[Missycat]

Here's a story about drug studies. I'm not taking one side or another; I'm just posting this so that others can read it.Drug company studies less critical Study finds drug company-backed research may be biased ASSOCIATED PRESS Oct. 19 � Studies on the effectiveness of drugs are far more likely to report favorable findings if they are sponsored by the drug companies themselves rather than independent groups, researchers found. THEIR STUDY � funded by a pharmaceutical company � appears to confirm long-held suspicions that doctors are less critical about a drug�s safety and effectiveness when they have financial ties to the manufacturer.�It is possible that these factors may result in some unconscious bias� in interpreting a study�s findings, the researchers said.Last year, the conflict-of-interest issue made headlines when a report found that the vast majority of doctors who defended the safety of calcium channel blockers had a financial relationship with manufacturers of the blood pressure pills.In the current study, published in Wednesday�s Journal of the American Medical Association, the researchers looked at 44 studies on the cost-effectiveness of cancer drugs. Twenty of the studies were funded by pharmaceutical companies and 24 by nonprofit organizations.Those sponsored by nonprofit groups reached unfavorable conclusions 38 percent of the time, compared with just 5 percent for studies sponsored by pharmaceutical companies. Also, researchers in company-backed studies were slightly more likely to overstate the cost-effectiveness. FINANCIAL TIES Some researchers receive funding directly from pharmaceutical companies. Some get funding in the form of honoraria or travel expenses. Some hold stock in drug companies and profit directly from increased drug sales.Dr. Charles Bennett, the lead author and a professor at Northwestern Medical School, said that in addition to the possibility of unconscious bias, there could be other explanations for the findings.For example, pharmaceutical companies are given early looks at studies. That enables them to abandon studies that appear to be unfavorable and focus on those they think are going to be positive, Bennett said.Bennett said the findings should not be seen as a major criticism of pharmaceutical companies."Our study was sponsored by a pharmaceutical company,� he said, adding that the company, Amgen Inc., did not comment on it before publication. He also said his paper analyzed studies sponsored by Amgen, which fared no better than other company-sponsored studies. OTHER SPONSORS NEEDEDBennett said the best thing would not be to stop pharmaceutical companies from sponsoring research, but to get other types of sponsors to underwrite studies, too, such as managed care organizations.Amgen spokesman David Kaye said: �If you want the best physicians in the world, you have to let them run the trials. If you kill a study or over control it, word gets out and the best investigators won�t do your studies.�Others not involved with the study said the findings raise serious concerns.�The best hypothesis I can tell for that is the person doing the research has internalized the values of their funder,� said Sheldon Krimsky, a Tufts University professor who studies scientific integrity and conflict of interest and who wrote an editorial about the study in JAMA.Dr. Sidney Wolfe, director of Public Citizen�s Health Research Group in Washington, agreed: �As in other studies of the drug industry, this shows the financial interests of the drug industry rides over the actual data.� � 1999 Associated Press. ------------------Fear can hold you prisoner.......hope can set you free.Missycat

 

[LDanna]

Thanks, Missycat! I'm glad to see that these studies are being more closely examined and that there is some unbiased reporting about it as well.

 

[Guest]

Missycat,Thanks for sharing that info. It doesn't surprise me, as it's a bit difficult to be objective when you have ties to the outcome of the study. I had heard about another study which showed that the MOST valuable thing that improved patient's well being was not any particular type of drug or treatment but rather the patient-provider relationship. Perhaps these vested parties are so interested in their drug succeeding that they treat their patients better????Hmmmm ---- maybe I'll join a study just so I can get a Dr. to treat me nice.

 

[Guest]

Missy,Thanks......------------------LET'S ALL PRAY FOR A CURE TO THIS IBS SOON!BETTIE

 

[kate-tn]

