Tagged: GSK

Glaxo’s Dark And Disturbing Medical Trials On Irish Orphans Still Making Headlines…


http://www.irishexaminer.com/viewpoints/analysis/new-bessborough-revelations-show-wider-range-of-products-tested-on-children-453349.html

 

Previously unseen details of a medical trial by Glaxo in 1974 at a Cork mother and baby home have generated a whole new series of questions for the nuns and the companies involved, writes Conall Ó Fátharta.

For almost two decades, the public has been drip-fed revelations about medical testing by British pharmaceutical companies on children in care in Ireland.

These tests involved the trialling of various vaccine combinations by predecessor companies of pharmaceutical giant GlaxoSmithKline (GSK) — Glaxo Laboratories and Burroughs Wellcome. These revelations generated more questions than answers — answers it is hoped the Mother and Baby Homes Commission can provide.

However, it has now emerged thashoot Glaxo Laboratories was also trialling other products on children here — namely lactose and baby formulas.

This occurred in 1974 in the Bessborough Mother and Baby Home in Cork and had never been made public. Once again, the revelation has generated lots of questions but few answers.

A trial sheet obtained by the Irish Examiner reveals that Glaxo Laboratories carried out a “clinical acceptability and safety trial” of “Golden Ostermilk and Lactose”, while a separate trial sheet reveals a trial of “overseas milk powders (by 0111)”.

The “clinician responsible” for the tests was Eithne Conlon — a local Cork GP who worked with the institution for many years.

The trial sheets recorded a range of reactions to the products. These included vomiting (slight, moderate, severe, or none), excessive regurgitation, wind (slight, moderate, severe, or none), stools (locae, normal, or constipated) and stool colour (yellow, grass green, olive green, yellow green, no stools, meconium, changing).

Other “abnormal conditions” were also noted. These included excessive crying, irritability, napkin rash, thrush, and others.

The latter trial sheet was contained in the records of Breda Bonass, who had sought information on her medical history from Tusla under Freedom of Information.

The former only came to light when Ms Bonass sought further information from Tusla.

However, this only confused matters further as the trial sheet for “Golden Ostermilk and Lactose” was found in the antenatal records of other women — and all contain identical details including patient numbers — something which the FOI officer told Ms Bonass was “perplexing”.

“In the majority of cases where this record was present the record was glued to another copy of the same record [front to front] and details about the respective baby’s feeding schedules, types of formula given, reactions to feeds, etc, were hand written on this paper,” said the FOI officer.

“When I pried the two sheets apart I noticed that these trial sheets all contained the exact same patient and trial numbers and identifying details as the trial sheet located in your file.”

Ms Bonass went to the religious order which ran Bessborough — the Sisters of the Sacred Hearts of Jesus and Mary — and GSK looking answers.

The nuns responded via their solicitors, telling her they no longer held the records nor had any access to them and that she should go to Tusla.

GSK’s UK data protection section informed her that the data had been “destroyed” as the “retention period has already expired some years ago”.

The Irish Examiner contacted GSK in an effort to get answers as to why this trial was carried out in Ireland, how many children it involved and if consent was sought.

It responded by saying it was “unable to locate any records relating to a 1974 study” but that it had located records relating to a trial from 1967.

“The assumption therefore would be that the 1974 study’s purpose was to compare current milk powder with a newer formulation. The records contain no names or information about the children involved,” said GSK in a statement.

The scene at the Littles Angles Plot, in Bessborough, Blackrock, Cork.Picture: Jim Coughlan

It had no documentation to explain why Ireland was chosen as a location, but that the 1967 trial was also carried out in the UK, Kenya, Argentina, Malaysia, “and probably more”.

With regard to the consent of mothers, GSK said that, due to the fact that it had no records, it could not confirm who gave consent but that its assumption was that it would have been “those Sisters running the homes as the legal guardians”.

Obtaining consent would been left to the doctor conducting the trial.

The company said that, to the best of its knowledge, no financial remuneration would have been provided to the Order for allowing children in its care to be used for the trial.

GSK said the identical sheets were probably blank forms or templates and that the information entered “appear to be codes, possibly relating to a spreadsheet collating all responses”.

It also confirmed that this was the first time it was made aware of this study and that it had not been asked to disclose it in any official capacity, “as this is clearly outside of the current Commission’s [Into Mother and Baby Homes] vaccines inquiry”.

That, of course, is technically correct. The Commission is only tasked with examining vaccine trials carried out by GSK legacy companies. This latest revelation confirms that it wasn’t just vaccines that were being tested on children in care here.

The involvement of Burroughs Wellcome and Glaxo Laboratories in trials on children in Mother and Baby Homes and other institutions is worth repeating.

It’s been a long tale which saw a previous State inquiry —the Commission to Inquire into Child Abuse (CICA) in 2000 — try and fail to fully investigate the matter.

Before that inquiry was halted following a Supreme Court ruling in 2002, GSK had confirmed just three vaccine trials in the 1960s and 1970s involving more than 250 children.

In 2011, in a response to an RTÉ investigation, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland.

However, in 2014, documents uncovered by Michael Dwyer of UCC’s School of History revealed a fifth trial of a measles vaccine on 34 children took place in 1965.

It was carried out by Irene Hillary and Patrick Meenan of UCD’s microbiology department and AJ Beale of Glaxo Laboratories. The UCD academics (both now deceased) were also involved in the first two vaccine trials also.

Earlier that year, Dr Dwyer also discovered evidence that Wellcome had carried out vaccine trials on more than 2,000 Irish children in 24 residential institutions between 1930 and 1935.

Despite this, the Inter-Departmental Group on Mother and Baby Homes published in 2014 only referred to three vaccine trials. It also failed to mention a 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough Mother and Baby Home in Cork.

Questions around the involvement of British pharmaceutical companies in vaccine trials in Ireland have been popping up in the media for almost three decades now.

They first hit the headlines in the 1990s, but it wasn’t until 1997 that then health minister Brian Lenihan gave an undertaking that the matter would be examined.

This resulted in the Kiely Report in 2000, by Jim Kiely, chief medical officer of the Department of Health, which confirmed three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation.

The i nstitutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children).

Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diphtheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Prof Hillary and Prof Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna.

A total of 65 children living at home in Dublin also received the vaccine.

The Bessborough Centre and Convent, Cork. Picture Denis Minihane.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report in 2000 concluded that, given the conditions which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“We are indebted to the medical officers in charge of the children’s homes for permission to carry out this investigation on infants under their care,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of CICA.

This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002.

It obtained documentation from GSK — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

It also sought records from a range of religious orders who were caring for the children used in the trials.

In November of last year, the Irish Examiner revealed that the files of vaccine trial victims from Bessborough involved in the 1960/61 4-in-1 vaccine were altered just weeks after the CICA sought discovery of records from the Sisters of the Sacred Hearts of Jesus and Mary.

The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.”

The changes made to files Nos 5, 8, 11, 12, and 15-20 are then detailed.

The changes include:

  • The alteration of discharge dates of mothers (by a period of one year and two years):
  • The changing of discharge dates of children;
  • The changing of admission dates of mothers;
  • The alteration of the age of a mother (by two years);
  • The alteration of dates of adoption;
  • The changing of baptism dates and location of baptism;
  • The insertion of certain named locations and information into admission books.

In a series of statements, the order said it wished to “categorically state that no documents were altered”.

“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer. This is entirely untrue; and we will continue to deal directly with the official commission on all such matters,” said a statement.

This document listing the changes was discovered in the Bessborough archive handed over to the HSE by the nuns in 2011.

It wasn’t discovered until 2016 — some 13 years after CICA’s investigation into the vaccine trials was suspended.

This occurred after the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

View of Douglas estuary including Bessborough with Douglas village in background in 1980. Picture: Richard Mills

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials and when the the Government declined to appeal this decision, the work of the Vaccines Module ceased in November 2003.

However, at the time, many people believed there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement in 2011, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

GSK stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

Then, in 2014, the Irish Examiner revealed a fifth trial also occurred during this period.

An article in The Lancet medical journal in August 1965, discovered by Dr Dwyer confirms that Glaxo Laboratories Ltd carried out another measles vaccine trial on 34 children aged between eight months and just over two years.

The trial was carried out by Prof Hillary and Prof Meenan and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial.

The report does not mention an institution. However, it makes reference to the fact that the reaction to the vaccine were monitored by “the adults looking after the children”.

It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

However, in response, GSK disagreed that these references amounted to evidence that the trial was carried out on children in care.

The pharmaceutical giant pointed out that, in other papers by the same investigator, it was stated explicitly that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA at the time.

So, three years on, we now know that it wasn’t just vaccines that were being tested on children in Ireland’s Mother and Baby Homes.

Now, we know that clinical acceptability and safety trials of lactose, Golden Ostermilk and “overseas baby powders” were being trialled in at least one Mother and Baby Home.

Can and will the commission examine this latest development? Why was a British company testing such products in Ireland?

Were religious orders benefiting financially by allowing children in their care to be involved in such trials? Was the consent of mothers obtained, or was it even sought?

The Mother and Baby Homes Commission said it will investigate all aspects of living conditions and care arrangements at Bessboro.

GSK’s Zofran Scandal..


“…..As of May 9, 2017, a total of 366 Zofran birth defect lawsuits have been consolidated in the US District Court of Massachusetts….”

 

 

 

http://zofranlegal.com/gsk-fights-fraud-claims/

GSK Fights To Strike Fraud-Related Zofran Lawsuit Claims

In their Zofran lawsuits, hundreds of families accuse GlaxoSmithKline of guiding a sweeping – and illegal – marketing campaign to convince obstetricians into prescribing the nausea drug as an off-label treatment for morning sickness. The company’s attorneys are now petitioning the US District Court of Massachusetts to have those claims of marketing fraud thrown out.

GSK Moves To Throw Out Zofran Marketing Claims

In some sense, the defense attorneys are simply asking Judge F. Dennis Saylor to follow through on one of his previous decisions. On April 24, 2016, Judge Saylor ruled that plaintiffs’ allegations of an illicit marketing campaign were “too broad” to be heard in court. Now, GlaxoSmithKline is urging the Court to strike those allegations from the record, claims that the company’s lawyers have dubbed “immaterial.” This isn’t an idle request, though.

