Personal Injury Law

Federal Preemption: Are lobbying dollars influencing medical research opinions?

By Steve Lombardi

Here is how it’s supposed to work. Pharmaceutical companies conduct research and develop drugs that treat our ailments and diseases. During the R&D phase the pharmaceutical company scientists conduct experiments; and when the research shows promise and appears to have indicia of being safe for humans the FDA through it’s medical scientists review the application along with all the research data and if it appears safe they approve the drug for sale to people; people like you and I and our mothers and fathers. Of course a person gets these drugs with a prescription written by their doctor. The doctor is supposed to read the warnings and discuss potential side effects with the patient. The doctor’s office is then supposed to do blood tests to monitor how patients’ organs are responding to the new drug. If there are complications or serious side effects from taking the drug, the doctor is supposed to write a report and send it to the FDA where those reports are accumulated and provide a data base for future decision making about the drug. The report and how it is written or whether it is written by the doctor is what this drug safety monitoring system is based. If no reports are written and filed then other patients may suffer the same fate. If the report is written in such vague terms as the FDA distinguishes this patient’s experience as not material, then other patients may suffer the same fate.

So when my colleague, Mike Bryant, reports that the University of Minnesota Medical School is considering banning all gifts to doctors from the pharmaceutical industry, it is a big deal. Because in doing so they are placing patient safety and the credibility of the FDA monitoring system, along with the doctor’s responsibility to their patient ahead of lobbying influence that is interfering with all of the above.

We think the University of Minnesota Medical School would be smart in doing so. That would be the correct diagnosis and treatment for what ails this issue. Full speed ahead!

Full post as published by Des Moines Personal Injury Lawyer on November 03, 2008 (boomark / email).