Stewart Dolin’s Paroxetine Induced Suicide..


Despite tens of thousands of reports of SSRI induced suicidal thoughts, behaviours and completed acts over the decades, GSK are still trying to deny the reality of Seroxat/Paxil (Paroxetine) induced suicides..

Paroxetine is a killer drug….

I hope that Wendy Dolin wipes the floor with GSK (and their sociopathic lawyers) in court…


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On a muggy evening, Wendy Dolin was walking her dog a month after the bewildering suicide of her husband, the former Reed Smith partner Stewart Dolin, when a friend accompanying her uttered a strange word suggesting an explanation: akathisia. Looking up the condition online that night in 2010, Dolin was stunned by how closely its symptoms of intense restlessness and anxiety seemed to match her husband’s puzzling behavior in the days before he took his life by jumping on the tracks of an O’Hare airport- bound Blue Line train in Chicago.

The name of the condition, more familiar to neuropsychiatry professionals and pharmaceutical injury lawyers than to Wendy Dolin, a licensed clinical social worker in Illinois, shone to her through the fog of an inexplicable act by a man she had known for 42 years. He had seemed his usual self until just days before the incident, she said, when he had begun taking paroxetine, the generic version of the antidepressant Paxil.

Stewart Dolin

He became so distressed soon after going on the medication that he pled to her one night that week in July: “I don’t get it, Wendy. I still feel so anxious,” she recalled.

After poring over internet search results about lawsuits that alleged that akathisia was a known side effect of Paxil, which belongs to a class of antidepressants called selective serotonin reuptake inhibitors, Dolin decided on a seemingly improbable course of action. She would sue the drugmakers responsible for the manufacturing and labeling of Paxil, a drug whose generic version her husband had taken for only six days before his death.

“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” Dolin said, referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.

“It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else,” she said.

Baum Hedlund Aristei & Goldman PC, a small personal injury firm based in Los Angeles, had been litigating wrongful death and injury suits involving suicides and suicide attempts related to antidepressants for about 20 years when Dolin contacted it in 2010 to take on her mission. Nearly two years later, the firm filed her negligence and wrongful death suit against Mylan Inc., the Netherlands- based generic-drug maker that manufactured the drug her husband was taking, and GlaxoSmithKline, which sold the drug’s branded versions and devised its labels, as the U.S. Food and Drug Administration requires.

The timing of her suit was inopportune for a plaintiff alleging an injury from a generic drug. The U.S. Supreme Court had just issued a landmark decision in 2011 in Pliva v. Mensing that shielded generic- drug makers from claims about their labeling of drug side effects and contraindications because FDA rules require them to follow the same warning language of their branded counterparts. Meanwhile, dozens of courts around the country were taking cues from a 1994 decision by the Fourth Circuit in Foster v. American Home Products Corp., which had found that although branded-drug makers are responsible for the labeling of their products, they don’t have a duty to warn patients taking generic versions of their drug.

The mountain of unfavorable case law had threatened to nip Dolin’s suit in its early pleading stages. Instead, she prevailed through multiple summary judgment motions by GSK — although the Mensing decision did jettison Mylan from her suit — as her lawyers strategized to counter the difficult precedent and found a willing ear in the Illinois federal judge overseeing the suit, James Zagel. Guided by the handful of courts before him to find branded-drug makers could be held liable under other tort theories besides strict product liability, he issued a surprising endorsement of Baum Hedlund’s arguments in the Dolin case, finding in February 2014 that GSK could be held liable for common law negligence claims.

Judge Zagel found that, unlike some other states, Illinois common law did not compel him to treat all claims stemming from a product injury as product liability claims.

“The injury here did indeed occur in connection with a product. And GSK manufactures products,” he wrote in his ruling. “Yet Plaintiff has not brought suit against GSK for tortious conduct committed strictly

The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable.

— Wendy Dolin

as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer.”

Under his watch, the case is set to proceed to a monthlong trial in January, and it will be the first to involve a suicide allegedly caused by a generic antidepressant, and the first to test whether a jury would actually hold a branded-drug maker liable for a generic-drug injury. Many of the earlier suits filed over suicides allegedly linked to generic antidepressants have either settled or been dismissed.

Wendy Dolin with her husband Stewart on a 2007 vacation in Aspen, Colorado.

If Dolin prevails, the stakes will be high for generic-drug patients across the country. Her attorneys believe it would likely set the stage for the Seventh Circuit to address the issue for the first time in the event of a GSK appeal. In that scenario, the question before the court would be whether branded-drug makers can be held liable for injuries caused by generic-equivalent drugs that they did not themselves make. If the Seventh Circuit were to answer the question differently from the few other federal appeals courts that have done so — the Fourth and Sixth circuits have ruled against the idea that a branded-drug maker could be liable for a generic-drug injury — the suit could very well wend its way up to the nation’s highest court.

“The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable,” Dolin said. “I’d love this case to be the one that says, ‘This is no longer acceptable.’”

The Paradox of Litigating Over Generics

Generic drugs account for roughly 80 percent of all prescription drugs dispensed in the U.S., according to the FDA. Their prevalence is due in part to their cost, which can be as low as a tenth of the price of their branded equivalent. In 2010, the use of generic drugs saved the U.S. health care system roughly $158

billion, according to an estimate by the generic-drug trade group the Generic Pharmaceutical Association, which the FDA cites on its website.