Capsules In Pill Bottle

After quashing the allegations of fraudulent marketing, Zofran’s manufacturer would like Judge Saylor to limit the scope of discovery, effectively blocking the families from accessing corporate documents on the sales visits that company representatives conducted with individual doctors. Many families have said that GlaxoSmithKline’s sales representatives routinely misrepresented the safety and efficacy of Zofran during their consultations – at the behest of corporate executives. While the company vigorously denies this accusation, it now hopes to block plaintiffs from the very evidence that would either confirm or disconfirm their beliefs.

Fight Continues Over Federal Investigation Communications

This isn’t the only front on which GlaxoSmithKline is fighting plaintiffs’ ability to access potential evidence of wrongdoing. In the late-2000s, the company came under federal investigation. Investigators from the US Department of Justice had been tipped off by a whistleblower lawsuit filed in 2003, which accused GlaxoSmithKline of orchestrating numerous illegal marketing campaigns. As two former high-level corporate employees related, their employer had regularly advertised FDA-approved products for off-label indications, flouting federal law in the process. Zofran had been specifically marketed as a morning sickness treatment, the men said.

The federal government soon took the case on. After years of intense scrutiny, the federal investigation yielded a stunning result. In 2012, GlaxoSmithKline agreed to plead guilty to three criminal charges, the Justice Department reports, notably “two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce.” Moreover, the company agreed to pay $2 billion to resolve the government’s civil allegations, including accusations that Zofran had been marketed illegally.

While some details from this investigation have been made public, most of the specifics remain locked in GlaxoSmithKline’s corporate servers. Families are clamoring to obtain these documents, hoping to understand the finer points of the company’s Zofran marketing strategy. In fact, the US District Court of Massachusetts has already ruled that plaintiffs’ have a right to this information, despite GlaxoSmithKline’s arguments to the contrary.

Fraud Dispute Shouldn’t Block Discovery, Magistrate Judge Rules

On April 6, 2017, Magistrate Judge Judith G. Dein denied the corporation’s request for a protective order that would have paused discovery into the documents. GlaxoSmithKline believes that, if the allegations of fraudulent marketing are thrown out, any discovery into the company’s communications with federal investigators should be ruled out as well. After all, and by the company’s own admission, “the DOJ investigation focused on whether the defendant’s sales force had provided false information to physicians.”

Judge Dein, though, felt that the discovery in question could well impinge on allegations beyond those of fraudulent marketing. For example, the families claim that GlaxoSmithKline was “negligent” in warning the medical community of Zofran’s alleged risks. This isn’t a fraud-related allegation, but halting discovery into the company’s communications could have the unintended consequence of preventing plaintiffs’ from gaining evidence to support their negligence-based claims. To avoid that pitfall, Judge Dein felt it was appropriate to compel GlaxoSmithKline to produce documents related to the Justice Department investigation.

The company has yet to produce these documents. Despite Judge Dein’s court order, issued on April 6, 2017, plaintiffs’ attorneys say GlaxoSmithKline is only “constructing new methods of delay and obstruction.” In a new motion to compel the documents filed on May 8, the families have asked the Court to force their opponent into making the information available.

As of May 9, 2017, a total of 366 Zofran birth defect lawsuits have been consolidated in the US District Court of Massachusetts. Judge F. Dennis Saylor has been guiding the litigation through coordinated pre-trial proceedings. Relying on a series of large epidemiological studies, parents from across the country say the potent anti-nausea drug can cause major birth defects, including cleft palate and various forms of congenital heart disease.

 


 

http://www.wbrc.com/story/31258552/zofran-looking-beyond-the-label

Zofran: Looking beyond the label

Thursday, February 18th 2016, 10:37 pm GMTThursday, March 17th 2016, 10:43 pm GMT

L-R: Jon, Nicholas and Clara Rickman. (Source: WBRC video) L-R: Jon, Nicholas and Clara Rickman. (Source: WBRC video)

At only five days old, baby Nicholas underwent his first of three heart surgeries. Source: Jon and Clara Rickman At only five days old, baby Nicholas underwent his first of three heart surgeries. Source: Jon and Clara Rickman

Clara Rickman and her son Nicholas. Source: WBRC video Clara Rickman and her son Nicholas. Source: WBRC video

BIRMINGHAM, AL (WBRC) – Over 200 lawsuits allege that pregnant mothers prescribed Zofran, or a generic equivalent, caused them to have babies born with congenital birth defects.

Jon and Clara Rickman, of the Birmingham area, are plaintiffs in one such lawsuit. They say their baby, Nicholas, was born with congenital heart defects after his mother took the generic form of Zofran, called “ondansetron,” to alleviate her morning sickness during her first trimester.

At only five days old, Nicholas underwent his first of three heart surgeries.

Nicholas’ mother blames herself for taking the drug.

“Every day, you see his scar. And I can’t never fix it and I think it’s my fault,” said Clara.

The Rickmans say if Clara had not taken the generic form of Zofran, Nicholas would not have been born with a heart problem. According to their lawsuit, there is no family history of his conditions and there are no signs of a genetic cause.

The Rickmans are speaking publicly about their lawsuit and Nicholas’ health because they believe they can prevent a similar fate for others.

“I don’t want other mothers to go through what I’ve been through. And I don’t want them to feel guilty for the rest of their life, like I do,” Clara said.

Zofran was FDA-approved in 1991 to prevent post-operative nausea, and to help cancer patients alleviate nausea during chemotherapy treatments. It was not FDA-approved for treatment of morning sickness.

“It’s never been tested in pregnant women for safety and for safety in unborn children,” said the Rickman’s lawyer, Don McKenna, a partner at Hare Wynn in Birmingham.

McKenna says physicians began prescribing Zofran for uses other than what is FDA-approved. This is called an “off-label” prescription, and according to Peter J. Hughes, Pharm. D., such prescriptions are not uncommon.

“The estimates are that as many as one in five prescriptions written and filled in a pharmacy is for an off-label use, so that’s 20 percent,” said Dr. Hughes. 

A professor at Samford University’s McWhorter School of Pharmacy, Dr. Hughes is an expert in drug information and off-label use.

“It’s nothing to lose sleep over, but I do think it’s important for patients to know what they’re taking and why they are taking it,” he said. “The medication in their medicine cabinets may be used for a purpose that’s not associated with original intended use of the drug product.”

Dr. Hughes says patients should initiate a conversation with their doctors about prescriptions. He says patients should ask: Why I am receiving this prescription? Is this an off-label prescription? If so, what is the level of evidence supporting the decision to prescribe it to me?

Clara says she was never advised by her OBGYN that Zofran was not tested on pregnant women. Her lawyer believes that is a problem.

“It’s being continued to be prescribed today off-label because a doctor can prescribe off-label for any use they believe is necessary,” said McKenna. “What we don’t believe they’ve been told by the pharmaceutical company is that this has never been tested for use in pregnant women and safety in their children.”

The Rickmans are suing GlaxoSmithKline, manufacturers of Zofran, alleging that the drug company illegally marketed the drug for use in pregnant mothers and withheld information about the drug’s safety and effectiveness.

McKenna explained it is illegal for a drug company to market an FDA-approved drug for an off-label use.

“You can only market a drug that has been approved for use by the FDA and they never sought approval for use in pregnant women,” he said.

The Department of Justice (DOJ) previously accused GlaxoSmithKline of illegally promoting the off-label use of Zofran for the treatment of morning sickness in pregnant women. The DOJ alleged that GlaxoSmithKline paid kickbacks to doctors to induce them to prescribe Zofran and other drugs. The company settled those claims, without admitting liability, in 2012. 

In a statement, a spokesperson for GlaxoSmithKline said, “There have never been any findings that GSK illegally marketed Zofran at any time. In 2012, GSK agreed to include Zofran in a larger settlement with the government in order to avoid the distraction and expense of litigation.”

GlaxoSmithKline paid over $3 billion for the total settlement, which included criminal and civil charges. It remains a settlement that the DOJ calls the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States.

Though the FDA does not regulate the off-label use of prescription drugs, it collects data about adverse events associated with use. The FDA has more than 5,000 adverse events involving Zofran reported by a patient, health care provider, or manufacturer. While reporting of adverse events is optional for consumers and healthcare providers, reports are mandatory for drug manufacturers.

More than 400 adverse events from Zofran are reported for “maternal exposure during pregnancy.” More than 300 adverse events are associated with “foetal exposure during pregnancy.” There are 170 adverse events reported for “congenital anomaly.”

These reports were reviewed and considered by the FDA when it issued a public letter in October 2015 about Zofran. The letter responded to a Citizen’s Petition filed with the FDA in January 2013 requesting that the agency reclassify the drug with stronger warnings of potential risks associated with its use by pregnant women.

The Citizen’s Petition also wanted OBGYNs to be notified that Zofran may lead to adverse maternal and fetal outcomes.

After reviewing the medical literature studying the off-label use of Zofran, the FDA denied the Citizen’s Petition.

A GSK spokesperson pointed to this FDA letter and said, “They found that the evidence did not support a conclusion that there is an increased risk of adverse fetal outcomes or birth defects from exposure to Zofran during pregnancy.”

Dr. Hughes has also reviewed the FDA letter. He explained that the denial is based on a review of publicly available published medical studies. It did not include a medical study initiated by the FDA.

According to Dr. Hughes, the letter concludes that current available medical literature is inadequate to support a definitive conclusion on whether there is an increased risk of fetal outcomes when pregnant mothers take Zofran.

“The studies that are published cannot support conclusions on whether there is an increased risk,” he said.

The FDA was critical of these studies because, “they were not the highest quality, had low sample sizes, and/or were retrospective studies.”

The FDA letter, itself, recognized, “While a potential association between use during pregnancy and cardiovascular malformation warrants continued vigilance, given the limitations…the study does not support a change in the pregnancy risk category at this time for those products.”

And with regard to its denial of the request to notify physicians about alleged adverse outcomes, the letter stated, :FDA does not believe that such an unusual notification is warranted in this case.”

“Absent a compelling legal or public health concern, FDA generally does not comment on the number or quality of studies regarding the efficacy of a drug product for an unapproved use or provide notification to health care providers regarding its relative efficacy as compared to other drug products for such unapproved use,” the letter stated.

