Posts Tagged ‘GlaxoSmithKline’

Drug Companies Hire Troubled Doctors As Experts

Wednesday, October 20th, 2010

NPR is investigating how pharmaceutical company payments to physicians are influencing physician prescription practices in partnership with ProPublica, an independent, nonprofit newsroom that produces investigative journalism in the public interest.

This collaboration also includes The Boston Globe, the Chicago Tribune, PBS Nightly Business Report and Consumer Reports.

Pfizer Headquarters in New York City

Mark Lennihan/AP— Pfizer, one of the largest drug makers in the U.S., saw $27.8 billion in sales in 2009. Seven drug companies, including Pfizer, have disclosed information about doctors who receive payment for speaking fees related to products they sell.

by NPR Staff and ProPublica

October 19, 2010Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies’ drugs.

But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

To vet the industry’s handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

“Without question, the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

ProPublica senior reporter Charles Ornstein detailed the findings with Morning Edition‘s Renee Montagne.

NPR: Tell us a little about the database. What have you found, and who’s on it?

Charles Ornstein, ProPublica: For many years, the pharmaceutical industry has been paying doctors to speak and consult on their behalf, but the names of those doctors have largely been a secret. So, for the first time we’re seeing from the companies who they’re paying for. Now we have a chance to take a look at their backgrounds and what they’re doing for the money.

What are these 17,000 doctors listed in the database doing for the seven drug companies that have released information?

The drug companies rely on doctors to speak locally and travel around the country to educate other doctors about the risks and benefits of the drugs. And they can get paid a lot of money. In our database we found that there were 384 doctors who, over the course of just the past 18 months, have received at least $100,000 from the drug companies that have reported so far.

What kind of money are we talking about, and what is that buying the drug companies in the way of sales?

We’re talking about big money. Just from these seven companies, they’ve paid out more than $257 million in the past 18 months, and remember not all of these companies have even disclosed their payments for that whole period of time, so it’s likely going to be substantially more, just for these seven companies.

What do they get for it? They wouldn’t be spending this kind of money if they weren’t getting returns from the perspective of increasing their brand in the market, letting doctors know about it, encouraging them to prescribe it. They say that doctors’ success at increasing prescriptions is not a means in which they’re measured, but some of the lawsuits against the industry have said that prescriptions and return on investment absolutely play a role.

And you have found among those doctors a few who have backgrounds that are a bit shocking, especially considering they’re representing these drug companies and, in a sense, representing themselves as experts.

If you take a look at the pharmaceutical company websites, you see that they take great pride in that they’ve recruited the top names in the field, the leading experts and academicians to speak on behalf of their products and consult with them, and when you start looking at the backgrounds, you find some, indeed, are the top names in their fields. But some you can’t find any information about.

We found several dozen of the top speakers did not have board certifications — which means they were not certified in their medical specialties — and then we found more than 250 doctors who had some type of sanction taken against them by a state medical board. And we just looked at a sampling of states.

Some of the discipline was really quite serious. The Ohio Medical Board, for example, voted a couple of years back to revoke the license of William David Leak, whom they accused of performing unnecessary nerve tests on 20 patients and subjecting some to an excessive number of invasive procedures. Dr. Leak is appealing the penalty, and his license is still active, but since 2009 he has received $85,000 from Eli Lilly and Co.

Another one is a hospital disciplinary case out of Georgia — the state appeals court in Georgia in 2004 upheld a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. He’s an anesthesiologist, and he admitted to giving young female patients rectal and vaginal exams without documenting why. He had also been accused of exposing women’s breasts during medical procedures, and when he was confronted by a hospital official, he said, “Maybe I am a pervert; I honestly don’t know.”

Dr. Leak did not return our phone calls, but I did talk to Dr. Taylor. He said that these incidents happened long ago, that they were old news and happened in the 1990s and didn’t want to talk about them, so he didn’t comment one way or the other, but he did say that nobody raised any issue one way or the other about his medical practice. And that’s really what was most important here — that his medical practice was not called into question.

The Survey Says…

Consumer Reports conducted a survey about the promotional activities of doctors on behalf of pharmaceutical companies.

The survey, conducted in October 2010, included 1,250 randomly selected adults in the U.S.

Highlights are below:

Some doctors take payments from drug companies in exchange for promoting the benefits of those companies’ drugs to other doctors in presentations at conventions and conferences.

Do you approve or disapprove of doctors taking such payments in exchange for promoting specific drugs to other doctors?

CR Survey Q4

Over the past five years, have you been told by a doctor you saw for medical treatment that he or she has taken payments from drug companies?

