According to Dr. John Abramson, pharmaceutical companies, medical journals, and federal health agencies have conflicts of interest that would harm the public “tremendously.”
The problem has been demonstrated by how clinical trial data is being handled, said Abramson, a Harvard Medical School lecturer and an expert in litigation.
“It’s a system that is inherently nonsensical,” Abramson said in a recent interview with EpochTV’s “Facts Matter” program.
Abramson explained that Big Pharma funds most of the clinical trials, and its influence could allow the data to be presented in a way that is in their best interest—selling more products. However, peer-reviewed medical journals don’t have complete data access and can’t guarantee the integrity of those studies. Government agencies also play a role in advancing Big Pharma’s agenda. These factors could lead doctors to prescribe or patients to accept a medical product without knowing its full risk.
Drug companies prepare a clinical study report for a major clinical trial, but the data in the report is “tabulated,” said Abramson.
“Medical students and doctors are being taught that they have to practice evidence-based medicine, meaning the articles that are published in peer-reviewed journals, and the recommendations in clinical practice guidelines, need to be followed by good doctors,” said Abramson.
“What they’re not taught is that the peer-reviewers don’t get to see the actual data from the clinical trial. They just get to see the data that is summarized in the journal article manuscripts that are submitted.”
Abramson said drug companies fund 86 percent of the clinical trials that are conducted in the United States, and those manuscripts are typically written with the help or control of the drug companies “to put the best light on their drugs to present the data in a way that will have the greatest impact in prescribing their drug.”
“This is why we’re having the problems of recalls and drugs that don’t turn out to be as good as they say.”
Abramson played an important role in the investigation of Vioxx, a drug made by Merck and Co. pharmaceutical company. The investigation later led to the largest drug recall in history.
He said the experts who write the clinical practice guidelines couldn’t see the actual data from the clinical trials either.
Who Funds Clinical Trials
Clinical trials, that is, the study of a pharmaceutical product in humans, are essential to develop or approve a new medical product, such as a drug or a vaccine.
According to clinicaltrials.gov, a website maintained by the National Library of Medicine at the National Institutes of Health (NIH), as of July 3, there are 1,234 clinical trials, or interventional studies, relating to COVID-19 that have been conducted in the United States. Among them, 177 were funded by NIH or other federal agencies, 510 were funded by the pharmaceutical industry, and 582 were funded by individuals, universities, or organizations.
The National Library of Medicine told The Epoch Times via email that multiple groups could fund a clinical trial so that a study may be counted twice.
For clinical trials funded by individuals, universities, or organizations, the money may actually come from Big Pharma.
It’s reported that universities relied upon Big Pharma’s grants for most of their medical research.
For individuals, universities, or organizations, another donation source is philanthropic organizations, such as the Bill & Melinda Gates Foundation.
The foundation announced in May that it would donate $125 million to help end the COVID-19 pandemic, which is in addition to more than $2 billion that the foundation has already committed to the global COVID-19 response. A significant part of the $2 billion has gone toward COVID-19 vaccines.
“The doctors and the insurers and the health policy people don’t understand the extent to which the drug companies are perpetrating the illusion that what they’re presenting is science, when in fact, it’s marketing,” said Abramson. “It’s their version of the science, but it’s not independently vetted.”
Medical journals have their conflicts of interest in not demanding the full data, said Abramson.
“They don’t want to demand data because they want to be an attractive site for the big drug trials so that they can then sell the reprints back to the drug company.”
Abramson said in the case of Vioxx, the New England Journal of Medicine, one of the most reputable journals in the nation, peer-reviewed and published a study in 2003 and sold about 900,000 reprints of the article. The study claimed that Vioxx is effective and safe while the drug could cause a severe heart attack, blood clot, or stroke.
The International Committee of Medical Journal Editors didn’t respond to a request for comment. Over a dozen renowned medical journals are members of the organization.
In May 2020, Lancet, another world-famous medical journal, retracted a study on the effectiveness of chloroquine and hydroxychloroquine against COVID-19.
The study claimed that these drugs had no evidence of benefit but increased the risk of “in-hospital death with COVID-19.”
The Guardian reported that the study had temporarily halted global trials of for COVID-19.
The Lancet’s editor-in-chief Richard Horton told the Guardian that he was appalled by the retraction, “This is a shocking example of research misconduct in the middle of a global health emergency.”
Horton once wrote that “perhaps half” of scientific literature might “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,” Horton wrote.
In July 2020, when schools considered how to return children to school in September, the New York Times reported on a South Korean study claiming children between 10 and 19 years old can spread the virus as adults do.
“Later on, it came out they admitted they could not define what direction transmission was happening within their study, so they had to issue a correction—also the New York Times [did a correction] a month later,” Immunologist Steven Templeton told The Epoch Times last year.
But the damage had already been done after this “highly publicized” report and other stories were published; schools had been closed, and people had decided to go remote, Templeton said.
