A major watchdog site released a highly skeptical review of current studies on the popular drug Plavix. Perhaps you’ve seen their ads on television where a stretcher follows people around as they do mundane things and then it goes away when they visit their doctor to get Plavix. After reading this article you’ll find that their commercials are oddly similar to their testing methods.

To correctly explain the studies, it is important to know what Plavix (clopidogrel biselphate) does.

Plavix is used to prevent blood clots after a recent heart attack or stroke. It is also taken by people with certain disorders of the heart or blood vessels. Plavix keeps blood from clotting to prevent blood clots that can occur with certain heart or blood vessel conditions. Because of this, Plavix has been known to make it easier for a patient to bleed, even from a minor injury.

Plavix is generally a drug used to accompany other drug treatments. This can be dangerous though. Recently the Food and Drug Administration (FDA) released a warning about serious side effects if Plavix and Prilosec are taken together. Other studies about the effects of Plavix and other drugs are currently underway.

The studies mentioned in this article aren’t about Plavix’s reaction with other drugs. It’s about some of the less-than-stellar and somewhat unscientific studies that are currently being conducted. Studies that could be used to tout the drug’s safety without using adequate test methods.

Watching the Watchers

Consumer Drug Safety (www.consumerdrugsafety.org) is a watchdog organization that allows physicians, pharmacists, and other heath care providers to communicate openly with consumers and vice-versa.

They found that the tests currently being conducted to determine whether Plavix, when taken prior to surgery, increases a patient’s chances of serious complications during and after the procedure.

They focused on a new fairly extensive Dutch study. The study included 1,069 people given clopidogrel (Plavix) before having stents implanted after artery-opening angioplasty.

They were then followed for a year to record the incidence of death, nonfatal heart attacks or strokes, and new blockages of the treated arteries. Three of the tests had some predictive value for those events, but three didn’t. None predicted the major side effect of Plavix treatment, which is excessive bleeding, which it should have been able to do.

“However, the predictability of these three tests was only modest,” the report added. “None of the tests provided accurate prognostic information to identify patients at higher risk of bleeding.”

According to the report in today’s issue of the Journal of the American Medical Association, three of the six tests, which measure the function of platelets, the blood cells that clump together to form clots, turned out to provide some useful information.

The Expert’s Opinion

Dr. Deepak Bhatt, chief of cardiology at the VA Boston Healthcare System, and a member of a group of U.S. cardiologists probably had the nicest things to say about the study and even his comments were lukewarm at best.

Several large studies are underway to provide an answer, Bhatt said. They are looking at large numbers of people who get clot-preventing drugs.

“The study is a starting point for understanding a complex clinical situation,” Bhatt said. “It sets us up for the next step. You have a patient at moderate risk; what do you do with that test information? That is a question that needs to be answered.”

“Right now, you can conclude that some tests are correlated with an increased risk of adverse events, but what to do with that information is unclear,” Bhatt said. “Those ongoing trials may provide an answer.”

Dr. Magnus Ohman, director of the Program for Advanced Coronary Disease at Duke University in Durham, N.C. was a little more skeptical of the studies.

While the Dutch study provided “an important observation,” it included a relatively narrow portion of people eligible for clot-dissolving drug therapy, Ohman said.

Even though the study population was relatively large, it is small in relation to the total population of people who get clot-preventing drugs, Ohman said. “If we studied more patients and higher-risk patients, we might get a better handle on this. We might find other cutoff points of greater value.”

“We are in the process of evaluating the bedside tests because they will have an important role to play in the future,” Ohman said.

Are You At Risk?

Dr. Ohman made an important point about a major study that is only yielding so-so results, that is, the right patients have to be tested to deliver the correct data. These patients are at higher risk of complications for taking anti-clotting agents such as Plavix.

Watching these studies is important because the drug company can use them to overstate the effectiveness of their drug and take questionable results out of context to help sell their drug.

It is important that you get the correct tests before treatment and particularly prior to surgery. If you or a loved one have been adversely affected or seriously injured by taking Plavix or other clot-preventing drugs it is in your best interest to get professional legal advice from an experienced firm in defective drug litigation. Call Phillips Webster for a consultation.