Eli Lilly trying to dodge the Zyprexa bullet… “we pay up – you shut up”

Despite talking tough like all drug makers when faced with court action, it looks like Eli Lilly don’t really want to defend themselves in court.

Drug companies have so much money that they buy themselves out of trouble each and every time and then enforce confidentiality agreements to keep the details of the cases out of the public eye.

It’s very much a case of the drug companies taking the line “we pay up – you shut up”.

A few days ago we learned that Lilly had settled another 900 personal-injury claims against its antipscyhotic drug Zyprexa, including five set to go to court next month, thus avoiding what would have been the first trial in the U.S. The Indianapolis drug maker confirmed the settlement Wednesday but declined to reveal the amount. With the latest agreements, Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled. Many of the plaintiffs have claimed Lilly underplayed the drug’s side effects, including weight gain and elevated blood sugar. Lilly has set aside $1.2 billion to pay claims.

Now Alex Berenson from The New York Times brings us this story:

Lilly in Settlement Talks With U.S.

Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments see Drug Files Show Maker Promoted Unapproved Use (December 18, 2006).

If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines.

Several people involved in the investigation confirmed the settlement discussions. They insisted on anonymity because they have not been authorized to talk about the negotiations.

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.

Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government programs that are the biggest customers for the drug. Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.

Lilly would neither confirm nor deny the settlement talks.

“We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information,” Lilly said in a statement Wednesday afternoon. “As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.”

Lilly also said that it had always followed state and federal laws when promoting Zyprexa.

The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid.

The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.

Prescriptions for Zyprexa have skidded since 2003 over concerns about those side effects. But the drug continues to be widely used, especially among severely mentally ill patients. Many psychiatrists say that it works better than other medicines at calming patients who are psychotic and hallucinating. About four million Zyprexa prescriptions were written in the United States last year.

Federal prosecutors in Philadelphia are leading the settlement talks for the government, in consultation with the Department of Justice headquarters in Washington. State attorneys general’s offices are also involved. Lawyers at Pepper Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm based in Chicago, are negotiating for Lilly.

Nina Gussack, who is representing Lilly at Pepper Hamilton, said she could not comment on the case. Joseph Trautwein, an assistant United States attorney in the Eastern District of Pennsylvania, also declined to comment.

While a settlement has not been concluded and the negotiations could collapse, both sides want to reach an agreement, according to the people involved in the investigation. Besides the escalating pressure of the federal criminal inquiry, Lilly faces a civil trial scheduled for March in Anchorage, Alaska, in a lawsuit brought by the state of Alaska to recover money the state has spent on Zyprexa prescriptions. A loss in that lawsuit would damage Lilly’s bargaining position in the Philadelphia talks.

While expensive for Lilly, the settlement would end a four-year federal investigation and remove a cloud over Zyprexa. While Zyprexa prescriptions are falling, its overall dollar volume of sales is rising because Lilly has raised Zyprexa’s price about 40 percent since 2003.

Federal prosecutors have been investigating Lilly for its marketing of Zyprexa since 2004, and state attorneys general since 2005. The people involved in the investigations said the inquiries gained momentum after December 2006, when The New York Times published articles describing Lilly’s multiyear efforts to play down Zyprexa’s side effects and to promote the drug for conditions other than schizophrenia and severe bipolar disorder — a practice called off-label marketing.

Internal Lilly marketing documents and e-mail messages showed that Lilly wanted to convince doctors to prescribe Zyprexa for patients with age-related dementia or relatively mild bipolar disorder.

In one document, an unidentified Lilly marketing executive wrote that primary care doctors “do treat dementia” but leave schizophrenia and bipolar disorder to psychiatrists. As a result, “dementia should be first message” to primary-care doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors “might prescribe outside of label.”

In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

The documents were under federal court seal when The Times published the articles, and Judge Jack B. Weinstein of Federal District Court in Brooklyn rebuked The Times for publishing them.

The settlement negotiations in Philadelphia began several months ago, according to the people involved in the investigation.

Last fall, the two sides were close to a deal in which Lilly would have paid less than $1 billion to settle the case, which at the time consisted only of a civil complaint.

Then Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities, according to the people involved in the negotiations. A few days ago, facing the possibility of both civil and criminal charges, Lilly opened new discussions with the prosecutors in Philadelphia.

If you want to find out more about this entire story, I suggest you type Zyprexa into the search box on the left hand side of this page.

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Dr. Thomas Laughren – rewriting history to cover his tracks?

In this article (the AHRP & The New York Times) – we discover just how bad Dr Thomas Laughren’s memory must be… it seems he can’t recall important events and he even suppressed release of troubling (for drug makers) data.

I have to ask once again why it is that the FDA in America and the MHRA in the UK seem to be run for the benefit and profit of the pharmaceutical industry rather than for the safety and protection of patients?

