Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, June 30, 2014

GSK's Private Investigator [The Video]

GSK's Mark Reilly

The Chinese website that hosted the video of  Peter Humphrey's arrest doesn't seem to be hosting the video anymore but I've managed to obtain a copy of it.

Humphrey was hired by GSK's Mark Reilly [above] to investigate Vivian Shi, the company's head of government affairs, as it was thought that she was behind a series of emails sent to GSK executives [including Andrew Witty]

An email was also sent which contained an attachment video of Mark Reilly having sex [see back story]

It's alleged that Humphrey was never told about the emails or video sent to GSK execs, he was just told to investigate Vivian Shi.

According to Jim Edwards over at Business Insider, "Inside GSK, management suspected that Vivian Shi, the company's head of government affairs, sent the emails. There was no evidence, but GSK investigated her travel expenses and eventually she left the company sometime after October 2012 along with her boss, John Lepore, who joined media group Reed Elsevier as head global government affairs. (There are no allegations of wrongdoing against Lepore or Shi."

Business Insider also reports that Humphrey's didn't know about the emails and video during his initial investigation of Shi but was told at a later date about them.
On July 10, 2013 Humphrey and his Chinese-American wife were arrested by Chinese officials and have been held in detention ever since.

One month later Humphrey made a confession on Chinese TV to accessing private information on Chinese citizens illegally. It's unknown if his arrest has anything to do with the bribery allegations made about GSK.

Here's Humphrey on Chinese TV.

Bob Fiddaman

Glaxo - The Sex Tape Scandal

Hey, sex is a natural thing for most of us [depending, of course on the pharmaceutical drugs we take]. When I was on Seroxat the 'wolf was kept from the door', a side-effect I wasn't warned about - did wonders for my ego but left me sexually frustrated at the same time.

Oooh er, Mr Fiddaman... don't be so course!

The bribery allegations in China have taken a rather bizarre twist this weekend. GSK's Mark Reilly, who was arrested on charges of ordering employees to form a massive bribery network, has, it appears, been the subject of a GSK internal investigation before he was outed as the brains behind a massive bribery scam in China.

The Sunday Times is reporting that Reilly was the subject of a secretly-filmed sex tape sent to GSK executives shortly before Chinese officials opened its investigation into alleged bribery of doctors.

The video, writes the Sunday Times, was sent anonymously by email to several senior GSK executives, including chief executive Sir Andrew Witty, in March 2013 along with allegations that the company was paying kickbacks to doctors and officials for using GSK drugs, according to people familiar with the situation.

The Telegraph claims that the anonymous email was an attempt to bribe GSK so, writes The Telegraph, "GSK authorised Mr Reilly to spend an initial £20,000 of the company’s money on hiring a private investigator, Peter Humphrey, to discover the perpetrators of the sting, believed to be part of wider attempts to expose the drugs giant to punitive action by Chinese authorities."

Humphrey’s report, code-named “Project Scorpion”,did not find who allegedly planted the camera in Reilly’s bedroom but his snooping around led to Chinese authorities launching a probe into GSK corruption just a few months later.

Humphrey [pictured below] and his business partner-wife, Yu Yingzeng allegedly illegally trafficked a huge amount of personal information on Chinese citizens to seek profits via registering so-called research companies in Hong Kong and Shanghai since 2003.

Humphrey and Yu run the Hong Kong-registered, ChinaWhys Co, a business risk advisory firm, and have, in the past, worked for GlaxoSmithKline.

Ironically Humphrey lists his successes as neutralizing a counterfeit-and-fraud syndicate that hijacked the business of a global consumer goods manufacturer, eliminating fraud from the buying operation of a leading megastore chain and uncovering fraudulent JV deals for a global appliances manufacturer.

I have to say that I feel kinda sorry for Mark Reilly here...I mean who would want Andrew Witty watching them have sex!

Reilly, if found guilty of forming a massive bribery network, faces up to 10 years in prison.

The sex-tape scandal has broke at a convenient time, for me at least.

Last week I met with GSK whistleblower Blair Hamrick. We sat and chatted over dinner and he told me how Glaxo promoted an antidepressant [Wellbutrin] off label for use in people with [ahem] sexual problems.

Glaxo marketing came up with the line the "happy-horny-skinny pill" so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]

This has left me pondering if Reilly ever took it.

Hey, wouldn't it be amusing if there was a box of Wellbutrin on Reilly's bedside cabinet and it appeared in the video sent to Witty and co?

Chinese authorities could throw a product placement charge at them too :-)

I also wonder if Witty ordered in popcorn for the premiere of Romping Reilly.

Bob Fiddaman.

Sunday, June 29, 2014

Health Canada Secrets and Birth Defects

Canada's medicine watchdog, Health Canada, are in the news once again.

Last week it was reported that Health Canada were refusing to release its own internal report on the state of a GlaxoSmithKline plant in Quebec.

The American medicine regulator, the FDA, had previously found  bacterial contamination problems and had raised concerns about the purified water system at the plant. Health Canada carried out their own inspection but refused to release their findings [Health Canada Refusing to Release Glaxo's Dirty Secret]

Coming on the back of this is news is a report that Health Canada are also refusing to publish data on off-label drug side effects.

In a revealing editorial in The Star, David Bruser, Jesse McLean and data analyst Andrew Bailey report that Health Canada have been collecting the adverse reaction reports but refusing to publish them on the grounds that "It’s been collecting this information for six years but technical limitations with the database have prevented the public release."

"Indeed, the Star analyzed the information collected in the FDA database and found nearly 400 off-label cases from 2010 to 2013 that involve a range of side effects ranging from death to heart attacks, strokes, birth defects and organ failure.
"In Canada, the federal regulator collects the same information but removes the off-label details before publishing its side-effects database. Without this information, doctors and patients can’t ask the proper questions. It’s an offensive lack of transparency."

Dr. Joel Lexchin, one of Canada s leading authorities on drug safety, says, “There are significant public safety implications. This is a major problem for doctors and patients alike.”

Health Canada must publish this information and they must do it now. They have no right to keep this information from the public or health care professionals.

If evidence was needed as to why playing God has implications then one only has to read the latest news coming out of Canada regarding  a powerful anti-nausea drug being prescribed to women who are pregnant.

