http://brodyhooked.blogspot.com/2008/10/more-on-emory-nemeroff-connection.html

Following up on the previous post, in which I asked what would it take to change the culture of academic medicine so that a Nemeroff phenomenon would become impossible, I think it worth drilling down a bit deeper into the past record of Emory med school’s relationship with its chair of psychiatry (who, it is now reported, has temporarily stepped down pending the promised new investigation). My text here is the previously cited NYT article: Gardiner Harris, “Top Psychiatrist Didn’t Report Drug Makers’ Pay,” New York Times, Oct. 4, 2008 (see previous post for link).

Threaded through the account unearthed by Congressional investigators, showing a pattern of underreporting huge payments from drug companies and concealing financial conflicts of interest related to NIH grants, is a record of periodic and ineffectual efforts by Emory to rein in or at least get a grip on Dr. Nemeroff’s behavior. Harris notes that in theory, if Nemeroff is found to have violated NIH reporting rules, Emory stands to lose $190M in NIH funding, assuming that the agency suspended all grants, which it hardly ever does.

Emory conducted an investigation of Nemeroff’s outside consulting arrangements in 2004. A 14-page report mentioned “serious” and “significant” violations of university procedures regarding conflicts of interest. Harris states that Emory then did nothing in response to that report.

In 2006, Nemeroff had to resign as editor of Neuropsychopharmacology, after the journal published a paper with Nemeroff as first author without disclosing the financial relationship between Nemeroff and the maker of the medical device described glowingly in the paper. (Nemeroff claimed that this was due to a clerical error.) This led according to Harris to a “bitter e-mail exchange” between Nemeroff and an associate dean at Emory, Dr. Claudia Adkison, who referred to the published paper as “a piece of paid marketing.”

In both 2004 and 2006, Emory’s final concrete action regarding the charges against Nemeroff was to ask that he sign a letter stating that he did not accept more than $10,000 annually from any drug firm, thereby keeping within the NIH-specified limit. Nemeroff cheerfully kept signing all these letters, despite the fact that he was raking in more than $100,000 annually from several firms. (Indeed, Harris reports that he actually signed one such letter while at the Four Seasons Resort in Jackson Hole, where he earned $3000 of what would eventually amount to $170,000 that year from GlaxoSmithKline.) The Emory policy in short seems to have been “ask but don’t expect him to tell, and since he didn’t tell you, you can claim not to know anything.”

The Emory statement in the wake of these new revelations, in addition to Nemeroff “voluntarily” stepping down as chair, is that the university is “working diligently to determine whether our policies have been observed consistently… Dr. Nemeroff has assured us that ‘To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures.’”

So naturally you might ask: how does it come to be that a chair of a department, who was shown by a university investigation four years ago to be untrustworthy in reporting financial conflicts of interest, is allowed simply to state on his own say-so that he has no conflicts, and the university meekly believes him? The answer may lie in an anonymous comment posted to this blog back in January when I first raised the Nemeroff issue. According to that respondent,who echoed a point of view I have heard from other academic psychiatrists, Nemeroff is pleased to bear the nickname “Boss of Bosses.” He has a reputation for wielding tremendous power in psychiatry, especially taking advantage of his leverage with the big drug firms, and is ruthless in attacking those whom he doesn’t like or who threaten him. One such event is described in some detail in HOOKED, the hiring and then subsequent firing of David Healy as head of a psychiatric research institute at the University of Toronto, due to Healy saying bad things about Prozac, whose manufacturer, Eli Lilly, was at the time considering a major grant to Toronto. Healy cheerfully sued Toronto and won, meaning that all the correspondence related to the firing is now in the public domain. In HOOKED I focused on Toronto’s spineless behavior, but it is also interesting to note that almost certainly, Nemeroff was in the background pulling all the strings that led to Healy’s dismissal.

Nemeroff was not shy about displaying his “Boss” side to his true bosses at Emory. He sent a confidential letter to the dean of the medical school at Emory in May 2000, listing the dozen corporate advisory boards in which he sat. He then ticked off the grants and endowments that those firms had paid to the Department of Psychiatry at Emory, and added, “Part of the rationale for [the companies'] funding our faculty in such a manner would be my service on those boards.” Translation–you mess with my cozy relationships with these companies, and the industry gravy train to Emory dries up. The threat is only slightly veiled, that should Emory decide to take any serious action against Nemeroff for his unreported conflicts of interest, he could easily jump ship to a more permissive med school, taking a lot of his captive research faculty and all of his industry funding with him.

So now we come to the $64 question (or in Nemeroff’s case, the $2.8M question), which is what has to happen to the medical school culture to not allow people like Nemeroff to have it all their own way. The incredibly optimistic answer is that universities and academic medical centers have to grow two pieces of anatomy, of which the one I can say in polite society is a backbone. They need to be willing to stand up to the blackmail and intimidation that a “Boss of Bosses” can throw their way–ideally cutting him off early in his career so that he never accumulates the incredible power that Nemeroff now seems to enjoy.

The more pessimistic answer is, what can you expect now that the post-Bayh-Dole university has declared its allegiance to making money over academic values? On this view, the conflict of interest train left the station a long time ago–some say, all the way back in 1980 when the Bayh-Dole act was passed (see HOOKED). If the university must make its research money from industry to stay afloat, then the unversity’s conflict of interest is much bigger than any individual faculty member’s conflict of interest, even Nemeroff’s. And that assures that the university dare not bite the hand that feeds it, whether the hand is Nemeroff’s or Eli Lilly’s or GlaxoSmithKline’s.

Emory University psychiatrist, Dr. Charles Nemeroff, has been accused of breaking federal research rules by taking in $2.8 million from a drug company and not reporting half of the income.

At the same time, Nemeroff, one of the nation’s most influential psychiatrists, was overseeing a National Institutes of Health study on five anti-depressants produced by the contributor, GlaxoSmithKline (GSK) between 2000 and 2007.

Dr. Nemeroff is the focus of Senator Charles E. Grassley, who has published an open letter to Emory University in the Congressional Record.

Grassley is aggressively advocating transparency in the medical establishment and is promoting the Physician Payment Sunshine Act, which will require drug companies and medical device makers to disclose any payments of value above $500 to physicians.

Dr. Nemeroff is the most prominent figure to date who has been the focus in a series of disclosures concerning apparent conflicts-of-interest between drug companies and the doctors they work with.

Sen. Grassley says that Dr. Nemeroff consistently lied about the amount of money he was making from GSK. For example, in 2003 while Nemeroff claimed he received $15,000, GSK claims to have paid him more than $119,000.

The New York Times reports that while Dr. Nemeroff signed a letter in July 2004, promising Emory he would earn less than $10,000 a year from GSK to comply with federal rules, he was at the Four Season Resort in Jackson Hole, Wyoming earning $3,000, part of the $170,000 he earned that year from GSK.

Emory University says in a statement, Dr. Nemeroff has properly disclosed his financial relationships with pharmaceutical companies. Emory says the contents of the letter are “serious allegations” and is conducting its own internal investigation to see whether the University’s policies against payments are being followed.

Sen. Grassley is conducting a larger conflict-of-interest Congressional inquiry to determine whether the current system for tracking financial relationships is working.  

“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere. The current system for tracking financial relationships isn’t working” said Senator Grassley.  

Dr. Nemeroff has volunteered to step down as chair of his department, effective immediately, pending resolution of the issue. A woman who answered the phone in his office, told IB News he was busy seeing patients.

 In a statement, Nemeroff said: 

“To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.”

In June, Sen. Grassley reported that Dr. Joseph Biederman, a psychiatrist at Harvard Medical School and two of his colleagues at Harvard, failed to report over three million dollars in payments they received from drug makers, while promoting the same drug makers psychiatric drugs for children.

Still, universities are in charge of policing themselves. Dr. Nemeroff was investigated by Emory in 2004 for outside consulting arrangements, but the university reportedly took little action.

The downside for any university is it faces the loss of federal funding by the National Institutes of Health if conflict-of-interest rules are violated. Emory has a portfolio of grants reported to be $190 million in 2005.

But there is some upside for a university to ignore disclosure rules. 

In a letter, now part of a Congressional hearing, Dr. Nemeroff reminded Emory that he sat on a dozen corporate advisory boards, including Smith-Kline Beecham Pharmaceuticals that donated an endowed chair to the university.

Nemeroff also said in the letter that Janssen Pharmaceuticals, AstraZeneca, and Bristol-Myers were likely to make a contribution as a result of his connections, and that Wyeth-Ayerst Pharmaceuticals has funded a career development program at Emory.