The federal judge presiding over the Zofran litigation, including the Rickmans’ lawsuit, also reviewed the FDA’s response letter. He noted that GSK could be in possession of additional information that the FDA did not consider.

“If – as plaintiffs allege – GSK was in exclusive possession of information not previously submitted to the FDA indicating a need for a new or strengthened warning…that information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it,” wrote U.S. District Judge F. Dennis Saylor, IV.

The Rickmans’ lawyer says the next 12 months, or more, will be spent collecting and reviewing internal company documents from GSK about the development, testing, and marketing of Zofran.  It could be three to five years before these cases are ready for a trial.

In the meantime, the Rickmans will raise Nicholas. About one year after his heart surgeries, Clara says baby Nicholas is doing better.

“I want him to know that he’s a really strong baby, that he’s a fighter, and that he should be proud of about it,” said Clara.

“If I could go back,” she said with tears streaming down her face, “I would never take anything, if I knew it would hurt him.”

Copyright 2016 WBRC. All rights reserved.


 

https://www.propublica.org/article/most-drugs-not-tested-pregnant-women-anti-nausea-cure-why-thats-a-problem

Most Drugs Aren’t Tested on Pregnant Women. This Anti-nausea Cure Shows Why That’s a Problem

For years, Zofran was the most popular morning-sickness medication in the U.S. Now it’s being accused of causing birth defects. The larger issue is a drug-safety system that excludes women from clinical trials, potentially putting them and their babies at risk.

Marquita Smiley and her son, Zaidan. (Bob Miller for ProPublica)

This story was co-published with Mother Jones and AL.com.

Marquita Smiley’s first surprise was discovering she was pregnant. Her second was how miserable being pregnant felt. With her older daughter, she had experienced some mild queasiness. This time, the nausea and vomiting were so bad, “I would be calling off work and not wanting to get out of bed.” As a single mom in Birmingham, Alabama, and a social worker who investigated horrific cases of child abuse, she didn’t have that option. Her ob/gyn wrote a prescription for Zofran, generic name ondansetron, which had been developed for cancer patients ravaged by radiation and chemotherapy but had become the preferred treatment for extreme morning sickness. The pills melted in Smiley’s mouth, dissolving the nausea with them. “I felt so much better,” she said. “So we just kept kinda going with it.”

Fifty to 90 percent of women spend some part of their early pregnancies sick to their stomachs, and what begins as simple nausea can become dangerously debilitating. Some expectant women use ondansetron for only a few days; Smiley took it two or three times a week into her second trimester. In her fifth month, an ultrasound showed that the left side of her baby’s heart was critically underdeveloped. Three days after her son, Zaidan, was born in April 2014, cardiologists at the University of Alabama Hospital in Birmingham performed open-heart surgery, but a blood clot caused the baby to have a heart attack and his kidneys began to fail. Somehow Zaidan hung on: At two months, he had a heart transplant; at four months, he went home.

Smiley was torn between feeling extraordinarily lucky — Zaidan was her “miracle baby” — and blaming herself for his suffering. As his first birthday neared, one of her coworkers mentioned she’d seen TV commercials by a law firm claiming that Zofran might cause serious congenital heart problems and other birth defects.

Smiley began doing her own research. She had assumed that medications prescribed in pregnancy are tested and monitored for prenatal use, perhaps even more carefully than other drugs. But ondansetron, for years the most widely used drug to treat the most common complication of pregnancy, was never approved in the U.S. or anywhere for use in pregnancy. The pharmaceutical giant GlaxoSmithKline vigorously denies Zofran causes birth defects, and most research so far seems to support that claim. Smiley acknowledges she can’t be certain what caused Zaidan’s problems. But if she’d known the drug hadn’t been approved for prenatal use, she said one morning in her lawyer’s office, distracting her squirmy toddler with Goldfish crackers, “I would not have placed him at risk.”

A healthy baby is the universal goal of pregnancy, shared by women and doctors, researchers and regulators alike. The nine months from conception to birth are extraordinarily dynamic and complex, and the complications that arise can have lifelong effects. There’s a critical need for knowledge about almost everything, from environmental causes of birth defects to how the mother’s preexisting medical conditions can affect her baby’s well-being.

Yet the same desire to protect the fetus often deters scientists and drug makers from studying the expectant mother. When it comes to drug safety, pregnancy is a largely research-free zone, women’s health experts say. The consequence? Treatment that often is based on informed guesswork rather than solid evidence, in which medications that have never been approved for use during pregnancy, and whose long-term dangers may not be known, become the standard of care. Zofran is a case study in just how problematic this system has become.

Zofran is far from unique — almost every drug prescribed during pregnancy in the U.S. is “off label,” meaning it hasn’t gone through the clinical trials required by the Food and Drug Administration before approving a drug for a specific use in a specific population. Only eight medications are currently approved by the FDA for prenatal use; from 1995 to 2011, the agency OK’d only one pregnancy-related drug. (By contrast, 29 drugs to treat cardiovascular-related conditions have won approval just since 2010.) Pregnant women have become what researchers and ethicists call“therapeutic orphans,” reliant on drugs of uncertain risk, sometimes during the earliest and most vulnerable stages of fetal development.

The problem goes back to efforts to protect women and babies from the kind of severe birth defects and other harm caused by thalidomide and other drugs in the 1960s and ‘70s — and pharmaceutical companies from legal liability for those injuries. Decades later, “pregnant women may be the most underrepresented group in the entire clinical research process,” a 2011 report by the National Institutes of Health’s Office of Research on Women’s Health declared. In a 2013 analysis, 95 percent of industry-sponsored clinical drug trials excluded expectant mothers; a mere 1 percent were designed specifically to study them.

Yet according to the Centers for Disease Control, as many as 9 in 10 expectant mothers use medications — for ailments that occur before they even realize they’re pregnant; for complications such as morning sickness, early labor, or gestational diabetes; for chronic conditions such as epilepsy, high blood pressure, or depression that often become more challenging to manage as the months pass. Hampered by a lack of peer-reviewed evidence and hard data, ob/gyns find themselves in the dark about some basic best practices: How does a drug work in an expectant woman’s body? What’s the right dose to take and the right time to take it? What are the true risks to the fetus (or lack thereof)?“Pregnant women are not like non-pregnant people,” observed Susan Wood, director of the FDA’s Office of Women’s Health from 2000 to 2005 and now an associate professor of health policy at George Washington University. “They have a different fluid volume ratio, a different metabolism … all sorts of [physiological] changes that could affect how well a drug works.”

Fewer than 10 percent of medications have enough information to determine their safety for prenatal use, the CDC notes. Off-label use of a drug during pregnancy thus becomes a kind of unregulated, unmonitored clinical trial. “We learn on the backs of [pregnant] women while pretending we don’t experiment on pregnant women,” said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics. “But in fact, we do.” By the time the real risks become apparent, several decades may pass. The watchdog group Public Citizen analyzed how long it can take the FDA to issue a “black box” warning after problems surface with a drug. The average: 27 years after the drug was approved.

In the absence of reliable information, sometimes mothers-to-be and their physicians conclude the risks are too great and stop a medication that’s really needed, triggering an avoidable medical emergency that can do more harm than the drug itself. “If research is important to tell us when medications are unsafe, it is also important to reassure us when drugs are safe,” Faden and a group of women’s health advocates calling themselves the Second Wave Initiative argued in a recent manifesto.

The question of how to improve research on pregnant women has greater urgency as new threats such as the opioid epidemic and the Zika virus have emerged. As policy makers, medical organizations and women’s health experts grapple for a solution, the most intractable problem may be a deep-rooted cultural bias that elevates the fetus above all else. “There’s been a dogma in which pregnant women come last,” Faden said. “Always last.”

Meanwhile, Marquita Smiley and other women are often left with no clear options or answers — and little or no recourse if something goes very wrong. It’s an awful position to be in, Smiley said. “I’m trying to find the words.”


Not so long ago, doctors viewed nausea and vomiting of pregnancy (the medical term for morning sickness, abbreviated as NVP) as largely a psychological problem, at its worst a sign that a woman was so unhappy being pregnant she literally wanted to throw up her fetus. Now, the key culprit is believed to be the hormone human chorionic gonadotropin, which is produced in the placenta and surges through a woman’s body as the embryo begins its rapid growth. Studies suggest that some nausea is actually a healthy sign, with mothers who suffer from it less likely to miscarry or go into premature labor. But up to 2 percent of pregnant women develop hyperemesis gravidarum (HG), nausea and vomiting so serious it can require hospitalization — Charlotte Bronte is believed to have died from it. As with so much else about pregnancy, the long-term effects of hyperemesis are mostly unknown: “Because they see HG as a maternal disorder that lasts three months, they don’t fund the research for it,” said Kimber MacGibbon, founder of the HER Foundation, a patient advocacy group.

Three decades before Zofran arrived on the scene, thalidomide seemed like an answer. The German drug was marketed as a sedative and sleeping pill. But it also eased nausea and was believed to pose no dangers to human fetuses — until women began giving birth to babies with severely deformed limbs. After thalidomide was banned in the early 1960s, doctors and women relied on a drug called Bendectin that had received FDA approval in the 1950s specifically for morning sickness and had a long track record for safety; still, lawsuits eventually blamed it for fetal harm, ranging from skeletal malformations to blood disorders and cancer. The claims proved to be unfounded, but in 1983, the litigation-weary manufacturer voluntarily yanked it from the market. For the next 30 years, there was no FDA-approved treatment for NVP.

Other reproductive-health scandals erupted over the cancer-causing synthetic estrogen DES, which was prescribed to prevent miscarriages, and the potentially deadly Dalkon Shield intrauterine device, used to prevent pregnancy. In their aftermath, the ethical and scientific pendulum swung in the direction of extreme caution.

Pharmaceutical companies and regulators concluded that the best way to avoid injuring women and their offspring — and the resulting crush of lawsuits — was to stop doing research on all women. “The fear of bad outcomes in pregnancy led to this sort of general exclusion,” said Wood, the former FDA official. In 1977, the FDA issued formal guidelines stating that women of “childbearing potential” — i.e., anyone who had not gone through menopause or been surgically sterilized — could only be included in late-stage clinical trials, after the safety and effectiveness of a drug had already been established (a rule widely interpreted as “never”).