Zofran [ondansetron] has been approved by Health Canada to treat nausea and vomiting in chemotherapy and surgery patients but it has never been approved for use in pregnancy. However, like most drugs, Zofran is being prescribed in this population off-label.

The Star are reporting...

"At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations."

Back in 2013 I was contacted by Tomisha LeClair. She informed me that she fell pregnant in 1999 and like many women developed  nausea and vomiting and was prescribed Zofran.

At seven months gestation Tomisha was given an ultrasound and was told by doctors that her unborn daughter had a renal cyst; a fluid filled sac on one of her kidneys. The medical staff explained there are many children born with this complication and if necessary she could be treated with antibiotics upon birth.

She told me:

In the latter part of 2000 I wrote to the (FDA) the Food and Drug Administration to complete a Med-Watch form reporting my daughter’s “abnormalities”. I initiated a (FOIA) a Freedom of Information Act request to the Food and Drug Administration inquiring about the adverse reactions reported by other patients who had also been prescribed this drug, to compare them to Ahjanee’s abnormalities. My suspicions were that the “wonder drug” had caused Ahjanee’s abnormality’s. Several weeks later I received a 20 page alphabetical list of all the reported adverse reactions reported by other patients, compiled into percentiles.

She added...

The "adverse reaction" list from the FDA is 26 pages long and contains every "abnormality/anomaly" my daughter and many of the other children have.The Center for Drug Evaluation and Research (CDER) Report is alarming to say the least! If I had to be scientifically specific regarding what Zofran has caused within the children, I would say that Zofran prescription during pregnancy causes clusters of symptoms such as cranial abnormalities; my daughter has microcephaly  [Fig 1], and another child hascutis cutis aplasia (characterized by the absence of a portion of skin in a localized or widespread area at birth), and there is one more cranial/skull abnormality that I can't recall by name. One child has Ebstein anomaly (a congenital abnormality that is present from birth and affects flaps that make up the tricuspid heart valve) and another has Hirschsprung syndrome (missing nerve cells in the muscles of part or all of the baby's colon) and another has clubfoot.[Fig 2] - [See Are GSK Concerned About the Zofran Noise?]

Fig 1

Fig 2

Zofran is manufactured and marketed by GlaxoSmithKline.

Are we really surprised anymore?

In Canada the generic version of Zofran is sold by Mylan.

What exactly are Health Canada playing at here?

I thought you'd have to go a very long way to beat the ineptitude of the MHRA and FDA...Health Canada have beaten them in the Stupidity Stakes by a number of lengths!

For more information on Zofran birth defects visit MA'Z (Mother's Against Zofran Birth Defects), a Facebook community page created by Tomisha LeClair.

Bob Fiddaman

Saturday, June 28, 2014

Pharmaceutical Ads Should be Allowed on British TV's

There are only two countries in the world that are allowed to air ads for prescription drugs, namely New Zealand and the good old US of A. This is called direct-to-consumer advertising, or DTC for short.

I'm calling for the British government to allow the same type of ads on British TV screens.

So, have I gone and signed a deal with the Devil, taken a kickback from the Pharmafia?


I'll explain.

In the US it is the job of the FDA to regulate direct-to-consumer advertising, any ad that falls short of their rules and regulations is either not aired or taken back to the editing room.

In the UK that job, if ads were aired, would be down to the British drug regulator, the MHRA. Anyone familiar with our toothless drug watchdog will know that they have, time and time again, given antidepressants a clean bill of health where adults are concerned. They normally refer to the Committee on Safety of Medicines [CSM] when asked about the safety of antidepressants in this population. Bizarrely Prozac can be given to children and teens in the UK whereas in the US it's not recommended.

Advertising a prescription drug on television used to be a lucrative tool for the pharmaceutical industry. In the US, for example, Paxil was heavily promoted as the pill to cure shyness. However, this lucrative tool has now become the Achilles heel for the marketing departments of the pharmafia.

Now, they are legally obliged to list the side effects of the particular drugs they are advertising on US TV screens.

Here's an example of a recent ad for Latuda [lurasidone] - a new atypical antipsychotic for the treatment of "bipolar depression" and developed by Dainippon Sumitomo Pharma and marketed by Sunovion in the USA.

How would the British public react to this ad if it were aired halfway through Coronation Street or the X-Factor?

Personally, I think it would be a wake-up call to all those British folk who think the pharmaceutical industry are whiter than white.

Did you hear the list of side-effects mentioned in the 90 second ad above?

The first 20 seconds of the ad describes the product and what it is indicated for.

Let's just take a look at what happens after the 20 second mark.

Latuda is not for everyone.
Call your doctor if you have unusual changes in moods, behaviours or thoughts of suicide. Antidepressants can increase these in children, teens and young adults. 
Elderly dementia patients taking Latuda have an increased risk of death or stroke. 
Call you doctor if you have fever, stiff muscles and confusion as these may be signs of a life-threatening reaction...or if you have uncontrollable muscle movements as these may become permanent.
High blood sugar has been reported with Latuda and medicines like it and in some cases extreme high blood sugar can lead to coma or death.
Other risks include decreases in white blood cells which can be fatal, dizziness upon standing, seizures, increased cholesterol, weight gain, increased prolactin levels, impairment in judgement or trouble swallowing.
Avoid grapefruit and grapefruit juice whilst taking Latuda.
Use caution when driving or operating machinery.

The side effects narrated by the softly spoken woman end at 1.15. The final 15 seconds asks the viewer [you, the consumer] to ask your doctor for Latuda and that "bipolar depression" is treatable.

I find it remarkable that the marketing team in this ad have added the following narrative, "Call your doctor if you have unusual changes in moods, behaviours or thoughts of suicide. Antidepressants can increase these in children, teens and young adults."

Latuda is not recommended for children or teens yet they felt the need to throw up the warning. This is because they know that Latuda will more than likely be prescribed off-label to this age group, they know because they will probably promote it in such a way when their reps visit the doctors in their workplaces.

The ad, to me at least, is more about the illness than the product. What they are trying to do here is make "bipolar depression" sound as if it is life-threatening if left untreated, they are trying to convince the consumer that this condition is as bad as a cancerous growth on the lung. This is designed to make you, the consumer, think that the risks stated are worth it.

Bipolar depression is the name given to the depression experienced in those who have bipolar disorder [in other words, they experience depression as well as manic or hypomanic episodes] least, that's what we are told.

