Seroxat Comics – reprise

When I was young a big part of my summer holiday were the comics I bought. So in the spirit of times past, here are the Seroxat comics yet again:

Comic 1

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Comic 2

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Comic 3

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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 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.

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Everything you ever wanted to know about… ‘patient groups’

Well, not EVERYTHING of course! This is the fourth post in a series that recaps (in one handy place) all I’ve written so far about a particular subject. The first three ‘everythings’ have been about Alastair Benbow, Ian Hudson and Serotonin.

But what about these patient groups I hear you ask…

I’ve written quite a lot on this subject, as I feel strongly about it. The collected posts run to four pages. You’ll learn about a complex cast of characters and organisations that include:

Jim Thomson & Amelia Mustapha, Rodney Elgie, Neil Bindemann, Dr Chris Manning, Innervate Ltd, The Centre for Mental Health, The Healthwell.org, The European Alliance for Access to Safe Medicines, Depression Alliance, The Diabetes Monitoring Forum, Primhe, the antidepressant Cymbalta, Eli Lilly, Boehringer Ingleheim, National Depression Week, MediSense, a division of Abbott Laboratories, GAMIAN-Europe, the European Patients Forum, the International Alliance of Patient Organisations, The European Patient Information Channel, Packer Forbes, the Medicom Group, the (non-existent) All Party Parliamentary Group on Depression, the Partnership for Safe Medicines, The National Alliance for the Mentally Ill, the Alliance for Better Medicare, Citizens for Better Medicare, Action for Access, Breaking through Barriers – Depression: The Painful Truth, Astroturfing, European Depression Day and the European Depression Association.

Jim Thomson himself has told me “What you have “uncovered” is a tissue of conjecture and you are, clearly, a master at putting two next to two and seeing several dozen.” He says it’s all a “fifth-form conspiracy theory.” That might be the case – please follow this link to the four pages of collected posts and you can make your own mind up… I suggest you read from page four backwards to page one to get the full chronological flow!

I think there are a lot of questions to be answered and as you read about these people and organisations just remember Jim’s own words “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

Recapturing the vision

Pharmaceutical firms need to make some drastic changes to the way they do business if they are to regain the public’s trust and must be seen to be more interested in medicines than market share to avoid even more damage to their image, a leading industry observer has told PharmaTimes World News.

Peter Claude, a USA-based partner at PricewaterhouseCoopers pharmaceutical and life sciences advisory services group, was speaking as the firm published a report, Recapturing the Vision which highlights the significant differences between the public’s view of pharmaceutical companies and the industry’s self perception.

Mr Claude said that “it is difficult to comprehend how an industry that has saved so many lives should be held in such low public esteem.”

At present, he told PharmaTimes WorldNews, “no-one is listening to them (the drugmakers) and no-one wants to listen to them,” which means that the industry has to change the dynamic of its communication, especially at a time when the sector is under such pressure from governments and a fairly hostile media.

However, I have to say the problem is not about “view” and “self perception” – Peter Claude is wide of the mark… the problem is about the reality that the pharmaceutical companies that are all too happy to create markets for drugs that they know to be unsafe and they are putting their wealth before patients’ health.

The age of the truly innovative blockbuster drug is over – Big Pharma knows this and so continues to market sub standard products to the public. This is the reason why we have seen marketing and advertising spend leap ahead of (by two to three times) the R&D spend at every major drug maker in the world.

This simple fact shows where Big Pharma’s priorities lie – science and discovery have taken a back seat and the salesmen are driving.

Shire and its Adult ADHD statistics

Dr Carlat continues to question Shire and the way it is continuing to create an adult market for its ADHD drugs:

Suddenly, a third of my patients with depression have ADHD, according to promotions by Shire. In a coordinated series of journal ads, CME newsletters, and a specially prepared “depressionandadhd.com” website, psychiatrists are being encouraged to further expand the diagnostic territory treatable by Shire’s products (which include Adderall XR, Vyvanse, and Daytrana).

“Could it be ADHD?”, asks a male model with a 5-day beard and an insouciant pout reminiscent of Tom Cruise in one of his rare blue moments. “ADHD was diagnosed in 1 out of 5 men with depression” continues the ad, referencing a 1996 study published in an obscure journal, Psychiatric Research (Alpert J et al., 1996;62:213-219). The problem is that if you actually read the paper, you find that only about 1/9 depressed men, or 11%, actually met criteria for current ADHD. In order to arrive at the more alarmist 1/5 figure, Shire included “sub-threshold” ADHD in the total.

