How Doctors And Pharma Manipulate Drug Trials


The classic standardized clinical trial used to be a simple trial of one endpoint, like death. But to find a way to reduce cost or improve the chance for a positive outcome cunning doctors along with Pharma are producing trials where there are composite endpoints or even trials that have “run-in periods” that toss out anyone with an adverse effect before officially starting the trial. Many may not be aware of this so I discuss two major trials, one with a positive composite endpoint even though the drug killed more people than placebo and another, run-in trial, where the investigators tossed out 15% of the participants because of adverse effects before the official trial began.
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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.

Stevie Describes Her Experiences Of Being Prescribed Seroxat (Paxil) In 1996..


If you haven’t listened to James Moore’s podcast series you really should.

James has notched up 29 Podcasts so far, and I think they are brilliant.

Stevie was prescribed Seroxat in 1996. Like many others, she was told by her doctor (from the propaganda of GSK at the time) that she had a chemical imbalance and that Seroxat would fix this. This was all nonsense of course, and merely just a marketing ploy to get more people on these drugs. More drugs and more patients on them- means more money for Glaxo’s coffers…

GSK are felons, proven criminals and fraudsters, do you think they tell the truth about their drugs?

Of course they don’t.

Do you think they care about people who suffer side effects?

Of course they don’t..

All they care about is GSK..

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.

Complelling Description Of Psych Drug (Paxil/Seroxat) Addiction ..


From the Deadmansvitamin Blog

Check it out here:

https://deadmansvitamin.com/2017/06/20/psychiatry-one-brave-man/

Psychiatry And One Brave Man

I recently came upon Michael Priebe’s blog where he tells his story of withdrawal from Paxil and Xanax.   The sheer hell he experienced while doing so and his precise accounting of the complete lack of consideration shown him by psychiatrists.  He really hits the mark on that.

His story is told in 3 parts, but I will put it up in its entirety.  Here is a link to his site if anyone wanted to get into communication with him.
https://www.michaelpriebewriter.com

The bed was soaked yet again, the sheets saturated with a pungent, urgent sweat caused by nightmares and the prescription toxins that were trying to leave my body. Once again the few restless moments of sleep I was able to “enjoy” were interrupted by the nightly ritual of my wife turning on the lights and stripping the bed so that we could lie on a surface that didn’t feel as if Patrick Ewing had just used it as his postgame massage table.

It was still dark outside—predawn hours—but I had to be up for work shortly. I lived just outside of Milwaukee in Waukesha, WI, but I commuted to my post at Madison (technical) College each day, a trip that took an hour and fifteen minutes one way in good traffic that didn’t include getting stalled by the notoriously long freight trains that passed through Waukesha.

I worked in the Testing Center at Madison College, a position that had me dealing not only with large numbers of students most days but also with the daily ups and downs of office interaction with coworkers.

I couldn’t believe I was still functioning at my job. How did people not know about my illness? When would they find out? How would they find out? How long until I had some sort of public breakdown that ended the whole charade?

Or maybe everyone already knew and was too polite to say anything. I mean, how could they miss the rapid weight loss and the sudden and persistent appearance of midnight-black bags under my eyes? I was sure I looked like a zombie, but maybe it was all in my head. I was getting trapped in my head a lot lately.

As my wife tidied up the bed and quietly cursed my relentless night sweats, I worried about the upcoming workday. How would I make the drive in my sleepless condition? How would I survive the office in my anxious condition? Even the tiniest hint of workplace stress might send my compromised system into a panic that exposed my “secret” illness. I wasn’t well-rested or well-nourished enough to survive the ups and downs that define a normal day for most people. I could barely eat or sleep and I hadn’t been able to do either of those things sufficiently for months, ever since making the decision to stop taking the Paxil that had been prescribed to me for anxiety attacks suffered as a 21-year-old college student.

I was now in my mid-thirties, and I was starting to suspect that prescription medicines were causing me anxiety and a host of other problems rather than fixing much of anything. It took me a long time to come to that suspicion, but as they say, Better late than never.

