Note to FDA: Get On-Label Use Right, Before Liberalizing Off-Label Use.

Posted on | May 9, 2015 | 4 Comments

Mike Magee

“At my own medical center we have banned pharmaceutical reps from coming because we don’t think they are a good source of information. You don’t ask the barber if you need a haircut.”

Dr. Rita Redberg, editor, JAMA Internal Medicine.

What Dr. Redberg is protesting is the possibility of liberalizing the prohibition on pharmaceutical reps discussing off-label use of their drugs. This is the latest in a series of moves designed to advance the commercial interests of pharmaceutical companies. They are banking on historically weak checks and balances between the FDA, pharmaceutical companies, and the academic leaders who are now entrenched in both camps, and profiting at every turn of the coin.

The idea of liberalizing off-label use, at a time when on-label use, and its risk/benefit ratio, is questionable at best, seems to many critics to be unwise in the extreme. This is the result of a government and corporate financed system of research that is non-transparent, riddled with inconsistencies, and geared toward quick approvals.

Consider some of the current issues whose origins trace back to two decades of liberalizing legislation supported by corporate, governmental and academic leaders.

1. Companies are supposed to register all trials (to ensure transparency of trials that yield both positive and negative results, and avoid cherrie picking just positive studies). But registries are not yet routinely enforced.

2. Journals have agreed not to publish articles that derive from non-registry studies. But some continue to do so.

3. Universities and their ethic committees continue to pass through corporate contracts that allow companies total control of data, and veto power over publication of results.

4. Databases in the hands of the FDA, on specific product studies, are very difficult to access by the public. This means that the information originally submitted for drug approval (which is often incomplete and skewed toward approval) is now presented by the FDA in a format that involves the use of non-searchable systems, lacking executive summaries and obvious indexes.

5. Laws do not exist that compel companies to publish all data derived from drug studies.

6. Many academic physician bodies, individuals and institutions, who now share licensing rights and patents for the discoveries from which new products are derived, are neutral or complicit in maintaining a system of non-transparency.

7. Industry advocacy organizations like the Medical Information Working Group (which includes Pfizer Inc, Sanofi, Novartis AG, Johnson & Johnson, Eli Lilly and Co and GlaxoSmithKline Plc), actively lobby to create a more liberal regulatory environment for the medical-pharmaceutical-industrial complex. The group expended $420,000 in 2014.

And the list goes on. The point is that the checks and balances between FDA and industry are at an historically weak level after two decades of chipping away at boundaries designed to protect consumers rather than foster commercialism.

Now the industry sponsored organization, supported by K-Street litigators and lobbyists, have designed a convenient First Amendment argument to justify market extension of heavily marketed products of varying value (like statins for everyone, or SSRI’s for sadness/don’t worry about suicide ideation). Extended off-label use (which could include pediatric use) in areas where there is neither proof of efficacy or safety, would be to reward current weaknesses in on-label use that remain to be resolved.

The words of Cleveland Clinic’s Steven Nissen ring true to me. “If off-label marketing is allowed then drugs will come to be used for a wide variety of conditions…You take away those checks and balances and it’s the wild, wild west.”

Before the FDA considers liberalizing off-label marketing, it should be able to demonstrate that the weaknesses in current clinical research design, execution and public transparency that support the approval of on-label therapies have been optimally resolved.

For Health Commentary, I’m Mike Magee.

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