Welcome to Thoreau-FDA.com… MHRA employees – are you watching?

Come on you MHRA employees and ex-employees – what are you waiting for?

Welcome to Thoreau-FDA.com, a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.

Thoreau-FDA stands for Thorough – High – Objectivity – Review – Ends – Are – Us – FDA.

Posted in FDA, MHRA. 2 Comments »

Lilly & Zyprexa – Glaxo & Seroxat?

I notice that Phil Dawdy at Furious Seasons has an update on the Zyprexa story. I’ve written about Zyprexa before but Phil is the Daddy on this one.

In March 2007, I wondered “how does a drug such as Zyprexa, that was approved for the treatment of adults with schizophrenia, and a few years later, was approved for short-term treatment of adults with manic episodes associated with bipolar disorder, become such a HUGE selling medicine?

“Despite its extremely limited original approved uses, Zyprexa has gone on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.”

This from Furious Seasons:

Late last week, US District Court Judge Jack Weinstein shot off his mouth in an opinion he filed in the midst of a merry-goround of opinions being filed as various Zyprexa cases under his purview are shaped up to march toward trial or settlement. Recently, Weinstein pressed Eli Lilly to settle all outstanding Zyprexa claims and various estimates put that figure at over $7 billion. Even at a payout of $7 billion, Lilly will be ahead on the deal. [Lilly has already settled about $1.3 billion in claims over its handling of Zyprexa].

Anyway, the judge let the FDA have it right in the kisser over Zyprexa, which, as most of you know, has been linked to thousands of cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

Weinstein’s opinion is well-supported by the facts and he had more to say about the FDA in his opinion, which you can read  here (pdf file). As he notes elsewhere in the opinion, the drug regulators in other countries were not fooled by Lilly’s various smokescreens, but the FDA was.

He also went after Lilly:

“Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation….Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.” [RICO is the federal Racketeer Influenced and Corrupt Organizations statute that was designed to prosecute various mafia families. That acronym coming out of the judge’s pen should have Lilly running for its settlement checkbook].

What strikes me about the the Judge’s opinion in this matter is that it could so easily have been written about Glaxo and Seroxat:

“… lack of transparency, failure to warn, and deceptive or illegal marketing practices… exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers… violation of obligations of transparency… deliberate encouragement of off-label use…”

And in the same way that the FDA has “failed consumers”, so in the UK we see the MHRA has done the same.

Seroxat suicide…? of course not, says Glaxo

Today, July 21, would have been Sara Carlin’s 20th birthday… Instead, on Sunday, May 6, 2007, Sara, suffering from the side effects of a powerful anti-depressive drug, grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parent’s house. “We thought this has to be murder. This girl would never do that,” said Neil, her father. “How could someone so beautiful and brilliant, who had so much going for her want to end her life?”

Sara had been prescribed Seroxat/Paxil and it changed the person she was. The full story is here.

What follows is from Bob Fiddaman. I couldn’t put it any better:

I could never even begin to imagine what it would feel like to lose one of my children, in fact the mere thought of it upsets me deeply, so much so that the following story rips at my heart and saddens me whilst at the same time it angers me and fills my heart with hatred.

To lose a child through natural causes is tough, to lose a child through an accident even tougher but to lose a child because at such an early age they thought suicide was a solution must be one of the worst experiences any parent must go through.

Quite what that ‘experience’ feels like, will hopefully be unknown to many of the readers of this blog.

Unfortunately for Neil and Rhonda Carlin, they no longer have the option of wondering what it would feel like to lose a child. Their daughter, Sara, had her whole life ahead of her. She was looking forward to finishing university to pursue a career in dermatology. Instead, on Sunday, May 6, 2007, Sara, suffering from the side effects of a powerful anti-depressive drug, [Seroxat]grabbed a piece of electrical wiring, made a noose and hanged herself in the basement of family home.

Sara began to experience anxiety and visited a doctor in an effort to alleviate it, explained her mom, Rhonda. The doctor prescribed Sara, then 17, Seroxat.

In 2003 and 2004 Health Canada had stated that the drug should not be given to children and adolescents under 18 years of age due to a possible increased risk of suicidal events. Sara’s parents were unaware of this and, I suspect, was Sara’s doctor. Why else would a doctor prescribe a potential suicide pill to a child?

