Saturday, November 21, 2015
Earlier this year I reported on how GSK, via their team of highly-paid lawyers, had targeted four expert witnesses that were due to give evidence in (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)
For those that don't know, Wendy Dolin had filed suit against GSK claiming that their antidepressant, Paxil, had induced the suicide of her husband, Stewart. Since filing, Wendy has, just like the four expert witnesses due to give expert opinion supporting her claim, has come under fire from GSK. In fact, Wendy Dolin has been sent more than 30 subpoenas from GSK, they have also made over 70 record requests and have shown the Dolin children their father's private medical notes. To top it all, GSK's lawyers have been asking (goading) Wendy about her love life since her husband killed himself.
Not satisfied with targeting a bereaved wife, GSK then turned their attention to four expert witnesses. One of those witnesses, Dr. David Healy, came under heavy fire from Glaxo's gunslingers, King & Spalding. They had accused Healy of being a radical activist who held an extreme bias against GSK (insert tears here). Furthermore, GSK had probed into Healy's private life and had, during a 10 hour deposition, talked more about his finances than the actual science behind Paxil and induced suicide.
The decision is in folks and.... (drum roll)..
GSK have been roundly trounced.
Judge James B. Zagel, in summary, said...
"I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable. My decision does not, however, mean that the reliable opinions of all four of these expert witnesses are correct—reliability is a measure of consistency of opinions, not necessarily a measure of correctness. Such a determination will be the job of a fact-finder at trial."
Healy, along with three other experts, namely; Dr. David Ross, Dr. Joseph Glenmullen, and Dr. Roger Grimson, will now be allowed to offer their expert opinions in the Dolin case, something that GSK have fought desperately hard to suppress and, as I suspect, may now be the factor in some sort of settlement being agreed upon.
This isn't the first time GSK have faced claims that Paxil induces suicides in adults. In 2001 a jury returned a verdict that Paxil was responsible for inducing homicide and suicide in Don Schell, who had, some years previous, shot to death his wife, daughter and granddaughter before turning the gun on himself.
Glaxo were ordered to pay $6.4 million to the remaining family members.To the layman, it beggars belief why Glaxo would oppose the claims of Wendy Dolin given that they have already lost one Paxil induced suicide case. The mud-slinging and goading of plaintiff and expert witnesses doesn't surprise me in the least, it's what I have come to expect of Glaxo and their defence lawyers. Wendy Dolin isn't the first plaintiff to have pressure put on her by Glaxo, she won't be the last. Healy et al aren't the first expert witnesses to have mud thrown at them, again, they won't be the last.
If anything, this ruling has shown Glaxo that no matter how hard they try to suppress those who wish to seek the truth, they will always fail.
I hope the Dolin case goes the whole hog and isn't settled. To put Paxil in the public eye (yet again) is something that needs to be done. The message that this antidepressant can cause homicidal and suicidal acts needs to be repeated. It is, in my opinion, a menace to society just as, I believe, GlaxoSmithKline are. Yeh, okay, we will have those that say Glaxo have saved millions of lives with vaccines and have helped millions of people with various respiratory diseases, fair enough, I guess, but that does not give them the right to market and manufacture drugs that can induce homicide and suicide - it's akin to the defence of a serial killer, 'He donated to charities every week your honour, so what if he killed a dozen or so adults, he's a decent man, at heart."
Glaxo need to step up to the plate. They need to compensate Wendy Dolin for her loss, they need to stop pussy-footing around and acknowledge that defending Paxil in suicide cases is a fruitless exercise, they know it, their shareholders know it and the general public know it. Paxil is a nasty drug that causes more harm than good. Glaxo claim Paxil has helped millions of people worldwide but just like the fictitious serial killer above, they throw a blanket over the darker side of Paxil, the induced homicide and suicide, the birth defects, the horrific withdrawal suffered by those trying to stop Paxil.
It will be interesting to see what Glaxo's next step is regarding the Dolin case. They've thrown pretty much everything at the grieving widow but she has stood firm and remained strong because she knows that the truth will, eventually, out.
