Thursday, February 26, 2009

DOJ lawsuit against Forest Labs: a bold new attack on a longstanding practice

The New York Times today reported that the Justice Department has sued Forest Labs for defrauding the government of millions of dollars by illegally marketing Celexa and Lexapro, its two blockbuster antidepressants. The fraud complaint is based on allegations that Forest Labs concealed negative findings that showed that these drugs were not only ineffective in children but caused an increased risk of suicidal thoughts and behaviors in some pediatric patients.

Sound familiar? That's because they were same allegations that formed the basis of New York State Attorney General's landmark case in 2004 against GlaxoSmithKline, which became the subject of my book, Side Effects. Just like Forest Labs, GlaxoSmithKline with-held negative findings about its blockbuster drug, Paxil, and instead published and heavily marketed one study that purported to show that Paxil was effective in treating depression in adolescents. It turns out that the data in this study did not show efficacy either (which is one of the reasons why the AG's office sued Glaxo for consumer fraud) and the story of how the detective-attorneys in the AG's office discovered this fraud is quite a tale!

Shortly after the New York AG's office launched the suit against Glaxo, it also began investigating Forest Labs for with-holding the results of several studies that found citalopram, the generic ingredient in both Celexa and Lexapro, to be no more effective than a placebo in treating depression in children. As I report in my book, the AG's office, then under the direction of Eliot Spitzer, used this investigation to force Forest Labs to post the results of all its clinical trials, negative as well as positive, on a publicly available website, from 2000 onward. By then, of course, GlaxoSmithKline had already agreed to do the same in order to settle the AG's widely publicized lawsuit against it. At the time, these settlements were seen as a major victory for health consumers and the next year, Congress passed a law requiring all drug companies to post all the results of their Phase 3 and 4 clinical trials online, putting an end to the widespread industry practice of concealing negative data about drugs from the public.

Now, the Justice Department has put an ambitious new twist on this case by charging Forest Labs with defrauding the government of millions of dollars. It is essentially saying to Forest Labs: you knew these drugs were not effective in treating depression in children and yet you went ahead and illegally marketed them (for off-label use) to minors anyway, costing government health plans like Medicare and Medicaid loads of money. The federal lawsuit is seeking to recover up to three times the amount of money spent by government programs to pay for pediatric prescriptions of Celexa and Lexapro, according to The New York Times .

Federal prosecutors have also charged that Forest Labs paid kickbacks in the form of baseball tickets, gift certificates and paid vacations to doctors who prescribed these drugs and that the company ran seeding trials that were really marketing efforts to promote the drugs' use by doctors.

Just think: if this case is successful, the steep fines levied against Forest Labs (and other drug companies who did the same) could go a long way toward helping fund health care reform.

9 comments:

Nancy Frugé said...

Alison, the scope of the investigation is impressive. The following federal agencies are involved:
U.S. Attorney’s Office for the District of Massachusetts

Civil Division of the U.S. Department of Justice

Federal Bureau of Investigation

Office of Inspector General of the Department of Health and Human Services

Office of Criminal Investigations of the Food and Drug Administration

Office of Inspector General of the Department of Veterans Affairs

Tax dollars well spent, in my view. The press release is posted here:
http://www.usdoj.gov/usao/ma/press.html

D Bunker said...

Yes; The action against Forest is laudable. I however, wish I might be as sanguine as yourself over the application of recovered monies actually accomplishing Anything meaningful in terms of bridging the Chasm we're now experiencing in Health Care coverage.

It's going to take Far more than the currently sought $Billions to even scratch the surface of our Health Care Indenture.

Twice, Every penny Pharma has so far collected selling psych drugs Might get them straightened out, but as it is, the fines currently sought were anticipated by the makers years ago. They knew they'd eventually have to pay. The publicity hurts them far worse than the monetary damages do.

A large part of our Health Care expenditures themselves could be foregone if those psych drugs were not being sold in the First place, and the Makers will Not stop until it becomes Long Term Impossible for them to profit from them.

Couple that with Board member and CEO prison time for hiding negative trial results which result in injury and death, and those new Co. Officers who replace the imprisoned will be forced out of the position of obeying the Shareholder Value imperative of "Sell Big, or be Replaced."

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Nancy Frugé said...

Srk,
Carl Jung reminded us that, "There can be no transforming of darkness into light and of apathy into movement without emotion."

RocketRed said...

Your pretty dumb for someone who appears to be intelligent? Correct me if I'm wrong but didn't Forest Labs drug Lexapro recently get FDA approval for the adolecent indication of depression? Do you believe its coincidence that the government filed this lawsuit only days after Forest Labs submitted for the approval of Lexapro in adolecent depression? I dont think so! The government knows Lexapro is probably the most widely prescribed branded medication for depression and the they just want a piece of the pie! Why don't you write something truthful about how corrupt our government is or how the healthcare insurance companies are truly the ones screwing the american people! Your book gives me side effects by not reporting the whole truth. Your just trying to exploit pharmaceutical companies for your own profit! Tell me...how much did you sell the rights for them to make a movie based on your book?

samantha said...

My wife is taking a knewly marketed drug by Forest Labs. The drug is called Savella. She has been near bedridden for 12 years with debillitating chronic pain from RA and lupus.
I am a physician and we have trialed everything. Alas ,nothing work and my wife was reaching tthe end of the road (WE can fill in blanks)
Since taking Savella,she has never looked back. She feels great annd is pain free for the first time in 12 years
Since she began she has lost her ability to tell weather changes 2 days ahead of the change.
Its amazing great medicine guys----SERIOUSLY

Diane said...

I was on the Savella titer pack and had just hit my first full dose when I started to have heart racing and waking up feeling like someone just scared the crap out of me. I backed down on the savella to the lower dose as per the doctor and it did not stop. The damage was already done. The fast heart beat kept coming and going but only would last a minute, then one day it stuck at a fast rate, A FIB... not fun. I was stuck in A FIB for over an hour. Ambulance could not get it to come back down to normal sinus rhythm. Rhythm was 260 and higher. They injected me twice with a drug to stop my heart, then restarted it. but still stuck in A FIB, I called to talk to a friend to tell him to take care of my ten year old son for me if I died and while I was talking it went to normal. For months after I keep having quick episodes of AFIB and I am wearing an event monitor so they can decide if they will put in a pacemaker. I can say that at first I was so happy with Savella!! My pain was almost gone!! But then it almost killed me, so... I had a few days of painfree, and now I am living with a heart that cant keep a beat anymore so, I think Iwas better off with all the massive pain.

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Hubert Haley said...

The New York Times today reported that the Justice Department has sued Forest Labs for defrauding the government of millions of dollars by illegally marketing Celexa and Lexapro, its two blockbuster antidepressants. The fraud complaint is based on allegations that how to lose weight fast Forest Labs concealed negative findings that showed that these drugs were not only ineffective in children but caused an increased risk of suicidal thoughts and behaviors in some pediatric patients.