The Bitter Pill

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Pfizer Makes List of Worst Corporate Evildoers

Evelyn Pringle March 6, 2006

On January 3, 2006 the Global Exchange Report named the top fourteen “Worst Corporate Evildoers” in the world for 2005. Pfizer, one of the most profitable drug companies on earth, with sales over $52 billion in 2004, made the list of Evildoers.

Pfizer’s participation in the cover-up of the deadly side effects of Bextra surely contributed to its membership. Because the drug was promoted and sold off-label for so many unapproved uses, the company made hundreds of millions of dollars in pure profits during Bextra’s short life on the market. However, experts predict that when all is said and done, the total amount of the drug’s damage to consumers will be in the billions.

Bextra belongs to the same class of drugs as Vioxx and Celebrex, known as Cox-2 inhibitors. Millions of people world-wide have taken these drugs.

It is now apparent that Pfizer knew Bextra was associated with extremely harmful side effects long before it was yanked off the market. However, Pfizer had good reason to stall its inevitable removal after Vioxx was recalled.

Bextra was on the market for about 3.5 years, but did not reach its full sales potential until Vioxx was eliminated from the competition. After the Vioxx recall, in one month alone, Bextra prescriptions went from 1.15 million in September 2004, to 1.48 million in October. All total for 2004, Pfizer generated sales of about $1.3 billion.

The marketing history of Bextra involves a train of suspicious conduct. On November 16, 2001, the drug’s original maker, Pharmacia won FDA approval for treatment of pain associated with osteoarthritis, adult rheumatoid arthritis and menstrual pain only and immediately went into overdrive promoting the drug for off-label use.

In July 2002, Pfizer acquired Bextra from Pharmacia in a $58 billion dollar deal that was not approved by the FTC until the following year in April 2003.

An FDA Talk Paper on the agency’s web site on November 15, 2002, announced new warnings on Bextra and said, “labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions – including Stevens Johnson Syndrome, and anaphylactoid reactions.”

The following month, the “Congress of California Seniors,” filed a lawsuit against Pharmacia in a Superior Court in Los Angeles, alleging the company had illegally promoted Bextra for off-label use.

According to the group, after the FDA refused a request to approve Bextra for pain related to impacted molars, Pharmacia helped fund a study that claimed Bextra could be useful in fighting acute dental pain and got it published in dental journals which led to the suit alleging secretive encouragement of ‘off label’ uses and attempting to circumvent the FDA’s refusal.

On November 2, 2003, after a year-long analysis of prescribing records, Knight-Ridder reported that more than half of Bextra pills sold were for off-label use.

About 5 months later, on March 14, 2004, Pfizer disclosed in a regulatory filing that the Justice Department was investigating the company’s marketing practices of Bextra for uses not approved by the FDA.

In October, 2004, the New England Journal of Medicine carried two editorials calling for renewed scrutiny of all Cox-2 inhibitors to assess whether the other drugs also caused heart problems.

In one editorial, cardiologist, Eric Topol, one of the first people to raise a red flag on Vioxx, from the Cleveland Clinic in Ohio, called for a government investigation into why Merck and the FDA allowed Vioxx to remain on the market for so long after its association with heart risks were revealed.

The FDA’s inaction was also noted by the Washington Post pointing out that in the late 1990s, the FDA took action when safety concerns were raised by withdrawing 10 drugs within 3 years. “But until the Vioxx withdrawal, only one other drug had been pulled since the Bush administration began, leading some to conclude that the agency had made a quiet policy change that emphasized “benefit” and sought to manage “risk” less intrusively,” the Post said on April 11, 2005.

As it turns out, Pfizer knew Bextra was every bit as dangerous as Vioxx and that the incidence of heart attack and stroke among patients using Bextra was more than 2 times that of patients taking placebos, which was revealed in a study presented on November 9, 2004, during the annual meeting of the American Heart Association in New Orleans.

