Fid Covers Day 7 Of The Dolin Trial…

Friday, March 24, 2017

Dolin Vs GSK – Day 7 – Abraham Lincoln

Day 7 in Dolin Vs GSK began with the continued cross-examination of former FDA official, Dr. David Ross, by GSK’s King & Spalding attorneys.

GSK is desperately trying to convince the jury that the company repeatedly sought to change the Paxil labeling but, supposedly, the FDA wouldn’t allow it. GSK’s attorney, Andrew Bayman, futilely tried to put words into the mouth of the witness, attempting to trick Dr. Ross into agreeing he said things he has never actually said.

It’s still a head scratcher for me – on the one hand, GSK is claiming that Paxil is safe for adults, on the other they claim they told the FDA there was an increase in suicidality in adults on Paxil. How could both be true?

It appears Glaxo concedes Paxil can increase suicidality in adult consumers but that this suicidality increase does not lead to completing suicide.  However, if you die by “suicide” when consuming  GSK’s product, Paxil, GSK’s drug didn’t cause it.

Yesterday, former FDA official, Dr. Ross, was asked by Bayman:

“Other than the 6.7 finding with respect to the secondary analysis of definitive suicidal behavior, you’re not aware of anything in GSK’s 2006 adult suicidality analysis that would meet the definition of reasonable evidence of an association between the use of Paxil and suicidality that would warrant a label change, correct?”

Dr. Ross, who remained unphased, replied:

“Well, the answer to that is yes, I am, but more importantly, as I said to your colleague two years ago, that’s a little bit like saying, ‘aside from that, Mrs. Lincoln, how did you enjoy the play?'”

This was a great response considering the excuses GSK regurgitates when faced with claims that Paxil induces adult suicidality, and severe withdrawal effects or birth defects, etc. It is the standard corporate response to repeat, “Paxil has helped millions of people worldwide.”

Why would GSK attempt to place an adult suicide warning on the Paxil label if it is the company’s position that Paxil does not induce suicidality in adult patients?

King & Spalding’s Bayman has been trying to catch Dr. Ross in non-existent contradictions for two days. Dr. Ross, who often quite brilliantly turns the questions back onto Bayman, remains steadfast that the Paxil suicidality data created by GSK is false and misleading.

Thus far GSK has claimed it wasn’t their fault they didn’t warn the public, it was the FDA’s failure. It wasn’t Paxil that precipitated the death of Stewart Dolin; it was his underlying illness. It is GSK’s position that Paxil causes suicidality in adult consumers; it’s also their position that it doesn’t.

Akathisia is the Paxil-induced medical condition that often precipitates suicidal thoughts and suicide itself. GSK continues to point out that there is an FDA class warning for all SSRIs stating the drugs can cause akathisia. However, what GSK attorneys don’t want to mention is that their product, Paxil, is more likely to cause suicidality than other SSRI offenders. Specifically, when the clinical trial data is correctly interpreted, it shows Paxil causes an 8.9 increase in adult suicidality.

All SSRIs can and often do cause akathisia and suicide. Unfortunately, drug companies and the FDA continue, to this day, to inadeqautely define akathisia. This collective failure continues to harm patients and ill-informed prescribers.

Today’s Paxil label describes akathisia simply as “psychomotor restlessness.” Further, it states:

“The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment.”

Once again, there is no mention that akathisia is a precursor to suicide. Of course, GSK’s Andrew Bayman doesn’t tell the jury this fact, either. However, GSK’s BigPharma colleague, former Pfizer Medical Director Dr. Roger Lane, confirmed this fact way back in the 1980’s.  Lane wrote two peer-reviewed articles about SSRI-induced akathisia. About akathisia-induced suicide, he stated, “It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.”

Lane was referring to fluoxetine, which is the drug, Prozac, just as paroxetine is the drug Paxil. An expert witness for Prozac manufacturers, Eli Lilly and Company, conceded under oath that SSRIs cause akathisia. At the Forsyth v. Eli Lilly and Company murder/suicide trial, Lilly’s expert witness, Dr. Victor Reus testified that both Paxil and Prozac can cause akathisia in patients.

King & Spalding’s Andrew Bayman frequently concedes in the Dolin Vs GSK trial that SSRIs can cause akathisia. Further, Bayman continues to point out that akathisia is listed on the drug class label. However, what Bayman doesn’t want to emphasize is what drug company scientists have known and confirmed for years: As Pfizer’s Dr. Roger Lane stated decades ago: “death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced.”

GSK has downplayed the suicide risk in adults taking Paxil for nearly 25 years. It’s absurd and misleading to claim that calling akathisia “psychomotor restlessness” would ever lead consumers and prescribers to interpret this intentionally vague definition as an increase in suicidality.

GSK and all SSRI manufacturers should be shouting from the rooftops the exact definition of akathisia, as should medicine regulators. Instead, yesterday the Dolin Vs. GSK jury was treated to some loud entertainment by Bayman. He tried to drown out the facts by shouting at the expert witness. It was so unprofessional that the Honorable Judge Hart had to tell Bayman to “stop shouting.”

Further witnesses will be called next week as this case unfolds. Meanwhile, here’s a short video produced by MISSD that helps everyone better understand akathisia.