Missycat-Thanks for your post. I spent a number of years coordinating drug studies for the microbiology department at our medical school, and I'd like to address and more fully explain some of the statements in the AP article as related to my experience. I found most of the statements true in themselves, but taken out of context, so that they are misleading in terms of how the situation works.First let me say, there are early stage "drug studies" and there are late stage "drug studies." What the AP article refers to isn't even a real drug study. Here's the process. A pharmaceutical company "invents" a new drug, which most of the time is an improvement on an old drug. The company's attorneys apply for and receive a patent on their formula, and at that point the time clock starts ticking. This patent is for a limitted number of years, and during that time, they have to do all the basic research on the drug themselves (or contract it out to a university research group, which is usually lots more cost-effective for them), then after they get positive results from that basic research (This will take a few years.) they begin the multi-stage clinical trials where actual people try out the drugs. These are very closely monitored by the FDA and Institutional Research Boards like the one I used to serve on. By the time the drug goes through this very long process, and the company can market the drug, there may only be 3-5 years left on their patent. So, even though the drug may cost a few pennies to make, we the consumer must pay high prices for the 5-7 years of research and millions of dollars spent to develop the drug. Once it goes off patent, then any manufacturer can come in and make a generic at a much lower price, because once the patent expires, the formula for making the drug becomes a matter of public record.At any given time, a drug company will be contracting out research on many different drugs, only a few of which will ever be marketed. At this early stage, which does not involve patients, the drug company gets all the data, and makes a decision on which drugs are most promising. It will abandon or postpone studies on others that either are not as effective, seem to have potential side effects, or (unfortunately) those they feel would not be cost effective to develop- not enough people suffering from that ailement for the drug company to ever make back the money it invested in its development. This early stage is where our laboratories were the most involved. While it's true that we received hundreds of thousands of dollars in drug company money over the years, this money paid for salaries of technicians (usually ranging from $15,000 to $20,000 per year) , equipment and supplies needed to do the work, and university overhead for allowing these studies to be done in its facilities (That covers things like electricity and water, etc.) My boss travelled all over the world on money from these drug company grants, but this travel was no picnic. He would travel for 2-3 weeks at a time, speaking about our research results every day at different universities and conferences, with time between to meet with researchers in different parts of the world doing the same kinds of research. It was a good way to exchange information and good PR for the drug company, but, believe me, it wasn't fun- not like he got to see the great sights of Europe. His travel expenses were paid, but he didn't receive any extra salary for this. If he hadn't been so interested in the work, he would have far preferred to sit on his front porch at home looking at the mountains.The latter clinical trial stages are very different from the early basic science ones. When I served on the IRB, I read many protocols, and in all cases, the doctors giving the drugs were blind to whether they were giving the real drug or a placebo. The only circumstances in which they were allowed access to what a patient was being given was if that person experienced new health problems that might be related to the study drug. For the patient's safety, the doc would then be allowed to see what he was being given, so a medical decision for that person's protection could be made. If that person was on the experimental drug, then a message immediately went to the drug company and the IRB in case the drug itself posed a hazard. So, it's hard for me to understand how doctors could bias their reports at the clinical trials stage, when they don't even know who is taking what.The AP quoted studies done on drugs already on the market. These were not drugs under investigation, and involved cost effectiveness, not efficacy (how good a drug it was.) The article then switched to a completely different type of study- the early stage ones, and you really can't mix up the two types when you're talking about this issue.From my experience, which is considerable, given that we live in a capitalistic country where the government does not contribute anywhere near enough for research for the improvement of our health, and, in fact, throws a lot of impediments in the way of medical research, the medical community and drug companies do a pretty good job of research, marketing, and getting new drugs to the public.kate(Picture Kate now stepping off a soap box and sitting down.)

 

[Missycat]

Thank you, Kate, for explaining. There's always more than one side to every story, and I'm glad you posted, since you've had direct experience with this.------------------Fear can hold you prisoner.......hope can set you free.Missycat

 

[kate-tn]

Missycat-I wouldn't be surprised at all if there are physicians doing their own studies which might be somewhat biased or simply inept on drugs already on the market, and these studies may not be as "scientific" as we'd like. Physicians have some pressure to publish, just like university professors, and, unfortunately, many of them are not trained in constructing good, controlled experiments- it's just not what they're taught in med school. Also, there are opportunists in every profession, including medicine.My main concern when I see an article like this is that people with problems like IBS will be suspicious of all studies, and be reluctant to try a new medication which might actually help them, and which has certainly gone through extnesive testing. Scientists are still regarded as a suspicious lot by many of the public, and while we sometimes tend to be a little wierd, we try our best to do things right.kate

 

[Persistance]

I very much appreciate your explanation and input, Kate.