Feel free to jump to the heading "Safety Net #3" below, everything stated until then is a repeat of what was written on the first post.
When it comes to products that are available for purchase, there are many safety nets that are established, to protect consumers from dangerous products, and to ensure that products are designed, manufactured, and distributed in such a way that potential harms can be more easily minimized, and/or identified more quickly once in distribution. Unfortunately, there are shortcomings in many of these consumer safety nets, or industry has found a way to bypass some of those protective measures. As a result, unsafe products continue to be made and distributed widely. What’s more unique to vaccines though, is that every single safety net that was established to protect people and ensure product safety, all those protective measures have actually been neutralized by the pharmaceutical industry. This neutralization has happened either by direct financial funding from pharma, or indirectly through Governmental conflicts of interest that affect internal policy, bureaucracy, and legislation. But before explaining how the consumer protective safety nets have been neutralized when it comes to vaccines, I’ll first list what those protective measures were, or should be. (Bolding in the list below denotes which topic point will be discussed in this article).
The consumer safety nets for vaccine products are:
Government and our political leaders who represent the people
Federal agencies that oversee vaccine regulation, research, safety, and distribution: These agencies include: Health and Human Services (HHS)The Food and Drug Administration (FDA), The Centers for Disease Control (CDC), The Institute of Medicine (IOM). Yes, these agencies are all based in the United States, however their policy are often adopted on a global scale.
Scientific research and medical journals
Our doctors and the institutions where they are educated and employed
Vaccine Adverse Event Reporting System (VAERS)
The legal system
Safety Net #3: Medical Journals
In this article, we will be discussing how medical journals play a role in protecting the public, and how the medical journals have been compromised, both directly and indirectly by pharmaceutical financial influence.
When it comes to indirect influence, the medial journals have been compromised as a result of what research gets published, and by who. Research from 2015 analyzed trials that were registered in ClinicalTrials.gov, and that analysis showed that the US Government and pharmaceutical companies are the biggest funders of research. The data showed that pharma funded research accounted for at least 36% of all registered research, and pharma funded research surpassed Government funded research 4.5:1.
A 2016 article by STAT media group explained another trend, which is that a significant portion of pharma funded research is never published. STAT's article was titled, Many clinical trials’ findings never get published. Here’s why that’s bad. The article states (emphasis mine):
New research suggests that nearly half of all clinical trials involving kids go unfinished or unpublished — either because the researchers lose interest in the work or take up more pressing projects, or, in some cases, because the companies that funded the studies don’t want the results to get out.
....by not publishing these studies, drug makers and scientists put young patients at risk, particularly if those data reveal dangerous side effects or other adverse events from taking medications
....And industry money was a significant predictor of whether data would see the light of day. Studies that received industry funding were more than twice as likely as those with non-industry grants — such as government or foundation money — to be unpublished two years after the end of the project, and more than three times as likely after three years.
In Safety and Efficacy - Part 1, I linked to the TEDMed Talk with Dr. Ben Goldacre. In that discussion, Dr. Goldacre explains that the medical journals are filled with research that shows positively towards pharmaceutical drugs. He explains this is because when a drug maker conducts research that shows a drug has serious harms, the drug maker will NOT publish the study. As a result, the medical journals have become biased and are only telling half the story.
Although recent research shows that half of all pharma funded clinical research goes unpublished, that only accounts for the research that is known about because it was registered within a period of time after the trial began. There is also a substantial body of research that is being conduct without any awareness of it. This is because not only was the research never published, it also was never registered at the beginning of the trial. Because of this occurence, Government regulation is being tightened, with legal requirement specifying that research on serious or life threatening conditions must be registered at the start of the trial, for ethical purposes. These measures have very good purpose, the consequence of not taking these measures is explained in British Medical Journal (BMJ) paper as follows:
Studies have shown that roughly 30–50% of clinical trials remain unpublished, often years after their completion, and most fail to meet baseline legal disclosure requirements, such as those established in the 2007 US Food and Drug Administration Amendments Act (FDAAA). Moreover, studies that are published by sponsors, journals and researchers tend to show favourable or statistically significant results. This selective trial dissemination can distort the medical evidence and challenge physicians, prescription guideline writers, payers and formulary decision-makers’ abilities to recommend and provide the right drugs for the right patients. It also represents a violation of the rights of human research subjects, as experimenting on humans is largely justified by its potential to contribute to generalisable knowledge (as stated in the 1981 US Common Rule). Furthermore, transparency may be essential to ensuring the integrity and trustworthiness of the clinical research enterprise.
This enterprise obviously includes the medical journals themselves.
This BMJ paper explains in it's introduction:
For decades, many clinical trials have been publicly inaccessible, raising ethics, medical practice and population health concerns. While recent transparency efforts have improved practices, a significant portion of both commercially and publicly funded trials and trial results still remain inaccessible, because they are unregistered and their results are unreported in trial registries, or they are never published in the medical literature.