Those savings often interact with state laws in ways that ensure the widespread use of generics. A number of states have laws that encourage pharmacists to choose cheaper equivalents to a brand name prescription, unless a prescribing doctor includes explicit instructions not to do so. Such is the case in Illinois, where state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs.

The Alabama Supreme Court, the highest state court in the country to address the issue of whether a branded-drug maker can be held liable for a generic-drug injury
— and one of the few to answer it in the affirmative —
emphasized those implications in a 2014 ruling.

“Additionally, many insurance plans are structured to promote the use of generic drugs,” the court wrote in the decision. Dolin’s own health insurance plan covers only generics, she said. The Alabama Supreme Court ruling, however, which came in the then-groundbreaking case Weeks v. Wyeth, has since been negated by a 2015 law by the state Legislature that rejects the notion that a branded-drug maker can be held liable for a generic drug.

The unique position of generics has a relatively recent history. The Federal Food Drug and Cosmetics Act once required all drugmakers to show that their drugs were safe and properly labeled before the agency would approve them. Then the 1984 Hatch-Waxman amendments to the FDCA sought to simplify the process for generic-drug makers, in order to expand affordable treatment options for patients. The amendments allowed generic-drug makers to sidestep requirements to conduct clinical trials to show the drugs’ safety and effectiveness, but it required them to show that they have followed the formulation and labeling of branded counterparts that have already undergone such trials.

Consumer advocates believe that such requirements have
created a significant gap in protecting patients for injuries they
may have sustained because of inadequate warnings, while protecting generic-drug makers from most liability claims involving their products. Public Citizen, the consumer advocacy group that petitioned the FDA in 2011 for the agency to allow generics to independently go about making changes to their labels, holds that view.

“A majority of prescriptions are filled with generic drugs because it makes health care more affordable, but when the drug doesn’t have adequate warnings on it, then physicians and patients can’t make proper decisions,” said Allison Zieve, the director of Public Citizen’s litigation group.

“Brand name manufacturers are required to update their labeling when they become aware of new information of drug risks, but once a generic is on the market, the market share for the branded version drops very quickly, and the brand name often stops selling the drug altogether,” she said. “There’s nobody under the current regime monitoring the drug to make sure that labels are updated.”

But the U.S. Supreme Court cited the Hatch-Waxman Act in cementing the protections for generic-drug makers in its 2011 Mensing decision. That case involved claims by Gladys Mensing and Julie Demahy, plaintiffs from Minnesota and Louisiana, respectively, that their long-term use of a generic version of the heartburn drug Reglan sold by drugmakers including Pliva caused them to develop tardive dyskinesia, a neurological condition that causes involuntary movements such as uncontrollable twitching or blinking.

The court found in its ruling that generic-drug makers cannot satisfy state law requirements to strengthen their warnings when they are already required by
federal law to match branded-drug labels.

In 2013, the Supreme Court expanded these protections further in Mutual Pharmaceutical Co. Inc. v. Karen Bartlett, largely blocking design defect claims by citing, among other factors, “Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic-drug manufacturers incapable of modifying either the drugs’ compositions or their warnings.”

The Dolin Litigation

It was around the time of this flurry of major precedent against generic-drug plaintiffs in the courtroom that Brent Wisner of Baum Hedlund, then an associate at the firm in its San Francisco office, took on Dolin’s suit in 2012, his first case as a practicing attorney.

The suit faced hurdles not only because of the Mensing decision and the eventual Bartlett decision but also because of the sweeping influence of the Fourth Circuit’s Foster ruling, which had barred just the type of allegations that Dolin was making, he said.

Dolin’s suit claimed her husband had killed himself after exhibiting
uncharacteristically high anxiety within days of taking generic Paxil,
which had been prescribed to him by his family doctor and friend
of 20 years, Dr. Martin Sachman. GSK’s warning label, which the generic version’s maker, Mylan, was required to follow, had misled patients and doctors, she claimed. It did not sufficiently warn that akathisia, which according to her complaint is marked by “profound inner restlessness and agitation,” could give rise to suicidal tendencies, she said. GSK has argued that the 2010 labels for Paxil contained warnings about akathisia that said the condition was “most likely to occur during the first few weeks of treatment.” Dolin insists that GSK did not connect the dots clearly enough between akathisia and suicide or sufficiently note the incidence of such risks in adults.

Her suit also claimed that although GSK apparently knew of a statistically significant risk of suicidal behavior in adults taking the medication — roughly 6.7 times higher compared with patients on a placebo — the drug’s label concealed that risk by claiming that “the suicidality risk did not extend past the age of 24.” GSK has said that this language was ordered by the FDA as part of its warnings on all SSRIs that “short term studies” of antidepressants did not show such risks of suicidal behavior.

The Fourth Circuit’s ruling in the Foster case involved the death of a six-week-old infant who had been given a generic version of a colic medication called Promethazine Syrup Plain. The appeals court squarely rejected the notion that a brand-name pharmaceutical
could be held liable for negligent misrepresentation claims in that

instance. But in the pre-Mensing era of that ruling, the court had found that generic drugs were responsible for their own labeling, emphasizing the benefits they enjoyed because of the Hatch- Waxman amendments allowing them to circumvent expensive clinical trials.