CR Survey Q5

Would you feel comfortable asking a doctor who is about to prescribe a drug for you if he or she has taken payments from the drug company that manufactures that drug?

CR Survey Q6

In general, how concerned would you be about the quality of treatment or advice you would get from a doctor who took payments from drug companies? Would you be …

CR Survey Q8

In your opinion, how often do you think doctors who take payments from a drug company would be biased enough by the money taken to prescribe that company’s drug even if that drug was no better and/or more expensive than an alternative drug that was available? Would you say …

CR Survey Q10

So put it in perspective. Of all of these doctors — and you’re really talking tens of thousands doing speaking — what does this represent? A few bad apples?

When we spoke to experts about this, what came up was that Pharma essentially has their choice — they get to pick the best of the best, and they have the pick of the litter. What one Yale professor told us is that the public definitely should care, because just as you wouldn’t want your child learning from a bad teacher, you wouldn’t want your doctor learning from a bad doctor. And if that person has displayed bad judgment in the past, what does that portend for what they may be speaking about when they are talking in front of doctors?

When you presented these findings about these doctors who had some real problems in the past to the drug companies, what did the companies say to you?

We asked the drug companies how they screen their doctors, because we felt that was a really important question. For the most part, they said that they relied on the doctors to tell them if they ran into trouble, or they checked federal databases to see if their misconduct had barred them from participating in federal health programs. But we didn’t find but two of the companies that said they checked state medical board websites to see if the doctors were disciplined in those states.

Did any of them suggest they were going to change?

The companies said that they’re certainly going to look into the doctors that we brought to their attention, and they also said they would be looking at their practices. So I think time will tell whether they take a more comprehensive look at the doctors before they hire them to go out and promote their products.

In the story you wrote for ProPublica.org, you talk about doctors who defend their speaking fees as purely educational. In some cases these are experts who go to rural areas where doctors can’t always attend conferences or meetings of experts. Is it the case that some of these payments to doctors for speaking about these products are actually doing some good?

Absolutely. I think one thing that can’t get lost here is that pharmaceutical products have been innovative and have saved lives and provided treatments for diseases that in the past there haven’t been treatments for. So without question, some drugs are absolutely necessary, and the more patients who take them, the better off society will be.

I think the question that some folks have raised is whether or not the drugs that are being excessively promoted are indeed those drugs that have really the breakthrough, the groundbreaking potential. But it does make a huge difference.

To give you an example: GlaxoSmithKline — their top drug that they’re using speakers for is a drug called Avodart, which is for enlarged prostate. And over the past five years, Avodart, which is really locked in a heated battle with another drug, has seen its sales more than quadruple and its market share double. So this has a huge effect.

I think what you hear from critics of the industry is that perhaps when they’re promoting drugs, they’re not suggesting what the alternatives could be — whether it’s watchful waiting or physical therapy or changes to diet and exercise.

In the interest of allowing patients to make some of these decisions themselves, ProPublica has compiled a database so people can search for their own doctor.

We have seven companies, and we’ve combined them all into one database, which was not easy to do. The documents they put on their websites and the databases they put on their websites are not easily analyzable and in some cases you can’t download them or even find out who the top speaker is.

So we are making available access to these doctors. You can search by state, you can search by company, you can search by doctor’s name. And we’re also letting folks have the ability to tell us if one of these doctors is their doctor, and what their experience has been with them. So this is really an opportunity to interact in a two-way conversation with the public about the doctors that work with the industry and hear what the public has to say about their experiences.

Folks will easily be able to look up the names of their doctors and pretty easily find if they’ve taken money from these seven companies.

They won’t know a couple of things. First, more than 70 companies have not yet publicly reported whom they have paid to promote their drug. You won’t see those in the database quite yet. But you also won’t know exactly what they’ve done for the money and if it’s influenced their prescription practices. And I know that we’re planning to continue our reporting in the coming months to provide additional clarity on that for the public.

What’s the use someone could practically put that information to?

We have extensively talked to experts across the country with that very question, and I think what we heard time and again was, if you see your doctor as receiving money from a company that makes your drug, it’s good to ask if there are alternatives that are less expensive, if there are alternatives that have fewer side effects, and to just exercise a degree of caution — not necessarily to distrust your doctor at all, but to ask questions to make sure that this is the drug that’s best for you.

