Pharmaceutical Industry Hustlers – Part I

After twenty long years, it appears that the epidemic in mental disorders in America might be coming to an end. It won't happen because of any great medical breakthrough but rather because the perpetrators of the greatest healthcare fraud in history are finally being exposed. The demolition of the giant "psycho-pharmaceutical complex" appears to be on the horizon.

For far too long, the focus has been on the drugmakers only. In recent months, the spotlight has shown where it belongs - on the highly-paid opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by doctors in every field of medicine and the research institutions that enabled the process.

The antidepressants known as selective serotonin reuptake inhibitors, or SSRI's, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of the storm. These drugs have been prescribed to more Americans than any other class of medications over the past two decades. Cymbalta, Effexor and Wellbutrin are often referred to as SSRI's, but they are slightly different chemically. However, the drugs all carry similar side effects and warnings.

The top sales pitch for SSRI's has been the "chemical-imbalance-in-the-brain" myth. "There is no evidence whatsoever that depression is caused by a biochemical imbalance," says Dr Peter Breggin, one of the world's leading experts on psychiatric drugs and author of the new book, "Medication Madness."

People take for granted pronouncements such as, "You have a biochemical imbalance," and "mental disorders are like diabetes," he explains in the book.

"In reality," Dr Breggin writes, "these are not scientific observations - they are promotional slogans, so adamantly repeated in the media and by individual psychiatrists that people assume them to be true."

"The psycho-pharmaceutical complex fosters these falsehoods in order to promote the widespread use of their products," he says. "Reluctant patients by the millions are pushed into taking drugs by doctors who tell them with no uncertainty that they need medication."

"If you have got a biochemical imbalance in your brain," Dr Breggin advises in the book, "the odds are overwhelming that your doctor put it there with a psychiatric drug."

All Eyes on Glaxo

At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly SmithKline Beecham), due to reports that the company is under investigation by the US Department of Justice, as well as the Senate Finance Committee, with Iowa's Senator Charles Grassley, the ranking Republican on the Committee, leading the charge.

The report that led to the investigation by Senator Grassley was generated in litigation and was only recently made public after it was unsealed by the court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in Psychiatry at Harvard Medical School and author of "The Antidepressant Solution" and “Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives.” He was retained as an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman. The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved, that people taking the drug were 8 times more likely to engage in suicidal behavior than people given a placebo, or sugar pill. Now, it stands to reason that even the most depressed person would decline to take Paxil if given these facts. Also, parents certainly would decline if they were told about the risks.

Dr Glenmullen explains that, by submitting what he refers to as "bad" Paxil numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to the label when the drug was approved. "GlaxoSmithKline's 'bad' Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992, with no warning to doctors or patients of the significant increased risk of suicidal behavior," he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the "run-in" period of the studies as if they happened in the placebo group. The run-in period, also called the "wash-out" phase, occurs when all patients are taken off their existing drugs to let the old drugs wash out of their systems, and all patients are given placebos. The rationale for washing out old drugs is to prevent them from confusing the results of the study, so that patients start out in a similar condition, according to the report.

The official trial only begins after the wash-out phase, once the patients are assigned to receive either the antidepressant or a placebo. The patients who continue to receive the placebo are referred to as the “placebo group.”

"Confusing the pre-study placebo wash-out phase with the placebo group in the actual study is improper," Dr Glenmullen writes, "especially when the concern is a potentially lethal side effect."

The "correct data shows that suicide attempts in patients on Paxil occurred at a rate eight times higher than the rate in patients on placebo," he notes.

Senator Grassley has also asked the FDA to go back and review the clinical trial data submitted on Paxil. In a statement on the Senate floor on June 11, 2008, he said: "Essentially, it looks like GlaxoSmithKline bamboozled the FDA."

"We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public," he stated. "These companies are selling drugs that we put in our bodies, not sneakers."

"When they manipulate or withhold data to hide or minimize findings about safety and/or efficacy they put patient safety at risk," Senator Grassley said. "And with drugs like Paxil, the risks are too great."

A good start

As the Glaxo scandal unravels, the public will learn that other antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories are equally guilty. Likewise, there are many more supposedly independent academic doctors who have been receiving substantial financial benefits from drug companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy Wilens, Stanford's Alan Schatzberg, Brown University's Martin Keller, Melissa DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush, who operated out of the University of Texas, might be a good place to start, but the trail of Big Pharma’s funding “academic research” for marketing purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley's June 4, 2008 statement in the Congressional record, although conflict-of-interest disclosure forms make it appear that the Harvard psychiatrists only received a couple hundred thousand from drug companies over the past 7 years, the true figures show Dr Biederman received over "$1.6 million," Dr Spencer "over $1 million" and Dr Wilens "over $1.6 million" in payments from the drug companies.

"Based on reports from just a handful of drug companies," he states, "we know that even these millions do not account for all of the money."

Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6 million in one drug company. Ed Silverman reports on Pharmalot that there are "30 or so physicians at two dozen universities which the Senate Finance Committee is probing concerning disclosure of grants from drugmakers." The names of those 30 doctors, along with the research mills they operate out of, need to be made public.

The new book, "Side Effects: A Prosecutor, a Whistleblower, and a Best-selling Antidepressant on Trial," by investigative journalist Alison Bass, provides the inside scoop on the fraudulent SSRI research conducted at Brown University by Dr Keller.

The book also supplies background information on the financial ties between the so-called "opinion leaders" in psychiatry and the other antidepressant makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as a team a decade ago to promote Bristol-Myers Squibb's antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium that touted the benefits of Serzone, and Dr Keller was one of the paid speakers at the event. The same year, Dr Keller received $77,400 in consulting fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also touting the benefits of Serzone. The drug was removed from the market in 2004 after it was found to cause liver damage but not before a number of patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998 tax return. But during her research for "Side Effects," she discovered he had earned personal income from Glaxo in 1998, as well as subsequent years. Keller admitted as much during a September 2006 deposition for a lawsuit filed against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the amount of money the academics are pulling in. The pharmaceutical industry also has a stronghold on most major research institutions in this country. Many could not exist if the drug companies withdrew all their research funding, a state of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific Misconduct Blog, when all is said and done:

"The chief villains remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students."

Universities keep corrupt academics on board for good reason. "Side Effects" reports that, between 1990 and 1998, "Martin Keller brought in nearly $8.7 million in research funding from pharmaceutical companies."

The clinical trial industry itself provides a perfect slush fund. Spending in the U.S. was an estimated $25 billion in 2006 and is expected to reach about $32 billion by 2011. Most of the money for trials comes from private industry, and federal funding assumes a second place position, with the National Institute of Health budgeting $3 billion for clinical trials in 2006, according to the paper, "State Medical Board Responses To An Inquiry On Physician Researcher Misconduct," by Dr Stefan Kruszewski, Dr Richard Paczynski and Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.

Paxil Study 329

"Side Effects" also covers the whole sordid affair on Paxil Study 329, the most infamous fraudulent pediatric trial of all time. The study "offers a landmark for the point at which science turned into marketing," according to Dr David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School of Psychological Medicine at the University of Wales, and an outspoken critic of the psycho-pharmaceutical complex, with 21 books to his name, including "The Creation of Psychopharmacology."

He explains that, in 1998, Glaxo's original assessment of Study 329 had concluded that it and another study had shown Paxil did not work for children, but that it would not be "commercially acceptable" to publicize this finding. "Instead the positive findings from the study would be published; they were in an article whose authorship line contains some of the best known names in psychopharmacology (Keller et al., 2001)," Dr Healy writes in the 2007 paper, "The Engineers of Human Souls & Academia."

Dr Keller gets most of the “credit” for the study, which was completed in the mid-90's. Keller et al had some difficulty getting it published at first, but finally found a journal willing to take the bate in 2001, the Journal of the American Academy of Child and Adolescent Psychiatry. In all, 20 academics allowed their names to be attached to this ghostwritten infomercial, and not one has stepped forward to acknowledge wrongdoing or to admit that a mistake was made.

Long before the paper was published, the authors of study 329 were fanned out all the way to Canada giving lectures and presentations to prescribing doctors at medical conferences and seminars to promote the off-label use of Paxil for kids. More than any other paper, Study 329 led to an epidemic in pediatric prescribing. "After its publication, the use of antidepressants for children skyrocketed," Dr Glenmullen notes.

These handsomely paid “key opinion leaders” all deserve to have their names in lights, especially Drs Graham Emslie and Karen Wagner from the University of Texas.

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only payment she reported to the university was $600 in 2005, according to Senator Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a “state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.”

“The Children's Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers,” the Morning News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records show Dr Emslie may have made up to “$125,000 from drug companies since 2004,” according to the report in the Morning News.

While Dr Keller took the lead on pushing Paxil for children and adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was the queen bee on Zoloft studies. The co-authors of papers that appear in the medical literature encouraging the use of SSRI's for kids include Drs Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.

Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry department after Senator Grassley’s investigation revealed that he failed to disclose to his university more than a million dollars in drug industry income. All total, Nemeroff had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among the authors of the SSRI papers and studies highlighted in the 2006 Third Edition of, "Essentials of Clinical Psychopharmacology," described as "a synopsis and update of the most clinically relevant material from 'The American Psychiatric Publishing Textbook of Psychopharmacology,'" by none other than Drs Schatzberg and Nemeroff.

Keep Following the Money

On July 10, 2008, Senator Grassley extended his investigation to include psychiatry's top industry-funded front group with a letter to Dr James Scully, Medical Director and Chief Executive Officer of the American Psychiatric Association, asking for "an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided to the American Psychiatric Association."

