The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Big Pharma Research Racket Is Killing People

Evelyn Pringle June 23, 2006

Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.

On June 20, 2006, the New York Times reported that “two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States.”

The Senators behind the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the committee.

“In broad terms,” the Times article by Gardner Harris explains, “the bill would require that drug makers disclose the results of all large human tests of their drugs, known as Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover and control any safety problems that arise after a drug is approved; and pay penalties if they fail to follow through with this plan, according to four experts who were briefed on the proposals.”

However, while lawmakers search for ways to ensure that Big Pharma does not continue to conceal adverse reactions that surface during drug trials and to sever the ties between the nation’s public health officials and Big Pharma, the Bush administration continues to promote their cozy relationships and help drug companies escape accountability for misconduct.

The best example of the administration’s efforts to protect Big Pharma was revealed recently when the FDA announced a preemption rule that would disallow lawsuits in state court against drug makers if a drug has been approved by the FDA.

“We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don’t have the same scientific knowledge,” said FDA deputy commissioner on medical and scientific affairs, Scott Gottlieb.

But in all fairness, the FDA is certainly not the only public health agency in bed with Big Pharma. Nobody can deny the fact that Big Pharma is an equal opportunity corrupter. Its obvious that drug companies have infiltrated every Federal regulatory agency in the US.

For instance, on June 14, 2006, a National Institute of Health Alzheimer’s researcher, Dr Trey Sunderland, asserted his Fifth Amendment rights, and refused to testify before the House Energy and Commerce Committee about accusations that he has profited from giving Pfizer access to spinal fluid and plasma samples collected by the NIH.

Documents presented at the hearing revealed that between 1996 an 2004, Dr Sunderland accepted consulting, speaking and advisory fees totaling about $612,000 and committee staff members estimate that about $285,000, was related to 3,245 samples taken from 538 patients who participated as volunteers at the NIH.

At a price of about $12,000 per patient, the committee estimates the cost of collecting the samples that Dr Sunderland handed to Pfizer is close to $6.5 million.

The committee also noted that he did not seek prior approval to work for Pfizer, and did not report any of the income to the agency as required by NIH rules.

In fact, at one point, when asked, Dr Sunderland said he had no outside deals. According to the December 22, 2004 LA Times, while reviewing financial disclosure reports from scientists at the NIH, in March 2000, ethics officer Olga Boikess noticed that Dr Sunderland had not declared any jobs with the industry so she sent him an e-mail that said: “You did not list any outside positions.”

To which, Dr Sunderland replied: “I do not have any outside positions to note.”

This case had been dragging on for years but the doctor has probably not been too worried because history shows that any time a Republican lawmaker get too pesky about the money trails leading to the NIH, Big Pharma simply offers enough money to induce him to jump ship.

A couple years ago, two Republicans on powerful committees switched sides shortly after they launched investigations into conflicts of interest between drug companies and employees at the NIH.

Representative, WJ “Billy” Tauzin (R-La), was chairman of the House Energy and Commerce Committee, and had cited “secret consulting fees and stock options from drug companies” as reasons to request documentation of all payments from Big Pharma to NIH scientists.

But next thing you know, Tauzin announces that he is not running for reelection, and leaves Congress to become President of the Pharmaceutical Research and Manufacturers of America, the giant trade group that represents Big Pharma, with a reported $2 million a year in salary, benefits and perks.

Next up to bat, was Representative James Greenwood (R-Pa), who led 3 hearings on NIH conflicts of interest and criticized the agency for allowing scientists to use “a swivel chair” to make decisions while taking drug company money.

But low and behold, shortly thereafter, in July 2004, Rep Greenwood announced that he was giving up his post as chairman of the Energy and Commerce subcommittee to retire, only to become President of the Biotechnology Industry Organization, a group that in the same year, urged lawmakers not to bar NIH scientists from entering into paid consulting deals.

A report by the Office of Government Ethics, released the same month that Rep Greenwood announced his “retirement,” said the NIH was beset by a “permissive culture,” and revealed that 40% of the 155 randomly selected sample payments to agency employees reviewed had not been approved or accounted for within the NIH.

The FDA remains at the top of the list for corruption simply because the FDA evaluates the safety and effectiveness of drugs and decides which drugs can be marketed in the US.

Typically, as a first step toward the approval process, a drug company will initiate laboratory testing to assess the effectiveness and safety of a drug and if the laboratory testing is successful, the company will begin testing the drug on animals. The FDA does not become involved until the drug maker seeks permission to test the drug on humans.

When the drug reaches that point, the FDA’s Center for Drug Evaluation and Research, evaluates the results of laboratory and animal testing prior to allowing any study on humans.

Once a drug is approved for testing on humans an Institutional Review Board (IRB) is appointed to review and monitor the research. An IRB is generally made up of outside scientists, doctors and other medical professionals and has the authority to approve or disapprove a study or to require modifications to secure approval of the research.

The purpose of an IRB is to assure that appropriate steps are taken to protect the rights and welfare of human subjects. To that end, an IRB uses a group process to review research protocols and materials such as informed consent documents and investigator brochures related to the research.

In recent years, serious questions have been raised regarding the impartiality of the review process due to the fact that many of the FDA advisors recommending approval of a product are at the same time employed by the drug company that developed the drug or hold some other financial interest link to the company.

Due to these conflicts of interests, critics say dangerous drugs are winning approval. For instance, nearly a third of the members of the advisory panel that reviewed the data on Vioxx, Celebrex and Bextra, and voted to allow the drugs to remain on the market, even after Vioxx had been pulled off the market, had financial ties to the makers of the drugs and had their votes not been counted, they would never have received a vote of approval.

In addition, problems continue to surface in the private research industry. Contract Research Organizations (CRO), are now hired by the industry to perform research.

Critics says the competing CROs are skewing research in favor of approval in order to win more contracts. The funding up for grabs is enormous. According to a March 24, 2006, MSNBC commentary by Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, “Private companies running studies for pharmaceutical and device companies are now a $14 billion industry in the United States alone.”

According to John Abramson, a clinical instructor at Harvard Medical School, and author of, “Overdosed America”, “When the institutional review boards were created, most medical research was conducted by universities and nonprofit institutions.”

“Similarly,” Mr Abramson says, “oversight of the safety of human volunteers in most U.S. studies is no longer done by nonprofit IRBs, but by for-profit review companies, hired directly by the for-profit research companies.”

In his opinion, he says the system lacks the appropriate checks and balances to protect human volunteers.

In the April 6, 2006 LA Times, Mr Abramson made a shocking revelation when he said, “the FDA recently approved “phase 0 studies” in which human beings can be given minuscule doses of experimental drugs even before animal studies are completed.”

A recent case in the UK demonstrates the dangers that could occur in such a study. In March 2006, six otherwise healthy men ended up in a London hospital in critical condition after participating in the trial of a new an anti-inflammatory drug, called TGN1412, to treat conditions involving the immune system, such as leukemia, multiple sclerosis and rheumatoid arthritis, conducted by the US based company, Parexel International Corp, on behalf of the German drug maker TeGenero.

The worst affected of the six men, Mohamed ‘Nino’ Abdelhady, called the Elephant Man because of the extreme swelling of his head, on April 5th, told the Daily Mail that he is plagued by nightmares.