Merck and Eli Lilly say they plan to disclose payments online beginning next year.

“Everyone is concerned,” said Dr. James Scully of the Council of Medical Specialty Societies, said to the New York Times. The organization’s 30 members represent more than a half-million doctors.

 

www.injuryboard.com

The psychiatry world is belatedly exhibiting outrage toward a man whose ability to lure pharma cash seems to know no bounds. He may be the textbook case of a key opinion leader. Of course, I speak of Charles “Bling Bling” Nemeroff. Rather than list the many questionable at best behaviors he has exhibited, each of which has called into question his standing as a scientist as opposed to a blatant drug marketer, I just want to a) direct everyone to a detailed list of his speaking engagements from GlaxoSmithKline and b) discuss a month of living the High Life, Nemeroff Style.

As is well known by now (1, 2), Nemeroff appears to have not been particularly forthcoming about the huge amounts he was making while moonlighting for every drug company on the planet (see below) despite requirements that he do so. According to psychiatrist Danny Carlat:

From 2000 to 2006, GSK paid Nemeroff a total of $960,488. Note that this was not research grant money, or money for Emory’s psychiatry department. These were fees that went into his personal bank account, which he earned by either sitting on GSK’s Advisory Board, or speaking to doctors about GSK products. His typical fee for a talk was $3500 plus expenses, but sometimes he made more.

Of this $960,488, the total amount he disclosed to Emory [his employer, to whom he was required to report such income] was $34,998.

According to a GSK document hosted by Senator Charles Grassley, Nemeroff took in over $20 grand in one month from speaking engagements for GSK. Not bad work if you can get it, eh? And this month doesn’t seem unusual for Nemeroff. These are only his speeches for GSK — he also gave speeches for several other companies. The document goes on and on — 39 pages of paid speech listings, nearly all of them featuring Nemeroff. I just picked 03-30-00 to 04-30-00 because they were on the first pages of the document, which covers expenses from 2000 to 2008 for Dr. Bling Bling.

Nemeroff GSK Honoraria from March 30, 2000 to April 30, 2000

Imagine making $20k in a month for basically reading slides a few times that were quite possibly entirely written by a drug company. And many of these talks were accompanied by posh meals, the kind that myself and most of my readers might eat once or twice a year.

Here’s a Nemeroff disclosure from a recent journal article:

Dr Nemeroff has received grants from or performed research for the American Foundation for Suicide Prevention, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Inc, Janssen Pharmaceutica, NARSAD: TheMental Health Research Association, the National Institute of Mental Health, Pfizer Pharmaceuticals, and Wyeth-Ayerst Laboratories; has been a consultant to Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb, Corcept Therapeutics, Cypress Bioscience, Cyberonics, Eli Lilly and Co, Entrepreneur’s Fund, Forest Laboratories, Inc, GlaxoSmithKline, i3 DLN, Janssen Pharmaceutica, Lundbeck, Otsuka America Pharmaceutical, Inc, Pfizer Pharmaceuticals, Quintiles Transnational, UCB Pharma, and Wyeth-Ayerst Laboratories; has been on the speakers bureau for Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer Pharmaceuticals; is a stockholder in Acadia Pharmaceuticals, Corcept Therapeutics, Cypress Bioscience, and NovaDel Pharma Inc; is on the board of directors of the American Foundation for Suicide Prevention, the American Psychiatric Institute for Research and Education, the George West Mental Health Foundation, NovaDel Pharma Inc, and the National Foundation for Mental Health; holds patents on a method and devices for transdermal delivery of lithium (US 6,375,990 B1) and on a method to estimate serotonin and norepinephrine transporter occupancy after drug treatment using patient or animal serum (provisional filing April 2001); and holds equity in Reevax, BMC-JR LLC, and CeNeRx.

No, I didn’t make that up. As Ed Silverman wrote at Pharmalot, “It also raises a question - when did he find time to do anything else?”

It really sends shivers down my spine when SSRI drugs are used to treat any condition that is not severe or life threatening. Paxil should be a last option! A risk you are willing to take when you have tried everything else and the condtion/disease is intolerable.  My definition of intolerable is Paxil withdrawal hell.    PMDD is not life threatening.  Deal with it!! Women have been dealing with it since the beginning of man and if your hubby is stressing over your PMS then tell him to suck it up.  Atleast he can escape you for a few hours.   Menopause is not life threatening.  I know it makes you feel like crap but nothing compared to what Paxil/Seroxat will do to you.  This is a perfect example of where the risk and benefits do not sit right with me.  There is no way that Paxil/Seroxat should be used for Menopause.  Menopause will not kill you.  Paxil just might. 

The following is an article I found tonight. I almost hit the roof when i read it.  What next? 

 Think you’ve heard everything about menopause? Maybe not. Even though women are more receptive to discussing this topic, numerous misconceptions abound while interesting news continues to surface.

Since Oct. 18 is World Menopause Day, this is a great time to unveil little-known and surprising information.

Item 1: Season of birth related to menopause.

Sound far-fetched? Not according to an Italian study of 2,541 naturally menopausal women. It concluded that women born in autumn reported the least severe menopause symptoms, while women born in spring reported the most. In fact, women born in March reached menopause at the earliest age while women born in October entered it at the latest. This was one of the few studies to focus on the menopause-birth season link, so others are needed to confirm it. However, this isn’t a new area of interest. There are several studies about seasonal influences on fetal growth, fertility and life span.

Item 2: Antidepressants can control hot flashes.

Initially the role of antidepressants was examined in women undergoing sudden menopause due to breast cancer treatment. Generally, these women aren’t candidates for hormone therapy, yet struggle with moderate to severe hot flashes and night sweats. Research has shown at least a 40 percent to 60 percent reduction in the frequency and severity of symptoms while on antidepressants. The same results have been reported in hysterectomized women undergoing sudden menopause, as well as women going through natural menopause. The medications studied included Effexor, Paxil, Prozac and Zoloft, but several others work, too. They are usually well tolerated and used at the lowest dose required to alleviate symptoms.

Item 3: Ovaries can be retained during a hysterectomy.

Each year 600,000 women get hysterectomies, mostly for noncancerous reasons. Peri-menopausal women think, and are often told by health-care providers, that because their uterus is removed, they might as well have their ovaries out, too. The reasons cited are prevention of ovarian cancer, a disease that strikes less than 2 percent of low-risk women, and the cameo role ovaries play as we age. Remember, ovarian removal plunges a woman into sudden menopause and increases her risk of osteoporosis and heart disease. Therefore, the decision to remove the ovaries needs to be made on a case-by-case basis. A hysterectomy doesn’t always require removal of healthy ovaries.

World Menopause Day is about increasing awareness of this stage in a woman’s life in an attempt to improve the quality of her life. When it comes to approaching menopause management, women have many options available. Be sure to base your decisions on current factual information.

DEBBIE DeANGELO, R.N.C., B.S.N., is a health educator at the Hamot Health Connection, host of the syndicated “Living Well” series on WFXP-TV and author of “Sudden Menopause.” Her column appears monthly.

http://ahrp.blogspot.com/2007/09/alison-bass-hits-bulls-eye-in-op-ed.html

Alison Bass hits the bull’s eye in an Op Ed column in The Boston Globe (below) by exposing corporate psychiatry’s manipulation of suicide rates as a public relations tool.

Similarly, an Op Ed in The New York Times by Christopher Lane (below), a professor of English at Northwestern, the author of the forthcoming “Shyness: How Normal Behavior Became a Sickness,” skewers psychiatrists who are pathologizing normal children’s behavior in order to medicate them. “It may seem baffling, even bizarre, that ordinary shyness could assume the dimension of a mental disease. But if a youngster is reserved, the odds are high that a psychiatrist will diagnose social anxiety disorder and recommend treatment.”

In an effort to answer the question, “How much credence should we give the diagnosis?” He notes that the revised third edition of the Diagnostic Statistical Manual (1987), psychiatry’s “bible” for diagnosing mental illness, “expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.” See industry’s pervasive influence in what’s included in the DSM. [Link]

As any scientist (or educated layperson) knows, trends in suicide rates, like any epidemiological data, have to be looked at over the long term because a one-year variation in rates could be a statistical artifact, or mean something else entirely.

Industry’s dilemma: the overwhelming validated scientific evidence from controlled trials confirms an INCREASED RISK of suicidal behavior in children and young adults who are prescribed SSRI antidepressants. To counteract the scientific evidence, drug companies hire influential academics to manufacture alarming ‘findings’ to support increased use of these drugs.