Neil and Rhonda Carlin both noticed a considerable change in Sara’s behaviour after she began taking the Seroxat. They both strongly agree that the change in Sara was due to the drug she was taking.

Sara missed several doses in the days leading up to her death because her medication had been stolen. Her parents believe that Sara made up for her missed dosages later by taking more than what she should have. “She had no idea what that would do to her, how potent and how dangerous these drugs are,” said Rhonda.

On Sunday, May 6, 2007 Sara Carlin was found hanging by a piece of electrical wiring in the basement of her parents house.

“We thought this has to be murder. This girl would never do that,” said Neil. “How could someone so beautiful and brilliant, who had so much going for her want to end her life?”

Today [21st July] would have been Sara’s 20th birthday. Her parents should have been celebrating, watching her unwrap her presents, watching her smiling face as her friends gathered around her. Instead, Neil and Rhonda Carlin will be grieving. Their hearts will be full of sadness. Their heads full of questions as to why this was allowed to happen.

Had GlaxoSmithKline said from the offset that Seroxat should not be given to children then maybe Sara would be around today, maybe her parents could have helped her blow out all 20 candles on her birthday cake.

My heart aches today – I celebrate my 44th birthday in 10 days time. I can sit with my family and friends. I can feel warm inside when my father and sisters hug me to wish me a happy birthday.

I contacted Neil on Sunday and he wrote back to me and offered me a letter that his wife, Rhonda, had wrote to her daughter, a special letter for her 20th birthday.

Both Neil and Rhonda have gave me permission to publish the letter on here.

I sincerely hope the letter opens the conscience minds of all those involved in the suppression of Seroxat data.

It begs the question why any company would want to hold back data that endangered our children.. and hold back that data they certainly did.

This letter hurts.

This letter goes out to the scientists and employees of GlaxoSmithKline whom were part of the suppression of data.

How many more candles will be unused Glaxo?

Rhonda’s letter:

July 16 2008

My Darling Sara,

Happy Birthday Baby.

July 21 1988 was such a happy day for us. You were such a gift and remained a gift for 18 short years. I guess that counting the birthdays you will never celebrate lets me age you in my mind;but the pictures and the memories all stay the same, no new ones to add. You only lived 18 years and nothing will ever change that. I miss you so much ‐ we all miss you so much. The pain is really not speak able, the intense longing unbearable. Your family, friends, and teachers they all are in shock at losing you. Even strangers wrote on your face book: “Sara, you probably don’t remember me, but you tutored me in Math, you were so beautiful and smart and made me feel so good about myself”. Your math teacher and the students you helped talked about your gifted nature in teaching others not as fortunate as yourself Your school hockey team had a service for you and Mr. Mac and your team was stunned in sorrow. You were so excited your last year of high school. You took calculus the summer before so that you could get top marks in your remaining courses. You got 98% on that calculus and you were so proud of yourself. You got accepted into Western Health Sciences and were set you go after your dreams. But you got a bit anxious in your last semester and went to the doctor about your anxiety. I didn’t agree that you should take Paxil® but you said the doctor said it would make you feel better. You told you sister that it made you “not worry about things”. It seemed to me that you became unwell when you started this antidepressant you had bad dreams, had trouble sleeping, started to go out more and stay up late, quit hockey. Then in the summer you became so tired and lethargic we found by September that you had mononucleosis affected by the medication you were taking. You told your doctor you had trouble sleeping and were not feeling well so she gave you sleeping pills, and when you couldn’t sleep through the night she gave you another antidepressant to take along with the Paxil® to help you stay asleep. When we questioned this you said the doctor knew best and didn’t agree that you should come off the Paxil®; and in fact doubled the dosage. Well, a few months later, you hung yourself in desperation. Afraid to go to sleep and face your dreams, sitting at your computer half way through taking off you make‐up, you decided to cut a length of electrical cord that your dad had left out to wire some lights, and you ended your life in an instant. Oh my God Sara, I am so sorry that I didn’t realize the depth of your pain, that I didn’t take you away and get you off these prescription drugs. We found out after, when we looked into the drugs that we had trusted to your doctors – that there was a Health Canada Warning about Paxil® to not prescribe the drug to anyone under 19 years of age, and to carefully take them off if they were currently on the drug. You were only 17 and you were prescribed this drug. If only we knew this before, but no one told you or us about the hazards of these drugs. Your dad is doing everything he can to help other families – there are so many others who are suffering as you did. Your dad’s life purpose now is to do everything he can to warn others of the dangers of these drugs.

