Top Medical Journals including JAMA and NEJM Challenged by Department Of Justice. there is truth here, I know.

Top Medical Journals including JAMA and NEJM Challenged by Department Of Justice

Donald H. Marks, M.D., Ph.D.

Emeritus Fellow, American College of Physicians

Morris County, NJ

NPR has published (2 May 25) a letter perceived as “threatening” that many major medical journals have received from the Department of Justice. “More journals and publications … are conceding that they are partisans in various scientific debates," wrote Edward R. Martin Jr., the interim U.S. attorney for the District of Columbia, in a letter to the journal CHEST. Martin then asked a series of questions — about misinformation, competing viewpoints and the influence of funders such as advertisers and the National Institutes of Health. The letter reminded editorial boards and publishers of medical journals that, "The public has certain expectations and you have certain responsibilities."

JAMA and NEJM have officially expressed surprise and were offended (oh dear!) by the Department of Justice accusations. If they were to be fair and honest about their past, the editorial boards of these "prestigious" medical journals would admit that they have published articles that have been inaccurate, deceptive, driven solely by profit, been shills for the pharmaceutical industry, and have a number of shameful examples of not serving medical science in its highest measures.

There have been many discussions about misleading or flawed research in major medical journals, including JAMA and the New England Journal of Medicine. Here are some sources that explore this issue:

- The Journal of Ethics (2013) discusses how research evidence can be misleading, citing bias, small sample sizes, and statistical manipulation in medical studies. The authors took a deep dive into the 2005 article by Ioannidis.

- JAMA Network (2024) wrote about false health claims in published articles and the challenges of misinformation in medical literature.

- JAMA Internal Medicine (2015) has examined the reporting of limitations in observational research across multiple medical journals, including JAMA and NEJM. The authors found that “Study limitations may be inadequately acknowledged and accompanied by disclaimers that diminish their importance.” They concluded that “publication in high-impact journals and dissemination by news media … frequently generates unreliable findings.”

JAMA itself has claimed that Merck used ghostwriters to draft studies on the now-withdrawn painkiller Vioxx and then recruited academic experts to put their names to them. JAMA stated that Merck downplayed the mortality risks associated with Vioxx in Alzheimer’s patients. I am not surprised at all by these claims because I was one of the pharmaceutical physicians who participated in these ghost writing schemes (on another drug, not VIOXX), and recruited academic and community opinion leaders as false authors. I was chosen for this endeavor because of my academic credentials (PhD from UCLA), my experiences as a medical researcher for a number of pharmaceutical companies, my record in publishing independent original research, and my experience as a practicing physician. I have published a number of scientific articles in multiple leading peer-reviewed medical journals, including JAMA, NEJM and Vaccine.

The JAMA article noted that litigation related to Vioxx (rofecoxib) “provided a unique opportunity to examine guest authorship and ghostwriting,” practices which it says “have been suspected in biomedical publication but for which there is little documentation. How totally disingenuous of JAMA! A review of 250 documents revealed that Merck worked independently or with ghost publishing contractors to prepare manuscripts but then asked outside experts to be first or second authors on the published studies. Documents were found describing Merck marketing employees developing plans for manuscripts, I personally worked on a number of projects like this, publishing articles which I was paid to write, but which instead carried the names of community and academic opinion leaders, and not my own name – the actual author. Journals that I published these ghost articles in, under those misleading circumstances, include: Cardiology, the American Journal of Cardiology, Drugs, American Heart Journal, and American Journal of Therapeutics.

Ioannidis (2022) listed a number of criteria that could indicate that published research findings are less likely to be true, including “greater financial and other interest and prejudice.” This leads to claimed research findings often being simply accurate measures of the prevailing bias.

Sponsored medical publications, including “special” issues or conference abstracts, can contribute to the promotion of false or misleading information on drugs in several ways:

1. Bias in Research and Reporting – When pharmaceutical companies fund studies or publications, there can be a tendency to highlight positive results while downplaying negative or inconclusive findings. This can lead to an incomplete or overly optimistic portrayal of a drug's efficacy or safety.

2. Selective Data Presentation – Studies may only publish favorable data, excluding research that reveals adverse effects or limited effectiveness. This creates an illusion that the drug is more effective or safer than it actually is.

3. Influence on Medical Professionals – Physicians and researchers may unknowingly rely on biased publications to inform treatment decisions. If the information they receive is skewed by corporate interests, it can influence prescribing habits and lead to widespread use of a medication that may not be the best choice for patients. I remember the many many times that drug reps handed me reprints of important articles from leading medical journals supporting the products they were detailing during their visits.

4. Ghostwriting and Conflicts of Interest – Some sponsored studies are written by third-party writers with industry affiliations, but they are published under the names of independent medical experts. This practice can make corporate messaging appear neutral and credible while concealing vested interests.

5. Regulatory Challenges – While regulatory agencies work to ensure medical research is accurate, they may not always catch misleading claims in sponsored publications before they spread. This can lead to misinformation persisting in professional circles and among the public.

6. Promotion of Off-Label Uses – Some sponsored publications subtly encourage off-label use of a drug—prescribing it for conditions it has not been officially approved to treat. This can mislead physicians into believing there is strong scientific backing for such uses when there may be limited evidence.

As the Medical Director, and the VP of Medical Affairs of a number of large pharmaceutical companies, I personally experienced and participated in a number of these conflict areas. Ultimately, addressing these issues is difficult and conflicting, requires rigorous peer review, transparency in funding disclosures, and independent verification of medical claims

Paid articles can be considered a form of directed, although stealth, advertising. Here are some examples of how sponsored medical publications have promoted misleading drugs:

1. Misleading Drug Advertisements – Research has shown that direct-to-consumer advertising often exaggerates benefits while minimizing risks. For instance, some ads display benefits in large fonts while risks are barely visible, or they use imagery that suggests a drug is approved for children when it is only meant for adults.

2. FDA’s "Bad Ad" Program Reports – The FDA has received thousands of reports of misleading drug promotions, including cases where companies overstated effectiveness or omitted risk information. One example involved an antibiotic advertised as working in three days, while clinical trials showed the primary endpoint was ten days.

3. Regulatory Violations in Drug Promotion – The FDA monitors promotional materials to ensure they are not false or misleading. Some companies have been warned for failing to present a balanced view of risks and benefits, making unsupported claims, or promoting drugs that were still under investigation.

These examples highlight the importance of independent verification and regulatory oversight in medical publications. My hope is that, with these disclosures and with pressure from the DOJ and the public, physicians will be more aware of the reliability and the (promotional) intent of medical information they read in “peer-reviewed” medical journals.

References

Ioannidis JPA (2022) Correction: Why Most Published Research Findings Are False. PLOS Medicine 19(8): e1004085,.25 Aug 2022:

Ioannidis JP. Why most published research findings are false. PLoS Med.

2005;2(8):e124.

Suran M, Bucher K. False Health Claims Abound, but Physicians Are Still the Most Trusted Source for Health Information. JAMA. 2024;331(19):1612–1613.

doi:10.1001/jama.2024.6837

Sarwar U, Nicolaou M. Fraud and deceit in medical research. J Res Med Sci. 2012 Nov;17(11):1077-81. PMID: 23833585; PMCID: PMC3702092.

Merck & Co hits back at JAMA attack on integrity, by PharmaTimes | 16th Apr 2008.