Radio Doctor admits being bribed by Glaxo to recommend drugs

I think it’s strange that the word bribe is not often used in articles about this kind of thing. But that’s EXACTLY what we’re talking about here:
bribe
[verb] – persuade (someone) to act in one’s favor, typically illegally or dishonestly, by a gift of money or other inducement.
[noun] – a sum of money or other inducement offered or given in this way.

This story by GARDINER HARRIS appeared in the New York Times last Friday and it’s about the lying, cheating, son-of-a-bitch Dr Freddie Goodwin

An influential psychiatrist who was the host of the popular NPR program “The Infinite Mind” earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program.

The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated.

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

“But as we’ll be hearing today,” Dr. Goodwin told his audience, “modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.”

That same day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. In all, GlaxoSmithKline paid him more than $329,000 that year for promoting Lamictal, records given to Congressional investigators show.

In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting but that neither thought “getting money from drug companies could be an issue.”

“In retrospect, that should have been disclosed,” he said.

But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drugmakers and that, after an article in the online magazine Slate this year pointed out that guests on his program had undisclosed affiliations with drugmakers, he called Dr. Goodwin “and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, ‘No.’ ”

Asked about the contradiction, Dr. Goodwin and Mr. Lichtenstein each stood by their versions of events.

“The fact that he was out on the stump for pharmaceutical companies was not something we were aware of,” Mr. Lichtenstein said in an interview. “It would have violated our agreements.”

Margaret Low Smith, vice president of National Public Radio, said NPR would remove “The Infinite Mind” from its satellite radio service next week, the earliest date possible. Ms. Smith said that had NPR been aware of Dr. Goodwin’s financial interests, it would not have broadcast the program.

Sarah Alspach, a spokeswoman for GlaxoSmithKline, said, “We continue to believe that healthcare professionals are responsible for making disclosures to their employers and other entities, in this case National Public Radio and its listeners.”

“The Infinite Mind” has won more than 60 journalism awards over 10 years and bills itself as “public radio’s most honored and listened to health and science program.” It has more than one million listeners in more than 300 radio markets. Mr. Lichtenstein said that the last original program was broadcast in October, that reruns have been running since and that “the show is going off the air.”

The program has received major underwriting from the National Institutes of Health and the National Science Foundation, both of which have policies requiring grantees to disclose and manage conflicts of interest. Mr. Grassley wrote letters to both agencies asking whether disclosure rules were followed for the grants. Spokesmen for both agencies said they were cooperating with the investigation.

Mr. Grassley is systematically asking some of the nation’s leading researchers and doctors to provide their conflict-of-interest disclosures, and he is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.

In October, Mr. Grassley revealed that Dr. Charles B. Nemeroff of Emory University, an influential psychiatric researcher, earned more than $2.8 million in consulting arrangements with drugmakers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules. As a result, the National Institutes of Health suspended a $9.3 million research grant to Emory, and Dr. Nemeroff gave up his chairmanship of Emory’s psychiatry department.

In June, the senator revealed that Dr. Joseph Biederman of Harvard, whose work has fueled an explosion in the use of powerful antipsychotic medicines in children, had earned at least $1.6 million from drugmakers from 2000 to 2007, and failed to report most of this income to Harvard.

Mr. Grassley’s investigation demonstrates how deeply pharmaceutical commercial interests reach into academic medicine, and it has shown that universities are all but incapable of policing these arrangements. As a result, almost every major medical school and medical society is reassessing its relationships with makers of drugs and devices.

“We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,” Mr. Grassley said. “Now it looks like the same thing is happening in journalism.”

Mr. Grassley has proposed legislation that would require drugmakers to disclose all payments of $500 or more to doctors. Eli Lilly and Merck have promised to begin doing so next year.

Dr. Goodwin has written an influential textbook on bipolar disorder and is an adjunct professor at George Washington University. In an interview, he blamed a changing ethical environment for any misunderstandings with Mr. Lichtenstein about his consulting arrangements. “More than 10 years ago, when he and I got involved in this effort, it didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest,” Dr. Goodwin said.

He defended the views he expressed in many of his radio programs and said that, because he consulted for so many drugmakers at once, he had no particular bias.

“These companies compete with each other and cancel each other out,” he said.

Industry critics dismiss that view, saying that experts who consult for drugmakers tend to minimize the value of nondrug or older drug treatments.