Such is the case with a much publicized report published in September 2007, the official journal of the American Psychiatric Association (AJP). The authors claimed a causal link between a one year increased suicide rate and claimed reduced prescription rates. These commercially driven unsupportable claims are an example of junk science. However, major newspapers uncritically reported the unsubstantiated ‘alarming study findings’ that suicides among young people were on the rise because of a precipitous drop in the use of antidepressants. [Link]

Alison Bass asks two questions that reporters suffering from shyness are afraid to ask:

1. “Why are some in the psychiatric community, despite lack of evidence, working to convince the American public that the FDA may have erred in putting the most serious kind of warning possible on the use of [SSRI antidepressants] in young people?”

Answer: The alarmist call by such ‘pillars of the psychiatric community’ as Dr. David Shaffer and Dr. J. John Mann of Columbia University, to rescind Black Box suicide warnings on antidepressant drug labels, may be viewed as protecting their investment in the antidepressant drug business. Both Dr. Shaffer and Dr. Mann–and an army of other academics who, like them, are ‘on the take’–can be counted upon by drug manufacturers to ring the fire alarm despite the lack of evidence of any fire.

In fact, Bass, points out, the authors of the AJP study overlooked the fact that prescription rates did not drop in the year when suicide rates among youth increased, (2003-2004). Since suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention, there is no evidence of a connection between variations in youth suicide rates and antidepressant prescription usage.

2: “Who stands to benefit from the latest alarm about an apparent upturn in youth suicide rates?”

Answer: The sharp drop in the sale of SSRIs since 2004 has put a big dent in their manufacturers’ bottom line. These companies have an enormous stake in reversing the current FDA warnings. That might explain why Pfizer (the maker of Zoloft) contributed $30,000 to cover the cost of collecting data for the American Journal of Psychiatry study, which was also funded by the National Institute of Mental Health.

“It’s also worth noting that the two lead authors of the paper have disclosed financial conflicts of interest: Columbia professor of psychiatry Dr. John Mann has been a paid consultant to at least two SSRI makers, Pfizer and GlaxoSmithKline (the maker of Paxil), and Robert Gibbons has served as an expert witness for Wyeth Pharmaceuticals (the maker of Effexor, another SSRI).”

September 24, 2007

EARLIER THIS MONTH, major newspapers reported the alarming news that suicides among young people were on the rise because of a precipitous drop in the use of antidepressants. This news was based on a study in the September issue of the American Journal of Psychiatry, which concluded that physicians had been scared away from prescribing antidepressants because of the Food and Drug Administration’s decision in October 2004 to put black box warnings on the pediatric use of these drugs. The FDA mandated the warnings after finding an increased risk in suicidal thoughts and behaviors among adolescents taking antidepressants such as Prozac, Zoloft, Paxil, and Celexa.

In the wake of the study, several psychiatrists called for the black box warnings to be retracted. “It’s time for the agency’s warnings to be modified,” opined Dr. David Schaffer, chief of child and adolescent psychiatry at Columbia University Medical Center in New York City.

News sources have since exposed a big hole in the journal’s argument. Several experts quoted in The New York Times and The Boston Globe pointed out that while there was indeed an upturn in suicide rates among youths (an increase of 14 percent, or a total of 252 more deaths among youths under 19 between 2003 and 2004), the number of prescriptions for antidepressants in the same age group remained basically unchanged between 2003 and 2004.

According to data presented in the American Journal of Psychiatry study, prescription rates for minors did not drop sharply until a year later (between 2004 and 2005). Since suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention, there is no evidence of a connection between variations in youth suicide rates and antidepressant prescription usage. Furthermore, experts say that trends in suicide rates, like any epidemiological data, have to be looked at over the long term and a one-year variation in rates could be a statistical artifact, or mean something else entirely.

So what’s going on here? Why are some in the psychiatric community, despite lack of evidence, working to convince the American public that the FDA may have erred in putting the most serious kind of warning possible on the use of these drugs in young people? In May, the FDA, after finding the same increased risk of suicidal behaviors among young adults taking the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), extended the black box warnings to young adults.

There is no doubt that many psychiatrists believe that antidepressants, particularly SSRIs like Prozac, Paxil, Zoloft, and Celexa, are helpful in treating depression in adults and adolescents. They have seen how these drugs have lifted the fog of despair from people with depression.

But there is another factor to consider: Who stands to benefit from the latest alarm about an apparent upturn in youth suicide rates? The sharp drop in the sale of SSRIs since 2004 has put a big dent in their manufacturers’ bottom line. These companies have an enormous stake in reversing the current FDA warnings. That might explain why Pfizer (the maker of Zoloft) contributed $30,000 to cover the cost of collecting data for the American Journal of Psychiatry study, which was also funded by the National Institute of Mental Health. It’s also worth noting that the two lead authors of the paper have disclosed financial conflicts of interest: Columbia professor of psychiatry Dr. John Mann has been a paid consultant to at least two SSRI makers, Pfizer and GlaxoSmithKline (the maker of Paxil), and Robert Gibbons has served as an expert witness for Wyeth Pharmaceuticals (the maker of Effexor, another SSRI).

This isn’t the first time that suicide rates have been trotted out as a public relations weapon. Proponents of psychotropic drugs have long argued that suicide rates among adults and children fell after the SSRIs were introduced in the United States. However, an examination of long-term trends in suicide rates indicate that suicides were declining here and in other countries well before SSRIs such as Prozac, Zoloft, and Paxil were widely prescribed, says Julie Zito, associate professor of pharmacy and psychiatry at the University of Maryland. Zito says there are other plausible reasons for the decline in suicide rates over the last two decades, including a more stable economy, better access to mental healthcare, and gun control.

So until new evidence emerges showing, unequivocally, a rising rate of suicides among our youths and a link between those rates and reduced antidepressant usage, it would be wise to treat the latest salvo with a healthy dose of skepticism.”

FEW children relish the start of a new school year. Most yearn for summer to continue and greet the onset of classes with groans or even dread. But among those who take the longest to adapt and thrive, psychiatrists say, are children trapped in a pathological condition. They are so acutely shy that they are said to suffer “social anxiety disorder” - an affliction of children and adolescents that, the clinicians argue, is spreading.

It may seem baffling, even bizarre, that ordinary shyness could assume the dimension of a mental disease. But if a youngster is reserved, the odds are high that a psychiatrist will diagnose social anxiety disorder and recommend treatment.

How much credence should we give the diagnosis? Shyness is so common among American children that 42 percent exhibit it. And, according to one major study, the trait increases with age. By the time they reach college, up to 51 percent of men and 43 percent of women describe themselves as shy or introverted. Among graduate students, half of men and 48 percent of women do. Psychiatrists say that at least one in eight of these people needs medical attention.

But do they? Many parents recognize that shyness varies greatly by situation, and research suggests it can be a benign condition. Just two weeks ago, a study sponsored by Britain’s Economic and Social Research Council reported that levels of the stress hormone cortisol are consistently lower in shy children than in their more extroverted peers. The discovery upends the common wisdom among psychiatrists that shyness causes youngsters extreme stress. Julie Turner-Cobb, the researcher at the University of Bath who led this study, told me the amounts of cortisol suggest that shyness in children “might not be such a bad thing.”

On what, then, do psychiatrists base their sweeping judgments? Most point to The Diagnostic and Statistical Manual of Mental Disorders - the fundamental handbook of psychiatry. Yet a glance at the manual reveals that the diagnostic criteria for shyness are far from clear. The third edition, which was published in 1980, said that a person could receive a diagnosis of what was then called “social phobia” if he was afraid of eating alone in restaurants, avoided public restrooms or was concerned about hand-trembling when writing checks.

The same guidelines could hardly apply to youngsters heading to kindergarten, children not yet potty-trained and toddlers just learning to eat. So in 1987, the revised third edition of the manual expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.

Self-help books and magazine articles further widened the definition of social anxiety disorder to include symptoms like test anxiety, aversion to writing on the blackboard and shunning of team sports. These ridiculously loose criteria led to more diagnoses, until social anxiety disorder in children began to look as if it were spreading like the common cold among second graders.

Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline, the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (”Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone ($3 million more than Pfizer spent that year promoting Viagra), social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent - higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.

This diagnosis was frequently irresponsible, and it also had human costs. After being prescribed Paxil or Zoloft for their shyness and public-speaking anxiety, a disturbingly large number of children, studies found, began to contemplate suicide and to suffer a host of other chronic side effects. This class of antidepressants, known as S.S.R.I.’s, had never been tested on children. Belatedly, the Food and Drug Administration agreed to require a “black box” warning on the drug label, cautioning doctors and parents that the drugs may be linked to suicide risk in young people.

