Cross a Line, Pay a Toll

April 28, 2010 at 9:26 am 2 comments

In another case of pharmaceutical giants taking part in what has become a convoluted pay-to-promote plan, AstraZeneca is set to pay a $520 million settlement as the result of a federal investigation revolving around their off label marketing of Seroquel. That sounds like a lot of money until you realize they made nearly 5 billion off of the drug in 2009 alone. That makes the settlement look a lot more like paying a toll than a hefty fine and still raises the question, When (if ever) will convictions start coming down?

From the NY Times:

“AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,”Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners.

Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment.

“It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,” Mr. Engelmann said.

If companies’ sidestepping safety measures and paying doctors to disregard patient safety is going to continue to be treated not as a crime but an indiscretion, there is little hope for a turnaround in any foreseeable future. It’s a bad step made worse by the fact that they’ve targeted some of the most at-risk and vulnerable among us. Children, elderly, veterans and prisoners are all  left with little choice but to take the drugs they’re given whether the perceived need is determined by medical inquiry or financial gain on the part of the doctor.

Of course it’s in the company’s best interests to deny the allegations and pay the toll. The alternative, in theory and on paper, is to go down the road of criminal litigation. Patient safety be damned, there’s money to be made and if a conviction resulting from “protracted litigation” can exclude companies from  government programs like Medicaid, then the best option for them will always be to pay these small settlements.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. The drugs have caused rapid weight gain in children, and side effects including deaths have prompted warnings against giving the drugs to elderly patients for dementia.

According to company e-mail messages unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study that showed Seroquel users gained 11 pounds a year, while publicizing a study that asserted users lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on unfavorable studies.

Warnings and small fines are not going to save lives or turn the tide of corruption in marketing and medicine, they will only serve as a payment of a toll and an acknowledgement of roles without consequence. If their actions are criminal and dangerous — and they clearly are — then they should be treated as such. Maybe we can start with actually prosecuting for their off label marketing and doctor kickbacks — or better yet, a few hundred thousand counts of reckless endangerment.

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2 Comments

  • 1. Duane Sherry, M.S.  |  April 28, 2010 at 2:49 pm

    “A few hundred counts of wreckless endangerment?”

    … You got that right!

    Duane

  • 2. Duane Sherry, M.S.  |  April 28, 2010 at 2:56 pm

    A few hundred (typo)… a few hundred thousand…

    Actually, it’s probably closer to a few million! (with the lack of informed consent, and no indication by docs or drug companies on how to slowly and safely taper off these drugs)…

    What a crime! Literally.

    Duane


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