Bob Fiddaman.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK – Day 6 – Ass Kicking Semantics


The MHRA (UK Medicines Regulator) Has No Interest In Seroxat Suicides…


“…Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake…”

Dr David Healy November 2015

“..In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults…”

“…Yet this BMJ study deals an especially sharp blow, for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. ”

The Atlantic 2015

The MHRA (The UK Medicines Regulator) has been utterly toothless in regards to bringing GlaxoSmithKline to book over the appalling Seroxat scandal. Seroxat was first licensed in 1991, therefore effectively for 25 years the MHRA has allowed GSK to make a profit off a drug which has killed, harmed and maimed many people. This drug should have been pulled from the market in 2001 when the first BBC expose about the dangers of Seroxat suicide, violence and withdrawal first surfaced. However, considering the current MHRA CEO, Ian Hudson, is a former long time GSK employee, who testified in favor of Seroxat (Paxil in the US) before he left to join the regulatory industry, I won’t hold my breath for the MHRA to act in patients’ interests any time soon. They are clearly more interested in protecting Pharma before patients.

In October this year, the BMJ (British Medical Journal)- the most esteemed medical journal in the world- published a damning re-interpretation of a study on Seroxat (study 329). Although, this study showed how dangerous Seroxat is in the under-18’s age group, it also opened up a can of worms about the safety of Seroxat in all age groups. If Seroxat is lethal in under-18′s, and causes them to commit suicide, self harm, and causes other horrible side effects, and the MHRA agree with these findings, then why do the MHRA dispute that Seroxat can cause the same effects in adults? It’s like saying that cyanide is not for kids, but adults are ok. It’s just simply absurd to say that Seroxat is in any way safe for adults; particularly in 2015.

Bob Fiddaman, the author of the Seroxat Sufferers Blog, has been asking the MHRA a very interesting question regarding Seroxat’s ‘safety’ profile; a question which I have been trying to draw attention to also on this blog for quite some time-

Dear Sir/Madam,

With respect, you have not answered my question. I am already aware of the Expert Working Group and their findings.

My question, which I believe, you have not answered, is…

If a patient, at the age of 16, suffers suicidal thinking whilst on paroxetine – but continues to take paroxetine and continues to feel suicidal thoughts. What happens when they reach, 25, 26 or 27, do these suicidal thoughts magically disappear?

The question we are asking here, is extremely important, and it bring the entirety of Seroxat prescribing into question.

The MHRA admit that Seroxat should not be prescribed to under 18’s because it can increase suicidal thoughts in those age groups. But, what happens when an individual is prescribed Seroxat when they are under-18 but continue on it until they are over-18? Does the risk magically  disappear?

This question is important because it’s ridiculous to assume that risks from a drug would change so dramatically just because of an over-18 threshold. We don’t automatically change into an adult body, or suddenly become completely different psychologically, biologically or behaviorally, when we turn 18. Growing up, maturing, and the changes which take place both physically and psychologically, happen over a gradual period.

The adolescent brain is different than the young adult brain, and the same could be said for a young adult and an adult’s brain. Nonetheless, peoples’ brains do not suddenly change from adolescent to a young adult on their 18th birthday. The age 18 threshold in regards to Seroxat side effects is ridiculous.

According to recent findings, the brain does not fully mature until at least 25 anyhow, and furthermore, it is also arguable that prescribing an SSRI drug over a long period of time could affect how the young adult brain develops. If SSRI’s cause birth defects so easily, I dread to think what kind of damage they do to our brains (at any age).

Millions of adolescents were prescribed Seroxat (Paxil/Aropax) when they were under 18, particularly in the late 90s/early 2000’s and many of them had serious reactions, but they weren’t warned of the dangers, so many they stayed on the drug until they were over-18, even though it was doing them damage. Many of these teenage Seroxat casualties could not come off it because of the severe withdrawal reactions Seroxat induces, some stayed on it well into adulthood. Some committed suicide because of Seroxat, some got off, and some are still enslaved to it.

The issue of Seroxat causing so much harm to under’18s raises a huge red flag for Seroxat in all ages groups, a red flag which many have been trying to draw attention to for over a decade now. However, the MHRA have no interest in Seroxat harming adults, or children, or Seroxat harming anyone in fact. After 25 years of constant bad press, and clear evidence that Seroxat is a dangerous drug, the MHRA continue to allow it on the market. Why?

Personally, I believe that the MHRA possibly suspect that Seroxat is lethal, but if they pulled it now (after all these years of ineptitude), or admitted that Seroxat harms adults in the same way, they would open themselves up for obvious negligence, and an admittance would open too many cans of worms, therefore they continue to deny, ignore or obfusticate because that’s the only way they know how to deal it. If they were to acknowledge the truth about Seroxat, that would open their whole regulatory system up to scrutiny. Seroxat was the ‘canary in the coalmine’. It serves as a warning that we are not safe, just like thalidomide did in the 1960’s. If we can’t trust the pharmaceutical companies, and we can’t trust the data on their drugs, and we can’t trust the regulators to keep us safe from harm, how do we trust in the efficacy of any pharmaceutical products? We can’t, and we shouldn’t.

The MHRA’s response to Bob Fiddaman on the question of Seroxat harming under-18’s (but still being prescribed to over-18’s despite the known risks) and the conundrum that is presented within the question itself, is the typically glib and sarcastic response that they have been giving for years now. They simply must not care that Seroxat has killed and maimed many people. If they did they would have done something about it by now..

But as we can see from their dismissive response to Bob Fiddaman, they will do anything to avoid opening the Seroxat can of worms..

