Lawmakers Want to End Big Pharma Recruitment Schemes – Part 1

Evelyn Pringle May 29, 2007

Federal lawmakers are stepping up the pace to put a stop to the pharmaceutical industry’s customer recruitment schemes used to boost the sale of psychiatric drugs by tugging at heartstrings in promoting mental health screening programs as suicide prevention tools.

On May 18, 2007, US House of Representative Ron Paul (R-Texas), a physician by calling, introduced a federal legislative bill HR 2387 that would block federal funding for any mandatory mental health screening programs. At last count, 12 other members of the House were listed as co-sponsors of the bill.

First of all, contrary to the lie that the industry is trying to sell the pubic, there is no epidemic of child suicides. There are roughly 50 million school-age children in this country, and according to the June 16, 2006, Washington Post, there were only 1,737 suicides by children and adolescents in 2003, the last year for which national statistics are available.

In addition, experts have said over and over that screenings do not work. A March 28, 2002 paper, “Suicide in the United States,” by Jane Pearson, PhD, chairman of the National Institute of Mental Health Suicide Research Consortium at the time, states: “[W]hen researchers have tried to predict suicide using as many known risk factors as possible, they are still unable to predict who will and who will not commit this act.”

In the paper, she also verifies a real danger that screening critics are concerned about, in stating that, “a prevention program for high-school aged youth found that participants were more likely to consider suicide a solution to a problem after the program than prior to the program.”

According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, “No matter how we define mental illness in children or adults, it cannot be found by simple screening.”

“Nobody can, by merely looking at someone else, or even on the basis of a pen and pencil questionnaire,” he says, “differentiate the transient emotional disturbances we all have from those which last longer.”

Dr Lehrman also says screenings won’t prevent suicide because those who are contemplating it usually won’t tell. “Only when gross insanity exists can “mental illness” be recognized on inspection – and then we need neither experts nor screening,” he states.

“There are as many causes of depression as there are people suffering from it,” he explains

“Troubled people can indeed benefit from good mental health care,” he advises, “But good treatment requires addressing voluntarily a patient’s unique individual problems.”

“For this, screenings are unnecessary,” he adds.

The drugs marketed with the screening programs are the new generation of selective serotonin reuptake inhibitor antidepressants (SSRIs), including Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, which were falsely promoted as more effective than the older class of drugs in treating depression while the increased risk of suicide by patients taking the drugs was concealed.

The other drugs are the new class of atypical antipsychotics with brand names of Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon. It should be noted that the atypicals were FDA approved for the limited use of treating adults with schizophrenia and manic episodes of bipolar disorder, also known as manic-depression, the most serious of all mental illnesses.

These new drugs obviously do not work. A June 2005 study lead by researchers from Harvard Medical School, funded mostly by the National Institute of Mental Health, found that although there has been a dramatic rise in the treatment of mental disorders over the past decade, there had been no corresponding drop in the rate of suicidal thought and behaviors in adults.

The study pointed out that there had been a huge increase in the use of antidepressants during the 10-year period studied, but the rate of suicidal ideation, gestures and attempts has not changed at all.

Dr Barry Duncan, author of “What’s Right With You,” also says, “rates of depression have not changed for thirty years,” and, “suicide rates, despite the millions taking antidepressants, have not reduced.”

Dr Duncan points out that more than 150 million prescriptions worth $14 billion were written for antidepressants in 2003 alone.

However, evidence continues to mount that shows SSRIs are linked to suicide. On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.

“In an analysis of ‘unnatural’ deaths recorded by the Virginia Medical Examiner’s Office for 1987 through 2003,” MedPage wrote, “Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims.”

This latest study echoes a report by records researcher Ken Kramer that found most child suicides in Florida were by children who are already on psychotropic drugs. Mr Kramer analyzed every autopsy and toxicology report on every child suicide in the state of Florida from 2000 to 2004.

“The majority,” Mr Kramer says, “had already received psychiatric drug treatment even with the FDA warnings that say these drugs can cause mania, suicide, psychosis, worsening depression and even homicidal thoughts.”

A recent March 2007 report by the Government Accountability Office on Pediatric Drug Research states: “About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing.”

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for a drug maker to promote off-label uses, but doctors are allowed to prescribe a drug for any use they choose. However, almost without exception, the lawsuits now pending against psychotropic drug makers accuse the companies of influencing doctors to prescribe the medications for off-label uses.

Critics say this profit-driven drugging of patients recruited with screening programs has got to stop, because a whole generation of Americans are becoming disabled right before our eyes, and lawmakers should realize that the government is going to have to pay to care for these disabled people for life and not just their medical care, but for their very existence.

Linda Hurcombe, author of “Losing a Child: Explorations in Grief,” admits that her concerns about mental health screening programs arise from a personal tragedy. She is a US citizen living in the UK where prescription drug advertising is illegal, but her daughter fell victim to drug advertising while she was visiting the US.

“A few years ago my undepressed teenage daughter saw an antidepressant ad on American television,” Linda explains, “and on her return to our rural home she went to her doctor and asked for the drug.”

“It took her about eight minutes to persuade the doctor,” Linda says, “followed by 63 days of descent into chaos which ended in her suicide by hanging.”

“As far as patient advocacy is concerned,” she notes, “it is alluring to an increasingly health-aware public to demand more knowledge.”

“But what sort of ‘knowledge’ is likely from a gaggle of marketing moguls?” she points out.

“We must give the marketing men and women their due,” Linda says, “as they medicalize the human condition from the cradle to the grave.”

“Disturbing examples,” she points out, “include toddlers taking mint-flavoured Prozac for bipolar disorder, antsy kids being calmed with methamphetamines, people diagnosed with ‘intermittent explosive disorder’ [read ‘anger’], being medicated instead of addressing the causes of the stress in their lives.”

Linda has a new book, “Depression: healing emotional distress,” coming out soon.

Even with the limited approved uses for atyicals, last year drug makers sold more than $15 billion in antipsychotic drugs, according to data compiled by Bloomberg. Lilly’s Zyprexa generated $4.4 billion in sales last year, and Johnson & Johnson’s Risperdal had sales of $4.2 billion. Sales of Abilify climbed 41 percent to $1.3 billion.

Some of the known adverse events associated with these drugs include rapid weight gain and high blood sugar levels which are risk factors for diabetes, and disfiguring tics, dystonia which produces involuntary, often painful muscle contractions, heart attacks and sudden death in elderly patients.

Sales figures are so high because the makers of atypicals have doctors prescribing the drugs for all kinds of unapproved uses. On May 10, 2007, the New York Times reported that when Anya Bailey developed an eating disorder at 12 years old, her mother took her to a psychiatrist at the University of Minnesota who prescribed Risperdal.

Risperdal is not approved for treating eating disorders or any disorder in 12 year olds.