Still recovering in the hospital at the time, he explained what he remembered. “I started to feel ill,” he said, “almost as soon as they had finished injecting me.”

“I felt as if I had rocks on my head,” he recalled, “and I must have started hallucinating.”

“Help me,” he told the newspaper that he screamed, “I’m dying.”

Ryan Wilson, the most critically ill man, begged doctors to put him to sleep because he was in such agony. His family was warned that his heart, lungs and kidneys failed.

His sister-in-law Jo Brown, recalled the horrific moment when they saw Mr Wilson in intensive care. She told reporters that his head had swollen to nearly three times its normal size, and that his neck was the same or wider than his head and that his skin had turned a dark purple.

Mr Wilson remained in a coma for three weeks, and upon awakening, learned that he may lose parts of his fingers and toes, which had turned black because of his reaction to the drug.

“I’m told it’s like frostbite and my fingers will just fall off,” he told the UK’s News of the World recently.

In addition, Mr Wilson also suffered from heart, liver and kidney failure, septicemia, pneumonia and dry gangrene and is considered very luck to be alive, according to News Target on May 20, 2006.

The Parexel research was at the Phase I stage, where a drug is tested for safety with a small number of people who are given a tiny dose under careful supervision, not to determine whether the drug works, but to check for side effects, according to Q&A Drug trials by BBC News on March 16, 2006.

Experts say the recruitment of subjects for the Parexel trial left much to be desired. The web site that announced the recruitment hardly mentioned the potential risks, but elaborated at great length about the good pay, free food and “plenty of time to read or study or just relax, with digital TV, pool table, video games, DVD player and free Internet access.”

Parexel also recruits by placing ads online or in local papers, where critics say, they draw the attention of the young and poor. Once on the books, recruits often get automatic offers. “The offers keep rolling in via text message,” Tom de Castella, a former Parexel volunteer said in the March 19, 2006 Times Online. “$650 for three days here, $1,000 for a week there,” he said.

Ethicists shown the Parexel consent form, which is supposed to describe the experiment and its risks, told Bloomberg News, “the document didn’t sufficiently inform participants of the therapy’s possible dangers or properly depict the treatment as a novel drug that can disrupt the body’s immune system.”

The 13-page form also exploited the subjects’ need for money, they said, by threatening to withhold the 2,000 pound ($3,500) payment if the men left the test early.

Highly questionable research recruitment techniques are also occurring in the US. On November 29, 2005, in Texas, CBS News channel 42 reporter, Nanci Wilson, revealed records showing that staff at state mental hospitals in Texas help recruit patients into studies of experimental drugs not approved by the FDA.

At a state hospital in San Antonio, CBS News found 16 beds set aside to allow drug companies to conduct studies on mental patients under the state’s care. CBS 42 asked Austin psychiatrist, Deborah Peel, to review some of the records they obtained.

Dr Peel said the situation raised serious questions as to whether this is moral and ethical treatment. “They are essentially turning the state hospital population into research subjects,” she noted.

Texas hospital officials claim the mentally ill patients give informed consent by signing a detailed form describing the risks and benefits of participating in the study. But Dr Peel says, “I think there are real questions how informed their consent would be under those situations, because these are not people who have the means to choose to go elsewhere for treatment, and so, there’s a powerful element of pressure, of coercion that they have to feel.”

“Once again,” Dr Peel points out, “we have people who have no means, who are dependent on the state system, and the state system is working hand-in-glove with private corporations.”

In many studies, CBS news investigators determined that patients had been taken off drugs that were working and in the new study, some patients were given the experimental drug while others received a placebo.

Critics point out that for patients taking a new drug, there is no guarantee it will work, and the risks and long-term effects are not known. “To take people off medication when they have just been admitted for an inability to function and might have even been a harm to themselves or others, that raises real questions for me,” Dr Peel told CBC News.

What’s worse, she says, is that patients are not told whether they are taking a placebo or a drug even when they are discharged from the hospital during the study. They could get suicidal, she said, or could harm others.

The FDA has ignored atrocities in research involving mentally ill subjects for years. Back in 1998, a review of the data on atypical antipsychotic drugs submitted to the FDA, obtained with FOIA requests by Robert Whitaker, revealed numerous safety problems for subjects who participated in the trials.

Mr Whitaker found that among 12,176 patients from the US and abroad at the time the data was submitted, there were 88 deaths, including 38 suicides, meaning there was an overall death rate of 1 out of every 138 patients, according to his article in the November 17, 1998 Boston Globe.

The suicide rate in trials was found to be 2 to five times higher than the norm. In the medical literature, Mr Whitaker reported, suicide rates for schizophrenics ranged from two to five deaths per 1,000 per year, while the rate in trials was close to 10 per 1,000.

In addition, he found that for the three approved drugs in the study – Zyprexa, Risperdal, and Seroquel – 60% of the 7,269 patients who received the drugs dropped out before the end of the study, which typically lasted six to 8 weeks.

In the 1990s the prospect of antipsychotic drugs gaining FDA approval, promised a major market for Big Pharma and therefore, drug companies needed to recruit trial subjects quickly. And drug companies were willing to pay top dollars to researchers for each patient recruited.

In the Boston Globe article, Mr Whitaker discusses a criminal case in Georgia that reveals just how far researcher are willing to go to meet recruitment goals.

Dr Richard Borison, chairman of the psychiatry department at the Medical College of Georgia, and Bruce Diamond, a pharmacologist on the school’s faculty, were favorites for schizophrenia drugs and demonstrated a knack for rounding up psychotic patients quickly for trials funded Eli Lilly, Janssen, Zeneca, and Novartis.

As faculty members, Borison and Diamond were supposed to get approval for research and payments for trials were supposed to go the school. But according to Georgia authorities, who indicted the duo in early 1997, in 1989 they started having the drug makers send payments directly to them.

They simply opened an office across from the school, hired a commercial service to do ethical reviews of their studies, and placed their staff on the school’s payroll but kept all the money for themselves.

As unbelievable as it may seem, the scheme worked for about 7 years. From 1989 to 1996, Borison and Diamond made over $10 million including more than $4 million from schizophrenia drugs, according to the indictment and testimony during an investigation by the Augusta Veterans Affairs Hospital, where Borison was chief of psychiatry.

And these guys were slick. To recruit the mostly male patients, they hired good-looking young women, who testified that they were paid bonuses that ran into the thousands, and one staffer was even given a Honda Accord.

To find their recruits, workers looked for mentally ill patients who were stable and living in the community and offered them $150 to check into the VA so they could be in a study. Patients already in locked wards were offered cigarettes to participate.

Study coordinators, many with no medical training, determined whether a patient belonged in a study. According to an FDA investigation, untrained staff drew blood samples and adjusted doses of the drugs, and Borison and Diamond hardly ever saw the patients at all.

But the two researchers lived high off the hog, according to Georgia authorities. They socked away more than $5 million in cash and securities, spent nearly a half a million on antiques and drove Mercedes-Benz vehicles.

But as the old saying goes, all good things must end. In December, 1997, Diamond pleaded guilty to theft and bribery charges and was fined, $125,000, sentenced to 5 years in prison, and ordered to pay $1.1 million to the college.

Borison pleaded guilty to theft and racketeering charges, was sentenced to 15 years in prison, fined $125,000, and ordered to pay $4.26 million to the college.

