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The birth control patch as evidence of the danger of federal premption

  The Bush appointees to the US Supreme Court are on a mission to preempt state rules and laws protecting citizens from unsafe products and drugs.  Johnson & Johnson's inadequate disclosure to the FDA with regard to Its Ortho Evra birth control patch demonstrates the inadequacy of the extreme conservative approach to regulation.

Traditionally, conservatives have been "state's rights" advocates.  From slavery to civil rights, including discrimination rules, schools issues,  and all sorts of "liberal" public policies, state's rights advocates have argued against a national concensus approach.  After gaining control of the federal government and then of the US Supreme Court, however, conservatives have reconsidered and launched their own effort to preempt state iniatives intended to protect consumers and victims.

Under the Constitutional Amendment that leaves to the states all powers not specifically turned over to the national government, traditional conservatives argued that states should be left alone to develop their own policies and standards on matters not enumerated in the Constitution.  Recently, however, these conservative initiatives to exclude state regulation have included efforts to impose federal rules on medical malpractice, products liability and numerous other traditionally "state" issues. 

Currently pending before the Supreme Court are several cases discussing federal "preemption" of state laws governing the safety of pharmaceuticals and medical devices requiring FDA approval.  It appears that the Court will throw out all state laws that attempt to regulate drugs and devices, pursuant to the rationalization that the FDA is adequately protecting us from big pharmaceutical companies.

Of course, this "preemption" argument does not really explain a fundamental change in conservative philosophy--unless that philosophy is a cynical "whatever it takes to win" form of pragmatism.  More importantly, though, it fails to take into account the fact that the FDA is not protecting consumers.  It is short-staffed and under-budgeted.  When under the control of an anti-regulatory President, it is essentially either "headless" (at best), or refers to the corporations it was intended to police as "customers" and rebukes employees who take their regulatory responsibility seriously.

The relative powerlessness of the agency becomes an acute problem when it becomes the only regulatory device in the country, and there is no remedy available in the event that companies like Johnson & Johnson abuse the regulatory process by obfuscating or misleading the FDA in the approval process.  We have cited numerous examples of pharmaceutical companies hiding or distorting drug research in other weblogs; in the case of the Ortho Evra patch, the company disguised the effect of allegedly excessive dosages of estrogen by applying a "40 percent" correction factor to obfuscate the difference between its patch and taking a birth control pill.

The "correction factor" is mentioned only once in the Company's 435 page report to the FDA, according to the New York Times, and then only in a complex mathematical formula which only a fully-informed scientist might detect and question.  The company has no scientific basis for this "correction", and the correction factor was not mentioned in the study when it was published in 2002.  Meanwhile, more than 3000 women have sued the company, arguing that the undisclosed excessive estrogen dosage of the patch resulted in blood clots or strokes.  Their cases will be dismissed, on the fictional rationalization that the FDA has already acted to protect their health, if the Bush Administration and its "reforming" Justices have their way.  And in fact, no one will have carefully examined this patch to assess whether it unreasonably endangers womens' health.

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