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Drug company money influences and corrupts research.  That is a given.

What is less understood is why drug manufacturers spend billions for research on off-label uses for their products – uses that were never cleared with the FDA when the drug was submitted for approval as safe and not causing personal injuries and wrongful deaths.
Off-label use allows drug companies to get “through the back door” what they could never, and I mean never, get away with by going directly to the FDA for approval for a new use of a product – what is known today as an off-label use.

You would hope that researchers wouldn’t corrupt the commercial experimentation of a new, or off-label, use of a drug to treat children by covering up their consulting fees from Big Pharma.  But that’s what happened.

More important than what happened is why it happened and at the bottom of all this is a terrible mistake the U.S. has made in allowing the exploitation of off-label use.

The devil is in the details, so here is the story as it has unfolded.

Leading Harvard professors studying off-label uses, the gold mine of the drug industry, have violated National Institute of Health reporting requirements when more than $10,000 has been received from a subject company, according to the New York Times, “Researchers Fail to Reveal Drug Pay” June 8, 2008.

Johnson & Johnson, Eli Lilly, Merck and the other big time operators, the leading exploiters of junk science, thrive on talking the FDA into approving a drug for one use and then encouraging research so doctors will use it for other purposes. Everybody knows the FDA can’t stop toxic food from being unloaded on Americans.  Yet few realize that the drug companies have hired off the FDA‘s most seasoned researchers, leaving juniors guarding our public health.

So it is easy to wing a drug application past the FDA‘s lap dogs and once that occurs, off-label use can exploited by the manufacturers.

Off-label use is allowed under our law on the theory that the doctor knows best, and once a drug is approved by FDA for one purpose, a physician can prescribe the medication for other uses. That’s where the big money is in pharmaceuticals. Off-label drug use accounted for more than 20 percent of drug sales in 2006, according to the Annals of Internal Medicine, which provides an excellent overview of who’s in charge of safeguarding patient welfare and FDA off-label policies.

Drug companies cannot directly market off-label use. That’s against the law and major companies such as Eli Lilly, Pfizer and Astrazenica have been prosecuted for doing so and causing serious personal injuries and deaths.

In many cases the harm caused by off-label continues for years. That’s the case with Wyeth’s Pondimin® and Redux®, better known as Fen-Phen, an off-label use for weight loss that is responsible for primary pulmonary hypertension. Fen-Phen continues to devastate lives with tragic and deadly personal injuries a decade after its marketing demise.  I know.  These innocent victims are my clients.

But what the FDA takes away from drug manufacturers on one hand it gives back on the other. Today there is a loophole in prohibitions against marketing off-label use big enough to drive a train through. Our FDA watch-kittens have eased the rules which allow drug companies to republish and distribute scientific articles on the topic.

It’s a bad policy that has been blasted by a leading Stanford researcher, Dr. Randall Stafford who said so in an editorial in the New England Journal of Medicine in April 2008.

The drug companies know the trick is to get someone else to talk about new ways to use their drugs and then pass on copies of the research articles they cannot publish themselves to every doctor in the western world under the companies’ First Amendment right to free speech. That’s why Merck wrote drug studies for doctors.

Drug companies need to have researchers finding new off-label uses. Since pushing research for off-label use is a key to profitability, that is what drug companies do and to the extent that it promotes scientific discovery that’s good, but it has to be above board.

Turns out that Dr. Joseph Biederman, a world-renowned Harvard child psychiatrist and his Harvard sidekick Dr. Timothy Wilens have been operating below the board.  They either cannot count over $10,000, or they have willfully violated NIH mandates and federal reporting requirements.

The duo collected $1.6 million in unreported consulting fees from drug makers since 2000 to experiment with antipsychotic medicines in children, but nary a disclosure.

They are not the only ones.

Dr. Thomas Spencer, another Harvard professor, pulled down at least $1 million in unreported drug money and reporting also slipped his mind.

So there must be more.

Thank you Senator Charles Grassley for forcing them to disclose. Good work.

Harvard needs to end this skullduggery by requiring their big league faculty to annually turn in their tax returns with the W-2s and 1099s attached to guarantee full disclosure and compliance with ethical research requirements. Then post it on a website. Let them complain. If they want the Harvard imprimatur, that’s the price.

Other major research institutions also need to make sure that disclosure requirements are mandatory, not merely “ethical” expectations. If the public and regulators are to have any confidence in research, the source of funds and the amounts must be publicly disclosed.

Harvard needs to make a strong public statement by making a public example of these outlaws. Saying “sorry” isn’t enough.

If Harvard doesn’t fire them, it will be complicit in the cover-up.

Throw them off campus. Ring the bell loud and clear that no matter how renown or stellar, if you don’t play by the rules, you can’t play at all. And the NIH should forever ban them from receiving grants.

Don’t throw out the baby with the bath water. Once appropriate punishment has been served, give these researchers a chance to polish their tarnished reputations. Allow them to conduct research under the supervision of a responsible administrator who knows that “veritas,” means truth, accuracy, honesty, and uprightness and that it’s more than just a motto.

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Richard Alexander