Now read on:

“At last, the FDA in America is going to ask drug makers to include questions about suicidality in clinical trials of some new drugs.

In the new spirit of transparency, FDA officials would not say which drugs or how many drugs would be examined.

The FDA claims new interest in suicidality was sparked by the results of Columbia University’s analysis a few years ago showing increased risk of suicidality in pediatric patients using antidepressants. Dr. Thomas Laughren, director of the FDA Division of Psychiatric Products, confesses: “Clearly we were somewhat surprised when this signal emerged in the pediatric antidepressant data.”

Surprised? Really?

We remind Dr. Laughren that back in 1991, a team from Yale University published a paper entitled “Emergence of Self-Destructive Phenomena in Children and Adolescents during Fluoxetine Treatment” [King et al, Journal of the American Academy of Child and Adolescent Psychiatry 1991;30(2):179-86].

That same year, Dr. Laughren attended the FDA advisory committee meeting at which the safety of fluoxetine (Prozac) was discussed and his boss, Dr. Paul Leber, proclaimed: “nobody in the agency dismisses the possibility that antidepressants may have the capacity to cause untoward injurious behaviors, acts and/or intensify them.”

In 1991, Drs. Laughren and Leber listened as the chairman of the advisory committee, after seeing the data presented, concluded: “yes there is a signal there.” However, FDA officials maneuvered to steer the divided vote against changing the label to warn physicians and patients about the potential risk. Dr. Martin Teicher, who first raised concern about the suicide link to Prozac [Teicher MH, Glod C, Cole JO: Emergence of intense suicidal preoccupation during fluoxetine treatment. Am J Psychiatry 1990; 147(2):207-10] predicted prophetically: “what is going to happen, people are going to say it is free of all risk.”

Dr. Leber sought to reassure the committee with promises that their concerns would be addressed: “The likelihood is that we will probably write a talk paper at some point on behalf of the agency which will probably say what is obvious from the votes that people reasonably remain concerned about the possibility that there are areas of information that we need that we do not have and we will pursue things as we ordinarily do.”

For public consumption, the FDA announced that the agency had found “no credible evidence” that antidepressant drugs cause suicidal behavior. [The Lancet 1991;338:875-6] No talk paper expressing concern about the potential risk that Dr. Leber acknowledged at the advisory committee meeting was ever released.

More than a decade later, an FDA reviewer in the Office of Drug Safety division looking at antidepressants in the pediatric population took it upon himself to combine clinical trials for different antidepressants (a meta-analysis) and found that suicidal behavior among the kids who received antidepressants was nearly twice the rate among kids who received a placebo. Dr. Andrew Mosholder raised his concern with Dr. Laughren who had issued the approval for these antidepressants.

Dr. Laughren, being the cautious type–where industry interests are concerned–calmed the reviewer and suppressed release of the troubling results.

Instead [Link] the FDA decided give the data to Columbia University to re-classify the cases so that FDA’s Office of New Drugs could re-analyze the data, then wait some more until the results could be presented to another advisory committee.

However, the Alliance for Human Research Protection obtained and posted Dr. Mosholder’s suppressed report: [Link]

In September, 2004, a Congressional hearing was held at which it was learned that Laughren’s presentation of the data analysis to the FDA advisory committee–failed to include both Dr. Mosholder’s conclusion about the suicide risk, but Dr. Laughren’s presentation failed to include the data that substantiated that conclusion. [Link]

Finally in September 13-14, 2004 we saw the numbers: the results from the Columbia reclassification of cases showed that the relative risk of serious suicidal events for antidepressants was 1.81 times greater than the risk for placebo. The original analysis conducted on the data submitted by the drug companies and analyzed by the FDA Office of Drug Safety (now the Office of Safety Evaluation) had produced a relative risk of 1.86.

One of the things we can learn from this exercise is that the re-classification of cases by Columbia University showed the same increased risk with antidepressants as was obtained using the original data submitted by the drug companies and gathering dust in the FDA files all these years. In other words, the Columbia case definition and suicidality scale were completely unnecessary. The answer was right there in the data submitted routinely by drug companies to the FDA.

Like Dorothy and her ruby slippers, the FDA all along had the ability to see that antidepressants increase the risk suicidal behavior . All they had to do was look. The problem was not the lack of a suicidality questionnaire, or the drug companies’ inability to recognize and report suicidal behavior. The problem is that suicidal behavior, like most serious adverse events, occurs too rarely to be associated with drugs reliably in individual clinical trials of the size required by FDA for approval.

The solution to this problem is-wait for it-yes, get more data. Did you hear the drug companies gasp? Larger studies take longer to complete and time, as we all know, is profit.