“Name brand manufacturers undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information,” the panel wrote. “Generic manufacturers avoid these expenses by duplicating successful pioneer drugs and their labels.”

At the time Wisner prepared to fight motions by Mylan and GSK challenging the viability of Dolin’s case, some 70 other courts had more or less adopted the Fourth Circuit’s view in Foster, according to court documents.

“Coming out of law school you want to deal with complicated legal issues,” said Wisner, who had just graduated with his law degree from the Georgetown University Law Center in 2010. “But I had a lot of people telling me I had no chance to prevail.”

I had a lot of people telling me I had no chance to prevail.

— Brent Wisner, Wendy Dolin’s attorney

So he hatched a plan. Anticipating that Mylan and GSK would seek to quickly dispose of his claims, he approached them in February 2013 with a calculated compromise. He would agree to put discovery on hold while the parties addressed questions of whether Dolin’s claims were preempted or not viable, but in exchange, Mylan and GSK would have to file their motions challenging her claims roughly at the same time.

That way, Wisner reasoned, he could address both defendants’ motions in a single opposition, creating a path for the judge to issue a cohesive response addressing the arguments of both defendants in the same opinion. Mylan filed its motion to dismiss in August 2012, citing the Mensing ruling. GSK followed suit with its summary judgment motion in January 2013, arguing that there was “virtual unanimity” among the numerous courts to consider this question and that they had rejected the kind of misrepresentation theories that Dolin was advancing. The drugmaker also argued that Illinois product liability laws require claims related to injuries caused by a product be brought against the company that actually manufactured it.

“Regardless of how plaintiff couches her claims, they are all barred under Illinois law because GSK did not manufacture, distribute or sell the immediate-release paroxetine that allegedly caused Mr. Dolin’s death,” it argued. “Without this fundamental predicate, Plaintiff cannot establish the necessary elements of her claims.”

Wisner believed his approach could nudge Judge Zagel to make a more comprehensive analysis about whether case and state laws truly end up leaving most generics plaintiffs with no legal recourse for alleged injuries.

“I wanted him to be ruling on the ability of my client to get any sort of justice,” Wisner said. “My thinking was, when you consider both of these issues together — innovator and generic immunity — it is easy to see how unfair the law has become.”

Judge Zagel took the cue and found in his now-renowned ruling in February 2014 that Illinois law doesn’t call for common law negligence claims to be treated like product liability claims just because the suit involves a product and an alleged injury it caused.

“GSK vigorously contends that the design and warning label are not in themselves ‘products,’” Judge Zagel wrote. “[But] GSK has not shown why Plaintiff should be precluded from claiming at common law that GSK, independent of its capacity as a manufacturer of one particular iteration of paroxetine, was negligent in connection with its responsibility for these ‘non-products,’ and that this negligence contributed to her injury.”

The ruling was a breakthrough for Dolin, too. “The phone rings [that day], and Brent [Wisner] says, ‘I think you just sorta made history here,’” she said.

The Trial

The Dolin trial is set to boil down to a few crucial questions for the jury, foremost of which is whether the drug Paxil, which the FDA first approved in 1992, causes suicidal tendencies in adults. Dolin’s experts, who are expected to testify on this issue of general causation, have so far withstood GSK’s challenges.

 

Among them is Dr. Joseph Glenmullen, a psychiatry professor at the Harvard Medical School who has written two books about antidepressant side effects. In a 2007 report to Baum Hedlund, unsealed in a different case over Paxil in Kansas state court, Glenmullen argued that GSK’s own data to the FDA in 1989 showed a substantial increase in risk of suicidal tendencies in patients on Paxil compared to those on placebo pills but that the drugmaker underreported or downplayed such risks to regulators.

It was only in 2006 that the company acknowledged in a so-called Dear Health Care Provider letter, which is meant to inform doctors of updated safety information, that Paxil could increase the risk of suicidal tendencies in certain patients by about six times as compared with a placebo, according to his report. That year, GSK modified its label to warn that it had found Paxil posed a “statistically significant” increase in the frequency of suicidal behavior in adult patients with major depressive disorder. This language made way for the FDA’s classwide labeling for all SSRIs the following year that would update all black box warnings — the agency’s most serious safety warnings — on the drug. The classwide label would warn patients and consumers only about increased suicidal tendencies among young patients aged 18 to 24.

In 2011, Wendy Dolin founded a nonprofit dedicated to spreading awareness of akathisia titled MISSD, shorthand for “the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.”

Glenmullen’s report, along with a similar one that followed the same year by the British drug safety regulator finding GSK knew of such risks in adolescent patients since 1998, prompted Iowa Republican Senator Chuck Grassley to urge the FDA in June 2008 to determine if the drugmaker had suppressed any safety information when it sought approval for the drug.

Glenmullen has maintained his position in the Dolin case, in which he has testified that taking paroxetine was a “proximate cause” in Stewart Dolin’s suicide. GSK sought to exclude his testimony in September, arguing that Glenmullen had not shown any idea linking Paxil to suicides, only to suicide attempts, which the drugmaker argued was not an adequate substitute.

Judge Zagel denied such motions in November, finding that Dolin’s experts had offered “reliable” testimony.

