Fake Science: When is Medical “Science” Not Science?

WE HAVE BEEN WARNED by our government and by specific social media outlets that much of the “news” we read online falls into a category of “Fake News”.  This warning has been identified as a very real threat to the freedom of expression and a move toward censorship.  I have witnessed first-hand how facts have been obliterated by government officials at press conferences, in testimony to Congress, and in conference calls to the scientific community.

Throughout my scientific career, I have championed objectivity, first-hand, with hands-on data, data analysis plans, study designs, reporting, writing papers, publishing, participating on NIH grant review panels, conducting peer review on studies submitted to dozens of different journals.  I served as founding Editor-in-Chief on a journal that was my brain child, and led a dozen or so of the Editorial Board in a threat of mass resignation against the publisher if they weakened the peer-review system I had established.  (I learned later that the idea came from a sick, jealous colleague of mine, who wished to weaken the journal).  To the publisher’s credit, he saw wisdom in keeping a blind peer-review process, and both the journal, and the online, open-access publisher, are thriving.

The appearance of news foretelling future censorship of so-called “Fake News” on social media is chilling. But it raises an interesting question: what about Fake Science?  If the corporate masters wish to dictate what “news” we know, will our benevolent information screeners allow Science to proceed unabated?  What would Fake Science look like?  And how would we know?

Having been trained every year for 16 years on the standards for regulatory compliance of proper conduct of science, and having taught courses on research study designs and research ethics, I have a fairly granular view on Fake Science. To understand what Fake Science would look like, we could start with funding agendas.

Every year, the Federal Budget is constructed in a manner that is supposed to provide funding (immense amounts of funding) to agencies that conduct research, and that fund extramural research studies at Universities, Medical Research Centers, and the like.  This funding often comes in the form of earmarks to fund research on specific public health concerns, such as cancer.  However, the Senate does not like to be involved in deciding the specific types of studies, nor the focus of the studies, to be conducted.  They have repeatedly stated that they would prefer to leave it up to “the Scientists”.  In reality, however, it is often left up to the agenda of the agencies, rather than the full population of scientists who might apply.  Much of it is never made available to extramural, independent researchers – and the process of securing funding for research within (intramural) research areas is ridiculously simple, and often lack rigor. Thus, science designed “to demonstrate” on point or “to disprove” another is inherently biased, and tends to fulfill policy, not scientific needs.  Let’s look at the various levels of control by which public policy is infused into, or in some cases, obliterates, bona fide science and replaces it with Fake Science.

Bias #1. Piracy: Regulatory Capture of Agencies

When corporations send people to secure high-ranking positions within agencies, the process is called “Regulatory Capture”.  When this occurs, it can alter the science that gets conducted in three important ways.  The first is in the determination of what area(s) get prioritized in the large but finite budget. The second is the in the determination of the types of studies (randomized clinical trials, retrospective studies, animal studies, translational studies) that are given priority. If essential areas of research are not funded, then specific, important questions (Do cigarettes cause cancer? Is ADHD overdiagnosed? Do pesticides cause cancer in humans?) are never asked.  And if earmarked dollars specify an area of research, the captured agency can still manipulate the types of questions that can be asked, either directly, or by restricting the type(s) of studies for which the funding will be allowed to be used.  If the questions are particularly gnarly, with big consequences for corporations, they might even dispense with extramural funding altogether, and instead conduct all of the research in-house, where it can be more easily managed and controlled.

Bias #2. The Block: Non-Objective Peer Review (Grant Application Stage)

Let’s say some plug of funding escapes an agency, and makes it way into an independent researcher’s budget. They are funded after a process of peer-review, managed by the funding agency, many times in response to specific calls for proposals, or program announcements. Sometimes a cabal of scientists will work to review each other’s grants, and turf competitors’ grant applications with harsh reviews.  The NIH has a process in which a huge percentage of the grant applications are “triaged” – returned without further review – because a superficial review found them not worthy of being carried forward.  This is ostensibly a time-saving step; however, it can readily be used to send back grant applications that ask the “wrong” questions.  I have witnessed this first-hand while serving on an NIH review panel. One particularly aggressive reviewer claimed (without evidence) that their competitor must have “made up” the data in their grant proposal.  Naturally, I asked them if they had any independent evidence other then their level of disbelief in the outcome of the study.  He had none.