But there are all sorts of ways to get the necessary data, even without lengthening the approval process. For instance, the FDA could issue a conditional approval (during which time all advertising would be prohibited) pending timely completion of large safety studies.

Even simpler, the FDA could as a matter of routine conduct meta-analyses in which individual trials (even including different drugs within the same class with similar effects) are analyzed together. A meta-analysis, such as the one eventually conducted by the Office of Drug Safety would have shown years earlier that antidepressants cause rather than prevent suicidal behavior.

The underlying problem, however, is that the FDA still does not take safety seriously.

In 1990, Dr. Teicher identified a suicide risk in patients prescribed Prozac–surely a serious adverse side effect. In 1991, Dr. King independently identified the same risk in children. Both reported the suicidal behavior link to Prozac in leading psychiatric journals. When separate re-challenge case reports were also positive in increasing suicidality, the event was linked by physicians to antidepressants.

The Chairman of the FDA advisory committee concluded that a signal is present. Yet, FDA officials told us there was “no credible evidence.”

The FDA judged the data to be insufficient, but for more than a decade they did nothing to address the alleged shortcomings of the data. Perhaps they prayed at night that in the morning new data would somehow manifest itself.
Today, the FDA still has not implemented the structural changes recommended by the Institutes of Medicine, but some drugs will now use the Columbia suicide questionnaire that had been contracted by the FDA.

However, reclassification of terminology will not change the culture at the FDA that trivializes safety issues.”

Heath Ledger’s deadly cocktail of anti-depressants and sleeping pills

This from the Daily Mirror:

He was one of the greatest actors of his generation – but tragic Heath Ledger could not hide his anguish at being parted from his daughter.

Sick at heart and exhausted by crippling insomnia, the Brokeback Mountain star tried to stave off his mounting depression with cocktails of prescription pills.

On Tuesday he was found dead from a suspected accidental overdose.

Drugs nearby included Ambien and Zopiclone sleeping aids, the anti-depressant Zoloft, antianxiety drugs Xanax and Valium and antihistamine Donormyl.

Yesterday as tributes poured in Jack Nicholson – who has spoken out against Ambien – said grimly: “I warned him to stop.

“I tell people about Ambien. Somebody said ‘Take this, it’s mild’. I almost drove off a cliff 50 yards from my house.”

Oscar-nominated Heath, 28, was so besotted with two-year-old daughter Matilda Rose that he said after her birth: “I feel in a sense ready to die because you live on in your child.”

He was felled by grief at not being able to see her after splitting with fiancee and Brokeback Mountain co-star
Michelle Williams, 27. Weeping Maggie Gilliam, wife of director Terry Gilliam who was working with Heath on his latest movie, said: “He was on prescription drugs because he was dealing with tragedy in his life.

“It was not being with his daughter. It was very, very hard for him. It’s a tragedy for everybody who knew him.”
Despite Heath’s despair, Maggie insisted he was not suicidal.

She and Terry met him for dinner in London a week ago. She said: “He was on great form, sparkling and really relaxed. He was speaking about Matilda.

“He was a fabulous and generous person who threw himself 100 per cent into everything whether it was being a father or an actor.”

But fellow actor Jonathan Zarin told of the dark undercurrents in his friend’s life. He said: “I’d been hearing for a while that he was in a really bad place.”

Heath’s naked body was discovered at his New York apartment on Tuesday afternoon by his housekeeper Theresa Solomon and masseuse Diane Lee. A postmortem was inconclusive and toxicology tests are still being carried out.

Sources claimed the apartment was in a “brokedown” state, virtually unfurnished with a mattress on the floor serving as a bed.

In one of his last interviews Heath confessed to taking one Ambien pill after another while filming the new Batman movie The Dark Knight – only to wake an hour later.

He said: “My body was exhausted and my mind was still racing.”

At the time of his death he had pneumonia.

Ambien is not recommended for people with respiratory diseases.

Patients prescribed Ambien, sold in the UK as Zolpidem, have driven their cars and had eating binges while still unconscious.

Britain’s official medicines watchdog, the Medicines and Healthcare products Regulatory Agency, recorded 68 incidents of adverse reactions to Zolpidem between 2001 and 2005.

Michelle flew to New York with Matilda from Sweden after learning the grim news of Heath’s death.
She left the star after three years, reportedly concerned by his increasing use of drugs including heroin. Her father Larry said: “My heart goes out to everyone in Heath’s family.

“The saddest thing is his daughter who he loved so dearly.”

What he was on..
AMBIEN
Sleeping pill. Patients report binge-eating and driving while unconscious after taking. Known in Britain as Zolpidem.

VALIUM
Used for insomnia and anxiety. Can cause dizziness and depression.
Should not be taken with anti-depressants.