To cover all bases, over the years, Big Pharma has also become adept at corrupting the judicial process.

For instance, Dr Bruce Levine, PhD, Clinical Psychologist and author of, World Gone Crazy, tells a story about Eli Lilly corrupting the judicial process in a case that began in 1989 when Joseph Wesbecker opened fire at his former place of employment, killing 8 people and wounding 12 more, before committing suicide, a month after he began taking Prozac. The victims of the shooting sued Eli Lilly, claiming that Prozac had pushed the guy over the edge.

It has long been known that Prozac induces violence in some patients but the FDA never required Lilly to list violence on the drug’s label. But as it turns out, five of the 9 members on the 1991 FDA advisory panel investigating the association between Prozac and violence that voted against requiring a warning label for violence, had ties to Big Pharma and two of the members had served as lead investigators for Lilly-funded Prozac studies.

The Wesbecker trial did not take place until 1994, but in the meantime, according to Dr Levine, “Eli Lilly had been settling many Prozac violence cases behind closed doors.”

In fact, he says, more than 150 Prozac lawsuits had been filed by the end of 1994, so “it was looking for a showcase trial that it could win.”

A crucial component of the victims’ legal strategy in the Wesbecker case was for the jury to hear about Lilly’s history of reckless disregard toward consumers, especially about the drug Oraflex, introduced in 1982 but taken off the market 3 months later.

“A US Justice Department investigation linked Oraflex to the deaths of more than 100 patients,” Dr Levine notes, “and concluded that Lilly had misled the FDA.”

In the end, Lilly was charged with 25 counts related to mislabeling side effects and pled guilty.

At the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be too prejudicial for the jury to hear and the Judge initially agreed. However, when Lilly attorneys used witnesses to testify about it’s superb system of collecting and analyzing side effects, the Judge said that Lilly had opened the door to evidence to the contrary and so the Oraflex information would also be allowed in.

However, to Judge’s amazement,” Dr Levine says, “victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case. “

It was later learned that Lilly was successful in corrupting the judicial process in the case by cutting a secret deal with victims’ attorneys to pay them and their clients not to introduce the damaging Oraflex evidence.

However, Dr Levine says, the Judge “smelled a rat” and fought for an investigation, and in 1997, Lilly quietly agreed to the verdict being changed from a victory to “dismissed as settled.”

Legal experts are finding ways to expose and punish Big Pharma for conducting fraudulent research that requires no involvement by the nation’s compromised regulatory agencies. Barry Turner, Lecturer in Law at Leeds Law School in the UK, is a great fan of the False Claims Act legislation in the US.

As an academic lawyer, he has for a number of years been involved in litigation regarding the activities of the pharmaceutical industry and for the past two years, he has been involved in Qui tam litigation preparation.

“Tying Qui tam into human rights and civil liberties issues is easy,” Mr Turner says. “When President Lincoln initiated this law in 1863 it was because Union soldiers were going into battle in shoddy boots and uniforms equipped with guns and ammunition that were third rate,” he explains. “All because ‘businessmen’ saw the war as a gravy train.”

“Qui tam,” Mr Turner explains, “protects taxpayers and since tax revenue is the lifeblood of any state, any evasion of liability or deliberate defrauding of a taxpayers is an attack on all taxpayers and consequently all citizens.”

Qui tam in its long history, he says, has brought to book many crooks who stole from the US taxpayer and is based on the individual citizen being able to blow the whistle for the benefit of fellow citizens and the country.

The more recent Sarbanes-Oxley Act of 2002 (SOX), was enacted in the wake of the Enron and WorldCom scandals, and was designed to restore investor confidence in the nation’s financial markets by improving corporate responsibility through changes in corporate governance and accounting practices and by providing whistleblower protection to employees of publicly traded companies who report fraud.

SOX contains a civil and a criminal whistleblower provision. Section 806, creates a civil cause of action for employees who have been subject to retaliation for whistleblowing, and Section 1107, makes it a felony for anyone to knowingly retaliate against or take any action harmful to any person, including interfering with employment, for providing truthful information relating to the commission or possible commission of a federal offense.

According to Mr Turner, SOX is not limited to shareholders of a company. “What needs to be understood,” he says, “is that many millions of people who own no stock at all get defrauded in scams all the time.”

“Those who pay into pension funds are vulnerable to the financial shenanigans not only of fund managers but of boards of companies,” he explains, “and CEO’s that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices.”

SOX came into being to prevent those financial shenanigans, he says. “The fat cats may lose a small amount of their stake in any scam,” he points out, “but the little man as ever stands to lose all.”

One of the features of SOX, he says, is the ability to bring an action against those who recklessly and fraudulently deal with stockholders money. Big Pharma, and its handmaiden psychiatry, he notes, is built on fraud.

For example, Mr Turner explains, Ritalin fraud consists of labeling millions of children as basket cases based on fraudulent research and a consensus of the vested interest.

“SSRI fraud,” he advises, “extends depression into the world of normal human experience to ever-extend the peddling of the often useless and frequently dangerous treatments.”

In other instances, he says, many poor and elderly people are starved of life saving drugs because the budgets of Medicare and Medicaid are bled dry by claims from drug companies for ‘me too’ drugs that in many cases are superfluous.

“Even where there is some justification for the use of these drugs,” he explains, “there is a drive to constantly increase the dose above the minimum effective one because a ‘minimum effective dose’ to the drug company means minimum effective profit.”

“Where money is diverted from real healthcare provisions, to a profit greedy industry that manufactures an illness to fit the drug,” he notes, “rather than provide drugs for real illnesses, then the most fundamental of constitutional rights ‘Life, Liberty and the Pursuit of Happiness’ is most at risk.”

Every unnecessary dose of Ritalin, Prozac, Paxil, and other psychiatric drugs prescribed and paid for with US tax dollars, he says, deprives patients dependant on state healthcare programs of drugs they need for cancer, diabetes, heart disease and other serious conditions.

In addition, Mr Turner points out that, “the marketing of these drugs and the ever expanding definition of psychiatric disorder that is part of this marketing strategy labels, discriminates against, and stigmatizes hundreds of thousands of American Citizens.”

“It is indeed a dramatic irony,” he says, “that in very many of these cases the US taxpayer gets to fund an industry that acts in a manner so alien to the American Constitutional ideals.”

For purposes of the litigation, “knowingly” is defined as: (1) Actual knowledge of the false information; (2) Acts in deliberate ignorance of the truth or falsity of the information; or (3) Acts in reckless disregard of the truth or falsity of the information.

Therefore, according to Mr Turner, “inducing people to invest in companies that engage in illegal and reckless activity is a violation of SOX.”

“Inducing people to take vast amounts of drugs that are known to be harmful and deliberately hiding the known dangers is a violation of SOX,” he contends.

“One day this edifice will come tumbling down,” he says, “and what will the investors in Big Pharma say then?”

In light of the Vioxx disaster, Mr Turner says, we should perhaps ask people who invested in Merck.

“Those at the top of this company,” he notes, “gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed.”

“Those who today peddle drugs for fictitious illnesses and push dangerous and useless medications on the children,” he warns, “in our societies are doing just this.”