Anya gained weight, the Times noted, but within 2 years, she developed a crippling knot in her back the result of a nerve condition called dystonia, and now receives regular injections of Botox to unclench her back muscles and she often wakes up crying in pain.

The Times reported that the mother was surprised to learn that her daughter received a drug for a treatment not approved by the FDA, but was more surprised to learn that the psychiatrist who supervised Anya’s care received more than $7,000 from 2003 to 2004 from Risperdal maker Johnson & Johnson, in return for giving lectures about one of the company’s drugs.

These new drugs are being fed to so many people in all age groups for uses not approved by the FDA that experts say its often impossible to determine whether a symptom is caused by a mental disorder or a side effect from a drug.

Dr Elliot Valenstein, PhD, author of “Blaming the Brain”, says, “It is now difficult to find mental patients who have not had a history of drug treatment, and as a result many of the brain abnormalities found in these patients are probably iatrogenic, that is, produced by the treatment rather than being the cause of the disorder.”

“It is well established,” he advises, “that the drugs used to treat a mental disorder, for example, may induce long-lasting biochemical and even structural changes, which in the past were claimed to be the cause of the disorder, but may actually be an effect of the treatment.”

Dr Lehrman warns that the screening programs will “harm thousands of Americans by giving them stigmatizing diagnoses which can follow them for the rest of their lives, and then drugging them.”

In some cases, patients, including children as young as 2, are being given SSRIs, atypicals and ADHD medications all at the same time in drug cocktails that would make any patient act crazy. And when the weird behaviors start, the dosages of the drugs are increased and often another medication is added to the mix to treat the “new strange behaviors” which are actually side effects from the drug cocktail.

The serious side effects associated with these drugs are only now being revealed to the public and health care providers because the drug companies concealed studies that showed the adverse events had occurred in their own clinical trials years ago.

Also, the drug makers are starting to pay dearly for a decade of illegal marketing practices and the concealment of the adverse effects of the drugs.

For instance, to date, Eli Lilly has spent more than $1 billion to settle out of court with about 26,000 Zyprexa victims, with still more litigants waiting in the wings. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

The company is also facing lawsuits by 10 states and 4 class actions, filed on behalf of shareholders, charging Lilly with fraud in promoting the off-label sale of Zyprexa while concealing its side effects.

Zoloft maker Pfizer’s March 2007 SEC filing states in part, “A number of individual lawsuits have been filed against us in various federal and state courts alleging personal injury, including suicide and suicide attempt in certain cases, as a result of the purported ingesting of Zoloft.”

Pfizer will no doubt be facing more lawsuits in the near future because Zoloft has now been linked to life-threatening birth defects in babies born to mothers who took the drug during pregnancy.

Merck has no Plan to pay Vioxx Victims

Evelyn Pringle April 30, 2007

In 2006, Merck spent $500 million, including $175 million in the fourth quarter, in legal defense costs worldwide related to Vioxx litigation, according to SEC filings.

In addition, after reviewing actual costs and estimating future costs, the company says it has recorded a charge of $75 million to increase the reserve for future defense costs related to Vioxx to $858 million as of December 31, 2006.

However, although the legal team obviously plans to get paid well, there is no indication that Merck plans to pay any money to people injured by Vioxx because, according to the filing, Merck has not established any reserves for potential liability related to Vioxx.

Judging by the win-lose scorecard for Vioxx, it appears that juries are ignoring Merck’s culpability in placing a lethal drug on the market with full knowledge that people would be injured and killed and that 100s of thousands of Americans were in fact injured and killed.

People who may have forgotten how much damage was done while Merck was raking in billions of dollars off Vioxx should go back and read the transcript of a November 19, 2004 hearing before the Senate Finance Committee, where Dr David Graham, a career scientist at the FDA who has no dog in this hunt, stated, “Vioxx has been a disaster.”

“This is unparalleled in the history of the United States,” he testified.

To give a clearer picture of the Vioxx disaster, he described the harm in relationship to the number of Americans who took the drug and experienced heart attacks and strokes. Based on an estimated range of 88,000 to 139,000 people, Dr Graham said, “Of these, 30 to 40 percent probably died.”

He also offered a hypothetical scenario to help members of the committee recognize the magnitude of injuries and deaths caused by Vioxx, stating:

“Now, imagine that we were talking about jetliners. If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 139,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to two to four aircraft every week — week in, week out — for the past five years.”

Dr Graham testified that research indicated that Vioxx caused up to 160,000 heart attacks and strokes and was responsible for an additional 27,785 deaths from heart ailments from 1999 to 2003.

Years later, nothing has changed as far as Merck getting honest about the known dangers associated with Vioxx. A study in the September 2006 Journal of American Medical Association found that heart problems could develop in Vioxx users much sooner than the 18 months that Merck claimed and, in fact, could develop in one month.

Still another study in the same JAMA issue found Vioxx to be associated with an increased risk in erratic heartbeats, or arrhythmia, and renal events including swelling of the hands and feet, high blood pressure and kidney dysfunction.

According to the company’s SEC filings, as of March 31, 2007, Merck had been served, or was aware that it had been named as a defendant, in approximately 27,250 lawsuits, which include about 45,700 plaintiff groups alleging personal injuries and approximately 266 putative class actions alleging personal injuries and/or economic loss.

Of these cases, approximately 8,400, representing about 23,450 plaintiff groups, are slated to be in the federal MDL and approximately 16,550 lawsuits representing about 16,550 plaintiff groups in a coordinated proceeding in New Jersey Superior Court.

In addition, the filing notes, approximately 13,700 claimants had entered into Tolling Agreements with Merck, which halt the running of statutes of limitations for claimants who seek to toll claims alleging injuries resulting from a thrombotic cardiovascular event that results in a myocardial infarction or ischemic stroke.

The filing also reports that individual and putative class actions have been filed in state and federal courts alleging personal injury and/or economic loss. A number of these actions, it says, are coordinated in a separate proceeding in an MDL in the US District Court for the Eastern District of Louisiana, and in coordinated proceedings in state courts in New Jersey, California and Texas; and in the counties of Philadelphia, Pennsylvania, Washoe County, Nevada and Clark County, Nevada.

Legal experts agree that the greatest threat to Merck comes from class-action lawsuits seeking recovery under consumer fraud statutes with claims that Merck failed to disclose damaging information to the public and, as a result, received a higher price for Vioxx than it would have if the information had been disclosed.

Legal experts say the most worrisome is a class-action filed in October 2003, now pending before the New Jersey Supreme Court. In the case of International Union of Operating Engineers Local 68 Welfare Fund vs Merck, New Jersey State Superior Court Judge Carol Higbee held that New Jersey’s consumer fraud statute applies to all Vioxx sales in the US and granted class-action status to third-party payors nationwide in July 2005.