Now, the reason I believe that we, here in the UK, should allow such ads on our TV screens is simple.

People already on these types of drugs probably haven't read the patient information leaflet that accompanies these drugs, even if they have it's hardly as powerful as the spoken word.

Airing ads like the above on British TV screens would serve a purpose. It would show how dangerous these drugs are. It wouldn't just be bloggers like myself telling you how dangerous they are, it would be the actual pharmaceutical company who manufacture the drug.

Can you imagine if Carlsberg listed that you should call your doctor if you had thoughts of suicide or if drinking their beer could cause an increased risk in strokes for elderly dementia patients?

Imagine if Carlsberg told us...

"Call you doctor if you have fever, stiff muscles and confusion as these may be signs of a life-threatening reaction...or if you have uncontrollable muscle movements as these may become permanent.

"High blood sugar has been reported with Carlsberg and beers like it and in some cases extreme high blood sugar can lead to coma or death."

Would we still be clambering down the aisles at our local supermarket for the 'buy one, get one free' packs of Carlsberg?

Of course not.

So, why do people still ask their doctor for the drugs advertised on US TV?

It's simple, they are told that they have a condition. What they are not told is that the condition came about as a result of heavy marketing and DSM madness. The DSM is the Diagnostic Statistical Manual of Mental Disorders, a book that lists mental diseases [labels] - they are as ludicrous as the pills used to treat them.

I'm not suggesting for one minute that people don't suffer bouts of depression, they do. But the ad above, and ads like it, are not aimed at those people. The ad is aimed at the consumer who would have been convinced that his or her depression is more serious than your average depression.

I'm all for the MHRA sanctioning these types of ads. It will make the British public ask questions. It will also highlight how dangerous these types of drugs are... and how those that market them probably should be labelled with a mental disorder themselves.

Bob Fiddaman.

Friday, June 27, 2014

Health Canada Refusing to Release Glaxo's Dirty Secret

The Canadian medicine's regulator, Health Canada, are reportedly sitting on information pertaining to a recent FDA  inspection of a GlaxoSmithKline plant in Québec, Canada.

In a letter to John Glavas Site Director, Quebec Operations GSK Biologicals, North America, the FDA raised concerns that related to bacterial contamination problems that were ongoing and may date back to 2011. Moreover, the FDA raised concerns about the purified water system at the plant.

The FDA also noted that since 2011 a total of 60 lots of vaccine from the plant have been rejected due to endotoxin levels that are over a pre-specified limit. Endotoxins are created by bacteria.

Glaxo manufactures roughly half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract.

Health Canada carried out its own inspection of the plant but, according to The Toronto Star, are refusing to release its findings,

“Health Canada seems to be prioritizing what the companies claim is confidential business information over patient safety and that really isn't acceptable,” said Dr. Joel Lexchin, a health policy professor at York University and drug safety expert.
Health Canada refused to release the eight-page report in an emailed response. The agency said the inspection found no “critical risks” and the factory was given a “compliant” rating, but that it documented problems with contamination levels.

Great line, “Health Canada seems to be prioritizing what the companies claim is confidential business information"

So, if there is information that could be potentially damaging Glaxo scream, "Hey that's confidential business information".

Back in April  the FDA sent GlaxoSmithKline a warning letter listing a series of violations regarding one of their plants in Ireland. The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

A month later the Brazilian drug regulatory agency, ANVISA, sent Glaxo a warning letter stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues. As a result, the sale of Paxil was temporarily suspended.

Furthermore, in 2010 Glaxo were fined $750 million for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico. Violations that included...

  • Antidepressants containing different dosage strengths.
  • Heart medication containing different strengths.
  • A diabetes medication with a defect.
  • A children's ointment that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.
  • And a injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.

Glaxo's mission statement is that they are "are committed to fighting disease by bringing innovative medicines and services to patients throughout the world".

Maybe they should start by reassuring consumers that there are no contaminated medicines leaving their plants!

Bob Fiddaman.

Thursday, June 26, 2014

Hey Glaxo, Guess Who's Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman

I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.

Eight years on and I have learned so much about GlaxoSmithKline... I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo's fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.

Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn't get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of. 

Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn't bring himself to promote the antidepressant Wellbutrin off-label to doctor's.

Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn't bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. "It was wrong, it wasn't indicated for kids and I just couldn't bring myself to tell doctor's it was okay for kids to take," Blair told me over a glass of wine in the plush settings of one of Westminster's finest hotels in London. "They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives." [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the "happy-horny-skinny pill" line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]

Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo's drugs.

"We'd pay doctor's between $2-4000 to give a talk to other doctor's.
"6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they'd be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label "wonders" - that's how Glaxo rolled.
"Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor's that it was okay to prescribe a number of drugs off-label.
"Some doctor's, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.
"I was also given luxury private box tickets for sporting events, these would be given to doctors as a 'thank-you' or incentive to prescribe more and more of Glaxo's drugs."
Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.

Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.

"The way it worked was that a doctor would be visited by a rep who would  then add notes to a hand-held device.
"It was useful because we knew what these doctor's liked, be it a particular football, baseball team or if he had a sweet tooth - on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies - it was just a way to keep them prescribing more drugs."

Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to "write right", in other words write down the legal stuff and not the violations.

I asked Blair about Glaxo's recent announcement that they are going to be more transparent.

"The whole transparency thing wasn't a conscious decision by Glaxo, their hand was forced, it was all part of the settlement - it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that's what they had to do as part of the agreement they entered into with the Department of Justice."

Regular readers of this blog will note the tagline I use, "It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency."

I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.

Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It's no coincidence that Glaxo are now being investigated for the same type of violations in other countries. 

Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK - what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?

On a side note, I wasn't just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.

I now have something to tell my grandchildren.

I once had dinner with Blair.

Bob Fiddaman

Tuesday, June 24, 2014

GSK Target Guinea Pig Students

TouchPoint Digital, an agency hired by British pharmaceutical giant GlaxoSmithKline, have been dangling a financial carrot to hard up students in an effort to persuade then to enroll in clinical trials.

Graduate Fog, a graduate careers website, have published the advertisement [disguised as a guest post proposal] that sees TouchPoint Digital, on behalf of Glaxo, entice students with cash incentives to take part in clinical trials.