Merck acted with reckless disregard for the truth because it had prior knowledge of the adverse effects of Vioxx. The same goes for Eli Lilly and its prior knowledge of the lack of efficacy of Prozac and GlaxoSmithKline’s knowledge of Paxil’s suicide ideation

While suppressing negative studies, these companies placed drugs on the market that were known to be faulty in one way or another. All of these drugs have cost taxpayers dearly, not to mention the personal suffering they have inflicted in other ways

In considering other acts of fraud, Mr Turner looked at the Pharma backed charities that are based on fraudulent research to see what Federal laws they may be violating.

“Since a number of imaginative illnesses are based on this fabricated research and since a number of charities are based on the ‘imaginative illnesses’ that arose out of the imaginative research,” he says, “its just a matter of connecting the dots.”

Because charities receive tax breaks, he says, fraudulent charities defraud US taxpayers.

“The fraud in this industry is not divided into that which injures by over drugging and that which cheats taxpayers and stockholders out of their money,” he explains. “They are two sides of the same counterfeit coin.”

Mr Turner says we must tackle them together, and that lawyers in the US should be actively seeking clients who have lost money by these frauds and getting the matter before the Security and Exchange Commission now.

Filed under: 2006, antipsychotics, Eli Lilly, NIH, NIMH, Parexel, Prozac, SOX, SSRIs, whistleblower

Tracking the American Epidemic of Mental Illness – Part IV

Evelyn Pringle June 22, 2010

Non-Profit Advocacy Groups

As a main component of the Psychopharmaceutical Industrial Complex, the so-called “patient advocacy” organizations have become the leading force behind the American epidemic of mental illness over the past two decades.

Drug makers, and their foundations, funnel millions of dollars to these non-profits every year. In return, the leaders recruit their members as foot soldiers to carry out the latest marketing campaigns and to provide a fire-wall so that no money trail can be tracked back to the drug companies.

Gigantic Pyramid

The psychiatric front groups form a gigantic pyramid and once pharmaceutical money enters the system through a major organization, it gets channeled into a huge spider-web that weaves through many groups, making it nearly impossible to keep track of where it came from or where it all went. Often, when the grant reports of the drug companies list a large donation to one organization, the annual reports of the other groups will show smaller gifts from that same organization.

The “charity” groups are exempt from income tax and the “contributions” funneled through them are tax deductible. The money is used for disease mongering campaigns to both market disorders and pressure public health care programs and private insurers to pay for expensive treatments.

“Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent,” according to Citizens Commission on Human Rights International, a mental health watchdog group.

In a June 2, 2010, commentary titled, “Psychiatric Fads and Overdiagnosis,” on the Psychology Today website, Dr Allen Frances points out that it “is too bad that there is no advocacy group for normality that could effectively push back against all the forces aligned to expand the reach of mental disorders.”

The leaders of the supposedly “non-profits” earn outrageously high salaries, along with excellent benefit packages, while many of the patients they claim to represent are encouraged to seek federal disability payments of under $700 a month, and apply for public housing, food stamps, and Medicaid, to make ends meet. The top officials will often move from a leadership role in one organization to a higher position in another.

The drug makers rely on the front groups to do their bidding any time profits are threatened. For instance, if the FDA is considering adding a black box warning about a deadly side effect to a drug’s label, which may result in a drop in sales, representatives of front groups will show up at the FDA advisory panel hearings to testify against adding the warning.

They will also lobby FDA panels whenever there is a chance to increase profits, such as enlarging the drug customer base. In June 2009, the Psychopharmacologic Drugs Advisory Committee was set to meet to evaluate AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa for use with 13 to 17 year-olds diagnosed with schizophrenia, and 10 to 17 year-olds diagnosed with pediatric bipolar disorder.

On June 8, 2009, nine front groups issued a joint statement urging the panel to vote to approve all three drugs for kids. The groups signing the letter included the American Academy of Child and Adolescent Psychiatry, American Foundation for Suicide Prevention, American Psychiatric Association, Child and Adolescent Bipolar Foundation, Children and Adults with Attention-Deficit/Hyperactivity Disorder, Families for Depression Awareness, Mental Health America, National Alliance on Mental Illness, and the National Council for Community Behavioral Healthcare.

“As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations,” they wrote. “Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents.”

In an obvious attempt to downplay the serious side effects of the antipsychotics, the groups stated: “Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment.”

“Like cancer,” they wrote, “aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer.”

The National Council for Community Behavioral Healthcare only recently began showing up in public pharma campaigns with the other front groups. Last year it was listed as a supporter of one of the most evil customer recruitment schemes ever devised, targeting the roughly four million pregnant women who give birth in the US each year, through passage of federal legislation known as the “Mothers Act.”

On its website, the Council is described as “a non-profit association representing 1,300 mental health and addictions treatment and rehabilitation organizations.” But a review of the few grant reports available on drug companies found this non-profit received over a half a million dollars since 2008, from Eli Lilly and Wyeth alone.

Lilly’s grant reports shows a $440,000 donation in 2008, and another $25,000 grant in 2009. The Council also received $20,000 in 2008, and $10,000 in 2009, from Wyeth (now owned by Pfizer). For the first quarter of 2010, Lilly’s lists two grants to the Council totaling $90,000.

The front groups all have “experts” serving on advisory or scientific boards and committees from major universities and government agencies, who have financial relationships with drug makers of one kind or another. Some organizations even have drug company officials, often from marketing and sales departments, sitting on boards and committees. Many of the same people will serve in multiple groups within the pyramid.

For example, Dr Herbert Pardes, a former director of the NIMH, is president of the scientific board of the National Alliance for Research on Schizophrenia and Depression (NARSAD). He is also a past president of the American Psychiatric Association, and served as chairman of the APA’s Council on Research for several years. A bio on the internet says he is a regular advisor to the National Alliance for the Mentally Ill (NAMI), the Anxiety Disorders Association of American, and Mental Health America. He has also served on the board of TeenScreen and is a charter associate member of the Depression and Bipolar Support Alliance.

Collapse of the Pyramid?

For several years, with Iowa’s Republican Senator, Charles Grassley, leading the charge, the US Senate Finance Committee has been investigating pharmaceutical industry funding, as it relates to marketing practices, involving Continuing Medical Education, consulting arrangements, publications in medical journals, the non-profit professional and patient advocacy organizations, and the conflicts of interest among academics who receive federal funding from the National Institutes of Health through research grants to major universities.

The Committee oversees spending in public health care programs, such as Medicaid and Medicare, for coverage of more than 100 million Americans, including mental health treatment and prescription drugs.

The “drug industry’s most powerful means of boosting the bottom line is funding research, which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool,” Shannon Brownlee explained in an April, 2004, Washington Monthly report titled, “Doctors Without Borders.”

“By penetrating the wall that once existed around academic researchers,” she says, “drug companies have gained access to the “thought leaders” in medicine, the big names whose good opinion of an idea or a product carries enormous weight with other physicians.”

“Companies target academic KOLs, or Key Opinion Leaders, in the lexicon of marketing, and woo them with invitations to sit on scientific advisory committees, or to serve as members of speakers’ bureaus, which offer hefty fees for lending their prestige to a company and touting its products at scientific meetings and continuing medical education conferences,” she reports.

