Ever gone to the butcher for counsel on fixing your car? What about your hairdresser — ever asked her for guidance on preparing your taxes?
Hopefully not. It’d be as wacky as seeking medical advice from a politician. New Yorkers, however, may soon find themselves living in such a crazy, mixed-up world.
In the coming weeks, state legislators are set to consider a number of proposals that would put government workers in the doctor’s office. If these measures pass, the damage to New York’s health-care system — and patient health — would be enormous.
Last month, Assemblyman Richard Gottfried put forth a measure that would prohibit pharmaceutical sales reps from engaging in “any deceptive or misleading marketing” when peddling their products.
It’s doubtful that Gottfried actually believes that government officials are better able to recognize dishonest marketing than licensed physicians. In reality, his proposal is an attempt to sharply curtail off-label prescribing of drugs.
“For the purposes of this section,” the legislation states, “it shall be considered an act of deceptive or misleading marketing to provide information regarding a use of a pharmaceutical product not approved by the federal Food and Drug Administration.” Notice that the bill would bar sales reps from providing “information,” regardless of whether that information is “deceptive or misleading.” You see, it’s already illegal to market or promote a drug for any use that isn’t approved by the FDA.
Doctors, however, have a long history of prescribing drugs for purposes that are outside the scope of a drug’s approved use.
Consider Revatio. In June 2005, this breakthrough medicine was approved for use in treating pulmonary arterial hypertension, a rare, life-threatening lung disease. Physicians, however, were already prescribing the medicine to those with the disease.
How? In 1998, the FDA approved the active ingredient in Revatio — sildenafil — for use. The drug was only approved, however, to treat erectile dysfunction; Revatio is the same exact drug as Viagra. If Gottfried’s proposal had already been enacted, those suffering from pulmonary arterial hypertension would have likely gone without this life-saving treatment.
So Gottfried’s measure would really just undermine physicians’ judgment and keep needed medicine away from patients.
Shortly after Gottfried introduced his bill, Gov. Paterson proposed several new rules to limit drug companies’ influence over doctors.
One proposal is a ban on gifts of over $50. For physicians, this proposal is as insulting as it is ridiculous. Most doctors aren’t swayed by letter-openers from Pfizer and desk calendars from Merck — they understand the gravity of their decisions. Plus, bribing doctors to prescribe a certain brand of medicine is already illegal. The anti-kickback statute of the Medicare and Medicaid Patient Protection Act explicitly prohibits this type of activity, as do other anti-bribery regulations. On top of that, drug companies themselves prohibit gifts of more than $100.
The New York law would simply create more red tape without improving anything.
Paterson’s proposal would also stick health-care administrators with mountains of additional paperwork every time a doctor wants to change a patient’s prescription. This provision is intended to keep the health-care system transparent. In reality, however, it would simply slow down treatment and inflate already-skyrocketing medical costs.
New York spends more
According to the Kaiser Family Foundation, New York spends more than any other state on health care. And every year, administrative costs account for 31 percent of health-care spending, according to a study published in the New England Journal of Medicine. Gov. Paterson’s redundant regulations would simply make this problem worse.
New York’s lawmakers really just have it backwards. If they were genuinely interested in improving health care, they’d be cutting back on bureaucratic red tape and trusting physicians to practice medicine.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
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