Dr Curt Furberg, a professor at Wake Forest University School of Medicine, helped conduct the study and said: “Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information.”

On November 18, 2004, Dr David Graham, head of the FDA’s Office of Drug Safety, testified before the Senate Finance committee and listed Bextra as one of five drugs whose safety needs ”to be seriously looked at.”

On December 9, 2004, the FDA announced that Bextra would come with a new bolded warning contraindicating its use in patients undergoing coronary artery bypass graft (CABG) surgery.

The FDA knew Bextra was being widely marked for off-label use. Its December 9, Talk Paper, noted that Bextra was “not approved for use in the treatment of postoperative pain of any type;” but added: “however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG.”

The FDA also ordered a black boxed warning on the label stating that patients taking Bextra had reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis.

Come to find out, as of November 2004, the FDA had received reports of 87 cases of SJS associated with Bextra. Thirty-six patients required hospitalizations, and 4 people died. Twenty involved patients with a known allergy to sulfa.

Although the other Cox-2 selective inhibitors also showed a risk for SJS, the FDA found reported cases to be greater with Bextra.

SJS is a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases, according to a December 12, 2004 press release by the SJS Foundation.

People also develop SJS as a reaction to other commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such ibuprofen products.

On January 26, 2005, Jean Farrell McCawley, the founder of the SJS Foundation testified before a joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Ms Farell-McCawley told the panel that although SJS was referred to as a rare skin reaction, since 1995, the SJS Foundation had been notified of far more cases of the condition than those recorded by the FDA.

By one estimate, each year, SJS effects three to eight people per million in the US. However, the frequency is thought to be much higher since the FDA acknowledges that only between one and 10% of all adverse drug reactions are reported each year.

“SJS is not as rare as we are led to believe,” Ms Farrell McCawley advises. “During the winter months, we learn of 15 new cases a week, and that’s only people with Internet access,” she says.

It is hard to imagine a more severe adverse drug reaction than SJS. In the April 2005 SJS Newsletter, SrA Tanner Claybaugh published a letter describing what his sister, Mollie, went through after developing SJS as a reaction to children’s Advil.

Shortly after taking drug, Mollie developed blisters and rashes all over her body and was hospitalized. “She was put in the Intensive Care Unit (ICU) where there were countless machines keeping her alive,” SrA says.

“After about a weeks time,” he continued, “she was put in the burn unit as if she had burns from a fire, but the allergic reaction was the cause of her third degree burns.”

She was hanging on to life by a thread for weeks. “Back and forth she went,” her brother said, “from the burn unit to ICU.”

“As soon as her condition improved it worsened,” he noted. “It was always the same pattern entering ICU,” he recalls, wash your hands with warm water and soap and then put on medical mask and gloves.

“I was an 11 year old boy,” he wrote, “who had to do this just to watch my sister through a glass door of an isolation room.”

Mollie’s head had to be shaved and her skin was covered in blisters. “Her whole body was wrapped in gauze to stop the bleeding blisters,” SrA recalls.

“I remember sitting in her burn unit room watching two therapists lift her up and try to sit her in a wheelchair,” he said and described how drops of blood would fall from Mollie’s burnt flesh.

SrA says Mollie could not even scream out in pain. “All she could do is cry because her vocal cords had been burned,” he said.

After five months in the hospital Mollie was allowed to go home.

“Our living area transformed into that of a hospital room,” SrA said, “it had a ventilator for her tracheotomy, IV stand, stomach tube stand, heart rate monitor, and medications galore.”

Therapists came everyday and a nurse was always with Mollie giving her care. She required surgeries almost every other week to stretch her esophagus and the ligaments in her feet and hands. She also had cornea surgery.

According to SrA, today Mollie cannot walk, see, or talk very well. “She is fed through a stomach tube and it’s hard for her to breath,” he says.