Grassley’s investigations at major universities turned up more conflicted academics in the field of psychiatry than in any other specialty. His chief investigator, Paul Thacker, developed a system where he would request conflict-of-interest records on psychiatrists from their universities and simultaneously ask drug companies to provide reports on what they paid the same researchers.

Some of the biggest names in the field appear on the list of psychiatrists who failed to disclose all their financial benefits from drug companies, which thus far includes three from Harvard, Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, outgoing president of the American Psychiatric Association, and chair of psychiatry at Stanford; Martin Keller, a former chair of psychiatry at Brown; Karen Wagner and Augustus John Rush from the University of Texas; and Fredrick Goodwin, of George Washington University, and also the host of a radio show called “Infinite Minds,” that was broadcast for years by National Pubic Radio.

All of the above “KOLs” have served as officials, or on boards and committees, of major front groups, and many have received awards, consulting and speakers fees, and research funding from various organizations.

Ensuing Outrage

The revelation that millions of dollars have been flowing from drug makers to academics in psychiatry, undetected for a decade, has drawn outrage and demands for more accountability in the entire field. “Financial transparency and full disclosure is not just an advocacy position anymore,” says anti-drugging proponent, Vince Boehm. “This is rapidly becoming the order of the day.”

“While the efforts of advocates were crucial in precipitating this amazing shift in public policy,” he says, “our efforts were unwittingly helped by the massive greed of our opponents and the public furor that ensued.”

“Events such as the Biederman scandal at Harvard and other equally disgusting problems of the same proportions have provoked public outrage,” he points out.

Back on June 18, 2008, Dr Bruce Levine, author of, “Surviving America’s Depression Epidemic,” issued a warning in an Alternet commentary. “If those physicians who are not drug-company shills want to save their profession they might want to start taking aggressive actions against their colleagues who are on the take,” he said.

“Perhaps it will help motivate clean physicians to be reminded that history shows that any institution — no matter how large and powerful — can arrogantly cross those lines leading to its demise,” he advised.

On the Health Care Renewal website, Dr Bernard Carroll, former head of Duke’s psychiatry department, says the leaders of the major professional and scientific organizations, like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry, may not be stepping up to the plate publicly because “perhaps they are confounded by the awkward fact” that some of the exposed individuals “are current and past presidents of these very organizations.”

They may also be confounded by the “awkward fact,” that all the medical journals, textbooks and other literature put out by the so-called “professional” groups in the field of psychiatry are filled with ghostwritten infomercials, fraudulently crediting the shills on Grassley’s list as authors, with major universities following their names, and nothing short of a mass book burning event will erase all the false advertising.

About a year ago, Grassley asked eight leading medical journals to describe their policies and practices regarding ghostwriting as part of a “broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals,” according to his July 2, 2009 press release.

In a June 16, 2010, letter to the editor of the Miami Herald, Dr John Nardo, a former faculty member in Emory’s Department of Psychiatry, alluded to this problem while complaining about the fact that the University of Miami has “hired a a chairman for the Department of Psychiatry, Dr. Charles Nemeroff, who has become the poster child for what’s wrong with academic medicine in our country.”

“Nemeroff was relieved of his chairmanship at Emory University in Atlanta for failing to disclose conflicts of interest in his publications and presentations,” he said. “That means that he was a well-paid frontman for a number of drug manufacturers.”

“Now it has been revealed that many of his articles were ghost-written by the drug companies and that he recommended a drug, Paxil, as safe for pregnant women when, in fact, it can cause congenital heart defects in newborns,” Nardo wrote.

“One has to wonder what the people at UM are thinking?” he said. “Or if they’re thinking at all?”

Nardo’s letter is related to the latest scandal, in the seemingly never-ending Charles Nemeroff saga, which now involves the Director of the National Institute of Mental Health, Thomas Insel, who apparently worked behind the scenes to help Nemeroff get hired at the University of Miami, after he was kicked off the chair of psychiatry thrown at Emory, according to a June 6, 2010, article by Paul Basken in the “Chronicle of Higher Education.”

Bernard Carroll, who was Nemeroff’s boss for over 6 years while Nemeroff was a professor at Duke, says Nemeroff probably called in some markers. Because back in 1994, Nemeroff found Insel a position at Emory when Insel was facing nonrenewal of a research job at NIMH. And, in addition to being Insel’s boss at Emory, Nemeroff also lobbied for Insel’s appointment as NIMH director, and soon after Insel moved to the NIMH, he appointed Nemeroff as an advisor, Carroll says.

In a November 5, 2009, press release, UM announced Nemeroff’s hiring and described him as “one of the world’s leading experts in the field of psychiatry.”

Although not a peep was said about his fall from grace or the problems Nemeroff caused at Emory, the release stated: “He moved to Emory in 1991 as chairman of psychiatry. There he took an average department to become one of the top ten in the country.”

On January 4, 2010, Ed Silverman posted a Pharmalot blog under the title, “Charles Nemeroff and the House That Glaxo Built,” with a link to a December 30, 2009, headline for a story by BlockShopper, in South Florida, that read: “Psychiatrist spends $1.91M on Miami 6BD.”

“Dr. Charles B. Nemeroff and Gayle Nemeroff bought a six-bedroom, seven-bath home at 1780 Espanola Dr. in Miami from David and Carolyn Shulevitz for $1.91 million on Dec. 4, ” BlockShopper reported.

In addition to pointing out that Nemeroff had taken a new job at UM, Silverman wrote, “the new home appears big enough to house plenty of consulting materials.”

The next day, he informed readers that the first house that Glaxo built for Nemeroff in Atlanta was up for sale at a price of $1.25 million. “This one sports just five bedrooms, but still plenty of room for storing consulting materials,” he wrote.

The Emory investigation found Nemeroff was paid more than $960,000 by Glaxo, from 2000 through 2006, but he listed less than $35,000 on disclosure forms. All totaled, he had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million, according to Grassley’s reports.

The real outrage toward Insel stems from the reporting that Pascal Goldschmidt, dean of the UM’s medical school, told Baskin that Insel guaranteed him Nemeroff would be allowed to apply for NIH research grants, even though Emory had suspended Nemeroff’s work on an NIH grant, and in December 2008, placed a 2-year ban on Nemeroff applying for NIH funding. Goldschmidt claimed Emory’s ban “was an immediate reaction to the political pressure that the university was under.”

Further fanning the flames, was the Chronicle’s revelations that Nemeroff is serving on the NIH expert panels that help decide “which grant applications win federal financing,” at a time when there is still an ongoing investigation into the NIH’s lack of oversight of Emory and conflicts of interest involving Nemeroff, by the Department of Health and Human Services Office of Inspector General.

After reading Baskin’s article, Grassley fired off a letter to Daniel Levinson, the Inspector General, on June 7, 2010. “I was extremely disturbed to read a story today in The Chronicle of Higher Education,” he told the IG.

“For almost a year,” he wrote, “Dr. Charles Nemeroff has been under investigation by your office for failing to fully disclose his conflicts of interest regarding his grants from the National Institute of Mental Health (NIMH).”

“During this same time, The Chronicle of Higher Education reports that the Director of the NIMH was assisting Dr. Nemeroff in obtaining a new job and made assurances that Dr. Nemeroff would be able to apply for new NIMH grants,” he said. “I ask that you look into this matter and proceed as you deem appropriate.”

