Seroxat Scandal : How Many Victims?


There has been so much written, blogged and filmed, about Seroxat, in the past 15 years that often I find the most insightful comment gets lost amongst the Seroxat noise on the internet. Therefore, I thought it might be useful for my readers if I was to compile what I think to be some very important and definitive statements from what is out there about Seroxat. It is quite amazing that the first article comes from 2003, that’s over 7 years ago now, the coroner here had grave concerns that Seroxat causes suicide and should be withdrawn from sale, yet the regulator does nothing. Note : Statements/quotes in bold..

http://www.walesonline.co.uk/news/wales-news/page.cfm?objectid=12725058&method=full&siteid=50082

Continue reading Seroxat Scandal : How Many Victims?

Seroxat continues to make headlines..


And never in a good way!..

It always puzzles me when I read a new headline about GlaxoSmithKline’s notorious Seroxat drug. Surely any product that generates such continual bad press for a decade should at least be considered to be taken off the market. If a faulty electric razor was killing people on a regular basis and the manufacturor was known to have covered up these risks and suppress safety information, would shops still sell the razor? Would the public demand that the product be taken off the shelves? Would the regulator pull the product? It’s no different with Seroxat, Seroxat kills people on a regualr basis, and when it doesn’t kill them, it certainly brings some close to the abyss, and even if it doesn’t plunge you over the edge, it can certainly leave you with emotional and psycholgical scars that can take years to heal. So why is it still being prescribed? I wish I knew the answer to that cryptic question.

The following article is from April of this year…

http://www.artslondonnews.co.uk/seroxat

page last updated at: Wed, 28 April 2010 15:27 PM BST Printable version
Seroxat: more harm than good?
by Kim O’Donnell and John Ashmore

According to the NHS, severe depression will affect about 15% of us at some point in our lives. Photo: Mostafa RajaaiAccording to the NHS, severe depression will affect about 15% of us at some point in our lives. Photo: Mostafa RajaaiSeroxat is one of the most popular antidepressants on the market, but this particular medicine is proving to harm some students instead of curing them of their depression.

Despite its popularity, the drug has been reported to have alarming side effects for some users.

In trials it was found that 3.4 per cent of teenagers on the drug experienced mood changes, tried to harm themselves or thought about committing suicide, compared with 1.2 per cent on placebo pills.

Drug company, GlaxoSmithKline (GSK) has known since 1998 that there was a higher risk of suicidal behaviour among under-18s using Seroxat and that the controversial drug was ineffective in dealing with depression in teenagers.

GSK failed to inform its regulator of the findings and told its employees to “effectively manage the dissemination of these data in order to minimise any potential negative effect”.

A later letter from GSK in 2006 explicitly warned doctors in the US that clinical trials “showed a higher frequency of suicidal behaviour in young adults treated with paroxetine [the active ingredient in Seroxat] compared with placebo”.

As a result, suicide is now listed as one of the possible side effects in the safety information enclosed with the medication, as with all of the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.

Originally there had been no side effect warnings on the packet about an increase in self-harm, and doctors had not been warned not to prescribe Seroxat to those under 18.

The reason for the difference in risk between adults and teenagers remains unclear. One possible explanation is that young people are more sensitive to missed or delayed doses of Seroxat.

The drug works by inhibiting the production of serotonin in the brain, a chemical that is involved in mood regulation. Seroxat is the most potent type of SSRI and has racked up huge sales for GSK for the treatment of major depression, obsessive-compulsive disorder and anxiety.

Seroxat, also sold under the name Paxil, is the most prescribed drug in the US.

A BBC Panorama programme documented how 16-year-old Sharise Gatchell had taken her own life after being prescribed Seroxat.

In a response to the programme GSK maintained that suicide was a “well-recognised, tragic outcome” of depression, implying that the anti-depressants themselves were not at fault.

Aside from the risk of self-harm, the drug has been extremely difficult for some users to come off. In 2002 a group of over 4,000 Seroxat users launched a lawsuit against GSK for failing to inform them of the drug’s withdrawal risks.

This is not the only lawsuit against GSK – in the US the company is being sued over claims that Seroxat has caused birth defects.

Withdrawal symptoms for the drug can be strong and can include an increase in self-harm. In fact, in 2003 GSK raised the withdrawal risk of Seroxat from 0.2 per cent to 25 per cent overnight.

The risk of withdrawal difficulties went from one in 500 to one in four.

