Alabama Product Injury Lawyer Blog

A study issued by the U.S. Food and Drug Administration (FDA) on Tuesday of this week confirms that people under age 25 who take antidepressants are at a greater risk of suicidal thoughts and tendencies than older adults taking the same medication. The antidepressant drugs specifically addressed were those generally referred to as SSRIs and SNRI's which include medications such as Prozac, Paxil, Effexor and Zoloft. This study was not a shocking result, but did confirm the validity of the "black box" warning the FDA required on these types of drugs addressing the increased risk of suicidal thoughts and tendencies in individuals below the age of 25 taking this kind of medication.

The article explains that many psychiatrists have complained about the warnings indicating that it has scared people away from using these type of medications. In fact there had been encouragement in the psychiatric community to do away with the warnings the FDA has imposed on these types of drugs based on the significant decline in people seeking treatment for depression. However, this recent study by the FDA, which looked at 372 clinical trials from eight different drug makers involving over 100,000 individuals, confirmed the increase risk of suicide in those under 25 taking these type of medications.

I have handled several cases over the years involving suicides of young people who committed suicide shortly after beginning a course of treatment with a SSRI antidepressant. Before the black box warnings were imposed by the FDA in 2005, primary care physicians were prescribing this type of medication to children and young adults going through what can only be described as "teenage angst". There typically was no diagnosis of depression, much less any formal testing to address whether the young adult or child was indeed depressed. Several weeks later, these young, vibrant souls, with many promising years ahead, were found dead as a result of self inflicted injury. In my view, the significant warnings on these medications were justified and necessary and if it has changed the prescribing habits of primary care physicians as it relates to young adults, then it has had its intended results and more importantly, saved the lives of many children and young adults who essentially were told to pop a pill and they will feel all better.

Posted by Craig P. Niedenthal | Permalink | Email This Post | Comments (0)

Posted In: SSRI/Anti-Depressants

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The New York Times recently reported about the ties between radio host Dr. Frederick K. Goodwin, host of an independent program called "The Infinite Mind" which airs on over 300 NPR stations, and several Big Pharma companies, some who manufacture and distribute anti-depressant medications (SSRI's). The Times reports that between 2000 and 2007 Dr. Goodwin received at least $1.3 million for marketing lectures he gave for several drug manufacturers. This income has not been previously disclosed on the program.

In March of this year, Dr. Goodwin had a show in which he took the position that there was no credible scientific evidence linking anti-depressants and violent or suicidal behavior. The Times reports that that same week Dr. Goodwin earned approximately $20,000 lecturing on behalf of GlaxoSmithKline who manufacturers Paxil, an SSRI. GlaxoSmithKline, the Times indicates, has suppressed studies for years that indicate that Paxil increased suicidal behavior and ideation.

One of my favorite blogs addressing the pharmaceutical industry, Pharmalot, has several posts here and here addressing this issue. NPR has indicated they will be removing the show from its satellite service within the next week. The bottom line of all this investigation and disclosure is that the pharmaceutical industry has attempted to push its agenda behind the scenes in so many ways from influencing our Drs. and pharamcists, our legislators, and now the airwaves of National Public Radio, one of the most respected news outlets for "unbiased" reporting. We have a serious problem when Drs. holding themselves out to the public as experts do not fully disclose their conflicts of interest. Clearly, being paid over $1 million has some influence on your perspective of issues which you are directly addressing and discussing and the public is entitled to full disclosure of those potential interests so it can judge for itself what effects such influences may have on the positions you take. As Senator Chuck Grassley, ranking Republican on the Senate Finance Committee, is reported to have said, “We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where, Now it looks like the same thing is happening in journalism.”