You might think the specter of children on suicide watch from taking remedies for shyness would end any impulse to overprescribe them. Yet the tendency to use potent drugs to treat run-of-the-mill behaviors persists, and several psychiatrists have already started to challenge the F.D.A. warning on the dubious argument that fewer prescriptions are the reason we’re seeing a spike in suicides among teenagers.

The recent book “Nurturing the Shy Child: Practical Help for Raising Confident and Socially Skilled Kids and Teens,” insists, “Don’t be afraid to try medication.” “When an S.S.R.I. is properly prescribed and monitored, medication can be very helpful,” say the authors, two psychologists. This book says it is a sign of social anxiety disorder if a child complains about or tries to avoid asking the teacher a question or getting up from his or her desk to sharpen a pencil.

Clearly, there is a need to reconsider the diagnostic standards. A team of mental health experts has recently gathered to oversee a new edition of The Diagnostic and Statistical Manual, and this time they should make sure to carefully distinguish normal - even healthy - shyness from social anxiety disorder. They should also remove shyness from the lists of symptoms of avoidant personality disorder and schizoid personality disorder. With so much else to worry about, psychiatry would be wise to give up its fixation on a childhood trait as ordinary as shyness.

Federal Preemption Part III – Who are the players for you and for big business?

www.INJURYBOARD.COM

http://desmoines.injuryboard.com/defective-and-dangerous-products/federal-preemption-part-iii-who-are-the-players-for-you-and-for-big-business.aspx?googleid=248678

 

Consumer Advocate Groups concerning Federal Preemption –

Americans For Drug & Device Accountability - AMERICANS FOR DRUG AND DEVICE ACCOUNTABILITY is a bi-partisan coalition of health-care professionals, patient advocates, business people, and concerned citizens. Our goal is simple: To spread the word about a vitally important issue. We hope some of you will join us in that effort.

 

We have come together to urge Congress to guarantee the right to a day in court if a person is harmed or killed by an FDA-approved product. Specifically, we stand against the policy of FDA preemption.

 

The ADDA provides a sample letter for you to send to your Congress person about individual rights versus corporate profits and which is more important.

Drug Injury Watch- Prescription druge side effects news and information by Tom Lamb. Also provides a list of lawsuits filed concerning prescription drugs.

American Association for Justice- Today, AAJ is a broad-based, international coalition of attorneys, law professors, paralegals, and law students. As the world’s largest trial bar, AAJ promotes justice and fairness for injured persons, safeguards victims’ rights–particularly the right to trial by jury–and strengthens the civil justice system through education and disclosure of information critical to public health and safety. With more than 56,000 members worldwide, and a network of U.S. and Canadian affiliates involved in diverse areas of trial advocacy, AAJ provides lawyers with the information and professional assistance needed to serve clients successfully and protect the democratic values inherent in the civil justice system.

Paxil Harms Children– “This web site was developed with the intention of bringing awareness to ordinary Canadians, and the general public worldwide, the dangers of the prescription drug Paxil ( paroxetine HCL ), as it is marketed and known in Canada, and as Seroxat in the United Kingdom (UK), by the GlaxoSmithKline company (GSK). This site is especially dedicated, in bringing attention to the deaths and damage that Paxil has caused, and continues to cause children, adolescents and young adults.”

 

The Paxil Protest Website

This site had disappeared off the internet. It has magically appeared again and is full of information regarding medications, articles, excellent links. For anyone wishing to understand how one feels coming off of paxil, the ‘Prisoner Of Paxil” journal lays it out.

 

Big Pharma Victim

This website was put together to inform mothers of the possibilities of damage caused to a child in the womb. Her son was born with a congenital heart defect due to taking paxil in the first three months of pregnancy.

 

Her son Manie had open heart surgery when he was 8 days old, that lasted 13 long hours. Today Manie continue’s to struggle with medical problems, and surgery, because the dangers of taking paxil were not made available to parents.

 

SSRI Stories

This website is a collection of 2100+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned.

 

Pharmalot

Pharmalot is a blog run by Ed Silverman. Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey for the past 12 years. He closely follows a variety of topics of concern to those who work for, and with, pharmaceutical manufacturers. Topics touched are drug development; mergers and acquisitions; regulatory oversight; safety and pricing controversies, and marketing issues.

 

Psychiatric Drug Facts

This website exposes how psychiatric drugs really work, adverse drug effects on the brain and mind, the role of the FDA, and drug company practices.

 

An Interview with Paxil Lawyer Karen Barth Menzies

Karen Barth Menzies is a partner of the Los Angeles based law firm of Baum, Hedlund, Aristei, Goldman & Menzies and heads the firm’s Pharmaceutical Antidepressant Litigation Department. April 2007

Los Angeles, CA: Karen Barth Menzies is a partner of the Los Angeles based law firm of Baum, Hedlund, Aristei, Goldman & Menzies and heads the firm’s Pharmaceutical Antidepressant Litigation Department. An activist and consumer advocate, she has been involved with SSRI-induced suicide/violence litigation involving Prozac, Paxil and Zoloft for 15 years and she is now a leading legal authority on Paxil and birth defects. The first birth defects cases were filed in the spring of 2006.

Ms. Menzies, along with other drug product liability lawyers at Baum Hedlund, has seen first-hand the harm caused by defective drugs and the lives destroyed. She has testified four times before the government regarding the increased risk of child suicide with antidepressants, as well as adolescents and adults. “Put me out of business for the right reasons — warn [the public] about these drugs,” said Ms. Menzies during her February 2004 testimony before the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee. Ms. Menzies had no idea she would be this busy; as a consequence, she has gotten to know the drug companies very well indeed.

Why have you specialized in SSRI litigation?
KBM: I didn’t mean to spend so much time and energy on the SSRIs–five years ago I thought that by now the drug companies would have been more forthcoming and forced to warn the public about the risks associated with their drugs; the FDA would have done its job; and that patients and parents would be informed about the real risks related to SSRIs.

It seems that every time I turn around, there is another side effect caused by SSRIs; people have not been warned about all of the dangerous and often lethal side effects of these anti-depressants, and most distressing is that they are harming kids, including babies. Only now, after the drugs have been on the market for over 15 years, is the public learning about the risk of birth defects. That is just unacceptable.

Who are possible clients/plaintiffs and how do they find you?
KBM: Unfortunately we have to turn away some potential clients. We can’t help some people the way we want simply because there are so many people who have been harmed. For example, we can’t help children who were on multiple drugs. We try our best to disseminate the information we have and try to raise public awareness: there is a huge portion of the population that has no idea of the risks involved with SSRIs. The drug companies have not been forthcoming to the public or the health care providers about all of the risks of their drugs.

Why not?
KBM: They are protecting their market share. They are generating profits and treating the medical profession like a money-making venture, at all costs so you have both patients and physicians desperately seeking information. They find our law firm on the Internet and they want to hear both sides of the story. Remarkably, I have been contacted by numerous doctors, trying to find out accurate information about the side effects of these drugs. I never thought a doctor would contact a plaintiff lawyer, asking advice regarding his patient! They are clearly not getting information they need from the drug companies.

Where is litigation now?
KBM: Each of the different side effects is in different stages. Litigation is winding down on withdrawal claims for Paxil: GlaxoSmithKline (GSK) began warning the public about withdrawal symptoms in Dec 2001; therefore the many statutes on those cases have mainly expired, except for certain states.

As for suicides, the black box warning was issued in January 2005 and we are beginning to see, for the majority of cases, the two-year statute expiring, even though there is still new litigation. But from here on out, attorneys will have to consider including a medical malpractice claim against the physician, along with the failure to adequately warn from the drug maker.

Birth defects cases are in the early stages. The litigation itself has been going on for about a year. We have many cases on file and the numbers are growing.

Where is it heading?
KBM: Discovery will probably take a year or so. We need to establish what GSK knew and when. So far, the biggest problem is having them turn over documents in a timely fashion; they have many delay tactics.

Why can’t the court order them to turn over documents?
KBM: We often do seek the court’s help. We had to go to court again this week to help put pressure on the drug company to stop the delay. Their lawyers try to stall for as long as they can.

What is the point if they have to give you the documents eventually?
KBM: Perhaps GSK just wants to wear plaintiffs’ attorneys down. Maybe they are hoping the plaintiff lawyers won’t spend the time and money necessary to dig. But we’ve already dug trenches for the long haul - we have dug deep for many years now. They know we aren’t going away.