Dolin’s experts also include Dr. David Healy, a psychiatry professor at the University of Wales in England. Healy, who has worked as an expert witness for Baum Hedlund for years in lawsuits involving antidepressants, has stated in the case so far that GSK’s own labeling documents from 2006, including letters to physicians, had acknowledged that “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo … this difference is statistically significant.”

If the jury agrees on that question of general causation, it would then have to decide whether GSK adequately warned of the risk. If it decides the warnings were insufficient, the jury would then have to consider whether the failure to warn led to the suicide — that is, whether better warnings would have led Dr. Martin Sachman to prescribe a different treatment.

Baum Hedlund has also enlisted former FDA physician David Ross to testify on the regulatory history between GSK and the FDA and what data the drugmaker shared with the agency.

One of the key points of contention is whether GSK did its thorough due diligence to make sure its labels contained warnings specific to Paxil’s potentially increased risk for suicidal tendencies — the FDA’s own analysis found a 2.76 times higher risk for patients taking paroxetine.

Although GSK had asked the FDA about adding Paxil-specific warnings to the agency’s classwide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.

GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded-drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.

Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.

“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise,” said Henninger Bullock of Mayer Brown LLP, who has represented branded-drug makers in similar suits. “But GSK can say: ‘Well, we tried, and the FDA told me twice already that I couldn’t modify the classwide label, so to request a meeting would be futile.’”

A spokeswoman for the FDA declined to comment on pending litigation.

Besides experts, Dolin and her two adult children with Stewart are expected to testify, along with Sachman, who said at deposition last year that he didn’t know of the drug’s risks and if he had he would never have prescribed it to his best friend, Wisner said.

Wendy Dolin may be questioned at trial over the circumstances surrounding her husband’s death. “I knew my husband, and I don’t even consider it a suicide anymore,” she said.

GSK, which has taken a whopping 30 depositions in the case over a one-and-a-half-year period, has designated more than two dozen witnesses, including company witnesses and about nine experts.

“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court,” spokeswoman Jenni Ligday told Law360 in a statement.

Dolin herself may be grilled on the specifics of her husband’s mental state and activities leading up to his death. Some salient details of his final hours stand out to her as especially convincing evidence that he did not plan his suicide in a state of anxiety over long-simmering work-related problems, as GSK has argued.

The drugmaker had argued that Stewart Dolin had experienced work-related anxiety and depression for years, according to a heavily redacted segment of its summary judgment motion in October.

Shortly before his bizarre and tragic visit to the subway station, he had had lunch with an accountant at the Rivers Restaurant near his office in the Chicago Loop. There, he had ordered a chicken salad, requesting the dressing on the side, Wendy recalled, remarking ruefully, “You had the dressing on the side an hour before you [supposedly] planned to die?”

“I knew my husband, and I don’t even consider it a suicide anymore,” Dolin said. “I consider it a fatal drug reaction.”

Sindhu Sundar is a feature writer at Law360. Follow her on Twitter.

What’s Happening With GSK’s Recent Bactroban Recall?


bactroban_15gx1tube__78108_zoom

Bactroban is a skin product produced by GSK for the treatment of Impetigo and other types of skin problems. Last year (2015) GSK ordered a recall of almost half a million Bactroban tubes due to contamination of the product (with Penicillin and other substances) in the manufacturing process (it is produced at GSK’s Worthing site in the UK). According to FiercePharma (who have done great work in their reporting of this, and other GSK ‘incidents’) :

“….the U.K. drugmaker is recalling 427,513 tubes of its Bactroban (mupirocin calcium) cream and Bactroban Nasal Ointment in different sizes. Mupirocin calcium cream is an antibiotic used to treat skin infections such as impetigo.

GSK said it voluntarily initiated the recall of the 22 lots after it was discovered that the API for the product was potentially contaminated with penicillin and foreign substances during manufacturing process….”


According to the FDA website (on guidance and compliance regulations), cross-contamination with Penicillin has the potential to be quite dangerous.

 3. Is cross-contamination a concern with penicillin drugs?

Yes, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. Differences in the chemically substituted 6-aminopenicillanic acid side chain can generate allergic reactions ranging from skin rashes to life-threatening anaphylaxis.


 

Anaphylaxis is a potentially life threatening reaction from a Penicillin allergy. Although the life threatening Anaphylaxis reaction is rare, sensitivity, in general- to Penicillin- is not.

According to the NHS website-

The most common side effects of antibiotics affect the digestive system. These occur in around 1 in 10 people.

Side effects of antibiotics that affect the digestive system include:

  • vomiting
  • nausea (feeling like you may vomit)
  • diarrhoea
  • bloating and indigestion
  • abdominal pain
  • loss of appetite

These side effects are usually mild and should pass once you finish your course of treatment.

If you experience any additional side effects other than those listed above, you should contact your GP or the doctor in charge of your care for advice.

Antibiotic allergic reactions

Around 1 in 15 people have an allergic reaction to antibiotics, especially penicillin and cephalosporins. In most cases, the allergic reaction is mild to moderate and can take the form of:

  • a raised, itchy skin rash (urticaria, or hives)
  • coughing
  • wheezing
  • tightness of the throat, which can cause breathing difficulties

These mild to moderate allergic reactions can usually be successfully treated by taking antihistamines.

But if you’re concerned, or your symptoms don’t respond to treatment, you should call your GP for advice. If you can’t contact your GP, call NHS 111.