Read the rest of this article here: http://www.npr.org/templates/story/story.php?storyId=130644774&ps=cprs

Explore the database Dollars for Docs logo

Dollars for Docs: What Drug Companies are Paying Your Doctor here: http://projects.propublica.org/docdollars/


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When Big Pharma Breaks the Law—Prosecute the CEO

Tuesday, October 19th, 2010

New Scientist

October 19, 2010

Avandia's manufacturer won't release all its documents about the drug (Image: Bloomberg/Getty)
(Image: Bloomberg/Getty)

Patient safety will remain at risk until big pharma’s top executives are brought to book for their companies’ actions, says Paul Thacker

THERE have been so many stories about pharmaceutical companies promoting the misuse or abuse of their drugs that the names seem to merge – Zyprexa, Seroquel, Paxil and more.

The latest case concerns GlaxoSmithKline’s Avandia (rosiglitazone), an anti-diabetes drug linked to heart attacks. Last month, the European Medicines Agency recommended its suspension from the market, while the US Food and Drug Administration made it all but impossible for doctors to write prescriptions for the drug.

With sales worth over $3 billion in 2006, Avandia was the world’s best-selling diabetes drug until May 2007, when The New England Journal of Medicine published a study linking it to heart attacks. Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents.

As the main investigator into Avandia for the Senate committee for the past three years, I looked closely at the documents. I was appalled. From 2000, GSK pulled out all the stops to keep the drug on the market. Not all studies were provided to regulators, and it intimidated a doctor who criticised the drug. Even though GSK is in the middle of multibillion-dollar lawsuits brought by thousands of patients, it still has hundreds of documents hidden from public view under court seal – a feature of the US system that leaves documents provided under discovery accessible only to the parties involved in the litigation.

How can we stop this? One way is to slash what pharma can spend on encouraging doctors to prescribe their drugs. Companies spend billions wining and dining doctors. For instance, Forest Laboratories’ 2004 marketing plan for its antidepressant Lexapro notes it planned to spend $34.7 million to pay doctors to give lectures to their peers, and $36 million on lunches for doctors to create “an extended amount of selling time for representatives”.

In legal settlements reached with the US government, several companies have been forced to publish databases listing monies they provide to doctors. A provision in the Health Reform Bill passed this year will from 2013 require companies to disclose payments above $10 made to doctors, and explain why. This will be available in a searchable public database.

This will help, and may shame doctors into not taking handouts, but we also need professional societies to tighten ethical requirements to stop doctors accepting pharma gifts.

A second route is to reform the continuing medical education (CME) courses doctors must take every year. Of the $2 billion spent on CME in the US, pharma funds almost half. Companies claim this has no influence on prescribing practices, but internal company documents made public by the Senate finance committee contradict this. For example, Forest Laboratories’ marketing material on Lexapro discussed how CME courses could be used to push sales of the drug.

Several universities have revised rules on industry funding. Stanford University in California now requires companies to pool their money and fund a number of activities instead of funding individual courses, as is still allowed in most medical schools. The Memorial Sloan-Kettering Cancer Center in New York has ended all commercial support for CME in 2007, without ill effects.

Third, we need to penalise executives when companies are caught committing illegal acts. Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.

Paul Thacker is an investigator at the Project On Government Oversight, a non-profit organisation exposing waste, fraud and abuse in federal government. He was congressional investigator for the US Senate’s finance committee, where he was Senator Chuck Grassley’s lead investigator on Avandia

Read the rest of the article here:  http://www.newscientist.com/article/mg20827826.900-when-big-pharma-breaks-the-law-prosecute-the-ceo.html

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Public ‘misled’ by drug trial claims

Wednesday, October 13th, 2010


Tablets
BBC NEWS
October 13, 2010
by Michelle Roberts

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.

Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective.    Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.

But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.  This is not the first time a large drug company

has come under fire about its published drug trial data.

Trial information

Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

GSK rejected claims that it improperly withheld drug trial information.

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture

The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.

They warn that the lack of all information means policy makers are unable to make informed decisions.

Read the rest of this article here:  http://www.bbc.co.uk/news/health-11521873

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Paxil Birth Defects Lawyers Site Offers News And Information About Antidepressant Heart Defects

Monday, September 27th, 2010
Quote startDespite evidence suggesting that Paxil could cause birth defects, Glaxo deliberately chose not to conduct studies that would have uncovered the true dangers of the drug.Quote end

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy. Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects.

PR WEB

September 27, 2010

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy.

Paxil is part of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). After it first went on the market in December 1992, Paxil has gone on to become one of the most widely prescribed drugs in the United States, with annual sales of $3.2 billion by 2002.

Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects. In December 2005, the Food and Drug Administration called for stronger birth defects warnings on the drug’s labeling after two studies found that Paxil doubles the risk of birth defects when taken by women during the first trimester of pregnancy. Most of these birth defects involved cases of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

Paxil has also been linked to an increased risk of birth defects when taken later in pregnancy. A 2006 study published in the New England Journal of Medicine found that women who take Paxil or similar antidepressants after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), a condition which causes breathing and circulation problems that may lead to hospitalization or death.