Dear Mr Fiddaman,

Thank you for your email.

This is a theoretical question which we are unable to respond to as a patient’s health condition will vary for each individual. The clinical care of a patient is the responsibility of their doctor; healthcare professionals are recommended to closely monitor their individual patients on SSRIs for suicidal thoughts and discuss their symptoms with them to determine the best course of action with regards to possible treatment.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency

It’s interesting how the MHRA are trying to deem that Bob’s question is merely theoretical. It may be theoretical in the way it is phrased, but it is also a real question based on real scenarios, and there are many under 18’s who were prescribed Seroxat and had serious adverse reactions, but because they were in the dark at the time of being prescribed Seroxat, they continued on the drug until adulthood.

The ‘theoretical’ scenario which the MHRA are trying to denigrate and dismiss actually happened to many people. It’s not astrophysics. These events happened to people, and people suffered for it. This is not ‘theoretical’- many people have been harmed from Seroxat. That’s a fact.

It seems to me that when people question GSK about Seroxat they are told to talk to their doctor, but when they ask their doctor their doctor says that its the regulators responsibility to keep us safe from harmful drugs and that they are not responsible for it. If we question the regulator about our concerns about Seroxat, the regulator also tells us that its the doctors responsibility, not theirs. So effectively patients are pushed upon a never ending ‘circle of pass the buck’ with nobody ever taking responsibility. This is just not good enough. Patients deserve better.

I will be interested to see what the MHRA have to say in response to Bob’s last question to them. Their obfuscation tactics, in regards to avoiding the Seroxat Scandal, are really wearing thin after 25 years..

Keep an eye on Bob’s blog for more on this-

Then, based on your answer, pediatrics and adolescents taking SSRi’s off-label are at risk of suicidal thinking but when they reach a certain age (26) they are not at risk, that risk, according to the MHRA SSRi prescribing guidelines, magically vanishes?

Currently, SSRi’s are not recommended for anyone up to the age of 25 years, correct?
How did the MHRA arrive at this? Was it based on a set of theoretical circumstances?
Please explain, in detail, how the MHRA arrived at the decision that any person up to the age of 25 is at a higher risk that those over the age of 25, ie; what criteria did you use?
Bob Fiddaman

From Bob Fiddaman: GSK Roll Out ‘Patient First’ Program

Wednesday, April 02, 2014

GSK Roll Out “Patient First” Program


Anti-depressant ingredient from Cork plant contaminated with waste

Reminds me of the Puerto Rico Incident.

Glaxo’s Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company’s sale of Paxil (Seroxat) and Paxil CR.

A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo’s Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004

Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra… they didn’t.

After leading her recovery team Eckard found more violations that the FDA had missed first time round.

In a nutshell, she brought this to the attention of her senior managers, her managers ignored her… then fired her.

According to Eckard’s complaint: “persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. … rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for “black market” packaging and distribution …”

Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it’s committed to continuously improving manufacturing quality. The company denied Ms. Eckard’s allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.

Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.

Back in 2013 GSK, the company who have had more fines than I’ve had hot dinners, rolled out their “Patient First” program. At the time they said this…

“GSK has an important role to play in supporting education for healthcare professionals and in providing accurate information about its medicines to help them make the best treatment decision for their patients, such as sharing new clinical data, details of label changes or safety updates.”

Now read this letter sent to Andrew Witty from the FDA on March 18, 2014

March 18, 2014

Sir Andrew Witty
5 Moore Drive
Research Triangle Park, NC 27709

Dear Sir Andrew:

During our October 18-23, 2013 inspection of your pharmaceutical manufacturing facility, SmithKline Beecham (Cork) Ltd., located at Currabinny, Carrigaline, Cork, Ireland, investigator(s) from the U.S. Food and Drug Administration (FDA) identified deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations cause your APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have conducted a detailed review of your firm’s response and note that it lacks sufficient corrective actions.

Our investigator observed specific deviations during the inspection, including, but not limited to, the following:

1.    Failure to fully investigate critical deviations.

Your firm discovered that the (b)(4) used to manufacture (b)(4) batches of (b)(4) and (b)(4) batches of (b)(4) was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. Examples of chemicals that are collected in the waste tank include (b)(4). Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of (b)(4) manufactured using the contaminated solvents on April 19, 2013. Your firm distributed (b)(4) shipments of (b)(4) potentially contaminated (b)(4) batches after becoming aware of this significant deviation. In contrast, (b)(4) batches made with the contaminated (b)(4) were rejected.

Quality impact assessments were made for both (b)(4) and (b)(4), but we note that the approach taken in the two assessments was different. For instance, the (b)(4) assessment noted that the standard release testing did not detect significant quantities of contaminants in the potentially impacted (b)(4) batches, but that additional testing on (b)(4) from (b)(4) showed the impacted batches were exposed to significant amounts of (b)(4). The assessment states that the sample preparation used in the (b)(4) sample release testing appears to be incapable of complete extraction of the potential contaminants, and it therefore relied on results obtained from the additional testing from the (b)(4) of (b)(4) product to demonstrate that the (b)(4) batches were impacted by the pharmaceutical waste contamination event. Your firm’s assessment for (b)(4) included no such additional testing and relied on the (b)(4) samples’ passing test results, concluding that there was no quality impact to the (b)(4) batches.

