October 29, 2008

Why This Election Matters: The FDA

There's a reason we pay taxes and support a Federal government. It's because there are things we need done that none of us has the resources to do alone.

One of them is to ensure the safety of our food and drug supply. Progressive Republicans under the leadership of Teddy Roosevelt created the modern FDA in 1906 after some high profile cases hit the news where people had been blinded or poisoned by drugs, foods, and cosmetics sold to the public in a hitherto unregulated "free market".

Testing our food and drugs for poisons is expensive. You and I can't do it, nor can local government. That is why it is just the kind of function that our Federal government, funded by our shared resourced--a.k.a. tax dollars, should do. And for more than a century, we have been relying on the Federally funded FDA to do this testing for us.

Unfortunately, the Republican love affair with deregulation has hit particularly hard on the FDA. For the last decade, at a time when the number of new drugs and new food threats has risen its budget has been slashed. Even more troubling, the Bush administration has appointed leaders to the FDA based on their adherence to right wing ideology, not their familiarity with science.

This should not surprise anyone. Bush insider Donald Rumsfeld spent some of his years out of power heading up drug company Searle. Among his accomplishments? Pushing for the legalization of direct to consumer drug marketing--the marketing that has let drug companies make what they know are false claims for their drugs that sell millions of prescriptions in the interval between when the ad appears and when regulators finally get around to pushing them off the airwaves.

Once Bush got into power he appointed industry insiders and Republican ideologues to run the FDA. These were people with strong ties--i.e. people receiving huge amounts of money from--the industries they are supposed to be regulating. They have, as a result, ignored strong scientific evidence when the evidence might lead to an outcome that impacted the profits of their industry buddies.

The refusal to face the truth about Bisphenol-A is only one of many decisions that the FDA has made by relying on "experts" who are in the pay of the very industry under scrutiny.

Putting the fox in charge of the hen house has also led to FDA to pretty much give up inspecting more than a tiny fraction of foreign food imports or to enforce existing regulations that could prevent e coli and Mad Cow Disease from being spread by slaughterhouse operations run by a few politically well connected food processors. In fact, the FDA has worked to weaken oversight of the meat we eat at the behest of cattle producers.

Finally, and most importantly for people with Diabetes the FDA has shortened the approval cycle for new drugs and then completely given up any attempt to follow the safety of these drugs once they are in the marketplace. Though the FDA orders companies to do followup testing, they have never enforced these orders, and as a result most companies have not done the studies they were ordered to do. The only true system we have for tracking the safety of drugs in the marketplace is a "voluntary" system which most doctors ignore, as it involves them in paperwork. And from what I have been told by doctors who have reported problems with new drugs to the FDA, the usual response is an assurance that the drug is safe--based on pre-release testing.

The current FDA drug testing criteria are a joke. They do not require that a drug be shown to be more effective than an existing drug. All they ask is that a drug be more effective than no drug at all.

They do not require that the company selling the drug investigate what it is that the drug actually does as long as it affects some surrogate marker. So Vitorin, a drug that lowers LDL cholesterol can be marketed as preventing heart disease, even when the evidence suggests it has no positive impact on heart attack incidence and may actually increase heart attacks.

Most importantly they FDA not only does not force drug companies to show that their drugs do what they say before the drug is approved, they do nothing to prevent drug company representatives and advertisements from making unsupported claims for the drug's effects after they are released into the marketplace.

This is why statin drug manufacturers can claim their drugs prevent heart attacks, while the data only shows that they lower LDL cholesterol and that if they do prevent heart attacks at all, it is only in one subgroup: middle aged males who have already had heart attacks and that that they have no impact on heart attack incidence in women, as documented exhaustively in Good Calories, Bad Calories, by Gary Taubes

This is also why companies selling SSRIs can claim that their drugs prevent depression because boost serotonin levels, when in fact it turns out that this effect is transient and what these drugs really do is remodel neurons in hippocampus, the part of the brain responsible for storing memories.

The lax FDA drug approval process combined with virtually no oversight of drug company marketing practices is also why the costs for treating diabetes have doubled in the last eight years.

The companies selling expensive and unproven new drugs like Avandia, Januvia and Byetta have been marketing these incredibly expensive drugs to PCPs claiming--based on flawed evidence--that they cause beta cell mass to rejuvenate. These claims have been debunked for the glitazone drugs like Avandia and Actos--though they were marketed to doctors on that premise for almost a decade. These claims will probably be debunked in time for Januvia and Byetta, too, as the evidence supporting these claims is seriously flawed. But meanwhile millions of people will buy and use them, even though these drugs may be doing them harm.