Taking Paxil during pregnancy may also be linked to a number of other serious heart defects in newborns, including cardiomyopathy, tricuspid stenosis, cleft mitral valves, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valves or patent ductus arteriosus (PDA).

Documents uncovered in the ongoing litigation against GSK [Paxil] products liability litigation (MDL-1574)] have revealed that GlaxoSmithKline, the drug’s manufacturer, was aware of the potential link between the antidepressant and birth defects as early as 1980, but failed to recall the drug or properly warn about its dangers until these risks were made public by researchers.

“Despite evidence suggesting that Paxil could cause birth defects, GlaxoSmithKline deliberately chose not to conduct studies that would have uncovered the true dangers of the drug,” says David Friend of Hissey Kientz, LLP. “It is impossible to say how many lives were drastically altered because of the company’s failure to heed the advice of experts and investigate the link between Paxil and birth defects.”

Read the rest of the article here: http://www.prweb.com/releases/2010/09/prweb4565144.htm

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Stop the Stigma of Mental Illness? Try Stopping the Pharma Funded Campaigns & Groups Behind the “Stigmatizing”

Friday, September 17th, 2010

(Image taken from: http://herinst.org/sbeder/corppower/pharm-agenda.html)

by CCHR Int

A new study, the result of a joint collaboration between Indiana University and Columbia University, and published  by the American Journal of Psychiatry, reports that prejudice and discrimination still exists among people with serious mental illness.  Headlines include “Mental Illness Stigma Hard to Shake, Survey Finds” and “Despite Deeper Understanding of Mental Illness, Stigma Lingers.”

So what exactly is behind this study? Taking aside the fact that Columbia University is well known for its collaboration with pharmaceutical companies, its medical center having collaborated with AstraZeneca, GlaxoSmithKline, Janssen Pharmaceutica, Merck, Novartis and Pfizer. Or the fact that Indiana University received a $1 million grant from Eli Lilly.

With a seemingly altruistic agenda, the fact is the campaign to end the “stigma” of mental illness is one driven and funded by those who benefit from more and more people being labeled mentally ill—pharma, psychiatry and pharmaceutical front groups such as  NAMI and CHADD to name but a few.   For example, take NAMI’s campaign to stop the “stigma” and “end discrimination” against the mentally ill—the “Founding Sponsors” were Abbott Labs, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, Novartis, SmithKline Beecham and Wyeth-Ayerst Labs. (For an in-depth look at what else Pharma funds and how this funding not only helps set mental health policies but campaigns such as this, read Pharmaceutical Industry Agenda Setting in Mental Health Policies at the bottom of this post)

The fact is that the  “stigmatization ” is coming from those that benefit from people being labeled/stigmatized with mental disorders that have no medical/biological evidence. Case in point, if you are rebellious, you are “stigmatized” with the label “oppositional defiant disorder.” If your kid acts like a kid he is “stigmatized” with the label “ADHD.” If you are sad, unhappy (even temporarily) you are “stigmatized” with the label “depressive” or “bi-polar disorder.” If you are shy you are “stigmatized” with the label “social anxiety disorder.” Moreover, you or your child are now stigmatized for life as this label, which is based solely on opinion, is now part of your medical record, despite the fact there is no medical evidence to prove you are “mentally ill”.

This is also true of people diagnosed “schizophrenic.” There is no medical test to verify someone has a brain abnormality or medical condition of schizophrenia. And while no one claims  people can’t become psychotic, the fact remains there is no biological evidence to support schizophrenia as a brain disease or chemical abnormality.  And consider this, if people do become psychotic, or irrational,  is it in fact caused by some  underlying medical (not psychiatric) problem?   And why did a 15-year multiple follow up study find that there was a 40% recovery rate for those diagnosed schizophrenic who did not take antipsychotics, versus a 5% rate for those who did?  What happened to their supposed “brain disease?” Did it simply vanish?  Moreover, if they could recover from such a mental state, do they deserve the “stigma” of “schizophrenia” still being part of their permanent medical record?  For life?   Think about it.  Imagine you were extremely overweight—obese.  You lose all the weight so you are no longer obese.  Yet your medical records continue to say that you are.