ZOLOFT
Most popular antidepressant in US. Said to carry lower risk of suicide than other drugs. Also known as Sertraline.

XANAX
Treats anxiety disorders. Success is reduced if taken for more than eight weeks. Highly addictive.
Can cause hallucinations.

ZOPLICONE
One of the most addictive sleeping pills. Patients can suffer increased heart rate, mood changes, anxiety and fatigue.

DONORMYL
Antihistamine with common side-effects of drowsi – ness, insomnia and anxiety. Users should check before taking with others drugs.

Jury Trials In 2008 Expected To Expose SSRI Maker’s Dirty Secrets

It seems that the High Court case in England over Seroxat withdrawal and addiction is gathering pace. But it’s not just the UK where drug makers are going to have to face injured patients in court. This from Evelyn Pringle in America:

The blockbuster sales figures for the new generation of selective serotonin reuptake inhibitor antidepressants (SSRI’s), which have resulted from their promotion for so many unapproved uses, represents the most profitable off-label marketing coup in the history of modern medicine. Sales total about $21 billion a year, according to IMS Health.

However, in the end these drugs will probably also hold the title for the most lawsuits filed against drug companies for overstating their benefits while concealing their serious side effects from as far back as 20 years ago.

The SSRI’s include Prozac by Eli Lilly; Paxil marketed by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro from Forest Laboratories. Cymbalta by Eli Lilly and Effexor by Wyeth are often called SSRI’s, but they are actually serotonin norepinephrine reuptake inhibitors (SNRI’s). Wellbutrin sold by Glaxo is an inhibitor of the neuronal uptake of norepinephrine and dopamine. Several of these antidepressants now have generic counterparts.

In 2008, at least a dozen jury trials are scheduled all over the country for Paxil suicide-related cases, all of which allege that Glaxo failed to warn consumers and doctors about the known risk of suicide associated with the drug. Many of these cases will be tried by Baum, Hedlund, Aristei & Goldman, the national law firm with the longest track record of handling SSRI cases.

Going into the trials, Baum Hedlund will be armed with the largest collection of internal GSK documents, depositions of GSK employees and experts, as well as the fruits of the firm’s investigation of antidepressants and their makers for the past decade and a half.

During litigation, virtually every Paxil-related document obtained by Baum Hedlund was stamped “confidential” by Glaxo and sealed under a court order. However, through a series of legal challenges, the firm was able to unseal many of the documents, in part, by forcing Glaxo to admit that they did not contain trade secrets and should never have been sealed to begin with.

Off-label Promotion and Prescribing Drive Profits

The FDA approves drugs for uses that have been tested for safety and efficacy and includes those uses on the drug’s label. The term off-label means prescribing a drug for a use that has not been tested and proven safe and effective or for a different patient group, or at a different dose, or for a longer duration, or in combination with other drugs.

While doctors may legally prescribe a drug for an unapproved use, it is illegal for drug makers to promote off-label prescribing. Over the past 20 years, SSRI’s have been prescribed off-label to children as young as infants, the elderly and pregnant women, and for off-label uses that include insomnia, anxiety, shyness, grief, menstrual discomfort, pain, bed wetting, ADHD, dementia, impotence and restless leg syndrome, to name just a few.

To gain FDA approval to legally sell SSRI’s to kids, all the drug companies would have to do is provide two clinical studies showing that the drugs work better than a placebo in depressed children, and they can conduct 100 trials to achieve the necessary results. But after 20 years on the market, they still have not been able to give the FDA two positive studies to prove these drugs work with children, with the exception of Prozac.

Critics are quick to point out that this is certainly not for lack of trying because there have been dozens of pediatric trials conducted that show the drugs work no better than a placebo. How Prozac gained approval remains a mystery in light of the thousands of adverse events that were already recorded among children.

A study conducted at the University of Georgia and published in the June 2006 Journal of Clinical Psychiatry reviewed prescribing records for 107,000 Medicaid recipients on drugs that act on the central nervous system and found that 75% of SSRI patients received the drugs off-label and most of the time without their knowledge.

In April 2004, the CDC reported in the Journal of Women’s Health that antidepressants were the top drugs prescribed to women in doctors’ offices and outpatient departments, ahead of estrogens and progestins, antiarthritics and drugs for acid/peptic disorders.

According to another report by the CDC, during 2005, antidepressants were the most prescribed drugs overall in visits to doctors and hospitals and were even prescribed more often than drugs used to treat high blood pressure, cholesterol, diabetes and headaches.

Chemical Imbalance – Selling Sickness in the Absence of Efficacy

The standard line used to sell SSRI’s is that mental illnesses are caused by a chemical imbalance in the brain and that SSRI’s correct the imbalance. The Lexapro website even states: “Antidepressant medicines relieve the symptoms of depression by restoring chemical imbalances in the brain.”