We intend to expose what GSK knew and when it knew. And we will use whatever means we can, by the court and otherwise, to have them turn over the documents and witnesses.

How do you work with other lawyers?
KBM: The number of lawyers taking on birth defect cases is also growing. We try to coordinate our efforts and it helps when you are taking on such a huge company such as GSK — to take on Goliath, the more help you have in a cohesive manner makes it more likely that we will succeed. If there are more plaintiff lawyers it makes for a more even playing field, there are more David’s to help in the fight.

What can a SSRI victim do to get involved with litigation?
KBM: Do research and find an attorney who is actually litigating the case against GSK. Ask the people you are contacting the following:
Who is going to be my lawyer?
Are you litigating against GSK?
Have you actively filed any cases or are you sending them to other firms?

We don’t accept every case. We carefully consider the facts of each case to see if it is viable for litigation purposes. The drug may have caused the problem but there are many variables that can preclude the claim. Medically it could be legitimate, but maybe not for litigation. However, we will let a caller know that there are other firms out there accepting cases.

What are you up against?
KBM: It is not so much from a litigation standpoint, but a public health and safety standpoint — my biggest concern right now is that physician “opinion leaders” with industry ties are actively trying to convince doctors and patients that a pregnant woman is at greater risk of depression during her pregnancy and should take antidepressants despite the risk to her unborn child. It’s unconscionable and disgusting to me. Women of childbearing years are big business for antidepressant manufacturers and women who are pregnant may be especially vulnerable given the emotional ups and downs that can be caused by shifting hormones. Thus, they are an enticing market. Look at any woman’s magazine and you can see this is an important market for them. There appears to be a carefully orchestrated and concerted effort to counteract the concerns that have been raised by the studies showing a real risk. Drug industry apologists are trying to deflect attention off of the potentially catastrophic risks of cardiac birth defects and trying to shift attention to “the dangers of untreated depression.” But there are alternatives and given the risk, most women would never risk their unborn babies’ lives.

In 2004 Ms. Menzies was named Lawyer of the Year by Lawyer’s Weekly, California Lawyer of the Year by California Lawyer magazine and in 2005, one of The National Law Journal’s Top 40 Under 40 for her “extraordinary achievements” and “impressive track record” for “stepping up her fight in the past few years, advocating that pharmaceutical companies should warn about the alleged risks of antidepressant drugs.” In 2006 she was a Finalist for the 2006 Consumer Attorney of the Year Award re: Paxil Products Liability Litigation “In Recognition and Appreciation of How Consumer Attorneys Use Skill and Determination to Create a More Just Society for California Consumers.”

Baum Hedlund has been representing victims of harmful drugs since the late 1980s. The firm started taking on SSRI-antidepressant cases 17 years ago and has been handling these types of cases continually ever since, longer than any other law firm in the country. The firm represented the widow of 1960’s rock star Del Shannon and the family of comedian Phil Hartman in their antidepressant related death cases. Against great odds, attorneys at Baum Hedlund have prevailed in representing thousands of people harmed by antidepressants. Baum Hedlund lawyers fight vigorously for the rights of their clients.

 

Paxil Five-Year Litigation History - By Evelyn Pringle

 

Evelyn Pringle: Paxil Five-Year Litigation History Monday, 16 October 2006, 12:29 pm Opinion: Evelyn Pringle

 

Paxil Five-Year Litigation History

By Evelyn PringleIt would be difficult to find a better career than employment as a GlaxoSmithKline attorney, especially if job security is a top priority. Not a year goes by when the company is not doling out millions of dollars to defend against charges involving corporate misconduct of one kind or another.

A limited review of the company’s involvement in the legal system over just the last five years reveals a clear pattern of habitual corruption. However, although Glaxo has paid billions of dollars in accumulated fines, penalties and awards to plaintiffs in civil cases, not one company official has been arrested and charged with a crime.

Glaxo’s latest escapade was revealed on October 5, 2006, when Bloomberg News reported that Glaxo conducted a recall of Paxil CR, a selective serotonin reuptake inhibitor antidepressant, last month because some of the pills may lack an active ingredient, but that the company did not warn patients who may be taking the useless pills.

Doctors told Bloomberg that patients who either abruptly stop taking Paxil or get inactive pills, can face the risk of suicidal thoughts, shooting pains and flu like symptoms.

The Paxil CR pills are the highest dose sold, and can cause severe withdrawal symptoms, according to Dr Stephen Ellen, a psychiatrist from the University of Massachusetts Medical School in Worcester. “If it is true that patients might have gotten dummy pills without knowing it, it is outrageous,” he said.

According to Glaxo, the FDA knew about the problem and approved the limited recall plan, but FDA spokeswoman, Susan Cruzan, told Bloomberg that she did not know the details of the September Paxil CR recall.

This incident is even more outrageous because back on March 4, 2005, the government cited Glaxo for the exact same wrongdoing when the FDA and the Department of Justice initiated the seizure of Paxil CR tablets after Glaxo failed to meet the standards laid out by the FDA to ensure product safety, strength, quality and purity.

Among the violations noted then by the FDA, was the finding that the tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect.

The seizures followed warrants issued by the U.S. District Courts for the District of Puerto Rico and the Eastern District of Tennessee and were executed by the U.S. Marshals Service at Glaxo’s Cidra, Puerto Rico manufacturing facility, its Knoxville, Tennessee distribution facility, and a Puerto Rico distribution center.

The FDA said that Glaxo had voluntarily recalled some of the affected lots of Paxil CR but had failed to recall all of the affected lots and that failure resulted in the seizures by federal authorities.

“FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing,” said John Taylor, FDA Associate Commissioner for Regulatory Affairs in a statement released by the agency at the time.

“Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner,” Mr Taylor stated.

“American consumers,” he said, “deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products.”

A month and a half later, on April 28, 2005, the FDA announced that Glaxo had signed a consent decree to correct the manufacturing deficiencies at its Cidra, Puerto Rico facility.

However, the consent decree required Glaxo to post a penal bond of $650,000,000 contingent upon either successfully reconditioning the drugs seized in March 2005, or destroying them and paying the costs to the government.

To resolve the matter, Glaxo supposedly recalled all of the lots of Paxil CR made before November 2004, and agreed to an independent quality review of the manufacturing.

But now here we are in October 2005, with Glaxo still putting patients at risk due to the exact same wrongdoing.

When it comes to civil lawsuits against Glaxo, a steady stream of cases have been filed as a result of Glaxo’s concealment of the known dangers associated with Paxil, including an increased risk of suicide, birth defects, violence and withdrawal syndrome.

But the company’s most egregious conduct, many critics say, in light of all the serious adverse effects now linked to Paxil, was the concealment of the fact that with many patients, and especially children and adolescents, Paxil does not even work.

Glaxo has clearly put profits over patients when marketing Paxil. While concealing clinical trials that showed Paxil was ineffective and could cause children to commit suicide, according to New York state Attorney General, Elliott Spitzer, Glaxo raked in $55 million by selling Paxil to adolescents and children in 2002 alone, when more than two million prescriptions were written for pediatric patients.

The Los Angeles based Baum Hedlund law firm is handling lawsuits involving Paxil related child suicides. On March 23, 2006, the firm filed a national class action lawsuit against Glaxo on behalf of the mother of Trevor Blain, an 11-year old Kansas boy who committed suicide after being prescribed Paxil, and Tonya Brooks from Texas who attempted suicide while taking Paxil.

Trevor Blain was prescribed Paxil for “separation anxiety disorder” in October 2000 and he immediately began having angry outbursts and sleeping problems. However being the side effects of Paxil were not discussed with his parents, they did not realize that the troubling behavior could be linked to the drug.

Trevor continued to take Paxil until early November 2000, when he hanged himself in the family laundry room using his dog’s leash. After the suicide attempt, Trevor remained in a coma until he died on December 7, 2000.

Plaintiff Tonya Brooks, age 17, was prescribed Paxil in 2004 after being diagnosed with social anxiety disorder. She too became agitated, aggressive and had sleep problems but was unaware that she might be experiencing the adverse effects from Paxil.

Tonya first attempted suicide by taking an overdose of Paxil and Ambien, a sleeping medication, and when that attempt was unsuccessful, she took a pair of scissors and gouged a hole in her leg two days later and was hospitalized for several days.

The two named plaintiffs in the case seek to represent all individuals under the age of 18 in the US who attempted suicide while taking Paxil, or the families of individuals who killed themselves while taking the drug.

