Its title even begins with “Access, Compassion, Care …”
Its details, however, illustrate the need for caution and critical evaluations of what one hopes are the good intentions of its authors.
The bill proposes to facilitate the availability to sick patients of drugs whose efficacy has not yet been proved.
Unquestionably, the process of proving that a drug works is slow.
The bill would allow the administration to patients of an unproven drug provided that it has first been shown to be safe (statistically, of course), and if there is “preliminary evidence” from perhaps a case history or computer modeling that it might work.
In the bill, the drug would be designated a “Compassionate Investigational Access drug.”
Compassion certainly has a place in medicine.
Thousands of medical providers (including myself) have countless times over the years offered their services without compensation to patients at home and abroad.
Except that word “compassion” in the bill seems strangely placed when one gets to the paragraph saying that “a sponsor (drug company) or investigator may charge for the investigational drug.”
Furthermore, sponsors can charge whatever they want without prior approval.
If they are truly motivated by compassion, why wouldn’t the pharmaceutical industry and other supporters of the bill want to provide these unproven drugs free?
Patients may benefit, and drug companies will learn more about their new agents. They already do that for many studies conducted by the National Institutes of Health.
Moreover, the FDA has for years allowed for single-patient or emergency investigational drugs to be given, albeit under strict conditions.
These conditions include supervision by an Institutional Review Board, agreement by the administering doctor to report the results to the FDA, and agreement by the manufacturer not to charge the patient, except for special-cost recovery.
Do we even need a new law?
In an era when at least 20 percent of our population is uninsured and others are significantly underinsured, one might hope that Brownback would take into account that fact that the resources of the American people are becoming too limited to pay for this sort of unproven compassion, and alter his bill accordingly.
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