In the fine print of a study he wrote in 2003, Dr. Goodwin reported consulting or speaking for nine drugmakers, including Pfizer, Johnson & Johnson and Novartis. Mr. Grassley asked for payment information only from GlaxoSmithKline. Dr. Goodwin said that in recent years, GlaxoSmithKline paid him more than other companies.

He said that he had never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled “Prozac Nation: Revisited.” which he introduced by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.”

That same week, Dr. Goodwin earned around $20,000 from GlaxoSmithKline, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.

Tom Rosenstiel, director of the Project for Excellence in Journalism, said that although concerns about news media bias were growing, few people believed that journalists took money from those they covered. Disclosures like those surrounding Dr. Goodwin could change that, “so this kind of thing is very damaging,” Mr. Rosenstiel said.

Read more here at Furious Seasons.

More on Marty Keller and his lies about Paxil/Seroxat – does this man have no conscience?

I’m just catching up here with a post about the lying, cheating, son-of-a-bitch Dr Martin Keller (…so sue me Marty…)

This from Alison Bass, author of Side Effects, the book which covers the whole sordid affair of Keller’s 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:

When I was a reporter for The Boston Globe in the 90s, an employee of Brown University’s department of psychiatry handed me a raft of internal university documents. A number of these documents pertained to an ongoing clinical trial that compared the antidepressant Paxil to a placebo and older antidepresssant (imipramine) in the treatment of depression in adolescents. My book, Side Effects tells the story of how researchers at Brown University misrepresented data in this key clinical trial, known as study 329, so in the interest of transparency, I am posting these and other pertinent documents on my website.

The first document here is from the final GlaxoSmithKline report of study 329 (publicly available on its website), which shows that a 14-year-old boy who was in the Paxil arm of the study lost control, punching pictures, breaking glass and injuring himself in November 1994. He was hospitalized and seen as suicidal by the psychiatrists treating him. Yet this patient , known as #65 in the study, was not labeled as suicidal when the study was published in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. (The following year, Paxil became the most widely prescribed antidepressant in the U.S.).

The second document here is a memo to Brown University’s Institutional Review Board from Martin Keller, chief of psychiatry at Brown and principal investigator of study 329. In the memo, Keller reports that a teenager in the Paxil study was hospitalized in September 1995 due to becoming combative and suicidal. Yet in the memo, Keller says he has labeled this patient (#106) as noncompliant instead of suicidal as a result of taking Paxil. Likewise in the published 2001 study, this teenager is labeled noncomplaint and not included in the list of adolescents withdrawn from the study as the result of adverse side effects.

The third and perhaps most mysterious document is a memo from Keller to the IRBs at Brown and two of its affiliated hospitals, Butler and Bradley. In this January 30, 1995 memo, Keller reports that a teenage girl, patient #70 in study 329, ingested 82 Tylenol pills on January 19 and was hospitalized at St. Ann’s Hospital. She was discontinued from the study at the end of January and coded as noncompliant according to another memo from Keller to Brown’s IRB here. Yet according to the GlaxoSmithKline’s final report, patient #70 in the same study was a 12-year-old boy enrolled in the trial on February, 22, 1995 and withdrawn on March 24 after suffering from chest pains. This patient had been randomized to the imipramine arm of study 329.

So the question remains: how did patient #70 go from being a teenage girl who overdosed on Tylenol to a 12-year-old boy with chest pains?

As I report in my book, Donna Howard, the former assistant administrator in Brown’s department of psychiatry who gave me the internal Brown documents, said the data in study 329 was changed to satisfy the study’s sponsor, SmithKline Beecham (which later merged with another company to become GlaxoSmithKline).

“Everybody knew we had to keep SmithKline happy and give them the results they wanted,” Howard said. And she reiterated that comment last week when she was interviewed by Brown’s own student newspaper, The Daily Herald.

In an editorial accompanying the news article, The Daily Herald editors raised the issue of why the university seemed to be judging faculty members by a different standard than it judges students who misrepresent or falsify data. Good question!


Another rigged drug trial? What’s the truth behind the latest Crestor research…

I spent last Thursday at the APRIL Conference – Adverse psychiatric side effects of medicines: What’s our responsibility? I particularly enjoyed Dr Ben Goldacre’s (Bad Science) presentation entitled ‘How drug trials are rigged’.

I was reminded of his talk just this morning as I woke to be greeted by news stories about the latest study into a drug called Crestor – stories such as Wonder drug hope for heart patients and NEW WONDER HEART PILL THAT MAY SAVE MILLIONS

Millions of potential heart patients were handed a lifeline last night… a new cholesterol-lowering drug has proved so successful in trials that doctors want to speed it on to the market… the statin was found to dramatically cut illness and death rates in one of the largest studies ever conducted…the results were so surprising that the trial was stopped more than a year early so work could start on making the drug available to patients.