We have some of you friends coming over on Sunday to celebrate the beautiful life you lived.

Wish you were here too.

With All My Love, Mom XXX OOO

And Glaxo’s response to this story? Peter Schram, of Corporate Communications at GlaxoSmithKline, the manufacturer of Paxil, issued this statement: “Any suicide is tragic and the greatest risk for suicide is untreated depression.

“Paroxetine has been used by tens of millions of patients and has been proven to be a safe and effective treatment since its launch more than 15 years ago.

“The label contains instructions regarding the use of paroxetine and important safety information about the product

“If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health-care professional.

“Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor.”

Perhaps Peter, you might like to comment on the negative trial data that your company kept hidden about the dangers of the use of Seroxat in children and teenagers – you know – Study 329.

Seroxat comics… back by popular demand – but what’s happened to Pharma Giles?

So farewell then Pharma Giles… does anone know what has happened to the excellent (and oh so funny) Pharma Giles blog?

Was Giles paid off?  Was he threatened?  Why no explanation?

Maybe the answer lies over at Pharma Gossip?

Anyway, as it seems that Big Pharma doesn’t like being made fun of, here are the Seroxat comics once again!

Although the wonderous ego that is JP Garnier has left Glaxo now, I for one will never forget the caring, sensitive man who watched as Glaxo’s share fell by 40% during his leadership. And what about the MHRA investigation that this year found Glaxo had withheld evidence that the controversial drug, Seroxat, increased the likelihood of suicide among teenagers?

Way to go, JP…

Comic 1

page 1page_2.jpgpage_3.jpgpage_4.jpg

Comic 2


Comic 3


I’m not sure which one I like best – it’s maybe a bit unfair to pick on poor Alastair Benbow quite so much because Breckenridge of the MHRA was just as useless when he was interviewed on Panorama.

OK – I’m sorry, I’ve had a chance to reconsider that last remark – I take it back. Pick on Benbow as much as you like, he deserves it!

You’ll remember that Benbow is the man, who, when asked on television by pharmacology expert Dr Andrew Herxheimer about why GSK had given no warning about the severe reactions from Seroxat despite knowing about it for 5 years… simply replied “Seroxat has provided countless benefits to many people and enabled them to do more, live longer and feel better… and I think that speaks for itself…”

That reply certainly does speak for itself – Glaxo’s corporate mission statement is “… enabling people to do more, feel better and live longer.” In fact, you can download GSK’s corporate brochure here – it’s entitled “Do more, feel better, live longer”.

Good to know we can rely on Dr Alastair Benbow to seriously address patient concerns about one of Glaxo’s drugs without even bothering to consider the direct question that had been asked.

Watch Benbow in action here and marvel at the way he continually avoids questions.

Please remember Alastair – it’s just a little bit of fun!

Barack Obama and John McCain go to war with Big Pharma

Big Pharma’s days are numbered – the age of the truly innovative blockbuster drug is over and this is why Glaxo, for instance, was driven and develop ‘new’ versions of its best sellers – like Paxil CR (in the USA). It’s not better for us punters – it’s just better for Glaxo, as they can get a fresh patent on the ‘new’ version, and make more money – for longer. One analyst says: ‘Big Pharma spends too much time promoting treatments that are mere variations of top-selling drugs already on the market. That way, the companies make big profits, while spending relatively little on research and development.’

Another way that drug companies can extend the cash generating life of their products is to get them approved for new ‘indications’ – such as Seroxat for OCD; for panic disorder; for social phobia; for GAD and for PTSD. Perhaps soon we may be able to add a new money making indication to the list: seroxat for hypochondria.

Another way that drug companies can extend the cash generating life of their products is to get them approved for say, use in children – God knows Glaxo tried hard enough on this idea with Seroxat.

