Generic Paxil Suicide Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, February 09, 2018

Masterfully Harming Kids for Profit







eu·phe·mism (noun)
1. the substitution of a mild, indirect, or vague expression for one thought to be offensive, harsh, or blunt.

"Part of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing." -- Guess Who?

If you think the above quote is from a sleazy character in the hit TV series Mad Men, you'd be partly right. It is indeed uttered by a sleazy character, but in this case, it's a real person, a mad woman named Amy Rubin. When you learn what Rubin did, you'll understand why this woman can't accurately be called a lady.

As a Regulatory Affairs Manager for Forest Pharmaceuticals, Rubin proudly used her marketing skills to help pull the wool over the FDA's eyes regarding Forest's dangerous, ineffective drug, Celexa, which carries the generic name of citalopram. Rubin made her self-aggrandizing declaration in a memo sent to Dr. Charles Flicker, Senior Medical Director of Forest Laboratories as the two concocted ways to stretch the truth so that more doctors would prescribe Celexa for children and adolescents.

Spin Doctors At Work

Forest Pharmaceuticals conducted the MD-18 study involving Celexa, an SSRI now owned by Allergen. MD-18 was supposed to be a double-blind, placebo-controlled clinical trial of pediatrics. According to unsealed documents and testimony, MD-18 was only able to achieve a positive result by including nine patients in the study that were, as Forest’s medical director stated, “automatically unblinded” due to a supposed dispensing error. (Blinded means that a study's investigators are not supposed to know who consumed the product and who consumed the placebo.) The MD-18 investigators did know who was consuming Celexa and who was consuming placebo. And Forest Pharmaceutical execs knew this, too. The MD-18 study was flawed and biased.

The company then whitewashed the data in a draft letter to the FDA stating that incorrectly dispensed pills could have “potentially unblinded the study,” - After the draft was passed around Forest Labs they decided to rephrase the term and acknowledged that the wrongly dispensed pills could have the  “potential to cause bias.” By omitting the word 'unblinded' Forest was deliberately trying to hoodwink the FDA and create the false impression of positive results.

Forest then actively promoted the MD-18 study to encourage doctors to prescribe Celexa for children. The company later used the flawed MD-18 study to gain FDA approval for its other SSRI, Lexapro (escitalopram) and promoted it for adolescents. The result: Forest made money peddling snake oil to doctors knowing that unsuspecting parents would likely later make funeral plans for their children.

Last month Los Angles law firm, Baum, Hedlund, Aristei & Goldman, wrote a letter to Greg Shapiro, Chief of the Affirmative Civil Enforcement Unit, regarding a series of agreements that Forest made in 2010 with the United States Attorney’s Office for the District of Massachusetts. (USAO). Baum Hedlund points out that the 2010 settlement agreement missed some crucial evidence.

Baum Hedlund states:

"Over the past several years, our litigation has revealed that the scope and extent of Forest’s fraud was not honestly disclosed to the USAO (or, to the Food and Drug Administration) and that Forest misrepresented material facts underlying the USAO’s prosecution.  Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection, and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the USAO will consider reopening its investigation."

The unsealed correspondence between Rubin and Flicker shows how pharmaceutical companies intentionally and routinely put the public--including children and teens--at great risk of harm and death from their products.

Wreckless Endangerment of Children


I tried to find a photo of Amy Rubin to show you what an evil spin doctor looks like, but it seems Rubin is camera shy. For her role in creating a medical holocaust that harms and/or kills thousands of innocent children, I've chosen a makhsheyfe or Baba Yaga photo to represent Rubin. If today Rubin is a mother, I imagine the reckless endangerment she helped unleash in neighborhoods across the globe isn't something she'd want to do to her children or grandchildren. But harming children is merely business as usual for Amy Rubin and her pharma colleagues.

So, as Forest's Rubin once wrote that it was part of her job to "create ‘masterful’ euphemisms to protect Medical and Marketing", it's part of my job to protect children and adolescents.

I hope Amy Joyce Rubin, age 64, has no contact with the innocent children in her Paterson, New Jersey neighborhood.

There are many appropriate adjectives we could use to describe Rubin, most of which are four-letter words. I'll leave it to you to fill in the blanks.

Bob Fiddaman

Baum Hedlund's letter to the Chief of the Affirmative Civil Enforcement Unit can be read here.




Tuesday, February 06, 2018

BBC Newsround: Antidepressants





BBC flagship programme, 'Newsround', a children's news show, are looking to hear from families in the UK whose children (17 or under) have had good or bad experiences on antidepressants.

I'm promoting this as I feel education regarding these drugs really should start at a grassroots level, namely, our children.

Here's what lead researcher Oliver Newlan wrote me.