And what about the really astounding claim that “32% of adults with a depressive disorder” have ADHD? This is a figure pulled from the National Comorbidity Survey Replication, the controversial study that concluded that half of all Americans eventually develop a psychiatric disorder. This study sent lay interviewers to interview a sample of about 9000 people in the U.S., and they used a checklist to diagnose DSM-IV disorders. But since the interviewers were not clinicians, they were unable to accurately determine the clinical importance of the symptoms reported by the sample. The study tried to correct for this problem by having clinicians interview a subset of the sample, but many believe that the final reported prevalence rates were still vastly inflated.

You know what they say about statistics don’t you – “if you torture the numbers long enough, they’ll say whatever you want them to.”

A Psychiatrist Airs His Professional Doubts

Many thanks to Truthman30 for this article, written by Dr Michael Benjamin who has 38 years’ experience in the field of Psychiatry.

Did you ever stop to wonder or ask yourself ‘what am I doing?’ I did and in many ways I wish I had not. As a Psychiatrist, I still do not know what our profession is trying to do. It seems we have a series of solutions and now we are trying to find the problems that they can solve. My observations are either anecdotal or part of research that I have done as a Psychiatric Auditor and are based on my 38 years experience in the field of Psychiatry.

In the adult population, generally speaking, the influence of the Drug Companies is terrifying. Very few research projects disprove the efficacy of a drug when the trial is sponsored by the drug’s manufacturer. Harmful facts that may be discovered are not disclosed. When they are, their importance and significance are downplayed. For example, one of the major, popular, new anti psychotic drugs actively and substantially increases the risk factors for heart attacks or CVAs. In all the adult population the major medical goal is to reduce these risk factors. Only severely mentally ill psychiatric patients are the exception.

It has been shown that after 10 years of illness a psychotic not taking medications is four times more likely to be symptom free than one that is taking medications. Read that again. You would expect the complete opposite. In spite of the hype, the quality of life in patients using the older medications are better than the new. So we are paying more, endangering more and getting less. Not very impressive is it? The mantra of today’s Psychiatric Services are something like this:

• A patient gets ill.
• He goes to the emergency room where he is admitted or referred to community service organizations.
• On admission he is diagnosed, medicated and sent home to continue care in the community.
• He continues his therapy in the community.
• He is only re-referred if the community cannot cope.

What happens in reality?

• There are no hard and fast rules or consistency as to who is received and why. A large proportion of first time hospitalized patients will never re-appear in the Mental-Health system. Why were they hospitalized in the first place?
• Referrals to community care from the ER are done badly, if at all.
• The vast majority of hospitalized patients remain unknown to community care after discharge.
• A large proportion of the patients are no longer taking medications in a meaningful way three months after discharge from hospital.
• Most of the patients seen in community care were not hospitalized.

Grim reading indeed.

Record numbers of children prescribed anti-depressants

From today’s Daily Mail:

The number of school children prescribed anti-depressants and mind-altering drugs has more than quadrupled in the last decade, it has emerged.

New figures show GPs are prescribing pills in record numbers to combat stress, violent behaviour and even tiredness.

Under-16s were given drugs for mental health problems more than 631,000 times in the last year, compared to just 146,000 in the mid-Nineties.

The findings come despite the publication of research showing that children given anti-depressants run a higher risk of self-harm and are more likely to attempt suicide.

These figures, published by the Department for Children, Schools and Families, show a huge year-on-year increase in medication prescribed by GPs for depression, behaviour control and severe mental disorders.

Among the drugs effectively banned are Seroxat, which was taken by an estimated 50,000 British youngsters before guidelines ruled it out in 2003.

It was given to children as young as six but critics said young patients became more likely to commit suicide, and parents told how their children had mood swings, nightmares and personality changes.

Sign the 10 Downing Street petition…NOW!

I want to ask all those of you who UK citizens and read this blog to make sure you have signed the 10 Downing Street Petition:

“We the undersigned petition the Prime Minister to carry out a thorough investigation into the drug trials regarding Paroxetine/Seroxat/Paxil.

Whilst the BBC Panorama journalist Shelley Jofre’s passionate reporting of Seroxat/Paxil/Paroxetine is highly commendable, the British Government owes the users of this drug a thorough investigation into GlaxoSmithKline drug trial information.”