Thursday, November 19, 2015
A recent interview with Glaxo's Andrew Witty saw BBC journalist, Evan Davis, more or less told how to phrase questions. Davis had broached the subject of Glaxo's murky past - Witty, using the art of deflection, told Davis, "I think the bigger question is, where do you want to go forward?"
So, how do you polish a turd?
Well, you talk about what you have in the pipeline, (excuse the pun) thus eliminating tricky questions about the following...
6/4/2015 - India Meningitis Vaccine Market Collusion - GlaxoSmithKline, Sanofi-Aventis - $9,442,587
9/15/2014 - Clean Air Act Violation at Hamilton, MT Facility - GlaxoSmithKline - $172,900
8/11/2014 - Hazardous Waste Violations in King of Prussia - GlaxoSmithKline - $317,550
6/4/2014 - Multistate Illegal Marketing Settlement - GlaxoSmithKline - $105,000,000
5/13/2014 - China Bribery and Fraud - GlaxoSmithKline - $487,000,000
3/25/2014 - Mylan v. GlaxoSmithKline (Breach of Generic Paxil Agreements) - GlaxoSmithKline - $106,700,000
3/18/2014 - Contaminated Drug Ingredients at Ireland Plant - GlaxoSmithKline - FDA Warning Letter
12/17/2013 - Maryland Diabetes Drug Improper Marketing Lawsuit - GlaxoSmithKline - $15,000,000
7/24/2013 - Multistate Avandia Settlement (July 2013) - GlaxoSmithKline - $184,000,000
6/14/2013 - Cappellino v. GlaxoSmithKline (Gender Discrimination) - GlaxoSmithKline - Complaint
4/19/2013 - OFT Paroxetine Antitrust Investigation - GlaxoSmithKline - U.K. Office of Fair Trading Press Release
2/5/2013 - Louisiana Off-Label Marketing Lawsuit - GlaxoSmithKline - $45,000,000
11/15/2012 - Multistate Avandia Settlement (November 2012) - GlaxoSmithKline - $90,000,000
11/15/2012 - Flonase Antitrust Litigation - GlaxoSmithKline - $150,000,000
7/9/2012 - Dolin v. GlaxoSmithKline (Paxil Wrongful Death) - GlaxoSmithKline - Complaint
4/17/2012 - Idaho Average Wholesale Price Lawsuit - GlaxoSmithKline - $2,600,000
2/7/2012 - Defrauding Louisiana’s Medicaid Program - GlaxoSmithKline - $10,000,000
1/11/2012 - Argentina Vaccine Trials Fine - GlaxoSmithKline - $93,000
11/3/2011 - Criminal and Civil Investigations Settlement - GlaxoSmithKline - $3,000,000,000
10/27/2011 - South Korea Antitrust Fine - GlaxoSmithKline - $2,651,737
10/7/2011 - Current Good Manufacturing Practice Violations at Worthing, UK Facility - GlaxoSmithKline - FDA Warning Letter
6/27/2011 - Nigeria Trademark Infringement - GlaxoSmithKline - $7,873,706
6/23/2011 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $40,750,000
5/17/2011 - South Carolina Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint
2/15/2011 - Louisiana Attorney General Avandia Lawsuit - GlaxoSmithKline - Complaint
11/17/2010 - Humana v. GlaxoSmithKline (Reimbursement for Avandia-Related Injuries) - GlaxoSmithKline - Complaint
11/9/2010 - Utah Attorney General Avandia Lawsuit - GlaxoSmithKline - $8,500,000
10/26/2010 - Puerto Rico Drug Manufacturing Facility Settlement - GlaxoSmithKline - $750,000,000
10/6/2010 - Hawaii Average Wholesale Price Litigation - GlaxoSmithKline - $10,000,000
8/30/2010 - Kentucky Kytril and Zofran Average Wholesale Price Lawsuit - GlaxoSmithKline - $3,750,000
7/12/2010 - U.S. Senate Investigation of Avandia - GlaxoSmithKline - Senate Finance Committee Letter to FDA
6/23/2010 - Paxil Birth Defect Litigation - GlaxoSmithKline - Confidential settlement with 190 families
4/19/2010 - FDA Review of Altabax Promotional Material - GlaxoSmithKline - FDA Warning Letter
10/13/2009 - Kilker v. SmithKline Beecham (Paxil Birth Defects) - GlaxoSmithKline - $2,500,000