Most purchases for Vioxx were made by health plans run by insurance companies and health maintenance organizations, and the Union case could include millions of Vioxx users. Considering that an estimated 20 million consumers used Vioxx in the US since it came on the market in 1999, legal experts says, Merck could get hit with a judgment worth billions of dollars if it loses this one case.

The plans say they lost significant amounts of money after being persuaded by Merck’s marketing efforts to add Vioxx to their formularies, or the lists of drugs for which they agree to reimburse members. The Union alleges that Merck’s marketing and advertising of the drug was fraudulent and misrepresented the safety and efficacy of the drug.

Third-party payors in this case can recover the actual payments made for Vioxx, and they are entitled to treble damages, as well as attorney fees, under New Jersey consumer fraud laws. For instance, if there were 10 million Vioxx users who each bought $1,000 worth of the drug through the benefit plans at the going price at the time of $72 for a 30-day supply, a judgment could conceivably reach $10 billion, in addition to attorney fees.

Unlike personal injury cases, attorneys for the Union do not have to prove that anyone was injured, all they have to show is that the third-party payors were influenced to purchase Vioxx by Merck’s deceptive marketing and promotion of the drug.

In allowing the lawsuit to go forward, Judge Higbee drew no distinction between a company defrauding a person or a third-party payor. “This Court,” she wrote, “sees no reason why the duty to be honest about the safety and usefulness of a drug when marketing it as a product for sale should not extend to the third-party payors who actually pay for the purchase of drugs for members.”

Merck appealed Judge Higbee’s class certification, and in a unanimous decision in March 2006, the New Jersey appellate court affirmed the certification. From there, Merck appealed the appellate ruling to the New Jersey Supreme Court.

On March 19, 2007, a five-judge panel heard arguments, and the Union’s lead attorney, Christopher Seeger, told the court that, because Merck concealed the risks of Vioxx from the health care plans, the drug was chosen over about 30 other cheaper products.

Mr Seeger said, New Jersey consumer fraud statutes should govern the case because all of the decisions about what information was disclosed about Vioxx and how the drug should be promoted and advertised to the public were made at Merck’s New Jersey headquarters.

“It’s perfect for a class action,” Mr Seeger said. “If we really want to deter bad conduct, as is alleged in this case, the way to do it is to protect every purchaser of the product.”

Legal analysts say a ruling by the high court is not expected for several months.

Another class-action got the go-ahead in Canada on November 9, 2006, when Quebec Superior Court Judge Andre Denis authorized a lawsuit by Quebec residents who suffered “damages caused by the use of the medication,” between October 1999 and September 2004, according to the November 11, 2006 Moose Jaw Times Herald.

Dimitri Lascaris, an attorney for plaintiffs in Quebec and Ontario, said there have been more than 20 requests for class-action Vioxx lawsuits filed in Canada but this is the first case that has received clearance to proceed.

J&J Concealed Dangers of Ortho Evra Birth Control Patch

Evelyn Pringle April 16, 2007

Tens of millions of prescriptions have been written for Johnson & Johnson’s Ortho Evra birth control patch since it arrived on the market in 2002, and medical experts say the patch has harmed thousands of young women of childbearing age.

In September 2006, the FDA warned that use of the patch, made by the Ortho-McNeil division of J&J, increases the risk of blood clots, which can lead to heart attack and stroke.

Because the patch releases hormones directly into the blood stream, medical experts say, a much higher concentration of hormones enters the body than with birth control pills. A November 2005, FDA advisory reported that patch users were exposed to about 60% more estrogen than women on the pill.

A recent study in the February 2007, journal, Obstetrics and Gynecology, of 49,000 women who used the Ortho patch, and 202,000 who used oral contraceptives, found that blood clots or “venous thromboembolism” occurred in patch users at a rate of 2.2 times higher than with women on the pill.

Legal experts says proving causation in these cases will be easy because blood clots in young women are almost unheard of. No doubt due to the recognition of this fact, when the first lawsuits were filed, J&J quickly began settling cases out of court for substantial sums of money, trying to keep a lid on the news that women were being injured by the patch.

J&J has already settled lawsuits in state courts in New Jersey, Texas, and California, and federal courts in North Carolina and Pennsylvania, according to Bloomberg on April 2, 2007.

Texas attorney, Ray Chester, told Bloomberg that one settlement involved a 40-year-old woman with 2 children, who had a massive stroke after only 12 days on the patch and is now a quadriplegic with brain damage and requires around the clock medical care.

However, as the number of lawsuits multiplied, that strategy of quietly settling out of court could not continue for obvious reasons. J&J’s Annual Report filed with the SEC in February 2007, states that, as of December 31, 2006, “there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries allegedly due to ORTHO EVRA.”

Documents revealed in litigation, prove that J&J knew about the high rate of blood clots because they show the company had been analyzing the FDA’s reports on injuries and deaths in women using the patch, and had even compiled charts showing the higher rates of clots and deaths when compared to women taking birth-control pills.

One memo from 2003, reveals that the company refused to conduct a study to compare the rate of adverse events with the patch to its Ortho-Cyclen pill because there was “too high a chance that study may not produce a positive result for Evra” and a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

Newly released documents show that, instead of warning consumers and prescribing physicians about the clot problems, Johnson & Johnson has been doing everything in its power to stop the negative information about the patch from becoming public.

Documents unsealed this month by Superior Court Judge, Bryan Garruto, in a New Jersey state court proceeding involving more than 300 lawsuits, reveal that J&J bought up dozens of internet domain names related to the Ortho patch in an attempt to stop negative information from appearing on the internet.

By using the standard trick of claiming the documents contained trade secrets, J&J had previously obtained a court order to keep them sealed so the public would not learn about the extent of the company’s damage control efforts.

But in granting a motion by the plaintiffs’ attorneys to unseal the documents, Judge Garruto said they were not entitled to a protective order because the information did not constitute trade secrets that, if revealed, would benefit J&J’s competitors.

One document released calls for, “Defensive actions to minimize impact of negative presence,” to include buying internet domain names, monitoring blogs and purchasing the top key words related to the patch that would be picked up by Google and Yahoo search engines.

Apparently, drug companies do this on a regular basis. According to Kent Jarrell, a spokesman for J&J, quoted by Bloomberg News on April 2, 2007: “The purchase of the domain names is a standard and accepted business practice for companies that are trying to prevent product disparagement and to safeguard the defendant’s reputation.”

Legal experts view the situation differently. According to Attorney, Derek Braslow, of the Conshohocken, Pennsylvania firm of Pogust & Braslow, “While J&J’s purchase of key internet search terms and domain names does not prove that the Ortho patch causes injuries,” he says, “J&J’s conduct, like the conduct of most drug companies, does show an intentional disregard for the victims of its deadly drug.”

