How Glaxo Feeds Its Doctors..

“…GSK’s 2013 ban on paying doctors came amid a major bribery investigation in China, which landed it with a record fine, and was part of an effort by former chief executive Andrew Witty to improve the company’s reputation.

There was speculation at the time that other companies would be forced to follow suit, but in the event that did not happen.

Witty was replaced as CEO in 2017 by Emma Walmsley, who has brought a sharp commercial focus to operations, including a drive to reallocate resources to priority new medicines.

In addition to payments for speaking engagements, the updated GSK policy also allows for reasonable travel costs for medics to attend company-organized meetings – except in the United States – and registration fees for remote congress webinars and webcasts….”

Interesting case from 2011 (see below) involving drug reps suing Glaxo for overtime. This document gives a good insight into the culture of GSK at this time. Timely piece, considering Glaxo have decided to backtrack on their promises not to pay physicians to speak for the company (I wonder did Emma Walmsley make that decision?). Obviously profits must always come before ethics with Glaxo- we couldn’t have it any other way with them could we?

Basically this kind of thing is legalized bribery, that’s the job of a drug rep- to legally bribe/persuade a doctor to prescribe Glaxo drugs over competitors. Glaxo has everyone bribed (legally). From the key opinion leaders in the psychiatric profession- through money for talks etc (and every other medical specialty), to universities (sponsorship of research/bursaries, academic departments), lawfirms (glaxo spends billions on legal fees, and it has a legal war chest that can crush anyone and often it does – see Eric Holder fiasco), regulators (revolving door between industry and FDA/MHRA – see Ian Hudson fiasco), Charities (Well Child etc), many lords, and MP’s, and other high level business elites have stocks and shares in Glaxo (vested interests at high levels), the media (sponsorship of journalists prizes for pro-industry slanted articles etc- see Ben Goldacre fiasco).

The list is endless. The Pharmaceutical industry has every facet bought. They have endless cash reserves to bribe every corner of society.

Utterly corrupt.

Anyhow, here’s snippets from the document (click on the link for full read):

PSRs also try to build business relationships with physicians, respond to their concerns, and recruit them to attend Glaxo-organized dinners and conventions.

PSRs usually work outside of a Glaxo office and spend much of their time traveling to the offices of, and working with, physicians within their assigned geographic territories. Plaintiffs visited between eight and ten physicians each day, usually between the hours of 8:30 a.m. and 5:00 p.m. Plaintiffs claim that they worked between ten and twenty hours each week outside of normal business hours, for which they received no overtime wages. When not making calls on physicians, Plaintiffs studied Glaxo products and relevant disease states, prepared new presentation modules, answered phone calls, checked email, generated reports, and attended events on evenings and weekends.

Before a PSR makes his or her daily calls, Glaxo provides him or her with detailed reports about the physicians he or she will visit. These reports include information about a physician’s prescribing habits and drug preferences, the market volume of Glaxo products prescribed by the physician versus the volume of competitor products, and the volume of prescriptions filled in a particular region. Glaxo also provides each PSR with a budget to use for speaker programs and to engage socially with physicians.

Glaxo prepares and provides information about its products-called “Core Messages”-for PSRs to present to physicians during calls. Core Messages include information about product benefits and risks, dosage instructions, and the types of patients for whom Glaxo recommends each product. Glaxo expects PSRs to use the Core Messages and then “[d]evelop and deliver informative sales presentations based on customer needs.”

Plaintiffs received two types of pay-salary and incentive-based compensation. Incentive-based compensation is paid if Glaxo’s market share for a particular product increases in a PSR’s territory, sales volume for a product increases, sales revenue increases, or the dose volume increases. Glaxo aims to have a PSR’s total compensation be approximately 75% salary and 25% incentive compensation.4 However, the dollar value of incentive-based compensation is uncapped.



UK fraud office expects decision on GSK Case Next Year..



I’m going to make a prediction about this..

I think that the UK Serious Fraud Office will either let GSK off the hook completely (due to some technicality of law or loop-hole) or GSK will get off very lightly (a slap on the wrist). Either way, I would be extremely surprised if justice is adequately served.

In a just world, one where corporations like GSK don’t get to operate above the law- the top executives at GSK would all be in jail. However we don’t live in a just world, we love in a corporate driven world, one where corporations get to decide on what laws they can break at a whim, with little consequence from the establishment or the authorities.

It will be interesting to see whether the serious fraud office in the UK has the balls, or even the power, to bring the GSK Goliath to book…

Judging from past examples, of GSK criminality, I won’t hold my breath…

They are the UK’s prized Pharma Cash-cow…

Too many people, in places of power, are generating too much wealth from this cash cow for it- to ever be -put out to pasture…


UK fraud office expects decision on GSK, Rolls-Royce cases next year

LONDON (Reuters) – The UK Serious Fraud Office (SFO) said on Thursday it expects to decide next year whether it will file criminal charges in bribery investigations related to drugs giant GlaxoSmithKline (GSK.L) and aero engine company Rolls-Royce (RR.L).

The SFO launched an investigation into GSK and its subsidiaries in 2014. Britain’s biggest drugmaker has already been fined a record 3 billion yuan ($452 million) by Chinese authorities for paying bribes to doctors to use its drugs.

The SFO’s continued investigation into Rolls-Royce is focusing on individuals after the aero engine maker paid 671 million pounds ($870 million) in January to settle British, U.S. and Brazilian bribery investigations.

David Green, the head of the SFO, told Reuters in an interview that he hoped a decision about charges would be made before he steps down after six years in the job next April.

“I would expect resolution in both these cases in 2018, and hopefully prior to my departure in April,” he said.

Separately, a spokeswoman for the Attorney General’s Office, which is responsible for SFO director appointments, said the recruitment process for Green’s successor had yet to begin. But she said there was “still plenty of time” and that there “will be an appointment in due course”.

Prime Minister Theresa May’s Conservative Party pledged in May to abolish the specialist investigator and prosecutor and roll it into the four-year-old National Crime Agency (NCA) to “strengthen Britain’s response to white collar crime”.

But the proposal drew sharp criticism from white collar crime lawyers, lawmakers and anti-corruption groups and was later dropped from the minority government’s official two-year policy program.

Lawyers said the omission could signal a reprieve for the agency, which in June charged Barclays (BARC.L), one of the country’s biggest banks, and four former senior executives with fraud over undisclosed payments to Qatari investors in 2008.



Glaxo In Court Again… This Time Over Myodil…

Myodil is a truly scandalous and horrific GSK product…

Date of knowledge and Limitation – Lewin v Glaxo – Case Report
Blog piBlawg

United Kingdom January 18 2017

In cases concerning an allegation of bodily injury, time for the purposes of statutory limitation does not begin to run until the cause of action accrues or the date of knowledge of the alleged victim. The latter may be some months or years after the effluxion of the usual three year limitation period from the accrual of the cause of action. However it is rarely decades as it was in a recent case in the Queen’s Bench Division. In common with much of the extensive corpus of authority as to limitation, Keith Malcolm Lewin v Glaxo Operations Uk Ltd (Sued As Glaxosmithkline Unltd) [2016] EWHC 3331 (QB), turns on its own facts. It is however worthy of summary.

Here, upon hearing the trial of a preliminary issue on the subject, Mr Justice Goss found that the claimant’s claim was not statute-barred despite the claimant making complaint of treatment he received as long ago as 1973.

Some 44 years ago, the claimant underwent a diagnostic procedure during which Mydil was injected into his spine. It was held that the claimant’s date of knowledge arose when he was diagnosed as late as 2015 as suffering from post-Myodil adhesive arachnoiditis.

In the five or so years following the 1973 procedure, the claimant experienced persisting problems in his lumbar and cervical spine. This was investigated further in 1977 when it was considered that whilst the claimant may have had adhesive arachnoiditis, it could not be confirmed and further x-rays were unnecessary. The claimant’s problems continued during the 1990s, but it was not until 2007 when he developed severe left knee pain and thereafter other symptoms. An MRI scan in 20112 showed adhesions to his thoracic spine and the potential link between Myodil and the claimant’s condition was discussed. He underwent surgery in 2013, but it was not until March 2015 when a neurosurgeon concluded that the claimant suffered from post-Myodil adhesive arachnoiditis.

The claimant issued proceedings in October 2015 against the background of the fact that in the early 1990s group litigation had been pursued against the defendant in respect of Myodil in which settlements were agreed without any admission of liability. Over 4000 individuals had notified claims although, in the event, only 426 claims were proceeded with.

The Court was asked to determine the date upon which the claimant’s cause of action accrued; his knowledge for the purposes of section 14 of the Limitation Act 1980; and if the claim was statute-barred, whether the court’s discretion pursuant to section 33 of the same Act should be applied.

The court held that the cause of action accrued when the Myodil caused injury to the claimant, not the date it was injected. On the facts of this case this occurred around 2007.

The defendant argued that by the 1980s the claimant had constructive knowledge sufficient to commence time running (per section 14(3) of the 1980 Act): he knew by 1977 he had a serious back injury and that the possibility of arachnoidiis had been raised sufficient to prompt him to investigate. The claimant argued that no clear cause for his symptoms had been determined. This found favour with the Court which further held that even had the claimant drawn a link, it was not reasonable to have expected him to have investigated it further. It was held therefore that the claimant’s date of knowledge was when the neurosurgeon’s diagnosis in 2015.

Goss J went on to consider whether he would have allowed an extension of limitation in any event. He held that he would have done had it have been necessary on the grounds that the claimant had sustained a very serious injury and the main prejudice to the defendant would have been financial as the matters complained of had already been investigated.

Man Sues Glaxo Over Horrific Spinal Injury From Their Dodgy Dye Myodil…


Solicitor’s legal challenge against GlaxoSmithKline can continue

Myodil spine injury claim can proceed after High Court limitation ruling

Keith Lewin

22 December 2016

A 59 year old solicitor, Keith Lewin, has succeeded in the latest stage of his seven figure legal claim against Glaxo Operations UK Limited (part of the corporate structure of the pharmaceutical company GlaxoSmithKline) who he believes is responsible for the illness that has left him a wheelchair user.

Mr Lewin is represented by product liability solicitors Jill Paterson and Thomas Jervis.  You can read a full copy of the Lewin judgment.

Mr Lewin is suing Glaxo Operations UK Limited (part of the corporate structure of GlaxoSmithKline) for a seven figure sum arising out of his exposure to Myodil, an oil based contrast medium, which was injected into his spine in 1973 when he underwent a diagnostic Myelogram procedure to investigate back pain as a 15 year old.

It is alleged that his exposure to Myodil caused him to develop the spinal condition known as adhesive arachnoiditis which is a serious inflammatory condition of the spinal cord.  Mr Lewin is now severely, permanently disabled. He requires the use of a motorised wheelchair in order to mobilise.

Mr Lewin alleges that the Defendant (the successor of Glaxo Laboratories Limited) was negligent in respect of the manufacture, supply and use of Myodil.

Myodil was used as an oil-based contrast agent in the imaging of spines of patients with back pain in the United Kingdom from the 1940s until its product licence expired in 1987.

There was previous UK Group Litigation brought by a large number of other Claimants (eventually 426) in negligence against Glaxo in the early 1990s arising out of their alleged exposure to Myodil. That litigation settled in July 1995 for the sum of £7 million without an admission of liability.

Glaxo argued that Mr Lewin’s claim was time barred and should not be allowed to continue.  They say that he should have been put on a train of enquiry in the late 1970s or early 1990s which would have led him to make a legal claim much earlier.

Mr Lewin argued that it was not until 2012 that he was diagnosed with adhesive arachnoiditis before he underwent exploratory spinal surgery known as a laminectomy.  It was submitted that even if the Court were to deem that his claim had been brought outside the three year statutory limitation period, it would still be equitable to allow the claim to proceed.

Mr Justice Goss handed down his judgment on 20 December 2016 in the High Court ruling that Mr Lewin’s claim was brought within the legal time limit, and that he would allow the claim to continue.

Leigh Day product liability solicitor Jill Paterson said:

“My client is very pleased that his spinal injury claim is allowed to proceed. He suffers with constant debilitating pain and has to use a wheelchair. His life has been significantly affected”.

Information was correct at time of publishing. See terms and conditions for further details.

Another Little “Slap On The Wrist” For Naughty Glaxo…


“…The SEC said the company failed to institute and maintain an adequate system of accounting controls and that it lacked an effective anti-corruption compliance program.

The improper payments in China weren’t accurately recorded on GSK’s books, the regulators said”…


“…In a statement, the company said it had cooperated with the SEC and it had received credit for taking steps to improve its operations, such as changing how sales representatives are paid and stopping the practice of paying healthcare professionals to speak to doctors about the company’s products.

It also said the U.S. Justice Department, which had opened a parallel criminal investigation into the matter, was closing its probe without any action against the company.”….

GlaxoSmithKline to Pay $20 Million to Settle SEC Bribery Probe

SEC claimed drugmaker’s Chinese subsidiaries engaged in bribery schemes to increase sales

GlaxoSmithKline PLC agreed to pay $20 million to settle charges that the drugmaker’s Chinese subsidiaries engaged in bribery schemes to increase sales in the Asian country, the Securities and Exchange Commission said Friday.

The SEC alleged that between 2010 and 2013, GlaxoSmithKline’s subsidiary and a China-based joint-venture violated the Foreign Corrupt Practices Act by providing inappropriate gifts to foreign officials, including health-care professionals. The commission also alleged that the payments were often falsely recorded as legitimate expenses.

The bribes took the forms of gifts, improper travel and entertainment with no or little educational purpose, shopping trips and cash, among others, the SEC said in its order.

Glaxo entered into the SEC agreement without confirming or denying the charges, the U.S. agency said in its statement.

In a separate statement, Glaxo said it has installed several reforms, including shifts to the compensation of sales representatives and the end of payments to health-care practitioners for advocating for Glaxo products to other prescribers.

“The U.S. Department of Justice has also concluded its investigation into these matters and will be taking no further action,” Glaxo said in a prepared statement. “The SEC and DOJ investigations were initiated as part of an industry-wide inquiry in 2010.”

A Justice Department spokesman declined to comment.

In 2014, a Chinese court found the company guilty of bribery and penalized Glaxo $491.5 million in the same matter, which was touted at the time by Chinese state media as the largest-ever corporate fine in China.

Five of the company’s managers, including Mark Reilly, its former top China executive, were also convicted of bribery-related charges and received suspended prison sentences.

Write to Ezequiel Minaya at

This Is How Glaxo Treats Animals…


Glaxo Smith Kline laboratory, King of Prussia, cited after death of animal

Negligence at a Glaxo Smith Kline laboratory – the second largest employer here – has led to a primate strangling to death in violation of federal laws, according to a national research watchdog group.

A recently obtained government inspection report reveals the U.S. Department of Agriculture, which oversees research laboratories, cited Glaxo Smith Kline for violating federal laws, said SAEN (Stop Animal Exploitation NOW!), which monitors the nation’s research facilities for violation of law and abuse of animals.

A USDA inspection report dated June 14 specifically cited Glaxo Smith Kline for violating the primary enclosure requirements of the Animal Welfare Act – a primate was able to open the squeeze lock mechanism and move the back panel of the cage forward, which resulted in the primate getting caught in the space created and choking to death.

In its official complaint SAEN filed with the USDA, SAEN is insisting on an additional citation and a federal fine which could be as high as $10,000 per infraction.

“Glaxo Smith Kline’s primate enclosure did not satisfy the safety requirements set by federal law, and a primate suffered and died as a result. Because an animal was subject to prolonged suffering and death, this lab deserves of a severe penalty,” said Stacey Ellison, SAEN research analyst.

Is GSK’s Migraine Drug – Imitrex- Dangerous And Deadly?

I took GSK’s Seroxat (Paxil) Drug for over 3 years in my twenties and I’m lucky that I lived to tell the tale. The side effects from Seroxat are horrendous, and GSK suppressed them from public view for years. It took 4 BBC documentaries and much public outcry before GSK would admit to any problems at all with Seroxat. GSK still sell it, they still profit off it, even though it has harmed so many people.

GSK’s Avandia drug was also embroiled in controversy a few years ago with links to thousands of heart attacks, and their Pandemrix drug has been linked to Narcolepsy for quite some time. Their Myodil dye product has crippled, maimed and harmed patients for years too, with many still just coming out of the woodwork. In recent posts on this blog about Myodil, I regularly receive comments from people who were injected with the Dye decades ago, and they are still crippled from it. Many of these people will have no hope of justice for their pain and suffering, because GSK are often too powerful to tackle, particularly if one individual tries on their own. These are essentially forgotten victims of GSK’s fraudulent behavior.

From taking Seroxat, I know that GSK are capable of releasing extremely dangerous drugs and chemicals on to the market. I wouldn’t trust any of their drugs or products as safe or effective. However GSK have dozens of products on the market which are potentially harming people. One of the drugs listed in GSK whistle-blower Greg Thorpe’s 2012 Department of Justice complaint was GSK’s migraine drug- Imitrex.

The following article on Imitrex (from 1995) makes for disturbing reading:

Migraine Killer

Imitrex, a popular new drug for treating migraines, has been associated with hundreds of life-threatening problems and deaths. So why do the FDA and Glaxo, the drug’s manufacturer, both claim that it’s safe?


The Food and Drug Administration, sometimes criticized in past years for being too cozy with corporations, has lately come under attack for exactly the opposite failing. A powerful bloc of critics in industry and the Republican Congress is pushing to overhaul the FDA, claiming the agency is too tough on drug companies, unnecessarily inhibiting innovation and delaying the approval of new drugs and medical devices.

Leading the charge is Speaker of the House Newt Gingrich, who has labeled the FDA the “number one job-killer” in the country, and called its head, David Kessler, “a bully and a thug.” Gingrich’s Progress & Freedom Foundation has announced a radical plan to privatize much of the FDA’s oversight of drugs and medical devices. Not surprisingly, the foundation has financial backing from some of the biggest names in the pharmaceutical industry, including Bristol-Myers Squibb Co., Eli Lilly & Co., and Marion Merrell Dow. Glaxo, manufacturer of Imitrex (see main story), has also given an undisclosed amount to the foundation, in addition to contributions of approximately $325,000 to the Republican Party and Republican candidates (including $4,000 to Gingrich) in the last election alone. As a whole, the drug industry contributed more than $1.6 million to the Republican Party in the 1993-94 election cycle.

If enacted, the Progress & Freedom Foundation’s plan will place responsibility for drug development, testing, and review in the hands of private firms hired by the drug companies themselves, while retaining a weakened FDA to rubber-stamp their recommendations. Additionally, the plan limits the liability of drug companies that place dangerous drugs on the market. An interim report on the foundation’s study was released in June; the final version is due out later this fall.

Under the plan, government-licensed firms called DCBs –drug (or device) certifying bodies–would be retained by drug companies to develop, test, and review new products. According to the proposal, “competition between firms would inevitably produce a lower-cost, faster, and higher-quality development and approval process.”

FDA spokesperson Jim O’Hara offers an alternative view: “What this report proposes is dismantling many of the safeguards that protect the public from drugs and devices that are unsafe or just don’t work. This is basically a proposal that says public health and safety are commodities for the marketplace.”

Though drug testing and review would be privatized under the plan, the FDA would still exist and would theoretically have final say on new products. However, the report states there would be “a strong presumption that private certification decisions would not be overturned without substantial cause.” Further, the FDA would not be authorized to request additional testing or data, and it would “have to exercise its veto within a fixed time period (e.g., 90 days) after which the drug would automatically receive FDA approval.”

The Progress & Freedom Foundation plan also limits the liability of drug companies should a patient be injured or killed by a dangerous drug or medical device. According to the proposal, a victim could not sue for punitive damages if the manufacturer of the product could show that it had met regulatory standards–however weakened–during development and testing.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, says the plan to limit corporate liability is “hypocrisy at the very least.”

Even some in the drug industry believe the Progress & Freedom Foundation’s proposal goes too far. Steve Berchem of the Pharmaceutical Research and Manufacturers of America says that while some drug reviews can be handled by the private sector, it would be a mistake to weaken the FDA’s authority over product approvals. “We need an FDA that maintains public confidence,” Berchem says.

Nonetheless, the political writing on the wall is clear. Earlier this year, the FDA announced steps to reform itself, including the creation of a pilot program to allow private companies to review some medical devices. But this compromise isn’t going to satisfy the hard-liners. Progress & Freedom Foundation spokesperson Rick O’Donnell says the FDA proposals “don’t actually hit at the heart of the systemic problems that our plan is addressing.”

As the battle to reshape the FDA heats up in the coming months, the Progress & Freedom Foundation will coordinate its efforts with those of other heavily funded right-wing attacks. But look for Newt and Company to draw their proposals directly from the foundation’s plan.

Despite the medical risks posed by Imitrex injection, you are not required to take the medication in the presence of your doctor. Imitrex can be administered at home, at your workplace, or at any other location by using an “autoinjector,” a futuristic-looking plastic injector that contains a prefilled syringe of Imitrex and requires only the push of a button to release the medicine into the bloodstream.

The autoinjector looks so neat, in fact, that a picture of it was featured in the hip, new technology magazine Wired. “I thought it was a wild-looking device,” says David Jacobs, editor of Wired’s “Fetish” section, where the magazine promoted the product under the heading “Kill Migranes”–spelling error and all. Jacobs discovered Imitrex when a Wired employee who suffers from migraines brought her autoinjector to work. “You have to have an eye for things that just stand out,” Jacobs says. “I look for diamonds in the rough.”

Unfortunately for readers of Wired, the magazine editors didn’t look beyond Glaxo’s nifty packaging job. The autoinjector contains a six-milligram dose of Imitrex, which has been associated with heart attacks, strokes, and other health problems. Glaxo also recommends a second injection as soon as one hour after the first if the migraine symptoms come back. And although the company suggests that the first injection be given in a doctor’s office, that decision is left to the doctor’s discretion. –Andrea Buffa

On the morning of Feb. 4, 1994, Dianne Riley joked nervously with her husband and one of her four children about a dream she’d had the night before in which someone had died. This wasn’t a pleasant way to begin the day, because once before Riley had actually forecast a death in this manner.

To make matters worse, Riley had a miserable headache. For five days running, the 41-year-old assistant manager for a Ramada Inn in Kansas City, Mo., had felt the pain in her head build to the point where she would be overpowered by nausea.

Later that morning, Riley had an appointment with Dr. Samuel Ho, a specialist in internal medicine. He diagnosed migraine, a slowly developing headache with throbbing pain that is usually felt on only one side of the head. The condition is believed to affect between 15 and 25 million Americans, mostly women.

Ho recommended Riley try Imitrex, the brand name for sumatriptan succinate, a heavily marketed new drug for migraines. At 12:25 p.m., Riley was given a six-milligram injection of the drug. Within minutes, she began to sweat, vomit, and experience chest pains.

Technicians managed to hook her up to an electrocardiograph and quickly discovered that she had an abnormal heart rhythm. They called 911.

An emergency team reached Ho’s clinic at 12:56 p.m., and transported Riley to St. Luke’s Northland Hospital where she arrived with resuscitation efforts in progress. At 1:58 p.m., a doctor pronounced Riley dead. An autopsy performed the

next day indicates Riley’s cause of death was “a result of adverse effect of Imitrex.”

On April 15, two months after Dianne Riley’s death, her family filed a lawsuit in the Circuit Court of Jackson County, Mo., charging that Glaxo, the British-based manufacturer of Imitrex, had been aware that the drug could cause serious harm or even death. The lawsuit accuses the multinational and its Cerenex division in North Carolina of not adequately labeling Imitrex and not disclosing the drug’s true risks, “in order to collect substantially higher profits.” Glaxo will not comment on the lawsuit because it is under litigation. The case, still in the legal discovery phase, is expected to go to trial sometime in 1996.

Dr. Vincent Di Maio, one of the country’s leading forensic pathologists and editor of the American Journal of Forensic Medicine and Pathology, intends to testify on the Rileys’ behalf. He says he has examined all the microscopic slides of tissues and organs from the Riley autopsy and has no doubt that its conclusion was correct. Although Dianne Riley had some risk factors for heart disease (e.g., smoking, family history of heart disease), Di Maio says her heart and coronary arteries were healthy; the heart attack that killed her was precipitated by Imitrex.

“It is a very complete autopsy,” Di Maio says. “This is a simple case where a young woman took Imitrex, started to react to it badly, developed an irregular heartbeat, and died. The autopsy shows clearly that there was no evidence of hardening of her arteries, no evidence of infection, no evidence of an enlarged heart, no evidence of stroke, no evidence of meningitis or encephalitis, no evidence of a blood clot, no evidence of lung disease, no evidence of asthma or allergic reaction, no evidence whatsoever of disease. If there is no other cause of death, by deductive reasoning she died of a coronary vasospasm following the use of Imitrex.”

Imitrex, a top-line Glaxo drug, is used by more than two million people worldwide. The drug’s sales in fiscal year 1993-94 were $365 million. Both of those numbers are likely to increase when the tablet version of the drug becomes available on the U.S. prescription market this month.

To date, the Food and Drug Administration has received 3,526 voluntary reports of possible side effects, ranging from mild to severe, associated with the use of Imitrex. Included are reports of 83 deaths and at least 273 life-threatening complications.

Earlier this year, Glaxo became the world’s largest pharmaceutical company when it bought Wellcome, another British multinational. Glaxo and Wellcome sold a combined $11.6 billion worth of products last year, to fight everything from asthma and ulcers to heart disorders, infections, and migraines.

In the high-stakes pursuit of competitive advantage, drug giants like Glaxo must sometimes spend hundreds of millions of dollars to develop new drugs. To see returns on these investments, companies push hard to get the drugs through the regulatory approval process and promote them vigorously when they are first released. Glaxo’s push of Imitrex was no exception.

The history of Imitrex goes all the way back to 1972, when Glaxo launched a research program to develop a new migraine drug. The company’s goal was to find a chemical that could narrow swollen blood vessels in the head, thereby stopping the pain of migraine headaches. But it was also important that the drug not narrow or squeeze blood vessels in the heart, because this could cause spasm in those vessels and trigger a heart attack.

More than a decade passed before Glaxo scientists came up with Imitrex. The drug mimicked serotonin, a chemical produced naturally in the body. Serotonin contracts blood vessels by acting on their cells via the gateways or “receptors” known as 5HT. Glaxo researchers thought that Imitrex would affect only the type of 5HT receptor known as 5HT-1, which they believed was rarely found in heart vessels, and therefore the drug would not cause heart spasm.

Glaxo believed it had a blockbuster drug in the making, one with a potential market of hundreds of millions of dollars.

Looking back, however, some fundamental research data contradicted the presumption that 5HT-1 receptors were generally absent from heart vessels. In one small laboratory study, Glaxo researchers found that Imitrex caused small contractions in coronary artery samples from explanted human hearts, indicating the presence of 5HT-1 receptors in heart vessels. An independent study also supported this hypothesis by demonstrating that Imitrex could cause temporary narrowing in the coronary arteries of patients with or without signs of heart disease.

Glaxo, however, emphasized other research that supported Imitrex’s safety. Specifically, one Glaxo study showed that Imitrex did not affect the cardiovascular systems of dogs, indicating that 5HT-1 receptors were not present in the dogs’ heart vessels and suggesting that this might be true for human beings as well. The company also assured regulatory agencies that the drug was safe because its heart-monitoring tests during clinical trials showed that very few patients suffered heart disturbances.

Strong indications that these assurances were hollow first surfaced in Canada.

On Dec. 20, 1991, Dr. Michele Brill-Edwards, then the assistant director of the Bureau of Human Prescription Drugs at Health and Welfare Canada, wrote a memo to the bureau’s assistant director of operations, Peter Jeffs, expressing her suspicion that Glaxo was pressuring one of her reviewers to move faster on getting approval for Imitrex.

After Brill-Edwards reviewed the file herself, she believed that there were potential problems with Imitrex. She was particularly concerned that Glaxo had only thin documentation to show that Imitrex was not a danger to heart vessels.

Brill-Edwards also wondered about Imitrex’s recommended dosage of six milligrams. Glaxo studies had shown that a one-milligram dose was enough for some patients and three milligrams worked for up to 60 percent of patients. Only an additional 10 to 20 percent benefited from the six-milligram dose. Yet contrary to standard medical practice, which recommends tailoring dosage to a patient’s needs, Glaxo recommended six milligrams for everyone. (A Glaxo spokesperson told Mother Jones that the company chose the six-milligram dose as “the best balance between efficacy and safety.”)

For more than two weeks, Brill-Edwards (who is under orders not to discuss Imitrex with the media) raised concerns within her bureau about Imitrex’s safety, and questioned Glaxo’s efforts to expedite the drug’s approval. In a Jan. 7, 1992 memo, she described the situation to her boss, Dr. Claire Franklin, then the director of the Bureau of Human Prescription Drugs:

At 5:15 p.m. [Jan. 6], Ms. Gita Lingam, [then the] head of regulatory affairs for Glaxo, telephoned.a Threatening remarks were made courteously. Ms. Lingam noted that Mr. Randall Chase [then a senior vice president of Glaxo Canada] intends to take the matter “to a higher level” if there are further delays. Legal action was intimated.a

[T]he product monograph remains less than adequate in its characterization of safe usage of this valuable new product. My recommendation is that the clinical division should be required to remedy the deficiencies in the product monograph.–This action should be undertaken notwithstanding substantial pressure to the contrary from the manufacturer.

The deficiencies in the monograph were not remedied. On Jan. 16, 1992, nine days after Brill-Edwards wrote her memo, Glaxo announced that it would construct a $70 million manufacturing facility in Canada, promising more jobs and research spending.

Four days later, on Jan. 20, senior managers at Health and Welfare Canada approved Imitrex.

The next month, when Glaxo launched its promotional campaign for Imitrex in Canada, it claimed the drug “works only on the painfully swollen blood vessels in the head.” The labeling for Imitrex, however, recommended that people with serious heart problems shouldn’t be prescribed the drug, indicating that Glaxo was, in fact, aware of its potential effect on heart vessels.

But when reports began to file in at Health and Welfare about side effects following an injection of Imitrex, Glaxo officials took the public position that these reactions were rare and unexplainable. As of July 1992, Health and Welfare had received only 20 voluntary reports of adverse side effects associated with the use of Imitrex, including severe chest pain and breathing difficulties. But by November, an additional 70 reports had been filed, again including chest symptoms. That month, Health and Welfare and Glaxo quietly cooperated in rewording the product labeling. The new labeling advised doctors to take a careful medical history to avoid prescribing Imitrex to anyone with heart disease.

Meanwhile, in Britain (where Imitrex had been available since 1991), a new chapter in the drug’s story had begun. A case report was published in May of 1992 in the British Medical Journal concerning a 47-year-old man with no sign of heart disease who developed severe chest pain after injections of Imitrex. Further tests with the patient showed that within six minutes of receiving a shot, his heart vessels began constricting. A month after this case was reported, the U.K. Committee on Safety of Medicines, Britain’s drug regulatory group, reported that Imitrex could cause heart vessels to constrict.

Glaxo, however, continued to maintain that severe side effects were rare, and that those patients who suffered heart-related complications must have had some underlying heart problem.

In the United States, the FDA had the advantage of looking at several months’ worth of cases of side effects associated with Imitrex in Canada, Britain, and the Netherlands before deciding whether to approve the drug for the American market. Dr. Paul Leber, chief of the FDA’s Division of Neuropharmacological Drug Products, clearly struggled with the decision. In an August 1992 memo to Dr. Robert Temple, director of one of the FDA’s three Offices for Drug Evaluations, Leber questioned the value of Imitrex, writing that its benefit was difficult to determine because of the absence of comparisons with alternative treatments (such as painkillers, anti-inflammatory drugs, narcotics, and medications derived from a common fungus). “It is particularly difficult to get a clear view,” Leber wrote, “because the product has been promoted worldwide with considerable vigor. Indeed, one expert has privately communicated his belief that the utility and advantages of Imitrex have been considerably inflated.”

Four months later, with Imitrex on the verge of approval, Leber voiced deep concerns about the drug’s safety, particularly for patients who might have undiagnosed heart conditions. In another memo to Temple, dated Dec. 28, 1992, Leber wrote that if the drug is “widely used once marketed, a sizable number of patients with significant, but unrecognized, coronary vessel disease will be inadvertently exposed.a If this occurs, it is probable, if not certain, that some of these individuals will suffer serious harm, even death, following their use of Imitrex injection. In fact, postmarketing reports from countries in which Imitrex is available indicate that such events have already occurred.”

But despite this danger, Leber didn’t want to stop FDA approval of Imitrex. “What counts more?” he wrote. “The rights of millions of otherwise healthy migraineurs to have access to an effective and, for them, safe treatment, or the rights of those who may be inadvertently injured by its marketing?–If there are to be potent drugs like [Imitrex]–society must be willing to tolerate the injury they will cause to some proportion of those who use them.”

The FDA approved Imitrex for sale the next day.

As part of its Imitrex information package to the press, the FDA stated that “people with underlying heart disease should not take the drug because of its potential to cause constriction of coronary arteries.” As a precautionary measure, the agency also recommended that doctors consider giving the first injection in their office to patients who might have underlying coronary heart disease.

But the drug’s labeling included no recommendation to doctors to exclude patients whom they only suspected could be at risk for underlying heart disease. And there was no recommendation for how to treat patients who seemed to be suffering a negative reaction.

Imitrex’s reputation as a breakthrough migraine treatment was largely made in the initial burst of promotion upon its release. It wasn’t until August 1994a20 months after the drug’s approval–that the FDA and Glaxo cooperated in making the first significant labeling change for Imitrex. By this time, the number of reported deaths possibly related to Imitrex had grown to at least 33. A new section was added to the Imitrex label. Titled “Drug-Associated Fatalities,” it discloses that some of the reported deaths had occurred within a few hours of Imitrex’s use and that the drug’s “specific contribution–to most of these deaths cannot be determined.” The death of Dianne Riley is noted, though not by name, among them. (The notation, however, does not mention that Riley’s autopsy showed her to be free of heart disease. Instead, it lists her risk factors for heart disease–“positive family history, postmenopausal woman, and smoking”–implying that she might have had heart disease.) The FDA also asked Glaxo to send out what is known as a “Dear Doctor” letter, to inform physicians of the labeling change.

Three months later, there was a second major relabeling and another Dear Doctor letter. Glaxo now emphasized that Imitrex should only be used when a doctor had clearly established that a patient was suffering from migraine. The drug was not intended for any other kind of headache. The new labeling also recommended that Imitrex “not be given to patients in whom unrecognized coronary artery disease is likely without a prior evaluation for underlying cardiovascular disease.” These patients include postmenopausal women, males over 40, and those with risk factors for heart disease, such as high blood pressure, high blood cholesterol, obesity, diabetes, smoking, or strong family history of heart disease.

Of course, even a patient who does not fit these categories might have undiagnosed heart disease and thus could be at risk for serious Imitrex-related complications. According to Dr. Robert Vogel, head of the division of cardiology at the University of Maryland Hospital, the problem is compounded by the fact that there is no such thing as “insignificant” coronary disease. “So-called insignificant coronary disease can be lethal,” he says.

The most disturbing possibility is that Imitrex may also affect healthy hearts. Glaxo has consistently maintained that in cases like the one described in the British Medical Journal, some early coronary disease must have been present, even if it was never detected. But what does it mean to claim that someone had incipient (Continued on page 70) (Continued from page 31) heart disease if, as in Riley’s case, the patient was outwardly healthy and the disease could not be detected, even by an autopsy? And if the disease is undetectable, how can doctors rule out patients for Imitrex use?

Concerns that Imitrex might trigger heart attacks are not Glaxo’s only problem. Recent research suggests that coronary spasm, such as that apparently caused by Imitrex, can gradually damage heart vessels over the long term. There is also concern that the drug may induce strokes in some patients.

Speaking before an audience of doctors and at least one Glaxo representative in October 1994, Health and Welfare Canada’s Brill-Edwards discussed the potential long-term risks of Imitrex use. She pointed to animal research showing that if coronary arteries are regularly constricted, hemorrhaging in the endothelial tissues will occur and over time may promote clogging of the arteries, increasing the chance of a heart attack. “So, we could be dealing with a scenario where we are giving the drug thinking everything is fine and not realizing that, over years, the risk of atherosclerosis is increasing. We are not even looking for it or monitoring for it.”

To date, the FDA has also received reports of at least 31 strokes (damage to the brain due to interruption of the blood supply) and an additional 53 cases associated with stroke or with conditions that can lead up to stroke.

A lawsuit in Travis County, Texas, is currently in the discovery phase and scheduled for trial this October. On Sept. 1, 1993, shortly after injecting herself with Imitrex, Donna Sue Currie, a dental assistant, suffered a stroke that left her disabled. Her lawyer, Jay Winckler, says the discovery process has revealed other cases of Imitrex-associated stroke known to Glaxo, but he won’t say how many because the case is in litigation.

Dr. K.M.A. Welch, a migraine and stroke specialist affiliated with the Henry Ford Health Sciences Center in Detroit, Mich., confirms that strokes have been reported in association with Imitrex. Welch points out, however, that establishing a causal relationship is tricky, because anyone who suffers from a migraine already has a significantly greater risk of having a stroke. “It is often difficult,” he says, “to determine whether the drug or the migraine itself caused the stroke.” But he adds, “Because Imitrex is a vasoconstrictor, it may well play some role in tipping the balance.”

The FDA’s effort to balance Imitrex’s benefits and risks has two major flaws. First, there is insufficient data to show that Imitrex is more effective than other treatments. More importantly, the FDA, along with Glaxo, has failed to provide potential patients with enough information to make an informed choice about a drug that may pose serious health risks.

According to Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, a watchdog agency in Washington, D.C., “Imitrex is clearly a drug of last resort, to be used only when everything else fails.”

But that is neither the way Glaxo marketed Imitrex, nor the way the FDA and other regulatory agencies have recommended it. Had Dianne Riley known the risks, she might have decided against taking Imitrex. Had she first been prescribed another migraine treatment, it might have done the job. Had the labeling recommended that her doctor have nitroglycerin on hand in case of heart attack, Dianne Riley might still be alive.

Such a failure on the part of the FDA does not bode well at a time when the agency is under attack for being too tough on drug companies (see sidebar, page 28). If the anti-regulatory assaults of drug industry lobbyists and congressional Republicans result in further downgrading of the FDA’s ability to ensure drug safety, more patients like Dianne Riley may die.

Robert Temple, the FDA bureaucrat responsible for clearing Imitrex for the U.S. market, maintains that, thus far, the drug has been safe. He confirms, however, that there is “theoretical concern about Imitrex’s causing spasm of coronary arteries–[leading] to chest pain and, if prolonged, to a heart attack.”

Temple concedes that doctors might be advised to give nitroglycerin to patients who appear to be suffering heart-related reactions. But he says there was no real need to add this information to the label, because “we thought everyone would know that,” and it might cause “undue alarm.”

Moreover, Temple admits that doctors often cannot determine which patients will suffer heart-related complications, because it is not practical to give them advanced medical tests–and even these might not turn up incipient heart disease. Asked if this means that taking Imitrex is basically a crapshoot, he replies, “Realistically, there is not much you can do about it.”

Dr. Donna Gutterman, Glaxo’s director of medical affairs in the Central Nervous System Division, agrees: “It can be extremely difficult to work up a patient for heart disease.” But she claims that Glaxo cannot be expected to provide doctors with a series of instructions on how best to weed out patients potentially at risk, because the company believes “the physician is in the best position to evaluate the patient.”

Gutterman also confirms that although “it’s difficult to tease apart what might be happening” when a stroke occurs, Imitrex might in theory contribute. She points out that a stroke produces vasoconstriction and “the addition of Imitrex, which is a vasoconstrictor, can worsen the bleeding going on.”

Meanwhile, a universe away from the offices of regulatory agencies and multinationals, Dianne Riley’s husband Lionel remembers her as “a people’s person.” He says that after her death, “a part of me was just taken away.” Daughter Natousha Murray, 25, is furious at Glaxo for running TV commercials that show a woman her mother’s age walking in the park and feeling good because of the company’s new treatment for migraine. “My mother can’t walk in the park and play with her grandchildren,” she says. “It’s sickening to see this commercial.”

Nicholas Regush is an investigative reporter and television producer living in Montreal.

GSK recalls 3.9M tubes of toothpaste that may have wood fragments in them

In total, the recall includes almost four million tubes of the various brands of toothpaste. The toothpaste was manufactured by GlaxoSmithKline (GSK) of Indianapolis, Indiana from 2013 through September 2014 and distributed for sale throughout the U.S., Puerto Rico, and Taiwan from June 2013 to April 2015.

GSK has not explained how the wood fragments got into the toothpaste and reports that an investigation is still underway. After the company’s Consumer Relations division received several reports of the fragments in consumers toothpaste bottles, GSK decided to recall any and all potentially impacted lots.

– See more at:

and remember folks…

GSK really wants you to believe that they value patient health and well being over everything else…


GSK recalls 3.9M tubes of toothpaste that may have wood fragments in them

With its deal last year to combine consumer health operations with Novartis ($NVS) in a joint venture that GlaxoSmithKline ($GSK) will run, GSK CEO Andrew Witty bet a big piece of the drugmaker’s future on products like OTC pain meds and toothpaste. While Witty has lauded the future of that operation, it has stumbled in that market with the recall of nearly 4 million tubes of toothpaste products that may give users splinters.

GSK is recalling dozens of lots–3,977,252 tubes–made up of different varieties of Biotene and Sensodyne toothpaste, from the U.S., Puerto Rico and Taiwan. According to the FDA‘s most recent Enforcement Report, “fragments of wood were found when the product was extruded onto a toothbrush.” The toothpaste was actually manufactured for GSK by Oratech, a Utah-based contractor.

According to a letter to retailers posted by Smith Drugs, GSK started the recall several weeks ago but the product has been on the market for nearly two years. It was shipped from June 2013 through April of this year.

GSK said it was alerted to the problem by a “small number of complaints.” In a statement today, GSK said only that it hasn’t learned of any injuries from the tainted toothpaste but is recalling the product as a precautionary measure since they may contain wood fragments.

Sensodyne & Biotene Toothpastes Are Recalled By Wegmans Because Of This Unbelievably Terrifying Reason

Chad Buchanan/Getty Images Entertainment/Getty Images
Alex Gladu
July 21 News

On Saturday, GlaxoSmithKline (GSK) Consumer Healthcare recalled specific Sensodyne and Biotene toothpaste tubes, according to a post on supermarket chain Wegmans’ website. The affected toothpaste “may contain small fragments of wood” and can be returned to the store for a full refund. The voluntary recall affects only certain lots of the toothpaste brands.

The affected products cater toward people with specialized dental needs. Sensodyne is supposed to protect sensitive teeth that can be irritated easily by hot and cold substances. Biotene is supposed to help with dry mouth. To find out if your tube is affected, check the lot code on the left end of the toothpaste box or on the back seam of the tube itself. Affected toothpaste will fall into one of these categories:

Biotene Toothpaste, Fluoride, Dry Mouth, Fresh Mint Original, 4.3 oz. UPC: 0-48582-10050, only product with the following codes: X3J271, X3K171, X3K291, X3N171, X4B061, X4B081, X4C251, X4D291, X4D301, X4E081, X4G131, X4H111

Biotene Toothpaste, Fluoride, Dry Mouth, Fresh Mint Original, 4.5 oz. UPC: 0-48582-00220, only product with the following codes: X2K151, X3B211, X3C012, X3C141, X3C251, X3G021

Sensodyne Repair & Protect Toothpaste, Daily Repair, with Fluoride, Extra Fresh, 3.4 oz. UPC: 3-10158-84030, only product with the following codes: Q3H081N, Q3H101N1, Q3H131C, Q3J121C, Q3J121D, Q3J261, Q3J291, Q3M021, Q3M071, Q3N021, Q3N211, Q4A111, Q4B201, Q4C151, Q4C191, Q4D111, Q4D151R, Q4F161, Q4F201, Q4G301

Sensodyne Complete Protection Toothpaste, Sensitivity, with Cavity & Gingivitis Protection, Extra Fresh, 3.4 oz. UPC: 3-10158-08560, ONLY product with the following codes: C4D061, C4E161, C4E211, C4F051, C4H111

Wegmans shoppers can bring their tainted toothpaste back to the store for a full refund. There doesn’t appear to be any word yet about other stores offering a refund. In fact, Wegmans seems to be the only store carrying the affected lots, as it is the only store to have reported the recall.

Earlier this year, GSK recalled a specific type of flu vaccine in the United States for reduced effectiveness. That recall was also voluntary and did not pose a safety risk to the public, according to the company’s release. What’s interesting is that no such release can be found for this weekend’s toothpaste recall.

In 2014, GSK competitor Proctor & Gamble faced troubles of its own when a dental hygienist found that at least some types of Crest toothpaste embedded non-soluble plastic particles into users’ gums. The company announced it would reevaluate the ingredients of its products through March 2016.

(2012) GlaxoSmithKline Bribes..

GlaxoSmithKline’s bribes are evidence that Big Pharma isn’t working

Philip Ball The inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink

Wednesday 4 July 2012 14.45 BST Last modified on Wednesday 21 May 2014 05.11 BST

Comments 132

Perhaps the most shocking thing about the latest GlaxoSmithKline drug scandal is that malpractice among our overlords still has the ability to shock at all. Yet despite popular cynicism about doctors being in the pockets of the drug companies, there remains a sense that the people responsible for our healthcare are more principled and less corruptible than expenses-fiddling politicians, predatory bankers, amoral media magnates and venal police.

If this were a junk food company lying about its noxious products, or a tobacco company pushing ciggies on schoolkids, we’d be outraged but hardly surprised. When a major pharmaceutical company is found to have been up to comparable misdemeanours – bad enough to warrant an astonishing $3bn fine – it seems more of a betrayal of trust.

This is absurd, of course, but it shows how the healthcare industry benefits from its proximity to the Hippocratic oath. “Do more, feel better, live longer” GSK purrs. How can we doubt a company that announces as its priorities as “improving the health and wellbeing of people around the world” and “being open and honest in everything we do”?

Now GSK admits that, in effect, it risked damaging the health of people around the world, and was secretive and fraudulent in some of what it did. Among other things, it promoted antidepressant drug Paxil, approved only for adults, to people under 18. It marketed other drugs for non-approved uses; it suppressed scientific studies that didn’t suit (for example over the heart attack risks of its diabetes drug Avandia), and over-hyped others that did. It also hosted outings for doctors in exotic locations and showered them with perks, knowing that this would boost prescriptions of its drugs.


Glaxo Consumer Health Unit is Linked to a US Probe In 2012

10:18 am ET
Sep 9, 2014


Glaxo Consumer Health Unit is Linked to a US Probe In 2012


For the past year, the GlaxoSmithKlinebribery scandal in China has centered on its pharmaceutical business, but newly reviewed documents indicate the drug maker became aware of compliance issues in its consumer health care business as early as 2012, according toReuters.

Glaxo confirmed that it conducted an internal investigation into procurement practices in the consumer unit in China, the news service writes. Although the drug maker tells Reuters there was no sign of “unethical conduct,” it did find “some non-compliance with our procurement procedures.” Glaxo says the inquiry was unrelated to a Chinese criminal investigation into corruption in its pharmaceutical division, which was made public last year.

The investigation focused on specific people and suppliers in China – including some employees, academics and education institutes – and was related to a U.S. Department of Justice and U.S. Securities Exchange Commission inquiry into possible violationsof the Foreign Corrupt Practices Act, according to Reuters. The law targets illegal payments to foreign government officials used to boost sales.

The news service, which wrote that it reviewed three internal Glaxo notices, stressed that the documents do not amount to evidence of wrongdoing by Glaxo or its business partners. The notices were sent by Glaxo lawyers to employees and e-mailed to senior Glaxo staff in China, according to Reuters, which adds that the drug maker has since cut ties with some suppliers.

A Glaxo spokesman tells Reuters that the notices “related to allegations around adherence to procurement policies within our Chinese consumer healthcare business. We investigated using resources inside and outside the company, and did not find evidence of unethical conduct, but did identify some non-compliance with our procurement procedures and remedial action was taken.”

The disclosure raises questions about Glaxo operations in China that had not previously been in the public spotlight. The drug maker, you may recall, has been coping with turmoil ever since bribery allegations surfaced in China, which is a large and growing market not just for Glaxo, but the entire pharmaceutical industry.

As reported previously, Chinese authorities recently accused the former head of Glaxo operations in China of ordering subordinates, his sales team and other employees to bribe hospitals, health care organizations and others. Separately, the drug maker said it is investigating claims that its employees bribed doctors in Iraq, Syria, Jordan and Lebanon.

Glaxo has previously acknowledged that some of its Chinese executives may have broken the law, but has maintained there is “zero tolerance” for bribery. We asked Glaxo for comment about this latest report and will update you accordingly.


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