Your firm’s SOP regarding communication of significant deviations states that your firm must communicate to the receiving site information concerning deviations having a potential quality impact on the product. During the inspection, your personnel informed our investigator that your firm determined that there was no potential to impact the quality of the affected products manufactured with (b)(4) and chose not to “escalate” the deviation by notifying your customers. We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact. In your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse.

In your response to this letter, please address the concerns outlined above. Please also describe why the quality assessments appear to assume uniform distribution of contaminants following addition of (b)(4) to the waste stream and before the backflow of contaminants into the (b)(4) tank. Provide a revised quality assessment for (b)(4) that clearly describes all calculations used to support the conclusions, and clearly describe any altered conclusions after addressing the issues described in this letter. For each analytical method used to support your conclusions, provide method qualification information, including the limit of detection for each potential contaminant. Also, provide a quality impact assessment for your (b)(4) product, which was also manufactured using (b)(4) around the time of the initial contamination in the (b)(4) tank. Describe any contact you have had with the customers of the potentially affected products and your plans with respect to the disposition of any potentially affected batches that remain within expiry.

2.    Failure to investigate and document out-of-specification results.

Your firm tested solvent from the (b)(4) tank in September 2011 and October 2011 to look for potential (b)(4) contamination via a gas chromatographic method. The chromatograms from both samples show large peaks for (b)(4) as well as small but detectable levels of at least ten other contaminants. These unexpected peaks should have indicated to your firm that the (b)(4) tank had been contaminated with pharmaceutical waste, as described above. Instead, your laboratory personnel ignored these unexpected peaks and conducted no investigation into what gave rise to them. As a result, your firm did not notice the (b)(4) tank contamination until a third sample from the tank was tested in January 2012.

In your response to the Form FDA-483, you stated that there was no reason to expect (b)(4) contamination and therefore the analyst did not notice the (b)(4) peak. Your response does not address why the analyst did not notice the numerous other detected contaminants in the chromatogram, nor did it address why a second reviewer did not notice the unexpected peaks in the chromatograms. Please address these issues in your response to this letter. In addition, please explain why the (b)(4) testing sample from the tank was collected in November 2011 and was not tested until January 2012, and provide supporting documentation from the method validation describing the stability of the tank samples during this lengthy storage period.

3.    Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Your firm’s validation protocol for (b)(4) states that a minimum of three consecutive pre-nominated process performance qualification (PPQ) batches were to be produced to demonstrate initial process validation. However, your firm was unable to produce three consecutive successful batches due to (b)(4) during the production of multiple batches and therefore re-nominated the PPQ batches on two different occasions. Your firm made modifications to the equipment used in manufacturing after noticing (b)(4) during the first two batches manufactured, but these changes were not sufficient to prevent further (b)(4) during the fifth batch. Following the fifth batch, your firm replaced the(b)(4) used in the manufacturing process and produced a sixth batch. During the execution of the validation protocol, the originally “pre-nominated” PPQ batches that were rejected due to (b)(4) were assigned for reprocessing.[1]  Based on manufacture of the third, fourth, and sixth batches without this processing problem, your firm considered the process validation protocol to be successfully executed.

The process performance qualification studies described above suggest that your equipment has not been sufficiently demonstrated to reliably perform its intended function, namely (b)(4) and (b)(4) of the (b)(4) from the process stream. Demonstrating suitability of equipment used in the manufacturing process is a fundamental element of establishing the state of control of your process. Because of these equipment suitability deficiencies, we are concerned that your firm has not adequately demonstrated an ability to consistently and reproducibly manufacture (b)(4) without (b)(4).

In your response to this letter, please provide justification for the selection of non-consecutive batches during the execution of your validation protocol. Describe any revisions to your validation SOP to clarify under what specific circumstances “re-nomination” of PPQ batches would be considered acceptable. Provide any additional evidence of your firm’s ability to reproducibly manufacture (b)(4) without (b)(4) and while meeting all critical quality attributes. Specifically, provide the entire batch manufacturing history for (b)(4) following batch (b)(4), noting any other incidents of (b)(4) problems.

The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility.  You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations.

If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER’s Drug Shortages Program immediately, as you begin your internal discussions, at so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Program also allows you to meet any obligations you may have to report discontinuances in the manufacture of your drug under 21 U.S.C. 356C(a)(1), and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may be able to take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.

Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, your failure to correct these deviations may result in FDA refusing admission of articles manufactured at SmithKline Beecham (Cork) Ltd., Currabinny, Carrigaline, Cork, Ireland into the United States under Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). The articles may be subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the APIs at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 1000170338.

Please send your reply to: Mary Farbman, Ph.D., Consumer Safety Officer; 10903 New Hampshire Avenue; Building 51 Room 4234; Silver Spring, MD 20993-0002.

Steven Lynn
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

cc: Finbar Whyte
Site Director
GlaxoSmithKline (GSK)
Carrabinny, Carrigaline
Cork, Ireland

GSK  is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Doncha just love em.

Bob Fiddaman.

Bob Fiddaman (Seroxat Sufferers) Tells It Like it Is: Cronyism Chinese Style

Tuesday, December 03, 2013

Cronyism, Chinese Style

Cronyism – Favoritism shown to old friends without regard for their qualifications, as in political appointments to office.

British PM, David Cameron, is off to China, apparently he needs to drum up some business. It appears that the Prime Minister can’t do this alone, he needs to convince the Chinese government that the UK are good guys to deal with.

So, who better to tag along with Cameron than his old chum, Andrew Witty.

