INTERVIEW: How Safe is Our Medicine Today?” The Procedure for the Approval of Drugs.

Author: Sandy Zimm

We think our medicines are safe because they were approved by the FDA but Dr. Mary Ann Block, DO, the Medical Director of the Block Center in Texas, gave an insider’s view of the situation in the United States for my interview. Dr. Block, “I have a big concern about the safety of medicines today as long as the present processes are in place I have doubts whether we can say any drug is safe.” What are the steps in the process for gaining FDA approval for drugs? Dr. Block, “There are many steps in the process of bringing new drugs to the market yet every step from the research, the drug trials, and the drug approval down to the reps bringing the medicines to the doctors seems to have been compromised. During the approval process the pharmaceutical companies present data to the FDA and they have special committees that are supposed to be unbiased. If it is a drug for high blood pressure, the committee usually consists of doctors and authorities who are specialists in blood pressure. The problem is that the FDA allows financial conflict of interest in their committee members. It is not supposed to occur but they provide wavers to this conflict of interest, say, even though you might be making money strategy from this drug company, or you have an investment in this drug company, or they paid you to do research for them, we are going to let you sit on this committee and let you say yea or nay about this drug being approved. (1)(2) (1) (The FDA website states, “FDA advisory committee members can get waivers for conflict of interest.” “They can have stocks, other investments, primary employment, be a consultant, have grants or contracts, patent trademarks, royalties, be expert witnesses and teach, speak or write” for a pharmaceutical company and get a waiver. “26% received at least one waiver, 25% received multiple waivers and 32 members received 46 waivers.”) (2) (Propublica reported that 400 advisors received $100,000 or more since 2009 and that the FDA did not check for conflict of interest 31% of the time.) These procedures have been going on for years. Recently the drug companies are allowed to pay more money to actively have their drugs approved faster.”