Tuesday, September 23, 2008

Most Drug Studies Remain Unpublished

Many studies are submitted to the FDA but never published in the medical journals doctors use to evaluate drugs' safety and effectiveness.
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1 comment:

Greg Pawelski said...

Even negative results can provide useful information about the effectiveness of treatments. Having “all” the information you can gather for investigators is essential to maintain good scientist-to-scientist communication that would be beneficial for drug research.

No one is publishing “real world” studies. Evaluating “real world” data requires specimens that are tested as they are logged into the lab in question, with different laboratory reagents, in “real time.”

Collaborations between academia and industry has clearly brought discernible influence on clinicians, bringing with it erroneous results, suppressed data, or harmful side effects from these drugs.

When an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor’s training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities.

In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don’t be afraid to ask questions to make informed treatment decisions!

Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need. It would seem that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments. It is suggested by some that we make the search for minimum effective doses of these treatments one of the key goals of cancer research.

An increasing number of drug studies are developed through collaborations between academic medical centers and drug companies. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. It is important to understand the influence that industry involvement may have on the nature and direction of cancer research. Studies backed by pharmaceutical companies were significantly more likely to report positive results.

Over the past couple of years, if you watched TV with any regularity, it would have been difficult to miss the direct to consumer advertising that touted the benefits of some drugs over others, especially for patients undergoing treatment for cancer. Even to the point that buses covered with “shrink wrapped” advertising being strategically placed outside major cancer centers for patients and their families to see (EPO anyone?).

Drugmakers are going directly to the consumer at a time when their products are indeed at the margins of evidence-based medicine. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising. And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

More must be spent on analyzing drug data, and the need for larger and more detailed studies to figure out why there is an association between pharmaceutical involvement and positive results.

October 19, 2008 at 9:35 PM

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