And now, to top it all, the US public and both US Presidential contenders are saying enough is enough…

Carl Mortishead at The Times writes:

America has declared war on drugs, an industry that is bleeding the nation dry. The drug kingpins are running scared and, for the first time, the political mood on both Right and Left is in favour of taking action. The presidential contenders Barack Obama and John McCain have drugs at the top of the agenda and the stock prices of the drug merchants are crumbling.

These are the legitimate drug barons – Pfizer, Merck and Britain’s GlaxoSmithKline (GSK). Selling lifestyle drugs and medicines to alleviate the diseases of America’s affluent society made pharmaceutical companies rich.

But now the pool of available private cash is diminished – drained by the credit crunch and real estate collapse. Government is feeling the pinch and, for the first time since President Johnson signed the original Medicare Bill in 1965, a serious discussion about socialised medicine is beginning in the United States.

It is hardly surprising, because, despite what you may have heard, the US Government is already the biggest buyer in the US pharmaceutical market. Americans spend about £140 billion annually on medicine, compared with £11 billion in the UK. According to World Health Organisation statistics, American expenditure per head on healthcare is double the amount in Britain and a large part of that higher investment is related to the cost of drugs.

On average, for the same drug, an American pays twice that paid in the UK. American insurers pick up a great deal of the bill and their lack of efficiency is a big bone of contention, but the heaviest burden falls on the taxpayer because 45 per cent of total expenditure on healthcare in America is borne by government.

It’s a colossal bill, but the American taxpayer doesn’t get any pricing power for his dollar. In Britain, most other European countries and Canada, national agencies, such as the NHS, negotiate with the pharma giants, bully suppliers and set tariffs for a list of approved drugs.

In the US, such intervention is anathema – the US Food and Drugs Administration (FDA) approves drugs for their safety, but price and availability are market-driven and the drug barons argue that freedom leads to choice, a multiplicity of products and more rapid introduction of new medicines.

Into this jungle of corporate lobbyists, union activists and consumer firebrands, the presidential candidates are taking their first, tentative steps. Healthcare reform is dangerous territory. Hillary Clinton failed at her first attempt, but the costs have risen since – drug prices are rising at a rate of 7 per cent a year at a time when Americans are feeling poorer.

According to polls, healthcare costs are a bigger issue than Iraq for most Americans, hardly surprising given that it affects a greater number. Still, it is alarming for the pharma bosses to hear the Republican candidate bashing their industry, even supporting the direct importation of cheap drugs from abroad.

Many pensioners fly to Canada in search of cheaper prescription medicine and there is a continuing legal battle between state and federal government as state employee health benefit organisations seek to tap sources of cheap medicine north of the border.

Senator Obama also supports imports, but he wants to go further and grasp the nettle of pricing. He wants Medicare to negotiate directly with the drug giants, much as the NHS fixes drug prices in Britain.

This would be a disaster for Big Pharma – a federal agency setting discounted drug prices for senior citizens, the disabled and the poor. According to the Obama camp, it might save $30 billion (£14.9 billion) for the nation’s taxpayers, a huge bite out of the industry’s earnings – and it would not end there.

If Medicare patients were able to secure supplies of Lipitor, the bestselling Pfizer anti-cholesterol drug, at half-price, legions of middle-class and middle-aged taxpaying Americans would ask themselves why they were paying double.

The argument in favour of free market pricing in medicines would be shredded on the rack of fairness and a host of employee benefit organisations would combine forces and demand similar discounts. The Obama cheap drugs plan would open a crack in the foundations of Big Pharma’s tower of cash and quickly bring it tumbling down.

It will happen, it is just a question of when. Monopsony power has already taken root in the healthcare markets of most OECD countries.

You can see faith undermined in the share prices of the drug giants: in the UK, AstraZeneca has lost a third of its value since October 2006, while GSK has shrunk by a quarter. Over the same period, Pfizer has tumbled by 38percent and since December Merck has shrunk by 40percent.

In vain, the drug giants argue that without their US profits, the research that brings new medicines to market would not be possible. It is true that scientific research follows the money.

A big new drug is reckoned to cost $800 million in research and development and Europe has been losing its pharmaceutical edge to US labs, which generated two thirds of the new drugs launched in the world over the past five years.