Witty, whose company, GlaxoSmithKline, are currently being investigated by Chinese officials for corruption, bribery and other misdemeanors, is part of David Cameron’s business council.

I find this really amusing. Here we have the leader of a country who wishes to convince Chinese officials that business with the UK is the way forward. To help convince China that the UK have wonderful business practices the UK bring along a knight, a sir, if you will, whose company, a British one, who are currently under investigation by Chinese authorities.

Laugh? I almost soiled myself!

However, this knight is not shining, in fact Witty must be cringing at the thought of being asked about Glaxo’s behaviour in China. I can just imagine how the phone call between Cameron and Witty went. Maybe it was something like this…

DC – Hey, Andy me old mucka, DC here, you fancy an all expenses paid trip to China?

AW – Are you taking the piss, DC?

DC – No mate, honest, we seriously need to drum up some business and investors. The UK has pretty much had it and nobody really trusts me anymore, if you believe the polls that is.

AW – But you are aware the Chinese authorities are investigating my company, aren’t you?

DC – Of course Andy but why are you worried about something so trivial, it never happened on your watch did it?

AW – No, and that’s the position that I have taken. I would have used the era excuse but it was fairly recent and I just didn’t think people would buy into it again.

DC – So, let’s have dinner. I’ve invited some of our business greats along too.

AW – But don’t you think it will be awkward for me if the press start to ask probing questions about the bribery allegations?

DC – Andy, Andy, Andy. C’mon, It’s just a few bad eggs, don’t stress my friend. Bring some Seroxat with you in case you get an anxiety attack.

AW – Sod that, have you seen what that shit does to kids?

DC – Just part of an era though, hey mate.


Back stories on the China scandal below.

Bob Fiddaman

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Andrew Witty… I know narrrrrrrrthing

葛兰素史克公司 腐败 For Researching Chinagate

Glaxo’s Private Investigator Arrested

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing – Part II

Hammer to Fall on GSK’s Chinese Executives

Bob Fiddaman E-mails Ian Hudson (Former GSK Exec and Current CEO of MHRA)

Saturday, November 09, 2013

Email to CEO of the MHRA, Ian Hudson

I’ve just flicked the following email to the new MHRA Chief, Ian Hudson.

Any reply will also be made public.

Dear Mr Hudson,

As I understand you are now Chief Executive of the MHRA. I’d congratulate you but we both know that I’d be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.

That aside, I have to remain professional.

My question to you is one of great concern and one that I shall be making public on my blog

Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi’s?

I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people – Back story here.

This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.

Best wishes

Bob Fiddaman.

GSK’s Extensive and Long History of Corporate Misconduct… Bob Fiddaman Investigates..

And this is just the tip of the iceberg where GSK and bad deeds are concerned… 

Saturday, September 14, 2013

GSK – A Runaway Train…Running Right Off The Track

If there is one corporate company still operating when it really shouldn’t be that company that stands head and shoulders above any other I know is British based GlaxoSmithKline.No sooner had they been found guilty for a whole host of violations in the US [Resulting in an estimated $3 billion fine] they are back in the news again for yet more violations, this time in China.The Chinese violations are currently under investigation. GSK head honcho, Andrew Witty, has denied knowing about the shenanigans going on in China which include:

