Trusting Cancer Clinical Trial Results: Who is Funding the Research?
Big Pharma. Sounds like the name of an MTV personality, doesn’t it? But what it has come to refer to, especially in blogspeak, is the large pharmaceutical companies that sink millions of dollars into drug research, because they know there are millions of dollars to be made from drug sales. The ROI, or return on investment, for blockbuster drugs is very, very good. Big Pharma is big business, and money turns the wheels.
Now, a study in the April 1, 2007 edition of Cancer, the journal of the American Cancer Society, suggests a link between breast cancer treatment trials funded by major pharmaceutical companies, and positive outcomes of those trials. While studies in other areas of medicine point to a relationship between funding by drug companies and positive outcomes for the drug being tested, this newly released study is the first focusing on breast cancer drugs in particular.
The study, led by Dr. Jeffrey Peppercorn of the University of North Carolina School of Medicine, reports that trials with drug company support show “statistically significant differences” from trials supported by other entities, including the National Institutes of Health. The study involved 140 trials undertaken between 1993 and 2003; during that time, drug companies increased the number of trials they supported by about 30 percent, from 44 to 58 percent. Big Pharma currently spends far more on trials than the NIH.
One factor that might influence results is the fact that pharmaceutical companies often design and conduct studies that don’t use a control group, i.e., all of the participants are given the drug being tested, rather than some being given a placebo, for comparison. This kind of “single arm trial” is more likely to yield a positive result.
But does this mean we should mistrust the results of drug company-sponsored trials? These trials often involve the very sickest patients, those desperately in need of a cure. It would be difficult to find a placebo group under those circumstances. When you’ve exhausted all your options and are ready to try anything, you certainly don’t want to take a sugar pill to see how it works: you want drugs, proven or not. As Dr. Jay Brooks, chairman of Hematology/Oncology at Ochsner Health System in Baton Rouge, noted, “If the trial demonstrates a dramatic improvement in survival, do you really need to do a large study? We're looking at a very concrete endpoint: death."
New drugs, better treatments, and new links between genes and cancer, diet and cancer, exercise and cancer–you name it–are being discovered at a frenetic pace. Those of us with cancer are SO much better off than our parents or grandparents were… or even those who were diagnosed five years ago. We’ve seen the result of rushing drugs to market, without understanding the longest term effects; drug behemoth Wyeth is defending itself in a number of lawsuits involving Prempro, its HRT drug, which many women happily took for years before a landmark study showed a link with cancer. And Wyeth isn’t the only drug company going down that path.
But, in the face of extreme suffering and death, how long a trial is long enough? How many people die while the trial is going on? How fast can you get a promising drug on the market to start saving lives, and to start showing a return on the bottom line for the company that developed it? How fast is TOO fast? It’s an awfully fine line, when you think about it.
Learn More. Visit our clinical trials page.
Also, check out Newsweek's related interview of Dr. Jeffrey Peppercorn.