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


Unbelieveable: GSK Sales Reps In China Want To Be Reimbursed For Bribes!

From Bob Fiddaman’s blog:

Thursday, May 29, 2014

GSK’s Sales Reps Want Their Money Back

Where’s John Grisham when you need him?

Seriously, you really couldn’t make this shit up.

The Financial Times are running with a story that’s as jaw-dropping as anything I’ve read thus far regarding the bribery scandal in China. I had to do a double-take, had I fallen asleep last night and somehow travelled back in time to April 1st? There were no skid marks from DeLorean tyres in my bedroom and my computer told me it was 29/05/2014.

“GSK salesmen want ‘bribes’ reimbursed” is the headline, what follows is pure Grishamism.

GlaxoSmithKline, the UK pharmaceutical company at the centre of a Chinese corruption scandal, is facing protests from junior employees who say the company is refusing to reimburse them for bribes they were ordered to pay by their superiors.

Now some Chinese sales staff are complaining that GSK has denied bonuses, threatened dismissal or refused to reimburse them for bribes they say were sanctioned by their superiors to boost the company’s drug sales. In some cases, managers instructed them to purchase fake receipts that were used to cover up bribes paid in cash or gifts to doctors and hospitals, according to salesmen interviewed by the Financial Times.

In some instances, managers disguised their involvement by using their personal email address to instruct staff to pay bribes and by ordering junior staff to claim on their personal expense accounts – even if the bribe was actually paid out by the manager – according to these people.

In late March, disgruntled staff sent 25 representatives to GSK’s headquarters in Shanghai, where they unfurled a banner that read: “Return my hard-earned money.”

Cor blimey governor, can you Adam and Eve it!

So, let’s get this straight.

Glaxo’s reps paid bribes out of their own pockets that were later to be reimbursed by the company…and now they are telling Glaxo that they want reimbursing?

Here’s the Financial Times again…

“The expenses were paid with our own money, and although the receipts were not compliant, it was our managers who told us to buy the fake receipts,” said one former GSK salesman.

The FT article goes on to explain that some sales reps were warned not to implicate senior staff, in many instances, according to the FT,  management “approached each person [rep] before they were questioned and asked them not to mention his name. He even prepared a story for them to tell the investigator.”

Glaxo have denied that this is a systematic problem throughout their global operation – they’ve even denied it after other allegations of bribery have surfaced in other countries, namely Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and now the UK. [back story]

We hear the same old line from GSK when they have been caught by investigating officials, citing that they will “cooperate fully with investigators”.

I thought long and hard about this line. It’s pure psychology. By stating that they will cooperate fully with investigators eases the guilt and, at the same time, paints a picture that Glaxo were unaware what was going on. In essence, “We will cooperate fully with investigators”, actually means we’ve been caught red-handed and will answer any of your questions. We will not offer you any specific evidence unless you ask for it specifically. Glaxo do the same when faced with litigation too.

I find it laughable that reps who knowingly broke rules with their own money now want reimbursing. It’s akin to the Yorkshire Ripper billing the tool shop where he purchased his hammer from. Apologies for using such a heinous crime as an analogy – I’m referring to the Yorkshire Ripper and not Glaxo’s bribery.

It’s been alleged that female sales reps were told to offer sexual favours to doctors in efforts to get them to prescribe more of GSK’s drugs. [back story]

Are we to assume then that these female reps will be asking for reimbursement of the contraceptives and/or mouthwash they purchased?

The UK’s Serious Fraud Office recently announced that they are investigating GSK. It’s highly likely that they will just focus on GSK’s illegal activities overseas and won’t even bother to look to see if GSK reps have been doing the same here in the UK.

The FT article can be read here. You may have to subscribe to read all the content.

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’s New Year Message To GSK CEO – Andrew Witty

(In true Fiddaman style!)

Happy New Year Folks!..

Here’s to another year of keeping a critical and watchful eye on those sneaky folks at GSK..

Keep on keepin on Mr Fiddaman! 🙂

Dear Mr Witty,

Seeing as your American lawyers King & Spalding have been keeping tabs on me over the past few weeks I feel it’s a great opportunity to ask you if you would like to donate a couple of bottles of the finest champagne to a worthy cause?

As you are probably aware my blog has been running for some considerable time now and I am fast approaching 1 million views. I’d love to celebrate that millionth hit with a couple of bottles of champagne. I’ll toast your [ahem] good name and those of past employees of Glaxo.

You may think I’m being greedy asking for two bottles but there’s a reason I am requesting a set. You see, one is for me and me alone. I think I deserve it after highlighting stories of GSK, stories that the mainstream have avoided like the plague. You should be thanking me for bringing these stories to your attention Andy baby.

The other bottle will be for more sombre purposes. I wish to toast the dead kids killed by Seroxat. I wish to toast the dead fetuses mothers were forced to abort because Seroxat caused severe birth defects. I wish to toast all those who suffered severe withdrawal at the hands of Seroxat. I also wish to toast those who are still hooked on Seroxat because they have become addicted to it.

Hmmm, I’m thinking two bottles won’t even scratch the surface. Maybe a crate will suffice?

I’m not much of a connoisseur when it comes to champagne, I’m more of a beer person, but this is a special occasion, don’t you think Andy?

One million hits, that’s one million people who have read the work of a nobody. The guy who was wasting his time because GSK will just ignore him and he will, like so many others, just disappear.

I’m still here Andy. 

I may just be a flea on a giant sewer rat but I’m betting that I have become annoying hey? How’s that itch on the rat, has it spread to a rash yet?

Your American attorneys will no doubt tell you that I’m sitting on something pretty powerful, something that will question your recent comments regarding Glaxo’s past behaviour. “All part of an era”, I think you were quoted as saying?

Well, sadly, it’s not all part of an era. The concealment is very much alive today, just ask King & Spalding.

Hey, you ever thought about meeting with Seroxat victims, you know, the parents who lost their kids because they killed themselves whilst on your drug. How about the mother’s who gave birth to babies who had birth defects or those who had to abort because the Seroxat had caused so much damage that the chances of survival for the children they were carrying were slim to zero.

So, just a simple request. A crate of your finest.

Oh, don’t get popping those corks and replacing them either.

Here’s to a million more.

Yours sincerely

Bob Fiddaman


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