Posted by Craig P. Niedenthal | Permalink | Email This Post

Posted In: Pharmaceutical Companies , Recommended Websites/Blogs , SSRI/Anti-Depressants

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As I have mentioned in an earlier post, since coming over to the plaintiff's side, I have handled several cases involving children and adolescents prescribed SSRI antidepressants who shortly thereafter, committed suicide. I learned from these cases how the drug companies promoted these drugs to pediatricians telling them how safe they were and suggesting they be given to kids who are just having a "tough time of it" as they go through the challenges of adolescents. In turn, pediatricians handed these drugs out like candy to unsuspecting parents, explaining how it would help take the edge off for their child and was very safe. I also learned how the drug companies doctored their studies so indications of suicidal thoughts by those involved in the study were hidden and just kicked out of the study for "non-compliance issues".

Now, as reported at Pharmalot, one of my favorite websites for information on the drug industry, Alison Bass, a reporter at the Boston Globe in the 1990s, has written a book to be published this week entitled "Side Effects: A Prosecutor, A Whistleblower and A Best-Selling Antidepressant on Trial". Pharmalot's post includes a great interview with Ms. Bass. Among other things, when asked about what she learned from investigating the suicide issue and the SSRI Paxil, she had these thoughts:

"There has to be full disclosure of clinical trial data. And doctors have to acknowledge when they have conflicts of interest. Major academic centers should have requirements that doctors aren’t allowed to earn more than ‘X’ amount from a drug company. As I wrote in my blog recently, Marty Keller, the principal Paxil investigator at Brown University for the 329 study, acknowledged receiving consulting fees from Glaxo, but never reported them on his tax return. Researchers who are getting lucrative personal payments should be prohibited from studying these drugs if they’re making more than whatever minimum is established by the institution. But you know, these studies are a great source of income for these institutions."

As Ms. Bass explains and what is most concerning is that this is not a problem with just Paxil and SSRI's. It is a much deeper and more widespread issue across the pharmaceutical industry as a whole, as we have continued to see with drugs such as Vioxx, Vytorin and Trasylol. We as consumers, must continue to press our legislators and these corporations to incorporate protections and practices which will allow the consuming public to feel that all that is known about the drug at issue, including all potential safety issues, have been disclosed

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Posted In: SSRI/Anti-Depressants

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Today the FDA published an "early communication" regarding the drug Singulair which is used to treat asthma and allergies. According to the FDA, there is indication that taking of this drug might lead to suicidal thinking and behavior, otherwise known as "suicidality". Here is a drug meant for asthma and allergies and it is causing people to think about killing themselves?!? This is out of control.

I have handled several cases over the last many years involving children and adolescents who have been prescribed anti-depressants such as Paxil and Prozac and killed themselves. I have to tell you, there is no more difficult case to deal with on a personal level than a client who's young innocent child has decided to take their own life. The usual defense raised by the phamaceutical companies is that it was the disease i.e. depression, not the drug which lead the child to kill him or herself. In the cases I handled I was able to successfully show to the pharmaceutical companies that these children were never diagnosed clinically depressed, but instead were prescribed the medication by the family physician because the child was "going through a rough patch" i.e. adolescents. The doctors were lead to believe by the pharmaceutical companies that these anti-depressants were "safe" and promoted the drugs to be used to help those who are feeling "down in the dumps". This was despite the fact the drug was approved by the FDA to be prescribed for diagnosed depression. Thus, I was able to show that there was nothing else which could have caused the child to take the desperate act of suicide but the drug itself.

With Singulair, a drug prescribed for allergies and asthma, Merck, the manufacturer cannot claim the disease called the patient to take his own life. Should be interesting to see how Merck explains this one. Clearly, a patient taking a drug for allergies isn't expecting to feel suicidal. One thing I would say is it appears the FDA is trying to get information out there to the public on safety concerns alot quicker. I have to commend them for that. According to the FDA's website, Merck changed the adverse events on the package insert (what you generally get from the pharmacy when you pick up your prescription) on this drug in October 2007 to include suicidality concerns. They are working with Merck to figure out how to publicize this to the public and to doctors. It has been almost 6 months since they changed the package insert on this drug and they are still trying to figure out how to publicize this to doctors????? Something as significant as potential for suicide ??? Things that make you go "Hmmmm????"

Posted by Craig P. Niedenthal | Permalink | Email This Post | Comments (0)

Posted In: Drugs , SSRI/Anti-Depressants , Singulair

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