  • Bribing doctors with cash payments
  • Bribing doctors with sexual favours
  • Using a network of more than 700 middlemen and travel agencies
  • Inventing meetings that required travel payments (these payments were given to doctors to persuade them to prescribe GSK products)
Glaxo’s $3 billion fine in the US is just another piece of the jigsaw. Before this they have made settlements in and out of US Courts, paying defendants compensation and slamming down gagging orders as part of the settlements… in other words nobody can go public with amounts paid to them.
Let’s just take a look at some of the other violations committed by GlaxoSmithKline over the past few years.
Glaxo’s Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company’s sale of Paxil (Seroxat) and Paxil CR.
A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo’s Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004
Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra… they didn’t.
After leading her recovery team Eckard found more violations that the FDA had missed first time round.
In a nutshell, she brought this to the attention of her senior managers, her managers ignored her… then fired her.
According to Eckard’s complaint: “persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. … rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for “black market” packaging and distribution …”
Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it’s committed to continuously improvingmanufacturing quality. The company denied Ms. Eckard’s allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.
Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.
No criminal charges were laid against Glaxo despite allegations of their involvement in selling on rejected batches of drugs to MOVA Pharmaceuticals.
Glaxo suppressed patient-level meta-analysis of safety data from Avandia trials which demonstrated an estimate of excess risk of ischemic cardiovascular events and other potentially life-threatening complications.
A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication.
During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.
In 2012, after being ordered to pay $90 million to resolve allegations by prosecutors in 38 states that the they illegally marketed Avandia, Glaxo had this to say:
 “The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement” 
Paxil (Seroxat) Birth Defects
After deliberating for seven hours, a state court jury in Philadelphia found that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.
The case was the first to go to trial of more than 600 suits claiming that Glaxo hid knowledge of birth defect risks allegedly tied to Paxil.
What did Glaxo have to say after being found guilty?
“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.” 
You’ll probably find that the jury thought otherwise Glaxo.
Paxil (Seroxat) Suicide
On December 14, 2009, Bloomberg published an article entitled “Glaxo Said to Have Paid $1 Billion in Paxil Suits.” 
The article reported:
GlaxoSmithKline PLC has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
Why did they do this?
Well, it’s down to the Schell case in 2001.
Donald Schell, 60, had been taking Paxil for just two days when he shot and killed his wife, his daughter, his granddaughter and then himself.
Remaining members of the family filed suit.
During the trial GSK [then SmithKline Beecham] internal documents showed the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging didn’t, at the time, include a warning about suicide, violence or aggression.
Glaxo were found guilty and ordered to pay $6.4 to the remaining family members.
What did Glaxo attorneys say after this particular defeat?
“Paxil is a very effective medication in helping depression,” attorney Charles Preuss said after the trial. “Our only regret is that Mr. Schell did not have Paxil for a longer period of time.” [Link]
The link between Paxil and suicide has been raging for years.
Here’s what former Head of Psychiatry at GlaxoSmithKline, Alistair Benbow, had to say in a BBC interview.
Benbow {A} was being interviewed by investigative journalist Shelley Jofre.{Q}
Q. Let us move on. What has the company done about the Wyoming (Schell) verdict?
A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed…
Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.
A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.
Again, I think the jury would disagree with Benbow here.
If Glaxo believed their product was innocent in the suicides of these people why would they settle further cases? One such case involving the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.
They then settled with the family later.
Paxil (Seroxat) Addiction
In its 2008 annual report, Glaxo officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.
In other words a gagging order was place. This enables Glaxo to defend any further lawsuits regarding Paxil addiction. One such lawsuit is the UK Seroxat litigation which Glaxo are defending.
The UK lawsuit has been dragging on for over 10 years now. Glaxo have refused to make any such compensatory settlements to any UK citizen.
So, just a few reasons why it comes as no surprise to learn that Glaxo have been behaving badly in China. No surprise that Witty is denying any knowledge of what went on in China either.
Even when found guilty Glaxo continue to deny any wrong-doing… that trend will continue until compensation is put to one side and criminal charges are laid against the top executives at Glaxo. They are the past masters of buck-passing, of laying blame on others, of waving wads of cash [dangling carrots] in front of victims in the hope that a settlement can be reached. With settlement comes suppression and Glaxo just love suppression.
I anticipate that the bad behaviour in China will be settled and those responsible [the top management] will deny knowledge and let the area managers take the fall.
That’s their style, always will be until someone has the balls to come down hard on the senior management at GlaxoSmithKline.
Someone really needs to put a stop to this runaway train.
Bob Fiddaman

Bob Fiddaman on “Andrew Witty and GSK China Scandal”

Monday, August 26, 2013

Andrew Witty… I know narrrrrrrrthing

Like a script from the 70’s classic Fawlty Towers, GSK Head, Andrew Witty, has recently claimedthat GSK HQ in London knew nothing about the fraud occurring in China [back stories herehere,here]

If Witty is telling the truth one has to ask why he knew nothing. He’s the head of the company and surely this means keeping his fingers on the pulse at GSK, both at home and globally.

Witty, who last year, blamed Glaxo’s history of fraudulent promotion on “part of an era”, is, in essence, deflecting blame on his own poor performance as a Chief Executive.

Glaxo were found guilty and fined a record breaking $3 billion for that particular crime and Witty spun his company’s dirty deeds by blaming an era that he, allegedly, had nothing to do with. So, he was, it can be argued, blaming his predecessor Jean Pierre Garnier.

Nothing changes. Now, it appears, Witty is, once again, deflecting blame.

Digging through the archives we can see that this isn’t the first time Glaxo have been embroiled in controversy regarding payments made to doctors.

In 2003, admittedly before Witty was in charge, the Finance Police in Veneto, Italy, charged 72 Italian doctors and Glaxo employees with bribery and corruption, charging that Glaxo employees showered cash, gifts and trips on doctors to encourage them to prescribe more Glaxo products. [1]

Déjà vu anyone?

Just like the Chinese allegations Glaxo were accused back in 2003 of wining and dining doctors and sending them on lavish trips in an effort to get them to prescribe more of it’s products.

How did Glaxo’s then medical director, Giuseppe Recchia, react to news of the illegal activities?

“We think we acted according to the standards fixed by the law.”

Marvelous isn’t it.

During the 2003 investigation it was learned that 26 chiefs and assistant chiefs of hospital departments, five university professors, and four heads of hospital pharmacies were invited to “medical tours” to places such as Monte Carlo in the days of the Formula 1 Grand Prix or to Sharm el Sheik or Damascus, or they received tens of thousands of pounds cash with fictitious justifications.

The current Chinese investigation alleges pretty much the same although we can throw prostitution into the pot as well.

I wonder if Witty’s predecessor knew nothing about what was going on in Italy – that seems to be the standard these days. Run a large corporate company, cover oneself in garlands with praise received, deny any knowledge of any wrong-doing when criticism is aimed and fired.

Witty claims that London HQ had no knowledge of what was going on in China. His London HQ have known for years that thousands of people have found Seroxat withdrawal problematic… they still did nothing to help these consumers.

If Witty had any gumption about him, if he really wanted to practice what he preached then maybe it’s time for him to sit down with Seroxat victims, maybe he could write directly to Secure Law, the UK law firm representing claimants who became addicted to Glaxo’s wonder pill.

Then again, I’m guessing even Witty would find it difficult to face victims or even their representatives… he’d have to get past his own lawyers first who would gently advise him that meeting with Seroxat victims/representatives would be an admission of guilt… and we can’t have GSK looking guilty can we?