On June 7, 2010, Grassley sent a letter to UM president, Donna Shalala, basically stating the same thing except he told her: “I was also troubled by Dr. Goldschmidt’s comments that a ban against Dr. Nemeroff from receiving NIH grants was ‘an immediate reaction to the political pressure that the university was under.'”

“President Shalala,” he wrote, “I hope that you would agree–contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue–that enforcing federal conflict of interest policy involves ethical and legal issues that ensure taxpayer trust.”

In response to the letter, Grassley asked her to provide “all emails and communications by Dr. Goldschmidt,” regarding Nemeroff’s conflicts of interest and Nemeroff’s work and/or grants with the NIH, and “all emails and communications by Dr. Nemeroff,” regarding the same, along with all conflict of interest forms filed by Nemeroff with UM.

Money Laundering Operation

Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, “Unhinged: the Trouble With Psychiatry,” explains that “much of the continuing medical education (CME) industry in the United States is a legalized money laundering operation,” in a June 10, 2008 blog.

“Rather than paying doctors directly to give accredited CME courses (which is illegal), drug companies pay third party companies to create the courses,” he says. “The checks are actually written by the education company, but the ultimate source is clearly the sponsoring pharmaceutical company.”

The Harvard scandal represents the “perfect storm” of the CME industry money laundering operation, Carlat reported on his blog.

It’s clear that “the majority of money received by these doctors did not come directly from drug companies, but indirectly from various third party companies,” he says. “And this is likely the key to the mystery of why the doctors assumed they could ethically hide these payments.”

After going through the list of payments posted in the Congressional Record, Carlat found it appeared that “the vast majority of the money eventually reported by the Harvard Trio, a combined $4.2 million over 7 years, was drug company money that was laundered and processed to seem like it wasn’t drug company money.”

“The most glaring example,” he says, “comes from Dr. Wilens disclosures.”

Grassley posted slightly more than a third of Wilens’ payments ($612,303 out of a total of $1.6 million). Only $69,915 of this (11%) came directly from drug companies. Most of the money ($542,388) came from various third party companies, many, possibly all of which, are CME companies, Carlat reports.

“The biggest tool the industry has for off-label promotion is continuing education,” says Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center, involved with a program called PharmedOut, created to educate doctors about the prescribing influences of big drug companies, in the Star-Ledger on June 6, 2010.

“Physicians have freedom of speech and aren’t under the same constraints as industry employees,” she explained.

When drugs are prescribed for off-label or unnecessary uses, public health care programs not only have to pay for the drugs, they must also pay the prescribing doctors’ fees and the cost of medical care for any injuries caused by the drugs.

Government spending tied to psychiatric drugs has gone through the roof in the past two decades due to the bilking of public programs. And no doubt as a result, pharma CEOs are earning over the top pay packages. In 2008, the head of J&J pulled in $29.1 million, Abbott Labs’ CEO took home $28.3 million, the top dog at Bristol-Myers earned over $23 million, Lilly’s CEO pulled down close to $13 million, Pfizer’s took home over $15.5 million, Wyeth’s CEO earned nearly $26 million, and Forest Labs’ top official was paid more than $6.5 million, according to the AFL-CIO’s “Executive Pay Watch” website.

American Psychiatric Association

Early on in his investigation, Grassley asked the “American Psychiatric Association,” for an accounting of money received from drug companies and foundations created by drug companies. In 2006, the industry accounted for about 30% of the Association’s $62.5 million in financing, or about $18.75 million, according to the New York Times.

The 38,000 member APA describes itself as “a national medical specialty society whose physician members specialize in the diagnosis, treatment, prevention and research of mental illnesses.”

The outgoing president of the APA is Alan Schatzberg, the same guy whose name appears on the Grassley list.

The “American Psychiatric Foundation,” is the charitable and public educational arm of the APA, according to its website. In 2009, the Foundation’s 15 member board of directors included four Vice Presidents from the drug companies Pfizer, Eli Lilly, and J&J’s Janssen Pharmaceutica division.

On its website, the Foundation identifies drug companies that donate but does not give the exact amount. For example, AstraZeneca, Bristol-Myers, Lilly, Forest, Janssen, and Wyeth are listed as giving “$40,000 and above.” However, the few grant reports publicly available show drug companies may be giving more than ten times that amount. Lilly donated $450,000 to the Foundation in 2007, in addition to the $400,000 given to the American Psychiatric Association.

The Foundation also received one grant from Lilly for $241,915 in 2009, and another $20,000 donation to fund the Foundation’s Newsletter. The Foundation received $102,961 from Pfizer, and $205,400 from Wyeth, in 2009, as well.

In the first quarter of 2010, the Foundation received grants from Lilly of $36,000, $10,000 and $18,000. Pfizer gave the Foundation $20,000 in the first quarter of 2010.

Pfizer’s 2008 grant report shows donations of more than $700,000 to the American Psychiatric Association. Lilly gave the APA grants totaling more than $600,000 in both the first and second quarter of 2008. Wyeth donated $43,831 in 2008.

Lilly’s 2009 report shows the APA received four grants of $154,575, $142,575, $142,575, and $154,575. Pfizer gave the group $250,000 in 2009.

The American Psychiatric Institute for Research and Education (APIRE), is another philanthropic arm of the APA, established in 1998 “to establish the leadership role of the APA in contributing to the scientific base of psychiatric practice and policy,” with a stated mission to “improve the quality of psychiatric care through research, education, health policy analysis, and dissemination.”

For the March 6, 2010, paper, “Pharmaceutical Philanthropic Shell Games,” in Psychiatric Times, Lisa Cosgrove, PhD and Harold J. Bursztajn, MD, investigated the financial relationships of the APIRE board members with pharmaceutical companies that manufacture psychiatric drugs and found 9 of the 16 board members have industry ties.

“The fact that over half of APIRE’s board has financial ties to industry is problematic, and it is noteworthy that this percentage is a highly conservative estimate,” they wrote.

“Current disclosure policies do not require reporting of pooled industry monies (eg, when companies give large sums of money to academic departments, units, hospitals, and medical schools)—even when direct benefit, such as salary, may be derived from pooled funds,” they point out.

In addition, one board member who reported “no disclosure” in an APA publication “was found to be on the speakers’ bureau of multiple pharmaceutical companies,” they note.

The APA is currently revising psychiatry’s billing bible, the DSM-V. “Approximately 68% of the members of the DSM-V task force reported having industry ties, which represents a relative increase of 20% over the proportion of DSM-IV task force members with such ties,” Cosgrove and Bursztajn report.

“Also, of the 137 DSM-V panel members who have posted disclosure statements, 77 (56%) have reported having industry ties, such as holding stock in pharmaceutical companies, serving as consultants to industry, or serving on company boards—no improvement over the 56% of DSM-IV members who were found to have such industry relationships,” they point out.

The APA also issues “Clinical Practice Guidelines,” with recommendations for the use of specific drugs for mental disorders. “Ninety percent of the authors of 3 major clinical practice guidelines in psychiatry had financial ties to companies that manufacture drugs explicitly or implicitly identified in the guidelines as recommended therapies for the respective mental illnesses,” according Cosgrove and Bursztain.