BBC Newsround are interested in speaking to any families of children currently aged 17 or under who have had good or bad experiences of being prescribed antidepressants.
If there are any experiences you feel you would like to share please could you email oliver.newlan@bbc.co.uk by Thursday 8th February 5pm.
We will deal with your experiences sensitively and will not make anything public without your explicit consent.

Bob Fiddaman 

Sunday, January 28, 2018

Generic Paxil Lawsuits Filed




Canadian pharmaceutical company, Apotex, have been delivered a hammer-blow regarding the manufacturing and labeling of generic Paxil, an antidepressant known by its generic name of paroxetine.

Paxil is the brand name of paroxetine and has various different brand names all over the world, in the UK, for example, it's known as Seroxat.

The hammer-blow comes on the back of Baum Hedlund & Rapoport Law Offices glorious victory over Paxil manufacturers, GlaxoSmithKline (GSK) last year. GSK, who denied that it was their responsibility to advise generic makers that Paxil increased the risk of suicide to adults beyond the age of 24, lost in a landmark case in Chicago...and have been crying about it ever since. More on GSK throwing their toys out of the pram further on down this post.

Because of the victory against GSK, Baum Hedlund have now wrote a letter to Apotex, the content of which is pleasing to the eye for a drug safety advocate such as myself.

Baum Hedlund’s letter to Apotex:

Dr. Jeremy Desai
Mr. Bernard Sherman
Mr. Jack M. Kay
Apotex, Inc. 150 Signet Dr., North York,
ON M9L 1T9, Canada
Re: Paxil and Suicide
Dear Messrs. Desai, Sherman, and Kay:
I am writing to Apotex as the exclusive holder of the New Drug Application for Paxil. As of January 2014, Apotex became exclusively responsible for the content and accuracy of the Paxil and paroxetine label, charged with ensuring the label remains up-to-date and adequate at all times.
This letter officially places you on notice that the label for Paxil does not adequately warn about the risks of adult suicidal behavior and that it needs to be corrected. It is my hope that Apotex will take swift action to protect the health and safety of patients taking Paxil/paroxetine.
On April 20, 2017, a federal jury entered a verdict against GlaxoSmithKline, Inc. (“GSK”), and in favor of a widow of a Chicago man who killed himself six days after starting a generic version of Paxil. As part of that verdict, the jury concluded that the Paxil label, as it has existed since 2007, is inadequate because it fails to properly warn about the risks of adult suicidal behavior causally related to ingestion of Paxil/paroxetine. Specifically, the paroxetine label did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults with Major Depressive Disorder (“MDD”) of all ages and the FDA’s 2006 analysis of a statistically significant 2.7 times greater risk in adult patients across all indications. Indeed, since 2007, the Paxil label has not only failed to warn about this increased risk, it has stated the opposite—that the suicidality risk did not extend beyond the age of 24. This verdict was rendered after more than five weeks of testimony and evidence that focused on the extensive clinical, scientific and medical evidence pertaining to paroxetine.
The Dolin trial transcripts can be viewed here: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/gsk-paxil-trial-transcripts/
The Dolin trial exhibits can be viewed here: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/paxil-trial-exhibits/
Please review these transcripts and documents. They reveal a serious problem, one that Apotex is in a unique position to remedy.
This is your opportunity to do the right thing and remedy the deficiencies in the Paxil label. Failure to take action would mean your company is deliberately refusing to correct a known and quantifiable risk. Any suicides or attempted suicides that could have been prevented by a label change are now on you. We urge Apotex to take swift action to protect the public health.
Best,
BAUM HEDLUND ARISTEI & GOLDMAN, P.C.
Brent Wisner
Michael L. Baum
Pedram Esfandiary

Further to the letter sent to Apotex, Baum Hedlund are now looking for consumers who have attempted suicide whilst taking Apotex generic Paxil. Moreover, consumers relatives whose loved ones completed suicide whilst taking the Apotex version of Paxil.


If you would like to speak with a Paxil lawyer about filing a claim, please contact Baum Hedlund by filling out the form here, or calling them toll free at 1-800-827-0087.

As mentioned (above) GSK have been crying like big babies since the verdict against them was returned last year. They, via their poor performing attorneys, King & Spalding, have since asked for a retrial and been denied, they then, remarkably, rejected the decision of the Judge not to grant them a new trial (boo hoo)

Now, it appears, GSK who have blamed everyone but themselves for the untimely Paxil-induced suicide of Stewart Dolin, are now preparing to take their greivances to the United States Court of Appeals for the Seventh Circuit.

This, to me at least, smacks of obstinance on GSK's part and, it has to be said, on the part of their defence team of King & Spalding, whose lead attorney, Andrew Bayman, recently cited his firm's failure in Dolin Vs GSK as an "accomplishment."

