “Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare,”11 suggests) helped found the Cochrane Collaboration in 1993 and later launched the Nordic Cochrane Centre.
According to Gøtzsche and his coauthors, the HPV vaccine review “missed nearly half of the eligible trials,” and “was influenced by reporting bias and biased trial designs.” Overall, the review failed to meet Cochrane standards, Gøtzsche says.
Favorable Cochrane HPV Vaccine Review Riddled With Problems
Importantly, all 26 trials included in the HPV vaccine review used active comparators, meaning aluminum-containing vaccines, which can significantly skew results by hiding adverse effects. Making matters worse, the reviewers incorrectly described these active comparators as “placebos.”
Results may also have been skewed by the exclusion of women who had a history of immunological or nervous system disorders. “These exclusion criteria lowered the external validity of the trials and suggest that the vaccine manufacturers were worried about harms caused by the adjuvants,” Gøtzsche and his team writes.
According to Gøtzsche, the review also “incompletely assessed serious and systemic adverse events” and ignored “HPV vaccine-related safety signals.” These are exactly the kinds of tactics I discussed in “Questionable Tactics Used in Vaccine ‘Safety' Testing.”
Gøtzsche also notes the HPV vaccine reviewers incorrectly concluded the impact of industry funding on the included studies was insignificant. In reality, all 26 studies were funded by industry, and therefore assessment of funding impact could not even be done in a meaningful way. What's more, the reviewers brought their own conflicts of interest to the table.
“The Cochrane Collaboration aims to be free from conflicts of interest related to the manufacturers of the reviewed products … The Cochrane review only has four authors; three of whom had such conflicts of interest a decade ago.
The review's first author currently leads EMA's ‘post-marketing surveillance of HPV vaccination effects in non-Nordic member states of the European Union,' which is funded by Sanofi-Pasteur-MSD that was the co-manufacturer of Gardasil,” Gøtzsche and his teammates state.
Ousted Board Member Warns Cochrane Has Strayed From Mission
To Gøtzsche's and many others' surprise, the Cochrane governing board decided to simply expel Gøtzsche from the board. Four other board members (Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl and Nancy Santesso) immediately resigned in protest,12 leaving just eight of the 13-member board. In a joint statement, Gartlehner, Hammerstein Mintz, Meerpohl and Santesso said:13
“We believe that the expulsion of inconvenient members from the Collaboration goes against Cochrane ethos and neither reflects its founding spirit nor promotes the Collaboration's best interests.”
In a three-page letter14 to the Nordic Cochrane Centre — which is well worth reading in its entirety — Gøtzsche not only addresses his expulsion but also questions the path Cochrane's leadership has chosen in more recent years. Given its revelatory nature, I've included this longer-than-normal quote:
“No clear reasoned justification has been given for my expulsion aside from accusing me of causing ‘disrepute' for the organization. This is the first time in 25 years that a member has been excluded from membership of Cochrane …
[T]he Cochrane Collaboration has entered an unchartered territory of crisis and lack of strategic direction … Recently the central executive team of Cochrane has failed to activate adequate safeguards … to assure sufficient policies in the fields of epistemology, ethics and morality.
Transparency, open debate, criticism and expanded participation are tools that guarantee the reduction of uncertainty of reviews and improve the public perception of the democratic scientific process.
These are conditions and tools that cannot be eliminated, as has happened recently, without placing into serious doubt the rigorous scientific undertaking of Cochrane and eroding public confidence in Cochrane's work. My expulsion should be seen in this context.
There has also been a serious democratic deficit. The role of the Governing Board has been radically diminished under the intense guidance of the current central executive team and the Board has increasingly become a testimonial body that rubber-stamps highly finalized proposals with practically no ongoing input and exchange of views to formulate new policies …
This growing top-down authoritarian culture and an increasingly commercial business model that have been manifested within the Cochrane leadership over the past few years threaten the scientific, moral and social objectives of the organization …
There has also been criticism in Cochrane concerning the overpromotion of favorable reviews and conflicts of interest and the biased nature of some scientific expert commentary … There is stronger and stronger resistance to say anything that could bother pharmaceutical industry interests. The excuse of lack of time and staff (around 50) is not credible.
There has also been great resistance and stalling on the part of the central executive team to improving Cochrane's conflict of interest policy. A year ago, I proposed that there should be no authors of Cochrane reviews to have financial conflicts of interests with companies related to the products considered in the reviews. This proposal was supported by other members of the Board, but the proposal has not progressed at all.”
Clear Conflicts of Interest
Cochrane announced it was launching an investigation into the HPV vaccine review August 9.15 September 3, Cochrane's editor-in-chief issued a rebuttal16 to Gøtzsche's critique, saying the organization stands by the findings of the review. Considering the clear conflicts of interest, this seems rather ill advised.
