"We are not seeing isolated instances of misconduct," he told the panel, "but repeated practices within the industry that have resulted in significant loses to federal health-care programs."
The majority of lawsuits against drug companies alleging illegal marketing schemes aimed at public health care programs were filed under the provisions of the Federal False Claims Act, which allows persons who find evidence of fraud to bring suit on behalf of the government and collect a percentage of the amount recovered.
These whistleblower cases are first filed under seal until the DOJ investigates the charges and decides whether to intervene. Over the past six years, the government has recovered close to $4 billion in 16 cases involving Medicaid with Pfizer paying the highest penalty of $430 million for the off-label marketing of the epilepsy drug Neurontin.
The list of side effects associated with SSRIs that have surfaced over the past 2 decades continues to grow every year. But ironically, the drug companies have been so adept at keeping negative information about SSRIs hidden that most of the side effects only come to light as a result of litigation.
All SSRI makers have lawsuits pending involving a variety of adverse events. For example, in June 14, 2006, SEC filings, Lexapro and Celexa maker, Forest Laboratories says the company is a named defendant in approximately 25 active lawsuits, with most alleging that Lexapro or Celexa contributed to persons committing or attempting suicide.
In addition, Forest is under investigation by the US Attorney's Office for the District of Massachusetts to determine whether Forest committed civil and criminal violations of the Anti-Kickback laws related to the off-label marketing of Celexa and Lexapro.
However, legal experts say drug companies view lawsuits as a minor problem and chock them up to the cost of doing business. For instance, what are 25 lawsuits to Forest, when Celexa and Lexapro, accounted for 68% of the company's sales last year. In fact, Lexapro revenues were 16% higher in the 4th quarter at $464,100,000, compared to $399,381,000 in the same quarter the year before.
Raymond Badyna has a Lexapro-induced suicide lawsuit pending in New Jersey filed on behalf of his deceased son, Ray Badyna's estate, by attorneys, Derek Braslow and Harris Pogust, of the Pogust & Braslow, LLC firm, in Conshohocken, Pennsylvania.
Ray's suicide was totally unexpected. His friends and family members say there is no logical explanation for it other then the effect of Lexapro. On October 7, 2003, Ray received great news that for the second year in a row, his job performance for the year had qualified him to receive the, "Countrywide Circle of Excellence Award."
And yet two days later at age 32, he committed suicide. "Had Ray or his physician known of the increased risk of suicide and suicidal ideation from Lexapro," the lawsuit states, "Ray would have never taken the drug."
Although Ray said nothing to his family that would indicate he planned to kill himself, after his death, it became known that Ray had expressed thoughts about harming himself to other people. In one conversation with a friend, Ray complained that Lexapro was making him "feel weird" and he "had very strange thoughts running through his mind."
Mr Braslow explains that SSRIs are designed to alter serotonin levels in the brain. "For years," he reports, "it has been known that serotonin functioning is directly related to aggression and violence, both directed at oneself and at others."
"Unfortunately," he states, "there is a vulnerable population of patients who are at an increased risk of violence and suicide as a result of taking Celexa, Lexapro and other SSRI drugs."
According to Attorney Pogust, the SSRI manufacturers have known about this population of high-risk patients for many years. "And, yet," he says, "these companies have failed to conduct any tests to determine the frequency of this phenomenon or to develop ways of identifying and protecting those patients who are in the high risk group."
As far back as November 1991, Dr John Mann, who now regularly serves as an expert witness for SSRI makers, coauthored an article titled, "The emergence of suicidal ideation and behavior during antidepressant pharmacotherapy," in the Archives of General Psychiatry in which he discussed the phenomenon of "iatrogenic suicide," also known as physician-induced suicide, and warned that there may be a "small vulnerable subpopulation" of patients for whom SSRIs pose a risk of suicide or violence.
In the paper, Dr Mann took it a step further and suggested protocols for studies that could be used to test this hypothesis and the drug companies deliberately did not conduct the research because they knew it would confirm Dr Mann's findings and a warning of such serious adverse events on the labels of SSRIs would have had a negative impact on sales.
Evelyn:
I noticed today that you have an article that pertains to a situation I am facing and I plan to use the article in handling the situation. I would appreciate any thoughts you may have concerning it or if you would rather not express an opinion, I would totally understand. Almost 2 years ago my Dad's urinary function was blocked by an enlarged prostate. My Dad is 85 years old and they didn't want to do surgery but ultimately they did and he is doing pretty well physically though he is still on Flomax for the condition. Because his weight was very low on admission to North Shore Hospital in Manhasset, New York, his doctor and his second wife, Jan,(who is a nurse there in Hospital Administration) had him put on 10 mg of Lexapro a day which as far as I know, he is still on. I am alarmed at the dangers of this drug particularly heart attack. I am planning to show him him the data on the dangerousness of Lexapro and SSRIs because his second wife said he had an irregular heartbeat and heart problems before being put on Lexapro (which to me is asking for disaster). They installed a Pacemaker in his chest but only after he had been put on the Lexapro. I want to show him the adverse data and see if he will agree to go see another Doctor to get a 2nd opinion on whether he should stay on the Lexapro or not because it is extremely dangerous, and look at if he could be safely gradually weaned off of it under supervision of a competent Doctor. My Dad's second wife, Jan, started screaming at me in a threatening manner when I once mentioned my concerns about my Dad taking Lexapro in the past. She told me not to say anything because he could have a heart attack and die (which is exactly what I think might happen to him if he is kept on the Lexapro). I don't feel I am violating any law about offering medical advice or acting as a doctor in showing my father the adverse data and asking him if he will agree to go for a second opinion regarding staying on the Lexapro. My Dad has told me he has given given his 2nd wife, Jan, legal control over his medical care. I feel if I challenge Jan and my Dad's doctor that they are arrogant enough to do almost anything to punish one who challenges their viewpoint. I worry about being arrested for abusing my Father by asking him to go for a 2nd opinion. Do you know of this ever happening? Any thoughts or suggestions in case that should happen? Again, if you would rather not express an opinion on this I would totally understand. Thanks for your emails and information and for these articles.
by
larrybone (0 articles, 0 quicklinks, 0 diaries, 9 comments)
on Friday, February 23, 2007 at 9:04:05 AM