The Philosopher Karl Popper, father of falsificationism, taught us that the degree to which we are surprised by the outcome of an honest critical test of a hypothesis is correlated to the degree to which the hypothesis has been corroborated by surviving the test. One should not use background knowledge to dispense with the corroboration afforded a hypothesis, it’s the other way around: our background knowledge may in fact need to be updated when the outcome of the test does not falsify the hypotheses, and our degree of surprise should point us to look closely at our background and our collective knowledge.

Bias #3. The Check: Non-Objective Peer Review (Submitted Manuscript Stage)

Scientific journals should pride themselves on being objective sources of knowledge. To have a study published in a scientific journal (usually) means that it has survived a rigorous process of peer-review, by people who have (by design) no known conflicts of interest that would work in favor or, or against, acceptance or rejection of a particular study they have been invited to review. This process should never be influenced by nor controlled by the authors of the manuscript (although journals often ask study authors for 2-3 names of potential reviewers, there is no guarantee that those suggested will be utilized).

That said, studies can be harshly critiqued by competitors, or, worse, entire journals can be, like agencies, wholly owned subsidiaries of corporations.  They can be overtly captured, say via movement of people into Editors-in-Chief positions, or they can become owned more subtly, for example, via research program funding of the Editors-in-Chief by corporations, or by advertisement funds directly to the Journal.

Bias #4. Mob Censorship/Study Assassination: Retraction of Published Studies Unfavorable to Corporate Agenda

Lately, a very disturbing trend has emerged in which studies that have found risk associated with corporate-owned medical products have been set upon by ostensibly well-intentioned denizens of the internet – the bloggist, or people with email who issue an “expression of concern”.  With identities sometimes obscured, and pandering their presumed monopoly on scientific virtue with referential terms in their avatar or names, or their blog’s title (usually with terms referencing skepticism, reason, rationality… or some combination thereof), these individual set upon a peer-reviewed, published study with a frenzy and with a fine-tooth comb specifically seeking any minor flaw, or potential flaw in the study design, its implementation, or the authors’ interpretation. Invariably, something is found – it is unlikely that any published study given a complete vivisection could ever be found that was completely flawless – and they amplify the significance of the flaw first in terms of its impact on the study conclusion. This is followed by a scorched-earth tactic in which they claim that if this study, which had been published previously, is allowed to exist unscathed, it will bring about fire and brimstone of plague and pestilence on the earth never seen before.

Nowhere in their communications do they reference the Journal’s stated policies for retraction.  Authors of studies enduring such attack should reference the Journal’s stated policies for grounds for retraction when mounting their defense (if given the opportunity to do so).

This tactic has become so ridiculous that a study that was scheduled to be published after a first course of peer review was recently turfed by one journal due to few strongly-worded tweets encouraging scientists to take their papers to other journals unless a specific paper a Tweeter happened to not like is not retracted.  If Science is to survive in the new Corporatocracy, this practice must be met with strongly worded letters to the deciding Editor by the Editorial Board with threats of mass resignation and counter-boycott, if necessary.  An Editorial Board must stand by the Journal’s peer-review process, and the Journal must stand by the outcome of that process.  To do otherwise is to allow Corporations to sanitize the literature of what they deem to be “problematic” studies, one study at a time.

As an exercise in serving them their own medicine, I and co-authors recently found seven fatal flaws in a study by Zerbo et al. that originally found association of autism with vaccines given the first trimester, until they lost the association via statistical shamwizardry (a term I coined in “Cures vs. Profits”).