In rare cases, an antibiotic can cause a severe and potentially life-threatening allergic reaction known as anaphylaxis.

Initial symptoms of anaphylaxis are often the same as above and can lead to:

  • a rapid heartbeat
  • increasing difficulty breathing caused by swelling and tightening of the neck
  • a sudden intense feeling of apprehension and fear
  • a sharp and sudden drop in your blood pressure, which can make you feel light-headed and confused
  • falling unconsciousness

Anaphylaxis is a medical emergency and can be life-threatening if prompt treatment isn’t given. Dial 999 immediately and ask for an ambulance if you think you or someone around you is experiencing anaphylaxis.

If GSK have recalled up to half a million tubes of Bactroban last year, then how many people were put at risk of a Penicillin reaction? The life threatening Anaphylaxis can occur in one in 5000/10.000 doses, therefore were roughly 100 people at risk from this most severe side effect, and if so then how many were at risk from the less severe ones?

It seems like a lot of people were potentially put at risk…

Those who follow GSK related news would be aware that GSK have had compliance issues in their manufacturing process for decades now.

Who could forget their infamous Cidra Scandal? (also covered brilliantly by Fierce Pharma)

http://www.fiercepharma.com/pharma/gsk-whistleblower-details-cidra-plant-woes

“..The woman who raised the red flag on GlaxoSmithKline’s ($GSK) troubled Cidra, Puerto Rico, plant has now spoken to 60 Minutes. Cheryl Eckard, whose whistleblower suit yielded last year’s $750 million settlement and a guilty plea for one of GSK’s subsidiaries, gave the news program a behind-the-scenes look at the problems she observed at the plant and the company’s reaction to her criticism.

Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken.

It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says…”


And the other scandals over the years, listed here, from Fierce Pharma-

http://www.fiercepharma.com/partnering/updated-gsk-recalls-more-than-425k-tubes-of-antibiotic-cream

“…It has been a difficult couple of years for GlaxoSmithKline, with extensive recalls in the U.S. In April, the company recalled 1.7 million doses of its quadrivalent flu vaccine that were manufactured at a plant in Canada that ran into a series of manufacturing issues last year including an FDA warning letter.

Last month, the drugmaker had to recall nearly 4 million tubes of toothpaste that might have been contaminated with wood particles. But in that case, the product was not manufactured by GSK itself but by Oratech, a Utah-based contractor.

Last year the drugmaker recalled Paxil patches after being lambasted by the FDA in a warning letter for releasing potentially contaminated products from a plant in Ireland and not even bothering to tell customers about the potential for problems...”



Despite GSK’s recall last year, Fierce Pharma reports this month that GSK didn’t even bother to clean up it’s act – and this has led to sterner warnings, again from the FDA :

http://www.fiercepharma.com/manufacturing/gsk-recalls-nearly-130-000-ventolin-inhalers

The letter, posted Tuesday by the FDA, dates back to an inspection conducted a year ago in July 2015 which led the drugmaker to stop production in part of the plant in Worthing. The FDA said it uncovered 187 instances of penicillin in nonpenicillin manufacturing areas in 3 1/2 years, and that GSK has still not updated its cleaning validation plan.

“Contamination of non-beta-lactam drugs with beta-lactam drugs presents great risks to patient safety, including anaphylaxis and death. No safe level of penicillin contamination has been determined to be a tolerable risk,” the FDA warning letter points out.


In 2015, GSK recalled nearly 130,000 Ventolin inhalers because apparently they didn’t have the right dosage.

Fierce Pharma reported-

“…The GSK Ventolin inhalers were produced at its plant in Zebulon, NC. That is the facility that GlaxoSmithKline had to close for about a week last summer to clean cooling towers for the facility after testing turned up the bacteria for Legionnaires’ disease. The plant was idled briefly since cooling was essential to production, but GSK assured the public that products were unaffected by the discovery…”


Back in April 2015, a GSK Whistle-blower working in a GSK manufacturing plant (Stiefel in Sligo) in Ireland contacted me about possible asbestos contamination there, which – according to the whistle-blower – was affecting staff health as well as possibly contaminating GSK products made there…

see here :

“…Last year I received an e-mail from a whistle-blower based at the GSK (Stiefel) site who claimed that there was a major contamination problem at this GSK site in Sligo in Ireland. Allegedly, there was asbestos contamination which affected a few GSK drugs that are manufactured there (and also according to these claims- if they are true- some employees health has been affected by these health and safety breeches). I cannot verify with certainty if any of this is true or factual, as it seems the whistle-blower got cold feet and didn’t follow up after a few emails- (for one reason or other maybe they got scared, which is understandable considering GSK’s reputation). However, I happened to stumble upon this strange (locked) blog which is called gsksligo.blogspot.uk, and a number of posts on Google plus (screen-shots below) which seem to be from a Whistle-blower involved in somehow attempting to alert the public to the alleged various issues (contamination etc) at the GSK Stiefel Site in Sligo, Ireland…”

https://truthman30.wordpress.com/2015/04/17/asbestos-contamination-at-a-gsk-plant-in-sligo-ireland/


This whistle-blower didn’t contact further than a few e-mails at the time, and it seem that this scandal has been hushed up…

In light of all this, I have to wonder, how much of GSK’s dodgy manufacturing processes gets hushed up regularly, or how much information on contamination etc is suppressed?