Lines such as, "You could earn up to £2000 per trail [sic] for up to 4 trials per year", and "Register your interest in a clinical trials company and you'll be sent an application pack. Once you have filled this out, and sent it back, you will be asked to take part in a free medical check. Normally a medical check can cost from £150 upwards so getting one free is a perk of participating." [Fig 1]

Fig 1 [Click on image to enlarge]

When rumbled, after Graduate Fog went public, Glaxo acted swiftly and, according to the Wall Street Journal's Ed Silverman, have sacked the "consultant who solicited college graduates".

Isn't this always the way with Glaxo? Only be seen to act when they are caught red-handed.

This isn't the first time GlaxoSmithKline have been caught enticing potential consumers of their products. In the past they have enticed doctors with cash payments and lavish gifts to get them to prescribe more of their drugs.

Back in 2002 GSK lured patients in Australia with FREE counselling sessions...but there was one small catch. Those patients had to prove that they had first dispensed a prescription for Aropax, a drug better known as Paxil in the US and Seroxat in the UK. The promotional push was called 'The A Plus Project'

I was fortunate enough to get my hands on that particular promotion [see video]

I have to take my hat off to Graduate Fog for exposing GSK. The lure of money must have been tempting but they stood by their morals and saw through Glaxo's conniving antics.

An email exchange between Graduate Fog’s founder Tanya de Grunwald and TouchPoint Digital can be read here

It's a fascinating insight into the mechanics of the pharmaceutical industry. At one point Tanya de Grunwald asks if the study TouchPoint Digital were proposing to guest post about was a case study? TouchPoint Digital respond with, "It won’t be a case study. It would just be an informative article about ways to earn money while job hunting, ie. temporary solutions when struggling financially."

Classy huh?

Head on over to Graduate Fog to read the full exclusive.

GlaxoSmithKline corporate mission is to help patients 'do more', 'feel better', live longer'.

They are currently under investigation for fraud and bribery of government officials and/or healthcare professionals in the following countries: China, Iraq, Poland, Jordan, Lebanon,  United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Syria and the United Kingdom [Back story]

Bob Fiddaman.

Monday, June 23, 2014

Critics Slam New Antidepressant-Suicide Study

A new study has recently been slammed by fellow professionals in the field of medicine and a top US law firm.

The study, "Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study", was published in the British Medical Journal [BMJ ] last week and, basically, makes outrageous claims based on findings that seem to be based on bizarre methodology.

I had to look up the word 'quasi'  as I didn't know what it meant. I'd assumed for many years it was a shortened version of Quasimodo [ The Hunchback of Notre Dame]

The authors have, it would appear, cherry-picked studies in an attempt to manipulate the outcome.

In a nutshell the authors are suggesting that teenage suicide increased after the FDA toughened antidepressant warning [Black Box Warning]

Two things strike me here.

1. The BMJ is widely read by doctor's, many of whom have been fence-sitting for years regarding the off-label prescribing of antidepressants to children and adolescents. This study is the proverbial splinter up the backside for those doctors, with a sharp prick to the the buttocks they fall from their fence on to the side of the pro-antidepressant brigade.

2. The media reporting of this particular study is worrying. Retired psychiatrist Mikey Nardo, who writes the 1 Boring Old Man blog, breaks the media coverage down...

First the Washington Post (Dennis) reports:
As a result [of the FDA warnings] antidepressant prescriptions fell sharply for adolescents age 10 to 17 and for young adults age 18 to 29. At the same time, researchers found that the number of suicide attempts rose by more that 20 percent in adolescents and by more than a third in young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

According to NBC News (Raymond) :
New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults. After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent.
Comment from a non-study affiliated expert? NO 
How many limitations are discussed? NONE

Reuters (Seaman) reports that:
Antidepressant use decreased by 31 percent among adolescents, about 24 percent among young adults and about 15 percent among adults after the warnings were issued. At the same time, there were increases in the number of adolescents and young adults receiving medical attention for overdosing on psychiatric medicines, which the authors say is an accurate way to measure suicide attempts. Those poisoning increased by about 22 percent among adolescents and about 34 percent among young adults after the warnings. That translates to two additional poisoning per 100,000 adolescents and four more poisoning per 1,000 young adults, the researchers write.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)

According to USA TODAY (Painter):
Warnings that antidepressant medications might prompt suicidal thinking in some young people may have backfired, resulting in more suicide attempts, new research suggests.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

Forbes (DiSalvo) reports:
Antidepressant use fell 31 percent among adolescents and 24 percent among young adults after the FDA warnings, according to the study. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults in the same time period. Suicide attempts tracked in the study were largely the result of drug overdoses.
Comment from a non-study affiliated expert? NO
How many limitations are discussed? NONE

NPR (Stein) also reports on the story:
Antidepressant use nationally fell 31 percent among adolescents and 24 percent among young adults, the researchers reported. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)

Finally, the Boston Globe (Freyer) concludes that...
instead of declining as hoped, suicide attempts over the next six years showed a “small but meaningful” uptick among people ages 10 to 29, according to a study published Wednesday in the journal BMJ. That increase followed a substantial drop in the use of antidepressants.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

A perfect proxy for advertising the safety of antidepressant use in kids.

The study, which is open to opinion has, thus far, received a number of comments from fellow-professionals.

Gerald W Gaines, who owns Depression Recovery Centers in Arizona, writes...

" The study presents a statistical association and proposes a causal relationship with no proof and three key assumptions that anti-depressants have efficacy, increases in overdose were due solely to suicide attempts and the two were somehow linked. The study does not demonstrate causality and the preponderance of secondary evidence would suggest there is no causality at all in the way implied."

Worryingly Gaines uses the horse tranquilizer Ketamine to treat his depressed patients.

Peter C Gøtzsche of the Nordic Cochrane Centre in Denmark is highly critical of the study...

"The FDA’s large meta-analysis of 100,000 patients who had participated in placebo-controlled randomised trials found that antidepressants increase suicidal behaviour up till about the age of 40, and in young people, the risk was doubled"

He adds, "The findings in the report by Lu et al. should be ignored. SSRIs don’t decrease suicidal behaviour in young people, as they claim. SRRIs increase it, and it seems that the risk increases with dose, as would be expected."