Thanks in large part to the furious lobbying of feminists and anti-AIDS activists, the FDA finally reversed its stance against most women in research in 1993. But pregnancy remained a conundrum. The influential Institute of Medicine argued in a report co-edited by Faden, that “If a drug is going to be used in pregnant women, then the availability of safety and effectiveness information” is critical, including “adequate information about the risks and benefits.” Moreover, pregnant women should be “treated as competent adults capable of making their own decisions.”

Over the next two decades, the FDA encouraged the pharmaceutical industry in numerous ways. It ran a series of meetings and drafted a “guidance” on how to ethically determine the biochemical and physiological effects of drugs on the pregnant body. It spent years revising labeling rules on drug safety during pregnancy (the final version was issued in 2014) and pressed companies to establish pregnancy registries to simplify tracking adverse outcomes in drugs.

Yet, widespread aversion to prenatal research persisted. The National Institutes of Health continued to categorize pregnant women as “vulnerable,” with a “questionable” capacity to give informed consent — in the same category as kids, prisoners, and the mentally disabled. Conducting research on mothers-to-be was complicated and costly, and women themselves were often hesitant to sign on. “We honestly haven’t really addressed the issue of actively trying to recruit pregnant women into clinical trials,” a research expert for the drug industry said in a recent interview, speaking on the condition of anonymity. A 52-page document by the Pharmaceutical Research and Manufacturers of America, outlining principles for conducting clinical trials and revised in 2015, doesn’t contain a single reference to pregnancy.

Physicians responded by doing what they have always done: They prescribed drugs to pregnant patients “off label,” and shared the benefits and potential risks in medical journals and at conferences. The scientific establishment and the FDA consider this part of the basic practice of medicine, beyond the scope of regulators. The result was something of a vicious cycle, Faden said. “If your product eventually will be used in this population anyway, off label, what’s your incentive for testing the drug in pregnant women before it’s approved?”

Zofran’s introduction in 1991 occurred in the midst of this research vacuum. The drug worked by blocking the action of the chemical serotonin in the brain’s so-called vomiting center. It had been extensively tested on cancer and surgical patients, and on pregnant rats and rabbits. These studies showed “no evidence of impaired fertility or harm to the fetus,” the FDA-approved package insert said. But because animal studies are imperfect predictors of human toxicity and there were “no adequate and well-controlled studies in pregnant women,” the drug “should be used during pregnancy only if clearly needed,” the label added.

Plenty of ob/gyns believed it was needed — desperately. The journal Lancet soon published letters from doctors in Greece and Britain who had used Zofran on patients with severe hyperemesis. Physicians in Hong Kong described a patient so weak that she had considered having an abortion — until the drug turned her pregnancy around. The HER Foundation’s MacGibbon had HG with both her kids, and the drug was such a salvation that she and her husband joked about naming their daughter “Zofrana.” As a registered nurse, she understood the off-label dilemma, “but I knew that if I didn’t [take it], literally, I would just sit there and puke until I couldn’t breath.”

By the time Marquita Smiley was pregnant with Zaidan in 2013, Zofran/ondansetron was available in both liquid and pill form and as a generic from 30 or so manufacturers. The online price for 30 pills had plummeted from nearly $800 to $26. Last year, more than 21 million prescriptions were filled in the U.S. for all uses of the drug, according to an analysis by IMS Health — 10 times as many as in 2006. Doctors were no longer reserving the drug for only the most difficult cases, said Smiley’s lawyer, Don McKenna of the Birmingham law firm Hare Wynn. “It got to the point where if anyone complained of an upset stomach, they would get a prescription.”


Although doctors may decide to prescribe a medication for unapproved uses, it’s illegal for drug companies to encourage them to do it. In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line.

The allegations originated with ex-Glaxo marketing execs turned whistleblowers. The DOJ accused the company of engaging in all kinds of banned behavior to drive up sales — plying doctors with Caribbean vacations and hunting trips, misreporting clinical trial findings to a medical journal, withholding safety data from the FDA. The most serious, criminal charges covered the antidepressants Paxil and Wellbutrin and the diabetes drug Avandia. But in a civil settlement, DOJ said Glaxo had also spread “unsubstantiated and/or false representations” about Zofran’s use for morning sickness and “paid illegal remuneration” to doctors to promote and prescribe the drug, in violation of federal anti-kickback laws. Glaxo didn’t admit any wrongdoing where Zofran was concerned, but it pleaded guilty to fraud in connection with other drugs and paid a $3 billion fine, the largest ever levied against a drug maker. (Read ProPublica’s reporting about another drug in the civil case, the asthma medication Advair, here.)

The DOJ case hit the news at a delicate moment. For years, reports in medical journals raised few concerns about the Zofran’s use in pregnancy, but they were small and frequently observational — hardly the scientific gold standard. By 2012, however, large-enough numbers of pregnant mothers had used the drug to conduct more meaningful analyses. Researchers associated with the National Birth Defects Prevention Study found an increased risk of cleft palate in infants whose mothers had used ondansetron (a separate, unpublished analysis detected a “modest increased risk” of the type of heart problem suffered by Marquita Smiley’s son). Next came studies based on medical registries in Denmark and Sweden that tracked every pregnancy in those countries going back to the 1990s. One found no difference in birth defects between the Zofran-exposed and unexposed babies; another found an elevated risk — up to twice as high — of hole-in-the-heart defects.

Among scientists, the inconsistent studies triggered calls for more research but no major alarms. Birth defects afflict 3 percent of babies, and heart defects are the most common among them. If ondansetron does harm the fetus, “It absolutely can’t be anything huge or we would have already seen it,” said Christina Chambers, a professor at the University of California, San Diego School of Medicine who is a leading expert on environmental exposures and pregnancy.

Plaintiffs lawyers, though, thought they saw plenty of red flags. Over the next couple of years, they hired their own experts and began digging through everything from adverse-event reports filed with the FDA (more than 450 involving prenatal exposures), to the LinkedIn profiles of Zofran sales people, to obscure Japanese medical journals in which scientists working for Glaxo had published animal studies in the early 1990s.

By this spring, parents had filed more than 200 lawsuits, alleging that Zofran caused heart defects, cleft palates, and kidney problems in babies exposed to the drug in utero; in a few instances, the babies died. Lawyers contended there might be many more cases but for recent U.S. Supreme Court rulings that make it almost impossible for consumers in all but a few states to sue for injuries if the medication at issue was a generic version of a brand-name pill, as ondansetron is for Zofran. One state whose courts did allow such lawsuits was Alabama — until legislators there rewrote the law in 2015. Marquita Smiley, who took generic ondansetron, filed her lawsuit last fall, just before the courtroom doors slammed shut.

In a written statement, Glaxo said the allegations linking Zofran to birth defects are “entirely unfounded,” and pointed to the FDA’s rejection last fall of a citizen’s petition that had sought stronger pregnancy warnings on the label. The company said doctors have a right to “assess the health care needs of their patients and apply their own knowledge, training, and experience in deciding whether the therapeutic benefits of a medicine outweigh the potential risks in each patient.”

But plaintiffs’ lawyers argue that drug makers have a heightened responsibility to assure that medications likely to be used in pregnancy are safe — especially if they are used to treat a condition as common as morning sickness, and if they are marketed off-label.

“When you throw a stone in the water, you have to expect there will be ripples,” said Tobias Millrood, a Philadelphia lawyer who is one of the lead counsels. “It’s really quite that simple.”


(Bob Miller for ProPublica)

Under Alabama law, a woman who uses illicit drugs while pregnant can be arrested, prosecuted and stripped of her parental rights — even if she was just using marijuana to treat her morning sickness. Smiley’s agency, the state Department of Human Resources, is the one often called upon to investigate allegations that pregnant women and new mothers have chemically endangered their babies. Smiley doesn’t handle those kinds of cases, but she knows irony when she sees it: A woman could face 10 years in prison for endangering her unborn child with drugs, while a huge corporation could put children at risk with a drug that’s never been approved for use in pregnancy.“It’s crazy,” she said.

Take a Valium, Lose Your Kid, Go to Jail

In Alabama, anti-drug fervor and abortion politics have turned a meth-lab law into the country’s harshest weapon against pregnant women. Read the story.

In her lawyers’ office one late winter morning, Zaidan was sweet-tempered and surprisingly sturdy, exploring the unfamiliar environment with sippy cup in hand. But his skin was blotchy and his hair had been falling out. The transplant drugs have wreaked havoc on his immune system, and he spent most of March in the hospital with breathing and other problems. As much as Smiley worries about his physical health, she’s just as concerned about his cognitive and emotional development. “He had a lot of loss of oxygen to his brain early on,” she said. She has to protect him from infections, which means keeping him way from a lot of people, “and I know that’s bad because he needs social skills.” Thanks to her job, she knows where to get help: “The social worker in me had him sign up for early intervention….I’m on the receiving end of the services now.”

With so much to worry about, she hasn’t been paying much attention to the lawsuit. Glaxo lost a bid earlier this year to have the cases dismissed, and now the litigation is in its discovery phase: “GSK has to put all its cards on the table and say … ‘This is everything we knew,’” attorney Don McKenna said. The latest research has not gone in the plaintiffs’ favor: A new study looking at birth outcomes in more than 1,000 women who took Zofran or ondansetron for hyperemesis suggested that HG itself, and not the drug, might be to blame for birth defects.

Back in Washington, D.C., there has been quiet movement on the larger issue of research and pregnancy. Bipartisan bills introduced this spring in the Senate and the House of Representatives would establish a task force on research specific to pregnant women and (in the case of the House legislation) require annual updates from the FDA. The FDA is scheduled to issue its own draft guidance entitled “Pregnant Women in Clinical Trials — Scientific and Ethical Considerations” later in the year.

The agency also has approved a new drug for morning sickness called Diclegis — basically, the long-abandoned Bendectin under a new name. Last year the American College of Obstetricians and Gynecologists revised its practice bulletin, urging doctors to prescribe Diclegis as the first line of defense against NVP and ondansetron only after weighing the benefits against the risks. But Diclegis is less powerful, more costly, and Smiley and her lawyers believe women are still being given ondansetron out of habit.