He does not find the drug maker’s conduct surprising. “J&J has only taken the next step in the natural evolution of marketing,” Mr Braslow explains, “promote the drug at all costs during the life of the patent but eliminate all marketing and promotion after the money has been made and the victims start seeking answers and advocacy.”

“Purchasing the domain names has nothing to do with the merits of the litigation,” he says, “it has everything to do with damage control, protecting their drug at all costs and preventing victims from seeking and finding justice.”

After lives have been lost and families devastated as a result of using the patch, he states, the company is attempting to prevent the victims from finding legal counsel. “Instead of coming forward with the truth behind the patch,” he notes, “the company has gone to extraordinary measures to stop victims from finding attorneys to represent them.”

Attorney, Ted Chabasinski, who recently worked on a case involving the release of damaging Zyprexa documents that Eli Lilly had successfully kept hidden with a court order while settling out of court with about 26,000 litigants, agrees that J&J’s conduct is standard procedure when it comes to concealing damaging information about pharmaceutical products.

“What Johnson and Johnson is doing,” he says, “just reflects drug company practices in general.”

“None of them want the public to know that their products are dangerous and often ineffective as well,” Mr Chabasinski notes.

“America must wake up soon,” he warns, “to what these greedy corporations are doing to our health.”

“We need politicians,” he states, “who will stand up to the drug companies, and judges who will recognize that when drug company executives approve hiding the deathly effects of their drugs, thus killing thousands of people, they should be put in prison.”

“It isn’t enough,” he advises, “to make the companies pay damages.”

“Nothing will stop these practices,” he warns, “except holding the people who run these corporations personally responsible for their criminal behavior.”

According to FDA records obtained by the Associated Press with a FOIA request in 2005, in one 18-month period, there were 9,116 adverse events reported by women using the patch, a rate 7 times higher than women taking oral contraceptives.

A factor that must always be considered when assessing the number of people who may have been harmed by a product is that the FDA estimates that only 1% to 10% of adverse events are ever reported, which means the number of women harmed by the patch is definitely much higher. In 2005 alone, doctors wrote more than 9.4 million prescriptions for the patch, according to the pharmaceutical industry-tracking firm, IMS Health.

The review of records by the Associated Press revealed that the FDA knew that blood clots were at least 3 times more common with the patch before the device was approved.

The records show that in 2000, FDA doctors reviewing J&J’s clinical trials warned that clots could be a problem with the patch after finding that 2 women were treated for serious conditions where blood clots had traveled to their lungs.

One reviewer said, “The label should clearly reflect this reviewer’s safety concern about a potential increased risk.” But in the end, the label did not contain the warning, and there was no requirement for follow-up studies other than ordinary reviews of voluntary reports.

April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.

Makers of Zyprexa Risperdal and Seroquel Under Fire

Evelyn Pringle March 9, 2007

Eli Lilly, Johnson & Johnson, and AstraZeneca, are all named defendants in a new lawsuit filed by the state of Pennsylvania on February 26, 2007, to recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.

Pennsylvania is the 5th state to sue Lilly over its illegal marketing of Zyprexa. And according to SEC filings, Lilly was served with four Canadian lawsuits in 2005, with claims “similar to those in the litigation pending in the United States.”

So far, two states have sued Johnson & Johnson over Risperdal, but Pennsylvania is the first state to file a lawsuit against Seroquel-maker AstraZeneca.

The drugs belong to a class known as “atypical” antipsychotics, FDA approved only to treat adults with schizophrenia or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world. In 2006, Zyprexa sales were $4.3 billion, Seroquel’s earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.

A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.

According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.

When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug. Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.

On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZeneca, requesting information related to the exact same charges alleged in lawsuits filed by individual states.

The letter sent to Lilly states in part, “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa,” and requests information relevant to these allegations.

The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.

In addition, Rep Waxman wants Lilly to turn over all internal company documents that were kept under seal for years with a court order, but were provided to him by Attorney, James Gottstein, in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

According to the New York Times, some of these documents reveal that Lilly knew about Zyprexa’s link to high blood sugar and extreme weight gain that often leads to diabetes, and others show the details of off-label marketing scheme called “Viva Zyprexa.”

Rep Waxman’s letter to AstraZeneca basically asks for the same documents requested from Lilly except that he requests more information related to the physicians and authors involved in company sponsored studies and writing the reports.

Late last year, the atypical makers also received subpoenas from the attorney general of California seeking much of the same information.

In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has hired private attorneys. According to the complaint, the defendants cost Pennsylvania millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs.

The Pennsylvania case comes on the heels of lawsuits by two Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who say, drug companies are making a fortune from the off-label sale of drugs to patients whose care is funded by Medicaid and Medicare.

At the heart of the off-label scheme, they say, are the preferred drug lists, or medication formularies, maintained in many states. Once drugs are added to the list, they must be prescribed as a first line of treatment for all patients in state run institutions and patients in the general population who are covered by public health care programs.

In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with the Pennsylvania Department of Public Welfare, and charged with reviewing psychiatric care provided by state-funded agencies to identify waste, fraud, and abuse. He was also responsible for reviewing the deaths of individuals in state care who died under suspicious circumstances in facilities inside and outside of Pennsylvania.

Early in his investigation, Dr Kruszewski noticed that almost all of the patients under state care were on drug cocktails consisting of antipsychotics, antidepressants, and anticonvulsants. The populations he found drugged most often, he said, were children in state care, the disabled, people in state prisons, and children in the juvenile justice system.

For instance, he says, Neurontin was only approved for controlling seizures, but “was being prescribed for anxiety, social phobia, PTSD, oppositional defiant behavior, and attention deficit disorder with no evidence to support these uses.”

When he informed his superiors about the high rate of off-label prescribing and warned about the risk of liability to the state of Pennsylvania if it continued, he was told, “it is none of your business.”

In June 2003, Dr Kruszewski inspected a facility in Oklahoma that housed children from Pennsylvania after an unexpected death of a child, and found children were being overmedicated and housed in deplorable living conditions, in addition to being sexually and physically abused by staff and kept in unnecessary restraints and seclusion.

In a report, Dr Kruszewski recommended removing the children from the facility, “in order to protect other innocent individuals from morbid and mortal consequences of severe over-medication, including chemical restraints; emotional, physical and sexual abuse; seclusion; and dirty and inadequate living conditions.”

A day later, Dr Kruszewski was accused of “trying to dig up dirt,” and was subsequently fired in July 2004, because he refused to keep quiet and accept that it was none of his business, he says.

A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that patients under state care were being drugged for profit and prescribed as many as 5 psychiatric drugs at the same time, and that four children and one adult had died.

In his action, Dr Kruszewski alleged that his superiors violated his right to free speech by firing him because he made statements about the abuses in the state system, which were a matter of public concern.

Dr Kruszewski is represented by attorneys from Government Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and Mark Cohen, in Federal Court in the Middle District of Pennsylvania with Chief Judge Yvette Kane presiding.