10/1/2009 - Denture Cream Product Liability Litigation - GlaxoSmithKline - Complaint
12/23/2008 - Santa Clara County Drug Pricing Lawsuit - GlaxoSmithKline, Wyeth - Complaint
9/30/2008 - Paxil Class Action (National) - GlaxoSmithKline - $40,000,000
7/26/2008 - Medicines Australia Code of Conduct Violations - GlaxoSmithKline - $310,000
7/21/2008 - Relenza Litigation Settlement - GlaxoSmithKline - $19,500,000
5/19/2008 - Release of TCE in Scottsdale, AZ - GlaxoSmithKline - EPA Press Release
5/2/2008 - Wellbutrin Direct Purchaser Antitrust Litigation - GlaxoSmithKline - $49,500,000
2/27/2008 - Bartram v. GlaxoSmithKline (Paxil Birth Defects) - GlaxoSmithKline - Complaint
12/17/2007 - Avandia Marketing, Sales Practices and Products Liability Litigation - GlaxoSmithKline - $770,000,000
10/6/2006 - Paxil Class Action Litigation (Madison County, IL) GlaxoSmithKline - $63,833,148
9/11/2006 - Under-reporting Profits - GlaxoSmithKline - $3,400,000,000
7/10/2006 - Cunningham v. GSK (Paxil Wrongful Death) - GlaxoSmithKline - Complaint
3/28/2006 - Paxil Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $14,000,000
9/20/2005 - Zofran and Kytril False Claims Act Violations - GlaxoSmithKline - $150,000,000
4/1/2005 - Relafen Multistate Litigation - NY Attorney General Settlement - GlaxoSmithKline - $10,000,000
11/24/2004 - Relafen Consumer Litigation - GlaxoSmithKline - $75,000,000
8/26/2004 - Paxil New York Litigation - GlaxoSmithKline - $2,500,000
7/8/2004 - Augmentin Antitrust Litigation - GlaxoSmithKline - $92,000,000
2/6/2004 - Relafen Antitrust Litigation - GlaxoSmithKline - $175,000,000
4/16/2003 - Overcharging Medicaid - GlaxoSmithKline - $87,600,000
9/6/2002 - Average Wholesale Price (AWP) Drug Litigation - GlaxoSmithKline - $70,000,000
6/6/2001 - Tobin v. SmithKline Beecham (Paxil Wrongful Death) - GlaxoSmithKline - $6,400,000
**TOTAL - $10,057,614,485 (That's 10 billion, folks!)
**Federal Contractor Misconduct Database
There are many more missing from the Federal Contractor Misconduct Database, most notably the settlement (resolution) GSK made with over 3,000 Paxil plaintiffs who alleged the drug had caused them addiction problems, Also missing is the individual payment made to Pennsylvania mother Joanne Thomas who settled with GSK after losing her original case against them, see here and here.
The UK Seroxat Group Action is also missing from the list. The claim alleges that UK consumers become dependent upon the antidepressant, Seroxat. (Paxil)
Then, of course, we have the on-gong investigations of bribery and corruption in the following countries, United Kingdom, Iraq, Poland, Bahrain, Jordan, Kuwait, Lebanon, Syria, Oman, Qatar, and United Arab Emirates.
The mission of GSK, according to their website, is to improve the quality of human life by enabling people to do more, feel better and live longer.
(Insert laughter here)
Tuesday, November 17, 2015
Back in September I wrote to the British drug regulator, the MHRA, under the terms of the Freedom of information act.
The question I put to them was in regard to reported suicides associated with Lariam (mefloquine) reported on their database. Their Drug Analysis Print (DAP) had shown that there were 9 completed suicides associated with the drug.
For those that don't know, Lariam, marketed and manufactured by Roche, is a drug used to treat the prevention of malaria and I wrote about it here back in August. It's used a lot by the military to treat soldiers who visit and train in countries that have a high risk of malaria.