Before SJS, Mollie was a dancer. “She was suppose to perform in the opening show for the 1996 Olympics in Atlanta,” her brother says. However, the room where she used to practice her dance moves and back flips has now become a rehabilitation center.

SrA says Mollie cannot receive any more therapy because of the healthcare budget cuts so his mother became a nurse to take care of Mollie.

SrA believes there needs to be more public awareness of the dangers associated with the drugs that cause this horrible reaction.

In January 2005, the Bextra related cardiovascular problems were back in the news when the results of two trials were released that showed the drug tripled the incidence of heart attack and stroke in coronary bypass graft surgery patients.

On February 14, 2005, the Associated Press reported that while Vioxx and Celebrex increased patients’ risk of heart attack and stroke by about 20 percent, Bextra increased the risk by 50%, citing a study by WellPoint Inc.

In April 2005, Pfizer finally took Bextra off the market at the request of the FDA. At the same time, the FDA told Pfizer to include a black box warning on Celebrex.

In a prepared statement, Pfizer reported that the FDA said Bextra’s risk to the heart was not distinguishable from other drugs and that it was the skin reaction that led to the decision.

The FDA advisory said it “concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market.”

The FDA explained that the request to recall the drug was based on:

1) The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

2) Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

The FDA also cited a lack of any demonstrated advantages for Bextra compared with other NSAIDs and instructed patients taking Bextra to contact their physicians and consider alternative treatments.

At the same time, FDA officials said all painkillers in the category known as “nonsteroidal anti-inflammatory drugs,” or NSAIDS, would have to carry stronger warnings about risks of heart attack, stroke, ulcers, internal bleeding or skin reactions, the Philadelphia Inquirer announced on April 9, 2005.

The warnings affected dozens of medications sold by prescription, as well as over-the-counter, with worldwide sales of at least $18.7 billion, according to the British pharmaceutical research firm Lead Discovery.

The drugs included Wyeth’s biggest-selling over-the-counter product Advil, which had sales of $620 million in 2004, Wyeth spokesman Doug Petkus told the Inquirer.

Teva Pharmaceutical’s ibuprofen, diclofenac and naproxen were included as also McNeil’s biggest-selling NSAID Motrin.

A report in the San Francisco Chronicle on February 27, 2005, said the “painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors.”

“In 2003,” the report said, “their manufacturers spent more than $1.5 billion to promote the drugs through television spots, print ads and pitches to doctors,” the report wrote.

And the $1.5 billion turned out to be a sound investment because by 2003, combined sales of the 3 drugs topped $5.3 billion, according to IMS Health, a pharmaceutical information and consulting company.

People who helped derail this deadly money train by standing up to the giant drug makers responsible for marketing this class of drugs often end up with a bitter pill. In the third civil lawsuit against Vioxx, Dr Topel gave testimony against Merck in a deposition and less than a week after his videotaped testimony was played in a Houston courtroom, he lost his title as chief academic officer of the Cleveland Clinic’s medical college.

On December 10, 2005, Dr Topol told the New York Times he was fired as a result of going up against Merck and said in part:

“The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified. No wonder nobody stands up to the industry.”

But the icing on the cake for the Cox-2 inhibiter saga came on December 2, 2005, when Gooz News ran an article titled, “Pricey Pain Pills No Better at Reducing Tummy Distress.”

“It looks like the billions spent on expensive new Cox-2 inhibitors,” Gooz said, “was wasted – and not just because Vioxx was the likely cause of tens of thousands of heart attacks among its users.”

Citing a report in the British Medical Journal that day, Gooz said that “Cox-2 inhibitors do not reduce the gastrointestinal side effects of over-the-counter pain pills like ibuprofen.”

“This was the whole rationale for justifying the drug industry’s massive investment in this new class of medicines,” Gooz noted, “since they don’t reduce pain any more effectively than older pain pills.”