It seems that the FDA is useless when it comes to protecting the public, even when they have caught GSK, they aren’t tough enough with their follow up.

If what we do find out about (such as the Cidra scandal etc) is appalling – think about the stuff that goes on which the public never find out about…

How many contaminated GSK products harm oblivious consumers, and patients, on a daily, and yearly basis? And how much gets reported? or how much of this contaminated stuff goes by unnoticed in the pharmacies and the doctors surgeries. How many people get ill, damaged, or harmed, from contaminated GSK products without even knowing it?

And most importantly…

How many die?..

FDA savages GSK plant in warning letter


http://www.fiercepharma.com/manufacturing/fda-savages-gsk-plant-warning-letter

FDA savages GSK plant in warning letter

GlaxoSmithKline HQ

Paroxetine (Paxil/Seroxat) And Cognitive Impairment


http://qz.com/720419/when-meds-didnt-cure-my-depression-i-tried-retraining-my-brain-waves-instead/

“….But my experiences with psychotropic medication have shown similar problems. I started on paroxetine (the Paxil generic) in my 20s. It abruptly stopped working in my 30s—while I was taking it—and I slogged through five other medication trials before I found an effective replacement. Since then, paroxetine has been identified as having anti-cholinergic effects, which can include cognitive impairment and memory loss…”

Glad to see that the side effects of Cognitive Impairment from Paroxetine are beginning to be recognized in some media…

The ‘brain fog’ from Paroxetine never fully goes away..

http://i2.cdn.turner.com/cnn/2016/images/04/18/risacheretal_jamaneurology_final_inpress_041116.pdf

Former Glaxo scientists and the feds fight over reviewing allegedly stolen documents


https://www.statnews.com/pharmalot/2016/07/18/glaxo-trade-secrets-china/

Former Glaxo scientists and the feds fight over reviewing allegedly stolen documents

By Ed Silverman @Pharmalot

July 18, 2016

A pair of former GlaxoSmithKline scientists, who were indicted earlier this year for allegedly stealing trade secrets and funneling the information to a company in China, is fighting with the federal government over their ability to stage a defense.

At issue is a protracted tussle over how the former scientists — and two of their compatriots — will be able to review millions of pages of documents and other evidence that will be used at their trials, but remain under government supervision while they do so.

And more than mere logistics are at stake, at least according to the feds.

In court documents, the US Department of Justice expressed worries that the former Glaxo scientists and their alleged accomplices may continue to funnel information to relatives in China, where the data could be sold. They already “plotted to hide their ill-gotten gains in the names of family members in China,” the feds wrote in a July 12 letter to US District Court Judge Joel Slomsky in Philadelphia.

Drug manufacturer GlaxoSmithKline, under investigation in China on suspicion its employees bribed doctors, said Thursday, July 18, 2013 its finance director for the country has been barred from leaving. The executive, Steve Nechelput, has not been questioned or arrested and is free to travel within China, the British company said in a statement. It said it had been aware of the travel restrictions since the end of June. Nechelput continues to work in his role as finance director for the company’s China unit. (AP Photo/Kirsty Wigglesworth, File)

Glaxo scientists indicted for stealing trade secrets

The feds are also concerned that the Glaxo data — which includes details on compounds, biological summaries, and a business plan for a quality control unit — might be transferred to still another accomplice. This fifth person, who was also indicted, is now a fugitive and is believed to be in China, where he is working for Renopharma, the company they established to market the data.

The case comes as the federal government is under pressure to pursue cases involving alleged theft of trade secrets belonging to US life sciences and tech industries. Not every effort succeeds, though. In 2014, for instance, charges were dismissed against two former Eli Lilly scientists, who were accused of wire fraud for allegedly leaking proprietary data about experimental drugs to a Chinese drug maker.

And so, the Justice Department wants to station security guards in the homes of the former Glaxo scientists and their alleged accomplices.

The “materials could be transmitted to (the fugitive) in a number of different forms including email, text messages, or other types of communication with little chance of detection. This fact heightens the risk of continued theft,” the Justice Department wrote. “The criminal prosecution has obviously put enormous financial pressure on the defendants, and there will be great temptation to attempt to profit from this information as they attempted to do so in the past.”

The defendants include Yu Xue, who worked as a research scientist at Glaxo and had access to a substantial amount of information concerning procedures for drug development and manufacturing. She and another former Glaxo scientist, Lucy Yi, allegedly emailed the data to others with whom they formed Renopharma, which marketed itself as an R&D company doing business in China.
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Lawyers for the former Glaxo scientists have argued that security guards would be invasive and, instead, proposed that cameras be placed by stand-alone computers in set locations in each home. By doing so, the attorneys maintained the government could monitor the scientists whenever they review any documents. “The combination of these measures allows the government to reasonably ensure that nothing nefarious occurs with the … materials,” they wrote the judge in a July 1 letter.

But the feds countered that they don’t have the resources to continuously monitor the cameras; one camera could not adequately cover every possible angle, and cameras can malfunction or be bypassed. The feds are also worried that a stand-alone laptop could be stolen since the home addresses are now a matter of public record, and the information is known to be valuable. They also cite potential constitutional issues with constant videotaping inside their homes.

The judge is expected to issue a decision shortly, according to a spokeswoman for Robert Livermore, the US attorney in Philadelphia. A lawyer for Xue declined to comment.

What Kind Of ‘Treatment’ Did The Nice Truck Attacker (Mohamed Lahouaiej Bouhlel) Receive?… Was It Psychiatric Drugs?


http://www.dailymail.co.uk/news/article-3693752/Family-Nice-killer-reveals-suffered-psychological-problems-received-treatment-years-amid-claims-depressed-marriage-breakdown-deadly-attack.html#ixzz4Elv7mMp7

The terrorist who killed 84 people including at least 10 children in Nice had suffered from ‘psychological problems’, it has been revealed.

Mohamed Lahouaiej Bouhlel, 31, a French Tunisian and married father of three, had suffered a nervous breakdown and received medical treatment for mental health issues for ‘several years’ before leaving Tunisia for France in 2005, his family said today.

Bouhlel was shot dead by police after he ploughed a lorry into crowds of people who had gathered on the city’s Promenade des Anglais to watch Bastille Day fireworks. The attack left 202 people injured, including 50 who are ‘between life and death’, according to President Francois Hollande.

Five people connected to Bouhlel have been questioned as part of the police investigation, including his estranged wife Hajer.

Previous reports suggested Bouhlel was depressed about the break up of his marriage before he mounted the pavements at high speed and careered into the revelers on Thursday night.

From the BBC –
Dr Chamseddine Hamouda was the only psychiatrist who briefly treated Mohamed Lahouaiej-Bouhlel 12 years ago.

From the Independent UK-

http://www.independent.co.uk/news/world/europe/nice-terror-attack-killer-mohamed-lahouaiej-bouhlel-sent-84000-to-family-in-tunisia-days-before-a7141221.html

The killer’s father, Monthir Bouhlel, claimed his son suffered from psychological problems and was sometimes unstable. “He had some difficult times, I took him to a psychiatrist, he took his treatments and he said he had a serious mental illness.

“For four years, from 2002 to 2004 he had problems, he had a nervous breakdown. He would get very angry, and would break things for no reason, he was put on medication. But the one thing he did not get angry about was religion, he did not go to mosque, he drank.


Some interesting news coming out about the Nice Van Attack Terrorist, Mohamed Lahouaiej Bouhlel. According to some news outlets he was receiving psychological and psychiatric treatment for ‘several years’ before he carried out the attack.

Psychiatric and psychological treatment, almost always, means the prescribing of psychiatric drugs. If Mohamed Lahouaiej Bouhlel was prescribed psychiatric drugs for several years, it would be interesting to find out what drugs they were, on what dose was he prescribed them, and for how long?

Psychiatric drugs (such as anti-depressants like Seroxat, and anti-psychotics) are notorious for causing psychotic, manic and homicidal/violent/aggression reactions. The BBC are currently investigating the violence aspect of anti-depressants for a forthcoming documentary, according to Katinka Blackford Newman (author of a new book about her personal experience of SSRI’s and the devastation she suffered because of them).

It will be interesting if we find out what psychiatric drugs the Nice terrorist was on, and if these drugs contributed to this terribly violent act.

My heart goes out to all those who died, and to the injured, and their families, from the Nice tragedy. I have been to Nice several times (growing up we used to camp near Nice) and I have an affinity with that part of the world.

The websites AntiDepAware and SSRI Stories have both been documenting medication induced violence etc for years…

check them out here:

http://antidepaware.co.uk/

https://ssristories.org/

The Stewart Dolan Paxil (Seroxat) Suicide Case Rumbles On.. More From Bob Fiddaman…


http://fiddaman.blogspot.ie/2016/07/paxil-widow-steps-up-fight-against-gsk.html?spref=tw

Sunday, July 17, 2016

Paxil Widow Steps Up Fight Against GSK

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Law360 is a lawyer driven website that keeps many law firms across the globe up-to-date with legal news as it breaks. It’s subscription based and deals a lot in US litigation. I’ve read many articles from Law360 in the past none more interesting than their recent publication, ‘Reed Smith Atty’s Widow Wages Battle Against Paradox Of Generic Drug Injury Law‘.

It peaked my interest as it pertains to a case I’ve covered many times on this blog. (Links at the foot of this post)

Wendy Dolin is suing GSK over the death of her husband Stewart after he was prescribed Paroxetine (better known as Paxil and Seroxat)  in 2010  for “work-related anxiety and depression”. Six days after beginning his course of medication Stewart killed himself by leaping in front of a northbound train in downtown Chicago.

Wendy has maintained all along that her husband showed marked signs of akathisia during the short time he was taking Paxil. For those of you who don’t know, akathisia is basically when a patient, after administering psychiatric medication, becomes agitated, distressed, and shows signs of restlessness. Often the patient has an inability to sit still and, in some cases, will pace up and down for no apparent reason. In fact, as Wendy recalls, her husband told her one night, “I don’t get it, Wendy. I still feel so anxious.”

The Law360 article focuses, in part, on Wendy’s claim that her husband experienced signs of akathisia. This is quite an unusual step for Law360 as, in the main, they report impartially on trials (past and present) and rarely feature interviews with actual plaintiffs of trials that are pending litigation.

In the article Wendy tells Law360’s reporter, Sindhu Sundar, that she had heard the term ‘akathisia’ from a friend sometime after Stewart’s death. Like many people she had never heard of the word before. She told Law360…

“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” (referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.) “It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else.”


Here’s where it gets tricky and somewhat complex. Stewart, you see, was taking a generic version of Paxil manufactured by Mylan and, in a nutshell, Glaxo argued that it should be Mylan that she sued and not them. However, after much legal wrangling, it was deterred that Glaxo were responsible for the warning literature that accompanied Paxil and any of it’s generic forms. Ergo her claim of negligence and wrongful death should stand.

It’s not as straight forward as one might think when pharmaceutical companies try to make changes to their warning labels. GSK, after learning that they would have to go to trial, then argued that they had approached the American drug regulator, the FDA, on two occasions to change the warnings on their branded version of paroxetine (Paxil). GSK allege that the FDA refused on these two occasions to make any changes to the labelling.

A pretty decent defence one would think, however, GSK did not try a third time, as was the normal protocol. According to court documents and Law360…

Although GSK had asked the FDA about adding Paxil­specific warnings to the agency’s class wide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.

GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded ­drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.

Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.

“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise.”

It’s interesting to note here that GSK are admitting that, in 2007, they wished to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults yet they are defending the allegations that Paxil (paroxetine) caused Stewart to take his own life. GSK, it seems, don’t defend the fact that Paxil can cause suicide in adults, they use points of law to hide this fact instead.

Having your cake and eating it, anyone?

Since the claim was filed in 2012 GSK have sent Wendy more than 30 subpoenas, 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. Moreover, GSK have also tried (unsuccessfully) to exclude testimony from Wendy’s expert witnesses. Joseph Glenmullen is one of those witnesses and GSK argued that he “had not shown any idea linking Paxil to suicides, only to suicide attempts.”

Another expert GSK tried to exclude was David Healy. Their treatment of him became more of a personal attack. They claimed that Healy wasn’t qualified to testify because of his radical advocacy and extreme bias against GSK. They had taken extracts from Healy’s websites and cherry-picked certain paragraphs to make it look as though Healy had called upon people to extract violence upon GSK executives and journal writers. They were wrong and Judge Zagel has allowed all three testimonies into trial.

When experts give evidence in litigation they are first depositioned by the opposing party. In the case of Healy, his deposition with GSK’s lawyers last almost 10 hours, the majority of which focused on his personal life and not the science behind his expert opinion.

It’s just another classic case of GSK dragging out time in efforts to get the plaintiff, in this case, Wendy Dolin, to accept their first measly offer, should they make an offer (which history tells us that they more than likely will)

Glaxo just love to grind down the opposition in litigation ~ they are finding that Wendy Dolin and her law team of Baum, Hedlund, Aristei & Goldman, PC are not in the game of lying down and having their tummies tickled nor are they bothered by the amount of money Glaxo’s cigar chomping suits throw at the case.

Glaxo are also defending group action brought against them in the UK with regard to Paxil ~ it’s litigation that has been dragging on for almost ten years now – who knows, maybe Glaxo’s UK and US lawyers drag these cases out so everyone who works for their firms gets a regular wage, after all it’s GSK who are billed every month to pay their attorneys wages.

Wendy Dolin is, despite the death of her husband and the abhorrent tactics of GSK’s lawyers, still standing – her lance at the ready for battle – a female Don Quixote, if you will.

Stewart would be proud of her.



Bob Fiddaman.

Back stories related to this case.

GSK Claim Phone Calls May Shed Light On Suicide

GSK Use Delay Tactics on Grieving Widow

Glaxo’s Beef With David Healy

GSK Sink to New Level in Paxil Suicide Litigation

GSK: Motions Denied in Paxil Suicide Case

Paxil Suicide Case Set For Trial

Feeling very humble this morning


New Post from Seroxat Secrets…

seroxat secrets...

Last night I was out on the town – well not really, more like out at Waterston’s in High Street Kensington for the official launch of – The Pill That Steals Lives – a new book by Katinka Blackford Newman.

Of course the book is one thing (and I think you should go and buy a copy) but for me the highlight of the evening was meeting so many people who are campaigning to raise awareness of the problems that anti depressants can cause.

I say problems, but in reality the stories I heard were beyond belief and so very harrowing that I all I could do was to sit there quietly in tears… I urge you to read David Carmichael‘s story. It seems I got away with it. What I went through was nothing compared to what happened to some.

The pain and suffering in the room last night was…

View original post 184 more words

Protest To Disband The MHRA (UK Med Regulators) On July 5th 2016


Great to see this inspiring group of individuals get together to protest against the utterly corrupted- pharma-controlled– MHRA in the UK. The MHRA is the UK’s medicines regulator, however it seems that in regards to Seroxat, it wasn’t regulated at all. The revolving door between the MHRA and Big Pharma companies like GSK serves to make sure that the interests of Pharma are always first priority over patient health and well being…

Seroxat survivors know that only to well…

For more on this protest see the Facebook link below:

https://www.facebook.com/Protest-against-the-MHRA-1544624572513720/

And if you haven’t signed this petition, calling to disband the MHRA, please join the other 12,000 or so people who have signed it already.

https://www.change.org/p/house-of-commons-to-disband-the-medicines-and-healthcare-products-regulatory-agency-mhra-a-corrupt-government-body-charged-with-protecting-patients-from-avoidable-harm-in-the-national-health-service-and-in-public-health

MHRA

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