This study took a different and unique approach to evaluate how many trials are actually registered or completed, analyzing new drugs and all the trials used to support them. The paper stated (emphasis mine):
This study and approach are novel for at least five reasons. First, we evaluated the transparency around individual new drugs. Previous studies generally evaluate transparency on the trial level....When a new drug enters the market, the trials we evaluated in our rating system contain the safety and efficacy profile for that drug, and all, or nearly all, available evidence to inform clinical practice.
Second, we used FDA approval packages as a key data source, because they characterise all clinical trials supporting new drug approvals. Prior studies evaluate the transparency of already registered trials in ClinicalTrials.gov, which provide limited insights into the many unregistered studies. Third, we focused on large companies because, as a group, they sponsor a significant portion of the trials conducted annually and the majority of new drug applications (NDAs) submitted to the FDA. Also, they were expected to have the infrastructure to comply with regulatory and ethics standards. Thus, we likely captured a best-case scenario.
The conclusion of this research was that only 20% of the companies analyzed complied with all disclosure requirements. The research stated:
2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge.
...While nearly two-thirds of clinical trials, per drug, were publicly disclosed, there was wide variation among drugs and companies. At first approximation, it may seem difficult to understand failures to comply with federal law, now 8 years old, whose origins track back to 1997, and even more difficult to understand failures to meet the over-riding ethics obligation that human research be designed to contribute to generalisable knowledge.
When at least 50% of all pharma funded research goes unpublished, in many cases because the research shows unfavourably for the product in question, and when that percentage of unpublished research may actually be substantially higher recognizing that a signifant amount of research is never registered in this first place, and so it's unknown how much research that constitutes and what percentage of that is unfinished or unpublished, then it's likely that the medical literature published within the journals themselves is a very inaccurate and biased reflection of what has actually been discovered through scientific testing.
In addition to that, pharma's influence also indirectly affects the medical journals in an another way. This can be seen in the area of journal reprints. If pharma publishes a study that shows favourable results for their product, they are likely to purchase many reprints, to distribute to their medical clientele, to generate interest in their product and profits for their company. For the medical journals, considerable profit can be generated by these reprints (Here). As a result, medical journals may be more biased towards publishing pharma research that could generate a substantial reprint sale for them, as opposed to publishing independent research which may be less likely to have a reprint demand.
And when it comes to the direct influence that pharma uses, they provide a considerable amount of funding to the journals themselves, through advertising sponsorship. The journals need this advertising funding to remain profitable. If pharma learns a medical journal intends to publish an independent study that does not show favourabe support towards a pharmaceutical product, the company has been known to threaten to withdraw their advertising sponsorship. This is why you sometimes see a medical journal publish research, and then later retract that paper with no reason given.
It’s for all of these reasons that both Dr. Richard Horton, the Editor-in-Chief of the Lancet and Dr. Marcia Angell the former Editor-in-Chief of the New England Journal of Medicine have stated we can no longer trust and rely upon the research within the medical journals.
Dr. Richard Horton published a letter within the Lancet, a letter which says:
The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness...The apparent endemicity of bad research behaviour is alarming. In their quest for telling a compelling story, scientists too often sculpt data to fit their preferred theory of the world. Or they retrofit hypotheses to fit their data. Journal editors deserve their fair share of criticism too. We aid and abet the worst behaviours. Our acquiescence to the impact factor fuels an unhealthy competition to win a place in a select few journals. Our love of “significance” pollutes the literature with many a statistical fairy-tale.
...Can bad scientific practices be fixed? Part of the problem is that no-one is incentivised to be right. Instead, scientists are incentivised to be productive and innovative.
And Dr. Marcia Angell has been quoted as saying (Link Here):
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.
As a protective measure for public health, it only makes sense that regulatory agencies legally require that all research be registered and all testing be published. Until that time however, we must be cautious in how we review the scientific literature published in the medical journals, recognizing that current health regulation has allowed for the creation of a data library that has become so heavily biased from pharmaceutical influence.
Pharma outspends Government on research, funding 4.5 studies for every 1 Governmentally funded study Here
STAT article: Many clinical trials’ findings never get published. Here’s why that’s bad Here
British Medical Journal: Clinical trial registration, reporting, publication and FDAAA compliance Here
British Medical Journal - Potential bias based on reprint revenue Here
Brandy Vaughan - pharma doesn't publish research that isn't favourable to their product Here
Continue on to the next post in this series: Here
You can refresh your memory statements made by Dr. Richard Horton and Dr. Marcia Angell in Safety & Efficacy - Part 1
You are currently on Part 8 of a 14 Part Series.
View a Post in the Series Using the Links Below:
Part 1: Consumer Safety Nets Here
Part 2: HHS
Part 3: The FDA Here
Part 4: The CDC Here
Part 5: The DHHS & IOM Here
Part 6: Scientific Research Here
Part 7: Scientific Research Corruption Here
Part 8: The Medical Journals (You are on this page)
Part 9: Our Doctors Here
Part 10: Doctors Responsibility Here
Part 11: Medical Institutions Here
Part 12: VAERS Here
Part 13: The Media Here
Part 14: The Legal System Here