They also found the corporate advisory council of the Foundation “is made up of pharmaceutical companies that contribute significant funding to APF and that manufacture medications recommended in the APA’s CPG.”

On June 11, 2010, the Wall Street Journal reported that the APA “has seen a $7.5 million decrease in pharmaceutical industry dollars over the past year – a more than 10% cut in revenue, which funds its research and education activities.”

“The biggest changes at the APA have come at its money making annual meeting,” the Journal said. “Over the past three years it has been phasing out industry sponsored symposia – dinners and talks.” This translated to a loss of $1.8 million to $1.9 million in industry funding between 2008 and 2009, an APA official told the Journal.

However, according to Martha Rosenberg’s coverage of the group’s annual meeting in a May 31, 2010, Scoop article, although 200 protestors were chanting “no drugging kids for money,” and “no conflicts of interest,” at the convention hall, “polarizing figures” were still present at this year’s event.

For instance, she writes: “Sitting next to outgoing APA president Alan F. Schatzberg, MD, even as protestors chanted outside, was Charles Nemeroff, MD, former psychiatry chairman at Emory University who was investigated by Congress.”

“And a paper presented about attention deficit hyperactivity disorder (ADHD) was co-written by Harvard’s Joseph Biederman, MD, also investigated by Congress for pharma financial links and considered the father of the pediatric bipolar disorder craze,” she reports.

“Nemeroff was signing the Textbook of Psychopharmacology which he co-edited with Schatzberg, also investigated by Congress. Schatzberg, psychiatry chairman at Stanford, consults to seven drug companies, owns stock and patents with others and is on Sanofi-Aventis’ Speakers Bureau according to the meeting’s Daily Bulletin,” she wrote.

National Alliance on Mental Illness

Last year, the National Alliance on Mental Illness became the first patient advocacy group to come under investigation by Grassley’s Committee. In a letter to Michael Fitzpatrick, Executive Director of NAMI, in April 2009, Grassley asked for “an accounting of industry funding that pharmaceutical companies or foundations established by these companies have provided,” to NAMI since January 2005.

“Based upon reporting in the New York Times,” Grassley said, “I have come to understand that money from the pharmaceutical industry shapes the practices of non-profit organizations which purport to be independent in their viewpoints and actions.”

“Specifically, it is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products,” he explained.

The disclosures provided to Grassley revealed that the National NAMI group receives nearly two-thirds of its funding from the pharmaceutical industry. Between 2006 and 2008, drug companies, and their foundations, gave the group almost $23 million.

After receiving Grassley’s letter, NAMI’s executive director sent out an email to many NAMI supporters and stated in part: “NAMI does not engage in product promotion, endorsement, licensure or certification of any product, service or program owned by a corporate sponsor.”

However, Philip Dawdy pointed out the falsity of that claim on his Furious Seasons website. “Fitzpatrick has certainly engaged in product pimpery for J&J/Janssen,” he wrote in his daily blog. To substantiate the “pimpery” charge, Dawdy provided a link to a blog he wrote on December 21, 2006, in response to a J&J press release put out to promote its Risperdal’s me-too drug, Invega, with Fitzpatrick praising the drug using his official title of “Executive Director, National Alliance on Mental Illness.”

“New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives,” Fitzpatrick stated in the press release.

In her book, Side Effects, Alison Bass tells a story of how James McNulty, NAMI president from 2002 to 2004, failed to disclose that he was being paid thousands of dollars by drug companies to promote their products to NAMI members, and others, at speaking engagements. “In a particularly intriguing twist,” she notes on her website, “McNulty laundered this drug company money through a state chapter of NAMI.” Bass further explains how the scheme worked for funneling the cash to McNulty:

“He would be paid thousands of dollars to speak about the benefits of various antidepressants — McNulty himself suffered from depression — and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check.”

On May 8, 2008, when the APA announced the members of the work groups who would develop the DSM5, James McNulty was listed as a task force member with an expert qualification of “President Emeritus,” of NAMI.

Each year, NAMI gives awards to “Exemplary Psychiatrists,” at its annual banquet. In 2008, a May 5, press release reported that “support for the awards” is provided by Eli Lilly and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

NAMI was named as a defendant, right along with Pfizer, in a Medicaid fraud lawsuit filed by whistleblower, Mark Westlock, involving the illegal promotion of Geodon. Pfizer “conspired” with NAMI to act as a front organization in the off-label promotion of Geodon, the complaint says. Pfizer turned “NAMI into a Trojan Horse for the illegal marketing scheme to promote Geodon,” for use with children on the NAMI website.

Laurie Flynn, the former executive director of NAMI, and current leader of Columbia University’s TeenScreen, even went so far as to claim that with the advent of atypical antipsychotic medicines “the long-term disability of schizophrenia can come to an end,” the complaint alleges.

In addition to Geodon, the drugs currently marketed by Pfizer, through NAMI and the pyramid of front groups, include the antidepressants Zoloft, Nardil, Sinequan, Effexor and Pristiq, Xanax for anxiety, the anticonvulsants, Neurontin and Lyrica, and the anti-smoking drug, Chantix, and the ED drug, Viagra.

In September 2009, the US Department of Justice announced that Pfizer would pay the largest single criminal fine, and largest combined federal and state health care fraud settlement in the history of the DOJ. The company agreed to pay $2.3 billion, with $1.3 billion in criminal fines, “to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks,” according to the government’s “Stop Medicare Fraud Website.”

The charges included paying kickbacks to health care providers to “induce them to prescribe,” or “in connection with marketing,” for a list of thirteen drugs that included Geodon, Zoloft, Lyrica and Viagra. The six whistleblowers received a combined total of roughly $100 million for helping the government.

Brian Kenney and Tavy Deming of the Pennsylvania firm of Kenney Egan McCafferty & Young, represented the Geodon whistleblowers. The off-label marketing allegations were first made in a lawsuit filed on behalf of Harrisburg psychiatrist, Dr Stefan Kruszewski.

The antipsychotic was approved only for adults with schizophrenia or acute manic or mixed episodes of bipolar disorder, but Pfizer illegally promoted it for off-label conditions that included depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, ADHD, obsessive compulsive disorder, autism, PSTD, and for pediatric, adolescent and geriatric patients, according to the complaint.

Less than “5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales,” Attorney Deming reported in a September 2, 2009 press release.

As part of its marketing campaign, Pfizer claimed that Geodon had a safe metabolic profile when compared to other antipsychotics, such as Zyprexa, Seroquel and Risperdal, and urged doctors to switch patients to Geodon. The switching campaign “endangered patients by ignoring or materially understating Geodon’s serious, and even life threatening, side effects,” Attorney Kenney said in the press release.

On September 3, 2009, Kruszewski told the Philidelphia Inquirer that Pfizer sales representatives pushed him to prescribe Geodon to children for such symptoms as anxiety and agitation.

“Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide,” Kenney reported in the press release.

“Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists,” he said.

Apparently, NAMI will continue on with business as usual, except now it will disclose the amounts of Pharma gifts. In 2009, NAMI received 84 payments over $5,000 from different sources, according to an April 2010, analysis by John Mack, on his popular Pharma Marketing Blog. Of payments totaling $4,737,610, Mack found $3,836,750, or 81%, came from major drug companies, with the largest amounts coming from antipsychotic makers, including $1,255,000 from AstraZeneca, followed by Lilly with $750,500, and Bristol-Myers giving 506,250. Wyeth’s 2009 grant report shows donations to all NAMI groups totaling $268,000.

