A Tale of Two AnniversariesListening to my patient, I feel the enormous tragedy of the situation. This 80 year old woman survived smallpox, a war, and a revolution. But she is now being felled, slowly and cruelly, by dementia. Her memory is so poor that she can't recall her home address. Her family asks me what can be done. The answer: not much.
The Discovery of Alzheimer's and the Founding of the FDA
Medical Progress Today
July 5, 2006
A century has passed since Dr. Alois Alzheimer described the cognitive and pathological changes of the disease that bears his name. Our understanding of the illness has advanced – we know more about its biochemistry and genetics than the German physician ever dreamed possible. But I can offer little more actual help to my patient than Dr. Alzheimer could a hundred years ago. Such is the state of medical science.
A century ago today, an ocean away from Dr. Alzheimer and his clinic, President Theodore Roosevelt signed into law the Food and Drugs Act, creating the FDA. But as we consider this event, we cannot forget the other anniversary, the discovery of Alzheimer's – and the limited progress in curing this horrific disease since its discovery.
Never in its history has the FDA been so heavily criticized both inside and outside Washington. While Vioxx has raised issues about post-approval monitoring, the larger (and too often forgotten) issue is the agency's sluggishness in basic approvals.
Erbitux, a treatment for colon cancer, would be a case in point. The FDA withheld approval in 2001 because officials claimed inadequate data. The drug was finally given the green light, but more than two years later – and on basically the same data set as the original submission. As the Boston Herald noted last Sunday, colon cancer strikes about 8,700 people every month; Erbitux (used in combination with another chemo agent) halts tumor growth for roughly 4 months. The delay thus cost roughly 80,000 person-years of tumor arrest.
Erbitux is not the only example, of course, of bureaucratic sloth besting patient interest. Indeed, it is part of an alarming trend. It now takes longer (8.5 years) and costs more money ($800 million) to bring a drug to market than ever before. The cautious nature of the FDA has had a direct influence on the nation's drug cabinets – approvals are down by almost half since the robust mid-1990s.
Here is what Americans want: an innovative, dynamic market for pharmaceutical and biotech drugs. We want ground-breaking treatments for stroke victims, for those afflicted by Schizophrenia, and, yes, for my elderly patient, whose mind has been dulled by Alzheimer's.
But that vision cannot be realized with an agency that has raised the bar for drug approval so high. The FDA's hyper-regulation affects every aspect of drug development:
- Who develops. There are now only a handful of companies capable of spending the incredible capital necessary to take a drug to market.
- How they develop. With such huge regulatory hurdles to clear, companies have adopted the blockbuster model: developing drugs for common illnesses (high cholesterol, for instance), then pushing marketing and promotion to create a "blockbuster."
- At what price they sell. Once a drug comes to market, companies need to recoup their investment and the high cost of approval – and thus charge heavy prices.
What would be a good prescription for an ailing FDA? There are a host of measures that Congress could take. Start by approving the nomination of Dr. Andrew von Eschenbach, the White House's inspired choice to lead the agency. End tenure for FDA staff – originally meant to encourage diligence, tenure protects incompetence. Encourage the FDA to partner with regulatory agencies in other Western countries, helping to reduce the overlap (and thus the overall cost) of drug approvals.
These measures, however, are just small steps. Ultimately, Congress would be wise to reconsider the very nature of drug approval. In the short term, that would mean changing the role of the FDA, from that of uber-regulator to overseer of the approval process, relying on private and non-profit companies to cull and organize the data. When the FDA experimented with this concept during the first Bush administration, approval times dropped to an impressive 2 to 4 months.
Congress could push further, returning the FDA to its original mandate. The FDA's first task was, after all, drug safety. But, in the aftermath of the thalidomide disaster of the 1960s, the FDA's scope expanded to include efficacy. Such a standard is not applied to any other consumer good. Yet, despite the incredible cost of compliance, the requirement is increasingly irrelevant in an age of off-label prescriptions.
Much could be done to better the FDA. Indeed, much must be done. My Alzheimer's patient is waiting – as are millions of others.
Dr. David Gratzer, a physician, is a senior fellow at the Manhattan Institute.