Filed under: 2006, Bextra, NSAIDs, Pfizer, SJS, Truthout

US Kids Represent Psychiatric Drug Goldmine

December 12, 2009 Evelyn Pringle

Truthout

Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.

On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.

In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.

Parents can now have their kids declared disabled due to mental illness and receive Social Security disability payments and free medical care, and schools can get more money for disabled kids. The bounty for the prescribing doctors and pharmacies is enormous and the CEOs of the drug companies are laughing all the way into early retirement.

Psychiatric Drugs Explained

During an interview with Street Spirit in August 2005, investigative journalist and author of “Mad in America,” Robert Whitaker, described the dangers of psychiatric drugs. “When you look at the research literature, you find a clear pattern of outcomes with all these drugs,” he said, “you see it with the antipsychotics, the antidepressants, the anti-anxiety drugs and the stimulants like Ritalin used to treat ADHD.”

“All these drugs may curb a target symptom slightly more effectively than a placebo does for a short period of time, say six weeks,” Whitaker said. However, what “you find with every class of these psychiatric drugs is a worsening of the target symptom of depression or psychosis or anxiety, over the long term, compared to placebo-treated patients.”

“So even on the target symptoms, there’s greater chronicity and greater severity of symptoms,” he reports, “And you see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself.”

Whitaker told Street Spirit that the rate of Americans disabled by mental illness has skyrocketed since Prozac came on the market in 1987, and reports: (1) the number of mentally disabled people in the US has been increasing at a rate of 150,000 people per year since 1987, (2) that represents an increase of 410 new people per day and (3) the disability rate has continued to increase and one in every 50 Americans is disabled by mental illness.

The statistics above beg the question of how could this happen when the so-called new generation of “wonder drugs” arrived on the market during the exact same time period. The truth is, the “wonder drugs” cause most of the bizarre behaviors listed by doctors to warrant a mental illness disability.

Psychiatric Drug Goldmine

The CIA “World Factbook” estimate the world population to be about 6.8 billion and the US population to be a mere 307 million. In an April 2008 report, the market research firm Datamonitor reported that the “US dominates the ADHD market with a 94 percent market share.”

ADHD drug prices at a middle dose for 90 pills at DrugStore.com, are: Adderall $278, Concerta $412, Desoxyn $366, Strattera $464 and Vyvanse $385. Daytrana costs $437 for three boxes of 30 nine-hour patches.

The SSRI and SNRI antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, Wyeth’s Effexor and Pristiq and Lilly’s Prozac and Cymbalta. The average price of these drugs is about $300 for 90 pills at DrugStore.com.

The prices for anticonvulsants can run as high as $929 for 180 tablets of Glaxo’s Lamictal, and $1170 for 180 tablets of Johnson & Johnson’s Topamax.

In 2008, the atypical antipsychotics took over the slot as the top revenue earners in the US, and include Seroquel by AstraZeneca; Risperdal and Invega marketed by Janssen, a division of J&J; Geodon by Pfizer; Abilify from Bristol-Myers Squibb; Novartis’ Clozaril and Eli Lilly’s Zyprexa. The average price on these drugs for 100 pills at DrugStore.com is about $1,000. Lilly also sells Symbyax, a drug with Zyprexa and Prozac combined, at a cost $1,564 for 90 capsules at DrugStore.com in May 2009.

The briefing material submitted to an FDA advisory panel in April 2009 reported that an estimated 25.9 million patients worldwide had been exposed to Seroquel since its launch in 1997 through July 31, 2007, in the US, and the second quarter of 2007 for countries outside the US. Of that number, an estimated nearly 15.9 million took Seroquel in the US, compared to only ten million patients in the rest of the world. In 2008, the US accounted for roughly $3 billion of Seroquel’s $4.5 billion in worldwide sales.

For the full-year of 2008, Eli Lilly reported worldwide Zyprexa sales of about $4.7 billion, with US sales of $2.2 billion and only $2.5 billion for the rest of the world.

