It was a bad week for ethics in medical research.
A paper published Monday in Archives of Internal Medicine reported the case of a so-called "seeding trial" in which a study was apparently conducted not to gather meaningful scientific evidence, but for purely promotional purposes. In other words, a drug company asked doctors to recruit patients for a trial even though the intention was to increase prescriptions for a particular medication.
Joseph Ross, an assistant professor of medicine at Yale University, led a team that reviewed documents related to a clinical trial for the epilepsy drug gabapentin, known by the brand name of Neurontin. The documents, including internal and external corporate correspondence, became publicly available as a result of legal action launched by several U.S. states against the drug's maker Parke-Davis and parent company Pfizer. (Parke-Davis was not a subsidiary of Pfizer at the time of the medical trial.)
"We found that [the study]was a seeding trial posing as a legitimate scientific study," Dr. Ross said in a statement released with his study. "The trial itself, not trial results, was part of a marketing strategy used to promote gabapentin and increase prescribing" among the doctors recruiting patients.
The trial was conducted 15 years ago, but what happened is still relevant today said Dr. Ross, because the case provides a rare inside glimpse of how some drug companies operate. And there is a strong likelihood that seeding trials are still practised.
Although seeding trails are not illegal, he said they are considered unethical because patients and physicians are not told of the true purpose of the study.
Another example of questionable medical ethics was highlighted in a review article and editorial published Tuesday in the journal Spine.
Eugene Carragee of Stanford University School of Medicine and colleagues looked at studies involving Infuse Bone Graft, a controversial synthetic bone growth factor used in some spine-fusion surgeries.
Their review of 13 trials found that researchers with financial ties to the manufacturer, Medtronic Inc., did not report negative side effects or complications among patients treated with Infuse.
Researchers who were free of corporate connections, however, documented serious adverse events, including inflammatory reactions, cancer, infections and implant dislodgement.
An editorial in the journal challenged the integrity of the industry-sponsored research and noted the connections between companies and researchers often go unreported. "It harms patients to have unaccountable special interests permeate medical research," states the editorial.
Fifteen of the surgeons involved in Infuse clinical trials received a combined amount of at least $62-million (U.S.) from Medtronic for unrelated work over a period of years. In some of these cases, the researchers had invented or developed certain products and were receiving royalties, said Alexander Ghanayem of Loyola University Hospital, near Chicago, who was one of the authors of the editorial.
The researchers may be entitled to the funds, "but you need to disclose them," he said. The details of the financial payments were made public only after the U.S. Senate launched a probe of the pharmaceutical industry. In response to the criticism, Medtronic issued a statement saying it stands by the data in the studies.
In recent years, major medical journals have introduced policies requiring researchers to disclose any potential conflicts of interests. But some corporate connections may still go unreported.Report Typo/Error