King & Spalding's mediocre performance in Chicago last year was an eye-opener for me, this, of course, should not distract the brilliant teamwork of  Baum Hedlund & Rapoport Law Offices who revealed several telling documents during trial, one of which showed that an internal analysis, carried out by GSK in 2006, showed that patients taking Paxil were nearly seven times more likely to attempt suicide than those on placebo.

The Dolin v. GSK Paxil Trial Exhibits can be viewed here.

The Dolin Vs GSK Paxil Trial Court Transcripts can be viewed here.

Bob Fiddaman






Monday, January 08, 2018

Who's Hiding the Clinical Trial Benefits of Antidepressants?


First off, ponder this.

If an opponent in a pool game told you that if you use the 8 ball as the cue ball you will not foul, would you believe them? What about if they kept on insisting this claim to be true? Or would you ask questions to someone else to ascertain if the claims of your opponent were true?

Read on.

Over the past month or so I've been blocked on Twitter by three well-known psychiatrists.

Wendy Burn, a consultant psychiatrist at Leeds and York Partnership NHS Foundation Trust and president-elect of the Royal College of Psychiatrists.

Allen Frances, who was the chair of the DSM-IV Task Force and of the department of psychiatry at Duke University School of Medicine, Durham, NC. He is currently a professor emeritus at Duke.

Peter Kramer, Clinical Professor Emeritus of Psychiatry and Human Behavior. Kramer is also the author of numerous books, many of which he likes to promote on Twitter.

So, why have these three well-known, and some would say, intelligent orators, blocked me?

Well, it would appear that rather than answer a simple question I put to them, they decided to put their fingers in their ears and bury their heads in the sand. It's a question that should be answered and one that, to date, has not been adequately answered by anyone from the medical profession, the pharmaceutical industry or any global regulatory agency. It's a question the media never seem to ask either. It's a question I've put to the Royal College of Psychiatrists on many occasions too, they have just chosen to ignore me.

Wendy Burn, who regularly accepts adoration on Twitter yet fails to answer bereaved parents, was first.

My current view of her online profile looks like this.


Next up was Allen Frances, a man who changes his opinion like the wind, depending on whom he wishes to appease.

My current view of his online profile looks like this.


Finally, after attempting to answer my question with some quite unbelievable and unprofessional answers, was Peter Kramer.

My current view of his online profile looks like this.


So, three psychiatrists, all with one thing in common: An inability to answer a question that forms the crux of their beliefs. I urge anyone reading this to ask their healthcare professionals the same question and to contact me if given an answer. If three eminent psychiatrists or pharmaceutical companies, or even medicine regulators cannot answer, then I doubt very much if your average prescriber will either.

The question should be answered because it forms the basic safety and efficacy point of why antidepressants are on the market.

So, what was the question?

"Please list the benefits of antidepressants."

I asked this question because it was once put to me by an old advocate/friend of mine, Matthew Holford. It's a great question and turns the focus off the risks and onto the benefits. Remember, after the clinical trials of these drugs, which lasted between 8 & 12 weeks, a licence was granted because the "benefits outweighed the risks." We all know what the risks are because today most of them are clearly on the antidepressant labels.

Out of the three psychiatrists, Peter Kramer, who has authored such books as 'Listening to Prozac', came up with, or thought he did, an answer. The benefits are "having a good time with your kids", he told me, adding, "progress in your career."

Interesting. My response, which resulted in Kramer throwing his toys out of the pram (blocking me) was, "So, in the 8-week clinical trials for antidepressants the benefits of "having a good time with your kids" was seen. Benefits also seen in the 8-week trial was "progress in your career", is that your position, Peter?"

Ladies & gentlemen, boys & girls, we have all been duped for years and the claim that antidepressants outweigh the risks is, I believe, a fraudulent claim just as the 'depression is caused by a chemical imbalance' claim was.

It's incumbent of us all to seek an answer to this question because without an answer, without the actual truth, pharmaceutical companies and medicine regulators will continue to tell doctors that the benefits outweigh the risks - they, in turn, will continue to tell patients, who, in turn, tell friends and family members. The piss-sodden snowball will grow until we all stop it gathering more momentum.

So, next time you hear the term, "The benefits of antidepressants outweigh the risks", ask the person who is making this claim for a list of the benefits reported during the trials. Don't accept the anecdotal comments, such as, "they saved my life" or "they helped me." These are irrelevant anecdotes. What you are seeking is the list of benefits that persuaded the medicine regulators to grant these drugs a license. Ergo before all the hype came about them apparently saving lives.

Remember, suicidal ideation, self-harm and a whole host of other risks have been reported in clinical trials and we have all been told, 'Hey, there's no need to worry because there were more benefits.' Thing is, ladies & gentlemen, boys & girls, they have failed to show us a list of these benefits. They, if there are any at all, have been hidden from us in much the same way the number of suicidal subjects in clinical trials was hidden. Through various litigation we have unearthed a lot of the hidden risks but, to my knowledge, no drug company has ever been sued because antidepressants work too well.

