Dr. Stacie Bering: Unbiased drug studies necessary for patient safety

Merck, one of the largest drug manufacturers, has lost three out of five megamillion dollar lawsuits tried so far. Eleven thousand more product liability lawsuits against the company are waiting in the wings. The issue: Did the company fail to tell us about the down side of Vioxx?

If you care at all about all the hoopla, you might be berating the greedy tort lawyers looking to win the lawsuit lottery. Or you might be ranting about big business and its lust for profit. Or you might just dismiss the whole thing because you never took the stuff.

But we all need to care, because Merck and Vioxx provide us with a cautionary tale. How are the doctors who treat us getting their information about new medications, and how valid is that information? Why were doctors so eager to jump on the Vioxx bandwagon?

Nonsteroidal anti- inflammatory drugs, known as NSAIDs, are big business in the pain-reliever world. We all have aches and pains once in a while, so we might reach for the aspirin (the grand daddy of NSAIDs) or ibuprofen. Others of us have daily, excruciating pain from rheumatoid or osteoarthritis and need help just to keep moving throughout the day.

NSAIDs are good at relieving pain, but they have a serious downside. They can cause stomach ulcers, and those ulcers can perforate, leading to serious and sometimes fatal bleeding. Degenerative joint disease and osteoarthritis are more common as we grow older, and the effects of NSAIDs are more severe as we age – a double whammy.

So the drug companies developed the COX 2 inhibitor NSAIDs, thought to be kinder to the stomach lining. Now we know that the kindness comes at a price. Yet the initial studies on Vioxx said its cardiovascular effects were no different than one of the original NSAIDs, Naproxen.

An article in the Journal of the American Medical Association may give us the clue to what’s going on here. The authors looked at reported outcomes of major cardiovascular trials published in three prestigious medical journals – the New England Journal of Medicine, the Journal of the American Medical Association, and the Lancet. They wanted to know if who funded the studies made a difference in those outcomes. All the studies compared a new treatment to the current standard of care,

The studies funded by for-profit organizations (the drug companies) were more likely to report positive findings than those funded by not-for-profit groups (universities or government). If the trial was jointly sponsored, the result was somewhere in the middle.

One possible reason for this discrepancy surfaced in the case of Vioxx. An article published in the New England Journal of Medicine in 2000, funded by Merck, showed that Vioxx was half as likely to cause gastrointestinal problems as Naproxen. The cardiovascular risks, they said, were equivalent.

In 2005 and again this year, the journal published “Expression[s] of Concern.” Internal Merck memos and e-mails unearthed by the current litigation showed that three heart attacks in the Vioxx group were not included in the safety analysis even though they were known prior to the publication of the 2000 article. Even more damning was the revelation that there were more than twice as many serious blood clots in the Vioxx group. Blood clots were never mentioned in that original article.

Physicians look to these prestigious journals for rigorous, peer-reviewed studies on the newest treatments. In an era when government funding is dwindling, the drug companies, eager to find the next blockbuster drug, are stepping in to fund the research. The question the Vioxx debacle raises is, are they trying to buy the results?

It’s expensive to bring a new drug to market. It makes sense that the drug companies who stand to profit should make the initial research investments. But ultimately, we need studies funded by a neutral party. I know we all hate taxes, but not all taxes are bad. Funding nonbiased medical studies strikes me as a good use of our tax dollars.

Dr. Stacie Bering is a Spokane physician. Contact her with general questions and topics for future columns by mail at Dr. Stacie Bering, Features Department, The Spokesman-Review, P.O. Box 2160, Spokane WA 99210 or by e-mail at doctorstacie@mac.com. She cannot answer personal medical questions in her column.