However, “Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature,” in the November 8, 2005, PLoS Journal, by Jeffrey Lacasse, a visiting lecturer at the Florida State University, and Jonathan Leo, an Associate Professor of Neuroanatomy at Lincoln Memorial University, reports that, “there is not a single peer-reviewed article that can be accurately cited to directly support claims of serotonin deficiency in any mental disorder, while there are many articles that present counterevidence.”

In their most recent paper titled, “The Media and the Chemical Imbalance Theory of Depression,” appearing in the February 2008 issue of Society, Mr Lacasse and Mr Leo report that, “In spite of the enormous amount of money and time that has been spent in the quest to confirm the chemical imbalance theory, direct proof has never materialized.”

In fact, they advise that the Diagnostic and Statistical Manual of Mental Disorders, which almost all psychiatrists use to diagnose and treat their patients, clearly states that the cause of depression and anxiety is unknown.

Even when prescribed for their intended purpose in treating depression, many experts say SSRI’s are ineffective. One of the world’s most famous psychopharmacologists, Dr David Healy, author of “The Antidepressant Era,” and “Let Them Eat Prozac,” says that an overall review of the published clinical trial data on the new antidepressants reveals a 10% difference in the way people respond to the drugs verses a placebo.

He reports that 50% of patients taking the antidepressants showed some improvement and 40% of people taking a placebo showed improvement. And when the data from the unpublished clinical trials are added in, 45% of patients taking a placebo showed improvement.

The author of “Surviving America’s Depression Epidemic,” Dr Bruce Levine also says “legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all.”

However, most prescribing doctors have never heard about this 5% or 10% efficacy statistic, which researchers have referred to as the “dirty little secret,” because many of the studies that revealed the “secret” remained hidden for years.

In fact, much of the information is still not in the public domain. A new study in the January 18, 2008 New England Journal of Medicine reports that the makers of the new antidepressants failed to publish many of the clinical trials that were submitted to the FDA for market approval that did not show positive outcomes in patients taking the drugs.

The researchers found that a total of 37 studies were viewed by the FDA as having positive results and all but one were published. But 22 studies that were viewed as having negative or questionable results were not published and 11 were published in a way that conveyed a positive outcome.

The study compared drug efficacy inferred from the published literature with efficacy determined in the FDA reviews and found that in the published medical literature, it appeared that 94% of the trials were positive when the FDA analysis showed that only 51% were positive.

The clinical trials analyzed included the drugs, Wellbutrin, Celexa, Cymbalta, Lexapro, Prozac, Remeron, Serzone, Paxil, Paxil CR, Zoloft, Effexor, and Effexor XR.

“For each of the 12 drugs,” the researchers wrote, “the results of at least one study either were unpublished or were reported in the literature as positive despite a conflicting judgment by the FDA.”

A total of 12,564 patients participated in these trials and data from 3,449 patients were not published. Data from an additional 1,843 patients were reported in journal articles that highlighted findings that conflicted with the FDA-defined primary outcome.

For each of the 12 drugs, the researchers also found that the effect size derived from the journal articles exceeded the effect size in the FDA reviews, with the increases in effect size in the published reports ranging from 11% to 69%, with an average increase of 32%.

The literature-search strategy used for the study consisted of a search of articles in PubMed, references listed in review articles, and a search of the Cochrane Central Register of Controlled Trials.

The researchers also contacted the drug maker’s medical-information department by phone or email; and contact was also made by way of a certified letter to the company’s medical-information department, including a deadline for responding in writing as to whether the results of a study had been published. If these steps failed to reveal any publications, the researchers concluded that the results had not been published.

The researchers who conducted the study include Erick Turner, MD, Annette Matthews, MD, Eftihia Linardatos, BS, Robert Tell, LCSW, and Robert Rosenthal, PhD, from Oregon Health and Science University, Portland Veterans Affairs Medical Center; Kent State University; the University of California–Riverside, and Harvard University.

In their paper, “The Media and the Chemical Imbalance,” Mr Lacasse and Mr Leo point out the problem in the media where reporters still quote the people responsible for publishing bogus studies that have long been debunked.

“For instance,” they write, “several of the researchers involved with the studies of SSRIs in children are still cited in the press even though the following information has come out about their published studies: they downplayed the suicide risk; they exaggerated the benefits; and the papers published under their names were actually written by ghostwriters paid by the pharmaceutical industry.”

According to Dr Levine, depression is not a biochemical disorder and refers to it as a strategy used to shut down overwhelming pain. Dr Levine states that, if the strategy is used to excess, it can lead to immobilization and greater pain.

He explains that depressed people experience feelings of hopelessness and helplessness and that labeling them with a disease leads to more of the same feelings.