FDA as Promotional Tool

On June 12, 2009, an FDA advisory panel gave the green light to expand the marketing of Zyprexa, Seroquel and Geodon for use with 13 to 17 year-olds diagnosed with schizophrenia and 10 to 17 year-olds diagnosed with bipolar disorder. The FDA usually follows its advisers’ recommendations.

“Such approval gives manufacturers a shield from liability – for illegally promoting the drugs for off-label use,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection.

“And such approval ensures increased use of these drugs,” she warned. “Manufacturers and mental health providers will profit while children’s physical and mental health will be sacrificed.”

“The body of evidence showing these drugs to be harmful is irrefutable,” she said, “it is documented in FDA’s postmarketing database, and in secret internal company documents uncovered during litigation.”

According to Dr. Stefan Kruszewski, a Harvard-trained psychiatrist from Harrisburg, Pennsylvania, the atypicals increase the risk of obesity, type II diabetes, hypertension, heart attacks and stroke.

He said the drugs were marketed as safer and easier to tolerate than the older, cheaper antipsychotics because they would cause fewer neurological injuries like tardive dyskinesia and akathisia.

Those claims turned out to be totally false, he said, and “they continue to cause same neurological side-effects as the older antipsychotics.”

“Children are known to be compliant patients and that makes them a highly desirable market for drugs, especially when it pertains to large-profit-margin psychiatric drugs, which can be wrought with issues of non-compliance because of their horrendous side effect profiles,” according to a June 29, 2009 paper titled, “Drugging Our Children to Death,” in Health News Digest.com, by Gwen Olsen, who spent over a decade as a pharmaceutical sales rep, and authored the book, “Confessions of an Rx Drug Pusher.”

Children are forced to take their drugs by doctors, parents and school personnel, she said. “So, children are the ideal patient-type because they represent refilled prescription compliance and ‘longevity.'”

“In other words,” Olsen noted, “they will be lifelong patients and repeat customers for Pharma!”

“The initiative to drug our children for profit has exceeded all common sense boundaries and is threatening the welfare of every American child,” she stated, and it “is up to each and every one of us to stop this madness!”

Drug Makers Busted

Most all of the psychiatric drug companies have come under investigation over the past several years for promoting their drugs for off-label use, especially with children. However, the fines they end up paying are trivial compared to the profits earned through the illegal marketing campaigns.

In September 2007, Bristol-Myers Squibb entered into a $515 million civil settlement with the US Department of Justice for illegally marketing drugs, including Abilify, for off-label uses. In the first six months of 2009, Abilify had sales of $1.9 billion. In 2008, the salary and compensation package of Bristol-Myers’ CEO, James Cornelius, was $23,150,236, according to the AFL-CIO’s Executive PayWatch Database.

On January 29, 2009, Paxil and Wellbutrin maker, GlaxoSmithKline, announced that it would record a legal charge in the fourth quarter of 2008 of $400 million relating to an ongoing investigation initiated by the US attorney’s office in Colorado into the US marketing and promotional practices for several products for the period 1997 to 2004. The government inquired about alleged off-label marketing as well as medical education programs for doctors, “other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment,” according to a Glaxo annual report.

In January 2009, Eli Lilly settled with the DOJ and more than 30 states for $1.4 billion over the off-label marketing of Zyprexa. The agreement included a $615 million fine for a federal criminal charge. But $1.4 billion was chump change considering that Zyprexa was still Lilly’s best seller in 2008, with sales of $4.69 billion. Lilly also has paid over $1 billion to settle lawsuits filed by Zyprexa patients. In the first six months of 2009, Zyprexa sales were $1.5 billion. In 2008, Lilly’s CEO, John Lechleiter, had a pay package worth $12,856,882

In September 2009, the DOJ reached a $2.3 billion settlement with Pfizer related to the off-label promotion of several drugs, including the psychiatric drugs, Geodon, Zoloft and Lyrica, in the largest health-care fraud settlement in history. But even though Pfizer took the entire $2.3 billion as an earnings charge for the fourth quarter of 2008, the drug maker was still able to post a fourth quarter profit of $268 million. Pfizer’s CEO in 2008, Jeffrey Kindler, had a salary and pay package of $15,547,600.