The problem is that the pipeline is thin and the blockbusters are not emerging. This industry needs a new business model and, in the absence of self-generated ideas, someone in the White House might soon impose one.

Pressure builds on Marty Keller as Grassley & Senate Finance Committee probe

I’ve written a lot about Key Opinion Leader Marty Keller in the past… this link takes you to collected posts and downloads.

But enough of the past – the pressure is building NOW on Marty Keller and Brown University.

This from Pharmalot:

Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly.

In recent weeks, the committee has acknowledged focusing on three academic psychiatrists – Harvard University’s Joe Biederman, Stanford University’s Alan Schatzberg and the University of Cincinnati’s Melissa DelBello. Last week, Chuck Grassley, the ranking Republican on the committee, also asked the American Psychiatric Association to open its books (read the e-mail here).

Keller, you may recall, was the lead author of an infamous study published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry that Paxil, which is known as Seroxat in the UK, was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.

However, the study was later held in disrepute after it was learned the results didn’t tell the whole story. In fact, 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a suit charging Glaxo with “repeated and persistent fraud,” alleging the drugmaker had promoted positive findings, but hadn’t publicized unfavorable data (back story).

As it turns out, study 329, which already had a sordid history that included ghostwriting charges (here’s some background), were worse than imagined. A recent study in the International Journal of Risk & Safety of Medicine disclosed that, after sifting through some 10,000 documents that surfaced during Paxil litigation, highly selective reporting was used to skew the results favorably.

Curious to hear how Keller explains the process by which study 329 was drafted? Then feel free to wade through this lengthy deposition from September 2006 in which he discusses the role played by Scientific Therapeutics Information in preparing the study (see pages 242-266). You can also read more about Keller in the recent book about Paxil, Side Effects, by Alison Bass.

Aubrey Blumsohn has written once again on the subject – perhaps the title of his article gives a clue as to what he thinks about the Keller/Brown story:

Crooked academics and the Universities that shield them – more on Brown and Keller

Writes Blumsohn:

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

Last week I posted a copy of my letter to the new Dean of Medicine at Brown University, Professor Ed Wing. The letter was about scientific integrity at Brown, the problem of Professor Martin Keller, and the silence over Brown’s treatment of Professor David Kern.

I have not had a response.

Over at Seroxat Suffers, Bob Fiddaman is offering some valuable information for the Grassley investigation team:

No prosecution for Keller, in fact he seems to have escaped the justice system… until now… Sen. Grassley is hot on Keller’s heels, and not before time… There are many stories about Keller out in cyberspace, my only surprise is that it has taken this long to start probing him for answers… I hope these little snippets of information prove useful to Grassley and his team of investigators.

Joe Biederman – Key Opinion Leader…

Key Opinion Leaders (KOLs) are a very important part of the marketing mix that pharma companies use to promote their product. This article from the San Francisco Chronicle by Dr Lawrence Diller tells the story of one KOL.

Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill.

In 1996, for example, Biederman suggested that drugs like Ritalin might serve 10 percent of American kids for Attention Deficit Hyperactivity Disorder. By 2004, one in nine 11-year-old boys was taking the drug. Biederman and his team also are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.

The science of children’s psychiatric medications is so primitive and Biederman’s influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind – instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America.

That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic. If true, this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like me – and more importantly, with the parents of the patients I deal with every day.

American medicine, with psychiatry the most culpable, has fallen back to a time more than 100 years ago when doctor credibility was tantamount to the promotion of patent medicine. Subsequent reforms severed ties between medical school doctors and the drug industry – and for decades there was a much more ethical balance between the industry and physicians.

Now once again, drug company money is corrupting medical practice and the maintenance of our country’s health. In a market economy, both doctors and the companies are motivated by profit. However, doctors’ Hippocratic oath and their personal/professional relationships with their patients attenuate the most crass aspects of a fee-for-service system.

In contrast, drug companies owe primary responsibility to their shareholders. Of course these companies must operate within legal business and Food and Drug Administration restraints, but the drive to push such rules to the limit is implicit in any business.

Such a strategy isn’t always beneficial when our children’s health is affected.

The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.