The lawsuit’s claims against Glaxo include fraud, negligence, strict liability and breach of warranty.

The Baum Hedlund firm has been handling SSRI lawsuits since 1990, and served on the Plaintiffs’ Steering Committee in the first suicide related case involving Prozac, the first SSRI approved by the FDA.

Baum Hedlund partner, Karen Barth Menzies leads the firm’s SSRI Department and was Lead Counsel for the Plaintiffs’ Steering Committee in Paxil Products Liability Litigation.

Ms Menzies’ advocacy efforts on behalf of SSRI suicide victims have not been limited to the legal arena. She has also testified on the matter before the California State Assembly and the FDA’s psychopharmacologic Drugs Advisory Committee and has met with members of Congress from both the House of Representatives and the Senate regarding the risk of SSRI induced suicidality.

The firm is also now handling Paxil birth defect litigation. On July 28, 2006, Baum Hedlund filed a lawsuit on behalf of the parents of Adrian Vasquez, who was born with life-threatening birth defects on April 19, 2004, as a result of his mother unwittingly taking Paxil during pregnancy.

Adrian was born with congenital heart defects and since eight days old, he has undergone three open heart surgeries in an attempt to repair the heart defects. He will also likely have to undergo more surgeries in the future and possibly a heart transplant at some point.

The lawsuit alleges that Glaxo, “by directly and indirectly advertising, marketing, and promoting Paxil for the treatment of women during pregnancy and by placing this drug in the stream of commerce knowing that Paxil would be prescribed to pregnant women in reliance upon the representations … that Paxil was safe and effective for the treatment of women during pregnancy and without significant risk to the fetus.”

The complaint also alleges that Glaxo “did not timely warn the medical community and consumers generally that taking Paxil during pregnancy is associated with a significant increased risk of birth defects and abnormal development of the unborn child.”

In reviewing Glaxo’s entanglements in the legal system over the last five years, the first guilty verdict in a Paxil-related suicide case was issued on July 7, 2001, when a jury in Cheyenne, Wyoming, ordered SmithKline Beecham (now GlaxoSmithKline) to pay $6.4 million to the relatives of Donald Schell, who after taking Paxil for only 2 days, shot and killed his wife, daughter, and granddaughter before killing himself.

At trial, the jury heard the expert testimony of British psychiatrist and SSRI researcher, Dr. David Healy, who told the panel that all SSRIs could trigger suicidal and violent behavior in some patients. On the stand, Dr Healy described his own studies that showed that SSRIs could even cause one in four “healthy volunteers” to become agitated, and in some cases suicidal.

“Healthy volunteers” means the subjects were not mentally ill to begin with.

Dr. Healy further revealed internal SmithKline documents from clinical trials conducted by the company to support his findings. He presented a summary of a study involving more than 2,000 healthy volunteers, taking either a placebo or Paxil, that found that hundreds of healthy volunteers on Paxil had experienced adverse reactions, ranging from insomnia or anxiety to attempted suicide, that doctors in the study coded as “possibly,” “probably” or “definitely” caused by Paxil.

Glaxo’s defense team told the jury that taking 2 Paxil pills could not have caused Mr. Schell’s violent and suicidal behaviors. However, the summary of the company’s own study showed that some healthy volunteers experienced anxiety, nightmares, hallucinations and other side effects coded as “definitely” caused by Paxil within two days.

In as early as four days, another volunteer experienced akathisia, a severe form of agitation that experts believe increases the risk of violence and suicide, and 2 other volunteers attempted suicide after taking Paxil for 11 and 18 days.

In the end, after considering all the evidence, the jury placed 80% of the blame for the tragedy on Glaxo.

Glaxo is notorious for concealing negative information from Paxil and legal experts say civil litigation has played a major role in exposing the dangers kept hidden for so long. According to Attorney Menzies, “Civil lawsuits uncover internal company documents to which not even the FDA has access.”

“Through our Paxil litigation,” she notes, “we’ve obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.”

“That’s about as reprehensible as you can get,” Ms Menzies says.

There is certainly enough available evidence to back up that assertion. For instance, on July 15, 2003, after meeting with the Canadian regulatory agency, Health Canada, Glaxo issued a public advisory in Canada alerting pediatric patients, their parents or guardians, and healthcare professionals that until further information was available that Paxil should not be given to pediatric patients, due to concerns of a possible increased risk of suicidal thinking, suicidal attempts or self-harm.

The advisory also said, “Paxil must not be used in pediatric patients with major depressive disorder due to the additional fact that studies have failed to show that Paxil was effective in this patient population.”

In addition, Glaxo distributed letters to physicians in Canada and the UK, informing them that studies had failed to demonstrate the efficacy of Paxil in the pediatric population and that there was a doubling of the rate of adverse events, including emotional lability. However, Glaxo did not provide American physicians with this information.

Instead, it sent Medical Information Letters only to those physicians who specifically requested information concerning Paxil as a treatment for children and adolescents.

Glaxo also took steps to actively conceal the negative information about Paxil from the American public. In a June 10, 2003 press release in UK, Glaxo disclosed the suicidal thinking or attempts in children, and particularly in adolescents. But the company’s American press release on June 19, 2003, stated that “there is no evidence that Paxil is associated with an increased risk of suicidal thinking or acts in adults” and that “not a single person committed suicide.”

The American press release also provided no safety or efficacy information about Paxil regarding its use in the treatment of pediatric patients.

The five-year litigation history of Glaxo involves many different types of cases. For instance, in April 2003, Glaxo paid $88 million and signed one in a slew of corporate “integrity agreements,” to settle charges that the company overcharged the Medicaid programs for Paxil and the nasal-allergy spray, Flonase, using a complex scheme that involved the re-labeling of products sold to an HMO at deeply discounted prices, to avoid the obligation to pay millions of dollars in rebates to the Medicaid program.

The Medicaid Rebate program requires Glaxo to give Medicaid the same discounts it gives to commercial customers like HMOs, hospitals and drug store chains. Drug companies have to report their lowest discount price for each Medicaid covered drug on a quarterly basis, and then pay a rebate based on that price.

To resolve another shady deal, in a February 6, 2004 press release, Glaxo announced that it had agreed to pay $175 million to settle an antitrust class action lawsuit involving the anti-inflammatory drug Relafen filed on behalf of direct purchasers, including pharmaceutical wholesalers.

This lawsuit alleged that Glaxo used “sham” patent litigation to block generic versions of Relafen from reaching the market. Glaxo filed the patent infringement lawsuits against two generic drug makers in 1997, which triggered an automatic 30-month stay of the FDA’s authority to grant approval of the generic drug applications.

However, Glaxo lost the patent litigation when U.S. District Judge ruled after a trial that Glaxo had obtained the Relafen patent through fraudulent misrepresentations to the U.S. Patent and Trademark Office.

The two generic companies, Teva Pharmaceuticals USA and Eon Labs Manufacturing Inc., later filed antitrust suits alleging that Glaxo’s patent lawsuits were “sham” litigation filed for the purpose of maintaining a monopoly.

In regard to these lawsuits, Glaxo’s Februay 6, 2004 press release said, “Similar actions from other plaintiffs in the Relafen antitrust matter, including claims made by Teva, chain drug stores and Eon Labs have also been settled, resulting in further payments from GSK.”

And of course the press release contained the standard claim that Glaxo “continues to believe that its actions were appropriate in obtaining and enforcing its patent for Relafen.”

Five months after the announcement of the settlement in the patent case, on June 2, 2004, New York State Attorney General, Eliot Spitzer, issued a press release to report the filing of a lawsuit against Glaxo for concealing information about the safety and efficacy of Paxil in treating children and adolescents.

The complaint alleged that, starting in 1998, Glaxo engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning the drug’s safety and efficacy when prescribed for depression in children and adolescents and pointed out that Paxil “has not been approved for any condition or illness in children or adolescents.”

Specifically, it said, Glaxo conducted at least five studies on the use of Paxil in children and only published and disseminated one, which showed mixed results on efficacy.

According to the lawsuit’s complaint, because its studies failed to demonstrate efficacy and suggested a possible increased risk of suicidal thinking and acts for these youth:

 

“GSK sought to limit physicians’ access to only the most favorable aspects of the data from these studies. To accomplish this, GSK embarked on a campaign both to suppress and, conceal negative information concerning the drug and to misrepresent the data it did reveal concerning the drug’s efficacy and safety.”

The complaint also alleges that Glaxo failed to disclose this information in “Medical Information Letters” that the company sent to physicians.