We need a list of the benefits and we need them now!

We have all just taken their word on trust.

And we should all, rightly, be very angry!

Bob Fiddaman





Saturday, January 06, 2018

GSK Call In the Fireman




I've recently finished reading, for the second time, John Grisham's excellent, 'The King of Torts', a novel that highlights underhand tactics used by the pharmaceutical industry. 

In 'Torts' we are introduced to a character who goes by many names. To keep this simple I'll just be referring to him as 'Max Pace.' Pace is hired by pharmaceutical companies to douse the flames when it arises that a drug that has been on the market has serious and life-threatening side effects. The information is purposely leaked by the pharmaceutical companies via Max Pace whose job it is to target prosecuting attorneys in the hopes of a quick and cheap settlement. Pace describes himself as a fireman, someone whose job it is to 'put out the fire.'

The character reminded me a great deal of Peter Humphrey, the outsider who was brought in by GSK China to douse the flames of a whistleblower who, at the time, was threatening to spill the beans on GSK China's illegal activities which included, but weren't limited to:


  • Bribing Mark Reily, GSK's head of China Operations, in the form of 'sexual relations' in return for maximizing business for China Comfort Travel (“CCT”). - CCT was an important part of the GSK bribery and promotion scheme because it facilitated a money laundering operation in connection with the bribing of hospitals and doctors who prescribe GSK drugs to patients. 
  • Funneling 3 billion yuan (US$482 million) through this network to recipients. Receipts were forged for purchases and transactions that never took place, including fake conferences.
  • Bribing doctors and other medical staff were to sell GSK products, the cost of those bribes was added to the price of the products that consumers paid for.

Enter the fray Peter Humphrey and his wife Yu Yingzeng who were hired by GSK China to investigate a whistleblower whom they believed was behind a series of emails sent to the company big-wigs, including the then CEO of GSK UK, Andrew Witty. Humphrey and Yu operated ChinaWhys, an International Business Risk Advisory Firm.

Humphrey and Yu were told by GSK China that they believed Vivian Shi, then the company’s government relations head in China, was the whistleblower but they needed proof. The allegations made by the anonymous whistleblower did not concern them.

In a nutshell, it was the job of Humphrey and Yu to create a report on Shi to frame her as a vindictive former employee.

The Sex Tape

Whilst in talks with GSK China, Humphrey, and his wife learned of a sex tape that the anonymous whistleblower had sent in via an email attachment. The sex tape showed Mark Reily and an unnamed woman and was sent to GSK executives along with the corruption allegations. A further 23 emails were sent to Chinese governmental entities throughout China.

GSK told Humphrey and his wife that the allegations had previously been investigated and were false.

According to a court document, during an April 15, 2013, meeting, Humphrey asked GSK officials for copies of the anonymous whistleblower allegations, but GSK refused to provide them. Instead, the document claims, GSK officials stressed that GSK had improved its compliance mechanisms following earlier corruption and other illegal activities that led a DOJ settlement in 2012 ($3 Billion to resolve fraud allegations and failure to report safety data)

The court document. PETER HUMPHREY; YU YINGZENG; CHINAWHYS COMPANY LTD Vs GLAXOSMITHKLINE PLC; GLAXOSMITHKLINE LLC, was filed in United States Court of Appeals for the Third Circuit on 1st January 2018.

More on this 'appeal' later.

In essence, GSK was playing down the allegations, even though they knew them to be true, and using Humphrey and Yu into advancing GSK’s efforts to conceal its bribery activities.

The court document, which I have a copy of, also states:
On June 26, 2013, a GSK employee finally sent two of the whistleblower emails to Humphrey while he was in the United States.
Over the next two days, police raided multiple GSK China offices. Following those raids, GSK senior legal counsel Jennifer Huang asked ChinaWhys to investigate the Public Security Bureau (PSB) and to “prepare an Organic analysis ASAP on the Chinese political regime, particularly on Chinese Communist Party Regime, PSB, and state council with official’s name identified.” 
Humphrey and Huang had a phone call that same day, while Humphrey and Yu were in the United States. Huang said she wanted to investigate the PSB “to find out who’s who in the investigation.” At that point, Humphrey became concerned that GSK was seeking now to obstruct the investigation by Chinese authorities and replied that he could not do anything that could be deemed as violating state secrets and thus could only use public information for his research.
On July 1, while Humphrey and Yu were still in the United States, GSK China’s head of business development, Leslie Chang, asked Humphrey to investigate various government organs. Humphrey refused. Then, after returning to China, Humphrey met again with Mark Reilly (the head of GSK China) in a hotel room as Reilly was preparing to flee the country. At that time, Humphrey advised Reilly that ChinaWhys could no longer provide service to GSK. 
On July 10, 2013, ChinaWhys was raided by the police who told Humphrey, “This was ordered from above. This is related to GSK.”

