What I'd Like to See Change at the FDA

The FDA announced some changes in how it will approve drugs for Type 2 diabetes which have sparked controversy in the diabetes community. Unlike many, I believe this is good news, not bad. A fellow diabetes activist asked me what I would like to see changed in the FDA and I wrote him a reply which I am sharing with you here.

The most important thing I'd like to see change at the FDA is going to happen without our needing to submit petitions: restoring science as a criteria for drug approval. The Bush FDA was notorious for the way that decisions were made based on financial connections of FDA staff to drug makers and their religious beliefs. But beyond that I think the following are most important:

1. End "direct to consumer" drug advertisements. These are well-known to be full of lies, but it takes so many months until an ad is shut down for false claims that these lies cando their work.

2. Make drug testing compare a new drug with the safe, cheap existing drugs. If there is no significant benefit compared to safe, cheap drugs, do not approve the drug. Right now, most drugs are only compared to placebo. So a new drug that is no more effective than a safe, cheap proven drug but costs 20 times more per pill gets approved with huge fanfare and becomes the subject of a billion dollar advertising campaign that gets doctors switching patients to it from the safe cheap drug.

3. Do not let drug companies claim a drug "rejuvenates beta cells" until this has been proven by direct measurement in humans. Every single such claim for a drug in the past, which included the major claim used to market Avandia, has been based on surrogates like HOMA measurements which turn out to be a false guide or on findings in rodents which did not extend to humans.

After a decade we finally saw research that showed conclusive evidence that Avandia did NOT rejuvenate beta cells. But for a decade doctors prescribed it on that premise.

Currently Januvia and Byetta are being sold with the same claim, based only on test tube and rodent studies. This motivates doctors to keep people on these drugs EVEN when their blood sugars are deteriorating and they are experiencing severe side effects. The long term deterioration in blood sugars experienced by people who are taking Byetta long-term suggests that just like Avandia, it does not rejuvenate beta cells. But doctors continue to tell patients it does.

4. When a new designer drug is targeting a gene or specific receptor, the approval process MUST included investigation of the other uses of that gene or receptor and the impact of the drug on those other functions must be explored.

The dangerous side effects of ALL drugs from sulfonylureas to Avandia to Januvia turned out to be caused by the OTHER functions of the genes or receptors they target. There is currently NO requirement in the testing process that the drug company do this. The technology for exploring gene expression has advanced greatly and the cost of this kind of research has dropped dramatically. It is now very possible to see which genes are expressing in response to different stimuli. It is possible to see which receptors are accepting a drug.

We can no longer approve 21st century drugs only with techniques developed in the first half of the 20th century.

People who have not been prescribed the drugs given to people with Type 2 diabetes can have little idea how dreadful the many side effects of Type 2 drugs really are.

But many patients trust their doctors completely, and if the doctor gives them a drug, no matter how awful it makes them feel, they take it, especially if they have been told, as many have, that the drug is "regrowing their beta cells."

Their reward for this may be enormous weight gain, osteoporosis, and even blindness (Actos and Avandia), heart attack (Avandia, Glipizide), pancreatitis (Byetta), irreversible inflammation syndromes or cancer (Januvia.)

I get heartbreaking emails from people who have suffered these permanent side effects. They are very real. I myself live every day with a miserable permanent side effect of a prescription drug. So I would far rather that a drug not be approved, than that it be "fast-tracked", sold to hundreds of thousands of people, and worsen their lives. Especially when there are already other drugs that work just as well.

To the argument that making drug approval harder will stifle drug development, I say only, look at the profits on a single successful drug. As long as a company can earn $200 a month from a vial of 30 pills or 60 units of an injectable drug, drug development will continue.

As it is, the drug companies are not doing new research. They are putting most of their efforts into making tiny changes to existing drugs to keep them under patent or into developing copycat versions of drugs sold by other companies. If the incentive to copy other drugs were lost, we might actually see new drugs coming in the pipeline, which is far from the case now.