Recently, she saw an old friend at church who happened to be pregnant. “She said, ‘I’m having these really bad spells with nausea. It’s hard for me to get out of bed. It’s hard for me to go to work.’”

Smiley told her friend about Zaidan and everything her family had been through. “I was like, ‘Hey, whatever you do, I don’t know if there’s any truth to this, but please find something else to take.’”

What Will Become Of The UK’s Serious Fraud Office Investigation Into GlaxoSmithKline?…


“…In March 2017, the SFO director David Green has stated that he would like to resolve the GSK investigation by the time he leaves the SFO in April 2018…”

 

Back in 2014, after GSK were fined almost half a billion pounds for bribery in China, the UK’s serious fraud office began an investigation into the company. Ever since GSK’s department of justice fine (of 3 Billion) in 2012 for fraud, the company has been under scrutiny for fraud in several other jurisdictions (the UK investigation is just one of several allegations across several countries).

GSK are never held to account in the UK, despite being a UK company. The closest they came to it was- briefly during- the former CEO, Andrew Witty’s interview with the BBC’s Evan Davis; but even Davis, it seems, couldn’t really rattle the cage of the GSK Goliath.

GSK are the UK’s pharma cash cow, they are worth tens of billions. There are elite British business interests at stake here (and very powerful people involved), therefore I would be very surprised, if we will see any prosecution (or serious charges against executives) in the UK, as an outcome of the SFO investigation. The rich and the powerful operate above the law in the UK (and elsewhere), that much is clear.

Nonetheless it’s interesting to document the sheer scale of fraud allegations leveled against the company the last few years. It’s staggering how they get away with it, but we have come to expect that kind of thing when it comes to GSK.

 

This- from Trace-Compendium-gives a good outline of what’s happening…

https://www.traceinternational.org/TraceCompendium/DetailPDF?id=195&type=1

GLAXOSMITHKLINE PLC
INDUSTRY
Pharmaceuticals /Medical Devices /Health

CORPORATE HEADQUARTERS
London, Brentford, United Kingdom

SUMMARY OF ALLEGATIONS

Nationality of Foreign Officials: China
Summary of Allegations:

Between 2010 to June 2013, employees and agents of GlaxoSmithKline (China) Investment Co Ltd (“GSKCI”), wholly-owned indirect subsidiary of GlaxoSmithKline plc (“GSK”), and Sino-American Tianjin Smith Kline & French Laboratories Ltd (“TSKF”), joint venture between GSK, Tianjin Zhong Xin Pharmaceutical Group Corporation Ltd and Tianjin Pharmaceutical Group Co Ltd., allegedly provided bribes to Chinese public officials in order to increase sales of its pharmaceutical products. As part of the bribery scheme, bribes were allegedly paid to influence individual Chinese healthcare professionals writing prescriptions and hospital administrative staff responsible for product selection or purchase. The bribes were allegedly in forms of gifts, improper travel and entertainment with no or little educational purpose, shopping excursions, family and home visits and cash payments.

GSKCI allegedly utilized several methods to fund these improper payments to healthcare professionals. During the relevant period, GSKCI allegedly spent nearly RMB 1.4 billion (USD 225 million) on planning and travel services provided through third party vendors.

Also, GSKCI allegedly provided approximately RMB 14 million (USD 2.2 million), out of RMB 106 million (USD 17 million) in total spent as speaker fees, to speakers whose qualification as healthcare professional could not be verified. In addition, GSKCI allegedly used marketing programs to provide healthcare professionals with gifts such as laptops, tablets, and other electronic programs. Although the marketing program was purportedly for the purpose of providing clinics with tools to facilitate the storage and administration of vaccines that required refrigeration, the clinics were allegedly selected based on the potential to market additional GSK products. GSKCI allegedly paid out RMB 14.6 million (approximately USD 2.3 million) over the life span of the project.

GSK regional and district managers were allegedly aware of such improper practices.

For example, a sales representative allegedly submitted a 2013 work plan to sales manager describing intent to pay and provide holiday gifts to a healthcare provider in exchange for guaranteed monthly prescription of more than 40 boxes of GSK product.
These payments were allegedly recorded in GSK’s books and records as legitimate expenses, such as medical association sponsorship, employee expenses, conferences, speaker fees, and marketing costs.

Approximate Alleged Payments to Foreign Officials: Unspecified amount of bribes in forms of gifts, improper travel and entertainment with no or little educational purpose, shopping excursions, family and home visits and cash payments. Business Advantage Allegedly Obtained: Increased sales in China through increased prescriptions of GSK pharmaceutical products

Nationality of Foreign Officials: Iraq
Summary of Allegations:

On 6 April 2014, a person familiar with GSK’s Mideast operations emailed the company saying, “I believe GSK practices in Iraq violate the FCPA and the U.K. Bribery Act.”

According to the Wall Street Journal, the person said that GSK hired 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government.

A government-employed Iraqi emergency room physician allegedly prescribed GSK products, even when they weren’t in the hospital’s pharmacy and a competitor’s brand was in stock. The e-mail went on to say that GSK hired government-employed Iraqi doctors as medical representatives and paid their expenses to attend international conferences. GSK also allegedly paid other doctors high fees to give lectures in exchange for promoting and prescribing its drugs.

After GSK won a contract with the Iraqi Ministry of Health in 2012 to supply the company’s Rotarix vaccine,

GSK paid for a workshop in Lebanon for Iraqi Ministry of Health officials, the email alleged. That included paying for a doctor’s family to travel to Lebanon “so it would be a family vacation for him at the hotel.” Approximate Alleged Payments to Foreign Officials: Employment, travel and fees to government-employed physicians Business Advantage Allegedly Obtained: Promotion and prescription of GSK pharmaceutical products

Nationality of Foreign Officials: Jordan

Summary of Allegations:

According to e-mails first sent to the company in December, GSK sales representatives allegedly bribed doctors in Jordan to prescribe GSK drugs by issuing free samples that the doctors were then allowed to sell. GSK representatives also allegedly permitted Jordanian doctors to bring their spouses on business trips that GSK paid
for, according to the emails.

According to the e-mails, doctors were issued with business-class tickets to attend conferences but would
exchange them at travel agencies for two economy-class tickets, allowing their spouses or other family members
to come along for free, a practice local GSK employees were aware of.

It is against  GSK policy to allow airplane tickets to be exchanged for tickets of a lower value or refunded. The emails alleged that GSK sales representatives gave doctors in Jordan up to 60 free samples of its vaccine Synflorix, which they then sold on at up to USD 70 a vial.

Approximate Alleged Payments to Foreign Officials: Free samples, tickets for spouses/family members to travel with healthcare professionals Business Advantage Allegedly Obtained: Unspecified

Nationality of Foreign Officials: Lebanon

Summary of Allegations:

In Lebanon, GSK employees allegedly gave doctors free Synflorix vials as part of an incentive scheme to get them to prescribe the vaccine and not its competitors, according to a whistleblower e-mail to company representatives. GSK allegedly made payments to “key opinion-leader” doctors?influential and leading practitioners in their field?for lectures and other speaking engagements that may not have taken place, the emails allege, in return for them prescribing more drugs produced by GSK. Approximate Alleged Payments to Foreign Officials: Free vials of a GSK vaccine Business Advantage Allegedly Obtained: Prescriptions of the GSK vaccine Nationality of Foreign Officials:

 

Poland
Summary of Allegations:

GSK is facing criminal investigation in Poland for allegedly bribing doctors to promote its lung drug Seretide. GSK said the allegations related to the way a respiratory disease program was conducted in the Lodz region. The 2010-12 program centered on GSK’s top drug Seretide, also known as Advair, which has worldwide sales of around USD 8 billion a year.

According to the BBC, one doctor has admitted guilt and has been fined and given a suspended sentence, after accepting 100 pounds (USD 170) for a lecture he never gave. The bribes allegedly involved 11 doctors and a GSK regional manager.

GSK said an internal investigation into the matter found evidence of inappropriate behavior by just one employee, whom it disciplined in 2011.

Approximate Alleged Payments to Foreign Officials: Unspecified
Business Advantage Allegedly Obtained: Sales of a GSK pharmaceutical product

 

Nationality of Foreign Officials: Romania

Summary of Allegations:

 

On 27 July 2015, a whistleblower sent a letter to company management alleging improper payments in Romania. GSK allegedly made improper payments of hundreds or thousands of euros to Romanian doctors to prescribe GSK’s products, including treatments for Parkinson’s and prostate issues. The improper payments allegedly consisted of payments for speaking engagements where the doctor did not actually speak, or spoke less times than the number of engagements paid for. Other alleged improper payments include payments for “participating” in advisory boards and for doctors to take international trips. Approximate Alleged Payments to Foreign Officials: Payments for speaking engagements, travel and participation in advisory boards
Business Advantage Allegedly Obtained: Prescriptions of GSK pharmaceitucal products

Nationality of Foreign Officials: Syrian Arab Republic

Summary of Allegations:

GSK announced it would be investigating a whistleblower report it received on 18 July 2014 addressed to Chief Executive Andrew Witty and Judy Lewent, chair of GSK’s audit committee. According to the e-mail, GSK employees paid incentives to doctors, dentists, pharmacists and government officials to win tenders and to
obtain improper business advantages. “GSK has been engaging in multiple corrupt and illegal practices in Syria and its internal controls for its Syrian operation are virtually non-existent,” the email said. In addition, the email said GSK had engaged in apparent Syrian export control violations, including an alleged smuggling scheme to ship the drug component pseudoephedrine to Iran from Syria via Iraq. Pseudoephedrine is
regulated as a precursor for making methamphetamine.

The whistleblower’s email alleged that GSK used its own employees and Syrian distributor Maatouk Group to make illicit payments. The email listed a range of alleged improper activities, including payments of USD 1,500 each to two doctors to promote Panadol. The document also highlighted bribes paid to pharmacists and payments for medics to visit a Mediterranean holiday resort.

Approximate Alleged Payments to Foreign Officials: Unspecified

Business Advantage Allegedly Obtained: Unspecified

 

Nationality of Foreign Officials: United Arab Emirates
Summary of Allegations:

On 7 October 2014, GSK began an investigation into allegations of corrupt payments in the United Arab Emirates following a whistleblower complaint. The company confirmed the investigation following the receipt of an email alleging improper payments, which was purportedly from a GSK sales manager in the United Arab Emirates.

Approximate Alleged Payments to Foreign Officials: Unspecified
Business Advantage Allegedly Obtained: Unspecified

ENFORCEMENT RESULTS

Agencies: China: Ministry of Public Security
Results: Civil Penalty
Year Resolved: 2014
Compliance Monitor: N/A
Ongoing: No

Details:

On 22 July 2013, following a meeting with Chinese authorities, Abbas Hussain, GSK’s President International, Europe, Japan, Emerging Markets & Asia Pacific, said, “Certain senior executives of GSK China who know our systems well, appear to have acted outside of our processes and controls which breaches Chinese law. We have zero tolerance for any behaviour of this nature. I want to make it very clear that we share the desire of the Chinese authorities to root out corruption wherever it exists. We will continue to work together with the MPS and we will take allnecessary actions required as this investigation progresses. . . .”

On 3 September 2013, Reuters reported that a Chinese police investigation claims the alleged bribery was coordinated by GSK, and not the work of a few individual employees. It reports that GSK implemented salary policies based on sales volumes and goals that could not be accomplished without “dubious corporate behavior.”

On 19 September 2014, GSK agreed to pay an unprecedented USD 491.5 million to Chinese authorities after the company’s Chinese subsidiary was found guilty of bribery. The ruling followed a one-day trial in Changsha, Hunan, and the penalty marks the largest corporate fine ever imposed in China. GSK published an apology in Chinese to the Chinese government and its people on its website. And previously, in 2013, a confession by GSK’s Vice President of China operations was broadcast on television.

Agencies: China: Ministry of Public Security
Results: Conviction, Prosecution of Individuals
Year Resolved: 2014
Compliance Monitor: N/A
Ongoing: No
Details:

In China, four GSK executives have been detained pursuant to the Ministry of Public Security’s investigation of potential economic crimes. According to a Bloomberg News report from 15 July 2013, the executives are:
Huang Hong (a GSK business development manager), Liang Hong (GSK’s vice president and operations manager in China), Zhang Guowei (a GSK human resources director), and Zhao Hongyan (a GSK legal affairs director). According to the same story, all four executives are Chinese nationals. Bloomberg News also reported that the head of GSK in China, Mark Reilly, “returned to the U.K. on a routine, planned business trip and has
been working from company headquarters on the response to the investigation.”
On 16 July 2013, the Telegraph cited a statement from the Ministry of Public Security as saying that “[a]fter initial questioning the suspects have admitted to the crimes, and the investigation is ongoing.” The Telegraph also reported that the vice president of operations in China, Liang Hong, who is one of the four detained executives, confessed to the crimes on a news broadcast on 15 July 2013.

The Guardian reported on 26 July 2013 that an additional group of eighteen or more GSK employees have been detained by the police in Zhengzhou. Additional details were unavailable. On 14 May 2014, Chinese prosecutors filed criminal charges against Mark Reilly. Reilly allegedly ordered his sales teams to bribe doctors and hospitals to achieve the company’s sales targets, according to police in Changsha, Hunan province. Two other GSK executives, allegedly helped execute the bribery scheme, which netted the company revenue worth billions of yuan. GSKs drugs in China cost more than those in other countries because the company allegedly inflated drug prices to recoup bribery funds, according to Chinese police. Reilly was sentenced to three years in prison after allegedly ordering his sales teams to bribe doctors and hospitals to achieve the company’s sales targets. Reilly received a three-year prison sentence that was suspended for four years; he will be expelled from China following the four-year suspended sentence.

Agencies: Internal Investigation
Results:
Year Resolved:
Compliance Monitor:
Ongoing: Yes
Details:

The Wall Street Journal reported on 7 July 2013 that GSK had begun investigating “allegations that sales personnel in China rewarded doctors with cash and perks for prescribing Botox, and allegedly tried to cover
their tracks by using private email, as part of a broader probe into allegations of bribery that date back several years.” According to the article, an anonymous tipster presented GSK with allegations that between 2004 and
2010 its China sales staff provided doctors with speaking fees, cash payments, dinners and all-expenses-paid trips in return for prescribing the drug company’s products.

On 15 July 2013, GSK released a statement indicating the GSK is reviewing all third party agency relationships and have put an immediate stop on the use of travel agencies that have been identified so far in the Chinese allegations/investigation. GSK is conducting a thorough review of all historic transactions related to travel agency use and intending to conduct a rigorous review of the company’s compliance procedures in China.

In April 2014, the Wall Street Journal reported that GSK terminated employees in China following increased monitoring of employees amidst bribery probes, but it is not known how many employees have been let go.

GSK previously said that it employed about 7,000 people in China. GSK confirmed that it fired staff in China for bribing officials in 2001 in a case that predates the wider allegations of corruption. About 30 staff in GSK’s vaccines business were dismissed for bribing Chinese officials after they were found to be involved in bribing Chinese officials and taking kickbacks, according to Reuters.

In addition, GSK is conducting an internal investigation into the alleged bribery in Poland, the United Arab
Emirates, Lebanon, Jordan, Syria, Iraq and Romania.

Agencies: Poland: Central Anticorruption Bureau
Results:
Year Resolved:
Compliance Monitor:
Ongoing: Yes
Details:
Poland’s Central Anti-Corruption Bureau (“CAB”) opened a criminal investigation into GSK and announced on
14 April 2014 that 13 people had been charged in connection with the investigation.

Agencies: United Kingdom: Serious Fraud Office
Results:
Year Resolved:
Compliance Monitor:
Ongoing: Yes
Details:

According to the media reports, GSK met with the Serious Fraud Office (“SFO”) regarding the allegations in China on 21 July 2013. However, the SFO reportedly has not launched a formal investigation into the matter. On 27 May 2014, GSK disclosed that the UK’s Serious Fraud Office opened a formal criminal investigation of the company’s commercial practices. GSK has stated that it has responded to the investigation.

In March 2017, the SFO director David Green has stated that he would like to resolve the GSK investigation by the time he leaves the SFO in April 2018.

Agencies: United States: Department of Justice
Results: No Action
Year Resolved: 2016
Compliance Monitor:
Ongoing: No
Details:

The DOJ’s investigation of the pharmaceuticals industry in a variety of countries appears to be ongoing. On 30 September 2016, the DOJ reportedly told the FCPA Blog via email statement that they have concluded their investigation and will be taking no further action.

Agencies: United States: Securities and Exchange Commission
Results: Cease-and-Desist Order, Civil Penalty
Year Resolved: 2016
Compliance Monitor: N/A
Ongoing: No
Details:

On 30 September 2016, GSK, without admitting or denying the SEC’s findings, entered into cease-and-desist order to settle the charges that GSK violated the internal controls and books and records provisions of the FCPA. As part of the settlement, GSK agreed to pay a civil money penalty in the amount of USD 20,000,000 to the SEC. In addition, GSK agreed to provide report of the status of GSK’s remediation and implementation of compliance measures to the SEC for a period of two years at no less than nine-month intervals.

The SEC noted its consideration of GSK’s prompt remedial actions and full cooperation provided to the SEC in
coming to the settlement.

ENTITIES/INDIVIDUALS INVOLVED

GlaxoSmithKline plc (“GSK”)
GlaxoSmithKline (China) Investment Co Ltd (“GSKCI”)
Sino-American Tianjin Smith Kline & French Laboratories Ltd (“TSKF”)
Tianjin Zhong Xin Pharmaceutical Group Corporation Ltd
Tianjin Pharmaceutical Group Co Ltd.
Shanghai Linjiang International Travel Agency (alleged intermediary of GSK in China)
Mark Reilly (head of GSK’s China operations)
Xi’an China Travel Service Co.
Maatouk Group, Syrian distributor
Huang Hong
Liang Hong
Zhang Guowei
Zhao Hongyan

DETAILS OF HOW CONDUCT WAS DISCOVERED
Discovery Method: Whistleblower
Details:

A person familiar with GSK’s Mideast operations emailed the company and threatened to disclose to the DOJ
and SEC.

Country: Iraq

Discovery Method: Whistleblower
Details:

The whistleblower who disclosed bribe allegations in Syria said the information would be passed on to the DOJ
and SEC.

Country: Syrian Arab Republic
Discovery Method: Whistleblower
Details:
Whistleblower e-mail.

Country: Romania
Discovery Method: Whistleblower
Details:

In January 2013, an anonymous 5,200-word email describing a systemic fraud and bribery scheme at GSK was received by the GSK board. Over the next 17 months, the whistleblower sent nearly two dozen emails to Chinese authorities, GSK executives and auditor, PricewaterhouseCoopers (“PwC”). Despite the emails, GSK dismissed the whistleblower allegations as a “smear campaign” and neither properly
investigated the allegations, improve its internal controls nor change its marketing practices.

Country: China

Discovery Method: Whistleblower
Details:
Whistleblower e-mails.
Country: Jordan

Discovery Method: Whistleblower
Details:
Whistleblower e-mails.
Country: Lebanon

Discovery Method: Unspecified
Details:
Country: Poland

KEY TAKEAWAYS
TBD

RELATED DOCUMENTS

GlaxoSmithKline plc: Form 20-F (4 March 2011)
Wall Street Journal: “Glaxo Probes Tactics Used to Market Botox in China” (7 July 2013)

New York Times: “GlaxoSmithKline Accused of Corruption by China” (11 July 2013)
Bloomberg News: “Four Glaxo China Executives Held in Criminal Probe” (15 July 2013)
New York Times: “Glaxo Used Travel Firms for Bribery, China Says” (15 July 2013)

Telegraph: “GSK executive confesses to bribery on Chinese television” (16 July 2013)
Telegraph: “GlaxoSmithKline briefs Serious Fraud Office over China case” (20 July 2013)

Guardian: “GlaxoSmithKline contacts Serious Fraud Office over its China activities” (21 July 2013)
Press Release: “GSK statement regarding recent meeting with Chinese authorities” (GlaxoSmithKline plc) (22

July 2013)

International Business Times: “GlaxoSmithKline Bribery Scandal: 18 More People Arrested in China” (27 July
2013)
Reuters: “Bribery by GSK China was coordinated at company level: Xinhua” (3 September 2013)
Wall Street Journal: “GlaxoSmithKline Cuts Staff in China Amid Probe” (4 April 2014)
Wall Street Journal: “Glaxo Investigates Bribery Accusations in the Mideast” (6 April 2014)
Reuters: “GSK faces criminal bribery investigation in Poland” (14 April 2014)
Wall Street Journal: “Glaxo Investigating Bribery Claims in Jordan and Lebanon” (16 April 2014)
Wall Street Journal: “Glaxo Being Investigated by U.K. Serious Fraud Office” (28 May 2014)
GlobalPost: “Exclusive: Allegations of GSK corruption spread to Syria” (24 July 2014)
Reuters: “Exclusive: GSK faces new corruption allegations, this time in Romania” (29 July 2015)

SEC: Cease-and-Desist Order (GlaxoSmithKline plc) (30 September 2016)
FCPA Blog : “GSK pays SEC $20 million to settle China FCPA violations” (30 September 2016)

GlaxoSmithKline: Form 6-K (26 October 2017)
New York Times: “Drug Giant Faced a Reckoning as China Took Aim at Bribery” (1 November 2016)
The Wall Street Journal: “SFO Moving Into High Gear to Resolve Big Corruption Cases” (22 March 2017)

© 2017 TRACE International, Inc.

GSK’s New York Guinea Pig Orphans…


Ginea-Pig-Kids

 

“…One New York social worker told the BBC she had never been informed that the drugs she was administering to children were experimental and highly toxic. Jacklyn Hoerger said, “We were told that if they were vomiting, if they lost their ability to walk, if they were having diarrhea, if they were dying, then all of this was because of their HIV infection.”

In fact it was the drugs that were causing many of the problems. The BBC identified pharmaceutical giant GlaxoSmithKline as one of the companies that provided drugs for the tests….”

http://allnurses-breakroom.com/lounge/bbc-reveals-nyc-86567.html

Interesting documentary from the BBC on Youtube about how GSK provided drugs to be tested on poor New York orphans.

This is an old story, however I had not seen the documentary, and I will delve into this story further at a later date…

This atrocity was reported back in 2004…

Have GSK changed?

Are they more caring?, more humane? or more ethical?

What do you think?


http://news.bbc.co.uk/2/hi/programmes/this_world/4038375.stm

 

‘Serious side-effects’

One of the homes to which HIV positive children were taken was the Incarnation Children’s Center, a large, expensively refurbished red-bricked building set back from the sidewalk in a busy Harlem street.

It is owned by the Catholic church and when we attempted to talk to officials at Incarnation we were referred to an equally expensive Manhattan public relations company, which then refused to comment on activities within the home.

Dr David Rasnick from the University of Berkeley

Dr Rasnick is internationally renowned for his work on numerous diseases, including cancer

Hardly surprising, when we already knew that highly controversial and secretive drug experiments had been conducted on orphans and foster children as young as three months old.

We asked Dr David Rasnick, visiting scholar at the University of Berkeley, for his opinion on some of the experiments.

He said: “We’re talking about serious, serious side-effects. These children are going to be absolutely miserable. They’re going to have cramps, diarrhoea and their joints are going to swell up. They’re going to roll around the ground and you can’t touch them.”

He went on to describe some of the drugs – supplied by major drug manufacturers including Glaxo SmithKline – as “lethal”.

https://www.democracynow.org/embed/story/2004/12/22/guinea_pig_kids_how_new_york

 


Yes Bob… This Shit Really Does Just Write Itself..


Unsurprising to see the revolving door swing so wide, and how blatantly, however it’s a disturbing development nonetheless..


 

http://fiddaman.blogspot.ie/2017/06/trump-nominates-king-spalding-attorney.html

 

Wednesday, June 07, 2017

Trump Nominates King & Spalding Attorney

http://www.facebook.com/plugins/like.php?href=http://fiddaman.blogspot.ie/2017/06/trump-nominates-king-spalding-attorney.html&layout=button_count&show_faces=false&width=100&%20action=like&font=arial&colorscheme=light

Who is Christopher A. Wray?

Well, he’s a litigation partner in King & Spalding’s Washington DC and Atlanta office.

And who, I hear you ask, are King & Spalding?

Well, they’re the law firm who just got spanked in Chicago. They defended GlaxoSmithKline, arguing that their antidepressant, Paxil, did not cause the suicide of Stewart Dolin.

The jury saw through the weak defence and found Glaxo liable.

Prior to joining the firm, Wray served from 2003 to 2005 as the Assistant Attorney General in charge of the U.S. Department of Justice’s (DOJ) Criminal Division, the same department who, in 2012, slammed down a $3 billion fine after GlaxoSmithKline pleaded guilty to a whole host of federal crimes.

So, what duties does one who becomes director at the FBI have to carry out?

Well, he’s basically responsible for its day-to-day operations.

The FBI has jurisdiction over violations of more than 200 categories of federal crimes.

So nice to know that one of King & Spalding’s biggest and wealthiest clients, GlaxoSmithKline, may now have someone to oversee any future criminal behaviour of theirs.

This shit just writes itself.

Nice move, Don.

Bob Fiddaman

60,000 People Had GSK’s Dangerous And Toxic Myodil Dye Injected Into Their Spines…


Just reading through an article from 2013 about an Australian woman who had GSK’s Myodil dye injected into her spine, and in the article it mentions that up to 60,000 other people had Myodil injected into them over the decades. I don’t know if this figure is a global estimate or just an Australian estimate, but either way, it’s extremely disturbing to think that 60,000 people have been crippled by GSK’s Myodil dye and that GSK couldn’t give a damn about their suffering.

Utterly shameful..


https://www.sunshinecoastdaily.com.au/news/artist-lives-with-pain/1829450/

Artist hanging on to hope after 40 years of screaming agony

Internationally renowned artist Philippa Stewart-Hall, from Palmwoods, endures crippling pain every day.
Internationally renowned artist Philippa Stewart-Hall, from Palmwoods, endures crippling pain every day.Iain Curry

PHILIPPA Stewart-Hall wakes in the middle of the night with a blood-curdling scream.

After almost 40 years, it’s something she’s grown used to.

In 1975, Mrs Stewart-Hall was admitted to hospital with a back injury and was subsequently injected with Myodil during a routine Myelogram before her operation.

Myodil was an injectable dye used by doctors for x-rays in myelography.

“They put you on this tray and balance you back and forth like a seesaw so the dye will go through your body,” Mrs Stewart-Hall said.

“They don’t take the dye out … it doesn’t take much to do the damage.”

Three months later Mrs Stewart-Hall knew something was wrong.

“I was still numb in one part of my leg,” she said.

“I was getting shocking cramps, I had to sleep standing up.

“These days it’s getting worse to the point where I will wake up screaming, thinking something is trying to attack my leg.”

Mrs Stewart-Hall has been diagnosed with peripheral neuropathy, but shows symptoms of arachnoiditis.

The constant pain felt is as if her legs are “a conduit for an electrical fault”.

A spokesman for Myodil supplier GlaxoSmithKline said although a link between Myodil and arachnoiditis was not established, they became aware of a possible association in 1971 and immediately warned of potential risk.

Myodil was not withdrawn from the market in Australia, but discontinued in 1987, when newer diagnostic radiographic techniques became available.

In 1999, a court action around Myodil was launched and Glaxo reached a settlement with claimants.

However fewer than 200 people received compensation, despite more than 60,000 people being injected with the drug.

Mrs Stewart-Hall is preparing to visit a neurosurgeon in three weeks to find out if anything can be done to slow down her condition.

“Once the nerve endings are gone, they’re gone,” she said. “I have to put up with it and get on with life.”

Fortunately Mrs Stewart-Hall still has the use of her hands and refuses to let it damage her brain.

The internationally-renowned artist has been a part of “the game” for about 30 years and revels in teaching children and adult beginners the tricks of her trade.

“I’ve got a lot of knowledge and I love to pass it on,” she said.

GSK asks for new trial over claims its anti-depressant labeling contributed to lawyer’s suicide


The manufacturer of an anti-depressant drug is trying to get out from under a $3 million jury judgment, which blamed it for a Chicago lawyer’s suicide, saying a federal judge made multiple mistakes that hamstrung the manufacturer’s defense against the claim its labels failed to warn the drug and its generic equivalent can lead to suicide.

On May 25 in U.S. District Court for Northern Illinois, the United Kingdom-based drug maker GlaxoSmithKline filed a motion for a new trial. The company’s American operations are centered in Philadelphia. GSK developed the anti-depressant Paxil.

Stewart Dolin, of Glencoe, a 57-year-old corporate lawyer with the Chicago firm of Reed Smith LLP, took paroxetine, a generic version of Paxil, for several days in July 2010, before killing himself by stepping into the path of a Chicago Transit Authority train in the Loop. In 2012, Dolin’s widow, Wendy Dolin, sued GSK, alleging the drug company was liable for her husband’s death.

Wendy Dolin argued the drug’s label did not adequately warn the drug could increase suicidal thoughts and behavior. GSK countered it did not make the actual drug the dead man had taken. Rather, paroxetine was made by the Mylan company. GSK further maintained the label’s text had passed muster with the U.S. Food and Drug Administration.

The case went to trial in March 2017, lasting almost five weeks, with the jury deliberating three days before finding GSK to blame April 20. Jurors awarded $3 million to Dolin.

GSK has asked Judge William Hart, who presided over the trial, to overturn the verdict, because plaintiff’s evidence was insufficient to reasonably support its case. If Hart does not accede to that request, GSK then wants Hart to grant a new trial, because GSK said Hart improperly admitted and excluded evidence, and gave off-base instructions to jurors before they deliberated.

One of the numerous miscues Hart committed, in GSK’s view, was to bar GSK’s expert witnesses from testifying against plaintiff’s claim the “hallmark” of suicides caused by Paxil-paroxetine, was their violent nature.

GSK said its experts would have told jurors that Dolin’s method of self-destruction was not uncommon for Chicago in 2010, as there was a cluster of train suicides in summer 2010 set off by a high-profile rail suicide in May that year. Further, the experts would have testified that when white, middle-aged men, like Dolin, kill themselves, they often do so more violently than other demographic groups.

As another example, GSK said Hart also stumbled when he refused to let GSK’s expert witness on the nature and dynamics of large law firms, testify to the pressures the 2008 economic downturn put on firms such as Dolin’s, and in turn, on a lawyer such as Dolin himself. GSK said this testimony would have shown Dolin committed suicide, not because of paroxetine, but because of anxiety and depression from work.

Another GSK expert was barred from testifying that anti-depressants, rather than causing suicides, have significantly reduced such acts.

“The Court (Hart) did not allow for the fair presentation of evidence: it gave Plaintiff free rein to violate basic rules of trial, while precluding GSK from responding and unreasonably restricting the presentation of its case,” GSK argued.

GSK further claimed Hart also fell short in his instructions to jurors as to how they were to approach deliberations, omitting “numerous essential instructions.”

According to GSK, in the instructions, Hart “misled” the jury about the drug maker’s duty to warn users and the FDA’s role in label contents, as well as failed to explain the requirements of a “failure-to-warn” claim.

“These many errors resulted in extraordinary prejudice to GSK, jury confusion, and ultimately a verdict unsupported by the weight of the evidence. A new trial is required,” GSK declared.

GSK is defended by the following firms: King & Spalding, of Atlanta, Ga.; Dentons US LLP, of Chicago; and Phillips Lytle LLP, of Buffalo, N.Y.

Dolin is represented by the Rapoport Law Offices, of Chicago, and Baum Hedlund Aristei & Goldman P.C., of Los Angeles.

GlaxoSmithKline Ventolin recall hits 1.1M units as drugmaker retrieves half-million more


http://www.fiercepharma.com/manufacturing/gsk-ventolin-recall-hits-1-1m-units-as-drugmaker-retrieves-half-million-more

GlaxoSmithKline has added three more lots of its Ventolin inhalers to its recent recall, bringing the total to more than 1.1 million units.

According to a recent FDA Enforcement Report, the drugmaker this month voluntarily recalled the three lots, amounting to 562,883 of the inhalers used by patients with asthma or COPD to prevent bronchospasms. The class II recall again is because the company discovered an elevated number of units that were out of spec for leak rate.

The company in March had recalled three lots amounting to 593,088 inhalers. This brings the total to 1,155,971 units, which a GSK spokesperson pointed out amounts to about 4%  of total US annual Ventolin volume. The inhalers were made at GSK’s plant in Zebulon, North Carolina.

GSK in late 2015 recalled nearly 130,000 Ventolin inhalers over a similar issue.

In an email Thursday, the GSK spokesperson said the extended voluntary recall “is due to product complaints relating to overly inflated overwraps or pouches”. He said that could could indicate leaking, which may result in the inhaler delivering fewer doses than anticipated on the dose counter. The company again pointed out the recall is not to the consumer level, meaning patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level, so products are being removed from those channels.

“GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this extended voluntary recall may cause,” he said.

Ventolin continues to be a strong-selling product for GSK, which is adding capacity to its production line for the product. While GSK’s top-selling respiratory drug Advair turned in fading sales in 2016, Ventolin had a 23% jump to about $527 million, as a competitor struggled with supplies of a competing COPD drug.

In February, the U.K.-based company informed local authorities it intended to build a $137 million, four-story facility at its site in Scotland for the production of salbutamol, the API in Ventolin.

Theresa May And GSK: Is This Why GSK Get Away With Decades Of Unethical Corporate Behavior?


Seems to me, it all boils down to economics.

When you have the prime minister of the UK, effectively bolstering the status of a company like GSK (a huge asset to the UK economy) perhaps that also helps the company to believe it can operate above the law, morals and ethics?

Does Theresa care about Seroxat ?

Does she even know anything about it?

Does she know about GSK’s decades of unethical behavior? Or Greg Thorpe’s Department of Justice Complaint? (the details of which would make your hair stand on end).

These are recent speeches from UK prime minister Theresa May at GSK’s Maidenhead factory.

1492787336988.jpg--Theresa+May+GSK+speech+sack

 

 

Why Is Greg Thorpe The Only GSK Whistle-Blower Willing To Speak The Truth About GSK’s 3 Billion Quid Pro Quo (Sham-Fine) With The US Department Of Justice?…


Greg Thorpe originally blew the whistle on GSK’s fraudulent activity- and it was as a direct result of Greg’s actions- that GSK were fined 3 Billion in 2012 by the department of Justice. Greg regularly leaves comments on this blog, and they are always extremely interesting, particularly in relation to the department of Justice- GSK fine -debacle.

I call this scandal a debacle because I have long thought that GSK’s fine of 3 billion, and the corporate integrity agreement etc, was merely a little slap on the wrist for GSK. People died because of GSK’s various unethical shenanigans; crimes committed by GSK over many years: many patients were harmed, maimed or killed. GSK should have had its license to trade revoked, instead the department of Justice fined them 3 months profits and allowed to them continue on -business as usual. The executives all sailed off into the sunset, dripping with even more wealth and money than they had previously earned – golden parachutes all-round for the GSK top brass-despite being party to the biggest health care fraud of the 21st century.

Astounding isn’t it?

I’ve always felt that the whole thing stank to high heaven, and furthermore, I have always wondered, why is Greg the only whistle-blower willing to tell the truth about this sham fine?

There were, apparently, another 5 whistle-blowers- why do they not speak out about the quid pro quo? Why do they not criticize Eric Holder and the revolving door? Why do they not speak out about this grave travesty of justice to consumers and patients? Why do they not speak about this slap on the wrist for GSK? Why do they not tell the public that far from being a success for patients, this fine was merely a sleight of hand and a smokescreen?- as GSK were allowed to continue on- as evident by their China-Bribe scandal in 214, to commit more bribery and fraud in different countries, further afield.

Why do they not inform the public about the real scandals of this debacle?

Thankfully, we have people like Greg, he’s not afraid to speak out- here is his latest comment-

https://truthman30.wordpress.com/2017/05/12/interesting-comment-by-whistle-blower-greg-thorpe-about-gsks-lamictal-scandal/#comments

May 13, 2017 – 3:58 pm High Plains Drifter

There are hundreds if not thousands in the DOJ that are to say the least, are not interested in real justice or the truth. They are not in lockstep with Jeff Sessions to say the least. They regularly monitor this site. Truthman knows this. I hate to coin a phrase, but this swamp cannot be fully drained.

I have been threatened and put myself at risk with everything I say…they violated my constitutional rights by putting a gag order on me for 9 1/2 years…so GSK could continue to reap off label marketing profits and worst of all patients and physicians were kept in the dark. The law I filed under, the False Claims Act has no provision for this conduct, for such a length of time. They are allowed to seal the case only to investigate whether it has merit. I was interviewed under oath by the FBI…3 months after I filed. every government agency was present who had a stake in the case…DEA, HHS, FDA, DOD, IRS, CIA, VA ,DOJ, FBI and others…Shortly after that, I was informed through Counsel that DOJ had dozens of people on the case, and a entire floor at DOJ working on the case. I assume this was true. The False Claims Act seal is to only be extended after they decide to take the case, usually 6 months, for good cause. Obviously it became apparent after 9 years that the seal only remained in place so DOJ could secretly, without public knowledge cut a deal with GSK or go to trial. During this long, long period of time, I was never told that they had joined my complaint until the 11th hour AFTER the settlement was reached. They used this tactic to threaten me with non joining and tossing me out for 9 years plus. During this time, patients continued to receive prescriptions on the 9 drugs I reported …physicians were kept in the dark. In short, the carnage continued…I consistently objected but to no avail. The lead prosecutor told me after I demanded that this go to trial that they “would bankrupt the company, and nobody would get anything”…at the time I thought the statement may have merit, although I now know it was sheer B.S. It would be hard to bankrupt a company with a market cap approaching 200 billion dollars or more.. So I kept my mouth shut while people died, and that haunts me to this day. It included my mother who developed congestive heart failure while kept on Avandia, for diabetes. I did not know GSK had hidden data showing it caused CHF, until it was too late. Hundreds of thousands of patients suffered the same effect, and this was going on with all the drugs reported…but did the DOJ care. Hell no they kept all of this important data sealed from patients and physicians. Why ?

The only reason I know now was to negotiate a sweetheart deal for GSK under a former attorney for the company….ERIC HOLDER. Holder was supposed to have recused himself. I have no evidence that he did. I BELIEVE after he gave GSK the quid pro quo for his law firm, Covington Burling….IN A FINE THAT AMOUNTED TO 3 MONTHS OF COMPANY PROFIT..that he had his hand on the trigger. Supporting this is the fact that he returned to Covington Burling to what has been reported as a “hero’s welcome and a huge raise”.They were even nice enough to give him his old office back, supposedly saved for his return. Holder committed many acts as Attorney General which warrant investigation …but none of this caliber.
GSK lost 3 billion dollars…one month of profit. Nobody was prosecuted .
Nine and one half YEARS is a long time…especially to rob the taxpayers who fund these illegal prescriptions of 40-50 billion dollars, at least. This would not even be what the punishment calls for under the statute. People should be in prison and maybe the company should be bankrupt…they continued the crimes all over the world after the settlement, while under 3 corporate integrity agreements, which called for the so called “death penalty” meaning no Federal program Medicare, Medicaid, VA, etc could use ANY GSK drug..

Why? It defies anything I can come up with except massive criminal fraud and corruption at the highest levels of government. This is a huge story, what I saw and heard over ten years makes me literally sick…yet Nobody seemingly will say anything…the other , second to file whistleblowers, were a joke…copied my complaint, took their money and hid . Mere accomplices to the crimes in my opinion.

Do I fear retaliation for what I say…hell yes I do, but someone has to speak up on this.

I am hopeful someone in the DOJ will come forward, everyone cannot be corrupt or cowardly and I hope we will see under a new administration, something done.
As to the post about Jeff Sessions.. the answer is I don’t know what he can or will do. All I know is my son was in second grade when this began , now he is about to graduate from college. This hasn’t been easy for my family or me and I’m not sure if the swamp can ever be drained. I know a lot more, but someone in the DOJ has inside information…I hope they come forward. The lead investigator, Sara Bloom …would be a good start.