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Attorney to Sue Doctors Who Misuse Drugs on Children

It’s true that the drug industry was hard hit last year with some pretty hefty fines for the illegal off-label promotion of drugs — $1.4 billion against Eli Lilly for its off-label promotion of Zyprexa and $2.3 billion against Pfizer for doing the same with several drugs. But such fines, many say, are still considered the cost of doing business in an industry that raked in close to $300 billion in U.S. drug sales in 2008 (and more in 2009), according to IMS Health Reports.
Now, Alaska attorney Jim Gottstein has proposed a different and potentially more effective approach toward curbing the systemic over-drugging of economically disadvantaged youngsters in this country, a sad reality which I’ve written about here and here. According to one recent study, children covered by Medicaid are given anti-psychotics such as Zyprexa and Seroquel (which have serious side effects) four times as often as children whose parents have private insurance. These drugs are often prescribed as chemical straitjackets to control children whose parents or foster families are unable to give them the attention and parenting they need. That was certainly the case for four-year-old Rebecca Riley, who died from an overdose of psychoactive drugs prescribed by a psychiatrist at Tufts Medical Center, Kayoko Kifuji.

Gottstein has launched an initiative to sue doctors like Kifuji who blithely prescribe potent drugs that are not approved for use in children. These lawsuits, filed under a federal Qui Tam complaint, would target not only the individual doctors but the hospitals and clinics that employ them and the pharmacies that fill their prescriptions and submit them to Medicaid for reimbursement. It is Gottstein’s contention that these prescriptions constitute Medicaid fraud since they are written for uses that are not medically accepted (i.e. off-label). There is legal precedent for this kind of argument. Indeed, the Department of Justice’s news release announcing its $2.3 billion settlement with Pfizer says that the drug giant caused false claims to be submitted to government health care programs for uses that were not medically accepted indications. So if the feds can succeed with this kind of argument, why not individual claimants?

Gottstein is planning to discuss his medicaid fraud initiative in a lecture webinar on Feb. 24, sponsored by the International Center for the Study of Psychiatry and Psychology. So if you know of a disadvantaged child who was slapped on drugs he or she didn’t need, you might want to listen in.

Alison Bass

Alison Bass (www.alison-bass.com) is a Pulitzer Prize nominee and author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, which won the NASW Science ...
Read more about Alison Bass ->

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Daniel Haszard says:

Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use.

A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder. Perhaps it is statistics like these that caused the FDA to finally require warnings on the labels of the ADHD drugs.

The use of atypical antipsychotics for children should be banned.
--

Daniel Haszard Zyprexa Whistle blower

February 9, 2010, 11:10 am
Gregg A. Miller

Gregg A. Miller says:

This is unfortunate. While no-one supports over-drugging children, it's chilling that a malpractice attorney views lawsuits as a way to shape medical practice. Lawsuits have negative effects--doctors over-order tests and unnecessary medications, costing society and individual patients. In this case, the pendulum could swing the other way, leading to children with serious illness who are not receiving treatment they need due to fear of legal action (a la chronic pain under-treatment, the DEA, and Ronald McIver).

Furthermore, drugs should be available for off-label uses in cases where the FDA has not caught up with current science. This is not Medicare fraud. This is allowing a doctor and patient to use their best judgment, and recognizing the FDA is a flawed agency that cannot possibly keep up with every medication as quickly as science progresses. In some cases, off label use can even save money (see Avastin vs. Lucentis).

Thanks for a thought provoking article!

February 9, 2010, 11:19 am


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