Retraction Watch, an organization focusing on retracted medical studies, found that over 200 articles relating to COVID-19 have been retracted globally, including preprint studies.
Dr. Abramson was a family doctor for 20 years. After he realized the medical journals were being increasingly influenced by the drug companies, he left his family practice and wrote a book “Overdosed America” in 2004. Later, he spent 10 years in national pharmaceutical litigation consulting with the Justice Department and the FBI.
“I got to understand exactly how the drug companies work, some of which I can share in the book and can share now, because the cases were heard in open court and the documents unsealed,” said Dr. Abramson.
In February, he published a new book titled “Sickening: How Big Pharma Broke American Health Care and How We Can Repair It.”
“What I learned about how the drug companies’ routine operating procedures involve keeping their data confidential so that they can’t be held to the standards of independent scientific analysis.”
“That’s what sickening is,” said Abramson.
A whistleblower has alleged that a contractor of Pfizer had falsified data, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s phase III trial for COVID-19 vaccine.
Brook Jackson, a former clinical trial overseer for a contractor holding trials of Pfizer’s COVID-19 vaccine, sued Pfizer and two contractors in January 2021. She claimed they “concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.”
“Due to Defendants’ scheme, millions of Americans have received a misbranded vaccination which is potentially not as effective as represented,” Jackson alleged.
In May, Pfizer asked the court to throw out the lawsuit.
Pharmaceutical Research and Manufacturers of America, a trade group representing pharmaceutical or biotechnology companies in the United States, referred The Epoch Times to their “Principles on Conduct of Clinical Trials (pdf).” The principles said the pharmaceutical companies “are committed to the transparency of clinical trials that are sponsored by our member companies.
“As sponsors, we are responsible for receipt and verification of data from all research sites for the studies we conduct; we ensure the accuracy and integrity of the entire study database, which is owned by the sponsor,” the document added.
Abramson said federal health agencies sometimes played a “cheerleading” role for Big Pharma, such as in the case of COVID-19 vaccines.
“The vaccine makers are pushing their data on the government. They’re doing press releases so that the public thinks they know, and doctors think they know, what’s going on because of how the news reports press releases. But that information is not accurate,” said Abramson.
“The key here is that the government has been cheerleading, in my opinion, too much. They’ve gone out over their skis. And they’ve promised safety when the studies haven’t been long enough to be safe.”
The Centers for Disease Control and Prevention (CDC) acknowledges that COVID-19 vaccines have two-months of safety data but claims they are safe.
“The clinical trials showed no serious safety concerns within eight weeks following vaccination. This is an important milestone, as it is unusual for adverse effects caused by vaccines to appear after this amount of time,” stated CDC.
“And they’ve made efficacy claims that are consistent with a drug company’s press releases and claims, but not a thorough independent analysis of the data. So I think the government has played a role in not being rigorous enough about the data,” said Abramson.
Abramson said he’s not an anti-vaxxer and believes the evidence shows the benefit of vaccination.
Cardiologist and epidemiologist Dr. Peter McCullough is one of the loudest voices doubting the efficacy of COVID-19 vaccines. He said the claim that COCID-19 vaccines could reduce hospitalizations and deaths is a “complete false narrative.”
“None of the vaccines have had clinical trials done versus placebo with that composite endpoint,” McCullough told The Epoch Times last month. “What’s happened over time is a false narrative that’s developed from observational data.”
McCullough said there were many “biased analyses” by investigators, doctors, and those in the biopharmaceutical complex trying to promote the vaccines.
Abramson also found it hard to understand why regulators approved and recommended the second booster based on observational data.
“Why the FDA [the U.S. Food and Drug Administration] and CDC relied on Israeli observational data to approve the second booster completely escapes me,” said Abramson.
On March 29, FDA authorized a second booster dose of either the Pfizer or the Moderna COVID-19 vaccines for people over 50 and immunocompromised individuals.
Abramson said when Israel approved a second booster without data, it was a “perfect situation” to run a randomized controlled trial on hundreds of thousands of people to see if a booster really works.
“But Pfizer chose not to do that. They chose to do an observational study,” said Abramson, adding that FDA did not insist on a randomized control trial in Israel, and even extended the booster to people over 50 years old.
Neither CDC nor FDA responded to a request for comment by press time.
Abramson said that people are learning that the benefit of Paxlovid was exaggerated and the original study only applied to high-risk people. Paxlovid is an oral antiviral medication used to treat COVID-19 that was developed by Pfizer.
“But that discovery has been going on for a long time. The data have been hidden, and the doctors don’t understand it. And this is a huge problem that is driving up the cost of health care that is harming American itself, that’s impeding doctors and other health care professionals from practicing the job that they’ve committed their lives to practice, and harming the public tremendously.”
Zachary Stieber contributed to this report.
https://www.theepochtimes.com/nonsensical-system-dr-john-abramson-on-conflicts-of-interest-among-big-pharma-medical-journals-and-regulators_4574480.html, The Epoch Times