Bias #5. Flawed Meta-analyses, Inflated Presumption of Statistical Power

Once the scientific literature has been sanitized of any studies that could show harm for a corporation’s product, someone is funded (usually by the corporation with financial interest) to conduct a special type of study called a meta-analysis.  In a meta-analysis, a supposedly unbiased sample of available studies are pulled together, and their statistical analyses and results condensed into one, large conclusion.  Well, if the previous four biases were not enough to sanitize the literature, there is always obfuscation by combining studies of different types, or rejection of studies with significant effects for having too small sample sizes – even though the positive result already demonstrated sufficient power at the sample size at which the study was conducted. The meta-analysis then finds no overall significant negative effect, and is cited as being “the largest study to date”, based on “over a million patients”, both of which are non-sequitur descriptors of meta-analyses, and are therefore patently untrue.  One hundred poorly designed, under-powered studies that found no significant negative effect will result in one large meta-analysis that conclude no significant effect – so the citation of hundreds of thousands of patients involved in a meta-analysis does not imply increased power.

Bias #6. Flawed Medical Education and Kick-Backs

Medical education programs that are based on an intrinsically biased scientific literature are harmful to medicine, because they fail to transmit the full body of knowledge that exists on, say, risks of harms, serious adverse events, etc. to practitioners of medicine.  Well before receipt of their degree, medical professionals are bombarded with messages of the utility and efficacy of certain drugs and medical procedures – and they learn that even though it is illegal for individual medical doctors to receive kickbacks to incentivize specific medical options, their practices can be given significant kick-backs (monetary incentives) or selecting the medical options being promoted by very wealthy corporations.

There are ethical individuals, such as the 80% of opthamologists who refuse to use Avastin to treat patients when Lucentis is clearly a clinically equivalent drug (see See Andrew Lam’s  2015 Commentary in the Chicago Tribune: Why do doctors choose a $2,000 cure when a $50 one is just as good?).

Those with clear vision will see, as I point out in “Cures vs. Profits”, that the profit motive thereby has a dramatically homogenizing effect on medicine – all for one, not one for any.  This homogenization effect restricts the freedom of choice to the health care consumer, whose options are pre-selected by what the law has referred to as “learned intermediaries” led by industry cheerleaders called “Key Opinion Leaders” who spin the positive and further minimize the negative consequences of a drug or medical procedure they are peddling.  [See See Carl Elliott’s “The Secret Lives of Big Pharma’s ‘Thought Leaders”, Chronicle of Higher Education, 2010].

Bias #7. Failure of Duty to Warn, Neglect of Rights to Informed Consent

Seven minutes, per patient, $400 per fully vaccinated child. Those two numbers should stick in your head. Pharmaceutical companies incentivize doctor’s practices with $400 per fully vaccinated pediatric patient – and yet the goal for an entire well-child visit is seven minutes.  Health care providers shame parents who ask questions about vaccine risk by putting down “those crazy anti-vaxxers”. Each and every time a health provider fails to give a patient, or their parent, a vaccine information sheet, that patient/parent pair is being denied the right to informed consent.  The pressure to restrict each well-child visit to seven minutes is to ensure as many patients are seen as possible, increasing  the practice’s profit. In 2016, the AAP encouraged its members to refuse medical care to children whose parents ask too many questions  – the threat of which by any definition is “coercion”.

Informed consent laws and rights exist, are enforceable, and the very point of consent procedures is to limit deception and coercion and exploitation. Our modern culture of respect for informed consent derives in part from the cruelty of Nazi experiments, which led to the Nuremberg Code of research ethics, which stipulated, “The voluntary consent of the human subject is absolutely essential”.  Vaccines, of course, are on ongoing clinical trial, the safety of which is assessed via post-market surveillance.

Which explains why the 21st Century Cures Act has made is possible for those conducting medical experiments to enroll any American citizen in a clinical trial – without their consent – as long as those conducting the trial can convince their IRB the risk is minimal. According to the interpretive summary,

“(Sec. 2263) Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.”

 

Rational analysis of the change in the wording points to an attempt at a CYA over retrospective vaccine safety studies. It seems unlikely that the 21st Century Cures obliteration of informed consent will ever be invoked.  Clearly, the clause in the 21st Century Cures Act cannot apply to any American because the risk to those enrolled in clinical trials cannot be known until the conclusion of the trial. There remains a very large body of regulation and rules that exists that guarantees informed consent.

