Posted by : Ed Lott, Ph.D., M.B.A.
In 2000, the healthy life expectancy of Americans ranked 38th in the world.
In 2019, we were at 68th – behind China, Cuba and Jamaica.
Citizens of Japan live eight years longer in good health than Americans.
Canadians live five years longer.
And yet, we spend $1.5 trillion more per year on our healthcare system than do other wealthy countries.
Why is this happening?
In a nutshell, it’s the power of large multinational pharmaceutical corporations.
It is Big Pharma that funds most clinical trials and therefore controls the research agenda, withholds the real data from those trials as corporate secrets, and shapes most of the information relied upon by health care professionals.
That’s the conclusion of Harvard Medical School’s John Abramson in his new book Sickening: How Big Pharma Broke American Health Care and How We Can Repair It (Mariner, 2022).
At the heart of the book is corporate crime. One section deals with Vioxx, a pain killing drug that caused 40,000 to 60,000 deaths. There was civil litigation and compensation of about $4.7 billion. There was a $322 billion criminal fine. Merck sold $12 billion worth of Vioxx over four and a half years.
Nobody went to jail.
Abramson says that doctors are just not aware of the power of the pharmaceutical industry to set the healthcare agenda in this country.
Take the pivotal question of peer review journals.
Peer review as in – your peers get to review the data.
Except that they don’t.
Abramson says that one of Big Pharma’s best kept secrets is that the peer reviewers charged with ensuring the accuracy and completeness of the clinical trial reports published in medical journals do not even have access to complete data and must rely on corporate-influenced summaries. Same for the experts who write the clinical practice guidelines that define our standards of care.
Abramson worked for ten years – from 2004 to 2014 – as an expert for lawyers suing pharmaceutical companies.
Why did he quit?
“One reason is that it is extremely high pressure,” Abramson told Corporate Crime Reporter in an interview last month. “It’s like being in a heavyweight boxing championship match. When I would go up against the defense attorneys, they would be supported by teams of lawyers with teams of experts behind them. I had to be right. I couldn’t let any prejudice or whim that I had slip through. Everything that I said in my reports about what I said the drug companies did wrong had to be exactly right. That’s really hard work. So, I needed a break.”
“Also, my whole motive for doing this was to get the information out so that doctors and the public could understand how much the drug companies were controlling and misrepresenting the data from the clinical trials and how they were misdirecting American health care.”
“And not much of it got out. I served as a consultant to the FBI and the Department of Justice in a case involving the drug Bextra. I had worked in civil litigation to try and figure out what Pfizer had done. I took that information to the Department of Justice and FBI. And it led to the largest criminal fine in U.S. history at the time – $1.2 billion in 2009.”
“I testified in a case where Kaiser Health Plan sued Pfizer for fraudulently marketing Neurontin to Kaiser’s doctors. The jury in federal court in Boston found that Pfizer had not only committed fraud but racketeering violations.”
“I was doing this work. It was enormously satisfying and extremely stressful, but I was not making progress. What was happening in the world of litigation wasn’t getting out to doctors and consumers. I understood what was going on, but I couldn’t get the word out.”
“I decided that the only way to get this information out was to write a book. The doctors and patients were not getting the information they needed and it was compromising the quality of American health care. It took me more than five years to write this book.”
“A lot of the material is still sealed. But enough of it is unsealed so that I can tell the story in a way that non health care professionals can understand how their beliefs are being played with by the drug companies in order to maximize sales.”
“What I found was that this system is a system of maximizing the return on investment for the investors, private equity investors and hedge funds in the pharmaceutical industry. And the entire system is designed to maximize the amount of money that is taken from patients and given to the financial investors and drug companies.”
“Medical journals are caught up in this. The journals tolerate peer reviewers not getting the data. The peer reviewers don’t get the data. The medical journal editors don’t get the data, so they don’t really know what is true. They say these articles are peer reviewed, but they don’t get the data. This goes from the New England Journal to JAMA on down. They don’t get the data.”
“The experts who write clinical practice guidelines that set the standards for American medicine, they too don’t get the data. They have to trust the manuscripts that are published. And they are usually overseen by the drug companies.”
What’s the underlying problem with medical journals?
“The more prestigious a journal, the more true what I’m going to say is. Much of the income of the prestigious journals comes from selling reprints and advertising. They sell reprints of articles that they published back to the manufacturers of the drugs to be handed out by their drug reps as marketing tools.”
“It’s hard to get this data. In 2005, 41 percent of the Lancet’s income came from reprints. And it’s highly likely that the New England Journal had an even higher percentage. In order to sell reprints, the journals need to publish commercially important articles that reflect well on the drugs so that the manufacturer will want to buy the reprints and use them as marketing material.
The journals abide by this system that pretends to peer review articles, but doesn’t demand transparency.”
Would you prohibit reprints?
“That would help. But there is a much more direct way. Make sure that the peer reviewers get the data. I personally need a statistician to handle raw data. But there is a thing called a clinical study report. The raw data is electronic. It’s a huge amount of data. That raw data is tabulated into clinical study reports that are usually several thousand pages long. From that clinical study report, the authors write articles.”
“Those clinical study reports are prepared for all major studies. It wouldn’t take anything, nothing, to send those clinical study reports, with the manuscripts, to the journals. A 3,000 page document is daunting. But as long as it’s searchable, people with experience can get through those pretty quickly. You can figure out what they said they were going to do and compare it to the data, at least the data the clinical study report said they relied on and how they reported that. There is no reason whatsoever not to include those clinical study reports with the manuscripts they submit for publication.”
Do any journals demand clinical study reports?
“To demand them would lead to a death spiral. The prestigious studies that lead to reprint sales and advertising would move away from a journal that demanded it.”
“There is a committee called the International Committee of Medical Journal Editors. They have danced around increased transparency. But what they have come away with is simply that authors of studies have to say how they will make their data available if they will make their data available. The author just has to make a statement as to what they will do with their data. They don’t have to make the data available.”
What reason do the medical journals give for not demanding the underlying data
“Jeffrey Drazen, the editor of the New England Journal of Medicine, wrote an editorial addressing this. He says he doesn’t think the data should be made available because he thinks a new class of researchers, who he calls data parasites, will emerge. And they will analyze the data their own way and they might come up with contradictory conclusions and therefore they shouldn’t get the data.”
You would think that there would be a rogue medical editor who would demand the data.
“Some of the journals have taken stronger stands. But they are not the prestigious journals that are publishing the articles that are seen as leading edge in bringing information about innovation to the medical world.
What’s the pathway to a breakthrough?
“The International Committee on Medical Journal Editors has to do it. All of the journals have to do it. This is a classic case of market failure. There needs to be Congressional action. It’s in the drug companies’ interest not to be transparent. It’s in the journals’ interest not to be transparent. It’s in the researchers’ interest not to be transparent. But it’s not in the public’s interest.”
[For the complete Interview with John Abramson, see 36 Corporate Crime Reporter 6(11), Monday February 14, 2022, print editon only.]
The post John Abramson on How Big Pharma Broke American Health Care appeared first on Corporate Crime Reporter.
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