Around the same time, four senior GSK China executives were also arrested.  In response to those arrests, GSK’s global CEO, Sir Andrew Witty, claimed that GSK’s head office in London lacked knowledge of the whistleblower’s allegations and “had no sense of this issue.” This, according to the court document, was untrue.

Humphrey and Yu were arrested for illegally buying and selling private information and detained for almost a year before their trial. During this year of detention and whilst awaiting trial, GSK stated that its China business “hired ChinaWhys in April 2013 to conduct an investigation following a serious breach of privacy and security” (the Reilly sex tape) but that ChinaWhys was “not hired to investigate the substance of the allegations of misconduct made by the whistleblower.” This, according to the 2018 court document, was a misleading statement by GSK and prolonged Humphrey and Yu’s incarceration because British diplomats attempting to intervene on Humphrey and Yu’s behalf did not have accurate information about what had led to their arrest.

One British official involved in those efforts to intervene on behalf of Yu and Humphrey claimed,“GSK were really cagey. They just kept saying it was routine work and kept the information deliberately vague. When we went to the Chinese we were arguing with one hand tied behind our backs.”

On September 19, 2014,  GSK PLC issued a Statement of Apology to the People of China in which it announced that “GSK China Investment Co. Ltd (GSKCI) has been identified according to Chinese law to have offered money or property to non-government personnel in order to obtain improper commercial gains, and has been found guilty of bribing non-government personnel.” GSK was fined $492 million for its bribery activities in China in the biggest such penalty ever imposed by a Chinese
court. The then GSK CEO, Andrew Witty, stated that “Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK.” In addition, Mark Reilly, the head of GSK China, was convicted for his part in the bribery scheme. He was sentenced to three years prison with a four-year reprieve and ordered deported, meaning he will never serve his sentence.

Humphrey and Yu. however, were treated less favorably. In August 2013 they were both convicted and imprisoned in China under harsh conditions for almost two years in squalid conditions and crowded jail cells. They were both denied urgent medical attention and were separated from each other  Humphrey developed prostate cancer, for which he did not receive proper treatment and as a result, the cancer became life-threatening.

In June 2015, the couple was released from prison.

Humphrey watched the TV coverage of the GSK trial from his Shanghai prison cell. He was shocked by the contrast between his punishment and theirs.

"Suspended jail sentences for three or four of the main culprits when I and my wife had been sentenced to years in prison," he says, adding, "Someone asked me recently why someone like Mark Reilly (GSK China's boss) could be set free and we were in jail. I think it's very simple, we don't have half a billion dollars. That story was about money from the beginning. Money got them into trouble and money got him out."

In November 2016, Humphrey and his wife filed suit against GSK where they sort to seek damages from GSK relating to the loss of their business (ChinaWhys), compensation for the emotional and physical harm and damage to their reputation.

Almost one year later, U.S. District Judge Nitza Quinones Alejandro, threw out the case claiming that a U.S. Supreme Court ruling barred lawsuits filed under the federal Racketeer Influenced and Corrupt Organizations Act (RICO) over injuries that occur entirely outside the United States such as this one involving incidents in China.

“For this reason", he said, "Plaintiffs lack standing to assert civil RICO claims, and these claims are dismissed."

Undeterred, Humphrey and Yu have now appealed this decision, hence the Jan 1, 2018, filing. They are requesting that the United States Court of Appeals reverses the order of the District Court dismissing the Complaint for failure to plead a “domestic injury”.

I covered the Chinagate scandal in great depth when news broke back in 2013. A chronological list of the blogs can be seen below. To date, it's some of the most rewarding research and reporting I've ever done on this old blog of mine.

Remarkably, GSK re-hired the services of Vivian Shi, whom they thought was the whistleblower. Reily, according to MalayMail Online, became part of GSK's senior executive team in London


Bob Fiddaman

BACK STORIES:

Glaxo - The Sex Tape Scandal

GSK's Mark Reilly Accused of Running a "massive bribery network"

I'm Just a Blogger - Here's GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK's Sales Reps Want Their Money Back

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA - Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing










GSK's Sales Reps Want Their Money Back

Glaxo - The Sex Tape Scandal

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

"GSK were really cagey", Claims Whitehall Official

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations

GSK CHINA - Bribery was Rife 13 Years Ago

GSK's Hired Detectives - Day One, As It Happened

So, What Do You Think, Mr Harvey Humphrey?