Associate Professor, Dept. of Family Medicine, McMaster University Dee Mangin,  hits the nail on the head with...

"Almost none of these drugs are licensed for use in depression in this age group. This article could by its implications endorse off-label use."

Psychiatrist Bernard J Carroll of California adds input to the controversial study with, "I won’t even bother to critique the special pleading and the tendentious tone of this report. The decision to publish it was not the BMJ’s finest hour."

While David Healy, Professor of Psychiatry Bangor University, adds, "There is in summary so little basis in the data presented here for the argument being made that this paper perhaps offers better evidence of an agenda than anything else."

It's a pity the mainstream media chose not to ask any of the above professionals for their expert advice, opting instead for sensationalism and eye-catching headlines.

The lead author [instructor] of the study is one Christine Y Lu.

Lu is a  a pharmacist, pharmacoepidemiologist, and health policy researcher. She also mentors students and fellows through the Harvard Medical School Fellowship in Pharmaceutical Policy Research.

Her findings, along with her co-authors, must be a kick in the teeth for the parents who have lost children and other family members to antidepressant induced suicide. Their findings border on moronic given that the methodology used was just a means to widely promote using this group of medications on children and adolescents. At least that's the way I see it... hey I'm an old cynic approaching 50, what do I know?

Even if the study has been criticized they have successfully spread the word without actually lifting a finger.

The BMJ publish it, doctor's read it.

The mainstream press run with it with very few opposing views - the public read it.

Your average family may have been considering their family doctor's offer of an SSRi to help treat their child.

"But don't these drugs cause suicide?"

"No, in fact a new study has shown that suicides have increased since the warning came out... your child is perfectly's a prescription for Paxil, Zoloft, Celexa, Lexapro, Prozac." [delete where applicable]

I've not yet witnessed a study [so fresh] that has caused so many fellow-professionals outrage. To my knowledge I've never witnessed a law firm come out and chastise the findings of a study so soon after its publication.

Step forward Baum Hedlund, a top US law firm operating out of Los Angeles, Washington, D.C, New Orleans, Philadelphia, and Tallahassee.

They've taken the unusual step of issuing a press release via their webpage.

You can read their full press release here.

In the meantime it's job done for the pro-antidepressant crowd. Their goal may not have been to change the opinion of the FDA, it may have been much simpler. Get the story in a journal widely read by white-coated prescription pad bearers and convince the public [via shoddy journalism] that it's okay to give antidepressants to kids [albeit off-label]

The FDA have issued a statement saying that they have no plans to change the black box warnings [See the Baum Hedlund article for more details.]

Christine Lu has, in my opinion, unleashed a sugar-coated turd. One only has to scratch at the surface to smell the stench. Pinch your nose when going through the study.

Bob Fiddaman.

Dinner with Blair

Nice title for a post. Fortunately, for me at least, it's not Tony Blair.

Meeting up with GSK Whistleblower, Blair Hamrick this week. Dinner, chat and a few beers.

Should prove interesting.

You can see a previous interview with Blair in the video below.

I'll be tweeting this post to the 'usual suspects', Glaxo, FDA, MHRA and Glaxo's attorneys.

A future post will feature how it all went.

Bob Fiddaman

Wednesday, June 11, 2014

The Secret Life of Babies

This one goes out to the pharmaceutical companies who have, over the years, manufactured and promoted SSRi drugs. The off-label promotion of these drugs, along with the monetary awards for doctors who prescribe them to pregnant mothers is something you have all done remarkably well, if counting those dollars is a remarkable achievement.

It's a groundbreaking documentary entitled, The Secret Life of Babies.

Here's the press release...

Secret Life of Babies shows how the first two years of our lives are the most critical; we grow more, learn more, move more and even fight more than at any other time in our life. We have more bones in our body at birth than an adult does; yet we don’t have kneecaps. We laugh 300 times a day as a baby, but in the first few months we can’t produce tears when we’re upset.
The programme, narrated by Martin Clunes, tells some truly powerful and awe inspiring personal stories; from the baby who survived being blown off a pier in his pushchair, trapping him underwater for six minutes, to the baby whose brain has rewired itself despite the fact that half his brain had to be surgically isolated from his body when he was just a few months old.
This heart-warming and often surprising documentary tells the story of what it’s like to be a baby from their perspective. From a baby’s preference for sweet foods and aversion to plants, to the fact that they will have crawled 70 miles by their second birthday, the programme offers fascinating insights into babies’ development.

The following documentary also goes out to defence attorney teams who protect the pharmaceutical industry and their multi-billion dollar antidepressant business.

After watching, ask yourselves if you think what you do is right. If you still say 'yes' then your hearts are truly blackened.

Bob Fiddaman.


Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Two Hours With Matthew - The Story of "Effexor Baby", Matthew Schultz

Tuesday, June 10, 2014

Leaked Video Shows GSK Management Discussing Transparency

Here's a screenshot.

Bob Fiddaman

Monday, June 09, 2014

Irish Babies and GSK - Why the delay?

News that almost 800 bodies of babies had been found in a septic tank in Ireland surfaced last week. Now known as the 'Irish Baby Graves Scandal', 796 babies are thought to have been interred alongside what was called "The Home", run by Bon Secours nuns in Tuam. The proprietors took in "fallen women" and "illegitimate children" between the 1920's and 1960's.

The story has been linked to a vaccine clinical trial from the 1930's. The International Business Times writes...

Over 2,000 babies and young children at a number of Irish orphanages linked to the mass baby graves scandal were injected with a vaccine for diphtheria in the 1930s, it has been revealed. The children were used as guinea pigs on behalf of drugs giant Burroughs Wellcome. No evidence of consent has been discovered and there are no records of how many children became ill or died as a result.

Burroughs Wellcome, later subsumed into drugs giant GlaxoSmithKline (GSK)

Many are sickened by this news and both GSK and the Catholic church have come under fire.

It's a story, however, that isn't as fresh as what the mainstream press are letting on.

Four years ago, in 2010, the Irish Independent reported that legal action was being planned against GlaxoSmithKline and the Sacred Heart Order, which allowed the tests at the Bessborough Mother and Baby Home in Cork.

Campaigner and abuse survivor John Barrett alleged that was used in four different experiments when he was aged 12 and 13 at the Lota home.