Worryingly, it wasn't just the completed suicides that concerned me. There were a number of other psychiatric events associated with this drug, namely;
- 18 reports of Abnormal behaviour.
- 24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
- 61 reports of Agitation
- 304 reports of Anxiety
- 38 reports of Aggression
- 82 reports of Paranoia
- 11 reports of Personality change
- 67 reports of Confusional state
- 61 reports of Disorientation
- 19 reports of Delusion
- 341 reports of Depression
- 10 reports of Depersonalisation
- 14 reports of Dissociation
- 28 reports of Irritability
- 59 reports of Mood swings
- 15 reports of Mental disorder
- 11 reports of Mania
- 162 reports of Panic attack
- 119 reports of Abnormal dreams
- 146 reports of Nightmares
- 113 reports of Hallucinations
- 19 reports of Acute psychosis*
- 76 reports of Psychotic disorder
- 9 reports of Completed suicide
- 33 reports of Suicidal ideation
- 12 reports of Thinking abnormal
* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" category - unless, of course, the person died naturally?
The MHRA took approx one month to answer my question. Their full response is below.
They told me...
"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."
Hopefully, this somewhat blasé response from the MHRA will help those campaigning, or, as I strongly suggest, get those campaigning to write to the MHRA to ask them why the follow-up rate has been so poor regarding the reported suicides and other psychiatric adverse events associated with this drug.
The MHRA can be contacted via email here.
Thursday, November 12, 2015
It's kind of set in stone these days that Seroxat, the antidepressant manufactured and marketed by British pharmaceutical giant, GlaxoSmithKline, is a faulty product. It's been through the American court system in various types of litigation.
1. Suicide - GUILTY - APPEALED - SETTLED - Compensation paid
2. Birth Defects - GUILTY - APPEALED - SETTLED - Compensation paid
3. Withdrawal problems - RESOLVED - Victims compensated
To date, GlaxoSmithKline have not settled any cases that relate to Seroxat use and suicide, birth defects and withdrawal problems in the UK.
They are a British company yet, it appears, will only settle with American consumers of Seroxat (Known as Paxil in the US)
To go up against a pharmaceutical company in the UK is notoriously difficult. Many law firms prefer not to touch cases against pharmaceutical companies because they can drag on for many years, the risk is too high, they can either 'make' or 'break' the claimant's legal representation.
The UK Seroxat litigation is fast approaching 10 years since it was first filed. Glaxo, represented by Addleshaw Goddard, have not, at any point, expressed an interest in resolving the litigation. They, it appears, wish for the cases, involving just over one hundred claims, to go to trial... at least they do at this point in the proceedings.
The litigation has been laboriously slow - claimants have been dropped by law firms, despite those law firms attesting that their cases against GSK were strong. Public funding has been given, then put on hold, then taken away.
In America, the Seroxat withdrawal problems lawsuit involved over 3,000 claims against GSK. The whole process of filing and agreeing to resolve took as little as two years. Each of the 3,000 were awarded compensation. Each of the 3,000 had to sign confidentiality agreements - ergo, they could not tell anyone how much they were awarded by GSK.
Meantime, UK consumers who suffered Seroxat withdrawal problems, some who still do, continue to wait for their cases to be heard in trial. The date of which has yet to be determined.
Almost 10 years.
It's a showing of the iron fist by GlaxoSmithKline and it sends out a strong message to consumers of pharmaceutical products. That message being, "We won't bend over for British consumers, even though we are a British company."
Glaxo are denying that they knew there was a withdrawal problem with Seroxat, this despite settling the 3,000 or so case in America. This, despite public documents that have shown that hey did indeed know about the withdrawal problem in adults but 'hushed up' these findings.
Project 1059 revealed a series of emails between Daniel Burnham of SmithKline Beecham and a ghostwriting company. In those emails, below, the Seroxat withdrawal issue was raised. Burnham became concerned and decided to pull the plug on Project 1059. There was no way that they could have this Seroxat withdrawal issue made public.
You can view the series of emails here.