Defendant, Christopher Gorton, is the Chief Medical Officer for DPW, who fired Dr Kruszewski. He filed a motion for summary judgment to dismiss the First Amendment claim on the basis that the law does not protect whistleblowers if they are fired for making comments they would be expected to make in the context of their employment.

In reading the Court’s March 2, 2007, Decision denying Mr Gorton’s motion, it appears that Mr Gorton tried to have it both ways. When Dr Kruszewski was employed and tried to report the harm to people under state care, he was told it was none of his business and to quit digging up dirt. Under oath in a deposition, Dr Kruszewski stated that he was told that the subjects of his statements were not part of his job duties.

However, in his motion, Mr Gorton now claims that Dr Kruszewski’s comments were made pursuant to his official employment duties. In her written opinion, Judge Kane, quoted relevant case law to describe comments that are protected:

“A public employee’s statement is protected activity when (1) in making it, the employee spoke as a citizen, (2) the statement involved a matter of public concern, and (3) the government employer did not have an adequate justification for treating the employee different from any other member of the general public as a result of the statement he made.”

“The statements in question can be categorized,” Judge Kane wrote, “as: (1) reports regarding poor quality of care, including abuse of patients by staff at treatment facilities; (2) complaints about the lack of qualifications of another private contract doctor; and (3) statements about use and costs of medications.”

In order to grant a motion for summary judgment, a judge has to find that there are no genuine disputes of material fact that would require a jury to resolve. In this case, Judge Kane found there were disputes regarding Dr Kruszewski’s job duties and whether his statements were substantial and motivating factors in his termination.

In his motion, Mr Gorton claims the statements were not protected speech, but then says, even if they were, they were not a factor in his decision to terminate Dr Kruszewski, because he was unaware of the statements when he decided to fire Dr Kruszewski.

However, Judge Kane found evidence in the record that, “if credited by a fact-finder,” she wrote, “would support Plaintiff’s claim that Gorton knew of at least some of Plaintiff’s protected statements.”

“Because there remain genuine disputes of material fact,” she states, “regarding Plaintiff’s job duties and whether Plaintiff’s statements were substantial and motivating factors in his termination, the Court cannot grant summary judgment for Defendant Gorton.”

According to Dr Kruszewski, apart from all the legal wrangling, his focus remains on trying to protect Pennsylvania citizens against unwarranted drugging, sexual and physical abuse, and unnecessary restraint and seclusion.

His original lawsuit alleges that drug companies used “political friendships, money, and other emoluments” to achieve “a level of influence with Pennsylvania’s state government” to promote “the use of their products.”

These charges echo those previously made by the other Pennsylvania whistleblower, Allen Jones, who was also a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, and was fired after he informed his superiors that drug companies were funneling money to state officials and policy makers in positions of influence over the state’s preferred drug formulary known as PennMap.

Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania, also with the assistance of the Government Accountability Project. While he did not agree to a gag order regarding his concerns, he did agree not to discuss the terms of the settlement.

During his investigation, Mr Jones found collusion between drug companies and several state officials and specifically, Steven Fiorello, Pennsylvania’s chief pharmacist, a valuable player because he monitored pharmacy operations at 9 state hospitals and served on the committee that determined which drugs would be prescribed to patients in state hospitals.

On November 21, 2006, Mr Fiorello was arraigned on two felony counts of conflict of interest and misdemeanor counts of accepting money and failing to disclose the income on his yearly financial interest statements.

A year and a half earlier, the Pennsylvania State Ethics Commission had determined that Mr Fiorello had repeatedly violated state ethic laws by using his position to earn money from drug companies. To settle the charges with the Ethics Commission, Mr Fiorello paid fines totaling $27,269, before the case was referred for criminal prosecution.

Down in Texas, another state official, Dr Steven Shon was fired from his job in October 2006, after the state’s attorney general, Greg Abbot, found J&J had improperly influenced Dr Shon to list Risperdal in a state formulary called the “Texas Medication Algorithm Project,” or TMAP, while receiving money from J&J.

In December 2006, Mr Abbott joined another whistleblower lawsuit filed by Mr Jones, against J&J, alleging in part, that the company misrepresented the safety and effectiveness of Risperdal and unduly influenced Dr Shon and others, to make it a drug of choice for persons covered by public health care programs in Texas.

TMAP required doctors to prescribe atypicals rather than the older, less expensive antipsychotics. “The plan,” Mr Jones explains, “was part of a larger scheme designed to infiltrate public institutions to influence prescribing practices in which drug companies bought the opinions of a few key doctors and state policymakers, and opened the door for spending billions of tax dollars on dangerous drugs.”

The Texas lawsuit describes exactly how the TMAP preferred drug list was developed in Texas in 1997, and according to the complaint, Dr Shon traveled around the country at J&J’s expense to convince officials in other states to adopt the TMAP model, which is now used in 17 states.

The lawsuit says, J&J promoted Risperdal by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments and that Risperdal was recommended as the drug of choice for children, even though it was not approved for use with children.

TMAP was highly successful in getting doctors to prescribe atypicals to kids. According to an investigation of psychiatric drug use by Texas children on Medicaid, ACS-Heritage, a medical consulting firm, found 19,404 teens were prescribed an antipsychotic in July or August of 2004, with nearly 98% being atypicals.

ACS also found that more than half of the doses were inappropriately high, almost half of the prescriptions did not appear to have diagnoses warranting their use, and one-third of the children were on two or more drugs.

The Texas lawsuit alleges that J&J concealed Risperdal’s link to hyperglycemia, stroke, and renal failure, to qualify for reimbursement under Medicaid, and that Texas seeks to recover money paid to purchase the drug for off-label uses and the cost of medical care for the people injured by Risperdal.

In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.

Critics say, the Governor of Pennsylvania is suing atypicals makers now to portray a hard stance against the pharmaceutical industry because he wants to run for higher office, when in reality, he has known about the PennMap off-label scheme for years.

The consensus is that Mr Rendell believes he missed a chance for national prominence by allowing the two whistleblowers to be fired and sweeping the results of their investigations under the rug. Critics point out that PennMap is still in place even though TMAP has been discredited in Texas and other states.

In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David Graham’s estimate that 62,000 Americans die each year from the off-label prescribing of atypicals. According to Mr Jones, this translates into nearly 10,000 deaths occurring in Pennsylvania during Governor Rendell’s first term.

During a congressional hearing last month, Dr Graham testified that the off-label use of atypicals to sedate people in nursing home kills roughly 15,000 people a year. Based on this estimate, Mr Jones says, about 2,400 Pennsylvania senior citizens died in the Governor’s first term.

“During this time,” Mr Jones reports, “Pennsylvania citizens, insurers and taxpayers paid in the neighborhood of one billion dollars for drugs proven to be no more effective, and far more deadly, than the older antipsychotic medications.”