The deadline to sign is 22 August – so before you go away on holiday take the time to add your name to the list – it’s easy – just click on this link and follow the instructions.

“Pregnant Mothers Should Not Take SSRI Antidepressants”

Dr Peter Breggin writes:

On June 28, 2007 more than 250 headlines around the world promised that SSRI antidepressants (such as Prozac, Paxil, Zoloft, and Celexa) are safe for pregnant mothers and their developing babies. “Mom’s Antidepressant Use Poses Little Danger to Baby,” heralded the Atlanta Journal Constitution. “Antidepressants pose low birth defect risk,” claimed Boston Globe. The New York Times ran with the Associated Press’s article titled “Antidepressants Not Big Risk for Defects.” The Wall Street Journal’s coverage was titled “Reassurance on Antidepressants in Pregnancy.” The day before the news stories broke, the Centers for Disease Control spun the news in advance with a press release headlined, “New Study Finds Few Risks of Birth Defects from Antidepressant Use During Pregnancy” (CDC Division of Media, 2007).

The headlines and the CDC press release were incredibly misleading. In the CDC study, several severe birth defects were doubled or nearly tripled in frequency when SSRIs were taken in the first trimester. This combined with the other known toxic effects of SSRIs, including brain damage and dysfunction, make these drugs contraindicated in pregnancy.

In the abstract to the report, the CDC study claimed that it found no association between SSRI use in pregnancy and heart defects in neonates. However, that’s not true. The study found that obese women who did not use SSRIs had an increased risk with heart defects and that obese women who did use SSRIs had an even greater risk of neonatal heart defects with an adjusted odds ratio of 5.9 (95% CI, 2.4-14.3)!
The second study by Carol Louik and her colleagues did not find an overall correlation between SSRI use and the two defects, craniosynostosis and omphalocele. It did however find an association between sertraline (Zoloft) and both omphalocele and septal defects in the heart, and between paroxetine (Paxil) and right ventricular outflow tract obstruction defects of the heart.

Louik made many statements to the press reassuring people, in effect, not to worry. She made no mention of other birth defects and neonatal problems associated with SSRI antidepressants. Her study had funding from two pharmaceutical companies, including GlaxoSmithKline, the manufacturer of Paxil (Seward, 2007), one of the most implicated antidepressants in regard to birth defects. The company’s money was well spent. Thanks in part to Louik’s highly publicized comments, headlines throughout the country played down the risk.
Women and their doctors who only catch the headlines created by these studies are being grossly misled. SSRIs should never be used during pregnancy.

Drug advocates, including the CDC, justify the use of SSRIs during pregnancy on the basis that depression has its own hazards. But these hazards pale in comparison to the upheaval that will befall new mothers, fathers and the extended families of the children who are born with profound birth defects.

The worst hazards of depression in pregnancy are those of suicidality and, very rarely, infanticide. But the SSRIs are implicated in increasing the risks of both suicide and violence (Breggin, 2001, 2003; Breggin and Breggin, 1994). In fact, the new FDA labels for antidepressants specifically warn about SSRI-induced suicidality in youth and in young adults, the very group most likely to become pregnant (Food and Drug Administration, 2007). Now we know that the SSRIs not only threaten to cause the death of the mother through suicide but the death of the child as well through lethal birth defects.

The CDC and other pro-drug authorities urge pregnant mothers to speak with their doctors about the risk/benefit ratio of taking SSRI antidepressants. But doctors will have read the headlines inspired by the CDC, and imagine there is little risk. Furthermore, few physicians realize that meta-analyses have shown that antidepressants work no better than placebo at lifting depression (Kirsch et al., 2002; Moncrieff and Kirsch, 2005). The risk/benefit ration weighs a placebo effect against increased parental suicide and violence, and babies with congenital defects, babies undergoing withdrawal reactions, and babies whose brains have been forever changed by being soaked in SSRIs during their development.

No one can or should blame the parents. But when the mother has been taking an SSRI antidepressant, increasing her risk by 240%, we must hold responsible the doctor who prescribed it, the drug company who manufactured and falsely promoted it, and the medical establishment that covers up and minimizes the drastic hazards associated with these toxic chemicals, including risks to adults, children and the unborn.

Read Dr Breggin’s entire article here at the Huffington Post.

And to learn more about the real life effects that Seroxat can have on babies, then you need look no further than Manie’s Story.