In this climate, drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than nondrug (e.g., parenting and education) approaches.

That’s why we’re seeing famous (or infamous) Newsweek cover boys like Max, a 10-year-old who has taken 38 psychiatric medications in his short, unhappy life.

Research funding must be directed to the needs of patients and their doctors – not to the bottom line of stockholders. Drug companies can still make money, but it’s ethically immoral when stockholder profits trump children’s health needs (as in the cover-up of negative studies of antidepressants in children).

More money must be directed toward head-to-head competition between existing generics and the new products, and toward more studies comparing nondrug or combination approaches to drug-only interventions for children’s problems.

Drug company funding of medical research is not going to end – nor should it entirely stop. Yet a new set of federal rules dictating the transparency and direction of such funding is desperately needed to redress a dangerously corrupt system. It’s not enough to simply have doctors more explicitly report their incomes from drug companies, though it is a very useful first step.

I remember about six years ago when I read a major article by the Biederman team on the advantages of a non-Ritalin drug pathway for ADHD. On the same day, much to my dismay, I also heard him give a speech – for a Wall Street audience – promoting a new drug by Eli Lilly called Strattera.

Although Strattera turned out to be a bust both clinically and commercially for ADHD, I was still shaken that such a prominent researcher could be so brazen with his potential conflict of interest appearance.

The $1.6 million that Biederman didn’t declare is only a small fraction of the full amount of research funding that his clinic receives from nearly a dozen companies that pay for not only the cost of running studies but also the salaries of the doctors involved. Virtually all doctors who receive drug company money say they are not influenced, but every independent study examining the effects of such money says they are.

The leadership of Harvard’s psychiatry department is strangely silent or even defends Biederman. These are good men with solid reputations both in drug and nondrug aspects of treatment. Yet they know that their psychiatry department would not exist were it not for drug company money – considering the withdrawal of federal research dollars over the past 25 years and the meager reimbursements that psychiatrists receive for their services from insurance companies and Medi-Cal.

Sens. Grassley, a Republican, and Herbert Kohl, a Wisconsin Democrat, have introduced the Physician Payments Sunshine Act, which will require more vigorous reporting and enforcement on payments (anything more than $500) received by doctors from drug companies.

But in addition, we need laws to have the federal government, along with the major academic research centers, coordinate and direct the use of drug company money in medical research. This is not pie-in-the sky wishing. Such reform was precisely what the doctors of 100 years ago accomplished in this country.

Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF. He is the author of “The Last Normal Child” (Praeger, 2006).

Glaxo drug trial uses children from third-world countries, who are “pressured and forced into signing consent forms” – 12 babies dead

This news coming in today from tradingmarkets.com – maybe it’ll give GSK’s Paul Blackburn some pause for thought as he has such “a passion for children”.

12 Babies die during vaccine trials in Argentina

Buenos Aires, Jul 10, 2008

At least 12 babies who were part of a clinical study to test the effectiveness of a vaccine against pneumonia have died over the past year in Argentina, the local press reported Thursday.

The study was sponsored by global drug giant GlaxoSmithKline and uses children from poor families, who are “pressured and forced into signing consent forms,” the Argentine Federation of Health Professionals, or Fesprosa, said.

“This occurs without any type of state control” and “does not comply with minimum ethical requirements,” Fesprosa said.

The vaccine trial is still ongoing despite the denunciations, and those in charge of the study were cited by the Critica newspaper as saying that the procedures are being carried out in a lawful manner.

Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.

Since 2007, 15,000 children under the age of one from the Argentine provinces of Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve.

“Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria,” pediatrician Enrique Smith, one of the lead investigators, said.

In Santiago del Estero, one of the country’s poorest provinces, the trials were authorized when Enrique’s brother, Juan Carlos Smith, was provincial health minister.

According to pediatrician Ana Maria Marchese, who works at the children’s hospital in the provincial capital where the studies are being conducted, “because they can’t experiment in Europe or the United States, they come to do it in third-world countries.”

“A lot of people want to leave the protocol but aren’t allowed; they force them to continue under the threat that if they leave they won’t receive any other vaccine,” said Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero.

Fesprosa’s Juan Carlos Palomares said that “in most cases these are underprivileged individuals, many of them unable to read or write, who are pressured into including their children” in the trials.