The Senator wants records from January 2003 to the present. According to the July 12, 2008, New York Times, in 2006, the "industry accounted for about 30 percent of the association's $62.5 million in financing."

A factor rarely discussed in this debate is the amount of money doctors who prescribe SSRI's make during brief office calls charged at regular rates. This practice has taken a tremendous toll on public healthcare programs and has resulted in higher insurance premiums and overall healthcare costs for all Americans.

In fact, the bilking of public healthcare programs is what led to the current investigations by the Finance Committee, which has the responsibility of overseeing spending in Federal programs. When doctors prescribe drugs for unnecessary uses, public programs not only have to pay for the drugs, they must also pay the fees of the prescribing doctors and for the medical care for injuries caused by the drugs. Government spending tied to the prescribing of psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services' Office of Inspector General, discussed kickbacks to doctors and told the panel:

"Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective."

Mr Morris explained that, "kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements."

Vermont is a rare state in requiring the pharmaceutical industry to disclose the money paid to doctors. On July 8, 2008, Vermont’s Attorney General William Sorrell released the state's annual report on "Pharmaceutical Marketing Disclosures," which lists the payments made by drug companies in 2007. Of the top 100 recipients, once again, psychiatrists received the highest payments. Eleven psychiatrists received a total of $626,379, or about 20% of the total value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it's impossible to embarrass them. Last year, the press ran major stories when this report came out, highly critical of how much money they were making. This year, the average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of the top 10 drugs for which disclosures were reported, five are used to treat mental illness and include Lilly's Cymbalta and Forest Lab's Lexapro. Ironically, Cymbalta sales are also up 25%, according to Lilly's latest SEC filing.

Overall, estimates indicate that the drug industry spends $19 billion annually on marketing to physicians in the form of gifts, travel, meals and other consulting fees, according to a May 22, 2008, press release by Senator Grassley's office. In the November 1, 2007, New England Journal of Medicine paper, "Doctors and Drug Companies — Scrutinizing Influential Relationships," Dr Eric Campell, associate professor at the Institute of Health Policy at Massachusetts General Hospital and Harvard Medical School, writes:

"Individual physicians can take some steps to maximize the benefits for patients and minimize the risks associated with their own industry relationships. They can start by recognizing that such relationships are designed to influence prescribing behavior and by carefully considering the potential effects that their own associations may have on their patients."

"And they can bear in mind," he says, "that the costs of industry dinners, trips, and other incentives are passed along to their patients in the form of higher drug prices."

Antidepressant prescribing is more rampant in this country than any other. The US accounted for 66% of the global market in 2005, compared to 23% in Europe and 11% for the rest of world, according to a December 2006 report by Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital visits in 2005 showed that the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions issued by primary care physicians. They have remained in the number one position ever since. Last year, 232 million prescriptions were filled for antidepressants worth nearly $12 billion, according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler's pay package was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A previous CEO, David Shedlarz, left last year with an "exit package" worth over $34 million. In 2007, the total value of Wyeth's then-CEO Robert Essner's pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of the mental illness epidemic occurring only in the US. Attorneys General all over the country are using consumer fraud statutes to sue the drug giants to recoup the money lost due to the illegal off-label promotion of psychiatric drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of individuals and entities such as insurance companies in California, Florida, Illinois, Massachusetts, Minnesota, Missouri, New Jersey, North Dakota, Ohio and Washington.

The cases are based on documents showing Glaxo promoted Paxil for kids, fully aware that Paxil failed to out-perform a placebo in the clinical trials and had higher suicidality rates. A national class settlement of individual claims was reached in April 2007 in which Glaxo agreed to reimburse parents for all of the money paid for Paxil prescriptions for their children. A national class settlement on behalf of third party payors (insurance companies) was just approved in September 2008.

If not for the few law firms willing to stay the course, the truth would never have been revealed. Baum Hedlund has been pursuing the SSRI makers for nearly two decades. Most recently, it has taken up the fight for babies born with birth defects caused by SSRI's.

Because the industry was so successful at keeping the original SSRI trial data hidden, the drugs’ most serious side effects largely became public only as a result of the bravery and integrity of such medical experts as Dr Healy, Dr Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an increased risk of suicidality, knowing all the long that the risk existed. Now, the companies are making the irresponsible argument (in defense of lawsuits claiming they failed to warn doctors and the public of the risk) that the FDA did not require them to add a warning, so they are immune from liability.

Worse yet, the industry-controlled FDA under the Bush Administration is supporting this audacious preemption defense and siding with the SSRI makers against private citizens in courts all over the country, telling judges to rule in favor of the drug companies and throw out the SSRI cases before they even make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case involving federal preemption, in Wyeth v Levine, on November 3, 2008.

Evelyn Pringle
epringle05@yahoo.com

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department www.baumhedlundlaw.com)

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