Janice Simmons is head of the Seroxat Users’ Group, an organisation which campaigns on behalf of those who have suffered due to using Seroxat. Simmons’ husband has been on Seroxat for over a decade.

According to Simmons, her husband has been unable to stop using the drug during this long period because of the severity of the withdrawal symptoms that he has experienced when trying to come off it.

Even advocates of the drug have reported its harmful side effects. Dr Peter Swinyard, national chairman of the Family Doctor Association, describes Seroxat as “safe” and says that he has reported no problems with any of his patients.

However, Swinyard has himself been prescribed Seroxat and was compelled to stop taking the drug because it made him feel, in his own words, “terrible”.

Dr Peter Haddad, consultant psychiatrist for Salford’s Mental Health Service NHS Trust, told the British Medical Journal that “withdrawal side effects from antidepressants are far more common than many people realise, and there’s evidence that paroxetine [active ingredient in Seroxat] has one of the highest rates”.

And what of those who should be protecting the public from potentially dangerous medication?

The Medical Health products Regulatory Agency (MHRA) has been criticised for its handling of the problems associated with Seroxat.

In 2003, after reports of undisclosed side effects, the MHRA came under scrutiny.

The main source of contention was that the data which showed a link between Seroxat and suicidal thoughts in teenagers had been in the hands of the MHRA for some time, yet for some reason this information hadn’t been passed on to doctors or the public.

GSK were accused of burying controversial information amid reams of trial data.

There appears to have been a conflict of interests at the MHRA.

Following patient complaints, in 2003 the MHRA set up an Expert Working Group (EWG) to investigate Seroxat.

In that inquiry, two of its four members were forced to resign after they were found to be shareholders in GSK, and the EWG was prematurely dissolved.

The question of whether people with vested interests in pharmaceutical companies should serve on these committees was put to a member of the MHRA, who replied: “The short answer is that there are virtually no experts who don’t have some interests with drug companies.

“We work in pharmacy. There are studentships, postgraduates who may get from £5,000 to £100,000 from companies – not necessarily to work on a product specifically. Many members of the MHRA do consultancies for companies – that’s where they make their money. But they are obliged to declare their interests.

When drugs are submitted for approval, manufacturers are allowed to only select the trials that showed measurable results and discount the rest. Two positive trials are enough for a drug to be approved.

Irving Kirsch, a professor of Psychiatry at the University of Hull, thinks the system is deeply flawed.

“It would be OK if one only conducted two trials. If one conducts a large number of trials, saying two are statistically significant is no longer meaningful,” he said.

Seroxat Induced Suicide : Why is Seroxat still on the market?


Among the many Seroxat induced side effects, one of the most controversial has been the focus on the drugs propensity to induce suicide. This recent news story is shocking, not because it is another disturbing and upsetting case of Seroxat-induced -suicide, but because it is astounding to me why this drug is still being prescribed.

Seroxat is one of the most controversial medications of the last decade, that notoriety has been long earned, is it time to pull this drug?

http://www.thisislincolnshire.co.uk/news/Bereaved-man-hanged-pet-died/article-2411598-detail/article.html

Bereaved and depressed man hanged himself after his pet dog died

A BEREAVED dog owner was found hanging in a wooded area of Lincoln after a locum doctor failed to refer him to psychiatric services.

Marine engineer Stuart Reed’s body was found hanging from a tree by a dog lead at Botany Bay Plantation off Birchwood Avenue at 6am on May 7.

Yesterday, an inquest into Mr Reed’s death heard that the 29-year-old had suffered from depression since childhood and had taken the recent loss of his 11-year-old dog Roger badly.

Coroner Stuart Fisher heard that the former Ancaster School pupil had taken the drug paroxetine, more commonly known under its brand name Seroxat, for many years to treat symptoms of anxiety and social phobia.

On October 27 he paid a visit to locum GP Dr Paul Stratton at the Crossroads Medical Practice in Lincoln Road, North Hykeham, where he had been registered since birth.

The inquest heard that Mr Reed told Dr Stratton that he felt Seroxat was no longer helping his anxiety and he was suffering from suicidal thoughts.

He and the locum decided that he should be referred for psychiatric help,

But Dr Stratton failed to make the referral and Mr Reed never received an appointment to talk to a psychiatric nurse.

Mr Fisher told the inquest: “It could be argued by members of his family that if he had seen a psychiatric nurse it is possible that this tragedy could have been avoided.

Dr Stratton replied: “It is almost impossible to comment either way.