According to Fesprosa, “the laboratory pays $8,000 for each child included in the study, but none (of that money) remains in the province that lends the public facilities and the health personnel for the private research.”

Open letter to Paul Blackburn, GlaxoSmithKline

I understand that Ofsted recently asked you to resign from your post as a non executive member of their Board (just days after you were appointed). [Interested readers can see an excellent article about this story from Eileen Fairweather of the Daily Mail here.]

Said Ofsted “…His [Paul Blackburn] resignation follows public concerns about the activities of his employer GSK. Paul did not want any negative press interest to detract from the excellent work of Ofsted and therefore resigned.”

You said “At Ofsted’s request, I have resigned… I wish to make it clear that this decision should in no way give credibility to the spurious allegations which have been reported regarding GlaxoSmithKline. These are entirely without foundation and have been previously addressed by the company.”

Now Paul, what I’d like to know from you in detail is this – just are these “spurious allegations” that “have been previously addressed by the company”?

Do you mean the way that GSK did not release negative paediatric trial data (Seroxat/Paxil – Study 329), but rather spun the data and used it to promote the sales of Seroxat/Paxil?

Do you mean GSK’s participation in unethical AIDS drug-vaccine trials in the U.S. which were the subject of a BBC-Two documentary “Guinea Pig Kids” that aired Nov. 2004. “The New York health authority recently investigated claims that drugs were tested on 100 babies and toddlers with HIV at the city’s Incarnation Children’s Centre. GSK was one of the firms that supplied the drugs.”

Do you mean that in 2000 Glaxo Wellcome was accused of extraordinary ‘obfuscation’ by Ireland’s senate after a commission unsuccessfully sought files concerning vaccine trials it conducted in the Sixties and Seventies on children in care homes. At the time the firm said: ‘Glaxo Wellcome regrets any distress that may have been caused to individuals involved in these trials.’

I’ll ask again – exactly what are the “spurious allegations” you mentioned Paul?

I think we’d all like to know…

Heart attacks and suicides… yet the dangers were all kept so quiet. So how CAN you trust your medicine?

Thanks to Truthman30 for this from today’s Dail Mail by Jerome Burne:

Few of us would think to question the safety of our prescription drugs. After all, they’ve been developed to make us better.

But just how safe are they really — and is the official drug watchdog doing enough to protect us?

Last month, for instance, it was revealed that the number of powerful anti-psychotic drugs being prescribed to children had almost doubled in past six years.

Yet despite the growing evidence that these drugs can seriously harm children — causing excessive weight gain, a rise in blood pressure, severe lethargy and even lactation — the Medicines and Healthcare Products Regulatory Agency is powerless to limit their use.

The problem is that these drugs aren’t officially licensed for use on children — they are given on doctors’ own authority and the MHRA is not able to interfere.

In other areas where the MHRA does have power to act, it turns out to be a watchdog with rubber teeth. Critics say it simply isn’t robust enough.

Over the past four years, there has been a string of disturbing reports suggesting that, with some major drugs, the watchdog and doctors were not told the whole story.

As a result, patients were prescribed medicine thought to be safe and effective but which actually put them at risk of dangerous side effects, including heart attack and suicide.

Information about these risks simply hadn’t been passed on to the regulators.

This has prompted some experts to ask if our drug watchdog is up to the task. The best-known of these drugs is the antidepressant Seroxat.

Specialists had been warning for years that it raised the risk of suicide in children.

But the MHRA, relying on evidence it had from the manufacturer ( GlaxoSmithKline), issued assurances that there was no suicide link.

Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the company had hidden information about the suicide link.

More recently, an American academic who looked at more than 60 trials found that other manufacturers had concealed data about the effects of their antidepressant drugs on adults.

Half of the studies were positive and all of these had been published; virtually none of the negative ones had.

When the results of both the published and ‘concealed’ trials were combined, the drugs were shown to be no better than a placebo for mild to moderate depression.

There were similar revelations about the anti-inflammatory drug Vioxx. This was withdrawn from the market in the UK four years ago after a U.S. study found it doubled the risk of heart disease.