WOW

However all is not what it might seem, a quick search on the internet found this article about the ‘research’:

The latest study on statins and heart disease, which appeared in the New England Journal of Medicine website yesterday and in all the major papers this morning, is worth a second look, not because of what it says about heart disease, which is mildly interesting at best, but because of what it reveals about profit-driven medical research and how it contributes to making the U.S. health care system the most bloated and wasteful in the world.

The randomized clinical trial, code-named Jupiter, involved giving a statin drug or placebo to 17,802 “apparently healthy men and women” (their words) with normal cholesterol but elevated levels of a biomarker for inflammation called C-Reactive Protein (CRP). Did it reduce CRP levels, and did that reduce heart attacks, strokes and, most importantly, sudden death from cardiovascular disease?

The answer to both those questions is yes. But before we go to the data, the first thing you need to know about this trial is that its lead investigator, Paul Ridker of Brigham and Women’s Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more “apparently healthy men and women” on rosuvastatin, it’s an additional $2 billion-plus in sales for AstraZeneca. If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it’s $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.

I don’t mention these conflicts of interest to cast doubt on the validity of the data presented in the NEJM paper. Rather, it puts me, as it should all analyzers of this trial, on guard to see if there were any flaws in its construction, biases in its analysis, or slants in its presentation. The answer to all three of those questions is yes.

First let’s take a look at these “apparently” healthy people (men over 50 and women over 60). The median body mass index for the group was 28.3, which means more than half were significantly overweight. Indeed, a third were categorized as obese, which isn’t surprising since 41 percent had metabolic syndrome, a suite of conditions that suggests the person is well down the road to developing Type II diabetes.

This profile raises some disturbing questions about the ethical oversight of this trial. Were these trial participants offered counseling about lifestyle changes necessary to avoid developing diabetes, which is recommended for people with metabolic syndrome? The methods section suggests they were only offered the right to participate in the trial, which involved taking a drug that might prevent a heart attack because they had heightened levels of CRP.

The data monitoring committee overseeing the trial stepped in to halt it once it became apparent there would be a statistically significant reduction in cardiovascular events. Where were they when the protocols were being written? Why didn’t they step in at the beginning to insist that the at-risk portion of this patient population be offered the best available treatment (diet and exercise counseling) for their condition (metabolic syndrome)?

This oversight becomes even more glaring when we look at one of the more disturbing findings of the trial, noted in an accompanying editorial but “not adjudicated” by the study’s endpoint committee. The group on rosuvastatin developed diabetes at a higher rate than the group given a placebo, 3.0 percent versus 2.4 percent, an increase of six-tenths of a percentage point.

Keep the size of that percentage in mind as I now turn to the actual benefits of giving the statin for elevated CRP. While the overall rate of cardiovascular incidents fell from 2.8 percent to 1.6 percent by giving the statin, the number of so-called hard events — heart attacks and strokes, including those that were fatal — fell from 1.7 percent in the placebo group to 0.9 percent in the statin group, a drop of eight-tenths of a percentage point.

In other words, for every person who didn’t get a serious cardiovascular event, three-quarters of a person got diabetes.

We can look at the benefits another way — in terms of the number of people who need to be treated to avoid a serious event. In this trial, 120 patients had to be treated for 1.9 years to prevent one serious cardiac event. Remember what rosuvastatin costs? $1,250 a year. That’s $285,000 per event prevented just for the statin pills. The physician visits, CRP tests and lab work add additional thousands more. Can you imagine how many heart attacks and strokes could be prevented if that money were targeted at people who are truly at risk of heart disease (the obese, smokers, hypertensives, diabetics) to help them modify their lifestyles and get treatment for their underlying conditions?

There’s one other curious element in the trial data. In table 4, Ridker and his fellow authors report that the number of “serious adverse events” in both arms of the trial was almost exactly equal: 15.2 percent in the statin arm versus 15.5 percent in the placebo arm. Presumably, all cardiovascular events (2.8 percent and 1.6 percent, respectively) were included in this total.

On the one hand, I’m not surprised that one in seven trial participants suffered a serious health event during the two years of this trial. The median age of this predominantly overweight group was 66, with some as old as 90.

But what were those other serious events? Alas, the study is silent on this point. I, for one, would like to have seen that data published since the raw number suggests that at the end of the day, both of these groups fared almost exactly the same. In other words, giving a statin to people with elevated CRP did nothing to improve this population’s overall health.

