David Egilman '74 MD'78 teaches community health at the Alpert Medical School. But once in a while, he dabbles in ethics.
Egilman, a clinical associate professor of community health, along with Joseph Ross of New York's Mount Sinai School of Medicine, was hired to examine risks associated with Vioxx, a drug used to treat conditions that cause chronic pain, like arthritis. In 2004, pharmaceutical giant Merck and Co. pulled the drug off its shelves because some were concerned that its long-term use increases the risk of heart attack among patients. Many people even sued Merck for the wrongful death of their family members.
Egilman and Ross were just a small part of the controversy surrounding Vioxx. They were hired to serve as plaintiff's witnesses in a case against the company, which meant they had access to many internal Merck documents while researching the drug.
"When looking through old clinical trial results, we stumbled, literally, across examples of guest authorship that were disturbing," Ross said, referring to studies conducted by Merck but signed by scientists who were not actively involved in the work.
Unsettled by what they had found, the physicians went back and began a formal investigation of Merck's documents. Egilman said they didn't have to look too deeply - simply reading the documents turned up evidence of misconduct.
Led by Ross, the group of four physicians found that certain published articles about Merck's products had a suspicious origin: The drug studies had been conducted and written by Merck but were signed by scientists unaffiliated with the company.
Such unethical practices have always been rumored to exist, Ross said, but they were surprised to find such blatant examples. Last week, the doctors released a study in the Journal of the American Medical Association exposing several of Merck's articles as having been ghostwritten by the company and signed by scientists as "guest authors."
"If a student did that in one of my classes, I wouldn't call that legitimate work," Egilman said. "In fact, I might call that plagiarism."
Both doctors emphasized that this practice is not limited to Merck and that it affects the entire pharmaceutical industry. The physicians were able to make an example of Merck because of their access to documents normally kept hidden, they said.
In an April 15 statement, the company called the article "false, misleading or lack(ing) context."
"We have explicit policies governing the authorship of papers related to Merck's medicines and vaccines, and we take those policies very seriously. The outside authors of the papers about Merck's clinical trials referenced in the JAMA article were intimately involved in the studies," Dr. Peter Kim, president of Merck Research Laboratories, said in the statement.
"(Merck is) no worse or no better," than other pharmaceutical companies, Egilman said. "They do what they're supposed to do. ... It is unethical in this country for a company to act ethically if it will reduce profit to their shareholders."
"This is the system," he said of the culture of profit-seeking pharmaceutical companies. "This is not a bunch of bad apples. This is a barrel that is making the apples rotten."
Rules against plagiarism that seem standard to students are missing from faculty handbooks, Egilman said. Despite the unethical nature of what pharmaceutical companies do, they are technically not breaking any laws, and neither are the scientists who sign papers they did not write.
"It's natural for a for-profit industry," Ross said. "(But) science should not be conducted in this way."
In an April 16 editorial, JAMA criticized scientists who allowed their names to be attached to studies they didn't play a big role in. "Individuals, particularly physicians, who allow themselves to be used in this way, especially for financial gain, manifest a behavior that is unprofessional and demeaning to the medical profession and to scientific research," the editorial reads.
The doctors called their paper a part of a process that could improve research standards.
"We're standing on the top of the tallest mountain we can find and screaming that the system is corrupt," Egilman said. "It only takes one person to step forward and say, 'The emperor has no clothes.' And then everyone will say, 'You know what, the emperor has no clothes.' But it's not easy to be the person who runs around saying (that)."
Much of the responsibility for reforming the system falls on universities, medical schools and faculty deans, both doctors said. The institutions must keep a closer eye on their faculty who are collaborating with the pharmaceutical industry, Ross said.
Universities are not-for-profit and therefore have an obligation to enforce ethical standards, Egilman said.
"They don't have an obligation to stockholders, so they're not supposed to act like a business," he added.
Those looking to improve the system of drug-related research should improve standards for published material, Egilman said. But there's no authority that will correct the articles Merck has already published, he added.
Ross said journals need to have explicit disclosure criteria for authors, explore whether an author has truly contributed and ensure that those who did contribute are credited.
When asked how he felt about Merck ghostwriting for legitimate scientists, Egilman said, "They're well-recognized, famous, prestigious scientists - I didn't comment on whether they're legitimate or not."
"Having someone else do your work for you," he said, "makes you less than legitimate."