What happened in China “I know nothing”

What happened in Italy? I know nothing”

Ignorance is bliss eh.

This one’s for you Mr Witty.

[1] Italians Link Glaxo to Illegal Doctor Gifts

Bob Fiddaman

GSK And The M.H.R.A. : Corrupt bastards?..

Definition of corruption:

“dishonest or fraudulent conduct by those in power”..

corrupt |kəˈrəpt|
1 having or showing a willingness to act dishonestly in return for money or personal gain : unscrupulous logging companies assisted by corrupt officials.
• evil or morally depraved : the play can do no harm since its audience is already corrupt.
See note at depraved .

Bastard :

2 informal an unpleasant or despicable person : he lied to me, the bastard!
• [with adj. ]

Bob Fiddaman of “Seroxat Sufferers” has some great posts on the ‘revolving door’ syndrome which regularly occurs between pharmaceutical companies and the regulators (whom allegedly are supposed to police them), Bob’s beef (and mine) is about GSK and the MHRA (the UK drug regulators). But you can be damn sure that the same thing happens across the globe in regards to all pharmaceutical companies and all regulators. This is a post from 2010, but it is just as significant to raise these issues today.

Initially, this was going to be a two-parter, however, more research has led me to another witness for GlaxoSmithKline in the UK Seroxat Group Action – more about him in Part III.

Part IV will show you how another of GSK’s witnesses, they are using for the up and coming UK Seroxat Group Action, works for a company who are in receipt of huge funds from The Wellcome Trust.

Following on from my previous post where I have tried to highlight instances where both GlaxoSmithKline and the MHRA either failed to spot or chose to ignore warnings about Seroxat withdrawal.

I turn my attention now to the UK Seroxat Litigation.

The defining issues of this group action are thus:

Does Seroxat have a capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as prevent or make more difficult the ability of users to discontinue, withdrawal from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)

As I have said, my previous post highlighted the reasons why I think this litigation will be a failure for GlaxoSmithKline. I’m not a lawyer, nor do I work for lawyers. I can, however, determine what is wrong from right.

Before I move on to name one of the ‘expert witnesses’ for GlaxoSmithKline in this litigation I will recap on the evidence I have found just by searching the Internet.

In 1993, the Committee on Safety of Medicines (“CSM”), the UK’s counterpart to the FDA, reported 78 cases of withdrawal after discontinuation of paroxetine, reporting that “such reactions have been reported more often with paroxetine than with other SSRI’s.” (“Current Problems in Pharmacovigilance” (1993; 19:1).

GSK, then SKB, and the MHRA, then the MCA, did not react to this warning.

In 1997, Dr. Haddad reported that the highest incidence of discontinuation reactions among the SSRI’s was paroxetine. (J Clin Psychiatry 1997; 58 Supp l7:17-1; discussion 220.)

In 1997, Young and Currie of Newcastle reported on their survey indicating that a sizeable minority of physicians were aware of the existence of antidepressant withdrawal reactions. This included psychiatrists, 28% of whom expressed no awareness that antidepressant medications could induce discontinuation reactions. The conclusion of the authors was that “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.” (J Clin Psychiatry 1997;58 Suppl &:28-30.)

This particular paper is of interest to me as it was co authored by Allan Young. At the time of the publication [1998] Young was Senior lecturer in psychiatry at Hadrian Clinic, Newcastle General Hospital, Newcastle upon Tyne. The conclusion of Young, along with the other two authors of the publication, Peter Haddad and Michel Lejoyeux, is evident for all to see – “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.”

It is interesting because Allan Young will be one of the expert witnesses on behalf of the defendants, GSK, in the UK Seroxat Group Action. It seems rather odd, to me at least, that GSK would want a witness who has in the past wrote about antidepressant withdrawal reactions.

This is just one of the witnesses for GSK. Another is Dr. Rashmi Shah.

Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.

Shah’s previous employment history will shock quite a few people who read this article.

Shah was employed by the MHRA between 1987 and 2004. Positions held were:

Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

An employee of the MHRA for 17 years.

Now a witness for the defence [GSK] in the UK Seroxat Group Action.

Shah retired from the MHRA in 2004.

A summary of the Committee on Safety of Medicines meeting, held on the 25th of November, 2004, attests to this:

1. Apologies and Announcements

1.4 The Chairman informed the Committee that Rashmi Shah’s was retiring and that this was his last meeting and on behalf of the Committee thanked Rashmi for his outstanding contributions to the work of the Committee over a 17 year period and wished him well in his retirement.

I, along with many others, have always been weary of the relationship the regulators have with the pharmaceutical industry so this revelation should come as no surprise.

It would appear that the MHRA’s long standing relationship with GlaxoSmithKline will continue through the High Court in London.

For those of you that don’t know, the MHRA spent four years investigating GlaxoSmithKline.

The investigation focused on whether GSK had failed to inform the agency in a timely manner of information it had on the safety of Seroxat in the under 18’s. The investigation, the largest of its kind in the UK, was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation, and included the scrutiny of over 1 million pages of evidence. The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that “there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

The punishment for Glaxo? A “Whose been a naughty boy?” type of letter sent to the then CEO of GSK, JP Garnier. Garnier later went on record to say that GSK had been cleared and that they had done nothing wrong [See audio recording left hand sidebar of this blog]

It’s also worthy to point out that the Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK, then SmithKline Beecham [SKB] – As is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has appeared on national TV defending Seroxat, he has also made his feelings known about Seroxat in various publications, one such being the New Statesman in 2005. Here’s what the Chairman of the MHRA [and ex- SmithKline Beecham employee] had to say about Seroxat:

“If you go back – and I read this out to the Health Select Committee to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

What Breckenridge ‘read out’ to the Health Select Committee is even more confusing:

“…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.