Paxil—one of the biggest rock stars among the SSRI super pills that flooded our society around the millennium—had been causing certain health issues for me, not just physical ones but emotional ones as well. I had little energy or tolerance for exercise, I dealt with stress by drinking and eating too much, I gained weight, I had elevated blood pressure, I had elevated liver enzyme levels, and I just kind of “floated” through many aspects of life, unable to fully engage with existence the way other people did.

As I found myself within striking distance of turning 40, I desperately wanted the sort of healthy, “normal” life that I suspected other people had, so I finally decided the Paxil had to go.

I thought that life would get better when I quit taking the Paxil—remove the problem and life gets better, I reasoned—but I was wrong. And not just a little bit wrong. Once the Paxil was removed from my life, all hell broke loose and I didn’t even see it coming.

And a short time later, when I began cutting out the Xanax that the family doctor had prescribed to go along with my Paxil, all hell broke loose again. And once again, I truly couldn’t have predicted the strange physical pains and extreme mental anguish that would pummel me and not let up for years.

You see, that’s the problem with antidepressant and benzodiazepine withdrawal—especially the drawn-out or ‘protracted” kind like I experienced: you don’t expect it because few people even acknowledge that it exists. Doctors will dismiss you, loved ones will have a hard time relating to you, and all across the world the gigantic pharmaceutical machine will continue to grind its profitable gears without so much as a hiccup. The lines at CVS and Walgreens never get shorter, and people are still willing to turn their emotions and brains over to the modern inventions of profit-driven chemistry.

If you tell someone in the medical establishment that you are sick because of a prescription medication or because you are trying to quit one, they will most likely tell you that it sounds as if you need a different prescription medication.

Withdrawal? What is that?

The clock signaled that it was almost time for me to leave for work. There would be no more sweating in bed wondering about what new withdrawal-related symptoms the day would bring, because it was time to experience it all firsthand again. I always hoped that one morning it would all be over, but like Groundhog Day, each morning seemed to bring more of the same.

I left the relative safety of my bed and made my way across the hall to the spare bedroom that housed the treadmill. The sun was about to rise, and I needed to get the anxiety out of my system somehow. This wouldn’t be the spiritually refreshing, five-mile morning jog of a healthy man on his way out to conquer the world. No, this would be the uncoordinated and breathless five-minute effort of a man who was hoping for a small hint of calm in the anxious storms that were becoming the norm in his life.

When my short session on the treadmill was finished, I showered, dressed for work, and resolved that I would try to survive another day in the strange and terrifying new reality that was my world since quitting Paxil.

I went into the bedroom and kissed my wife goodbye. Fear was visible in my eyes and pulsated from my fragile body language. I felt as if some demonic force (or even a strong wind) could send me through the earth’s crust and into hell at any moment.

“Pray for me,” I told my wife in a desperate voice, and then I went downstairs to get on with the commute.

MORE THAN A GLIMPSE OF HELL PART 2: UNFROZEN

November 15, 2016

I awoke to a heavy circle of pain pressing down over my heart. The day seemed pale and gloomy in a way that was out of line for even the most overcast of winter mornings in Wisconsin. My house was full of family—brothers, in-laws, and a new nephew—but I felt alone, and that strange feeling of isolation swirled around the day’s first moments like an ominous wind.

“Good morning,” my youngest brother said in a singsong voice as he lowered my baby nephew close to my face. Playing the role of good hosts, my wife and I had surrendered our bedroom and were sleeping on an air mattress on the floor of my office. I wanted to stay on that air mattress indefinitely. I didn’t want to be awake. A photographer was scheduled to come over later in the day for family pictures, and I couldn’t imagine how I would play the role of “normal human being” for that.

“Say hello to your Uncle Mike,” my brother said to his firstborn.

Baby Jackson: He was tiny and fresh, a physical manifestation of both life’s beauty and God’s genius. I responded to the sight of his cherubic little face by descending even further into my sludgy pit of depression.

The thick blanket of terror and despair that now suffocated me was unlike anything I could recall feeling before. As dull sunlight tried to creep through the blinds of my office windows—as my one-month-old nephew cooed and stared at his confused uncle—I somehow felt that death was upon me.

Life equals death: that was how my mind was working now.

I’d quit taking Paxil the month before, after almost a decade and a half of ingesting it for the “generalized anxiety” that had been diagnosed by a family doctor and a short self-assessment checklist. Ever since quitting, my life had gotten confusing and sinister in a way that seemed to speak of impending doom.

