Thursday, November 30, 2006

Haunted Science

“You are a bit like a puppeteer,” a journalist for PBS’s Now told medical writer and ghostwriter Linda Logdberg in a 2001 interview. “You pull the string and the doctors dance.” Logdberg quickly corrected the journalist: “I pull the strings,” she said, “After being told how to pull the strings.” Who is the head puppeteer? The advertising company in charge of the drug company’s PR campaign.

Logdberg had, for years, ghostwritten articles for medical journals on behalf of drug companies. In 2001, she was asked to rewrite an article on Attention Deficit Hyperactivity Disorder that a company called Intramed had asked her to write. (Intramed is owned by a marketing company, Sudler & Hennessy.) The reason for the rewrite: Novartis, the maker of Ritalin, hadn’t liked it. Novartis had thought they could get a quickie article published, one that was favorable to its drug. They didn’t get it from Logdberg, and so she was dismissed from the project. (She has since retired from ghostwriting and teaches science to children.)


The scientific and medical communities are filled with scientists and doctors who accept money from industry to put their names on articles that endorse new medicines, climate change theories, environmental studies, and so on—articles they did not write. Instead, the articles are written by ghostwriters, medical writers paid by drug companies. The WHO has officially expressed concern about the ties between industry and researchers. In 1998, documents came to light regarding a tobacco-industry wide effort to plant sympathetic letters and articles in respected medical journals. Tobacco companies had secretly paid thirteen scientists a total of $156,000 to write a few letters to influential medical journals. Tobacco industry law firms did the drafting and the editing!

The makers of Fen-phen, Wyeth-Ayerst Labs, hired two ghostwriters to pen articles promoting the drug as an obesity treatment. Two of these articles were published, and in the many lawsuits that followed, it was revealed that Wyeth-Ayerst had edited the articles to play down and sometimes delete descriptions of the drug’s side effects.


Then there is New England Journal of Medicine (NEJM), the most prestigious medical journal in the country, which has, in many cases, been taken for a ride by pharmaceutical companies. Take, for example, the 1986 Amoxicillin fiasco, in which the NEJM published one study and rejected another that reached opposite conclusions about the antibiotic, even though both studies were based on the same data. Scientists involved in the first study had received nearly $1.6 million in grants from the drug’s manufacturer. The author of the critical study had refused corporate money. NEJM proclaimed the first study the authorized study. The author of the critical version underwent years of discipline and demotions from the academic bureaucracy at his university, which took the side of the industry-funded study. Five years later, the dissenting scientist’s study was finally published in the Journal of the AMA, and other large scale testing of children showed that those who took amoxicillin actually showed lower recover rates than kids who took no medicine at all.

In 2000, NEJM finally addressed the issue of conflict of interest in an editorial titled “ Is Academic Medicine for Sale”. “Ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.”


But three years later, in 2003, the NEJM loosened its rules regarding publication by authors with financial ties to the manufacturers of the products being reviewed—it claimed it was getting hard to find authors unburdened by those conflicts.

Friday, November 10, 2006

Aca-preneurs

In 1980, Congress created the “academic entrepreneur.” It did this by passing a law that made it easier—and financially lucrative—to patent their products, and to profit by them. The law was passed in the hope that financial incentive might spur innovation in the sciences. Within a year, scientists were stockholders, consultants and even members of the board for the manufacturers making the drugs the scientists were testing.


The problem of conflict of interest among aca-preneurs and the companies in whom they have a stake—or who have a stake in the scientists—was merely an institutional problem throughout the eighties and nineties. Universities policed their own researchers and quietly addressed anonymous complaints of conflicts of interest. When, in 1989, the National Institutes of Health—the largest federal funder of scientific research in the United States—attempted to require researchers and academics publishing research to disclose their corporate affiliations, the organization was flooded with angry letters. From scientists and researchers. Their charge: the National Institutes of Health was compromising academic freedom. The National Institutes of Health let the matter drop. Not until 1998, when the Wall Street Journal asked “Did Ties to Alzheimer’s Test Maker Sway NIH Report?” did the problem of aca-preneuers hit the mainstream—aca-preneuers like Dennis Selkoe.

Selkoe is a rock star in a three piece suit, and not because he can rock out. He is a rock star in the world of Alzheimer’s research, had been one of the leading researchers searching for a cure for this dreaded disease. More than a scientific stud, though, Selkoe is an aca-preneur: with one foot in the lab and the other on Wall Street, Selkoe has made millions from his company, Athena Neurosciences, which developed an Alzheimer’s blood test. At the same time, however, he co-authored that NIH report endorsing the test, without mentioning that his paycheck comes from the manufacturer of the test, Athena Neurosciences.


Pharmaceutical companies have started to mine university research departments as well. Brown University’s Chief of Psychiatry, Dr. Martin Keller, received nearly a half a million dollars annually from pharmaceutical companies making anti-depressants, which he would then praise in published medical reports. His clients included Pfizer, Eli Lilly, Bristol-Myers Squibb, and Wyeth-Ayerst. When confronted by the Boston Globe, Brown University officials told reporters that “the School of Medicine has no problem with Keller’s consulting arrangements.”

Despite this endorsement, Massachusetts’ Attorney General launched a three year criminal investigation, which resulted in Dr. Keller returning more than $300,000 of taxpayer money for research he never performed because of the research he was undertaking for the pharmaceutical companies. In an article in The Washington Monthly, a journalist asked: “Could the fact that Dr. Keller brings in tens of millions of dollars in research grants annually to Brown University--about $14.4 million in pharmaceutical funding, $8.4 million in Federal grants from NIMH--influence the university's inability to recognize a conflict of interests?”


There is currently no national requirement forcing scientists to disclose their corporate ties, even when they publish research on the drug they are connected to financially. And it’s not just the individual scientists who have vested interests in the performance and the marketplace fate of certain chemicals and pharmaceuticals: in agreements with pharmaceutical companies, universities themselves are patenting drugs. This leads to situations where, as Joel Bakan noted in The Corporation, of the 1400 new drugs developed between 1975 and 1999, only 13 were designed to treat or prevent tropical diseases (which kill millions of people in Africa each year). In 2000, no drugs were developed to treat tropical diseases, but eight were developed to treat impotence and seven to treat baldness. Perhaps more practicably, though, it creates a gap between the public and its public agencies and universities, which have historically promoted disinterested science and which have been the institutions we turn to in order to find out what is safe for us, and what isn’t. The last part of the chapter sets the stage for Chapter Six, which focuses exclusively on industry relationships with universities, institutes, and other academic organizations.