Because the FDA does not require rigorous post-marketing testing but relies on the drug companies themselves to police the safety of their products, we may never know the toll the newest drugs are taking on our health.

We only learned of the dangers of Avandia and Vioxx from the drug companies' own studies which were intended to increase the market for their products. We can assume that the drug companies learned from these fiascos never to test the health benefits of any drug already approved for sale. So we are not likely to ever learn the long term dangers of Januvia--with its dangerous shut down of the immune system mechanism that kills metatastic cancer cells or of Byetta.

This is why we desperately need leaders in Washington who will appoint aggressive regulators to watch over the safety our food supply and of the drugs being marketed directly to us on TV and to our doctors. We need regulators whose primary allegiance is to we, the people, not to the corporations they regulate. We need stronger disclosure rules to make sure that drug companies can no longer cherry pick the studies they run and publish only those that show positive outcomes for their drugs while suppressing those that show the drugs to be ineffective or dangerous.

We also need to know who is paying the "experts" who evaluate the safety of new drugs and who determine which chemicals in our environment are safe.

Most importantly, we also need regulators who are familiar with and respectful of the principles that drive Science. It is hard to believe anyone would need to state such an obvious principle. But the Right Wing of the Republican Party has made it crystal clear that they consider science to be an elitist frill.

Whether it is Sarah Palin proclaiming that dinosaurs and humans lived on earth at the same time and citing fruit fly research as a waste of money--though any person familiar with science knows that fruit fly research continues to be where the vital first steps are taken towards understanding many of the genes that operate in humans, or Bush's stopping of funding to stem cell research, or the way that the release of a vaccine that could prevent our daughters from cancer was blocked for years on ideological grounds, the Republicans have made their priorities clear.

And those priorities are indeed faith based: because as long as people with those priorities are running things, you are going to have to pray to God to keep you safe and healthy, because the FDA sure isn't going to.

Bottom line: We can't afford four more years of the same old thing.


Note: As has been my practice in previous posts involving politics, I welcome comments that address the topic discussed in the post but will delete any hate posts and generic diatribes from anonymous posters which do not relate to the actual topic under discussion here.


Scott S said...

As is often the case, we are in complete agreement on this issue! I would dearly love to see 1 additional change, namely the elimination of the FDA user-fees which fund most of the FDA's budget, but that was rushed into law under the Congressional leadership of Newt Gingrich back in 1993 when budgets were tight, and things are worse today than they were back then. But the real issue is that there is a culture in the FDA that they are "partners" to industry which needs to change, they are NOT partners, they are there to ensure the safety of the American public.

AmyT said...

Here, Here Jenny! Good post.

Anonymous said...

A major issue with the FDA is that we expect it to eliminate all risk. Rather than encourage innovation, it discourages innovation due to the high development and testing costs and the long wait times for approval. As a nation, we need to understand that we can never eliminate risk, and that your level of risk avoidance is different from mine. As long as we understand that the therapy we choose involves specific risks, and accept the risks as a possible consequence of the therapy, then we and our practitioners should be allowed (and indeed encouraged) to use our therapies of choice.

To assume otherwise is to bury our heads in the sand and to allow many to die needlessly to prevent possible injury to a few.

For more information on how the FDA (not who is employed by the FDA, but the existence and raison d'ĂȘtre of the FDA, reference Dr. Mary Ruwart (Healing Our World and other publications).

Anonymous said...

I normally don't look at this site in the evening, but I was expecting you to comment on the new ADA recommendations on treatment plan for type 2 diabetes. The plan is closely aligned to your recommendations, and what I figured out from you and others almost two years ago. Essentially it says that Metformin and Insulin are the drugs of choice. RobLL

Jenny said...


The new concensus statement is appearing all over the diabetes blogosphere so, as is the case with stories that get this kind of exposure, I don't feel a need to discuss it immediately.

I'm not thrilled with the A1c targets it includes, because in effect it is going to mean American doctors continue to ignore people with Type 2 until their A1c is 8.5% for a year. This is already what studies have found they are doing, and is a main reason why so many people with Type 2 develop complications while under a doctor's care.

I also want to see the full text of the recommendations, not the summaries that I have been able to find, to see exactly what they are recommending for "lifestyle" etc.