“By concealing critically important scientific studies on Paxil,” Mr Spitzer said in the press release, “GSK impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.”

Mr Spitzer noted that an internal Glaxo document from 1998 showed that Glaxo intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”

The lawsuit also alleges that Glaxo misrepresented the results of its research to sales representatives who promoted Paxil to doctors and portrayed the drug as having “remarkable efficacy and safety in the treatment of adolescent depression.”

According to the lawsuit, Glaxo’s studies did not demonstrate efficacy and in fact in one study, the children in the placebo group actually out performed the children in the Paxil group.

This impression was reinforced, the lawsuit said, by the mischaracterization of much of the information that Glaxo did disclose, and its Paxil-related targeting of psychiatrists who treated only pediatric patients.

In a statement responding to the allegations in the lawsuit, Barry Perlman, M.D., President of the New York State Psychiatric Association, said:

 

“The relationship between a doctor and a patient must be based on a sense of trust. In order to hold true to that principle, physicians must have access to all relevant medical information regarding treatment. Any obstacle placed in the way of full and complete communication with our patients undermines the trust upon which the doctor-patient relationship is based and prevents us from providing the best care we can to our patients.”

Other members of the medical profession expressed similar views. Arthur Levin, Executive Director, for the Center for Medical Consumers, stated: “The ability of drug companies to pick and choose the research they provide doctors in support of their product is an outrageous conflict of interest and puts us all in harm’s way.”

Less than 3 months after the filing of the lawsuit, in an August 26, 2004, press release, Attorney General Spitzer reported that Glaxo would pay $2.5 million in disgorgement and costs to the State of New York as part of the agreement to resolve the charges that Glaxo concealed information about the safety and effectiveness of Paxil.

In addition, the press release said, Glaxo will establish an online “Clinical Trials Register” that will contain summaries of results for all GSK-sponsored clinical studies of drugs conducted after December 27, 2000 and any earlier studies that may be relevant.

“Each clinical study summary posted,” Mr Spitzer advised, “will contain over 20 categories of information including information regarding the effectiveness of the drug tested, the type and severity of adverse side effects the study participants experienced, whether the goals or other components of the study were changed mid-stream, and whether the study was terminated early before full completion and why.”

“This settlement holds GSK to a new standard of disclosure about studies concerning its drugs,” Mr Spitzer said, “a standard that helps to ensure that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients.”

As part of the settlement, Glaxo also agreed to ensure that all Medical Information Letters provided to doctors concerning off-label use of Paxil and other drugs “will fairly and accurately reflect the safety and efficacy data from clinical studies concerning off-label use.”

Shortly after the settlement was announced, Mr Spitzer said that he would continue to watch Glaxo despite the settlement, because the company and its CEO, J.P. Garnier, appeared “unrepentant” with regard to changing behavior related to the disclosure of adverse clinical trials.

He referred to the “arrogance” of the Glaxo official as “offensive and problematic” and said, “We are going to be watching them with a hawk’s eye to see that they have abided by the terms of the settlement.”

In addition to Paxil suicide related litigation, for the past few years, Baum Hedlund has also been engaged consumer fraud litigation against Glaxo. The firm filed a class action similar to that of Mr. Sptizer’s, likewise alleging that Glaxo suppressed evidence of Paxil’s failed efficacy and increased risk of suicidality in children and adolescents, on behalf of residents of California, Florida, Massachusetts, Nevada, New Jersey, Pennsylvania, Texas and Washington under the title, Smith v. GSK, Case No. 04CC00590, Superior Court of the State of California, County of Orange. According to Baum Hedlund, these particular states were selected because they have similar consumer protection laws.

The firm filed another similar class action in Minnesota on behalf of residents of Minnesota, Illinois, Missouri, North Dakota and Ohio, titled, Engh v. GSK, Court File No. PI 04-012879, State of Minnesota, County of Hennepin, District Court, Fourth Judicial District.

Although discovery is on-going in these cases, hundreds of thousands of documents have been amassed and reviewed, with key documents selected, organized and categorized to prove up the various causes of action in these cases. Depositions of key Glaxo employees have been taken and are continuing, as well as depositions from academic “thought leaders” hired by Glaxo to tout the benefits and safety of Paxil.

A little more than a month after Mr Spitzer charged the company with fraud in New York, on July 8 2004, Glaxo announced an agreement to settle anti-trust litigation involving the antibiotic drug, Augmentin, by paying $92 million to settle a class action brought on behalf of direct purchasers, including pharmaceutical wholesalers, and indirect purchasers such as consumers and third party payers.

The press release said the settlements were being submitted for review to the U.S. District Court for the Eastern District of Virginia, where the cases have been pending since 2002.

In an all too familiar refrain, Glaxo once again said that it continued to believe that its actions were appropriate in obtaining and enforcing its patents for Augmentin.

That said, on November 18, 2004, in a press release, the self-proclaimed not-guilty Glaxo said it had agreed to pay $29 million to settle a class action lawsuit brought by the New York State United Teachers Union and other plaintiffs on behalf of consumers forced to pay more for Augmentin.

NYSUT joined the class action in 2002 and other major plaintiffs included the Welfare Fund of the United Federation of Teachers, NYSUT’s affiliate in New York City schools.

The suit alleged that Glaxo illegally maintained a monopoly over Augmentin, and without a generic equivalent, consumers were forced to pay more for the drug, according to a press release issued by the Teacher’s Union.

“This should send a loud and clear message to the prescription drug industry,” said the union’s President Tom Hobart in hailing the settlement.

On November 18, 2004 Paxil was back in the spotlight when a press release announced a notification program ordered by the US District Court for the Eastern District of Pennsylvania, to alert consumers, insurers, and employee welfare benefit plans who paid for Paxil, or its generic equivalent, paroxetine, to a proposed $65 million settlement of the case against Glaxo.

This lawsuit claims that Glaxo broke antitrust and consumer protection laws by keeping lower cost generic versions of Paxil off the market and included a class of people who paid for Paxil or a generic paroxetine, from January 1, 1998 through September 30, 2004 and included consumers who paid any portion of the cost of Paxil or a generic paroxetine, as well as insurers and Employee Welfare Benefit Plans that paid on behalf of patients and insureds.

In a similar case, on December 1, 2004, the drug Relafen was back in the news again when Glaxo announced in a press release that the company would pay $75 million to settle a lawsuit with a class of consumers and third-part payors who purchased Relafen.

The Prescription Access Litigation (PAL) project had previously announced on May 24, 2004, that its attorneys had settled a suit against Glaxo alleging that it used illegal tactics to maintain its patent on Relafen, and to keep a generic, cheaper version off the market.

“This settlement agreement is a significant victory for consumers who struggle each day with the enormous cost of prescription drugs,” PAL Project Director Alex Sugerman-Brozan said.

“Cases such as this,” he stated, “put the drug industry on notice that consumers are fed up with the manipulation of drug prices: When drug companies use the courts to illegally extend their patents and keep drug prices artificially high, consumers will not hesitate to turn the tables and fight back through the courts.”

The plaintiffs in this case also alleged that Glaxo fraudulently obtained a patent to cover Relafen when internal company documents showed that Glaxo knew that a patent should not be issued.

The settlement involved many Federal cases that had been consolidated in a US District Court in Massachusetts, that claimed that the monopoly had resulted in consumers and payors paying exorbitant prices for Relafen.

“Once approved by the court,” PAL said in a statement, “the settlement will result in the creation of a $25 million consumer pool through which individuals may seek reimbursement for Relafen overcharges, and a $50 million pool for third party payors.”

The court issued its final order approving the settlement on October 13, 2005.

In a completely different type of litigation, on January 21, 2005, the New York Daily Record reported that 1,300 Glaxo workers who were improperly classified as temporary employees were awarded a $5.2 million settlement.

With such classifications, the Record said, workers were not able to take advantage of the drug maker’s employee benefit plans.

Six months later, in a September 20, 2005 press release, the US Department of Justice announced a $150 million settlement with Glaxo to resolve charges that the company engaged in a scheme “to set and maintain fraudulent and inflated prices” for two drugs, knowing that federal healthcare programs established reimbursement rates based on those prices.

According to the DOJ, the difference between the reimbursement rate and the actual price paid by healthcare providers is commonly known as the “spread,” and the larger the spread the larger the profit or return on investment.

The drugs involved are typically administered in doctors’ offices or hospitals to counter nausea brought on by chemotherapy and radiation. The DOJ said that Glaxo purposely overcharged government programs and then charged health care providers less than the reimbursement rate, to make it more profitable for those providers to sell Glaxo drugs.