Zyprexa Injury Clock Keeps Ticking Away

Evelyn Pringle February 2, 2007

The on-going legal battle over the disclosure of secret Eli Lilly documents that reveal the serious health risks associated with Zyprexa and the company’s off-label promotion of the drug involves a matter of grave public concern.

But observers on the sidelines of this courtroom circus say the conduct of the judge in helping Lilly keep documents secret that give the specific details of an illegal marketing scheme that is literally killing people is almost as disturbing as the underlying acts.

The off-label prescribing of Zyprexa has created a public health crisis. According to the New York Times, the secret documents show a pattern of unlawful activities that may have left the 20 million individuals who have taken Zyprexa with incomplete information regarding the side effects of the drug.

Harvard trained psychiatrist, Dr Stefan Kruszewski, reports that Zyprexa increases the risk of obesity, diabetes, hypertension, cardiovascular complications, heart attacks and stroke.

Keeping in mind that the FDA says that only between 1% and 10% of adverse events are reported to the agency, a study conducted 5 years ago, in the July 2002, issue of Pharmacotherapy, reviewed the adverse event reports submitted on Zyprexa and found that of the 289 cases of diabetes reported, 225 of the patients were newly diagnosed.

The review also identified 100 Zyprexa patients who had developed ketosis, a serious complication of diabetes, 22 cases of pancreatitis, a life-threatening inflammation of the pancreas, and 23 deaths associated with the drug.

Zyprexa is an antipsychotic approved by the FDA to treat adults with schizophrenia and bipolar disorder only. But doctors are prescribing the drug for conditions, treatment durations, and patient populations for which it was never intended and worst of all it is being widely prescribed for children.

For instance, in February 2006, public health officials in Florida ordered an investigation into why the number of children who are prescribed antipsychotics billed to Medicaid in Florida had nearly doubled in five years, from 9,500 children to almost 18,000.

The lawsuits filed against Lilly to recover the money paid for Zyprexa by state Medicaid programs due to the company’s off-label promotion say the drug is being sold for unapproved uses such as anxiety and other mood disorders, sleep disruption, autism, attention deficit disorders, hyperactivity, and dementia.

According to the attorney general of Mississippi, about 10% of Zyprexa patients on Medicaid in that state, have developed diabetes. In fact, the health problems associated with Zyprexa have become so prevalent, that one class action lawsuit is demanding money to cover the medical monitoring of all patients who took Zyprexa but have not yet been diagnosed with high blood sugar, diabetes, or pancreatitis.

Children on Zyprexa are developing life-long injuries. At the annual meeting of the American Academy of Child and Adolescent Psychiatry in Washington, DC, on October 20, 2004, researchers from the Johns Hopkins Children’s Center reported that atypical antipsychotics were found to trigger insulin resistance in children. The researchers evaluated 11 children who gained significant amounts of weight while taking the drugs.

Weight gain is a known risk factor that contributes to insulin resistance. Insulin is produced by the pancreas to help cells absorb glucose and provide energy. When resistance occurs, the pancreas tries to keep up with the demand by producing more insulin until it eventually cannot keep up, and excess glucose builds up in the bloodstream which can increase the risk of type-2 diabetes, heart disease, and stroke.

All six children in the John Hopkins study who were on moderate or high doses of an antipsychotic developed symptoms of insulin resistance, and three of the 5 children on low doses did as well.

The study’s lead author, Dr Mark Riddle, director of the division of child and adolescent psychiatry at the Center, said, “The insulin resistance seen in these children was greater than what would be expected from weight gain alone, suggesting there is a factor distinct from excess weight that directly induces insulin resistance.”

Experts say Zyprexa is poison for some people. According to Dr Louis Caplan, Professor of Neurology at Harvard Medical School, there is overuse of antipsychotics in patients admitted to hospitals. “These drugs,” he said, “are often given in high doses to very sick patients in intensive care units or on medical and surgical units,” in the February 21, 2006, journal Neurology.

“They cause symptoms and neurological dysfunctions that are a common reason for neurological consultations in the hospital,” Dr Caplan warns.

“Old sick people with abnormal brains do not tolerate these drugs well,” he says. “In patients with Lewy-body disease and some Parkinsonian syndromes, their use is a disaster, setting patients back for weeks,” he warns.

When the FDA approves a drug, it also approves the labeling which explains the manner in which the drug is to be prescribed. While doctors may prescribe drugs as they see fit, its illegal for drug companies to promote drugs for uses outside the labeling.

However, as vividly evidenced here, drug makers do it and get away with it all the time and the leaked Lilly documents prove that the US court system is aiding and abetting drug companies in hiding their illegal marketing schemes.

For instance, in one article, the Times quotes a sealed document that served as a script for a company meeting in 2001, where a Mr Bandick praised sales representatives for the number of new Zyprexa prescriptions they got doctors to write. According to the script, more than 100 representatives convinced doctors to write at least 16 extra prescriptions.

The legal battle over the documents began in December 2006, when Dr David Egilman, provided the documents to Alaskan attorney, Jim Gottstein, and Mr Gottstein turned them over to Alex Berenson, a reporter for the New York Times.

Dr Egilman first learned about Lilly’s illegal conduct when he reviewed the documents a few years back as an expert witness in the Zyprexa litigation. However, when Lilly was successful in the settling the cases out of court, Dr Egilman was forcibly silenced because the court allowed Lilly to continue to keep the documents hidden with a protective order.

As soon as the articles began to appear in the New York Times, describing an off-label marketing scheme called, “Viva Zyprexa,” Lilly got a judge to issue a mandatory temporary injunction on December 18, 2006, ordering Mr Gottstein to return the documents and list the names of everyone he disclosed them to or discussed them with.

After he supplied the list, Lilly got the court to issue a second temporary injunction on December 29, 2006, to prohibit the dissemination of the documents by Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall.

The above list reads like a Big Pharma hit list. It includes about every well-known expert on the side effects of psychiatric drugs in the US, as well as the journalists and authors who have investigated and written most extensively about the misconduct of drug companies when it comes to the off-label promotion of drugs, and specifically Zyprexa.

Conspicuously absent from the injunction is the New York Times and the reporter who actually used the documents when writing five articles on the matter. Most curious is the fact that Lilly has never even asked the court to issue an injunction for the Times.

On January 3, 2007, a hearing was held on a request by Lilly to extend the temporary injunction, and to force Mr Gottstein to appear in New York City for a deposition within 5 days, as a prelude to charging him with civil and criminal contempt of court for publicizing the documents.

As a result of that hearing, several more entities were added to the injunction list including Eric Whalen and his web site at; the MindFreedom web site at, and the Alliance for Human Research Protection (AHRP) web sites at and

Once again, the Times and Alex Berenson were not added, and in fact, during the hearing, Judge Jack Weinstein said he was not about to issue an injunction against the Times.

