Jewish World Review May 10, 2002 / 28 Iyar, 5762
Drs. Michael A. Glueck & Robert J. Cihak
http://www.NewsAndOpinion.com | Do you know about your "Right to Know"? Idiotic question. Of course you do. The purpose of this "Right"? Naturally, to enhance your rights to "Life, Liberty, and the pursuit of Happiness."
But alas, what the government thinks it gives, it tries to take away, both in health and politics. Once you start to ponder it, it's truly amazing how much the FDA and the Campaign Reform Act of 2002 (signed into law by President Bush in March) have in common.
Both, by design, limit the information available to people who are intensely -- and appropriately -- interested in health and electoral politics.
Among the functions of the FDA is approving prescription drugs for sale in the United States once they meet FDA requirements. To receive FDA approval, the manufacturer must show that a drug is safe and effective; usually that requires many years, even decades, of testing. Two quick observations. First, FDA approval takes a lot longer than drug approval in other advanced countries, hurting tens of thousands of desperately ill Americans whose lives might be saved or prolonged by access to drugs widely available in Europe but not yet approved by the FDA. Second, one could argue that the FDA's mandate should be limited to proving a drug safe, leaving issues of effectiveness to the medical profession and to patients who might benefit.
In any event, the approval process is not always straightforward. For example, a manufacturer might test a drug for its effectiveness in treating high blood pressure; and if the FDA judged that the tests showed that the drug would be effective, it would be approved for sale. But sometimes such a drug shows unexpected side effects helpful in treating other conditions. Doctors are free to prescribe the drug for that use as well. That is what happened with Minoxidil, better known by its stage name RogaineŽ.
However, under current rules, if a drug does turn out to have an additional, desirable application, regulations prohibit the manufacturer from telling doctors about it until the FDA approves the new use. That requires millions of dollars in additional spending on additional tests.
Because the manufacturer cannot tell doctors about a newly discovered beneficial application, it cannot tell doctors what doses have been effective or warn them about complications of that use. It all makes a certain Alice-in-Wonderland bureaucratic sense -- and it points to the link with the campaign finance law.
The Campaign Reform Act severely restricts citizens or groups from paying money to talk to voters about campaign issues or politicians, especially in the last 60 days -- the most crucial -- before an election. Violators risk fines and prison terms.
At issue is not whether that talk, which usually takes the form of paid advertisements, is true or false, or even "safe and effective." At issue is the right - - in a country where flag-burning, flamboyant advertising, and pornography are constitutionally protected speech -- to address your fellow countrymen on matters of common urgency.
What's the rationale? Beneath all the fretting about the "corrupting effects of Big Money," it's a doctrine called "equality of influence." It holds that those who are most directly affected by government policies should have no more, and possibly less, influence over decision-making than anyone else ... precisely because they're affected.
In medical terms, that seems akin to making it very difficult for a drug company to tell a patient about adverse effects of a planned medication. "Equal influence," indeed! Should someone in Washington, D.C., have as much to say as you have about who your doctor is and what your treatment should be?
To be consistent, we may as well go ahead and limit what a surgeon can tell a patient about possible complications of a planned surgery: "Sorry, Doc, but under the new medical campaign reform rules, you gotta explain the whole business in three minutes." Under such "reform," a doctor would have to say, "The closer we get to the operation, the less I can tell you"!
If that sounds far-fetched, consider.
To the Founding Fathers, elections entailed
much more than simply voting. To them,
voting came at the end of a long
deliberative process in which candidates
talked to people, people talked to
candidates, and people talked to each other.
Communication meant clarification,
individually and communally. In like
measure, the most important aspect of any
doctor-patient relationship is unfettered,
clarifying, mutual communication. To
restrict in any way what may or may not
be said, or when it may be said, is not
reform. It is the destruction of the process
by which we achieve rational and desirable
results, whether in public elections or
05/03/02: Medicine's Vietnam