I was 35 years old, and I truly felt that my best days were behind me.

Looking back on those first months of Paxil withdrawal, I can now recognize that some characteristics of my emotions were bubbling to the surface after years of being suppressed in some way. After spending so much time under the depths of medication, the emotions were understandably waterlogged and confused, so their first attempts to speak came through as some inexplicable depression—the kind one experiences when looking at a precious newborn baby, of course.

During antidepressant withdrawal, a certain numbness slowly gives way to the tingles of normal emotional experience, but nothing feels normal for a long time. In fact, a few months after suffering that baby-induced episode of depression, my younger brother and his wife were visiting again when I was overcome by another confusing sensation, a pain really.

We were watching the movie Ted—that classic, raunchy comedy starring Mark Wahlberg and a stuffed bear—when I noticed something strange happening to my face. It hurt in a way I didn’t recognize.

I’d been having weird body pains ever since taking that last dose of Paxil, but this sort of facial discomfort was a new one. My cheeks ached in a sharp way, especially near the dimpled areas involved in smiling and laughing.

Then I realized, my face was hurting because I’d been smiling and laughing. It wasn’t used to being stretched by such spontaneous displays of joy anymore.

My face had been frozen in some painful mask of withdrawal-induced stoicism for months, but now it was becoming “unfrozen.”

Becoming unfrozen: that’s an apt way to describe the profound and painful thawing process that takes place as prescription medication fades from a person’s mind and body. There is so much blunted awareness that wants to come back to life, and there are so many repressed emotions that want to have a voice, but the person in withdrawal really isn’t ready for such a flood of activity. He or she really isn’t strong enough. The person who was taking medication was flying around the edges of life without truly feeling or noticing thoughts for a long time, and then BAM. The pills are gone, and the icebergs start to melt. It is overwhelming and confusing.

Tears flow for little or no reason—sobs can be sparked by the last few “teachable” minutes of a family sitcom or by the melodrama of a Lifetime movie, for example—and then there is the unprovoked depression, the twisted anxiety, and the legions of thoughts that race day and night.

Day and night the thoughts and emotions run wild and confused, and after several months of this, when all of those thoughts and emotions continue to gather en masse and dance and fornicate like some sleepless group of college students on ecstasy, a person starts to wonder if maybe he’s insane.

And that’s when beginning the prescription madness anew starts to seem like a reasonable idea. Maybe the old pills were necessary. Or maybe some new ones are needed.

I had wanted so badly to be free of the medication, but shortly after quitting Paxil, I began to wonder if maybe it wasn’t time to admit defeat. Maybe I simply had to accept that I was broken in a way that could only be fixed by the contents of little orange bottles. I thought that I’d been making progress—painful progress in small increments, but progress nonetheless—but maybe I’d just been kidding myself.

Maybe the doctors—the ones who had played no small role in creating my current lunacy—really did have the answers, and maybe those answers only existed as 21st-century pills. Despite my misgivings, maybe I needed to go see one of them again, at least to make sure that I wasn’t dying. What was the worst that could happen if I went back to the “experts” in white coats, or maybe even went back to the Paxil or something similar?

I was about to find out.

MORE THAN A GLIMPSE OF HELL (PART 3): THE DOCTORS

January 18, 2017

As the world around me enjoyed a pleasant Saturday afternoon, I sat on my bed trembling, wondering if I was dying or going insane. While other people sipped lattes at coffee shops and ran casual errands or watched movies or college football, I fought to keep a faint grip on some sense of normalcy and well-being. I was 35-years-old and I felt utterly alone, as if I were some unfortunate astronaut whose tether to the mothership had been tragically severed while he was performing exterior maintenance on the craft.

Whoosh. Away I flew into a vast, empty darkness. As I careened by the occasional burning star or foreign sun, I could still see, faintly, the people and the life that I’d left behind. However, like a ghost, I could no longer touch my loved ones or share with them a laugh or a bit of sunny enjoyment on a weekend. I could only wonder about my murky place in the universe and hurt.

Two months or so earlier, I’d quit taking the Paxil that had been prescribed to me in college for that nebulous, modern affliction known as Generalized Anxiety. Since taking my last dose of those pink pills, the world had become a ghoulish place indeed. The physical symptoms of the drug withdrawal were uncomfortable—the constant nausea, chronic insomnia, and damned fatigue were draining—but it was the mental and emotional troubles that were truly frightening.

I could no longer make sense of or enjoy a normal day because my system was a toxic stew of depression, guilt, and dread. And I was routinely getting “trapped” in my own head, sequestered in uncomfortably close quarters with a motley mix of intrusive and negative thoughts. I was alone in such a way even when surrounded by loved ones. I was constantly slipping further and further into that empty darkness, and there only seemed to be one solution: I needed to get back on the Paxil.

Despite all the hard work I’d done up to that point to quit the potent medication—and despite the physical and emotional side-effects that had compelled my decision to quit in the first place—I reluctantly ran backward, back toward the prescription bottle that I still kept in my office, ostensibly in case I needed to pursue an emergency reinstatement such as this.

I fished a little pill from the orange, plastic bottle that had become such a familiar sight over the years, and I swallowed the bitter pharmaceutical hopefully. However, almost immediately I knew there was a problem. My bedroom started spinning and shifting, and I felt a nausea so profoundly upsetting that it seemed as if I were receiving some divine punishment from above—a punishment for crawling back to the devil instead of seeking God in my hour of need.

Because my body had fought so valiantly to rid itself of paroxetine’s chemical intrusions—after my tired mind had perhaps seen some reprieve in the near future—the entirety of my being protested the medication’s sudden return. My systems began to kick and scream, yelling at me, What have you done? My world seemed to be crashing down quickly, so I did what any married man in his midthirties would do under such duress: I called my mom.

“Please, please don’t think less of me for taking the pill,” I cried into the phone. “If I really need this medication because I’m sick, then please don’t think less of me.” I’d said that I was going to stop the medication and get healthy, but now I wasn’t sure what healthy was. Was it quitting the pills or taking them? Was I now sick because I’d been duped into taking the pills, or had I really needed the pills all along because I was born sick, the woeful and unlucky recipient of a deficient serotonin or norepinephrine supply.

As my mother listened to me cry and ramble, I felt like a scared little child who just pretended to be a man at times. Maybe I would never accomplish anything in life, not even the basic goal of sorting out my own wellness.

“You know that your dad and I would never think less of you,” my mom reassured me as only a mother can. Her words made me feel a little less like a failure, but I still felt gut-wrenchingly sick from the pill I’d swallowed. I wondered when the effects of that pill would subside, and I wondered when my wife would be getting home.

Dr. Feelgood was tanned and confident. He had a nice haircut and a paunch that seemed to speak of nice restaurants. He smiled often through the adornment of his goatee, and he often tried to reassure me that we were buddies more than anything. He acted casual and cool by throwing me winks and even the thumb-and-index-finger gunshot on one occasion, and he always gave me more pills when I asked for them.

Now that I was trying to get off the pills, Dr. Feelgood didn’t seem to fully understand me anymore. Either that or he didn’t want to admit to playing any part in the gruesome scene I was now presenting to him. I was in pain, all the time, and I was looking for answers and reassurance.

“Well, any withdrawal effects from the Paxil should have been relatively minor,” Dr. Feelgood said, “and they should have been over after a week or two.”

I couldn’t believe what I was hearing. I’d been off the Paxil—with the exception of that one, ill-advised reinstatement dose—for about four months, and nothing felt close to being over. If my harrowing pains and mental fog weren’t withdrawal, then I was seriously ill with something that seemed willing and able to kill me.

“It sounds like your pains are mostly stress related,” Feelgood said. “We all channel stress in different ways. If you don’t want to take an SSRI antidepressant, then maybe you’d have some luck with Wellbutrin.”

During that first, confusing half year of withdrawal, I ended up trying Wellbutrin, a norepinephrine-dopamine reuptake inhibitor that can apparently be prescribed for just about anything. I would later learn that the medication is marketed as both an antidepressant and as a smoking cessation aid (in addition to being used in an “off-label” manner for ADD and anxiety), and at Feelgood’s suggestion I took the multitalented pharmaceutical for about a week, until I could no longer stand how it filled me with useless adrenaline and agitation.

After the Wellbutrin, I almost tried other prescriptions, too. Every so often at work—when the withdrawal had me feeling as if I were about to lose my mind or go into cardiac arrest—I’d step outside and place a frantic phone call to Feelgood’s office. “Maybe Pill X or Pill Y will help,” I’d suggest to his nurse hopefully, but I never followed through on those suggestions, because the thought of eventually having to tackle yet another pill withdrawal was more than I could stomach. In addition to quitting the Paxil, I’d begun a tapering schedule to quit the Xanax that had been prescribed alongside the Paxil so many years ago (for acute instances of panic), and it was starting to seem like more than coincidence that my body pains and mental confusion increased as my levels of medication decreased.

After a while, I wanted nothing more to do with medications. I just wanted my doctor to define my situation and offer me hope that it would get better. I just wanted to know that I wasn’t dying, really. I wanted expert guidance that would take me through the prescription drug withdrawal process, but unfortunately, Dr. Feelgood didn’t have much to offer in that department.

“You should have quit the Xanax first,” was about all Feelgood had to say when I outlined my situation for him and pressed for withdrawal-specific information. I’m still not sure of the logic behind that statement, but I think he was giving a sly nod to the pain he knew I was yet to endure if I continued to cut my Xanax dosage. I’m almost certain that he had seen my sort of situation before (how could he not have?), but he never came out and said so. Instead, he acted a little confused.

I was starting to feel hopeless. Was I somehow imagining it all? Where besides the Internet could I find information regarding the strange physical and mental symptoms that had been torturing me for months? Where could I turn for help?

Oh, how I wished that I’d never left my first doctor. Some time earlier, when that primary care physician whom I’ll call The Good Doctor had started to get squeamish with my Xanax levels and refused to increase them any further, I’d sought a replacement for him and quickly found a sympathetic goatee in Dr. Feelgood. But now I desperately wished that I’d never switched loyalties.

The Good Doctor was a man who truly cared about his patients. He had a healthy BMI, a clean-shaven face, and a compassionate demeanor. He’d truly seemed to care about me. The Good Doctor had preached about the need to attack anxiety and other illnesses with methods other than pills, and when he didn’t understand something—as was the case when he admitted to being a little green about clinical levels of anxiety—he acknowledged his ignorance and tried to make a wise referral (in my case, a referral to a therapist whom I don’t remember ever calling).

The Good Doctor had been so kind and concerned. He’d talked about total wellbeing and things like exercise and a healthy diet. Appointments with him might last upwards of 40 minutes—well, well past the 15 minutes or 20 minutes that I’m sure the clinic held as sacrosanct “best-practice” parameters—and he was not a man who relished reaching for the prescription pad, which seemed to be a last resort for him.

The Good Doctor was the opposite of Dr. Feelgood in nearly every way—you would never be able to picture him going on the lecture circuit for big pharmaceutical companies or complying with calloused appointment time limits—and after a while, I think he was forced out of the medical establishment because of his unique posture.

One day, after I’d already been seeing Dr. Feelgood for some time, I received a letter from The Good Doctor, a communication he must have sent to all current and former patients. The letter said that he was leaving the medical profession to teach middle school. The Good Doctor said that he was looking forward to helping children learn about the planets.

Because my interactions with Dr. Feelgood had been disappointing—because the medical establishment didn’t seem to recognize prescription drug withdrawal as a condition that might last for months or years—I stayed away from doctors for a while, hoping that my situation would resolve itself so that I wouldn’t feel the need to talk to people in white coats anymore. However, when every new cut to my Xanax dosage brought with it otherworldly pains that left me searching for answers, I relented and made an appointment with Dr. Dipstick, a colleague of Feelgood’s who worked at a clinic across town.

By this time my situation had become more confusing than ever. I was often depressed, perplexed, fatigued, paranoid, and anxious, and new and fantastical body pains arrived on my doorstep regularly like taunting packages that had been sent by GlaxoSmithKline or Pfizer.

When I arrived for my appointment with Dr. Dipstick, I was broken, fragile, and nervous. I was desperately looking for someone to help me, but would he be the one? I tried to remain optimistic. Maybe he would smile and tell me, “The truth is that we see this all the time. We prescribe A LOT of these medications, so we have to help a lot of people get off them, too. Don’t worry, you’re not dying (friendly chuckle), you’re just going through withdrawal. You’re going to be all right, and I’m going to help you until you are fully recovered.”

But Dr. Dipstick didn’t say any of that. Instead, he was at first indifferent and then insulting. He actually made me feel foolish and ashamed for coming to him, and he often seemed confused as to what I wanted out of the visit. I tried to explain to him how I’d been suffering since quitting Paxil and then embarking on a Xanax-reduction schedule, but my words hit a wall. Maybe he was ignorant of prescription drug withdrawal, but if he was, he could have admitted that ignorance and providing a referral to someone else like The Good Doctor would have. Instead, he began to fill the void with blame.

“Do you ever need an eye-opener?” Dipstick asked me accusingly. His full beard made him appear gruff and even menacing.

“I don’t know what that is,” I told him.

“It’s when you need a drink to get going in the morning,” he explained, certain that he wasn’t telling me anything new.

“I don’t understand,” I said.

“Well, you said on your intake form that you drink beer pretty regularly, and just going through your medical history here, I see that you’ve had some elevated ALT and AST liver function numbers in the past.”

I tried to steer the conversation back to the Xanax taper that I was in the midst of—back to the anxiety and pains that increased with each step in that reduction schedule—but he just didn’t seem interested.

“Maybe you could refer me to someone who could guide me through this?” I asked, shaking. “Maybe to someone in your psychiatry department who specializes in anxiety and the medications used to treat anxiety.”

“I don’t know of anyone like that in particular,” Dipstick said flatly. “I can give you the general triage number for psychiatry, and they’ll probably have you speak with a social worker who will assess your needs.”

“How would a social worker help me?” I asked desperately.

“Well, maybe they’d refer you to a substance abuse treatment facility.” Dipstick answered, and my stomach sunk to previously unknown depths of despair.

I was beginning to see a disturbing picture emerge. When I’d been dutifully taking the medications, I’d been a valued patient. The doctors had happily provided with information about “transition periods” and side-effects. But now that I was quitting the medications, I was nothing to them but an addict or neurotic who needed to help himself. They had no medical information for me, and they seemed to have no insight into the many symptoms that were making my life hell.

The visit to Dr. Dipstick was beyond disheartening. I could have gotten more sympathy for my situation by talking to the clerks at the corner gas station, and I could have gotten more information by staying at home and using Google, which would ultimately prove to be an invaluable resource during my ordeal.

The visit to Dipstick was bad, but the paperwork I received from his office several days later was almost worse. Under Reasons for Visit, Dr. Dipstick had written Alcohol Abuse. My mind raced, wondering why he was doing this. Was he a friend of Dr. Feelgood? Was he trying to protect his friend—the one who had seen my Xanax prescription balloon under his watch—from some sort of lawsuit? Whatever the case, the comments he’d added to my official medical record had just further muddied the waters of my situation at the clinic. Those comments would be the first thing that a new doctor would read (if I went to one), so there was now zero chance that I’d get any educated help.

A few days after my visit with Dr. Dipstick, I called his office and spoke with a nurse, relaying to her my concerns about the Reasons for Visit remarks that Dipstick had stamped onto my record. I asked her if she could please have the doctor remove those remarks, and a short while later she got back to me.

“Dr. Dipstick says that he won’t do that,” she said, not unkindly. I was both heartbroken and furious. I wanted to drive to the clinic and confront the doctor in person, but of course, withdrawal had left me too timid and weak for such a heroic effort. Instead, I wrote a letter to the clinic a few months later.

As I wrote my letter, I tried to channel my frustration and righteous anger. I told the clinic about Dr. Dipstick’s dismissive and judgmental demeanor, and I told them about how the increase in my liver enzyme numbers—the increase that Dipstick had attached, along with my withdrawal pains, to beer drinking—appeared to have been just another dangerous effect of the medications I was quitting. Those numbers had returned to normal once I’d quit Paxil and started reducing Xanax dosages, so I felt that such a fact needed to be entered into some official record. I wanted to enter every last bit of my situation into some official record so that future withdrawal cases wouldn’t be dismissed so easily.

But I never sent the letter, just in case I needed an appointment in the future.

As it turned out, I did make another appointment with the clinic, a final visit to Dr. Feelgood that would be my last doctor appointment to date. By that time I’d been off Paxil for nearly 16 months and completely free of Xanax for about four months. New physical and mental pains were still arriving every week, and although I doubted Feelgood had any new insights for me, I wanted him to run some tests to make sure that I wasn’t seriously ill with something other than withdrawal.

“I could prescribe you something for Fibromyalgia pain,” Feelgood suggested almost sheepishly, “but it doesn’t seem like you want to go the medication route anymore.”

I shook my head. “I just want to make sure I’m not dying,” I said.

“Well, we can definitely run some tests,” Feelgood said. “We will definitely try to rule things out.”

 “And I want to start cutting back on my blood pressure medications, too,” I said. “Now that I’m getting healthier, I just don’t think I need them anymore. Certainly not three of them.”

“We can start reducing those and see how it goes,” Feelgood said without much hesitation. He demeanor was friendly, and I even thought I sensed a newfound respect coming from him. I don’t know if he’d ever seen a patient of his successfully quit multiple medications or not, but now that he’d seen me do it, maybe he would have something hopeful to tell future patients who were suffering through similar scenarios. Or maybe I was just imagining increased attention and thoughtfulness on his part. Maybe I just wanted to see something positive in the situation.

Thankfully, my lab results from that last visit to Dr. Feelgood all came back normal. However, the pain of prescription drug withdrawal continued for a good while. Even the blood pressure medications that I was able to give up after getting back to a healthy lifestyle came with a ridiculous amount of withdrawal effects, things that could lead a person to believe that he was losing his mind or dying if he didn’t know better.

Pills do have consequences, even if a trusted doctor is prescribing them and even if health insurance is paying for them. Prescription drug withdrawal is real, even if a relatively small number of people are talking about it. It’s as real as any purported benefits of the medications that are so readily given out nowadays for every ailment under the sun. Think about it: if a designer mix of chemicals is introduced into a person’s system with the intent purpose of altering how the mind and body function, then why wouldn’t there be severe physical and mental repercussions when that mix of chemicals is taken away? I’m now of the opinion that patients should almost always look at prescriptions as a last resort: there are simply too many known instances of modern drugs making people’s physical, emotional, or mental health worse.

Recovery from prescription-drug withdrawal is possible: that’s important for people to know. I’ve now been free of Paxil for almost four years and off of Xanax for a little more than three. I consider myself mostly “cured” of withdrawal (time and healthy self-care habits seem to be the only remedies, by the way), but I still occasionally wonder if I might have some lingering fatigue, confusion, or other symptoms that are the result of taking or quitting the medications (although I realize that such complaints might also just be a common part of approaching 40 in a competitive and stressed-out society). And about the anxiety? I still get flustered and worried at times, but I’ve found that there are ways to fight through such emotions (or avoid them) without making a Faustian deal that involves sacrificing parts of my greater well-being.

I often wonder how different my life might have been if I’d never taken those damned pills in the first place. But such wondering is useless, as useless as the idea that doctors and their pills can keep a person healthy in the first place. True health requires nutritious eating, regular exercise, adequate downtime, meaningful relationships, spiritual enrichment, and professional fulfillment. The Good Doctor would probably tell you that, but unfortunately, he’s not practicing anymore.

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

 


The David Carmichael Story..


Anyone who takes psychiatric drugs like Paxil/Seroxat is playing Russian Roulette with their lives, and the lives of their loved ones. I could have ended up in a similar position to David, anyone on Seroxat/Paxil could. Bravo to David for speaking about his harrowing experience.


 

http://kellybroganmd.com/the-david-carmichael-story-violence-and-antidepressant-roulette/

The David Carmichael Story: Violence and Antidepressant Roulette

 

He never could have seen this coming. David was struggling through a stressful period in

his professional life, and took his doctor’s recommendation to take the edge off of his anxiety with a prescription antidepressant.

As others observed that he was “getting better,” he was actually descending into a private chemically-induced hell of delusion.

The price he paid for his psychiatric treatment will haunt him and everyone he loves, for the rest of his life.

Listen to his story and understand why the prescribing of psychotropics must be halted until and if we can better understand who may fall victim to this Russian Roulette of violence.