By its own estimate in the media, Lilly produced approximately 11 million documents in discovery for Zyprexa litigation thus far, and has designated them all confidential pursuant to Case Management Order 3, a protective order entered on August 9, 2004.

When issuing CMO-3, the court gave Lilly the right to designate documents confidential, as long as Lilly “in good faith” believed that they were. However legal experts say the secret documents at issue here never should have been covered by a protective order.

According to attorneys in the case, in entering CMO-3, the court did not articulate the reasons why a protective order was necessary or set forth any criteria to use when determining whether a document was actually confidential and deserving of protection.

Yet instead of keeping the focus on why the 11 million documents were ever permitted to remain hidden in the first place, Judge Weinstein is allowing Lilly to hammer away at the messengers who gave the documents to the press, after deciding that the information needed to be circulated before more people were injured and killed.

In a January 17, 2007, hearing, Mr Gottstein was asked: “In this particular case involving Zyprexa, at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?”

He answered: “Absolutely.”

Mr Gottstein was then asked whether it was his impression that there were thousands of cases of harm to people from Zyprexa, while Lilly was in the process of settling cases out of court, and he said yes and that was why he wanted the documents out there “to protect people from this drug.”

He had nothing to gain personally by providing the documents the Times. Mr Gottstein testified that he does not represent clients who were injured by Zyprexa for money damages and that his sole interest was protecting patients.

On January 25, 2007, in response to a request for Dr Egilman to appear at a deposition in preparation for Lilly to file civil and criminal contempt of court charges against him, though his attorney, Dr Egilman informed Lilly’s legal team that he will refuse to testify under the protection of the Fifth Amendment.

A number of persons restrained by the injunction have obtained attorneys to file briefs with First Amendment arguments including the public’s right to know what is in the documents and some people appeared at the last court hearing.

Ms Sharav and Dr Cohen point out in their brief, that they are not ex-employees of Lilly who have stolen trade secrets. They are merely a public health advocate and a professor who seek to share Lilly’s own words with the public and they view exposing the information that “Lilly wants so desperately to keep hidden” as their primary public role.

Ms Sharav testified at the January 17, 2007, hearing, and when asked why she was interested in the documents by a Lilly attorney, said because they document the fact that Lilly knew in 2000, that Zyprexa caused diabetes, “from a group of doctors that they hired who told them you have to come clean.”

“And instead of warning doctors who are widely prescribing the drug,” she testified, “Eli Lilly set about in an aggressive marketing campaign to primary doctors.”

“Little children are being given this drug,” she said, “Little children are being exposed to horrific diseases that end their lives shorter.”

“Now, I consider that a major crime,” she stated, “to continue to conceal these facts from the public is I think really not in the public interest. This is a safety issue.”

Lilly’s attorney asked the court to strike her comments from the record but the request was denied.

Attorney, Alan Milstein, appeared on behalf of Ms Sharav, the AHRP, and Dr Cohen, and toward the end of the hearing noted that in handling the underlying Zypexa litigation, the judge had had occasion to look at the documents in question or at least to read the Times articles and stated: “What is abundantly clear is that they are not trade secrets.”

“Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo,” Mr Milstein told Judge Weinstein.

“What Lilly wants to prevent,” he said, “is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it.”

“Documents like that are not confidential and should not be marked confidential,” he stated.

At the end of the hearing, the judge instructed the parties to file more briefs and another hearing is scheduled for February 7, 2007, for oral arguments.

In the latest turn of events, right out of the blue, Judge Weinstein issued an order this week with an “invitation” for Mr Berenson to appear in court to give testimony and be cross-examined on whether he participated in a conspiracy with Mr Gottstein and Dr Egilman to violate the original court order that sealed the documents.

In the meantime, while this circus plays out in the courts, every day thousands of doctors and patients are making uninformed decisions on whether to use Zyprexa. And the injury clock is ticking.

Allen Jones, a former fraud investigator in the Pennsylvania Office of Inspector General, states: “My best effort at correlating dollars spent with deaths suggests that people may be dying from side effects at the rate of at least one death for each one million dollars spent on the drug.”

DSM Billing Bible – Big Pharma Best Seller

Evelyn Pringle December 27, 2006

One-hundred percent of the experts involved in writing diagnostic criteria for mood disorders and schizophrenia for the, “Diagnostic and Statistical Manual for Mental Disorders (DSM),” have undisclosed financial ties to the pharmaceutical companies whose drugs are used to treat those conditions.

The April 2006 study in the journal, Psychotherapy and Psychosomatics, also determined that more than 80% of the members on the panels involved in decisions related to “anxiety disorders,” “eating disorders,” “medication-induced movement disorders” and “premenstrual dysphonic disorder” have financial ties to the pharmaceutical industry.

Experts say the importance of the manual, also referred to as the “Psychiatric Billing Bible,” cannot be understated, especially for the Big Pharma. The FDA will not approve a drug to treat a disorder that is not included in the DSM and public and private health insurance programs will not pay to treat a disorder that is not listed in the manual.

Medications for the treatment of schizophrenia and mood disorders are the top sellers of all psychiatric drugs in the US. In 2004, antidepressants and antipsychotics became the third and fourth-biggest selling classes of drugs, following cholesterol and heartburn medications, with combined sales of $20.7 billion.

The April study, led by Dr Lisa Cosgrove, a clinical psychologist from the University of Massachusetts, is the first of its kind, and was conducted in part, by sifting through legal files, conflict of interest databases, patent records, journal articles, and other records.

Dr Cosgrove told the Washington Post that she began the research after learning that 5 of six panel members deciding whether certain premenstrual problems should be considered a psychiatric disorder had ties to Eli Lilly, a company that was at the time seeking approval to market Prozac to treat those problems.

“I don’t think the public is aware of how egregious the financial ties are in the field of psychiatry,” she told the Post.

“The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry,” according to Dr Irwin Savodnik, assistant clinical professor of psychiatry at the University of California, in a statement to the Chicago Tribune.

A co-author of the study, Sheldon Krimsky, a science policy specialist at Tufts University and author of, “Science in the Private Interest,” told the Washington Post, “When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions.”

Critics say the pill-promoting list of bogus “mental disorders” in the DSM apparently has no end and kids appear to be the most sought after customers. For instance, in the DMS, a child’s behavior become an “oppositional defiant disorder,” if a child exhibits at least four of eight behavior patterns, four of which are “often argues with adults,” “often loses temper,” “often touchy or easily annoyed by others” and “often spiteful or vindictive.”

And to treat these alleged “disorders” the drug companies have doctors prescribing the strongest, most expensive psych drugs on the market. On November 11, 2006, the New York Times reported that 13-year-old Paul Williams “has had almost as many psychiatric diagnoses as birthdays.”

