Friday, January 28, 2005

More Opinions About FDA Changes

I've been reading Scientific American since I was about 14.  I haven't keep up a subscription for years, but I check their website fairly often.  It is rare that they publish anything about the governement.  In the last issue, though, they have an article about the FDA.  Seems as though everyone is getting into the act.  Their article, though, is worthy of attention, because it has an idea that I have not seen published anywhere else. 
Avoiding Another Vioxx
Guarding against unsafe drugs means major changes
By Sara Beardsley

"Too cozy" is how Senator Charles Grassley of Iowa referred to the relationship between the U.S. Food and Drug Administration and pharmaceutical companies in the aftermath of the Vioxx debacle. Although the FDA admits no substantive lapse in vigilance, congressional pressure and consumer outrage are forcing officials to rethink the agency's role and perhaps even the drug approval process itself.

Vioxx, of course, is the cox-2 inhibitor that was taken off the market, voluntarily, by Merck, after having been shown to increase the risk of vascular  problems.  Although this is only one of many such cases, it has generated a lot of media attention.  the author goes on to review the impact of the 1992 Prescription Drug User Fee Act, which I've discussed previously.  She mentions the suggestion that the government split the functions of the FDA: keep the approval process where it is now, but set up a separate agency for monitoring drug safety.  Personally, I think this is a great idea, although there will be considerable political resistance to the establishment of a new agency. 

In case any readers are thinking that it would be a waste of taxpayer money to set up a new agency, let's try to put things in perspective.  Currently, the FDA employs about 10,000 persons, and has a budget of $1.7 billion.  They are responsible for regulating products that account for about 20% of all consumer spending in the USA.  The Vioxx problem has been estimated to have resulted in 55,000 premature deaths.  The terrorist attacks on 9/11/2001 resulted in about 3,000 premature deaths.  So far, we have spend hundreds of billions of dollars in response (most of it wasted in Iraq, but that's another story).  

If we set up a separate drug safety agency, and, let's say, it employs 1,000 people and has a budget of $170 million, and it prevents just one incident like the Vioxx problem every ten years, it would be an incredible bargain.   And that's just looking at the economic side of things.  From an humanitarian perspective, it is just the right thing to do, never mind the economics.

Earlier, I mentioned that the SA article contained a new idea, or at least, an idea that's new to me. 
The Vioxx withdrawal may also mark a turning point for the industry. Instead of seeking blockbuster drugs aimed at large numbers of consumers, companies may focus on niche medications designed for particular groups of ailing people. Garret A. FitzGerald of the University of Pennsylvania School of Medicine, an expert on COX-2 inhibitors, notes that Vioxx might have been able to stay on the market if its use had been restricted to people who have a low risk of cardiovascular disease but a history of gastrointestinal problems. (Vioxx is less likely to irritate the digestive tract than nonprescription painkillers.) "Here are drugs that are very useful in a segmented market," he says, "and their usefulness is being put at risk by the pursuit of a blockbuster strategy. I think, inevitably, the trend is going to be toward more segmented indications."
I'm not sure what to make of this.  Presumably, Merck was not directly responsible for the wide use of Vioxx.  After all, they cannot sell a single pill without a physician writing a prescription.  Yes, they have a marketing machine, and yes, that machine is quite powerful.  But the physician has a responsibility to weight out the risks and benefits carefully. 

Hindsight shows that too many people jumped on the cox-2 inhibitor bandwagon too quickly.  One could argue endlessly about where the fault lies for that phenomenon.  My argument is that the medical profession has to accept some of the blame; it is not merely a case of a drug company going for a "blockbuster" drug.  We need to be more cautious about accepting new classes of drugs, take more time before expanding their use to wider patient populations, and pay careful attention to adverse effects that occur at a low frequency.  If a drug is given to tens of millions of people, even a rare adverse effect can have a big impact.

All of this reinforces the need for a large, national database to track prescriptions and outcomes.  There would be considerable potential for abuse of such a database, so it would have to be managed in isolation from industry influence (not to mention law enforcement and intelligence agencies.)  It seems clear that the only way to do that would be to establish a separate agency. 

As for the idea that drug companies would start to move away from the mindless pursuit of blockbuster drugs, that does not seem too likely.  The allure of an easy buck is pretty hard to resist; drug development cycles are long (12 years, on average) and development costs are high.  What we probably will see is a more prudent, limited approach to the marketing of drugs.  If the companies have any sense, they will instruct their sales force to avoid the temptation to boost sales by hinting at off-label use of the products.  Likewise, physicians will have to be cautious about expanding the use of drugs to new, untested indications. 

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