Nissen Says Its Time To Pull Avandia Off The Market: Video

Published on Mar 23, 2012 by 

Feb. 22 (Bloomberg) — Steven Nissen, chairman of cardiology at the Cleveland Clinic, talks with Bloombergs Betty Liu and Peter Cook about a Senate report that said GlaxoSmithKline Plc knew the diabetes medicine Avandia may cause heart attacks several years before a study, authored by Nissen, documented the risk. The Senate report, by Senators Max Baucus and Charles Grassley, said the company pressed doctors doctors to retract warnings about side effects.(Source: Bloomberg)


GSK: Drug Firms and Their Ties to Doctors

Rules shine light on drug firms’ ties to doctors, raising questions about ethics

Staff Writer

Saturday, April 21, 2012

This photo shows 40-milligram tablets of Lipitor, one kind of statin used for lowering blood cholesterol.
• How this story was developed
• How much area doctors were paid

Helen Carcio, a South Deerfield nurse practitioner, says she’s on a mission to educate other health professionals about treatment for overactive bladders – a quest paid for, in part, by Pfizer, the maker of a drug that treats the condition.

She is among 16 area medical professionals who have received anywhere from $280 to $254,000 from pharmaceutical companies for making speeches, consulting, doing research and for travel and meals, according to recently released documentation about medical professionals’ financial arrangements with pharmaceutical companies.

Carcio, founder and director of the Health & Continence Institute, is a member of Pfizer’s national speakers bureau. The drug company pays her $1,000 to $1,500 per event to speak about overactive bladders. In 2010 she spoke to medical professionals at 11 events.

From July 2009 through 2010, Pfizer paid Carcio $11,649 for consulting, speaking and travel expenses. She also earned $3,750 in 2009 speaking on behalf of GlaxoSmithKline.

Carcio said she lectures for Pfizer because many medical professionals don’t understand overactive bladders.

“I’m trying to take it out of the closet, to talk to providers that are clueless that something can be done about it,” she said. “First you want to get people better, and the majority of us want to be paid for it, but mainly we want to be helpful.”

While legal, the cash relationship between doctors and pharmaceutical/medical device representatives raises questions about conflicts of interest and other ethical issues, leading to federal legislation that will soon require public disclosure of these kinds of transactions.

Carcio is concerned about how people might interpret her relationship with Pfizer.

“I have a passion for making sure women are not incontinent. The more I raise awareness the better, but it’s a Catch-22,” she said. “I’d hate for someone to think I’m on the take, that I’m doing it for the money.”

Carcio says she’s one of the good ones.

“Some do it for the money,” she said of medical professionals who speak on behalf of drug companies. “Some make $150,000 in a year. That would bother me.”

Among the drug companies that have paid Valley doctors are GlaxoSmithKline, Pfizer, Novartis, Eli Lilly, Johnson & Johnson and Merck.

In 2010, Massachusetts doctors received $64 million from pharmaceutical companies, according to the Massachusetts Prescription Reform Coalition, an arm of the Boston-based advocacy group Health Care for All.

The financial relationships between drug companies and doctors will soon be even more transparent. Legislation for the 2010 federal health care overhaul included the Physician Payment Sunshine Act, which will require drug companies to disclose payments to medical professionals.

The details of the act are still being worked out by the Centers for Medicare and Medicaid Services.

The first report detailing the who, what, where, when and how muchof financial arrangements between doctors and pharmaceutical companies will be issued in September 2013.

In the meantime, 12 drug companies are already providing this information either voluntarily or as the result of legal settlements. ProPublica, a nonprofit investigative news outlet, has compiled the payments into a searchable, though incomplete, database (see related story).

Since 2008, the Massachusetts Executive Office of Health and Human Services has been tracking cash transactions between medical professionals and drug and medical device companies through the state’s gift ban law.

Proponents of the Sunshine Act contend that it’s important to make such relationships clear. They say money from drug companies could influence a doctor’s treatment decisions, even if only on a subconscious level.

According to an article titled “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” published in the Journal of the American Medical Association, studies have shown that physicians who meet with drug representatives are more likely to prescribe the drugs the representatives are promoting and decrease the number of generic prescriptions they write.

Alyssa Vangeli, a policy analyst for the Massachusetts Prescription Reform Coalition, said physicians and other health care providers who prescribe medications almost always have the best interest of the patient in mind, “but any kind of payment or financial transaction could potentially influence a doctor,” she said.

“Patients should never have to wonder if their doctor prescribed something because it was best for me or they’ve recently been taken out to an expensive meal by a pharmaceutical company pushing a certain drug,” said Vangeli.

Area doctors, however, say they are not influenced by money, gifts or meals.

“I can only speak for myself,” said Jonathan Bayuk, an allergist and clinical immunologist with offices in Florence, Springfield and Westfield, “but I’ve never been persuaded by a sandwich to change how I take care of patients.”

Marketing with wide reach

The pharmaceutical/medical device industry spends an estimated $20 billion to $57 billion annually to market its products. According to the Pew Research Center, detailing – face-to-face encounters between doctors and representatives – is the largest industry marketing expenditure after pharmaceutical samples.

Most doctors engage in some form of detailing.

More than 90 percent of physicians have some kind of relationship with a drug company representative, according to “A National Survey of Physician-Industry Relationships,” a 2007 article in the New England Journal of Medicine.

The survey reported that, in one year, nearly 80 percent of doctors nationwide received drug samples, 83 percent accepted food or drinks in the workplace, 26 percent received reimbursement or were subsidized for continued medical education, 18 percent were paid for consulting services, 16 percent were paid to speak at events, 9 percent sat on advisory boards and 3 percent enrolled patients in clinical trials.

Since 2008, Massachusetts doctors have been barred by state law from accepting samples, food, drinks or entertainment.

For the most part, Valley doctors who have received money from pharmaceutical companies are being paid to lecture at informational events. Some area physicians have spoken at more than 60 events in a single year, according to the Massachusetts Executive Office of Health and Human Services. Several local medical officials have been hired as consultants and a few received money for research.

Bayuk, for example, has spoken at scores of medical events, and said such engagements can range from small-scale affairs to large conferences. From 2009 to March 2011, Bayuk received at least $124,550 from pharmaceutical companies, mostly compensation for speaking engagements.

Typically pharmaceutical companies ask doctors to speak about the diseases and conditions the drug targets, not about the drug itself. Medical professionals also must follow U.S. Food and Drug Administration regulations about how they talk about drugs. For example, a drug’s risk factors must be addressed.

But Alison Bass, author of “Side Effects,” a book about the suppression of unfavorable research on the antidepressant Paxil, says that typically a speaker will mention a drug manufactured by the sponsoring pharmaceutical firm, saying it is an effective treatment for the disease.

Bass, a journalism professor at Mount Holyoke College in South Hadley, said doctors may be sincere in their endorsements of drugs, based on the data presented in clinical trials. But

she maintains these trials are often flawed.

Drug researchers are more likely to report positive outcomes when a pharmaceutical firm pays for the study, Bass said.

Studies that show negative results may go unpublished, or may even be falsified to present a better outcome. That was the case with Paxil, Bass said.

Brown University professor Martin Keller was paid hundreds of thousands of dollars by SmithKline Beecham (now GlaxoSmithKline) to perform research on Paxil’s effect on teenagers.


Teen participants who reported having suicidal thoughts were miscoded and counted as “noncompliant

,” Bass said. Court documents filed in 2008 in lawsuits against GlaxoSmithKline revealed that adolescents were six times more likely to become suicidal after taking Paxil.

“Money is too influential,” said Bass. She maintains the government, not drug companies, should pay for clinical trials.

From 2009 through March 2011, Bayuk earned speaker’s fees from AstraZeneca, GlaxoSmithKline and Novartis. He said drug companies and the medical community both benefit when he talks at an event. The drug companies spread awareness of their products, and his peers learn of advances in the field.

Bayuk said his medical decisions are in no way influenced by speakers fees he is paid from drug companies. “Not me, but there are some,” he said.

He also noted that when speaking, he may discuss several competing treatment options.

Bayuk says he sees no point in documenting pharmaceutical-physician relationships.

“It’s a total waste of time and money,” he said. “There’s been no impropriety done by me, and I think that’s the truth for 99.9 percent of physicians.”

“I’m a young guy,” he continued. “Maybe in the past there was a problem, but I’ve never seen one. … There’s nothing wrong with disclosing exactly what happens.”

Disclosure can be confusing

But disclosing exactly what happenscan be tricky and it’s one of the sticking points the Centers for Medicare and Medicaid Services are taking comments on as they work on the law’s language. For example, research money is a category that can both compensate a doctor as well as pay for patient care and supplies. Reporting that a doctor received research money could imply that the entire amount was compensation for his work.

Pharmaceutical interest groups and disclosure advocates agree: Financial transactions between pharmaceutical companies and doctors need to be reported with context.

“Patients need to understand that a relationship between their physician and a company does not mean their physician is compromised,” Kate Connors, a spokeswoman for the pharmaceutical industry interest group PhRMA, said in an email. “If anything, they should know that their physician is seen as an expert in his or her field.”

The CME Coalition, a lobbying group for continuing medical education providers, notes that the potential for misinterpretation could encourage doctors to forgo educational opportunities.

Dennis J. Rosen, an Amherst pediatrician, is concerned about how people will look at payments he has received from drug companies.

Rosen, who has been treating children with learning, emotional and attention problems for 42 years, received a total of $254,965 in speaking and consulting fees from Novartis and Shire Pharmaceuticals in 2009 and 2010.

He said he ended those relationships more than a year agobecause he no longer has time for speaking engagements. But he called his work with drug companies “meaningful and educational,” and said it benefited doctors, and subsequently, their patients. When he spoke, Rosen said, he was “fair and honest” about the use of drugs for particular disorders.

The money is not an indication of impropriety, he said.

“I don’t play favorites,” Rosen said of prescriptions. “I use whatever is necessary.”

Kristin Palpini can be contacted at

GSK: Seroxat: Insight into how pharma manipulates research evidence: a case study

5 April 2012, 6.41am AEST
Insight into how pharma manipulates research evidence: a case study


Jon Jureidini
Professor of Psychiatry at University of Adelaide

Jon Jureidini receives funding from the ARC. He is affiliated with Healthy Skepticism.

The Conversation
The Conversation is an independent source of information, analysis and commentary from the university and research sector—written by acknowledged experts, curated by professional editors and delivered direct to the public. read more

2 February 2012
Time to go back to the drawing board on mental health reform
12 May 2011
You can work it out: shrinks aren’t always the best option

SKB knew eight adolescents self-harmed or reported emergent suicidal ideas compared to only one in the placebo group but hid this. Michael Valli
TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Here Jon Jureidini explains what he encountered while examining internal documents as an expert witness in a case against a pharmaceutical company.

It’s well known that academic literature on medication in psychiatry is distorted by selective publication – failing to publish studies with negative results or selectively publishing only positive results from studies with mixed outcomes.

I had the unusual opportunity to see inside the process of how the marketing department of a pharmaceutical company controls and distorts information in the medical literature. This chance arose when I was provided with access to a huge number of internal documents because I acted as an expert witness for a US law firm.

Between 1993 and 1998, SmithKline Beecham (SKB, subsequently GlaxoSmithKline) provided $5 million to various academic institutions to fund research into paroxetine (also known as Aropax, Paxil (GSK) or Seroxat), led by Martin Keller. Keller was from Brown University and received $800,000 for participation in the project.

The results were published in 2001 by Keller et al. in the journal article, “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial”, in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP). The article concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents”.

This was a serious misrepresentation of both the effectiveness and safety of the drug. In fact, when SKB set out their methodology for their proposed study protocol, they had specified two primary and six secondary outcome measures. All eight proved negative, that is, on none of those measures did children on paroxetine do better than those on placebo.

HmanJp/ Wikimedia Commons

The published article misrepresented one of the primary outcomes so that it appeared positive, and deleted all six pre-specified secondary outcomes, replacing them with more favourable measures.

SKB papers also revealed that at least eight adolescents in the paroxetine group had self-harmed or reported emergent suicidal ideas compared to only one in the placebo group. But these adverse events were not properly reported in the published paper. Instead, some were described as “emotional liability” while others were left out altogether.

Although published in Keller’s name, the article was ghostwritten by agents of SKB, and the company maintained tight control of the article’s content throughout its development.

GlaxoSmithKline’s internal documents, disclosed in litigation, show that company staff were aware that the study didn’t support the claim of efficacy but decided it would be “unacceptable commercially” to reveal that.

According to a company position paper, the data were selectively reported in Keller et al.’s article, in order to “effectively manage the dissemination of these data in order to minimise any potential negative commercial impact”.

Ano Lobb/Flickr

As it turns out, the Keller et al. article was used by GlaxoSmithKline to ward off potential damage to the profile of paroxetine and to promote off-label prescribing to children and adolescents.

While problems with the study and the Keller et al paper have been thoroughly exposed in legal actions, the bioethical and medical literature, a book, and a BBC Panorama documentary, the paper continues to be cited uncritically as evidence of the efficacy of paroxetine for treatment of adolescent depression.

Repeated attempts to get JAACAP to retract the offending paper have been unsuccessful.

For paroxetine, the concern is that adolescents are being harmed because well-intentioned physicians have been misled about its safety and effectiveness.

But more broadly, the case raises questions about how widespread such dubious practice is in the academic community, and in the editorial practices of “scientific” journals.

This is the ninth part of Transparency and Medicine. You can read the previous instalment by clicking the link below


Irish former state pathologist claims: “Too many suicides linked to anti-depressants’…

‘Too many’ suicides linked to depression tablets

By Jennifer Hough
Monday, March 05, 2012
A former assistant state pathologist has expressed serious concern about the growing link between anti-depressants and suicide.

Dr Declan Gilsenan said in his 30-year experience carrying out postmortems, he had seen “too many suicides” after people had started taking the drugs and questioned whether GPs were over-prescribing them.

He said the evidence is “more than anecdotal” and he is willing to meet the minister with responsibility for mental health on the issue, as part of a delegation organised by campaigner Leonie Fennell.

Ms Fennell is the mother of Shane Clancy, who took his own life after killing his friend Sebastian Creane.

He had just started a course of anti-depressants and it is believed he took more than the prescribed amount.

At Mr Clancy’s inquest, Dr Gilsenan testified that there were “toxic” levels of citalopram (brand name Celexa or Cipramil) in Mr Clancy’s blood.

Ms Fennell has been campaigning since Mr Clancy’s death to raise awareness about the potential dangers of anti-depressants and is seeking a meeting with Kathleen Lynch, minister of state with responsibility for mental health.

She has enlisted the help of Dr Gilsenan and a former minister, who does not want to be named at this time, but who also has serious concerns regarding side-effects and over-prescribing of the drugs, whose popular brands include Prozac, Zoloft, Lexapro Paxil and Celexa.

“Based on my experience of doing postmortems on people where anti-depressants have been started fairly recently I would have concerns about the link to suicide,” Dr Gilsenan said.

He said the argument will be made that people who start taking anti -depressants are of course depressed, and so could be at risk of suicide. “This will be used against what I am saying, but in my work I have just seen too many cases. There are things like accumulation in the system and dose-related concerns, where people go over a safe level, and I am willing to sit down with the minister and talk to her about these things.”

Dr Gilsenan said doctors need to be more careful when prescribing anti-depressants and people need to be monitored more carefully. “It certainly seems GPs are using anti-depressants very frequently.

These are very important drugs to psychiatry and if they are deemed to be harmful then it’s a big blow to them and that’s why they are defended so much.”

Another expert, Professor David Healy, who also gave evidence at Mr Clancy’s inquest, maintains the pharmaceutical industry is being protected by psychiatry.

In the case of Mr Clancy, the Irish College of Psychiatry came out in defence of the drugs at a time when families in grief were going through a high-profile inquest.
Prof Healy said that although companies are legally obliged to agree that their drugs can cause people to take their lives, psychiatry is not. “Here they offer one of the greatest services they can to companies — they can and regularly do offer apologias for industry. They state in public that not only did the drugs not cause a problem, but that they cannot cause a problem,” he said.

At Mr Clancy’s inquest, Prof Healy stated that in a small but significant minority of patients, using anti-depressants can give rise to violent behaviour.

Read more:

GSK : Corporate Psychopath ?

“it’s your job to be willing to step across the line … to take action… to say…
… this is wrong…”

“the problem… the organizations themselves, the systems are sociopathic… you can’t expect them to have a conscience , you cant expect them to have a heart…”

” somebody at the very top of the organization is making obscene amounts of money… It becomes a situation where money and the desire for money becomes limitless…it’a primitive state of human desire and appetite…”

Lack of empathy..
Without a conscience….
Lack of concern for other people…
Ability to look at people as mere objects…

Does that sound like psychiatry or pharmaceutical companies to you?…

Scroll up to around 31 mins for the segment on anti-depressants…

Why (Some) Psychopaths Make Great CEOs

British journalist Jon Ronson immersed himself in the world of mental health diagnosis and criminal profiling to understand what makes some people psychopaths — dangerous predators who lack the behavioral controls and tender feelings the rest of us take for granted. Among the things he learned while researching his new book, “The Psychopath Test: A Journey Through the Madness Industry”: the incidence of psychopathy among CEOs is about 4 percent, four times what it is in the population at large. I spoke with him recently about what that means and its implications for the business world and wider society.

Are we really to understand that there’s some connection between what makes people psychopaths and what makes them CEO material?

At first I was really skeptical because it seemed like an easy thing to say, almost like a conspiracy theorist’s type of thing to say. I remember years and years ago a conspiracy theorist telling me the world was ruled by blood-drinking, baby-sacrificing lizards. These psychologists were essentially saying the same thing. Basically, when you get them talking, these people [ie. psychopaths] are different than human beings. They lack the things that make you human: empathy, remorse, loving kindness.

So at first I thought this might just be psychologists feeling full of themselves with their big ideological notions. But then I met Al Dunlap. [That would be “Chainsaw” Al Dunlap, former CEO of Sunbeam and notorious downsizer.] He effortlessly turns the psychopath checklist into “Who Moved My Cheese?” Many items on the checklist he redefines into a manual of how to do well in capitalism.

There was his reputation that he was a man who seemed to enjoy firing people, not to mention the stories from his first marriage — telling his first wife he wanted to know what human flesh tastes like, not going to his parents’ funerals. Then you realize that because of this dysfunctional capitalistic society we live in those things were positives. He was hailed and given high-powered jobs, and the more ruthlessly his administration behaved, the more his share price shot up.

So you can just go down the list of Fortune 500 CEOs and say, “psychopath, psychopath, psychopath…”

Well, no. Dunlap was an exceptional figure, wasn’t he? An extreme figure.

I think my book offers really good evidence that the way that capitalism is structured really is a physical manifestation of the brain anomaly known as psychopathy. However, I woudn’t say every Fortune 500 chief is a psychopath. That would turn me into an ideologue and I abhor ideologues.

Is it an either/or thing? It seems to me, thinking about it, that a lot of the traits on the checklist would be be useful in a corporate ladder-climbing situation. So maybe there are a lot of CEOs who simply have some psychopathic tendencies.

It is a spectrum, but there’s a cutoff point. If you’re going by the Hare checklist [the standard inventory used in law enforcement, devised by leading researcher Robert Hare], where the top score is 40, the average anxiety-ridden business failure like me — although the fact that my book just made the Times best sellers list makes it difficult to call myself that — would score a 4 or 5. Somebody you have to be wary of would be in early 20s and a really hard core damaged person, a really dangerous psychopath, would score around a 30. In law the cutoff is 29.

There are absolutes in psychopathy and the main absolute is a literal absence of empathy. It’s just not there. In higher-scoring psychopaths, what grows in the vacant field where that empathy should be is a joy in manipulating people, a lack of remorse, a lack of guilt. If you’ve got a little bit of empathy, you’re kind of not a psychopath.