Johnson & Johnson is also dealing with the DOJ and state-level investigations into the off-label marketing of Risperdal. The company’s latest SEC filing lists nine subpoenas received by the company involving promotions of Risperdal, including one “seeking information regarding the Company’s financial relationship with several psychiatrists.” In the first six months of 2009, Risperdal earned $660 million. J&J’s CEO, William Weldon, had a pay package worth $29,127,432 in 2008.

AstraZeneca’s third quarter SEC filing lists a $520 million tentative settlement agreement with the US attorney’s office in Philadelphia to resolve allegations related to the off-label marketing of Seroquel. At “least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes,” according to Ed Silverman on Pharmalot.

“A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years,” Dr. Roy Poses points out on the Health Care Renewal web site. In 2008 alone, Seroquel had world-wide sales of more than $4.4 billion.

As of July 13, 2009, AstraZeneca was also defending approximately 10,381 served or answered personal injury lawsuits and approximately 19,391 plaintiff groups involving Seroquel, according to SEC filings. Some of the cases also include claims against other drug makers such as Eli Lilly, Janssen Pharmaceutica and/or Bristol-Myers Squibb, the filing notes.

On September 23, 2009, Shire Pharmaceuticals received a subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US attorney for the Eastern District of Pennsylvania, seeking production of documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, according to Shire’s third quarter report for 2009.

In a November 6, 2009, SEC filing, Abbott Labs said the federal prosecutor for the Western District of Virginia was conducting an investigation for the US Justice Department of whether the company’s sales and marketing of Depakote violated civil or criminal laws, including the Federal False Claims Act and an anti-kickback statute related to reimbursement by Medicare and Medicaid programs to third parties.

In 2008, Depakote had sales of $1.36 billion and Abbott CEO, Miles White, had a salary and compensation package of $28,253,387.

In February 2009, the DOJ unsealed a lawsuit alleging that Forest Laboratories marketed the antidepressants Celexa and Lexapro for unapproved uses in children, and paid kickbacks to induce doctors to promote the drugs, including Dr. Jeffrey Bostic at Harvard University. In its latest SEC filing, Forest disclosed that it reached an agreement in principle in May 2009 to settle the civil aspects of US federal and state probes. “Penalties in the civil settlement are covered by a $170 million reserve Forest created in April,” according to a November 9 report by Dow Jones.

Forest also disclosed that the agreement “does not resolve the government’s ongoing investigation into potential criminal law violations” related to Celexa and Lexapro, and thyroid drug Levothroid, Dow Jones notes. In 2008, the salary and compensation for Forest CEO, Howard Solomon, was $6,565,324.

Over the past year and a half, a large number of so-called “Key Opinion Leaders” in the field of psychiatry have been exposed for not fully disclosing money received from many of the drug companies above through an investigation by the US Senate Finance Committee under the leadership of Iowa Republican Sen. Chuck Grassley.

The list so far includes Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association from Stanford; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas and Fred Goodwin, the former host of a radio show called “Infinite Minds,” broadcast by National Pubic Radio.

Fines as a Business Expense

The fraud settlements are “merely a cost of doing business to these pharmaceutical Goliaths and, in fact, caps their liability for these crimes,” said Alaskan attorney Jim Gottstein, the leader of the Law Project for Psychiatric Rights (PsychRights), a public interest law firm.

“Most importantly,” he noted, “these settlements have not stopped the practice of psychiatrists and other prescribers giving these drugs to children and youth and Medicaid continuing to pay for these fraudulent claims.”