So there you have it. A possibly unethical trial with marginal results gets trumpeted in the media as showing “wide benefit” (New York Times). Based on the laudatory quotes coming from the leaders of the American College of Cardiology, this off-label use of statins will quickly find its way into clinical practice guidelines and drug compendia. Within a few years, health care payers will be forking over billions more dollars to the statin drug makers in the name of preventing heart disease.

And those truly at risk of heart disease still won’t be getting the counseling that might save their lives.

So – is this new ‘research’ actually research – or just another piece of drug marketing?

I’ll leave you to make up your mind, I couldn’t possibly comment!

Pharmaceutical Industry Hustlers – Part I SSRI Antidepressants Pushers

As ever, Evelyn Pringle provides us with another well considered, in-depth article. This time she is writing about ‘Pharmaceutical Industry Hustlers’ – the key opinion leaders (KOL) whose reputations are for sale. Doctors such as Nemeroff and Keller in the USA and Montgomery in the UK can be relied on to say whatever a drug company tells them to, providing they are paid enough.

It’s an absolute scandal and the time has come to bring these KOLs to justice – in the words of Barack Obama’s campaign  – Change we need.

Now read on:

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.

Change pharmacovigilance reporting rules, UK govt is told

This story makes me laugh – the UK goverment has been told by the EU that the law needs to be changed to make it clearer to drugmakers when they should report new information which might influence the evaluation of a medicine’s risks and benefits to the Medicines and Healthcare products Regulatory Agency, the government has been told.

What I find so risable is the suggestion that there needs to be a law to ensure drug companies keep patients safe – that’s what it boils down to – “…report new information which might influence the evaluation of a medicine’s risks and benefits…”

This law change comes as a direct result of the 4 year criminal investigation into Glaxo and the way the company hid negative trial data from the regulator and the public in order not slow down sales of Seroxat and Paxil around the world (here, here and here).

Why companies should need laws to make them do what should be perfectly normal and natural is beyond me.

In particular, we are told there is a need for more guidance on what to report within what timeframe, and for further clarity over use of the terms “promptly” and “due diligence,” respondents (mainly manufacturers) have told the public consultation held by the MHRA on the issue.

The consultation was launched to discover if the current law – The Medicines For Human Use (Marketing Authorisations, etc) Regulations 1994 – needed to be changed, following the MHRA’s report earlier this year of its investigation into whether GlaxoSmithKline had failed to inform it in a timely manner about information which it had on the safety of its antidepressant Seroxat (paroxetine) when used in patients aged under 18.

Based on the findings of the investigation and legal advice, government prosecutors decided that that there was no realistic prospect of a conviction and that the case should not proceed to criminal prosecution.

However, the legislation in force at that time was not sufficiently clear or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside, its licensed indications, says the government, in its response to the consultation.

There have been several European Union developments since the Seroxat case, including the new clinical trials Directive and legislative changes to clarify the obligation to report, “promptly,” relevant safety information arising from clinical trials using products outside their normal conditions of use.

The European Commission is also proposing to strengthen the EU system for monitoring the safety of medicines but, given the length of time that this may take, the MHRA has committed to changing UK legislation in the interim to clarify the requirements.

Therefore, the proposed changes to the 1994 Regulations will state explicitly, to ensure there remains “no room for doubt in industry’s and regulators’ minds,” that Marketing Authorisation (MA) holders should report information from both clinical trials outside the licensed indication and arising from third countries and to provide a timescale for reporting, says the government.

Points from the consultation
The MHRA’s review of the consultation says that a number of respondents – including the Faculty of Pharmaceutical Medicine (FPM), Wyeth, the British Association of Research Quality Assurance (BARQA), the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIO) and the mental health charity Mind – expressed concern over the use of the word “promptly.” As a result, it says, the proposed new legislation will use the term “as soon as reasonably practical” instead.

The ABPI also felt there should be guidance on what type of information is caught, in which time frames this needs to be reported and when the clock for such reporting starts, while the BARQA said the MHRA’s preparation of the new regulations should provide a clear audit trail of the underlying legislation, so that MA holders “could understand at a glance exactly what is required of them, especially when severely punitive sanctions apply to non-compliance.”

From my point of view what the APBI is doing is responding in the usual big pharma manner – argue minor detail points and semantics, slow the process right down and ignore the big picture – the big picture which shows that the public has been shafted by big pharma in its pursuit of profits.

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