In October 2009, Grassley sent letters to all fifty state NAMI chapters asking them to disclose income from pharmaceutical companies and their foundations. On April 26, 2010, Grassley sent a letter to the leaders of NAMI National and included a chart showing the top 10 state chapters receiving the most money from January 2005 to October 2009, totaling $3.84 million.

Also in October 2009, NAMI CEO Fitzpatrick told the New York Times: “For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” and promised the industry’s share of NAMI fund raising would drop “significantly” in 2010.

However, NAMI’s grant report for the first quarter of 2010, shows the group received $1,247,128 from drug companies and foundations, or only $2,212 less than the $1,249,340 it received in the first quarter of 2009. So far this year, Lilly gave NAMI groups over $84,000, and Pfizer’s report shows $78,000 went to NAMI groups.

Conspicuously missing from NAMI’s 2010 first quarter report is AstraZeneca, being the Seroquel maker gave the National group $905,000 in the last quarter of 2009. It may be that Astra was too busy rounding up the more than $520 million it agreed to pay the Federal government and State Medicaid programs in April 2010, to resolve fraud allegations related to the off-label marketing of Seroquel.

“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General, Eric Holder, in an April 27, 2010, DOJ press release.

But Astra can’t be hurting financially because in 2008, even though it makes up only about 5% of the world population, the US accounted for over $3 billion of the roughly $4.45 billion in world-wide Seroquel sales. It was Astra’s second-best selling drug that year, behind the heartburn drug Nexium, and the fifth top selling drug in sales overall in the US. The price of Seroquel at DrugStore.com that year was $839 for hundred middle dose tablets in December 2008. By August 23, 2009, the price had increased by $50 to $890 for the same number of pills.

“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 website.

“This was a well thought out marketing campaign that operated on many levels,” said Brian Kenney, one of the attorneys who again represented, Dr Kruszewski, one of two whistleblowers in this case as well, in an April 28, 2010 press release.

“AstraZeneca orchestrated scientific studies, ghost written articles, and the payment of large fees to academic psychiatrists to act as ‘thought leaders’ to promote the drug off label,” he noted.

“The success can be seen in the huge numbers the campaign generated with 4.9 billion in sales in 2009,” Kenney pointed out.

“It’s particularly disconcerting that AstraZeneca successfully co-opted large portions of psychiatric academic community,” he added.

“The manipulation and misuse of Seroquel scientific data to support AstraZeneca’s off-label marketing campaign was the most disturbing aspect of the case to me,” Kruszewski said in the press release. “There were strong indications from AstraZeneca’s earliest clinical trials that Seroquel increased the risk of diabetes and induced profound sedation out of proportion to its weak antipsychotic effects.”

“In the elderly population, they basically marketed Seroquel as an expensive sleeping pill and put hundreds of thousands of patients at risk for serious medical complications, premature cardiovascular disease, pneumonias, and premature death,” he reported.

In addition to paying $520 million, Astra had to enter into a 5-year corporate integrity agreement that requires the company to post information about payments to doctors on its website, which no doubt will include payments funneled through front groups like NAMI, for Continuing Medical Education programs, speaker fees, research grants, and the various awards given out each years.

Because according to the DOJ press release, the government contends that Astra “promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored Continuing Medical Education programs.”

“The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel,” it says. “In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.”

According to a recent report by Jim Edwards on BNET, former NAMI policy director and board member, Jim Dailey, was a paid consultant for Astra’s Seroquel marketing team, and was paid $600, plus airfare and limousine service, to attend one Seroquel consultant meeting in December 2003.

A picture taken at the meeting shows Daily, along with current NAMI CEO, Fitzpatrick, and Chuck Harmon, NAMI director of corporate relations, meeting with several Astra sales executives. The agenda for the meeting was: Seroquel vision, Role of Advocacy Groups, Increasing role of State/Medicaid with MH issues and MAP initiatives, and Ensuring access for patients.

Edwards explains that “MAP” sometimes stands for “Medication Algorithm Project.” NAMI, along with J&J’s Robert Wood Johnson Foundation, is identified in a Medicaid fraud lawsuit filed against J&J by former federal fraud investigator, Allen Jones, and joined by the Texas attorney general, as participating in off-label marketing schemes to increase the sales of Risperdal, including the “Texas Medication Algorithm Project,” and “Texas Children’s Medication Algorithm Project.”

Latest Plan of Attack

On June 17, 2010, under the headline, “Psychotropic Drug Abuse in Foster Care Costs Government Billions,” Politics Daily reported that the Senate Subcommittee on Federal Financial Management, has asked the Government Accountability Office to look into the drugging of foster care children, who are typically concurrently enrolled in Medicaid.

“The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage,” according to the report.

“Often young patients under state supervision are also prescribed three or four high-risk drugs at a time — all paid for by Medicaid,” it pointed out.

“The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota and Texas, to search for patterns of abuse,” Politics said. “This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level.”

Alaska attorney, and founder of the Law Project for Psychiatric Rights, Jim Gottstein, told Politics that the increase of antipsychotic use in foster care amounts to “drug companies sacrificing children’s lives on the altar of corporate profits.”

In attempt to put a stop to the rampant off-label psychiatric drugging of foster kids, and other children on Medicaid, in Alaska, Gottstein and PsychRights have filed a Medicaid fraud lawsuit against a number of prescribing doctors, drug companies, pharmacies, and insurance companies in that state.

After learning NAMI was pulling in two-thirds of its funding from Pharma, Grassley sent disclosure requests to over 30 more non-profits. The final part in this series will cover the psychiatric front groups contacted including the Depression and Bipolar Support Alliance, Mental Health America, the National Alliance for Research on Schizophrenia and Depression, Screening for Mental Health, Children and Adults with Attention Deficit/Hyperactivity Disorder, and the National Center for Mental Checkups at Columbia University, or better known as TeenScreen.

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 'ADHD', 2010, AFSP, antipsychotics, APA, CHADD, DSM, FDA, front groups, ICSPP, Insel, KOL, MEDICAID, MHA, NAMI, NIMH, Paxil, TeenScreen, TMAP

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Protect babies from drugs

Eli Lilly Funds Depression Screening Initiatives

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Matthew Schultz killed by Effexor. Two hours old.

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Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 3 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • 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! 4 years ago
  • is scared to bond with this baby, just in case. 4 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 […]

UNITE ARCHIVES – Victims & Survivors Against The MOTHERS Act: YouTube Playlist

Videos: Psych Drugs, Birth Defects, Infant Death, Violence & Suicide

UNITE ARCHIVES – Add Your Group To The Coalition Against The MOTHERS Act

CADIMA: 54 Groups and Counting!

UNITE ARCHIVES – The MOTHERS Act Citizen Voting Area on Open Congress

Status: 76% AGAINST S. 324 The MOTHERS Act. Vote & Comment.

UNITE ARCHIVES – Join the Coalition Against The MOTHERS Act on Facebook!

3,271 Facebook Members and Counting!

UNITE ARCHIVES – Stop The Dangerous and Invasive MOTHERS Act!

13,500 Signatures and Counting!

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