GSK Plead Guilty For Being "Very Decent"

Glaxo's PI Released From Prison

The Penny Drops for GSK's Private Investigator

GSK's Mark Reilly and the Word, 'Opaque'

Glaxo and Former Whistleblower Suspect Reunite

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK's Witty Lied to the Media - Part I

ChinaWhys Vs GSK - The Claims - Part 2

More Woes for GSK as Peter Humphrey Files Suit






Friday, December 22, 2017

Merry Christmas to All




Something I penned many years ago.

A family friend did the artwork.




For Krissy




Merry Christmas!

Thanks for reading folks!

Bob Fiddaman



Monday, December 18, 2017

GSK's Attorney Labels His Failure An "Accomplishment"



King & Spalding's top asshat asset, Andrew Bayman (above), was featured last week in a special interview on the legal-based website Law360. His interview, as you would imagine, is seen as a massive PR exercise for the firm he works for and also the firm he represents in litigation, GlaxoSmithKline.

Bayman, along with his co-defender Todd Davis, were in action earlier this year in the Dolin Vs GlaxoSmithKline trial in Chicago, a trial which saw them roundly trounced by the legal team of Baum, Hedlund, Aristei & Goldman, PC and Rapoport Law Offices, P.C.

In his summation to the jury Bayman uttered the immortal words, "Don’t you think if these medicines caused suicide someone would have spoken up?"

Hmm, the jury returned a verdict against the company he was representing yet, according to his interview with Law360, he sees this as a personal victory.

Law360 put Bayman in the spotlight by claiming, "King & Spalding LLP's Andrew Bayman helped limit GlaxoSmithKline's damages to $3 million in a closely watched federal trial over the company's liability for the suicide of a Reed Smith LLP partner who used a generic version of Paxil, landing him among Law360's 2017 Product Liability MVPs."

Law360 asked Bayman what he thought his biggest accomplishment was this year. He cites the Dolin trial as his biggest 'accomplishment.'
"We knew it was a very challenging case. We knew there was a risk of a really big verdict, given his earnings and his age," he said. "The company felt so strongly about its legal position that it said we're going to try this case, knowing that there was a huge risk of a very large verdict."
Hang on a minute, didn't Bayman lose the case?

Why is he singing from the rafters about such failure? Why is that failure his own biggest accomplishment this year? He must lead an unaccomplished life considering he defines his Dolin Vs GlaxoSmithKline failure as a success.

On the pharmaceutical industry, Bayman believes that big pharma "have created medicines that have changed people's lives."

He's right. Just ask Wendy Dolin how her life has changed after her husband took paroxetine. Ask her kids and Stewart's friends how much their lives have changed, too.

Bayman continued by praising the efforts of the pharmaceutical industry.

"In the past", he said,"before they had these drugs, people were not able to get out of bed and lead normal lives." 

During the trial of Dolin Vs GlaxoSmithKline, Bayman was jumping up and down like a jack-in-the-box, almost objecting to everything the plaintiff team wanted to tell or show the jury. Bayman didn't, it seemed, like any visuals, none more so than the following that was shown to the jury.



The above visual showed the jury how 22 adults had died during paroxetine clinical trials, all but two had died by suicide, all of whom were taking GlaxoSmithKline's Paxil at the time of their death. So, Mr. Bayman, there are 22 people here who can't get out of bed and lead normal lives, 20 of them killed themselves after ingesting Paxil, a drug that certainly did change the course of their lives.

Bayman told Law360"I don't have any engineering background. I don't have any chemistry background," he said. "That in some ways has been an advantage, because I tell my experts, if you can't explain this to me, we're not going to be able to explain it to a jury who doesn't have a technical background."

So, the defense experts at the Dolin trial didn't explain their points to the jury correctly then? Or perhaps those experts weren't managed well by Bayman and co?

On giving advice to young product liability attorneys, Bayman told Law360, "There are different issues that you see in product liability litigation, and someone who has deep expertise can be particularly valuable." 

Nice of him to pay homage to Brent Wisner of Baum, Hedlund, Aristei & Goldman, PC.

The Law360 article is here.

Bayman's biggest accomplishment this year can be seen in the links below.

Bob Fiddaman


Coverage of Bayman's biggest accomplishment

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

Dolin Vs GSK - Day 7 - Abraham Lincoln

Dolin Vs GSK - Day 8 - Get to the Point, Todd!

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK: Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK - The Verdict

Exclusive: Interview With Wendy Dolin


From Chicago to New York - The Legacy of Stewart Dolin

Dolin Wins...Again

Dolin Vs GSK: Personal Vendetta or Bigger Picture?




Monday, December 11, 2017

British Medicines Watchdog Announce New Partnership




First off, watch the short announcement from the MHRA's CEO, Dr. Ian Hudson.



He looks almost apologetic, don't you think? Either that or he is embarrassed?