“Because of the massive, harmful, increase in the psychiatric drugging of America’s children and youth, who are inherently forced, PsychRights has made addressing the problem a priority,” he said.

Gottstein conducted an investigation and determined that the vast majority of off-label psychotropic drug prescriptions for children and youth that are paid for by Medicaid constitute Medicaid fraud.

PsychRights now has a national “Medicaid Fraud Initiative Against Psychiatric Drugging of Children & Youth,” designed to address this problem by “having lawsuits brought against the doctors prescribing these harmful, ineffective drugs, their employers, and the pharmacies filling these prescriptions and submitting them to Medicaid for reimbursement,” according to its web site.

“Anyone who submits or causes claims to be submitted to Medicaid for drugs that are not for a ‘medically accepted indication’ is committing Medicaid Fraud,” said Gottstein, in a July 27, 2009 press release announcing the launch of the national campaign.

“Those guilty of this Medicaid Fraud include psychiatrists and other physicians prescribing these drugs, their employers, and pharmacies submitting the false claims to Medicaid,” he pointed out.

PsychRights estimates that over $2 billion in such fraudulent Medicaid claims are being paid by the government each year.

“Once one sues over specific offending prescriptions, all of such prescriptions can be brought in, which means that any psychiatrist on the losing end of such a lawsuit will almost certainly be bankrupted, because each offending prescription carries a penalty of between $5,500 and $11,000,” PsychRights explained.

It is hoped that once the doctors and pharmacies realize they are subject to financially ruinous Medicaid fraud judgments, the practice will be stopped or substantially reduced.

“Each prescriber may have a million dollars or few, at most, to lose, but the pharmacies’ financial exposure can run into the hundreds of millions of dollars and it is hoped this will attract attorneys to take these cases,” the web site noted.

In September and October 2009, Gottstein gave presentations on the initiative at the annual conferences of the National Association of Rights Protection and Advocacy and the International Center for the Study of Psychiatry and Psychology in order to find people who are potentially interested and willing to pursue such cases.

“This was successful and we have at least a few such cases cooking,” he reported. “PsychRights stands ready to help people interested in bringing such suits.”

In late 2006, Gottstein won international fame by subpoenaing and releasing thousands of documents involving Eli Lilly’s illegal marketing of Zyprexa, which resulted in front page stories in The New York Times.

PsychRights also has an appeal pending on a lawsuit filed against the state of Alaska and responsible state officials seeking declaratory and injunctive relief that Alaskan children and youth on Medicaid have the right not to be administered psychotropic drugs unless and until a number of specific conditions are met. The lawsuit seeks to prohibit the state from paying for psychiatric drugs prescribed off-label to children and youth.

In responding to the lawsuit, the state claimed that they do have any control over or responsibility for the psychiatric drugging of children in their custody, or any responsibility under Medicaid, and moved for dismissal on the grounds that PsychRights does not have standing, or the right to bring the suit, because it was not harmed by the state’s actions.

The court agreed and dismissed the case. “We think the judge is wrong and have filed an appeal,” said Gottstein.

In May 2009, Gottstein sent letters to Sens. Charles Grassley and Herb Kohl and Reps. Henry Waxman, Bart Stupak, John Dingell and Barney Frank, describing the massive Medicaid fraud involved in the prescribing of psychiatric drugs to children in the US and asked for “assistance in stopping these illegal reimbursements.”

As of November 8, 2009, Gottstein reported, “I haven’t gotten as much as an acknowledgment of receipt from any of the members of Congress to whom I wrote.”

While pursuing causes on behalf of PsychRights, Gottstein donates all of his time on a pro bono basis.

Filed under: 'ADHD', 2009, antipsychotics, bipolar, SSRIs, Truthout

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  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 5 years ago
  • is scared to bond with this baby, just in case. 5 years ago
  • Happy 6 months today baby. I love you Matthew. 5 years ago
  • Living with loss, sucks. 5 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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