He said: "All of the boys of my age were taken off and given tests, X-rays and general examinations.

"Lists were made of those deemed to be 'healthy' and we would sometimes be lined up in one of the dormitories and given massive injections."

At the time of these revelations the then Irish Health Minister, Mary Harney, was called on to instruct her officials to make available all relevant information regarding the ongoing vaccine trials.

The call, according to the Irish Times, came as a result of Mari Steed, 50, breaking her silence into how she was subjected to a controversial vaccine trial as a baby without her mother's consent.

She said she the trial were carried out on her between December 1960 and October 1961, when she was between nine and 18 months old.

Ms Steed, who in 2010 was living in the US, and three others, were preparing to take legal action in US courts against GlaxoSmithKline.

Whatever came of that legal action?

Moreover, did  the then Irish Health Minister, Mary Harney secure all relevant information regarding the ongoing vaccine trials?

Do GlaxoSmithKline still hold records that belonged to Burroughs Wellcome, if so, why haven't these documents been released to investigators?

Why, four years on are we still asking for these documents and why, four years on, are GlaxoSmithKline being quoted as saying,  “The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.

“We would need further details to investigate what actually took place, but the practices outlined certainly don’t reflect how modern clinical trials are carried out. We conduct our trials to the same high scientific and ethical standards, no matter where in the world they are run.”

Was the investigation four years ago brushed under the carpet, was an out of court settlement made to those who intended to file a lawsuit in the US?

Who, exactly, is at fault here, is it the Irish government, the Catholic church or GlaxoSmithKline?

Not much is known about these clinical trials, the whole scandal seems to have been put to bed for the last four years...only to resurface again with the 'Irish Baby Graves Scandal'.

A good source of information can be found on Paddy Doyle's website, The God Squad. Paddy has been investigating the whole sordid affair for sometime now.

In the meantime we wait for Glaxo to get the "further details to investigate what actually took place".

Don't hold your breath folks.


Pressure mounts for GSK [inquiry into trials of vaccines]

Bob Fiddaman.

What GSK Told Reps to do.

The following video is for the UK Serious Fraud Office (SFO) who announced last month that they will be investigating GlaxoSmithKline.

It's assumed that the SFO will only be investigating Glaxo's foreign bribery allegations and won't be delving into any alleged bribery or fraud committed in the UK.

If the SFO think that Glaxo's UK practices are whiter than white then they really should take some time out to watch this video.

Blair Hamrick was one of the whistleblowers that blew the lid on Glaxo's off-label promotion of drugs and also how they bribed US doctor's to prescribe Glaxo's drugs.

All the SFO have to do is what I did. They need to put Glaxo UK in the spotlight and ask them if their sales team, including senior management and reps, paid doctors, hospital officials and health institutions to use GSK products in the UK, resulting in the "illegal revenue" of hundreds of millions of British pounds. Or if they, as a company, ever bribed UK government officials?

If GSK answer 'No' then the SFO can do one of two things.

1. Believe them

2. Investigate to see if they are telling the truth.

Here's the video.

Related stories.

A Message From the UK Serious Fraud Office re GSK

Cronyism, Chinese Style

GlaxoSmithKline: The Andrew Witty "Era"

Advair Launch 2001: GSK's “Myth of Mild” Campaign

Bob Fiddaman

Saturday, June 07, 2014

Working for GSK as a Rep - 1984 Vs 2014

CafePharma is a forum where reps, past and present hang out and discuss all aspects of the job. It's a free reign to discuss matters that piss them off the most.

An interesting thread was posted inviting readers to discuss what it was like being a rep for GSK between 1984 to the present date.

This is eye-opening. (Grammatical errors have been left in)

I began working in the industry 30 years ago, when it was easy, easy to bribe docs to use your drug, easy to make money, easy to do whatever you wanted to do. The stories I could tell you... For example:I didn't give a shit how smart or stupid a doctor was. I was given a territory that belonged to me in which to sell my product, and within that territory there were smart doctors, there were good doctors, and there were honest doctors, but the ones that I made a much better than average living on were the busy doctors that didn't give two shits about their patients -- and wanted something from me. On the books we all followed the rules; we had usual and appropriate expenses to do our job, but the reality was that we did what we had to do to sell our drug. Thursday was a usual night out for me with Dr. What he lacked in medical knowledge was more than made up for by his street smarts. He knew how to play the game and we did well by each other. He wrote tons of prescriptions and in return I gave him tons of samples that I later learned he sold to patients, and other perks.On paper we were having a round table discussion on some medical topic with a bunch of doctors, but in reality it was a night out with Dr who brought along his brother, his barber, his accountant, and a few of his other buddies. Including. the $1,000 fee for Dr ( for a talk that he, understandably, never gave) the night cost me almost $2,000 dollars -- well worth it because the following week I counted over 30 new prescriptions for my product. Oh I didn't tell you, but most big pharmaceutical companies purchase a list from a company that monitors doctor's prescriptions. It tells them exactly how many prescriptions a doctor writes for each product. If you think this sounds crazy, the next week he told me to go to his favorite restaurant, leave my credit card there , and he would take care of the rest – which he did by running up a tab for another two grand. Dont think for a moment the big shot doctors werent whores too; don’t be naive. Some of these assholes are bigger whores than Dr and they make a shit-load more money for their services. I get a call from my manager, Dr a big time professor of Medicine, who was part of the FDA board that approved our drug, is coming to town to give talks to the doctors in the area. At $3,000 dollars a night and another $3,000 to give a talk in the local hospitals each day, this elite doctor can take home $30,000 dollars in a week’s time. Hey, Dr just got a thousand bucks once or twice a month and free meals for himself and his buddies.I've taken docs to strip clubs,. Who hasnt? But I found a nice long massage, with happy ending, was far more cost effective, and I enjoyed it much more as well. Again, the people that run these places are not stupid, they accept American Express and the services aren’t billed to Mrs. Wong's massage palace. They usually have some kind of restaurant Doing Business As name. Anyway, as you can see. I've got so many I could write about but the one that always comes to mind is the following.

The poster continued with...