Before taking his role as CEO of the British Medicines Watchdog (MHRA), Hudson was the agency’s licensing director, responsible for the majority of its medicines licensing activities. Prior to that, he was the World Safety Officer for GlaxoSmithKline. He can be seen here defending Paxil, also known as Seroxat, (under oath) during a one-hour video deposition that was aired during the Tobin Vs GlaxoSmithKline case. A case which saw the Jury return a verdict against GlaxoSmithKline and, indeed, Paxil. (Fig 1)


Fig 1



Who Are The Gates Foundation?

Better known as the Bill & Melinda Gates Foundation, it was launched in 2000 and one of its primary aims is to "enhance healthcare and reduce extreme poverty."

What Are They Currently Involved In?

Well, aside from teaming up with the MHRA and having a say on the safety monitoring of medicines in low and middle-income countries, they are also embroiled in serious issues regarding a vaccine study they sponsored that was carried out in India in 2009.

Bill and Melinda's foundation funded the Program for Appropriate Technology in Health (PATH) to carry out the studies in which 5 young girls died after receiving the Human Papilloma Virus (HPV) vaccine, Gardasil, manufactured by Merck.

According to The India Times, "...consent for conducting these studies, in many cases, was taken from the hostel wardens, which was a flagrant violation of norms. In many other cases, thumbprint impressions of their poor and illiterate parents were duly affixed onto the consent form. The children also had no idea about the nature of the disease or the vaccine "

In 2015, Judges in India's Supreme Court demanded answers regarding the violations. An investigation carried out by the British newspaper, The Daily Mail, found that "children as young as nine suffered side-effects after being used as unwitting human guinea pigs for the new drug."

The Daily Mail adds:
An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics amounting to child abuse and 'a clear cut violation of the human rights of these girl children and adolescents'.
The committee's report said it had been established that clinical trials of the vaccines had been carried out 'under the pretext of an observation/demonstration project' in violation of all laws and regulations laid down by the government for such trials.
GSK is also embroiled in the controversy. Shortly after the Gardasil debacle, two more deaths were reported from Vadodara, Gujarat, where tribal children were also vaccinated with another brand of HPV vaccine, GSK's Cervarix.

Earlier this year, things got so bad that India's health ministry decided to take over funding responsibility for the immunization program backed by the Bill & Melinda Gates Foundation. The reason? "A possible conflict of interest arising from the foundation's tied to pharmaceutical companies." (Business Standard)

MHRA

So now, we seem to have gone full circle with today's MHRA announcement from Dr. Ian Hudson, who claims...
"We are delighted to be involved in such an important global initiative. New drugs and vaccines are being brought to the market for the first time in public health programmes in settings where the safety monitoring and regulatory systems need strengthening. The expertise we can bring to the project will help national safety monitoring centres identify risks and benefits early and take appropriate regulatory action to support global health."
So, let's get this straight. Bill and Melinda Gates funded an immunization program in India. That program kills a number of children and the protocol was found to be 'a clear-cut violation of the human rights of children'. Next, Ian Hudson, the former World Safety Officer at GSK, announces that Bill and Melinda Gates will be teaming up with the MHRA to strengthen "the safety monitoring and regulatory systems."

Someone pinch me.

If this hasn't got you thinking outside of the box, ladies, and gentlemen, then maybe this will?

An article published in 2012 entitled, 'The Gates Foundation connection to the Glaxo drug fraud scandal', is a fascinating read. It highlights, amongst many things, that Tachi Yamada, former head of global health for the Bill & Melinda Gates Foundation was formerly the head of research and development for GSK.

Yamada, while he was head of global health for the Gates Foundation, was accused in a U.S. Senate hearing of bullying a scientist to not publish negative findings of a GSK diabetes drug called Avandia. The same drug that Glaxo failed to report important data to the FDA showing that it increased heart risks in patients by 43%. Despite agreeing to a misdemeanour count in 2012, GSK still maintains "the civil settlement is not an admission of any liability or wrongdoing in the selling and marketing of Avandia." However, they agreed to pay $3 billion imposed on them by The Department of Justice for failure to report Avandia safety data.

I'm sure Ian Hudson knows of the links between GSK and the Gates Foundation. Probably why his announcement (in the video at the top of this post) looks like it's being delivered by someone who has soiled his underpants. Either that or he has become nauseous after being trapped in the incestuous revolving door at the MHRA!

Bob Fiddaman












Friday, December 08, 2017

The American Foundation for Suicide Prevention... A teaser






Pretty soon I'll be highlighting the American Foundation for Suicide Prevention (AFSP) on this blog.

The AFSP have been exposed by many before. I will be focusing on their online Digital Memory Quilt, whereby they invite relatives to post photos of loved ones who have fallen to suicide. There are, of course, restrictions, one being that nobody is allowed to mention any medications the suicide victim may have been taking at the time of their deaths. However, that's a future post.

In the meantime here are some tweets I've sent the AFSP tonight:










COMING SOON

The Suicide Quilt that Stifles Voices


Bob Fiddaman




Friday, November 24, 2017

MHRA Promote Broken System




Yellow Card System Remains a Red Flag

This weekend the British drug regulators, MHRA, are using Twitter to promote their broken Yellow Card ADR reporting system. The Yellow Card is MHRA's initiative whereby prescribers and patients can report adverse drug events regarding prescription drug use.

Here are some recent MHRA tweets:




One would think the MHRA are finally starting to acknowledge that reported adverse drugs reactions can improve patient safety and product warnings. However, the MHRA refuses to follow up on Yellow Card reports. Thus, reporting adverse drug reactions (ADRs) has little to no value in improving public health.

MHRA should follow up Yellow Card reports by contacting doctors and/or consumers to seek relevant info regarding the reported adverse drug event so that MHRA can then determine what role ADRs played in causing harm.

Let's say Mr. Smith loses his wife to suicide. After conducting independent research, Mr. Smith learns the drug his wife was prescribed may have contributed to her demise. He then submits a Yellow Card report to the MHRA.Upon receipt of his report, the MHRA will add the adverse event to a database. MHRA won't bother following up. They won't contact Mr. Smith to ask pertinent questions such as, "Did Mrs. Smith's mood worsen when she was talking the drug?" or "Was Mrs. Smith warned by her prescriber that the product is known to create suicidal thoughts and actions?"  Instead, the MHRA will merely add the adverse event to their database where it will sit for infinity without further investigation.

When consumers alert the MHRA that the adverse event might have possible causation, the MHRA routinely claims, "correlation does not equal causation." I say routinely because the MHRA failed to follow up Yellow Card submissions and can, therefore, continue to claim there's "no correlation."

As a patient advocate, I have, in the past, alerted the MHRA that there were 79 reported cases of suicidal and self-injurious behaviours on the same drug. (Paxil) If Paxil was the product Mrs. Smith was taking at the time of her death, the MHRA would again parrot their "correlation does not equal causation" line. Mrs. Smith's ADR then becomes just another suicide that has very little to do with the drug she was taking.

By promoting the Yellow Card reporting system on Twitter, the MHRA is asking prescribers and consumers to continue sending reports that the MHRA will never follow up. Even if the suicidal and self-injurious behaviours statistic for a particular drug increase, the MHRA will always be able to claim that just because people die of self-inflicted injury whilst taking a prescription drug, it doesn't mean the drug caused the suicide.

This works well for the MHRA but doesn't work to protect consumers. The MHRA responds by repeatedly claiming consumers are dying by suicide because of mental health challenges. They will further stress that patients should continue taking their prescriptions and talk to their doctors if new or worsening symptoms occur.

And so it is: The MHRA's new Twitter campaign promotes consumers as guinea pigs on a dizzying carousel ride. Round and round we go on a cheap carnival ride with faulty rivets and a drunken operator. Similar to the banking industry responsible for the financial demise of countless hardworking citizens, the MHRA knows there's a systemic problem and that it is the public who will pay the price for MHRA's willful indifference to critical drug safety.

Just as the banks sold dodgy mortgages, the MHRA peddle dodgy promises to further the myth that they exist to promote health and safety. In truth, they don't. Their protocol for managing dangerous drugs will always benefit the pharmaceutical companies who pay their wages. The MHRA is fully-funded by the industry who make the products noted in Yellow Card reports. Hence, the MHRA won't follow up Yellow Card reports.

MHRA's new tagline should be "correlation does not equal causation." At least this would help alert unsuspecting consumers that with MHRA at the helm, there is grave danger.

I've been banging the drum about this problem for years. Here's a recent Podcast I did that highlights this.



Bob Fiddaman


MHRA 'Yellow Card' Related

My Meeting With The MHRA - (PDF) September 2, 2008

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I - November 26, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" - November 27, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine - November 28, 2011

MHRA In Buck-Passing Specialist Cahoots - December 07, 2011

MHRA: Follow-Up Rate at a Price - September 29, 2015

MHRA: "We Now Consider This Request Closed" - October 20, 2015

The Mechanics of the MHRA - December 03, 2016

SSRI Deaths in Clinical Trials - May 05, 2017

MHRA Seek Payment For Info on Deadly Drugs - June 05, 2017

MHRA: No Deaths in Pediatric Trials, But What About Adults? - July 17, 2017

Danny Lee-Frost of the MHRA - July 20, 2017


EXCLUSIVE: MHRA Asked Sky News to Remove Antidepressant Reference - July 25, 2017






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