“I’m not a specialist in the field of psychiatry and to say whether a referral will have affected the outcome is almost impossible.”

Mr Reed’s mother, Chris Jammeh, told the inquest that Crossroads Medical Practice had another opportunity to help her son when he visited the surgery in February.

But she said that as electronic records were not kept, the doctor who treated him did not realise he should have been referred to psychiatric services.

“If the referral had been recorded on a computer screen then it would have been picked up by that doctor,” she said.

Mr Fisher recorded an open verdict.

Practice manager at Crossroads Medical Practice, Mark Ebb, later told the Echo: “This was a tragic case and we would like to offer our heartfelt condolences to the family and friends of Mr Reed.

“Following this tragic event we undertook a review of the case and as a result we have taken a number of steps to prevent a similar incident happening in future.”

GSK : The Corporate Culture of Denial


I have written before on the culture of denial about the dangers of SSRI medications in the psychiatric and medical professions. This culture of denial is also rampant within the pharmaceutical industry. It could be argued that because this culture of denial emanates from the industry, thus by association this mindset infects and contaminates the medical profession; which itself is an industry that relies on the pharmaceutical industry for support and funding. Note how the behavior of GSK, in regards to its dangerous diabetes drug Avandia, evokes the scandal of Seroxat. GSK’s long history of bad pharmaceutical practice is all too evident and all too clear. It seems that the culture of denial, suppression of data, intimidation of critics, corruption, spin and the corporate agenda is the GSK norm. Would you trust any of GSK’s products? When you consider the sheer volume of bad press this company has generated for itself over the past 20 years, would you trust their medicines?

http://online.wsj.com/article/NA_WSJ_PUB:SB10001424052748704720004575377552600421936.html

WASHINGTON—One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug’s maker, GlaxoSmithKline PLC, according to the company and its records.

The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.

Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo’s speakers bureau for several years and said he doesn’t see the relationship as a conflict.

I have not given any talks [to doctors’ groups] promoting Avandia,” he said in an interview. He said he spoke on behalf of another Glaxo drug called Lovaza, which can help lower triglycerides in the bloodstream that often lead to heart attacks.

Avandia, approved in 1999 as a medicine to lower blood sugar in diabetics, has been under fire because of a series of studies linking it to an increased risk of heart attacks. The two-day FDA meeting last week was closely watched by Wall Street and the industry because of its implications both for Glaxo and the agency’s stance on broader drug-safety issues.

Though the panel voted to keep Avandia on the market, 17 of the panelists in favor wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Dr. Capuzzi defended the drug during the meeting. He was one of only three experts who wanted the drug to stay on the market with no additional warnings or restrictions.

Glaxo’s website shows that he received $3,750 from the company as a speaker between April 2009 and March 2010. A Glaxo spokesman said Dr. Capuzzi also received about $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year, making the total payments about $14,750. The company has said Avandia is safe and should stay on the market.

None of the other panelists received money from Glaxo during the April 2009-March 2010 period, according to the company’s website.

Dr. Capuzzi said he told the FDA about his relationship with Glaxo. In a statement, the FDA said it screens all the financial ties of advisory-committee members and is looking into whether there was disclosure to the agency and, if so, why it wasn’t conveyed to the committee.

With so much at stake, FDA officials said before the meeting that they wanted to avoid any questions about conflicts of interest.

Dr. Capuzzi said that despite his vote he isn’t a fan of Avandia and uses metformin, an older diabetes drug, in his practice. He said one reason for his vote was concern that another drug that works similarly to Avandia, called Actos, might also have safety problems.

“The danger I worried about was that if we pulled Avandia, people might automatically switch to Actos and think it’s all hunky-dory,” he said. Actos maker Takeda Pharmaceutical Co. says its drug is safe; the committee members voted overwhelmingly that Actos poses few heart-attack risks than Avandia.

In the middle of a firestorm over a drug, all connections to the company involved should be disclosed,” said medical ethicist Arthur Caplan of the University of Pennsylvania. Otherwise experts leave themselves “open to post-facto criticism and second-guessing,” he said.

One of the panelists who voted to keep Avandia on the market, cardiologist Arthur Moss of the University of Rochester Medical Center in New York, said he wished the FDA disclosed that Dr. Capuzzi spoke for Glaxo. “I’m surprised we weren’t told,” Dr. Moss said.

—Eliza Gray contributed to this story.
Write to Alicia Mundy at alicia.mundy@wsj.com