The drug maker Wyeth has issued a press release on the topic of preemption, as related to the case before the Supreme Court of Levine v. Wyeth. Simply put, preemption strips away the rights of consumers to have redress in court if they have a toxic or fatal side effect from an FDA approved prescription medication. The good people of Michigan have been struggling with this law for a decade, and now the drug companies are trying to push it through to become the law of the land.
Here is their press release.
"The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings - rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret. Such a system would undermine the careful balance struck by the FDA when making approval decisions. If Wyeth prevails here, it will only reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling."
Ha! These are just a few of the reasons I think this argument is ludicrous:
How can you say that their viewpoints are carefully balanced, when they are guided by advisory panels of physician "key opinion leaders" that are usually on their payrolls as consultants, speakers, and/or advisory board members? And the fact that this advice is skewed can be shown by numerous examples, e.g. the fact that "expert guidelines" recommend the use of statins for the prevention of heart disease in women, when the evidence in the literature clearly shows that there is no benefit, only the risk of harm in the way of side effects? Preemption would effectively yank the protection that Americans get from the judicial branch of government and leave the executive and legislative branches in charge of protecting them. And what do they know about drug safety? Since the FDA's leadership is politically-appointed, this would put the responsibility for guarding Americans in the hands of a small group of politicians who frequently benefit from donations from pharmaceutical companies. Witness how Dan Troy went from representing pharma to a job as chief counsel at the FDA, where he filed friends of the court briefs on behalf of FDA on the side of pharmaceutical companies whose medications had caused serious injury or death, on the rationale that since the FDA had approved the medications that they had a stake in the outcome. After this little jaunt he then tripped back to a cushy job in pharma.
Or here is another example. George Bush was so concerned about protecting us from dangerous prescription medications that he appointed a veterinarian, Lester Crawford, to run our nation's drug regulatory body, the FDA. I'm not sure if I feel comfortable having an expert on cows deciding which drugs end up in my medicine cabinet. Thankfully, Lester was foolish enough to not disclose or divest of the stocks he owned in the pharmaceutical industry, and precipitously had to resign.
Lately we have had to watch senators shouting at the FDA to tell him how much money they needed to keep America safe from Chinese milk or pet food or the latest drug disaster. The Director couldn't tell him, or more likely wouldn't, since his marching orders were to keep the budget small.
With the Prescription Drug User Fee Act (PDUFA) resulting in pharmaceutical companies paying more and more of the budget of the FDA, with PDUFA mandating that less goes to drug surveillance (watching drugs already FDA approved), the FDA is essentially working for them, so sure pharma thinks it will be a good idea to have a "single regulatory body", especially if it is working for them. And outside reviews of the FDA have said they are putting Americans at risk through their shoddy regulation of prescription medications.
Another argument against preemption is that taking the issue out of the courts removes a potential way to uncover fraud and deception in the management of data related to clinical trials, something that has come up not just once, but repeatedly, through the discovery process of ongoing trials.
And what is the argument about the law being "impossible to interpret." I have a suggestion for you; if a prescription medication is found to have an adverse outcome, warn doctors and the public, and if is too dangerous, take it off the market. That is what you are paying your doctors and scientists to do, analyze your data and evaluate risk/benefit ratios.
How about "...reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling." Let me translate that one for you: Physicians, support this proposed ruling, because then you won't have to worry about covering your asses for prescription medication disasters.
I've got a thought for you, Wyeth. Maybe some of us physicians actually care about whether we are doing harm or good for our patients. What do you think about that?
Doug Bremner MD is author of Before You Take That Pill.