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.

Attacks on stimulus funding to compare medical treatment: Sound familiar?

In a long-overdue step toward health care reform, the massive economic stimulus bill that the Obama administration approved on Tuesday includes $1.1 billion to compare the effectiveness of drugs, medical devices, surgery and other medical procedures. The money will fund not only systematic reviews of published studies but also be used to pay for clinical trials that compare different drugs and treatments. This means that for the first time in decades, clinical trials will be funded by the government, not by drug or medical device companies with a vested interest in the research outcomes. As Robert Pear noted in The New York Times, such funding should help answer important medical questions including whether talk therapy and/or prescription drugs are more effective in treating depression.

This is very good news for doctors and consumers, not to mention those of us who have written about the conflicts and skewing of scientific data that emerge when clinical research is paid for by the makers of drugs and medical devices. Predictably, however, this part of the economic stimulus bill has been roundly attacked by conservative groups that derive some of their funding from, guess what, the drug and medical device industry. In Pear's Times article, for example, he quotes Betsy McCaughey, whom he identifies as a former lieutenant governor of New York, complaining that the new legislation will lead to rationing. What isn't mentioned is the fact that McCaughey now works for the Hudson Institute, a conservative think tank in Washington, D.C. that gets funding from drug and medical device companies.

Obviously, the drug and medical device industry is not looking forward to independent research that compares expensive new drugs or procedures to older and less expensive treatments, especially if it turns out there is little or no difference between the two. So it comes as no surprise to see that they have trotted out old warhorses like McCaughey, who was a principal critic of the Clinton administration's failed health-care reform efforts in the early 90s. McCaughey, of course, has a right to say whatever she wants, but don't the readers of the Times deserve to know who is behind her attacks?

And keep in mind this is just a foretaste of the blitzkrieg that will be unleashed when the Obama administration gets around to tackling health-care reform in earnest.

GlaxoSmithKline takes a $400 million hit

The health blog of The Wall Street Journal was the first to report Jan. 29 that GlaxoSmithKline is taking a $400 million hit related to federal and state probes into the drug giant's research and marketing shenanigans. Glaxo announced the charge in its fourth quarter filings to the SEC but was coy about which drugs and investigations the money is slated for, or when a legal settlement can be expected. Jeanne Whalen followed the blog report up with an article in Friday's Wall Street Journal in which she named two of Glaxo's drugs that are currently under investigation: Paxil and Wellbutrin.

As a number of news outlets have reported in recent months, the U.S. Department of Justice has been focusing on Glaxo's aggressive efforts to market Paxil, an SSRI antidepressant, for off-label uses in chidren and adolescents. As I've reported in this blog before (back story), DOJ officials are not only looking into off-label marketing (which is illegal) but into whether Glaxo officials pressured researchers to skew scientific data to make Paxil look safer and more effective in children and adolescents than it really was. (Such allegations are explored in some depth in my book, Side Effects). Given the latest news, I can only speculate that GlaxoSmithKline is getting ready to settle the Paxil probe to the tune of a $400 million fine.

A postscript: Now that I'm back to teaching, I am going to be taking a short hiatus from publishing this blog on a regular basis. I still hope to comment on key news items in the medical-pharmaceutical industry as they occur, but please don't expect a weekly posting until the new semester's dust settles down. Thanks for your understanding!