I called on one particular doctor for years and I guess we even became friends. It's hard to say what a friend is in this business because every good rep knows that if you get a doctor to like you then the doc is more likely to write scripts. This guy was really weird and claimed to be a general in the military reserve. He was a great customer until about a year ago when he claimed his practice had slowed down, but I learned that day that this married doctor was banging a rep and that that rep was my competition. Not only was he having sex with her, he was writing lots of scripts for her product, paying for her apartment, and the lease on her car.But now he needed me, and sadly, he called one of his only friends (again I still am not sure if I was truly a friend of his or just a savvy salesperson). He needed me to drive him to her house (his seventy-thousand dollar car would be too conspicuous) to see if she was home with someone else. We drove to an area in the Bronx, NY, to an area that was quite intimidating, especially since it was 2:00 A.M., and the few people who were out walked with ataxia from whatever they had smoked or injected or drank that day.She lived on the second floor, just ten feet or so above the sidewalk, her windows barred to discourage unwanted visitors. You could almost see through the window from across the street. He was too afraid to go to the door, as was I, and so he called her number, no one answered. I wanted to go home, to get out of there before some NYC cop arrested us for soliciting drugs or something (who else would be parked at this hour in an Acura) but instead Dr. S opened a small case he had brought with him, and strapped what turned out to be night vision goggles to his head. He claimed it was a gift from an Iraqi general. He called his paramour several more times and watched through his goggles until he saw the image of a man get up and walk to the window. Case Closed. This doctor who cheated his patients, his wife, his children, and even me, was himself a victim. 

For me, this sums up the collaboration with GSK and the FDA...

"I get a call from my manager, Dr a big time professor of Medicine, who was part of the FDA board that approved our drug, is coming to town to give talks to the doctors in the area. At $3,000 dollars a night and another $3,000 to give a talk in the local hospitals each day, this elite doctor can take home $30,000 dollars in a week’s time."

The whole thread, which can be viewed here, shows how Glaxo reps got doctors to prescribe more of their drugs.

Fascinating stuff.

Bob Fiddaman.

Friday, June 06, 2014

GSK: Thou Shalt Not

The recent settlement agreement between British pharmaceutical giant GlaxoSmithKline and a number of US states has been posted online - it makes interesting reading.

In a nutshell, GSK will pay $105 million to settle claims with California, New York and more than 40 other states that it illegally promoted asthma and antidepressant drugs.

It's only when we look at the terms of the settlement that we see how Glaxo have had their hand forced to be more transparent with what they do as a company, including their clinical trial results.

Last year GSK teamed up with AllTrials, an organisation that campaign for clinical trial transparency and support its call for the registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs).

The mainstream media and Alltrials, spearheaded by British doctor and author, Ben Goldacre ,rightly or wrongly, started singing the praises of GSK.

GSK, in fact, were also covering themselves in garlands, professing to be the first pharmaceutical company to release such information.

To outsiders it looked like a major turning point in the field of safe medicines but there are many that are not convinced of GSK's collaboration with AllTrials.

Glaxo announced their collaboration with AllTrials on the AllTrials webpage.

At GSK, we are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. We already publicly disclose a significant amount of information about our clinical trials. We register and post summary information about each trial we begin and share the results of all our clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. We have also previously committed to seek publication of the results of all of our clinical trials that evaluate our medicines to peer-reviewed scientific journals.
Expanding on this, we have committed to make CSRs publicly available through our clinical trials register. From now, we will publish CSRs for all of our medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.
In addition, while there are practical challenges, we also intend to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, we will put in place a dedicated team to conduct this work which we expect to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
Separately, we are also working to develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of our clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge.

Back slaps all around then.

Their announcement came on the back of a $3-billion U.S. settlement in 2012 over misleading information about some of its drugs.

A few days ago Glaxo also settled with a further 44 US states. The settlement terms being pretty much the same as the terms they agreed to in 2012.

Let's take a look a some of those terms.


The following subsection shall be effective for eight years from the Effective Date of this Judgement.

GSK shall report research in an accurate, objective and balanced manner as follows and as required by applicable law.

GSK shall register GSK-sponsored Applicable Clinical Trials beginning after the Effective date with the applicable registry and submit results of GSK-sponsored Applicable Clinical Trials completed after the Effective date to the registry and results data bank as required by the FDA Amendments Act of 2007.

For any GSK product, GSK shall also post on GSK's clinical trial registry any observational studies or Meta-analyses conducted by GSK that are designed to inform the effective, safe and/or appropriate use of any GSK product.

Remember, this 2014 agreement is pretty much in-line with the 2012 agreement GSK made with the US Department of Justice.

On GSK's promotional activities, the judgement/settlement states...

The following paragraphs D through F shall be effective for a period of eight years from the Effective Date of this Judgement.

D. GSK shall not make in a promotional context a representation, or suggestion, not approved or permitted for use in the labelling or under the FDCA that a GSK product is better, more effective, useful in a broader range of conditions or patients, safer, has fewer, or less incidence of, or less serious side effectsor contraindications than has been demonstrated by substantial evidence, or substantial clinical experience whether or not such representations are made by comparison with other drugs or treatments, and whether or not such a representation or suggestion is made directly or through use of published or unpublished literature, quotations, or other references.

E. GSK shall not promote any GSK product by use of Promotional Materials that...

1. Contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience.


...3. Present information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does or

4. Uses statistics on numbers of patients or counts of favourable results or side effects, derived from pooling data from various insignificant or dissimilar studies that suggest either that such statistics are valid if they are not or that they are derived from large significant studies supporting favourable conclusions when such is not the case.

F. When presenting information about a clinical study regarding GSK products in any Promotional Materials, GSK shall not do any of the following for information that may be material to an HCP prescribing decision:

1. Present favourable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions.

2. Use the concept of statistical significance to support a claim that has not been demonstrated to have clinical significance or validity, or fails to reveal the range of variations around the quoted average results.

3. Use statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data from studies the design or protocol of which are not amenable to formal statistical evaluations.

Now, let's take a look at some GSK spin.

Earlier this year GSK's Deidre Connolly wrote a piece on the Harvard Business Review blog entitled 'Bonuses Should Be Tied to Customer Value, Not Sales Targets'

She writes...

Critics may say it took a settlement with the U.S. Department of Justice over past sales and marketing practices to reach that conclusion. But we dropped sales targets well before the settlement, recognizing that traditional sales incentives were out of line with society’s expectations for our industry, and we had to change. Ultimately, past practices affected customer trust and satisfaction and, as a result, damaged the reputation of our industry.

