Scientific American: How Drug Company Money Is Undermining Science

Posted by on November 28, 2012 in Big Pharma, CDC & FDA with 1 Comment

The pharmaceutical industry funnels money to prominent scientists who are doing research that affects its products–and nobody can stop it


By Charles Seife | Scientific American


When Robert Lindsay chose to become a medical researcher in the early 1970s, he did not do it for the money. His field—the effect of hormones on bone—was a backwater. It was also a perfect opportunity for a young researcher to make his mark and, he hoped, help millions of people who suffered from the bone disease osteoporosis. As the body ages, sometimes bones lose the ability to rebuild themselves fast enough to keep pace with the normal process of deterioration, and the skeleton weakens. Neither Lindsay nor anyone else understood much about why this happened, but there was reason to think that hormones might play a role. Some women develop osteoporosis shortly after menopause, when their hormone levels drop sharply, perhaps upsetting that balance between bone creation and destruction. If so, Lindsay reasoned, replacing the hormones with a pill might halt or even reverse the progress of the disease. From a tiny, underfunded clinic in Glasgow, Scotland, he set up one of the first clinical trials of estrogen replacement therapy for bone loss in postmenopausal women. Lindsay’s star was rising.

His next project had big commercial implications and got the attention of the drug industry. Having moved to Helen Hayes Hospital, a rehabilitation center north of New York City, in 1984 he published work that established the minimum effective dosage of an antiosteoporosis estrogen drug called Premarin. Because the findings suggested that fighting osteoporosis was tantamount to encouraging millions of women to use the drug, it made Lindsay an important person in the eyes of the drug’s manufacturer, Wyeth-Ayerst Laboratories. Indeed, the company gave him a role as an author of its informational video Osteoporosis: A Preventable Tragedy.

By the mid-1990s, when Wyeth got caught in a patent battle over Premarin, Lindsay was a staunch Wyeth ally. He came out against approval of a generic version of the drug that would have cut into sales even though the generic form would have made it easier for osteoporosis patients to receive therapy. His reasoning was that such versions might not be precisely equivalent to the brand-name drug, a fact that can be true with certain drugs but was also a position that happened to echo the company line. “All we’re asking is that we don’t approve something now and regret it” later, he told the Associated Press in 1995. Lindsay’s close relationship with Wyeth and other drug companies carried on for decades, in ways that were sometimes hidden. He started allowing Wyeth to draft research articles and began taking tens of thousands of dollars from pharmaceutical interests that stood to gain from his research.

The scandal is not what Lindsay did so much as that his case is typical. In the past few years the pharmaceuticalindustry has come up with many ways to funnel large sums of money—enough sometimes to put a child through college—into the pockets of independent medical researchers who are doing work that bears, directly or indirectly, on the drugs these firms are making and marketing. The problem is not just with the drug companies and the researchers but with the whole system—the granting institutions, the research labs, the journals, the professional societies, and so forth. No one is providing the checks and balances necessary to avoid conflicts. Instead organizations seem to shift responsibility from one to the other, leaving gaps in enforcement that researchers and drug companies navigate with ease, and then shroud their deliberations in secrecy.

“There isn’t a single sector of academic medicine, academic research or medical education in which industry relationships are not a ubiquitous factor,” says sociologist Eric Campbell, a professor of medicine at Harvard Medical School. Those relationships are not all bad. After all, without the help of the pharmaceutical industry, medical researchers would not be able to turn their ideas into new drugs. Yet at the same time, Campbell argues, some of these liaisons co-opt scientists into helping sell pharmaceuticals rather than generating new knowledge.

The entanglements between researchers and pharmaceutical companies take many forms. There are speakers bureaus: a drugmaker gives a researcher money to travel—often first class—to gigs around the country, where the researcher sometimes gives a company-written speech and presents company-drafted slides. There is ghostwriting: a pharmaceutical manufacturer has an article drafted and pays a scientist (the “guest author”) an honorarium to put his or her name on it and submit it to a peer-reviewed journal. And then there is consulting: a company hires a researcher to render advice. Researchers “think what these companies are after are their brains, but they’re really after the brand,” says Marcia Angell, former editor in chief of the New England Journal of Medicine. “To buy a distinguished, senior academic researcher, the kind of person who speaks at meetings, who writes textbooks, who writes journal articles—that’s worth 100,000 salespeople.”

Peer-reviewed journals are littered with studies showing how drug industry money is subtly undermining scientific objectivity. A 2009 study in Cancer showed that participants somehow survived longer when a study’s authors had conflicts of interest than when the authors were clean. A 1998 study in the New England Journal of Medicine found a “strong association” between researchers’ conclusions about the safety of calcium channel blockers, a class of drugs used to reduce blood pressure, and their financial relationships with the firms producing the drugs.