Meantime, Glaxo CEO, Andrew Witty, continues to cover his company in garlands, he continues to refuse to meet with anyone who has suffered as a result if ingesting Seroxat. Irish blogger, the Truthman, who, like me, has been writing about GSK for almost a decade, perfectly dissects a recent interview between journalist Evan Davis and Glaxo's Witty here.
It's well worth the read, an edited version of the interview between Evans and Witty is also shared on the Truthman's post.
Glaxo, in my opinion, are psychopathic, it's hard to pinpoint who is the person behind the dodgy marketing and hiding of negative results, so, as a whole, Glaxo, to me at least are not only psychopathic but delusional too.
As for Witty, once again my opinion of him, is that he lacks compassion and empathy for those harmed by his company. He continues to harp on about how Glaxo (these days) are more transparent than any other pharmaceutical company. He fails to mention that they were forced to be more transparent by the recent $3 billion they paid the American Department of Justice for, amongst other things, a lack of transparency in sharing negative trial results.
Who knows if the UK litigation will ever see the light of day. I would love nothing more than a judge who sees through Glaxo's arguments and allows documents produced at trial to be made public and not sealed away.
The criticism of GlaxoSmithKline is warranted. As long as they continue to treat their consumers like lab rats then they will always fall under the spotlight.
We, as humans, have a desire to see more when something teasing is revealed, be that a woman in a sexy low-cut dress or a pharmaceutical company not disposing of emails that highlight how they ignored links of severe Seroxat withdrawal.
Glaxo are not sexy, in fact, the more that they reveal, the more sickened I become.
I'll eventually walk away from this blog, a change of direction and finding peace is, I feel, what I've earned over these past ten years or so. Until I feel that time is right I'll continue to cross swords with GSK - I guess that the Truthman will too.
Perfer et obdura; dolor hic tibi proderit olim. (Google it)
Tuesday, November 10, 2015
If you still believe that pharmaceutical companies have opened their doors and are being transparent then look no further than a recent report from the lawyer-based website, Law360.
Law360 are reporting on a recent investigation into Pfizer by the U.S. Food and Drug Administration (FDA)
Let me tell you folks, it's straight from the production team of Hanna Barbera. It's definitely a case for Scooby-Doo, Fred "Freddie" Jones, Daphne Blake, Velma Dinkley and Norville "Shaggy" Rogers.
It appears the FDA are being given the runaround by Pfizer officials who, it seems, are covering up manufacturing lapses at one of their sites in China.
According to the FDA, when Pfizer encountered "undesirable/suspect" test results, it simply performed new tests until satisfactory results were achieved.
"The original test results are not reported, and no laboratory investigation is initiated," the FDA wrote.
Agency officials also recounted fishy circumstances surrounding the availability of records. According to the report, investigators at one point noticed an 8-inch stack of documents in a room, then returned 10 minutes later to find that the stack had disappeared. When the investigators requested that the records be returned, only one-third of the papers were brought back, and the rest were later discovered stashed in a wooden crate in a construction area, the report said.
Subsequent analysis of those records revealed that Pfizer's internal documents contained conflicting data as well as references to possible use of expired ingredients, the 483 added.
Further, Pfizer's quality control unit lacked suitable oversight of records, and employees on occasion failed to document certain activities in a timely manner, according to the 483.
Never has the term "LOL" been more appropriate.
An 8-inch stack of documents that miraculously disappears into thin air, only to return somewhere else on the Chinese site... with two thirds of the stack missing! The likes of Dynamo, David Copperfield, Penn & Teller and even Paul Daniels must be quaking in their magical boots.
Scooby Dooby Doo, Where are you?
We've got some work to do now.
Scooby Dooby Doo, Where are you?
We need some help from you now.
Pfizer have responded in typical fashion...
"Materials and that drugs produced at the site met every national and international testing specification."
Thanks for clearing that up folks.
In other news, I recently bid on eBay for the complete series of Scooby Doo. I came so close to winning, but was outbid at the last second! I would have got away with it too, if it weren't for those meddling bids!
The FDA's 9-page warning letter to Pfizer below.
PS - I'd still do Daphne.