Instead of calling it an illness or weakness, Dr Levine says, depression can be lessened by helping patients understand that it is a normal human reaction and they can identify the source of the pain and heal.

More Disorders Equals More Profits

To expand the market, the SSRI makers have managed to create a whole new generation of psychiatric illnesses by simply padding the bank accounts of a few psychiatrists who determine the criteria for the inclusion of mental disorders in the DSM. With their inclusion in the billing bible comes the guaranteed payment for the cost of the SSRI’s and the visits to the prescribing doctor by public and private health insurance programs.

There are also a whole new slew of SSRI treatable disorders lining up for inclusion in the next DSM edition. For instance, an August 3, 2006 article by Reuters reported that, “People with ‘body dysmorphic disorder’ are 45 times more likely to commit suicide than people in the general population, a new study shows.”

“The findings underscore the importance of recognizing and treating this ‘often secretive’ psychiatric disorder,” Dr Katherine Phillips, the study’s co-author, told Reuters.

Individuals with body dysmorphic disorder, she said, have a distorted body image and think obsessively about their appearance, often for hours a day, but can be helped with drugs like Prozac or Zoloft and cognitive behavioral therapy.

On October 3, 2006, the New York Times ran the headline: “Can’t Keep From Shopping? Help Could Be on the Way,” for an article that said, compulsive buying, “in its extreme forms may be a psychiatric illness — an impulse control disorder associated with abnormal levels of depression and anxiety.”

The article discussed a study in the American Journal of Psychiatry, and the lead author, Dr Lorrin Koran, told the Times: “Many of those who come in for treatment suffer from depression, anxiety disorders and other impulse control disorders like pathological gambling and binge eating.”

She also threw in a sales pitch saying, “studies suggest that psychotherapy or medications help many compulsive buyers to stop.”

This news could potentially raise SSRI profits by 10%, because the Times says a statistical analysis of the study results found 5.5% of men and 6% of women could be afflicted.

The article also points out that compulsive buying is not yet a recognized psychiatric diagnosis, but that it is being considered for inclusion in the next edition of the DSM.

Good news for Pfizer came in the October 2006, Journal of Clinical Psychiatry, from a study led by Dr Susan Kornstein, at Virginia Commonwealth University, that claims low doses of Zoloft for 2 weeks before the onset of the menstrual period may be effective and well-tolerated for treating women with moderate-to-severe PMS.

The researchers also claim that other dosing strategies are effective, including taking Zoloft daily or waiting until symptoms begin to start taking it.

Zoloft is already approved for premenstrual dysphoric disorder (PMDD), but profits could skyrocket with widespread dissemination of this study because the researchers report that up to 60% of women suffer from PMS, while only about 5% suffer from PMDD.

On October 26, 2006, an Indianapolis Star headline warned that: “Midnight munchies can signal big problems.” The article explained that routine and heavy nighttime snacking can be a sign of eating for reasons other than hunger and more serious symptoms can point to “a little-known eating disorder called night-eating syndrome.”

But not to worry, because the researchers who did the study told the Star that Zoloft can help these poor souls as well, along with therapy to change eating and exercise patterns.

Great news for Glaxo came on October 27, 2006, when United Press International ran the headline: “Paxil helps compulsive hoarding syndrome”.

According to UPI, persons with this syndrome exhibit 3 features: failure to discard objects due to severe anxiety related to discarding what most might regard as inconsequential objects; excessive acquisition, sometimes resulting in buying sprees, and excessive clutter to the point where home and work spaces can no longer be used.

Here again, however, researchers led by Dr Sanjaya Saxena at the University of California, report that Paxil is effective in treating this dastardly new disorder.

Risks Outweigh the Benefits

Experts say that if patients were adequately informed about the long list of side effects associated with SSRI’s and their dubious efficacy before they took the first pill, they would be more than a little skeptical about whether their benefits outweigh the risks.

The SSRI labels now warn patients not to take them with common over-the-counter medications such as aspirin and many other pain relievers, or with cold remedies or herbal supplements like St John’s Wort, or with alcohol.

SSRI side effects include suicidality, violence and homicide, birth defects, abnormal gastrointestinal and uterine bleeding, a decrease in bone density, fertility problems, sexual dysfunction, severe withdrawal and the life-threatening condition, serotonin syndrome.

According to the SSRI labels, symptoms of serotonin syndrome include mental status
changes such as agitation, hallucinations, or coma; autonomic instability like tachycardia, labile blood pressure and hyperthermia; neuromuscular aberrations such as hyperreflexia and incoordination, and gastrointestinal symptoms of nausea, vomiting and diarrhea.

All the current labels say that anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania have been reported in adult and pediatric patients treated for major depressive disorder, as well as for other indications, both psychiatric and non-psychiatric.