And if schizophrenia is in fact a “disease” despite the fact there is no medical or biological evidence (note we did not say speculation, or theories, but evidence) then why is it that psychiatrist Loren Mosher, the former Chief of Schizophrenia Research for the National Institute of Mental Health (NIMH) openly state that there is no biological condition of schizophrenia as a disease or brain malfunction? And why didn’t the mental health industry take advantage of his 2-year-outcome studies proving that those diagnosed schizophrenic could recover without the use of drugs? Is it because this proved that recovery was possible and thereby disproved the theory that something was wrong with their brain? Or was it the fact that they recovered without the use of drugs, thereby threatening a multi-billion dollar pharmaceutical industry?  Maybe this explains why Mosher was fired from his position at NIMH (http://www.moshersoteria.com/)

As a final note regarding “stigmatization,” keep in mind that psychiatrists admit there is no recovery from “mental illness.” They admit no cures. So once you are labeled—game over.

The new “study” also reports, ” more people now believe that illnesses like schizophrenia and depression are caused by chemical imbalances in the brain.”  This is marketing at its best—say people believe in a chemical imbalance so you don’t have to bother pointing out the fact that there is no chemical imbalance .  How can the layperson be sure of this? It’s simple. Find one person who has a lab test showing their chemical imbalance.  Not one of the millions of people taking drugs to cure their “chemical imbalance” has a lab test showing they have an imbalance.  Now it really doesn’t take a rocket scientist to figure that out… does it?

For more information  about pharmaceutical front groups see this:  http://www.cchrint.org/psycho-pharmaceutical-front-groups/

For an in-depth look at this topic, read Pharmaceutical Industry Agenda Setting in Mental Health Policies


Abstract: The development of political agenda-setting through the use of sophisticated public relations techniques is threatening to undermine the delicate balance of representative democracy. This has important ramifications for policies aimed at providing mental health services and the implementation of mental health laws. The principal agenda setters in this area are pharmaceutical companies with commercial reasons to promote public policies that expand the sales of their products. They have manufactured highly effective advocacy coalitions that incorporate front groups in order to set the policy agenda for mental health. However, policies tailored to their commercial purpose are not necessarily beneficial either for patients or the society at large.



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Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

Thursday, September 9th, 2010

BNET

By Jim Edwards

Dr. Joan Luby, the preschool depression researcher at the center of a New York Times article that failed to mention her past research was funded by Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently testing the antipsychotic Risperdal on autistic children aged 30 months to 5 years old, according to the ClinicalTrials.gov database. Although the study is not funded by Janssen, the unit of J&J that makes Risperdal, it nonetheless typifies a new field of drug research: The use of mood-altering pharmaceuticals on the very, very young.

The NYT piece investigated the development of preschool depression as a diagnosis. Slate, like me, found it surprising that the author did not believe Big Pharma’s interest in the field was relevant. Minyanville thought the same thing. Such research is controversial. In November 2008, the FDA said antipsychotic drugs were over-used in children and that more should be done to discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in children, according to this press release — is just one researcher looking at extending the use of antipsychotics to very young kids. Here’s a study on Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on kids aged 6 and up. GlaxoSmithKline (GSK) is currently testing Paxil on 7-year-olds despite that medicine’s well-document propensity to trigger suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold: First, many of these products are not approved for use in children. Risperdal — the product in the Luby study of 30-month olds — is only approved for use in autistic children older than 5; and for schizophrenics older than 13. Eli Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone below the age of 13.

Read the rest of this article here http://www.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychotic-medicines-for-preschoolers/5624?tag=content;drawer-container

To see what side effects doctors, pharmacists,  health care providers and consumers have reported to the US FDA regarding antipsychotics and antidepressants on children (including 0-1 year olds) search CCHR’s decrypted FDA Medwatch reports here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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Psychiatrist pleads guilty to 15 counts of fraud in Paxil clinical trials for kids

Friday, August 20th, 2010

CNBC

Associated Press

NEW ORLEANS – A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil’s safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.

Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.

Read the rest of this article here:  http://www.cnbc.com/id/38783181

Read more about Maria Carmen Palazzo here: http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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NY Times—U.S. Broadens Bribery Inquiry Into Drug Makers—Federal Prosecutors Investigating Payments Made to Doctors

Tuesday, August 17th, 2010

The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010

At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.

In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.

But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.

Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.

More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.

Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.

Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.

“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.

Read entire article here:  http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp

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People & Power—Drug Money

Tuesday, August 17th, 2010

A 23 minute TV expose on Big Pharma by ALJAZEERA (see video at bottom of this page)

This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

  • “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.
  • Lewis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”
  • Sharon Ormsky, FBI Financial Crimes Unit states, “Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% of that is believed to be siphoned off into fraud—that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s  top ten pharmaceutical companies for fraud.  Investigations are ongoing against another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

http://www.youtube.com/watch?v=1TwdsYVHjGA&feature=player_embedded#!

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

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