“The first psychiatrist he saw, at age 7,” the Times said, “decided after a 20-minute visit that the boy was suffering from depression.”

A string of office visits with psychologists, social workers and psychiatrists led to labels with disorders such as “compulsive tendencies,” “oppositional defiant disorder,” and “pervasive developmental disorder,” or some combination of the others.

Each diagnosis was accompanied by a different regimen of drugs. By the time Paul was 11, his mother said, it was bipolar “with it a whole new set of drug prescriptions.”

In June 2006, a study in the Archives of General Psychiatry, said the use of antipsychotics to treat children for problems with aggression and mood swings had increased more than 5-fold between 1993 to 2002, even though none of the drugs are approved for children.

The study found that about a third of the kids who received antipsychotics were diagnosed with behavior disorders, such as attention deficit; another third listed psychotic symptoms or developmental problems; and the others were for mood disorders.

In addition to antipsychotics, the study found that more than 40% of the children were also taking one or more other psychiatric drugs.

Experts say the rise in prescribing antipsychotics to children corresponds with the introduction and heavy promotion of the new generation of antipsychotics known as “atypical” antipsychotics which include Risperdal, Zyprexa and Seroquel, promoted as superior to older and much cheaper antipsychotics like Haldol.

Atypicals are FDA approved for very limited uses in the treatment of adults with schizophrenia, psychosis, and bipolar disorder.

Over the past several years, these new antipsychotics have been shown to cause extremely serious side effects. According to Dr Stefan Kruszewski, MD, a Harvard trained psychiatrist from Harrisburg, Pennsylvania, they increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.

He says the atypicals were marketed as being safer and easier to tolerate than the older, cheaper antipsychotics because the drug companies said that they would cause fewer neurological injuries like tardive dyskinesia and akathesia.

Those claims have turned out to be totally false Dr Kruszewski says, and “at the same time they continue to cause neurological side-effects like the older antipsychotics.”

In addition, the new drugs have been shown to be less effective with children than the old. An August 2006 study by the New York Psychiatric Institute, found that the average response rate in children enrolled in 8 studies taking the new antipsychotics was only 55.7%, compared to 72.3% with children in 13 studies who were taking the older drugs.

The over-prescribing of the atypical drugs to children is found to be most rampant when the cost of the drugs is covered by government health care programs. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state’s Medicaid program, who were prescribed antipsychotics nearly doubled in six years.

The age group with largest increase was children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and perhaps the most alarming was a 61% increase in the use of antipsychotics with preschool children.

In the wake of budget busting costs, the state of Texas hired ACS-Heritage, a medical consulting firm, to investigate the prevalence of psychotropic drugs prescribed to children and billed to the state, and learned that during the months of July and August, 2004, more than 19,400 teens were prescribed antipsychotics, with nearly 98% prescribed for conditions not approved.

In fact, ACS said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and that one-third of the children were on 2 or more drugs.

The drug companies promote the life-long use of antipsychotics. For instance, a Relapse Prevention Booklet (2004), by the Manic-Depression Fellowship, sponsored by Eli Lilly, for Zyprexa states that “bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat.”

Some states have filed lawsuits against the drug makers to recoup the costs incurred by the over-prescribing of the atypicals for conditions not approved by the FDA, as well as the cost of medical care for citizens injured by the drugs.

A West Virginia lawsuit alleges that Eli Lilly promoted Zyprexa for “off label” conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint states, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.

The lawsuit also alleges that Lilly concealed the dangers of Zyprexa, such as an increased risk of diabetes, resulting in further cost to the state to treat Medicaid recipients who became ill from using the drug.

In June 2005, Lilly paid $690 million to settle claims by an estimated 8,000 people who claimed that before September 2003, the information on Zyprexa labels regarding the risk of hyperglycemia and diabetes was not adequate.

But on an up-note, according to the company’s SEC filings, Zyprexa’s sales are booming, with $4.2 billion in 2005, or 29% of Lilly’s corporate revenue.

All this money for a new drug that has been proven to be no better than the old antipsychotics which cost pennies a day. Referring to a study published in the New England Journal of Medicine, on September 21, 2005, The, reported that a “US Government-financed study of drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few — if any — benefits over older medicines that sell for a fraction of the cost.”

As for pushing pills for the mood disorders, with the help of President George Bush’s New Freedom Commission on Mental Health, put in place by an executive order as a gift to the drug companies in return for the millions of dollars in contributions, Big Pharma is zeroing in on children, even infants, as customers for Paxil, Zoloft, Prozac, Lexapro, Effexor, and Celexa, by setting up mental health screening programs in schools and daycare centers.

In a 2003 speech, the director of the Substance Abuse and Mental Health Services Administration, Kathryn Power, reported that mental health assessments are increasingly being conducted in “non-mental health settings,” and she praised one community for “placing mental health consultants in child care settings.”

She also bragged about the federal “Prevention and Early Intervention Grant Program,” and noted that the program’s goal is to reach children, and babies, before they have a diagnosable problem. At that time, Ms Power said that more than half of the administration’s programs were focused on infants and preschoolers.

Mental health screening programs for kids as young as age 0, are being implemented in states all across the country. For instance, in Minnesota an early childhood program is being integrated to ensure all children ages 0 to 5 are screened “early and continuously” and to link children and their families to mental health services.

In Florida, the Florida Strategic Plan for Infant Mental Health Plan is to develop a system to prevent children from 0 to age five from developing emotional and behavioral disorders.

In Illinois, “all children” are to receive social and emotional screens and the schools are to incorporate social and emotional standards as part of the state’s learning standards.

Its not as if infant recruitment schemes are necessary considering the record breaking sales of these drugs. According to SEC filings, Pfizer’s Zoloft, pulled in $2.5 billion in the first three quarters of 2005, and worldwide, Wyeth’s Effexor totaled $3.5 billion in 2005.

But then, Big Pharma would be out of the psych drug business in no time if not for the cooperation of the doctors writing the prescriptions. On August 17, 2005, the Wall Street Journal said, “If the icon of American psychiatry was for years a couch, it is now arguably a pill.”

“And that change in focus,” the Journal reports, “has brought to prominence a new type of psychiatrist: the psychopharmacologist.”

According to the Journal, “these doctors frequently prescribe complex cocktails of drugs for patients with multiple diagnoses of mental illnesses and sometimes prescribe other drugs to counterbalance side effects from the primary drugs.”

A 2003 study by the American Psychiatric Association, on “financial disincentives” for psychotherapy found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session, which boils down to an hourly pay cut of 41% for doctors doing therapy.

According to Dr Juan Riestra, associate director of medicine in the department of psychiatry at Mountainside Hospital in Montclair, NJ, a psychopharmacologist is often someone “using a trendy word as a marketing device.”

When a psychopharmacologist sees 30 or 40 patients a day, as some do, Dr Riestra told the Journal, “it becomes like a factory.”