Leading cardiologists had been flagging up the risks for years. After Vioxx’s withdrawal it emerged that data from clinical trials had been ‘fudged’. An article published in the prestigious Journal of the American Medical Association recently revealed how this was done.

The conclusion for one study was that the drug was ‘well tolerated’; in fact the study’s raw data (which emerged during a court case) showed that twice as many people who took Vioxx died compared with the placebo.

And yet the study was used to promote the drug. It was also said that the company used ‘ghost-writing’ — paying top academics to put their names to favourable articles written by the drug company’s employees — to make Vioxx appear more effective.

‘The manipulation is disgusting,’ wrote the journal editor. (The manufacturer, Merck, has since dismissed the journal’s article as ‘false and misleading’.)

Given drug companies’ readiness to produce evidence that puts their products in a good light, it seems curious our drug watchdog should be willing to rely so heavily on them. And yet it continued to do so.

Take the case of Strattera, the drug used to treat hyperactivity in children.

There have been concerns it could cause psychosis — hallucinations, delusional thinking, or mania — in some children. Three years ago, the American drug watchdog, the Food and Drug Administration, highlighted the risks and, as a result, the warnings on the

label were changed. Instead of issuing a similar warning, the UK drug watchdog contacted Eli Lilly and asked them to review the evidence.

The drug firm came to a rather different conclusion, including doubting whether the reports of hallucinations in children were genuine.

‘Asking a drug company to review its own product is crazy, but it goes on quite a lot,’ says Andrew Herxheimer, editor of the Drug And Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre (the organisation which gathers and assesses information about drug effectiveness and safety).

‘The problem is that the MHRA has always been far too trusting of drug companies. They almost never look at the raw data from trials when licensing drugs. Instead, they rely on summaries provided by the companies.’

Critics also say our drug watchdog isn’t robust enough about investigating drugs when problems come up. Last year, a study linked the diabetes drug Avandia to a raised risk of heart problems.

The drug watchdog’s reaction has been to point out that the link between the drug and heart disease has been in the list of side effects since the drug was first licensed.

‘That kind of advice is just useless,’ says Dr Aubrey Blumsohn, a researcher at Sheffield University until he became embroiled in a very public dispute with a drug company when it refused to allow him to see all the data from his research.

‘It doesn’t tell you anything useful about who is likely to get it, how high the risk is and so on.’

So is our drug watchdog really up to the business of protecting us?

Labour MP Paul Flynn believes it’s not. He was one of the members of the Parliamentary committee which produced a report on pharmaceutical drugs and the drug watchdog in 2005, just after Vioxx had been withdrawn.

It called for investigations; it said the drug watchdog ‘lacked competence’, and criticised it for a ‘passive process of drug surveillance’.

Professor Kent Woods, the chief executive of the drug watchdog, says at the time it was still a new agency. ‘It had only been set up in 2004. Much of the criticism was directed at the UK’s previous medicine sanctioning body, the Medicine’s Control Agency.

‘Today’s MHRA is very different; we have been much expanded and have new responsibilities.’

Evidence of this more robust approach is seen in the Agency’s lengthy investigation into the way evidence about Seroxat had been concealed.

This included pursuing interviews with employees of GlaxoSmithKline. The MHRA made more than 100 requests, but not one employee would talk.

So how confident is Professor Woods now that the Agency won’t be lied to again?

‘There have been positive gains from the exercise on both sides,’ he says. ‘We have learnt there needs to be greater clarity about the laws — and loopholes will be closed.’

Indeed, in March ministers announced that the laws requiring drug firms to release data from clinical trials would be tightened.

As for the question of whether we can be sure we’re told the truth about a drug’s safety, he says: ‘You are certainly being told the truth. But it is important to realise there aren’t any safe medicines.

‘There is always the potential for adverse side effects in a minority of patients. It is a matter of balancing risks and benefits. Our job is to give people the most up-to-date information about that balance.’

Paul Flynn is not convinced that the MHRA is doing enough. ‘For too long the British authorities have just followed the American lead in issuing warnings about drug safety.

‘When there is clear evidence that data about a drug has been concealed, there is never a full investigation. Other regulators like Ofwat fine companies for failing to meet targets and giving false information.

‘The MHRA never does.’

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