The government also alleged that Glaxo engaged in a “double dipping” billing scheme by encouraging health care providers to pool leftover vials of one drug to create an extra dose, which then would be administered to a patient and rebilled to health care programs.

“Because reimbursement from federal programs was based on the fraudulent, inflated prices,” the DOJ charged, “GlaxoSmithKline caused false and fraudulent claims to be submitted to federal healthcare programs.”

The investigation in this case was massive and involved the Civil Division of the DOJ, the US Attorney’s Offices for the Districts of Massachusetts and the Southern District of Florida, the Office of Inspector General for the Department of Health and Human Services, the Office of Program Integrity of TRICARE Management Activity, and the National Association of Medicaid Fraud Control Units.

The investigation began after the filing of a whistleblower lawsuit by a small, home-infusion company, Ven-A-Care of the Florida Keys under the False Claims Act which allows private persons to file whistleblower suits to provide the government with information about wrongdoing.

When persons submit false claims, under the FCA, the government is entitled to recover treble damages and $5,500 to $11,000 for each claim. In lawsuits in which the government is successful in litigating the case, the whistleblower can receive between 15-25% of the amount recovered. As part of the settlement in this particular case, the DOJ said the whistleblowers received approximately $26 million.

In addition, as a condition for doing future business with the Medicare and Medicaid programs, Glaxo signed an addendum to an existing Corporate Integrity Agreement requiring the company to report accurate average sales prices and average manufacturer’s prices for its drugs covered by Medicare and other federal healthcare programs.

“This agreement marks another in a series of cases in which a pharmaceutical manufacturer has settled claims that its fraudulent drug pricing cost federal healthcare programs and taxpayers millions of dollars,” said Assistant Attorney General Peter Keisler of the DOJ’s Civil Division in the press release.

“The Justice Department will continue to pursue these types of fraud schemes vigorously,” he said, “to make clear that we will not tolerate fraudulent pricing practices designed to reap profits for drug companies and doctors at the expense of healthcare programs for the poor and the elderly.”

“Any pharmaceutical company that intentionally inflates the cost of prescription drugs with elaborate pricing schemes robs states and beneficiaries nationwide of millions of Medicare and Medicaid dollars,” said Daniel Levinson, HHS Inspector General.

“We will not tolerate any company abusing programs intended to benefit our most vulnerable citizens,” he stated

About six months later in March 2006, in a new case involving the same old behavior, Paxil was back in the news when Glaxo paid $14 million to settle another lawsuit brought by New York Attorney General Spitzer on behalf of 49 states, alleging the company fraudulently tried to delay competitors from marketing a generic version of Paxil by filing frivolous patent infringement lawsuits.

In a statement, another state Attorney General involved in the case, Jay Nixon from Missouri said: “GSK used the courts to hold onto a monopoly for a popular drug and the end result was that consumers - including Medicaid - paid more than they should have.”

The settlement reportedly covered the cost of Paxil purchased by state and federally funded Medicaid programs but as usual Glaxo denied any guilt. “We made the decision that settling was appropriate,” it said, “to avoid the expense and distraction of protracted litigation.”

The next month, on April 17, 2006, the Sun Herald announced that a $3.5 million multistate antitrust settlement had been reached with Glaxo concerning the drug Augmentin, once again to settle charges that Glaxo fraudulently delayed generic competition.

In another case a few months later, in August 2006, Glaxo agreed to pay more than $70 million to settle a number of lawsuits alleging that the company over charged patients, health care plans and insurers for pharmaceuticals for more than a decade.

This litigation involved more lawsuits filed by New York Attorney General Spitzer and other state attorneys general claiming that Glaxo overcharged customers by hundreds of millions of dollars and accused the company of consumer fraud, commercial bribery, and false statements to government health plans.

Mary Anne Rhyne, spokeswoman for Glaxo, said the settlement would cover a class action filed by individual consumers, health-care plans, and insurers, according to Bloomberg News on August 11, 2006.

She said the company had also settled overpricing litigation or investigations by the attorneys general of New York, California, Connecticut, Montana, Nevada and Arizona and potential claims from 34 other states, including New Jersey, Delaware, and the District of Columbia, she said.

“Our lawsuit helped stop a long-standing practice that inflated the cost of drugs for people suffering from cancer and cheated the Medicaid system,” Mr Spitzer said in the Bloomberg article. “Today’s settlement provides significant restitution for consumers and the Medicaid program.”

It is worth noting that this settlement with state governments came less than a year after Glaxo agreed to pay the $150 to settle the same charges in the lawsuit filed under the False Claims Act by Federal health care programs.

But last month, the government hit the jackpot with Glaxo. On September 12, 2006, the Huffington Post reported that Glaxo had agreed to pay more than $3 billion to settle charges by the IRS that the company under-reported profits to avoid paying US taxes.

However, here too, in true Glaxo form, the company denied any guilt and said it only paid the $3 billion to settle the case to avoid protracted litigation.

 

*************Families seeking justice for infants born with Paxil related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/  

Suicide Rates as a Public Relations Tool (Shyness a Pathology) - By Alliance For Human Research Protection

 

- Federal Preemption Big Business Cheerleaders –

 

U.S. Chamber of Commerce, regularly enters litigation as a friend of big business, trampling on the rights of common working citizens who have been injured by corporate America. Their slogan is “Fighting For Your Business”, which is their way of admitting they don’t care how what they or corporate America does might injury you or destroy your economic way of life.

 

Institute of Legal Reform- The U.S. Chamber of Commerce’s cousin for taking away citizen rights to protect big business profits.

 

- CONCLUSION -

 

So what is wrong with this picture of how federal preemption is being used? Many times federal preemption is a defense that acts as a complete bar from you, the injured consumer, seeking the right to ask a jury for compensation for injuries that last a lifetime and cause havoc on your economic lifestyle. Like Dennis Quaid is quoted as saying federal laws that protect the actions of large corporations and prohibit mothers, fathers, sons, daughters, grandparents and infants from seeking to hold them responsible, takes away accountability and places the economic burden on the shoulders of those who are least able to pay the freight. The economic consequences of a personal injury caused by faulty products and product labeling passes the burden on to tax payers in the form of disability from the Social Security Administration; that in years to come will be overburdened with baby boomer payments. While Corporate American hands out multi-million dollar bonuses to it’s CEO’s, you and I get to do our own thing with how to live after suffering a stroke caused by a defective product or warning.

I will conclude today by saying that if you have complete faith in the products you use, both domestic and foreign manufactured, then you need not be concerned with federal preemption. On the other hand if product safety is a concern for you and your family then this is an area that should be of importance to you.

By Evelyn Pringle
evelyn.pringle@sbcglobal.net

http://www.a-paxil-lawyer-source.com/
http://www.antidepressantadversereactions.com/
http://www.paxilbirthdefect.com/

Wednesday, 14 March 2007

 

Dr. Diane M. Harper, a lead researcher in the development of the human papilloma virus vaccine, who says giving the drug to 11-year-old girls “is a great big public health experiment.” AHRP’s stated rationale for objecting to a policy mandating Merck’s HPV vaccine in 11 year old girls is validated by an internationally recognized expert in the field who tested the vaccine in clinical trials.

 

http://ahrp.blogspot.com/2007/03/nyt-vital-discussion-clouded-mandatory.html

 

 

Dr. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at

The Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, said: “It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue.”

All of her trials have been with subjects ages 15 to 25.

 

“This vaccine has not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer - they won’t know for 25 years if they will get cervical cancer.”

Dr. Harper said, Merck was required to put together a database on the efficacy in children before Gardasil was approved. But instead, the company put together four study sites that “are not necessarily representative, and may not even have enough numbers to determine what they need to know.”

She believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system. If the test comes back negative, then schedule the follow-up series of the three-part shots. But if it comes back positive? “Then we don’t know squat, because medically we don’t know how to respond to that,” Harper said.

She said that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most - meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won’t work at all if she was positive for the virus when she was inoculated in the first place. Merck knows this, Harper said. “To mandate now is simply to Merck’s benefit, and only to Merck’s benefit,” she said. Dr. Harper said, she’s been trying for months to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine. “But no one will print it,” she said.

Something is very wrong with this commercially driven frenzied marketing which all those who shape public policy and public opinion were caught shilling for Merck.

Independent advocates need to take to the streets to protect our children from irresponsible pharmaceutical companies whose financial largesse buys public officials, government agencies that are supposed to protect us from pot