One of the authors of the HPV vaccine review protocol17 — meaning the individuals who designed and determined the scope of the review — was Dr. Lauri Markowitz, who just so happens to be the HPV team lead for the division of viral diseases at the U.S. Centers for Disease Control and Prevention (CDC).18,19
Markowitz was also part of the U.S. Advisory Committee on Immunization Practices' (ACIP) HPV working group in 2006, and is the designated correspondent on ACIP's HPV vaccination recommendation issued in March 2007.20
This is about as clear a conflict of interest as you can get — especially when you consider the U.S. government has a financial interest in the sale of HPV vaccine.
The National Institutes of Health (NIH) receives royalties from the sale of this vaccine. Remarkably, NIH royalties from vaccines are protected from disclosure under the Freedom of Information Act (FOIA),21 so there's no telling just how much it stands to gain. The fact that these royalties are kept secret may be telling in and of itself, however. But there's more.
Merck, which manufactures and distributes the HPV vaccine Gardasil, has worked with a global health group called PATH22 to get the vaccine approved for use across the world. PATH, in turn, has received tens of millions of dollars from the Bill & Melinda Gates Foundation — $84.3 million in 2005 alone, for the expansion of low-cost tools that promote newborn health,23 and $10 million in 2013 to reduce cervical cancer deaths caused by HPV.24
Aside from that, Bill & Melinda Gates Foundation has been an ardent supporter and promoter of HPV vaccination25 — and donated $1.15 million to Cochrane in September 2016.26,27
In a June 5, 2018, article,28 the World Mercury Project, led by Robert F. Kennedy Jr., analyzed the financial ties between Cochrane, Gates and other vested players, noting that with Cochrane's HPV review, it appears several of them are “getting plenty of bang for their charitable buck.”
It's worth noting that while Markowitz is not listed as an author of the final report,29 she is still listed in the acknowledgements section as having provided “invaluable advice and contributions by reviewing the results and discussion sections.”
Ghosts in the Machine
The failure to disclose conflicts of interest has become so incredibly widespread, it seems more the norm than the exception these days. As just one among countless examples, last year I wrote about how STAT News, an otherwise reputable science and health news source, published an op-ed piece praising the benefits of pharma sales reps.
The article, “How Pharma Sales Reps Help Me Be a More Up-to-Date Doctor,” was written by Dr. Robert Yapundich, an experienced neurologist. The problem? Yapundich has received more than $300,000 from drug companies in recent years, and this fact was not disclosed anywhere, either by Yapundich himself or the editor.
Astute sleuths then pointed out other discrepancies, such as the fact that while Yapundich claimed he'd not heard of the drug Nuplazid until he had lunch with a drug rep, he'd actually been a paid consultant for that very drug. STAT News eventually retracted the article after multiple complaints.
The problem goes deeper than medical professionals and academics repaying the hand that feeds them with positive press, however. Sometimes, op-ed pieces such as these are actually written by the drug company itself, while it's being passed off as expert opinion. This practice is known as ghostwriting, and is one of the most insidious and deceptive tactics around.
The Industry's War on Science
While the drug industry is quick to claim that anyone questioning its integrity is part of a “war against science,” the evidence of malfeasance is simply too great and too disturbing to ignore. From my perspective, the industry itself is to blame for the public's dwindling confidence in scientific findings.
Loss of confidence is a natural result when lie after lie is unearthed, and there's been no shortage of scientific scandals to shake public confidence in recent years.
Still, the industry just keeps plugging away using the same propaganda tactics perfected by the tobacco industry, a key strategy of which is simply to keep uncertainty alive. Sometimes this may require the manufacture of biased research, but oftentimes it's as easy as repeating a lie enough times that it starts to sound like an established fact.
In a New York Times op-ed,30 health and science journalist Melinda Wenner Moyer31 blames those who question vaccine safety for stifling vaccine research.
Whether intentional or not, she follows a well-worn industry talking point groove, dishing out such classic statements as: “The goal is to protect the public — to ensure that more people embrace vaccines …” “The internet has made it easy for anti-vaccine activists to mislead,” and “[C]oncerns over what these groups might do are starting to take precedence over scientific progress.” What she — like everyone else before her — fails to address is the motive.
The vaccine industry has a significant vested interest in producing favorable results in their research. Ditto for the drug industry and chemical industry and most other industries that fund, conduct and publish their own research. When they publish flawed studies, they have a strong motive for doing so, which is why the public needs to be aware that the bias is real.
However, when independent researchers, journalists or indeed regular laypeople point out those flaws and refuse to buy the industry's nonsensical conclusions, what is the motive behind the rejection? According to industry, the motive is a “war on science.” Basically, we all hate science, we cannot tolerate progress and want to go back to the Dark Ages of bloodletting and humours.
A more pathetic and unconvincing motive simply cannot be manufactured. It's so illogical it can be ignored without comment or defense. If there's a war on science, it's fought by industry, because they're the ones benefiting.
In closing, I would direct you to read through Dr. Marcia Angell's article “Transparency Hasn't Stopped Drug Companies From Corrupting Medical Research.”32 A former editor of The New England Journal of Medicine for over 20 years, she has profound insight into these issues and has written extensively about how industry funding affects and distorts scientific research.