It is not just an academic problem. Drugs are approved or rejected based on supposedly independent research. When a pill does not work as advertised and is withdrawn from the market or relabeled as dangerous, there is often a trail of biased research and cash to scientists. For example, in the mid-2000s, when patients started suing Wyeth about another estrogen drug, Prempro (which has been linked to the risk of breast cancer, strokes and certain other diseases), Wyeth’s ghostwriting/guest-authorship arrangements became a central part of the case. When it was the turn of Merck’s Vioxx painkiller (which was linked to heart attacks and strokes), drug industry money came up, too. In one Vioxx study, for example, academic researchers appear to have signed on to a Merck-sponsored project after the company had already done all the data analysis. According to a 2010 study that appeared in the British Medical Journal, 87 percent of researchers who expressed “favorable views” of GlaxoSmithKline’s diabetes drug Avandia, despite indications that it might increase the risk of heart attacks, had some financial involvement with the drug’s manufacturer. And when a U.S. Food and Drug Administration committee debated whether or not to pull Avandia from the market because of the link to heart attacks, it came out that members of the committee, too, had been taking money from drug companies.

The scientific community’s answer to the conflict-of-interest problem is transparency. Journals, grant-making institutions and professional organizations press researchers to openly declare—to their research subjects, their colleagues and anyone else affected by their work—when they have any entanglements that might compromise their objectivity. That way the scientific community decides whether a study is ethical and, when the experiment is done, how far to trust the results. It is an honor system. Researchers often fail to report conflicts of interest—sometimes because they do not even realize that they present a problem. (Scientific Americanalso asks for voluntary disclosures about conflicts from researchers who write articles.)

In theory, there is a backup system. Several layers of checking are supposed to ensure that conflicts of interest are caught and exposed even when an oblivious or dishonest researcher does not report them. When a scientist fails to report such a conflict, the university or hospital he or she works for is supposed to spot it and report it. And when a university or hospital is not doing its job catching conflicted research, then the government agency that funds most of that research—the National Institutes of Health—is supposed to step in. Unfortunately, that backup system is badly broken. “Institutions often look the other way, or they have policies in place that are quite weak,” says Adriane Fugh-Berman, a professor in Georgetown University’s department of pharmacology and physiology. More shockingly, the NIH is not only failing to enforce ethics laws intended to stop the creeping influence of drug company money, but it may also be breaking those laws.

Congress has been trying to stop corruption of medical research through legislation. In 2010, as part of the health care reform package, it passed the Physician Payments Sunshine Act. Starting in 2013, the law compels all pharmaceutical companies and medical device manufacturers to reveal most of the money that they are putting in the pockets of physicians. Because most (but not all) medical researchers are medical doctors, in theory, these data will help universities, research hospitals and the NIH to pin down whether a grantee has a potential conflict of interest. The information, however, will be worthless unless it is used.

The case of Robert Lindsay shows how deep the problem of conflicted medical research is and how difficult it will be to fix.

A thicket of entanglements

The effort of pharmaceutical companies to influence science discourse often takes the form of ghostwriting. Once a drugmaker can steer the way that a research article is written, it is able to control, to a large degree, how a scientific result is understood and used by clinicians and researchers.

One of Lindsay’s most prestigious papers—a 2002 article demonstrating Prempro’s beneficial effects on postmenopausal women—was initially drafted by DesignWrite, a firm that had been hired by Wyeth to ghostwrite articles for publication in the peer-reviewed literature. After meeting with Lindsay in mid-April 2001 to discuss developing the paper, DesignWrite then created an outline and forwarded it to Lindsay (and Wyeth). DesignWrite sent a draft to Lindsay for comments by early June, did some additional analysis and revised the manuscript. In August theJournal of the American Medical Association accepted it for publication. Later in the year DesignWrite revised the manuscript in response to comments, and the paper was published in May 2002. At the end of the article, Lindsay and his three co-authors thanked Karen Mittleman for her editorial assistance without identifying her as an employee of DesignWrite or disclosing its relationship with Wyeth.

Lindsay denies that DesignWrite had a large role in shaping the 2002 paper or any of his subsequent ones. Rather the firm would merely “provide a draft under our direction,” he says. He and the other named co-authors were responsible for the design and direction of the study. If so, Lindsay deserves to be listed as a co-author of the paper, and Mittleman does not deserve anything more than the brief acknowledgment, according to Phil B. Fontanarosa, executive editor at JAMA. “It is not apparent that [Mittleman’s] activities included conception and design (of the study), acquisition of data, or analysis and interpretation of data,” he wrote in an e-mail to me.

This use of an outside writing firm was not a one-shot deal. Kathleen Ohleth, then a writer for DesignWrite, helped Lindsay draft a 2009 article for the journal Fertility and Sterility. (After my initial interview with Lindsay, he declined to answer any more questions, including those about who paid Ohleth in 2009, and referred me to a press officer.) Two years later, in an article in Osteoporosis International, Lindsay also thanked Ohleth for “medical writing support” and acknowledged that it was funded by Pfizer (which acquired Wyeth in 2009) but said that he “was the sole contributor to the concept and content direction of the paper.” The article declared that a set of hormones in Pfizer’s pipeline presented a “new paradigm for menopausal therapy.”

At the same time that Lindsay was accepting writing support from Pfizer, he was accumulating a number of financial arrangements that posed a potential conflict of interest. According to a database compiled by the investigative journalism group ProPublica, in 2009 and 2010 Eli Lilly paid Lindsay more than $124,000, much of it for speaking fees.

Read the rest of the article at Scientific American

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