What Deidre fails to mention is the settlement took nigh on 10 years, during which time GSK would have been making changes. Fact - the whistle had been blown on GSK's illegal promotional activities, they were being investigated. She claims that GSK dropped sales targets well before the settlement - of course they did - they were rumbled. She fails to mention that GSK dropped sales targets during the investigation.

Question is two-fold.

1. Why change something that was working so well for GSK if it wasn't illegal?

2. Why did it take GSK so long to make such changes?

Connolly's spin is typical of GSK being caught with their pants down. It serves one group of people, not us, the paying consumer, not doctors, that prescribe GSK drugs, but shareholders. Those that have a financial interest in GSK.

It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency. I hope that makes sense? First time I've used the word transparency twice in one sentence.

Further spin continues on Twitter in the shape of GSK's Mary Anne Rhyne.

Rhyne has often been the spokesperson for GSK, particularly where their product Paxil [Seroxat] is concerned.

Through the years Rhyne has had this to say...

These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive.
Mary Anne Rhyne
GlaxoSmithKline spokesperson

Notice the substitution of the word 'withdrawal' for 'discontinuation'

Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.”
Mary Ann Rhyne
GlaxoSmithKline spokesperson

So, in 2002, it appears that Rhyne was all for wining and dining doctors in an effort to get them to prescribe more drugs.

If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks.
Mary Anne Rhyne
GlaxoSmithKline spokesperson

This was in answer to reports that Paxil was causing a lot of people severe withdrawal symptoms. "Limited to two weeks"? Who is she kidding!

We follow the law, and we follow government guidelines.
Mary Anne Rhyne
GlaxoSmithKline spokesperson

[Insert laughter here]

Rhyne is now on Twitter. Below we see her posting a link to Deidre Connolly's piece on the  Harvard Business Review blog. [My response to her, which she never answered, is also included in the snapshot]

So, from collaborations with AllTrials to settlement agreements with US states, GSK have now, seemingly, put their past behavior to bed.

I cannot understand why AllTrials campaigner, Dr Ben Goldacre, would wish to be associated with GSK. In fairness he does chastise GSK. On Twitter he posted the following, once again the question I threw out, along with fellow blogger, Truthman, was ignored.

It's a fair enough question, don't you think?

Why, indeed, would Alltrials wish to be associated with GlaxoSmithKline?

Were they duped into believing that GSK, off their own bat, joined forces because transparency is the name of the game?

Reading all of the above would suggest otherwise.

Sadly, Ben has resorted to name calling on Twitter. A few months ago I asked him to send me a private message via Twitter.

Ben was promoting an updated version of his book 'Bad Science'.

We did, eventually talk via email but nothing came of it.

First time in my life that I've been labelled an 'angry, smeary conspiracy theorist' though.

My only question to Ben still remains unanswered. Why would he want AllTrials associated with GlaxoSmithKline?

The full settlement agreement can be downloaded here.

Bob Fiddaman.

Thursday, June 05, 2014

GSK: Writ for Paxil Suicide Case to Be Dismissed - Denied!

Glaxo's attorney's have been hard at it - alas they are coming up against a steadfast gavel in Judge James B. Zagel.

The whole argument stems from a lawsuit surrounding the suicide of Stewart Dolin. In June 2010 Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression". Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.

Glaxo have argued that Dolin took the generic form of Paxil manufactured by Mylan therefore they were not responsible for the side effects [suicide] but Judge Zagel ruled otherwise.

Zagel told Mylan that they would not have to face any trial but said Glaxo was responsible for the generic drug's design and warning label and would have to face negligence claims.

Yesterday  the 7th Circuit denied GSK’s writ questioning Judge Zagel’s ruling. (GSK argued that Judge Zagel’s decision was “patently wrong” and he - Judge Zagel - should be ordered to enter judgment in favor of GSK.)

Their petition for a writ of mandamus was denied.

Back stories:

GSK to Face Negligence Claims in Adult Paxil Suicide Trial

Another Paxil Suicide Adds to Glaxo's Woes

Bob Fiddaman

Glaxo to Settle With More States in $105 Million Deal

Following yesterdays news, that Glaxo had entered into an agreement with the Oregon Department of Justice, comes news of further settlement agreements being reached in the US.

It's now being reported that GSK will pay $105 million to settle claims with California, New York and more than 40 other states that it illegally promoted asthma and antidepressant drugs.

The deal isn't just a monetary one...Glaxo, however, would like the general public to think that it is.

Part of the deal is that Glaxo have to stop using paid doctors to promote its products. Glaxo, after being fined a record breaking $3 billion in 2012 for similar offences, have claimed to be doing this off their own bat...when in fact their hand has been forced by these settlement agreements.

The State of California are to receive $7.1 million, the highest payment to any of the other states mentioned in the agreement. Texas stands to get $6.2 million under the deal, while Pennsylvania and New Jersey stand to receive $4.1 million and $2.45 million

Glaxo have also recently settled many Paxil birth defect cases, a figure that is estimated at $1 billion.

Glaxo have also recently been in the news for bribing doctors in China, Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria and Jordan - back story.

On May 27th the British Serious Fraud Office (SFO) announced that GlaxoSmithKline were being investigated by officials in Britain. I have wrote to the SFO asking them to elaborate on the investigation and also asked them if they will be investigating any bribery or fraud committed in the UK by GlaxoSmithKline. The SFO have wrote back but have, as yet, not announced if they will be investigating bribery or fraud from any of GSK's UK practices.

So, Glaxo settling claims against them left, right and centre at the moment.

They refuse, however, to settle claims brought against them by members of the British public regarding Seroxat [Paxil] and its propensity to cause withdrawal problems. A lawsuit, filed over 10 years ago, sees Glaxo refuse to compensate a number of British consumers who became addicted to Seroxat. Glaxo have refused to enter into any type of settlement agreement and have denied all allegations that Seroxat is addictive. This, despite settling with over 3,000 consumers who made claims against them in the US a number of years ago.

It seems that GlaxoSmithKline, a British company, can pay the consequences of their illegal activities in foreign countries but refuse to do so when they do the same on their own soil.

Don't you just love the British Justice system!

Bob Fiddaman.

Please contact me if you would like a guest post considered for publication on my blog.