There was no mention of this on any patient information leaflet that accompanied Seroxat in 1990. There was no advice to ‘discontinue therapy gradually’ either.

Breckenridge further embarrassed himself and the MHRA with his performance on BBC TV’s Panorama [Taken on Trust BBC TV 2004] where he was reduced to a stuttering wreck by journalist, Shelley Jofre. [A condensed version of his performance can be seen HERE –

I don’t know why Breckenridge remains at the MHRA, it’s hard to decipher what he actually does. I can only assume that he won’t ever be allowed to appear in front of a TV camera anymore defending Seroxat, not after his display of arrogance back in 2004.

The MHRA’s Head of Licensing, Dr. Ian Hudson, is also a former employee of SmithKline Beecham [now GSK]. Hudson is no stranger to litigation, particularly where GlaxoSmithKline are concerned.

In the Tobin vs SmithKline Beecham trial in 2005, Hudson gave the following deposition

Hudson had previously worked for GlaxoSmithKline for 11 years where he held the position of Worldwide Director of Safety.

In a public Declaration of Interests document, Hudson openly admitted that he had a significant involvement with a number of drugs during his time at Glaxo [then SKB] – one of which was Seroxat.

Sarah Boseley, then health editor for The Guardian newspaper wrote in 2000, “Alarm as drug company chief joins watchdog.”

A top executive at one of the world’s leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.

Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.

Boseley also wrote in 2002, “Antidepressant Seroxat tops table of drug withdrawal symptoms.”

Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

Seroxat – known generically as paroxetine – leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the “yellow card” scheme set up for the reporting of medicines’ side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs – second after Seroxat comes Efexor (venlafaxine), with 272 complaints.

So, now, 6 years on from Alasdair Breckenridge’s embarrassing performance on BBC TV where he defended GlaxoSmithKline’s Seroxat and 5 years on from Head of Licensing for the MHRA, Dr. Ian Hudson, offering his services as a witness for GSK, we have yet another MHRA connection in Rashmi Shah.

This shower of regulatory authoritarians [MHRA] have sat with Seroxat advocates, myself included. They have nodded and empathised upon hearing personal stories of withdrawal. All the time, it appears, they knew there was a withdrawal problem with Seroxat but instead of tackling it head on, they decided, like GlaxoSmithKline, to ignore the warning signs from as early as 1993 [Current Problems in Pharmacovigilance] (1993; 19:1).

It’s staggering that they have the audacity to collect their wages each month from their bank accounts.

It’s astounding that they failed to prosecute GlaxoSmithKline after a four year investigation.

It’s appalling that they have not one but two ex-GSK employees working for them, one a Chairman who doesn’t really seem to do much, the other the Head of Licensing, one who grants licenses to the drugs you and I take.

It’s sickening that an ex MHRA employee, in Rashmi Shah, is now defending Seroxat by being a witness for GlaxoSmithKline in the UK Seroxat Group Action.

I cut off all communications with the MHRA last year after they failed to answer a simple question I put to them, Is Seroxat a teratogen?

It would appear that the MHRA have merely been offering token gestures to Seroxat advocates, all the time keeping a close eye on what their paymasters [GSK] might think of them discussing Seroxat with patients.

I’m not the first to pick up on the MHRA’s close ties with GlaxoSmithKline. In 2004, the Daily Mail, a UK tabloid, ran with the headline, “Agency blamed for promoting Seroxat.”

The mental health charity, Mind, said the MHRA were playing Russian Roulette with people’s lives over the common antidepressant drug Seroxat.

Mind chief executive Richard Brook said the MHRA had not listened to the experiences of people who had taken Seroxat.

“Many of these people have suffered terrible side effects when taking or trying to come off the drug and some people, it is believed, have died,” he said.

There is a terrible stench throughout the MHRA Headquarters, it reeks of back slapping and complete and utter disdain for the patient, particularly those who have ever had to experience the horrific side-effects of Seroxat.

The MHRA are not just in bed with GlaxoSmithKline – they are copulating with them.

I am not totally sure but it’s my belief that the expert witness owes a duty to the court to give independent and unbiased evidence, and must avoid assuming the role of advocate for his client.

Rashmi Shah worked for the MCA/MHRA for 17 years. Shah was an employee of the MCA/MHRA when they first granted a licence for GlaxoSmithKline’s Seroxat. He was also employed by them during the time when they received many adverse reaction reports about Seroxat.

I, for one, shall be looking forward to Rashmi Shah’s unbiased evidence when, or if, this group action lands in the High Court later this year.

Coming up in Part III – How another of GSK’s witnesses once called for the FDA to lift its black box warning on antidepressants.

Other stories of interest:

Antidepressant Seroxat tops table of drug withdrawal symptoms

Glaxo ‘played down Seroxat side effects’

Agency blamed for promoting Seroxat

Antidepressant addiction warning

Alarm as drug company chief joins watchdog


Drug firm issues addiction warning

Keep Seroxat dose low, doctors told

Why I resigned over ‘happy pill’ cover-up