Vaccine information sheets exists because parents do not always even know which questions to ask. If you are a parent of a vaccinated child, and you were not handed a physical copy of the Vaccine Information Sheets from the CDC for each and every vaccine administered to your child, you have been denied your right to informed consent under the law. You may find that your doctor cannot or will not answer straightforward questions about vaccine safety, such as those provided to parents by The Institute for Pure and Applied Knowledge (see IPAK Informed Consent Flyer).

Bias #8. News Media Blackout

Those following the story of Ebola will recall how, after daily stories of the drama
unfolding that could kill the world, the news media suddenly stopped reporting on Ebola. This was the direct result of the White House asking the Associated Press to stop reporting on suspected cases returning from countries in which Ebola was circulating in their populations. You will also notice that I managed to find 2,000 studies in Pubmed to read that show the specific mechanisms that cause vaccines to induce encephalopathy-mediated autism in some people, yet the press is extremely reluctant to cover new studies that support the link between vaccines and autism.  It took Robert De Niro’s pulling of the movie “VAXXED” from the Tribeca Film Festival to get the media to pay attention to a film produced by Del Bigtree, the former producer of the television show “The Doctors”. This, in spite of the appearance of two celebrity medical doctors who changed their views on the autism/vaccine issue upon being shown the evidence that Dr. William Thompson provided to Dr. Brian Hooker showing that CDC sanitized the results of a key report that was to made to the Institutes of Medicine during their consideration of the available science on vaccines and autism.

Of course, news media outlets are more than happy to carry forward the party line about a drug or medical procedure as long as the Direct-to-Consumer advertising fees keep streaming in from Pharma.  When confronted with ANY new study showing any connection between vaccines and autism, they don their cloak, and beat themselves about the head with wooden planks with their Gregorian Chant:

Watch VAXXED and let Dr. Wakefield tell you himself what he concluded in his study, which was retracted after a reporter – not a scientist – alleged impropriety in study design approval. Which, by the way, is precisely one of the complaints of the CDC Whistleblower about the CDC studies conducted to disprove Wakefield’s hypothesis.

Bias #9. Government Agency Censorship of Informed American Citizens

By law, the CDC must collect public comments during a period of time before issuing new rulings on changes to Vaccine Information Sheets.  Having read the Vaccine Information Sheets for accuracy and completeness for another project, I was aware of the deficiencies in the MMR and MMR-V sheets.  I was therefore astonished to read comments from certain well-known anti-vaccine risk awareness individuals that called, specifically, for a weakening for the MMR and MMR-V information sheets.  An associate of mine and I prepared a joint comment, and a rebuttal to the dangerous call for less information on risk in the vaccine information sheets, and we waited.

After some 300 comments had appeared, our own, and another associate’s comment had not appeared.  Finally, on December 23, 2016, our comment and rebuttal appeared, but altered.  Key sections of both our comment, and of our rebuttal to the individuals calling for weakened information on risk had been redacted. The content of these comments are the subject of pending litigation.

Summary

Fake science would involve biased science funding agendas, regulatory capture of agencies, conflicts of interest, willful ignorance of risk, failure of duty to warn, profit pressures, media blackouts, and government censorship of private citizens.  And that’s just in 2016.

Now you know why you think you know that vaccines do not cause autism.

And if you genuinely persist in your “knowledge”, in spite of this evidence of bias, I’ll point out the clearest evidence that exists that you do not know what you’re talking about. If you persist in your position that “Vaccines Do Not Cause Autism”, I say to you: How do you know?  In spite of what you think you know, not all vaccines have been studied for a link to autism, and some studies do, in fact, exist that have found association.

 

About the author

Dr. Lyons-Weiler is author of three books, “Ebola: An Evolving Story”, “Cures vs. Profits: Successes in Translational Research” , and “The Environmental and Genetic Causes of Autism”.