The labels also report that infants exposed in the womb have developed complications requiring prolonged hospitalization, respiratory support and tube feeding upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.

The labels note that these features are consistent with either a direct toxic effect or possibly a drug discontinuation syndrome and say it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.

On December 8, 2005, the FDA issued a public health advisory to report that women who take Paxil in early pregnancy are at an approximately 2-fold increased risk of having an infant born with a cardiac defect compared to the general population.

Also cited on the labels is a study finding that infants exposed to SSRI’s in late pregnancy showed a 6-times greater risk of developing the lung disorder known as persistent pulmonary hypertension of the newborn (PPHN), a condition that, despite treatment, results in the death of approximately 10 to 20 percent of affected infants.

In December 2006, a Journal of Clinical Psychiatry study reported that about seven of every ten people who take antidepressants have impaired driving ability and that 16% have severe motor impairments after taking the drugs.

A short list of the adverse effects listed on the various SSRI labels as “frequent,” and occurring on one or more occasions in at least 1 out of every 100 patients, includes light-headed feeling, appetite increased, increased weight, heartburn, abdominal cramp, gastroenteritis, allergy, pain in limb, fever, hot flushes, chest pain, lethargy, irritability, concentration impaired, abnormal dreams, sleep disorder, menstrual cramps, menstrual disorder, impotence, anorgasmia/orgasm abnormal, bronchitis, sinus congestion, coughing, migraine, sinus headache, vision blurred, urinary frequency and urinary tract infection.

Upcoming Jury Trials

Veteran trial lawyer, Ronald Goldman, who won one of the largest verdicts for the death of an unmarried person in Ohio state’s history last year, is leading the Baum Hedlund team in the trials.

Glaxo has good reason to fear jury trials. The first Paxil-related suicide trial resulted in a verdict for the plaintiff. The case took place in Wyoming in May 2001 and involved a man, Donald Schell, who shot and killed his wife, daughter, and infant granddaughter before turning the gun on himself, after being on Paxil for only 2 days.

The instructions given to the jury required a finding that, “Paxil was a proximate cause of Donald Schell committing the homicides and suicide involved in this litigation” and that Glaxo’s failure to test or to warn “was a proximate cause of the homicides and suicide in this litigation.”

On June 6, 2001, the jury returned a verdict in favor of the plaintiffs and the Court entered a judgment against Glaxo for more $6 million. Glaxo filed an appeal and the parties settled out of court while the appeal was pending.

Baum Hedlund has litigated over 3,000 pharmaceutical cases in the past 18 years and the firm currently has approximately 30 SSRI suicide-related cases in litigation.

What drug companies are not telling you about anti-depressants – watch the video

You’ve read the posts – now watch the Fox News video:

If you want to find out more, then here is a good starting point to learn about Glaxo and the infamous Study 329 and the MHRA and its 4 year long criminal investigation of Glaxo in the UK.

What drug companies are not telling you about anti-depressants like Paxil – Fox News

From Fox News tonight:

This is a rush transcript from “The Big Story With John Gibson and Heather Nauert,” January 17, 2008. This copy may not be in its final form and may be updated on Fox News – watch the video here.

HEATHER NAUERT, CO-HOST:It’s a big scandal tonight, what drug companies are not telling you about anti-depressants that they’re selling to millions and millions of Americans. Some people say that they can’t live without Prozac, Paxil and other drugs. But a new study says that the pills may not be helping them as much as they think or that they’re led to believe. “Big Story” correspondent Douglas Kennedy takes a fair and balanced look now at the findings. And by the way, Douglas was the first national reporter to link anti-depressant medications to adolescent suicide and violence which prompted government hearings.

Douglas, so what is going on?

DOUGLAS KENNEDY, FOX CORRESPONDENT: Yes, thanks, Heather. What this study confirms is what we have been reporting for years, namely that anti-depressants often do not do what they promise and are, in fact, causing harm to many.

KENNEDY (voice-over): When Lynn Michaels was 37-years-old, she contracted Lyme disease. She said she chose to go on an anti-depressant because she wanted for feel better and the drugs had gotten so much good publicity both in the media and in their commercials.

UNIDENTIFIED MALE: Talk to your doctor about Zoloft.

KENNEDY (on camera): What had you heard about anti-depressants?

LYNN MICHAELS, TAPERSAFELY.ORG: Well, at the time, they were non- habit forming drugs. There was no risk of addiction, and I could try Paxil, this new miracle drug and I could see if I liked it, and if not, I could get off of it.

KENNEDY (voice-over): But she couldn’t get off, even after the drug had stopped working.

MICHAELS: I went into complete and total despair. I was unable to think straight. I was unable to sleep. I was in total panic.

KENNEDY (on camera): And you spent years trying to wean yourself off?