Posted in Anti-depressant, Depression, Drug Marketing, Paxil, Seroxat, SSRI. Comments Off on “Pregnant Mothers Should Not Take SSRI Antidepressants”

FDA Avandia safety review – a done deal…?

Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.

The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn’t say how many members the committee will have.

The FDA was criticized by lawmakers for allowing conflicts of interest among members of an advisory panel in 2005 that concluded benefits outweighed risks for pain drugs, including Merck’s Vioxx, which already had been withdrawn, and Pfizer Inc.’s Celebrex and Bextra. Ten members of that 32-person panel had financial ties to companies whose products were examined. Without their votes, the panel recommendations would have been reversed for Vioxx and Bextra.

Some members of the panel on Avandia own stocks through mutual funds, collect speaking fees or advise drugmakers that compete against companies whose products are to be discussed at the meeting. In addition to Avandia, the panel is expected to discuss similar medications, including Takeda Pharmaceutical Co.’s Actos.

The FDA’s documents for Thomas Pickering, a professor at Columbia University Medical Center in New York, said he was paid less than $10,001 a year for serving on a drugmaker’s advisory board and had stocks in drug companies.

Pickering, 67, who is a voting member of the panel, said in an interview that he served earlier this year on an advisory board to Bristol-Myers Squibb Co., a New York-based drugmaker, and holds mutual funds that invest in pharmaceutical companies. The financial ties won’t affect his recommendations, Pickering said.

Another voting member, David S. Schade, a professor at the University of New Mexico School of Medicine in Albuquerque, received less than $10,001 a year as a member of a speaker’s bureau for a drugmaker whose products compete with those to be discussed at the panel meeting, according to the FDA. He also received less than $10,001 a year as a consultant to a pharmaceutical company on an unrelated product. The names of the companies were expunged on the documents made public. Schade didn’t return a phone call.

Morris Schambelan, a professor of medicine at the University of California, San Francisco, received less than $10,001 a year as a member of a drugmaker’s “complications committee” that focuses on side effects of antiviral medications, according to the FDA. Schambelan, a voting member, was out of the country and didn’t return phone calls.

John R. Teerlink, another Avandia panel member, holds stock in a health-sector mutual fund, according to the FDA. Teerlink, director of the heart-failure clinic at the San Francisco Veterans Affairs Medical Center, also received $10,001 to $50,000 a year as a study reviewer for a drugmaker, which he identified as Bristol-Myers. The FDA paperwork doesn’t make clear whether Teerlink will vote.

Read the whole Bloomberg article here.

Avandia – millions worldwide “taking part in a large-scale experiment”

New details on the side effects of the diabetes drug Avandia have been released (New Scientist 18 July 2007), indicating it can cause 50% more weight gain than similar medications and double the risk of dangerous fluid retention in the body. A team of researchers led by Bernd Richter at Heinrich Heine University in Dusseldorf, Germany, found the latest bad news to report about Avandia.

The team reviewed 18 studies, which had an average follow-up time of about six months. They found the risk of dangerous fluid retention in the body – a condition known as oedema – doubled in those taking the Avandia, compared with patients on other diabetes medications. The diabetics taking Avandia had a 7% risk of oedema – five times higher than those taking placebos.

Oedema is characterised by swelling of the ankles and legs, but can lead to more than just discomfort. Richter explains that the extra fluid in the body can create more work for the heart, causing a shortness of breath and possibly heart failure.

His team’s analysis also showed that patients receiving Avandia gained 50% more weight, on average, than their counterparts on other diabetes medications. The review of 18 previous studies, involving 8000 patients, also echoes earlier warnings that the drug can elevate the risk of bone fractures and heart problems.

But GlaxoSmithKline, the maker of Avandia, says the analysis included too few long-term studies to produce reliable results. Perhaps we could consider this argument – “the analysis included too few long-term studies to produce reliable results”.

Forgive me, but surely short-term studies were what Glaxo relied on to prove the safety of the drug and get it licensed in the first place? Now the company is saying that we can’t rely on short-term studies to produce reliable results… you can’t have it both ways, can you now Glaxo?

Richter, meanwhile, believes that the short-term results he analysed in his review offer enough reason to reduce the widespread use of Avandia, a popular medication in the US where up to 20 million people suffer from diabetes.

“We don’t have [enough] long-term data, and in the meantime the public takes part in a large-scale experiment,” he adds.

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