Access to Drugs
posted by Frank Pasquale
After the fireworks of the Abigail Alliance controversy, access to drugs has been a simmering political and legal issue. I noticed two interesting posts on it today.
1) Eric Goldman comments on a crackdown on a cyberpharmacy:
Today’s case involves the criminal prosecution of Dr. Thomas Hanny, a Connecticut-licensed doctor who retired after 30 years as a surgeon. He then hopped on the dot-com bandwagon, writing Internet-mediated prescriptions first for Pharmacon and then, after Pharmacon was shut down by law enforcement, for Jive. Hanny initially had doubts about the propriety of this line of work and even went so far as to hire his own attorney (who also expressed doubts), but Hanny either felt the issue was colorable enough or decided to look the other way, going so far as to ignore a cease-and-desist letter from Missouri prosecutors. Collectively, these proved to be poor decisions that will cost Hanny 33 months of his liberty.
Anyone interested in the topic might want to take a look at Nic Terry’s excellent article Prescriptions sans frontières (or how I stopped worrying about Viagra on the Web but grew concerned about the future of healthcare delivery).
2) Reason magazine has interesting coverage of the controversy over OTC status for certain statin drugs. Here’s their bottom line:
Last January a Food and Drug Administration (FDA) advisory panel considered a proposal to put Mevacor within easier reach. As they had during previous hearings in 2000, members of the committee fretted that patients would muck up dosages, lose track of cholesterol levels, and make poor decisions about diet and exercise if popping a pill appeared to produce the same results as a healthy lifestyle. One of only three doctors who voted to put the drug over the counter–David Schade, a professor at the University of New Mexico Department of Internal Medicine–based his vote on lack of access for the uninsured.
Despite Schade’s opposition, the panel voted 20-3 to keep the drug’s prescription-only status. By keeping statins locked within the burdensome and, for some, inaccessible health care system, the decision dampened hopes that statins could find wider use among the millions of Americans who ought to be taking them. For the time being, access to these lifesaving drugs depends on the tiny percentage of the population legally empowered to dole them out.
Though I’ve been skeptical of a general “right to medical self-defense,” the Mevacor story really makes me think. Here’s one counterargument:
[A]nalysis of the Merck data shows that 21.5 percent of people deciding on their own to purchase Mevacor over the counter did not need the drug. “This large proportion of purchasers would therefore be exposed to the risks of Mevacor – such as liver damage, muscle damage and other adverse effects – without evidence of any benefit,” Wolfe testified.
I do not know how I would vote if I were on the joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee considering this issue. UPDATE: It looks like the most recent vote was negative.
December 13, 2007 at 9:53 pm
Posted in: Cyberlaw, Health Law
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Responses (1)
Ted McClure - December 14, 2007 at 5:14 pm
From the perspective of access to drugs, we should remember that moving a drug from prescription to over-the-counter status tends to make it more expensive for those who have health insurance. I have observed that even when the price drops with the change to OTC status, the price is still more than the co-pay I paid when it was a prescription drug. Even the tax advantage of an above-the-line medical payment plan does not make up the loss.
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