MICHAELS: I spent eight years trying to find a way off the drugs.

KENNEDY: And what happened during that time?

MICHAELS: It cost me my personal life, my marriage, my professional life.

KENNEDY (voice-over): Now a blockbuster study in the New England Journal of Medicine confirms what Lynn already knew from personal experience, that the effectiveness of anti-depressants has been over-hyped.

In fact, the study, reported on today in The Wall Street Journal, goes even further, claiming pharmaceutical companies exaggerated the effectiveness of 12 popular anti-depressants including Paxil, Effexor, and Zoloft, by publishing the results of positive clinical trials, while suppressing the results of negative clinical trials.

FOX Business anchor David Asman interviewed the study’s author, Erick Turner last night.

DAVID ASMAN, FOX BUSINESS ANCHOR: What a bombshell, Dr. Turner. How did you find out about all this?

DR. ERICK TURNER, AUTHOR OF NEJM STUDY: Well, we used FDA review documents. I used to be an FDA reviewer and used these documents which I knew contained information on not only published — trials that were published, but also unpublished studies as well.

KENNEDY: And Turner also found that when a negative study was published, the negative parts of the study were simply left out. But an industry lobbying group called Turner’s report incomplete. Pharma found that its authors neglected to mention the fact that industry and government have already taken proactive steps to make clinical trial information transparent and accessible, meaning negative trials may be available on company Web sites.

But Turner points out most doctors get their information from reading medical journals and he says those journals have given doctors a skewed view about the effectiveness of anti-depressants.

MICHAELS: There are no long-term studies on the safety or efficacy of any of these drugs. They are very dangerous.

KENNEDY: Lynn says she has now designed a program to help fellow sufferers wean off anti-depressants. That program, she says, can be found at her Web site, ssri-research.com. She cautions however that no one should try to get off anti-depressants cold turkey. She says, John and Heather, it’s very important to wean off slowly.

GIBSON: Douglas, this anti-depressant scandal, aren’t, in fact, many people helped by these drugs?

KENNEDY: You know, that is a question that will certainly be debated for years to come, but where we can all agree is that people should have the information about the drugs before they start taking them, accurate, truthful information which they have not been getting.

NAUERT: Douglas, you and some others are saying that the pharmaceutical companies suppressed information.

KENNEDY: This study says they did.

NAUERT: Negative information, suicide rates, too?

KENNEDY: The suicide — absolutely. That’s where we start. These drugs — nobody knows up until now that these drugs actually increased the risk of suicide in clinical trials. They gave people placebo and they gave people the drug and the people that were taking the drug wanted to commit suicide at a far greater rate than the people who were taking a sugar pill.

NAUERT: Who were depressed and were taking the sugar pill.

KENNEDY: Yes. The other stuff that they have suppressed is that they increased violent tendencies and that when some people start taking them, they can never ever get off them, which means they are sentenced to a life of being completely disassociated from their bodies and their inner emotional life.

GIBSON: Douglas Kennedy, Douglas, thanks a lot, we’ll talk to you later as this develops.

If you want to find out more, then here is a good starting point to learn about Glaxo and the infamous Study 329 and the MHRA and its 4 year long criminal investigation of Glaxo in the UK.

Antidepressants: Hiding and Spinning Negative Data

More on my previous post – Antidepressants don’t work as well as reported – negative trials simply not published.

What follows are selected details from Clinical Psychology and Psychiatry – but you really need to go over and read the whole article.

“The FDA concluded that 38 studies yielded positive results. 37 of these 38 studies were published. The FDA found mixed or “questionable” results in 12 studies. Of these 12 studies, six were not published, and six others were published as if they were positive findings. Of the 24 studies that the FDA concluded were negative, three were published accurately, five were published as if they were positive findings, and 16 were not published.

Every single drug had an inflated effect size in the medical literature in comparison with the data held by the FDA. To move into layman’s terms for a moment, manufacturers of every single drug appear to have cheated. This is not some pie in the sky statistics review — this is the medical literature (the foundation of “evidence-based medicine”) being much more optimistic about the effects of antidepressants than is accurate. This is marketing trumping science.

The drugs that were found to have increased their effects as a result of selective publication and/or data manipulation:
Bupropion (Wellbutrin)
Citalopram (Celexa)
Duloxetine (Cymbalta)
Escitalopram (Lexapro)
Fluoxetine (Prozac)
Mirtazapine (Remeron)
Nefazodone (Serzone)
Paroxetine (Paxil)
Sertraline (Zoloft)
Venlafaxine (Effexor)
That is every single drug approved by the FDA for depression between 1987 and 2004.”

As I said – read the entire article at Clinical Psychology and Psychiatry – here.

Also Furious Seasons has written about this – here.

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