New York Times and Reader’s Digest Address Problem of Preemption in Drug Cases, Part III

Continuing on with some other points made by the Reader’s Digest Article regarding the problems with the FDA, the following issues of concern were raised:
3. Safety of New Drugs: The studies used by the drug industry to obtain approval from the FDA are so small and for such a short period of time, that the true safety of the drug cannot be determined before it is approved for marketing. As the article points out, typically, the studies used to obtain FDA approval only involve between 600-3,000 people and often only go on for a couple months. The studies also focus on specific type of people and often keep out people with any other problems other than the problem the drug is seeking to address. Therefore, once it gets on the market and used by the greater population who may have many other ailments other than the one which the drug addresses and be on many other medications at the same time which interact with the new drug, we all of a sudden see many other problems the drug can cause. As an example, this is one of the problems that arose with the drug Baycol which was ultimately withdrawn from the market. Baycol was a statin/anti-cholesterol drug, like Lipitor and Zocor, which was marketed to lower your cholesterol. People with cholesterol problems may also have a problem with their triglycerides. Historically, doctors will also prescribe a drug known as Lopid or gemfibrozil with the statin drug to also address the triglycerides. Even though this happens on a regular basis, when Bayer did its pre-marketing testing of Baycol, it never addressed Baycol’s usage with Lopid. Ultimately when it obtained approval and Baycol began to be sold, it was found that people who took Baycol and Lopid together had a signficant increased risk of developing the condition of rhabdomyolisis which I discussed in one of my previous posts. Bayer never addressed using its drug Baycol with a drug which is commonly prescribed with a statin type drug, therefore no one knew how patients would react until it was on the market. The question arises, shouldn’t the drug manufacturer be required to evaluate use of its drug with the types of drugs it is expected to be co-prescribed with? This is not required by the FDA and typically is never done. Moreover, many drugs are approved subject to the drug company performing additional testing. However, as the article points out, the FDA can’t enforce this agreement to do further studies and 65% of the studies that have been promised in recent years have not even been started.
There have been some recent changes instituted by Congress which should help this. More money has been provided to the FDA to improve drug safety. Also, FDA can now require companies to follow the long term effects of their drugs or face fines of up to $10 million. Also, companies can no longer cherry pick the tests and studies they publish and deep six the bad ones. All clinical studies have to be published within one year of completion. But, according to the article, companies can wait 3 years to publish summaries written for the general public to understand. It is definitely a step in the right direction.
4. The article goes on to discuss other problems at the FDA such as shutting up FDA employees who have something bad to say about a drug or FDA advisory boards which provide the FDA with recommendations of what to do about a particular drug, with over half their members being paid by the drug companies in some form or fashion. The question then becomes, are you going to bite the hand the feeds you???? (Yeah, my own dog has done that, but only when I was taking a bone full of meat out of her mouth.) There have been attempts by Congress to remedy some of these problems, but we still have a long way to go till we have a properly funded and fully independent FDA who can really do the job it has been given to do….protect us from unsafe drugs and food.
Which brings this all around to that nasty issue of preemption. If the argument goes that we should leave it to the FDA to decide what drugs are safe and what are not, and what warnings should be given for these drugs, and not to our court system and individuals who cannot understand the difficult scientific and medical issues which need to be balanced when addressing the sale and marketing of a drug, the argument assumes we truly have an agency who has all the tools to make those decisions in a proper and unbiased manner. What this article points out in so many ways is that at this point at least, we do not have such an agency. Yes, things are being done to improve the process and to give the FDA more autonomy from the drug industry in making these important decisions. However, much work remains before we can all feel confident that the pill we are putting in our mouth won’t do something to us that we don’t know about, and that Big Pharma forgot to tell us about. Thus it is important that the right remain to the court system and the jury system to determine if the public…and the FDA….was given all the information necessary to make a decision whether the drug at issue is safe.