Off-Label Confusion

Results of the WSJ Online/Harris Interactive Health-care Poll regarding off-label use of drugs were recently published ("Adults Are Divided On Off-Label Use Of Prescription Drugs").

Looking at the numbers, I would say that American consumers are confused rather than divided.

Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label").

Some Fun Off-Label Facts
A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses.

While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment.

A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure.

Here's the summary of the 2006 poll results as reported by the WSJ:

Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.

However, there is less division on this issue when the question is phrased this way:

"Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?"

In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed."

I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK?

Freedom for Docs, but Not for Pharma
While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it!

Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way!

Look on the Sunny Side
Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree."

I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.)

But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use."

Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle!