GlaxoSmithSwine

Glaxo unmasked: drug firm to make £1bn from swine flu

Source: Independent Minds

GlaxoSmithKline (GSK) is to sell the vaccine for up to £6 a dose in Western countries, and the first supplies are due to arrive in Britain in September.

Andrew Witty, GSK's chief executive, refused to apologise for the boost in earnings, pointing out that GSK had invested more than $2.5bn (£1.5bn) in its vaccine development programme over the past few years.

"Swine flu is going to be positive for the performance [of the company], but only because we have put ourselves in a position to do it," he added. "And we have done that by taking very significant risks over a long time, diverting a huge amount of resources to it and doing the research that nobody else has done, so I'm not going to apologise for the fact that the company is going to make a return."

Read more HERE

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Fid

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GSK Threatens Access to Weight Loss Supplements

Washington, DC - GlaxoSmithKline, the second-largest pharmaceutical company in the world, has threatened your access to supplements by petitioning the FDA to classify weight loss claims for dietary supplements as ‘disease claims’.

Washington, DC - On April 17th, 2008, pharmaceutical giant GlaxoSmithKline (GSK) submitted a Citizen Petition calling for the U.S. Food and Drug Administration (FDA) to reclassify all weight loss support claims for dietary supplements as disease claims. Read the full petition here.

Read full story at Citizens For Health

Fid

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Man fined £800,000 for treating customers with illegal Flabjab injection

Source: Nursing Times

Man fined £800,000 for treating customers with illegal Flabjab injection

"MHRA head of enforcement Mick Deats said: ‘This case highlights the robust action the MHRA takes against those who illegally advertise, sell and administer unlicensed medicines for cosmetic purposes." FULL STORY

Illegally advertise?

Here's where the MHRA think differently:

PFIZER & MHRA AIR AD IN CINEMAS

and

Is British TV Promoting Erectile Dysfunction Tablets?


Fid

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Biederman Protocol Breach

The most shocking disclosure: a Biederman study testing the use of powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol."

READ FULL SICKENING STORY OVER AT AHRP

Fid

*Hat-Tip: Stuart Jones

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The Joseph Biederman Song

Biederman, Biederman
Does whatever a liar can
Spins a web, of deceit
Playing God, his great feat
Look out! Here comes the Biederman!

Is he strong? Listen, Bud!
He's been totally misunderstood.
Can he fake trial results?
The Pharma brass he consults
Hey there, there goes the Biederman!

Some kid dies in the night,
He don't care a flying fuck
Data was not quite right
So he could make a fast buck

Biederman, Biederman
Not so friendly Dr Biederman
Health and safety, he's ignored
Money is his reward
To him, life is a great cover-up
Wherever there's a golden cup
You'll find the Biederman!

SEROXAT SUFFERERS STAND UP AND BE COUNTED

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Whistleblower Cases Under Federal and State FCAs

Whistleblower Cases Under Federal and State FCAs Settled with Prescription Drug Manufacturers as of September 30, 2004 [Source]

AstraZeneca
Settlement Date: 6/20/03
Product: Zoladex (prostate cancer)
Total Recovey: $355 million
Type of Alleged Fraud: Marketing the spread Concealment of “Best Price”
Whistleblower: Sales executive of competitor TAP Pharmaceuticals


Bayer I
Settlement Date: 1/23/01
Product: Kogenate, Koate-HP (hemophilia) Gamimune (immune deficiency)
Total Recovey: $14 million
Type of Alleged Fraud: Marketing the spread Concealment of “Best Price”
Whistleblower: Specialty pharmacy (same as Dey, Schering-Plough I)


Bayer II
Settlement Date: 4/16/03
Product: Adalat CC (blood pressure) Cipro (antibiotic)
Total Recovey: $257 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: Bayer marketing executive


Dey*
Settlement Date: 6/11/03
Product: Albuterol Sulfate and Ipratropium Bromide (asthma inhalants)
Total Recovey: $18.5 million
Type of Alleged Fraud: Marketing the spread
Whistleblower: Independent pharmacy (same as Bayer, Schering-Plough I)


GlaxoSmithKline
Settlement Date: 4/16/03
Product: Paxil (anti-depressant) Flonase (nasal allegy spray)
Total Recovey: $88 million
Type of Alleged Fraud: Concealment of “Best Price”(derived from Bayer marketing executive allegations)
Whistleblower: (derived from Bayer marketing executive allegations)


Pfizer I
Settlement Date: 10/28/02
Product: Lipitor (cholesterol)
Total Recovey: $49 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: National account manager for Pfizer subsidiary


Pfizer II
Settlement Date: 5/13/04
Product: Neurontin (anti-seizure for epilepsy)
Total Recovey: $430 million
Type of Alleged Fraud: Off-label marketing
Whistleblower: Medical liaison to physicians for Pfizer subsidiary


Schering-Plough I*
Settlement Date: 5/3/04
Product: Albuterol drugs (asthma inhalants)
Total Recovey: $27 million
Type of Alleged Fraud: Marketing the spread
Whistleblower: Specialty pharmacy (same as Bayer, Dey)


Schering-Plough II
Settlement Date: 7/29/04
Product: Claritin family of products (non-sedating antihistamines)
Total Recovey: $345 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: Three employees at Schering-Plough subsidiary


TAP Pharmaceuticals
Settlement Date: 10/3/01
Product: Lupron (prostate cancer)
Total Recovey: $875 million
Type of Alleged Fraud: Marketing the spread. Concealment of “Best Price”
Whistleblower: HMO physician and TAP sales executive

*Settled under the False Claims Act and the Texas Medicaid Fraud Prevention Act

Fid

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Pharmaceutical companies in the news - Taxpayers Against Fraud

Source: JOINT EFFORT BLOG

Forest Laborator is charged with defrauding the goverment
DoJ has charged Forest Laboratories with defrauding the government by illegally marketing the antidepressants Celexa and Lexapro for unapproved use in children and teenagers. Prosecutors charge former top executives at Forest with concealing a clinical study that showed that Celexa and Lexapro were not effective in children and might even pose risks, including causing some to become suicidal.

Amgen -biotechnology company -Massive Amgen Fraud Case
An unidentified whistleblower has filed a False Claims Act case against Amgen, the biotechnology company which makes arthritis and psoriasis drug Enbrel, and anti-anemia drug Aranesp. Amerisource-Bergen and online health-information provider WebMD Health Corp are also named. The case came out from under seal at a judge’s directive, and DoJ is still deciding if it will join. The case involves off-label marketing, kickbacks and Medicaid best price violations.

Johnson & Johnson and Scios are alleged in off-label marketing
The U.S. Justice Department has joined two whistleblower lawsuits alleging that Johnson & Johnson and Scios engaged in off-label marketing of the cardiac drug Natrecor.

GlaxoSmithKline has reserved $400 million to settle off-label and kick back chargesGlaxo’s $400 Million Reserve
GlaxoSmithKline has reserved $400 million to settle off-label and kick back charges related to “several products” sold from 1997 to 2004, including the antidepressant Wellbutrin. Glaxo said the reserve “reflects the current status of the [DoJ] investigation.”

1- Tenet Heathcare — $900,000,000 under the False Claims Act
2- HCA — $731,400,000 under the False Claims Act
3- Merck - $650,000 under the False Claims Act
4- HCA — $631,000,000 under the False Claims Act
5- Serono– $567,000,000 under the False Claims Act
6- TAP [Taketa-Abbott Pharmaceutical] Pharmaceutical Products Inc. — $559,483,560 under the False Claims Act
7- Schering Plough — $255,000,000 under the False Claims Act
8- Abbott Labs– $400,000,000 under the False Claims Act
9- Fresenius Medical Care of North America (National Medical Care) — $385,000,000 under the False Claims Act
10- Cephalon - $375,000,000 under the False Claims Act
11- Bristol Myers Squib — $328,000,000 under the False Claims Act
12- SmithKline Beecham Clinical Laboratories Inc. doing business as GlaxoSmith Kline — $325,000,000 under the False Claims Act
13- HealthSouth — $325,000,000 under the False Claims Act
14- National Medical Enterprises — $324,200,000 under the False Claims Act
15- Gambro Healthcare — $310,000,000 under the False Claims Act
16- Schering-Plough– $292,969,482 under the False Claims Act
17- AstraZeneca Pharmaceuticals — $266,127,844 under the False Claims Act
18- St. Barnabas Hospitals — $265,000,000 under the False Claims Act
19- Bayer Corporation — $257,200,000 under the False Claims Act
20- Schering-Plough — $255,000,000 under the False Claims Act

For more info read the Joint Effort Blog

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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GSK - The Internal Files

You will need Adobe Acrobat to view these files. Print them off and show your doctor if he/she doesn't believe the withdrawal you are experiencing is a result of the prescribed Seroxat he/she has given you.

GSK Business Plan Guide

GSK Money Bag Memo

GSK Public Relations Firm Memo

GSK Suicide Washout Paxil/Seroxat Data

GSK To Reps

GSK Where's My Paxil/Seroxat

MHRA Letter to GSK

GSK "Psychnet" *

GSK Paxil/Seroxat Fact File **

GSK Paxil/Seroxat Fact File Section 2 [Social Anxiety] **

GSK Paxil/Seroxat Fact File Section 3 [Managing the Discontinuation Issue] **

GSK Paxil/Seroxat Duration of Treatment and Depression: Relapse and Recurrence Rates **

GSK "Paxil CR" Product Monograph **

GSK Paxil/Seroxat Litigation Documents **



* Courtesy of Doug Bremner
** Courtesy of Christopher Lane



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Brian Deer’s Boss Joins MMR Manufacturer Glaxo’s Board

Child Health Safety blog has an interesting story regarding the appointment of James Murdoch to GlaxoSmithKlines board. Murdoch is also boss of The Sunday Times. Some wags have now dubbed the newspaper "The Sunday Glaxo".

'Read all about it' HERE

Hat tip - Steph Gatchell

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Priorities of Drug Regulators

Regulation: A rule designed to control the conduct of those to whom it applies. Regulations are official rules, and have to be followed...

Unless of course you are part of the team at Health Canada, the FDA or the MHRA, it seems.

Exactly what 'regulations' are put in to place at the three regulatory drug bodies above?

One would assume that they regulate the drugs people take but are they merely regulating the drugs that people make as opposed to regulating the pharmaceutical companies that make them?

Quite a bold question but all will become apparent in this latest rant of mine.

A story has just surfaced on CBC News, Canada, that is quite alarming. Although it centres strongly on Health Canada and the FDA it is quite conceivable to rope the MHRA in too.

The story centres around the sale of cheap drugs on the Internet and how online Canadian pharmacies are cashing in on this booming trade. One has to question Health Canada for overseeing this. Basically, drugs are cheaper in Canada than the US, so they make an awful amount of money by selling drugs online to the Americans. Paxil, Zoloft, you name it, they are all there.

Now things are at a delicate stage where the whole SSRi withdrawal protocol is concerned. As I understand proposals have been put forward to the BNF to amend the wording regarding withdrawal from SSRi's and the MHRA did promise me that they would meet with David Healy to discuss a tapering programme. As yet, no meeting has been secured. Anyway, I did tell the MHRA, or at least their former communications officer, that just because I had met with them it would not mean that I would stop writing about them if something niggled me and I thought it was newsworthy. I'm beyond lambasting individuals that work at the MHRA but will call Kent Woods, the CEO, to task if I think they are not doing their job properly. The buck, after all, stops at the head honcho does it not?

Anyway, I digress.

Today's rant sees me homing in on online pharmacies and how they are regulated. These, however, are not the pharmacies selling obesity, anti-baldness or erectile dysfunction drugs. These are online pharmacies that are selling popular drugs such as Paxil and Zoloft.

Late last year the MHRA teamed up with pharma giants Pfizer and made a special advertisement that was aired throughout cinemas here in the UK. The crux of the message was don't buy your drugs online. It was plainly obvious that Pfizer's Viagra was the subliminal message behind this footage.

I'm all for stamping out fake drugs but I am also all for regulating the 'proper' drugs we take too. It seems the MHRA, FDA and Health Canada much prefer to home in on the illegal sale of drugs over the Internet rather than the regulation of pharmaceutical drugs... that is after all their primary role is it not? They may argue that stamping out fake drugs is also a role of theirs - my argument is that it seems to be taking precedence over a much bigger problem!

The U.S. Food and Drug Administration's [FDA] official line on buying drugs over the Internet is if you're an American buying drugs online, you could be paying for:

Counterfeit drugs.

Medicine that's too strong or two weak.

Drugs made in unsafe conditions.

Drugs that are beyond their best-before date.

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Two arguments that are both feasible here:

1. The regulators have to protect the public safety so monitor fake drugs over the Internet, coming down hard on those that are caught.

or

2. The regulators are merely protecting the pharmaceutical industry who see small online businesses as competition.

The regulatory authorities are funded by pharmaceutical companies, in other words, any drug that comes through the door needs investigation by the regulator to see if it is safe and effective. Pharma pay for that investigation process. Unfortunately, many bad drugs have slipped through the system and onto pharmacy shelves because the regulators have had the most important data kept from them... by the very same people who have paid them to 'investigate the data!'

There is no conspiracy here. This is fact.

Two stories highlighted on this blog only yesterday is testament to that fact. [1] [2]

The FDA says there's nothing wrong with buying online, as long as the website is located in the United States, is licensed by the state board of pharmacy where the site is operating, has a licensed pharmacist on hand to answer your questions and requires a prescription from a doctor who is licensed to practice in the United States.

So, in essence, if any website meets the above criteria then it's okay to order... or at least be diagnosed with an illness that they just happen to have the cure for.

Question I have for the regulators - Why is this allowed to happen and why are you not making waves to stamp out this problem?

One would have thought that pharma would have been right behind you financially?

One has to take a step back and look at the bigger picture here.

Online pharmacies that are selling the likes of Paxil and Zoloft are, in the main, making money for pharma. Online pharmacies that sell anti-baldness, obesity and erectile dysfunction pills [of which there are many] are fleecing the pharmaceutical companies because they are much harder to regulate.

The FDA, MHRA and Health Canada should get their priorities in order if they want us to believe that they are looking after the welfare of the public. Too many drugs are slipping through their own 'robust' regulatory system and into the mouths of men, women and children. These same drugs [granted a licence by the regulators] are causing heart attacks, severe adverse withdrawal reactions and in some cases death! Far more than any online 'entrepreneur/s' who is/are selling fake tablets.

Yes, it's wrong to sell bad drugs. It is also wrong to grant a licence to bad drugs. Something Health Canada, the FDA and MHRA have done time and time again.

Face it, their reporting systems are out of date and largely ignored because to actually believe that a drug that they licenced in the first place is causing harm to an individual or individuals would show how flawed the regulatory system is.

Meantime, doctors prescribe us drugs such as Paxil [Seroxat], Zoloft, Vioxx, Seroquel, Lexapro and a whole host of others. Drugs that have been 'investigated' with money given to the investigators by the very same people who manufactured the drugs!

The regulatory systems in the USA, UK and Canada ARE NOT robust. Far from it.

Just ask the parents of any child who has died as a result of the regulators granting a licence to a drug that killed them, ask the grieving widow of a husband who killed himself as a result of SSRi use.

I get no satisfaction out of pulling up regulators for their failures, I just get a sense that they might one day listen to what the patients have to say rather than protect what pharma have to sell.

The Industry [pharma] commit the crime, the regulators aid and abet it.

It really is as simple as that.

Fid

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OBSCENE SALARIES FOR PHARMA HEADS

Source: FiercePharma May 19, 2008

1. Miles White - Abbott - $33.4M

2. Fred Hassan - Schering-Plough - $30.1M

3. Bill Weldon - Johnson & Johnson - $25.1M

4. Bob Essner - Wyeth - $24.1M

5. Robert Parkinson - Baxter - $17.6M

6. Daniel Vasella - Novartis - $15.5M

7. Richard Clark - Merck - $14.5M

8. Frank Baldino - Cephalon - $13.5M

9. Sidney Taurel - Eli Lilly - $13M

10. Jeff Kindler - Pfizer - $12.6M

11. Jim Cornelius - Bristol-Myers Squibb - $11.3

12. Franz Humer - Roche - $11.1M

13. Robert Coury - Mylan - $8.5M

14. Jean-Pierre Garnier - GlaxoSmithKline - $6M

15. Werner Wenning - Bayer - $4.77M

16. David Brennan - AstraZeneca - $4.3M

17. Gerard Le Fur - Sanofi-Aventis - $3.27M

No wonder Prime Minister, Gordon Brown, invited them to his den earlier this year!

Fid

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Obama battles big pharma

Tuesday, 27 January 2009

Source: The Independent

"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.

For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.

Full [hopeful] story here

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An Interview with Joanna Moncrieff: The Myth of the Chemical Cure

Thanks to one of my readers, Ruth, for passing this on to me.

It's an interview with Joanna Moncrieff, author of the book, 'The Myth of the Chemical Cure: A Critique of Psychiatric Drug Treatment'

I shall re-publish the entire interview here for you all to read. The original page can be found here.

----

In this interview she responds to questions about this so – called "chemical imbalance" and the treatment of depression.

1) Dr. Moncrieff, first of all, what led you to write this about about "the myth of the chemical cure"?

What is written in textbooks about psychiatric drugs and how they work never seemed to match up to reality to me. So I started to look carefully at the research on drugs and gradually I came to realise that there was no evidence that they were acting specifically- that they were reversing the basis of a disease- as it was claimed. At the same time I was interested in how drugs came to be so highly regarded in psychiatry- how they came to be the dominant form of treatment. I realised that it was because they were believed to be specific that they were seen as so important, because the idea that they are specific underpins the idea that psychiatry is a medical activity, concerned with reversing medical diseases.

So I began to try and trace how the idea- the myth as I believed it - that they are specific treatments was constructed.

2) I would think that when people have to deal with the death of a mother/father, brother/sister, or even a pet, I think that it is natural and normal to feel depressed. When did we start giving anti-depressant medication for the normal transitions of life that we all have to endure?

The modern concept of depression, as a common condition in need of medical treatment, was invented and promoted in order to market the earliest antidepressants in the 1960s. However, it was when the market for benzodiazepines collapsed in the late 1990s that the pharmaceutical industry turned to depression to create a mass market.

It was during the 1990s that the idea that depression affects up to 1 in 4 of the population and other such figures were publicised and the motive was to create a market for the new and profitable antidepressants known as SSRIs.

3) How exactly do psychiatrists find out if there is a real chemical imbalance in the brain? Or are they just experimenting with patients?

Psychiatrists have no way of telling that someone has a chemical imbalance. The idea that depression is caused by a chemical imbalance is simply a hypothesis. There is no consistent evidence that there is any biochemical abnormality in people diagnosed as depressed. The idea has been promoted by drug companies and professional organisations, but the evidence base for it is almost non existent. Most experts say that the fact that people improve when you give them antidepressants is the strongest evidence that there is a chemical imbalance. But there are other ways of explaining this- antidepressants are psychoactive drugs, that may suppress emotional feelings, or just sedate people.

Anyway, as recent research shows, people improve barely more with antidepressant than they do with a placebo.

4) The number of pills for a wide variety of so- called " mental illnesses " seems to have skyrocketed. Someone is making a lot of money pushing these pills. Is it all about money?

Partly, but it is also about professional status. Psychiatrists push pills because it bolsters their position as doctors. Also governments have supported medical interventions like drugs because they look like simple solutions to otherwise complex and intractable problems. Also we live at a time when big business is very powerful, and governments are unwilling to reign it in.

5) I know there are some violent, aggressive, assaultive patients who either have to be physically restrained, or put in a special room, or a straight jacket. In such instances, are we simply sedating the patient or are we really treating them?

I think everyone would admit that at times like these we are simply sedating them, or using chemical restraint. What is more open to dispute is what we are doing to people whose behaviour is chronically antisocial, disturbing and maybe irrational. People like this are usually diagnosed as having chronic schizophrenia, or some other mental disorder. In this case, the drug treatment they are inevitably given on a long-term basis is dressed up as a treatment, but is often aimed at controlling their behaviour.

6) Are there germs, bacteria, viruses, and things that can be seen under a microscope that cause "mental illness"?

No- there are no proven physical causes of any mental illnesses.

7) We all have to deal with anxiety- we have to work, take tests, deal with disgruntled people- why do some people need anti-anxiety pills for the problems that we all have to face---and do these folks have some type of chemical imbalance?

Everyone is different and some people find stress harder to deal with than others.

This is partly due to upbringing and environment, but some of it is probably due to the variation in our biological makeup. However, I don't think it is something you can pinpoint, like a chemical imbalance.

It's just that we are all different, biologically as well as psychologically. You can't "correct" these differences (assuming you could identify them, which I don't think you will ever be able to do) without eradicating individuality itself.

8) Is there really such a disease as attention deficit disorder or is this just a bunch of symptoms that have been lumped together in some fashion?

Its not my specialist area, but child psychiatrists I know say that they can always find a better explanation for a child's behaviour than calling it ADHD. ADHD is a label that locates the problem in the individual child, whereas I suspect the problem really often lies in the family and the wider environment. The only reason for giving someone the label of ADHD, of course, is in order to justify giving the child stimulants. There is a big debate about whether these are useful- and if so whether they are worthwhile. They can make a child pay attention at first, but whether this is really beneficial is unclear. Also their effects probably wear off (like most drugs taken for long periods)- and the latest 3 year follow up of the biggest randomized trial of stimulants shows no benefits over non drug treatment at three years.

9) I have read some crazy stuff on the Internet about statins being given to 8 year old children. Is there any sane, reasonable, rational, realistic reason to give an 8 year old child a statin?

I don't know about the wisdom of giving children statins, but childhood obesity (not a nice word) is certainly an indication that there is something very wrong with our society. It is also caused of course by drugs like the new antipsychotics, which are being more commonly prescribed to children. So some childhood obesity is being caused by drugs in the first place.


10) Here in the United States, we once had a commercial that said " relief is just a swallow away". Have the pharmaceuticals taken this mass drugging way too far?

Everyone is looking for a magic bullet for everything nowadays. The pharmaceutical industry have certainly helped create this situation, but again I think it is the broader political climate that has encouraged this to happen. Popping pills to solve your problems is a perfect consumerist activity, and it helps keep people so worried that they don't have time to challenge the system. Accepting life's ups and downs is not a good recipe for keeping people working their guts out to buy more stuff.

11) I often see individuals who seem to have no coping skills, low frustration tolerance and a lack of thinking skills. Should not these people get training and counseling, rather than some pill for their alleged " chemical disorder"?

Yes, these would be better, but often there is no individual solution. We have to ask why some people get this way, and what changes we can make to society to prevent it happening and to help them when it does.

12) Are there any psychiatric diagnosis which in your mind, are true "chemical imbalances" for example chronic schizophrenia?

No. Organic conditions like dementia and learning disability have a physical basis (but not a simple chemical imbalance). For mental illnesses like schizophrenia, manic depression and others, no physical cause has ever been proven. It is often said that we have evidence that they are genetic- but this evidence is much weaker than presented (Jay Joseph gives a good deconstruction of this). It is said that people with schizophrenia have different shaped brains- but again the evidence is weak and inconsistent and drug induced effects have not been ruled out.

13) Do you have a web site where we can get more information?

The Critical Psychiatry Network has a website where there are many interesting papers posted and other information. The address is www.criticalpsychiatry.co.uk

14) What question have I neglected to ask?

Whatever mental illnesses consist of, and we do not know, but have no good evidence at present to think they are caused by specific brain diseases like real neurological conditions, when we treat them with drugs we are merely drugging people. This may suppress the symptoms, which may be helpful for a while, but obviously there are adverse consequences. If you are drugged you are usually slower and less emotionally sensitive than if you are not under the influence of drugs. Psychiatrists need to be more honest about this- but so do politicians and society as a whole. We are pretending to treat or cure people with mental illness because that makes us feel alright about controlling them. Sometimes we need to control them but we should at least be honest about what we are doing. Pharmaceutical companies are cashing in on our dishonesty.

Published August 7, 2008

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Key opinion leaders: independent experts or drug representatives in disguise?

Ray Moynihan, visiting editor, BMJ
1 University of Newcastle, Newcastle, New South Wales, Australia
Ray.moynihan@newcastle.edu.au

Ray Moynihan examines the role of the influential experts paid by industry to help "educate" the profession and the public

In the world of medicine, "key opinion leader" is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs.1 These influential doctors are engaged by industry to advise on marketing and help boost sales of new medicines. Across all specialties, in hospitals and universities everywhere, many leading specialists are being paid generous fees to peddle influence on behalf of the world’s biggest drug companies.

Kimberly Elliott, who was a drug company sales representative for almost two decades in the United States, puts it directly. "Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations," she said. "If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back."

From the age of 23, Ms Elliott worked for several global drug companies, including Westwood Squibb, SmithKline Beecham, and Novartis, leaving the industry 18 years later, only last year. Many times a top national salesperson, part of her job was developing relationships with local and national opinion leaders, also described as "thought leaders." Ms Elliott says she would pay these respected doctors $2500 (£1280; 1610) for a single lecture, which was largely based on slides supplied by the company. Sometimes the company would pay the fee to an academic centre, which would then pay the doctor. "These people are paid a lot of money to say what they say," she said. "I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are."

In a candid interview with the BMJ, the medical director at the Association of the British Pharmaceutical Industry, Richard Tiner, agreed key opinion leaders play an important role for drug companies. "Companies will employ consultants to help advise on marketing strategies . . . and present and speak at conferences," he said.

Generous earnings

Two recent business intelligence reports on how drug companies identify, recruit, train, and pay their opinion leaders state that influential doctors can earn up to $400 an hour.2 3 The reports were produced by a company called Cutting Edge, which works closely with drug company executives, and are available to purchase at around $8000. A publicly available summary of one report shows that some doctors can earn more than $25 000 a year in advisory fees. A press release promoting the other report suggests that the average fee paid to a doctor for a "scientific speech" is more than $3000.4 Typically these speeches are delivered at educational events sponsored by companies.

The BMA said that although it might have had agreed fees for its members to be paid as key opinion leaders in the past, it had not happened recently. The association’s fee guidance schedule, however, suggests members may charge drug companies more than £200 an hour for participation in clinical trials. Although many doctors retain these earnings, it’s important to note that some donate their payments from drug companies to charities, or research.

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Musical Interlude and Message to Child Psychiatrists

Behavourial problems in children have been around for centuries. The real problems start when you feed them drugs!



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For Charlie Nemeroff

KA CHING MR BLING!

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SKYLAND TRAIL

Skyland Trail

WHO ARE THEY?

Skyland Trail began with the determination of Atlanta business leader Charles B. West to fill a void in mental illness treatment. In the early 1980s the dominant treatment model in Atlanta was hospitalization for acute cases, aimed at stabilization. There was no long-term treatment program with the goal of offering therapies, together with the skills needed to reintegrate back into the community.

Through a friend’s experience, Mr. West recognized the need for the latter approach. He was nearing retirement from the family business, West Lumber Company. Turning his energies to the new cause, in 1982 he established The George West Mental Health Foundation, named for his father, and recruited a committed board of directors. The board studied programs and innovations across the nation that looked beyond short-term stabilization to long-term recovery.

WHO THEY SERVE?

A project of the George West Mental Health Foundation, Skyland Trail serves adults with mental illness through innovative and individualized treatment that improves mental, physical and social well being. We specialize in the following disorders:

• Bipolar

• Depression

• Dual Diagnosis

• Schizophrenia

One name keeps popping up.

Board of Directors
Charles B. Nemeroff, M.D., Ph.D.

Professional Advisory Board
Charles Nemeroff, M.D., Ph.D.

National Advisory Board Members
Charles B. Nemeroff, M.D., Ph.D.

Old Chuck must be a multi-millionaire by now - he has his grubby little fingers in so many pies!

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Nemeroff Comment

A comment was left by Doug Brmener MD regarding my post, Did Glaxo/Lilly pay Nemeroff to discredit David Healy? Doug works at Emory University. Here is his comment and my response that he has yet to publish on his blog

I am a professor of psychiatry at Emory. Yes, Charlie Nemeroff can be intense; but I have seen worse. Most of the bloggers writing about him have never read his papers or have any real idea of what he has done. Admit it guys...

Mind you, I am not here to justify Dr. Nemeroff's bad behavior. To not disclose the payment of more than $10,000 a year from a drug company that makes a drug you are also studying with an NIH funded grant is clearly a violation of NIH policy (although not a violation of the law).

However, if the children want to throw rocks, they should be informed about the subject.

I have some questions for Senator Grassley.

First off, why are you only investigating psychiatrists? [Answer: psychiatrists have an approval rating in medicine that is only above chiropractors. Many people blame paxil for their problems. It is low hanging fruit]

Second, why don't you look at other specialties? Take a look at cafepharma.com, where the drug reps are gossiping in relation to the Nemeroff dispute that "key opinion leaders" for advair are at the front of the gravy train. [Answer: cardiologists make life saving drugs, while psychiatrists are pseudoscientists who are trying to invent a myth about serotonin imbalance so they can help sell drugs for their cronies, the drug companies.] [Answer to answer: Not true. You have to treat 100 heart disease patients with Lipitor to prevent one heart attack, while you treat only 8-17 depressed patients with an antidepressant to prevent a recurrence. And if you don't believe that depression is as bad as a heart attack, ask someone who has been there.]

Ask anyone who works in a university hospital. If their docs have any talent, they are never there. It is because they are always away giving talks for pharma. And pretty much all of it is undisclosed. Not to try and justify it, but lets get real.

Finally, I came under full frontal attack for my opinions about accutane and depression that went against pharma and for which they tried to ruin my career, and the ONLY person at Emory to stick up for me was Nemeroff. You can read about it on my web site.

Senator Grassley, if you really want to get to the bottom of the corruption that has permeated academic medicine, do a nation wide audit. Of ALL specialties. If you don't, you are a hypocrite.

http://www.beforeyoutakethatpill.com/blog.html

My response, which has been emailed to Doug:

Doug,

Firstly, thank you for leaving your comment. I would be grateful if you would allow this comment through on your blog as I have allowed yours through.

Quite why you would think Sen. Grassley would read this blog though is a mystery to me?

You are asking 'bloggers' to read Nemeroff's papers, do you think his papers are honest opinions or opinions based on money he has received and not declared from Pharma?

You know the guy personally and I see he stood by your side when you were getting a rough deal from Pharma regarding your work on accutane and depression. It's a pity he didn't give the same support to David Healy don't you think?

Way I see it is Grassley is merely making a start. Rome wasn't built in a day.

Finally, to label people who speak out against Nemeroff as 'children throwing rocks' is rather churlish. We are merely advocates fighting back because many of us were harmed by the very same drugs that Nemeroff has been paid to support. That would be our 'conflict of interest', if you will.

Could you do me a favour and pass on this message to your friend, Nemeroff:

Dear Blingboy,

How does it feel to have your world turned upside down?

You have received huge amounts of money from drug companies and given opinions on their drugs whilst being paid to give those opinions.

You have intimidated people who have dared to speak out against SSRi's [in particular Paxil]

You now have what you crave [media attention] albeit for the wrong reasons.

You may wish to try a course of antidepressants should this heat get too much for you. Only you will know when you are ready to taper off them. You can ask GlaxoSmithKline for a tapering program if you wish? I wouldn't bother though seeing as they don't have one!

Maybe the hordes of cash you have accumulated over the years will help you through this 'sticky period'. Some of us are less fortunate than you. You see because you bigged up the drugs we have struggled with, it is very hard for doctors to believe what we [the patients] are telling them.

You have no morals and you have caused misery to thousands, if not millions of people, worldwide.

In a wonderful play on words Blingboy, What does it feel like to have a taste of your own medicine?

I sincerely hope you go down for this. Hey, you and Keller can share a cell. How quaint.

Regards

Bob Fiddaman
[A Victim of your bullshit]

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Who Wants To Be A Millionaire?

Click on Image

LUCKILY THE STUDIO AUDIENCE HAD ACCESS TO THE FACTS

*Picture sent in by anonymous reader

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
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Dedicated to Emory Uni and Charlie Nemeroff

ALL TOGETHER NOW...

"DIRTY DEEDS...DONE DIRT CHEAP"

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Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON