An Update On The GSK Yemen Whistle-Blower….


Regular readers of this blog would be aware that over the last few months a GSK whistle-blower from Yemen contacted me alleging all sorts of unethical shenanigans by some GSK personnel in Yemen (see here). At the moment I cannot publish all that I know however the following is a small update from the whistle-blower:

 

“…Closing of 19 markets  in 19 countries has been done by Andrew witty just before his retirement.

This decision will deprive patients in needs in these countries of essential GSK medicine since the government or private supranational organizations wouldn’t be able to supply these medicine or purchase them from GSK.

And this decision is opposite to GSK mission rather than the access to medicines.

Instead, GSK could terminate the corruption and maintain the business and the supplying of medicines to these low income patients.

For example what happened in Yemen, instead of terminate the corrupted employees, GSK terminate all employees and distribution agreements with agents to expand the suffering of all Yemeni patients. Question, where is the access to medicines and where is the mission of GSK in light of this decision!

Yemeni government wouldn’t be able to make up the role of local agents in purchasing the medicines from GSK or distribution. The same for supranational organizations…”


I’m surprised that the charity ‘Save The Children‘ hasn’t made a statement about these allegations yet -as they have already been published by Ed Silverman of Pharmalot/WSJ…


https://www.statnews.com/pharmalot/2016/04/14/glaxo-bribes-novartis-yemen/

By Ed Silverman @Pharmalot

April 14, 2016

GlaxoSmithKline is conducting an internal investigation into allegations that its subsidiary in Yemen hired government employees to influence purchasing decisions and boost sales of its medicines.

Specifically, more than a half-dozen Glaxo employees allegedly have also held various paid positions — such as pharmacists — at the government health ministry. The allegations are similar to those made two years ago concerning its operations in Iraq.

“GSK has received allegations about staff conduct in Yemen and is investigating them thoroughly,” a company spokesman wrote us. He declined further comment.

Last month, Glaxo distributed a notice to its employees in Yemen — who only number about three dozen — that requires them to preserve documents in connection with United States and United Kingdom inquiries into its business practices in various markets. Pharmalot has reviewed a copy of the notice.

The drug maker is currently being investigated by the US Department of Justice and the US Securities and Exchange Commission for potential violations of the Foreign Corrupt Practices Act. The UK’s Serious Fraud Office is also investigating Glaxo for possible criminal violations of the Bribery Act.

In connection with the US and UK probes, the Glaxo notice mentions that employees must retain documents concerning payments to health care providers and government entities, as well as any “concurrent” employment involving Glaxo personnel.

The notice also required employees in the Yemen subsidiary to preserve documents concerning the Tykerb breast cancer medication, which Glaxo transferred last year to Novartis as part of an asset swap that sent much of the Glaxo oncology business to Novartis in exchange for a vaccines unit.

This is only the latest instance in which Glaxo has conducted an internal probe into business practices in various countries. Over the past two years, the company has also confronted allegations of bribery in Poland, Jordan, Lebanon, and Syria.

The most sensational episode, however, occurred three years ago in China, where GlaxoSmithKline was eventually found guilty by a Chinese court of bribing doctors, hospitals, and other nongovernment personnel and fined more than $490 million.

Glaxo is not the only drug maker encountering scrutiny over its business practices in far-flung markets.
Read More
After bribery episode, Bristol-Myers overhauls sales practices in China

In recent weeks, Novartis began an internal probe into allegations of bribery in Turkey and its South Korea offices were raided by authorities there. The company also agreed to pay $25 million to settle charges of violating the Foreign Corrupt Practices Act by making illegal payments to doctors in China.

And recently, Bristol-Myers Squibb ended payments to doctors in China shortly after agreeing to pay more than $14 million to resolve charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in the country.

Glaxo In Developing Countries: GSK’s Indian Guinea Pig Kids…


REP GLAXO

It’s interesting to note that GSK were named as one of RepRisk’s most controversial companies in 2013. That’s 5 years after CEO Andrew Witty took the helm and promised that all of GSK’s bad behavior was from ‘another era’. This fabled era which Witty keeps harping on about perhaps relates to GSK’s illegal an unethical behavior under Witty’s predecessor JP Garnier.

However, Andrew Witty was a high ranking corporate executive during JP’s reign and has been with GSK since 1985, therefore it’s kind of puzzling that he would try to allude that GSK’s unethical behavior has nothing at all to do with him or his leadership, surely as an employee of some 40 years Witty would have some knowledge of what GSK get up to?

Furthermore, even after GSK settled a 3 Billion dollar fine (from the brave and courageous whistle-blowing claims of previous GSK employee Greg Thorpe) in 2012- which apparently were to put an end to GSK’s corruption and bribery era- they were still named as one of the most controversial companies of 2013. They attained this accolade from their various ethical and moral transgressions such as a half a million dollar fine (and sentencing of GSK staff from) their vast bribery network uncovered in China and US office of fair trading accusations in relation to Seroxat and Wellbutrin violations etc, in 2013.

One of the most disturbing aspects of the RepRisk report is Glaxo’s testing of vaccines on young girls in India-

See the following links for more on this-

http://www.pharmaceutical-technology.com/news/newsgsk-msd-accused-of-conducting-illegal-vaccine-trials-on-indian-girls

GSK, MSD accused of conducting illegal vaccine trials on Indian girls

0

8 January 2013

Gardasil

Indian activists have accused GlaxoSmithKline and MSD Pharmaceuticals of conducting illegal tests of their HPV vaccines on tribal girls in Andhra Pradesh and Gujarat.

The Supreme Court said on Monday that the local activists filed a public interest litigation (PIL) alleging that the companies tested two unproven HPV vaccines designed to prevent cervical cancer – gardasil and cervarix – on 24,000 girls, including 44 patients at the Maharaja Yeshwantrao Hospital.

Of these 44 patients tested, 10 were male, said the report.

The Times of India reports that the PIL, filed by Kalpana Mehta of Indore, Nalini Bhanot and V Rukmini Rao representing Gramya Resource Centre for Women, alleges that the testing led to adverse effects on the girls’ health.

Seven girls allegedly died during the vaccine trial.

Justice S Radhakrishnan and Justice Dipak Misra have directed the Union government to immediately file its reply on the issue.

The Christian Medical College, Vellore, has also been asked by the apex court to examine the medical records of the girls in question.


November 18, 2013 9:13 am

Vaccination scandal taints reputation of India drug trials

About 72,000 Indian women die each year of cervical cancer, a disease caused by the human papillomavirus. Many of these deaths are preventable by vaccines already widely used in the US, Australia and Europe, and included in their recommended immunisation protocols.

In 2009, Path, a US-based health charity, launched a project funded by the Bill and Melinda Gates Foundation to study the cost and feasibility of incorporating HPV vaccines, produced by Merck and GlaxoSmithKline, into India’s public sector immunisation programme.

However, the programme to vaccinate 14,000 adolescent girls from poor families ran into trouble after seven died soon after their vaccinations. The ensuing media and political storm – highlighting sensitivities around drug trials in the developing world – has contributed to the restrictions on such studies, affecting both Indian and global pharmaceutical companies.

The causes of the girls’ deaths were never established or conclusively linked to the HPV vaccine. But serious questions were raised over whether the participants’ parents – many of whom were illiterate – had given informed consent, and whether the project adequately tracked any adverse reactions.

In August, an Indian parliamentary committee set up to probe the issue concluded the Path project was a clinical trial in all but name and that the organisation had used “subterfuge” to avoid the “arduous and strictly regulated process” of such a trial.

The committee report said many of the girls’ consent forms had apparently been signed by school principals and hostel wardens, and expressed scepticism that the girls’ parents were fully briefed on the pros and cons.

The committee also found there was no rigorous process to track adverse events, leading to “gross underreporting”. It came down hard on Indian government agencies for alleged dereliction of duty.

“The safety and rights of the children in this vaccination project were highly compromised and violated,” the report said.

It also claimed that Path’s “sole aim was to promote the commercial interests of HPV vaccine manufacturers, who would have reaped windfall profits had Path been successful in getting the HPV vaccine included” in India’s immunisation protocols.

Path called the parliamentary report an “inaccurate characterisation of this important work” and said it disagreed with its “findings, conclusions and tone”.

The organisation said the HPV project was driven by its belief that “poor and low-income girls in India should not be deprived of the right or access to this proven, life-saving and safe vaccine that wealthy and middle-class girls in India and around the world have access to through the private market and other public immunisation programmes”.


Home GlaxoSmithKline accused of illegally administering vaccines leading to the death of children in India

http://www.australiannationalreview.com/indian-sc-raps-government-inaction-illegal-drug-testing/

GlaxoSmithKline accused of illegally administering vaccines leading to the death of children in India

Apr 4, 2016

 By: Atreyee Chowdhury

 

drug testing
The Indian Supreme Court has sought answers from the government in a case involving tribal children, who were allegedly inducted into a drug trial without their consent years ago, and died because of the consequent reactions. The court criticised inaction on the government’s part and gave it a month’s time to respond.

Some children out of a group of selected children died after being injected with Merck’s Gardasil vaccine. The vaccine is manufactured by GlaxoSmithKline.

According to some campaigners, a study, promoted by Bill and Melinda Gates Foundation, failed to obtain consent from children or their parents before they were administered with the drug. The allegations, if proved, would mean that the drug companies conducted an illegal drug trial on the children.

The petitioners also asked judges to look into the way trials were conducted with Merck’s new cervical cancer vaccine, Gardasil 9. Research by MailOnline, revealed that some children showed abnormal symptoms after they were administered the drug. Gardasil 9, is expected to generate £1.2 billion a year in sales.

The Indian Council of Medical Research (ICMR) had in 2010, asked state governments to suspend the cervical cancer control vaccination programme for girls after four deaths and complications among 120 girls were reported. The girls complained of stomach disorders, epilepsy, headaches and early menarche.

An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics. Merck and GSK have both been ordered to respond to the allegations made by campaigners.

After taking into consideration the arguments from campaigners, the judges also ordered the government to produce an opinion on the issue of liability and compensation, which was welcomed by lawyers.

Speaking to Daily Mail, Kerry McBroom, one of the lawyers, said, ‘It is a very encouraging development that the judges are now discussing accountability and not just accountability but also compensation, so the tone of the hearing today was very positive for us because it’s clear from all the parties, including from government reports, that there were, at best, serious irregularities and, at worst, gross violations of fundamental human rights.’

The court expressed its unhappiness that the government had not come out with concrete action following the parliamentary committee’s findings. It gave the government a month to explain what action had been taken to investigate and what efforts had been made to obtain the consent of those taking part in the trials.

Gardasil is a drug that is used to prevent cervical cancer, which is the second most common type of cancer in women and kills more than 265,000 people every year according to Cancer Research UK.

 

Access Campaign: MSF delivers petition of nearly 400,00 people who demand Pfizer and GSK cut the price of pneumonia vaccine


http://www.msf.org/en/article/access-campaign-msf-delivers-petition-nearly-40000-people-who-demand-pfizer-and-gsk-cut

Access Campaign: MSF delivers petition of nearly 400,00 people who demand Pfizer and GSK cut the price of pneumonia vaccine

2,500 flowers are placed in front of Pfizer’s HQ, representing number of children who die of pneumonia each day.

New York – Despite there being a vaccine that can prevent it, pneumonia remains the leading global cause of childhood death in many developing countries, killing almost one million kids per year.

On the eve of Pfizer’s annual shareholder meeting, Médecins Sans Frontières (MSF) delivered to Pfizer headquarters the names of nearly 400,000 people who signed a petition demanding that pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) reduce the price of the pneumonia vaccine to US$5 per child in all developing countries and for humanitarian organisations.

“Millions of babies and young kids around the world are left unprotected against pneumonia because Pfizer and GSK charge such high prices for the pneumonia vaccine that many governments and humanitarian organisations can’t afford to vaccinate children,” said Dr. Greg Elder, Medical Coordinator at MSF’s Access Campaign. “After combined sales of more than $30 billion for the pneumonia vaccine alone, we think it’s pretty safe to say that Pfizer and GSK can afford to lower the price so all developing countries can protect their children from this childhood killer.”

MSF delivered the petition during a stunt outside Pfizer’s global headquarters in New York, where dozens of people  placed flowers at the company’s door. One flower was laid for every child lost to pneumonia each day, resulting in 2,500 flowers – representing the number of kids who would die from pneumonia that day – piled in front of Pfizer’s front door. Reams of paper with the names of nearly 400,000 people from 170 countries who signed MSF’s ‘A FAIR SHOT’ petition lay in an empty baby crib. The petition urges the two companies making the pneumonia vaccine to drop the price to $5 per child (for all three doses). With Pfizer having earned more than $6 billion in sales for this vaccine just last year alone, signatories of the petition sent a strong signal to Pfizer’s CEO, board and shareholders that the company should not put billions of dollars in profits over children’s lives.

Last year, 193 governments at the World Health Assembly unanimously passed a landmark resolution demanding more affordable vaccines and increased transparency around vaccine prices. The governments of more than 50 countries underlined the rising inequities among them caused by the increased financial burden of new vaccines, with many stating that the high price of new vaccines, such as the pneumonia vaccine, either prohibited them from introducing it or threatened their ability to maintain it in their routine immunisation programmes. Countries such as Algeria, Bosnia, Egypt, Indonesia, Jordan, Thailand, and Tunisia, among others, have expressed that they are not able to introduce the pneumonia vaccine because of its high price.

MSF has vaccinated children caught in emergencies with the pneumonia vaccine in the Central African Republic, Ethiopia, South Sudan, Uganda and other countries. After more than five years of struggling to get Pfizer and GSK to sell the vaccine to MSF at an affordable price, MSF last year launched its ‘A FAIR SHOT’ campaign to push the companies to reduce the price of the pneumonia vaccine to $5 per child (for all three doses).

In 2015, MSF released its vaccine pricing report, The Right Shot: Bringing Down Barriers to Affordable and Adapted Vaccines, which showed that in the poorest countries it is now 68 times more expensive to vaccinate a child than in 2001, with many parts of the world unable to afford new high-priced vaccines like that against pneumonia.

“We’ve seen too many children die of pneumonia, and we’re not going to stop until we know that all countries can afford this life-saving vaccine,” said Elder. “It’s tremendous to see that nearly 400,000 people globally have joined us to tell Pfizer and GSK they must drop the price so more kids’ lives can be saved. What’s the point of a life-saving vaccine if the most vulnerable people can’t afford it?”

“Fuzzy Boundaries”:Andrew Witty, GSK, And The “Perfectly Legal” Bribing Of Doctors…


Evan Davis
“….But this is a recognition there is a lot you’ve done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn’t it?
Because publishing data, to me, honestly, doesn’t seem like a great achievement. It just seems to me that that’s what you should be doing with data.
Not bribing doctors seems like a thing you would do…”
14
Andrew Witty
“….I wouldn’t say it’s bribing doctors
It’s perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it’s perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies?
They don’t, but we do….”

 

For those of you who haven’t seen the video (above) of GSK CEO Andrew Witty squirm in his seat under the heat of some serious questioning it’s well worth viewing…

There’s a lot of issues raised in just that short clip that are worth discussing but I’d like to focus on what the interviewer (Evan Davis) calls ‘Fuzzy Boundaries’ in the (so called) ‘perfectly legal’ (Andrew Witty’s words) bribing of doctors by GSK.

Andrew,

Just because it’s ‘perfectly legal’ to pay doctors to speak on behalf of drug companies does not mean it’s ethical. People aren’t stupid, the public instinctively feel that doctors who are paid consultants to drug companies are bound to be biased and easily influenced, and they would be right in thinking that.

The 2012 Department of Justice complaint (of which your company paid a 3 billion fine for) is riddled with examples of doctors literally prostituting themselves, and their reputations, to GSK. If these are the ‘perfectly legal’ scenarios which you think are ok then you really are out of touch with the public sentiment.

If your ‘perfectly legal’ bribing of doctors was reasonable and acceptable, then we wouldn’t need things like psychiatrist Peter Gordon’s sunshine act for Scotland. Peter has been taking Seroxat for over 17 years and he cannot come off it. He also works within the mental health system as a psychiatrist and he is trying to change things. Maybe you should team up with people like Peter and ask for his input?

That is, of course, if you really are serious about transparency?..

Here is a small sample of his work (and various videos) from his tireless campaigning for transparency on his blog:

 

https://holeousia.wordpress.com/about-me/a-sunshine-act-for-scotland/

 

A Sunshine Act for Scotland

Over two years ago I raised a petition with the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act for Scotland.

The official Scottish Parliament page for my petition can be 
accessed here. This page includes the petition history of PE1493 
and all the written submissions made on behalf of this petition.

Peter-Sunshine,-Jan-2015

A Sunshine Act would make it mandatory for healthcare workers (and hopefully academics and all allied health professionals) to declare fully any payments including payments in kind. The argument I presented was that a single, searchable, independent register underpinned by statute would ensure transparency, promote scientific integrity, reduce the potential for harm and save money

Current Guidance in Scotland (HDL62 issued by the Scottish Government) has failed for more than 13 years. Other governance bodies, such as the Royal Colleges, have separate systems which also appear to have failed to ensure transparency of financial payments. These overlapping, but ineffective systems of governance duplicate costs and bureaucracy to nobody’s gain

My petition was closed earlier this month by the Scottish Parliament as the Scottish Government had committed to “update guidance”.

One of the actions of the Government in response to my petition was to commission a public consultation:

Gathering public views on Sunshine Act

Last week the public voice of Scotland was revealed: the Scottish Public want sunshine:

Majority said mandatory register of financial interests is required

The majority of participants felt that the publication of financial payments to healthcare professionals should be made mandatory. There is substantial evidence from other  countries that the only effective way to make transparency mandatory is to have statutory legislation.

This is a landmark decision in the United Kingdom. By the voices of Scotland.

Of course there is much more to be done which requires energy and light.

However I have faith that the Scottish Government can provide this:

Shona-Robison---22-March-2016--mandatory-payments

I want to thank a number of people:

◾the participants in the Public Consultation

◾Eleanor Bradford Health Correspondent for the BBC who first 
suggested that I submit a petition to the Scottish Parliament

◾the Petitions Committee and its hard-working and dedicated clerks

◾John Pentland, MSP, former Convener, for being the first 
in Parliament to agree that statutory measures were required

◾Chrys Muirhead, friend, activist, and critical thinker 

◾The President and Vice President of the Royal College 
of Psychiatrists (the College I am member of) for doing 
their very best to improve transparency within the limitations 
of current guidance

Peter - parliament 12 Nov 2013

[above] At Scottish parliament presenting my petition (12th November 2013)


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http://www.heraldscotland.com/news/14206293.Consultation_on_payments_to_doctors_is_flawed__says_psychiatrist/

Consultation on payments to doctors is flawed, says psychiatrist
Psychiatrist Peter Gordon at home in Bridge of Allan

Psychiatrist Peter Gordon at home in Bridge of Allan

15 Jan 2016 / Stephen Naysmith, Social affairs correspondent
Share:

A CONSULTATION about whether doctors should be forced to declare payments they have received from drug companies is biased, according to the medic whose action led to the move.

Dr Peter Gordon, a former consultant psychiatrist at NHS Forth Valley, has petitioned the Scottish Parliament to introduce a Sunshine Act, which would demand healthcare workers be open about their financial interests related to the medical industry and pharmaceutical companies.

However, he says the Scottish Government’s consultation has presented “unbalanced” information which will not give the public the full picture about the status quo.

NHS staff receive around £38.5 million from the pharmaceutical industry annually, and Dr Gordon estimates up to £4m of this may go to workers in Scotland, with no way to judge whether it has an impact on activities such as prescribing decisions.

Dr Gordon said: “Only a tiny proportion of the £4m known to be paid to healthcare workers by the pharmaceutical industry has been recorded in NHS Scotland registers.

“As petitioner my overwhelming concern is that by presenting unbalanced information the Scottish Government has arranged consultations which will lack in validity.”

After a series of hearings, Holyrood’s petitions committee agreed to commission a public consultation about whether changes were needed to improve transparency for patients and the public.

But Dr Gordon says the consultation, being carried out by the Scottish Health Council (SHC), is not giving people the full facts and could render the process invalid or even look like manipulation.

A briefing being used for the meetings implies that existing rules on transparency may be sufficient and are currently working.

Dr Gordon says that is not the case, and key details have been excluded. “The petition would not have been raised, nor indeed considered by the committee, had it not been for… evidence which has not been provided to the discussion groups,” he said.

He said no NHS Scotland board has fully complied with official government guidance issued in 2003 requiring chief executives to set up registers of interests for all employees including GPs.

Continuing medical education is in some boards entirely supported by sponsors such as the pharmaceutical industry, Dr Gordon said, and patients have no way of knowing if a doctor prescribing drugs has been paid by a drug company or been trained by people who have received such payments.

Dr Gordon added: “If healthcare workers are ‘educated’ by those whose first loyalty is to shareholders, then scientific impartiality may suffer.”

The briefing was prepared for the SHC by the Scottish Government. It says figures from the Association of the British Pharmaceutical Industry show healthcare professionals receive payments for a range of activities including training, clinical trials, media work and market research. An ABPI register of payments is expected to be implemented this year.

A spokesman for the Scottish Health Council said: “One of the key functions of the Scottish Health Council is to ensure that members of the public have the opportunity to give their views on key healthcare issues.

“Following a request from Scottish Government, the Scottish Health Council organised and facilitated a series of discussion groups to gather views from the public on whether there should be a register of interests for NHSScotland.

“Twelve discussion groups have been held around Scotland so far and more are planned to provide further opportunities for people to comment on this issue. People taking part in the discussion groups have been drawn from a range of sources including local community contacts, Public Partnership Forums and voluntary organisations.

“Once the programme of discussion groups is complete, the Scottish Health Council will publish a report on the views gathered.”

Health Secretary Shona Robison said Dr Gordon had been given the chance to comment on the consultation before it began and added: “We look forward to seeing the outcomes of the Scottish Health Council work.

“The Scottish Government commissioned this work to gather views on what a robust, transparent and proportionate response to this issue should look like.

“It is important that this is done in the context of existing legislation, the role of professional and regulatory bodies and the significant progress towards voluntary registers by the pharmaceutical industry.”

 


“”The public have a right to know what that money was for and who received it,
particularly when those involved were influencing what treatments and
medications are used in our hospitals and sugeries.”

He added: “I’m not a whistleblower but I am someone who believes the drugs, medications and treatments doctors use to help patients must be chosen on the basis of scientific evidence, not advertising.

“I could spend forever listing heavily advertised and promoted drugs and treatments hailed as the next best thing only for them to be withdrawn when it was shown they caused harm. That’s what we have to protect against. Transparency is the only way forward.”

An investigation in July revealed health staff in England who help choose drugs for the NHS were paid to work as consultants to pharmaceutical firms.

It found some NHS managers were charging up to £15,000 to organise meetings, sometimes in luxury hotels.

Read more at http://www.dailyrecord.co.uk/news/scottish-news/campaigners-call-action-after-report-6391200#rYOhJGPPQ0VVqVBU.99

Glaxo’s Imitrex Kids…


Page_1

“….Mr. Witty explained that consumers may not be actively visiting their physician for a chronic problem like migraines, so when new drugs come along, they must find out about them through advertising….”

(Andrew Witty -then VP-General Manager of Marketing for GSK- speaking in the Advertising Age October 1997)

“...The new “breakthrough” Imitrex (sumatriptan) turned out to be a big disappointment. The pain magically disappeared for a time, but then the zigzag would return out of the blue a few hours later. It was almost worse than letting it happen to begin with. Other variations of Imitrex didn’t help much more…”

(Imitrex user in Salon.com article 2015).

According to Greg Thorpe’s Department of Justice Complaint which led to the 2012 fine of 3 billion dollars for GSK:

GSK maintained an elaborate illegal marketing regime for the prescription drugs included in today’s settlement, including, according to filed documents:

  • Paying physicians (who could be counted on to influence their peers) as much as $25,000 for being a GSK “advisory board” member;

  • Enrolling 49,000 physicians and health professionals to be part of its speakers bureau;

  • Identifying physicians in academia to pay to speak on behalf of one of the company’s drugs;

  • Creating the PowerPoint “slide kits” that  physicians would  use to deliver canned presentations;

  • Using an elaborate “FaxBack” system allowing drug marketing reps to suggest articles related to off-label uses. The physicians would order these -off-label promotional materials by calling a toll-free number, and thus not appear to be responding to an illegal marketing effort by the drug marketing representative;

  • Pushing Imitrex, an adult medicine for migraine, for mild headaches, as well as for use in children, despite the FDA’s rejection of GSK’s application for child use due to lack of efficacy;

  • Pushing Lamictal, a drug approved only for partial seizures, in adults for other diagnoses.  In at least one case a patient died from a reaction that the company had evidence could occur;

  • Marketing Paxil, the antidepressant, to children under 18 when it had not been approved for youngsters, and despite GSK’s own clinical trails that had shown that the drug was ineffective for children  and also heightened the risk of suicide or other self-harming behavior three-fold; and,

  • Marketing the antidepressant Wellbutrin as superior to other antidepressant alternatives due to increased sexual functioning and weight loss, pushing the drug as the “happy, horny, skinny drug,” to concisely encapsulate GSK’s off-label Wellbutrin marketing campaign.

If Andrew Witty was Glaxo’s VP-General Manager of Marketing in 1997, then what did he know about the various marketing scams, suppression of side effects etc- which went on in the company at that time?

I was prescribed Seroxat in 1998 and information (or misinformation) about side effects was likely contained in some kind of ‘educational’ promotion to doctors back then. How much was Witty aware about Seroxat prescribing to kids? or Seroxat side effects generally? how much input did he have in the promotion of these drugs?

And how much was he aware about Imitrex, or off label prescribing of Imitrex in kids? He seemed to be involved in Wellbutrin marketing also, and Wellbutrin was one of the drugs named in the complaint, alongside Imitrex, and Paxil of course.

According to the aforementioned AdAge article from 1997, Mr Witty, as VP general manager of marketing, was very much involved in all aspects of GSK’s marketing of its drugs at this time-

“…We started experimenting with DTC early and made a relationship with the rulemakers,” says Mr. Witty.

Indeed, Glaxo has been the top advertiser in DTC prescription drug advertising-a business expected to hit $1 billion this year-for two years running. Last year alone, Glaxo’s nasal spray Flonase received $32.7 million in support, migraine remedy Imitrex got $20.4 million, Serevent asthma inhaler had $16.4 million.

Mr. Witty also is adding more product firepower this year with Glaxo’s new anti-smoking pill Zyban getting an estimated $55 million in support (the brand is even getting TV teaser ads prior to its launch)….”


We know now that Seroxat/Paxil was extremely dangerous for under-18’s (causing kids to kill themselves, self harm etc).

The RIAT study proved that beyond doubt.

We also know that GSK’s Zyban also proved to be dangerous also, resulting in suicidal and neuro-toxic side effects similar to the one Seroxat/Paxil induces (see my recent post on Zyban here)

And what do we know about Imitrex (sumatriptan)? The drug which Witty mentions in the 1997 article above?

Well, we know it was illegally pushed off label to kids and according to a recent comment to me by GSK Whistle-blower Greg Thorpe, in regards to Imitrex he said (in a very brief synopsis):

“….Selling to kids , very young as migraines tend to run in families. They told us for years, the indication for kids was weeks away, seriously so everyone pushed it… also we paid off hundreds of physicians to promote it with lectures…not only for kids…but sinus headaches, tension headaches, menstrual migraine etc
 
 All off label ..and yes it was a dangerous drug. ..a Vasoconstrictor one that not only worked on cranial blood blow, but also cardiovascular blood flow. Not for kids, and despite years of studies it was never proven safe or effective in kids under 18.
In spite of that at least 25% was underage and another 25% off label.
More money was spent making hundreds of docs, literally millionaires, speaking to groups about off label use.
I can name many of them and did…”

However after nine years of decimating (or ignoring) Greg’s Formal Complaints, GSK paid nothing for promoting the use of Imitrex in children, or any other off label use (for that matter) he also mentioned that-
-The lead investigator, Sarah Bloom, at the end of the 9 year saga, told Greg…that “she was unaware that Imitrex never was proven safe or effective in children”..

As with Imitrex, this was also the case on some 8 other drugs- including Paxil/Seroxat- where they diminished his ability to mine government data, even as the Federal Court gave him permission to do. Furthermore, in spite of a clear order  by a Federal Judge, the DOJ did not let Greg data-mine any data including a lot of specifics on Paxil marketing that only he claimed.
Greg was the only major whistle-blower who was retaliated against and terminated by GSK and also the only one who reported misconduct to the company first, and did not do it for a possible  award.
All of the others were terminated and/or planners and initiators of GSK Fraud and corruption, some slipping into the case some 8 years after Thorpe’s initial complaints in 2001.
Greg went on to comment upon other aspects of the department of justice investigation- he said :

“….Although, I did not directly sell Paxil, I witnessed everything the Paxil reps said and did. I believe with what I knew and looking in the right places, a fine of much greater than 3 billion should have been paid for Paxil alone, and at least the same for Imitrex.
GSK sold 3 billion dollars of Paxil the year I filed, 2003..most off label, and denying addictive properties.
Obviously the DOJ was in coverup mode. Who was the ringleader,  Sarah Bloom ?
I highly doubt it. I also highly doubt they will do anything serious in other countries,  after seeing what was done here”….

I found an old article online from around 2004/2005 (advertising disguised as objective medical information) which shows the lengths Glaxo were willing to go in order to push this dangerous drug to kids.
If you google the article, you’ll see that it was widely disseminated online at that time.

OFF-LABEL USE OF MIGRAINE DRUG GIVES CHILDREN RELIEF, STUDY SAYS

COLUMBUS, Ohio – A new study suggests that when over-the-counter medications fail to help children who suffer from chronic migraine headaches, those children may find relief with a drug traditionally prescribed to adults.

Ann Pakalnis

Around one out of every 10 children experience chronic migraines, said Ann Pakalnis, a study co-author and a clinical associate professor of pediatrics and neurology at Ohio State University and Columbus Children’s Hospital.

She and her colleagues treated 57 children with sumatriptan (Imitrex) nasal spray. More than three-quarters of the families in the study reported good to excellent relief of their child’s headaches after using the spray, and nearly 100 percent of the children in these families continued using the drug.

But sumatriptan isn’t approved by the U.S. Food and Drug Administration for use in children. The participants in this study were prescribed sumatriptan on an off-label basis, a common practice in which a medication is used to treat a group of people or a problem it wasn’t originally intended to treat.


“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes.”


“By the time children see us at the headache clinic, they’ve already tried over-the-counter medications or milder prescription drugs,” said Pakalnis. “Their parents want a more aggressive treatment. They understand that it’s probably the best thing to do for their child, even if means an off-label use.”

The findings appear in a recent issue of the Journal of Child Neurology. Pakalnis conducted the study with Donna Kring, a nurse at Columbus Children’s Hospital, and Juliann Paolicchi, a pediatrician at the hospital.

The researchers took a retrospective approach to appraising sumatriptan’s effectiveness in children. They reviewed the medical charts of children 5 to 12 years old who were patients at Columbus Children’s Hospital, tallying the number of children prescribed the nasal spray. Each child’s family then received a questionnaire asking about the child’s use of the spray, its effectiveness and any concerns regarding the off-label use of the drug.

The majority (77 percent) of the 57 families who responded to the questionnaire reported that sumatriptan nasal spray had significantly helped their child, and 93 percent of these families noted that their child still used the drug.

Thirteen patients (23 percent) reported side effects from using the spray. Each of these children said the spray tasted bad, and five in this group stopped using it altogether. Sumatriptan nasal spray tastes very bitter and metallic to some children, Pakalnis said. Four of the 13 patients complained of dizziness. Two children found the spray difficult to use, and stopped using it.

“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes,” Pakalnis said. “Some kids have a lot of nausea and vomiting with their headaches, which rules out giving them a tablet. Injection is another choice, but not a great option for children.”

Migraine triggers such as dehydration, fatigue and hormonal changes cause changes in nerve impulses that in turn affect blood vessel diameter and biochemical release. Blood vessel dilation causes pain, which analgesics can help alleviate. But analgesics don’t address the symptoms that often accompany migraines, such as nausea, vomiting and sensitivity to light and sound, which are usually caused by blood vessel constriction.

Sumatriptan and related drugs stop pain by restoring the nervous system’s ability to block pain impulses and help constrict blood vessels. And the triptans also help dilate the constricted vessels that contribute to they symptoms that accompany migraine attacks.

About 30 percent of the patients coming to Pakalnis’ office seek help for migraines. She and her colleagues currently prescribe sumatriptan nasal spray to about three-quarters of these patients.

“It’s an effective and safe treatment for children who don’t respond to over-the-counter pain killers,” she said.

The study was supported in part by Glaxo Smith Kline, makers of sumatriptan nasal spray.

#

Contact: Ann Pakalnis, (614) 722-4605; pakalnisa@pediatrics.ohio-state.edu
Written by Holly Wagner, (614) 292-8310; Wagner.235@osu.edu


So if Glaxo were misleading their drug reps to sell drugs like Imitrex to under-18’s, and obviously the marketing department were creating content for product placement disguised as objective information (such as the article above) then who (or whom) was directing this behavior from the top?

You’d have to wonder, would Andrew Witty  have allowed any of his kids to take drugs like Imitrex, or Seroxat, or Avandia, or Pandemrix?

I very much doubt it…

Because he would have known their full side effect profiles perhaps wouldn’t he?..

Or he would have at least been aware of the rumors about their dangers within the company…

If you look at the latest prescribing information leaflet (PIL) for Imitrex you will notice that it’s just as frightening as Seroxat..

How many kids and adults were misinformed and harmed?

See document (directly) below (from Greg Thorpe’s complaint) for an example of how GSK pushed Imitrex off-label.

 Imitrex doc


IMITREX®
(IM-i-trex)
(sumatriptan succinate) Injection

Read this Patient Information before you start taking IMITREX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about IMITREX?

IMITREX can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking IMITREX and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

IMITREX is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

What is IMITREX?

IMITREX Injection is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.

IMITREX is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

IMITREX is not used to prevent or decrease the number of migraine or cluster headaches you have.

It is not known if IMITREX is safe and effective in children under 18 years of age.

Who should not take IMITREX?

Do not take IMITREX if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT®, MAXALT-MLT®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)
      Ask your healthcare provider if you are not sure if your medicine is listed above.
  • an allergy to sumatriptan or any of the ingredients in IMITREX. See the end of this leaflet for a complete list of ingredients in IMITREX.

What should I tell my healthcare provider before taking IMITREX?

Before you take IMITREX, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking IMITREX
  • are breastfeeding or plan to breastfeed. IMITREX passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take IMITREX.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

IMITREX and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take IMITREX?

  • Certain people should take their first dose of IMITREX in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
  • Use IMITREX exactly as your healthcare provider tells you to use it.
  • Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
  • For adults, the usual dose is a single injection given just below the skin.
  • You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine or cluster headache attack.
  • If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
  • If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner.
  • Do not take more than 12 mg in a 24-hour period.
  • If you use too much IMITREX, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take IMITREX so you can talk with your healthcare provider about how IMITREX is working for you.

What should I avoid while taking IMITREX?

IMITREX can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of IMITREX?

IMITREX may cause serious side effects. See “What is the most important information I should know about IMITREX?”

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events).
    Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • medication overuse headaches. Some people who use too many IMITREX injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with IMITREX.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using IMITREX, especially if IMITREX is used with anti-depressant medicines called SSRIs or SNRIs.
    Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • seizures. Seizures have happened in people taking IMITREX who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take IMITREX.

The most common side effects of IMITREX Injection include:

  • pain or redness at your injection site
  • tingling or numbness in your fingers or toes
  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • discomfort or stiffness in your neck
  • feeling weak, drowsy, or tired

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of IMITREX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IMITREX Injection?

  • Store IMITREX between 36°F to 86°F (2°C to 30°C).
  • Store your medicine away from light.
  • Keep your medicine in the packaging or carrying case provided with it.

Keep IMITREX and all medicines out of the reach of children.

General information about the safe and effective use of IMITREX

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use IMITREX for a condition for which it was not prescribed. Do not give IMITREX to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about IMITREX. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about IMITREX that is written for healthcare professionals.

For more information, go to http://www.gsk.com or call 1-888-825-5249.

What are the ingredients in IMITREX Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

IMITREX STAT dose System

Read this Patient Instructions for Use before you start to use the IMITREX STATdose System. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about IMITREX Injection when you start taking it and at regular checkups.

Keep the IMITREX STATdose System out of the reach of children.

Before you use the IMITREX STATdose System

When you first open the IMITREX STATdose System box, the Cartridge Pack and the IMITREX STATdose Pen® are already in the Carrying Case for your convenience.

The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.

The Cartridge Pack holds 2 individually sealed Syringe Cartridges. Each Syringe Cartridge holds 1 dose of IMITREX® (sumatriptan succinate) Injection. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue (as shown). Refill Cartridge Packs are available.


http://lighthouselegal.com/imitrex-lawsuit-can-go-forward-in-washington

Imitrex lawsuit can go forward in Washington

Dr. David Wilson can pursue a medical malpractice lawsuit against the hospital where his daughter, Dr. Sandra Wilson, was on staff and received treatment prior to her death in 2006, reports the Yakima Herald-Republic. Individuals in need of financial assistance to pursue medical malpractice lawsuits can often secure legal loans.

The lawsuit alleges doctors at Sunnyside Community Hospital improperly administered a migraine medication, Imitrex, to 35-year-old Sandra Wilson, who sought treatment for symptoms including nausea and speech problems, the Herald-Republic reports. The news source says Wilson began having seizures after being on the medication for three days. She died after being transferred to a Spokane hospital, where it was discovered the Imitrex had exacerbated a preexisting constriction of one of her major brain arteries.

According to the Herald-Republic, a previous ruling in the case found David Wilson could not sue Sunnyside in part because his daughter had been a contracted physician there. An appeals court recently reversed this dismissal, meaning the case will go to trial if a settlement is not reached.

Before the tablet version of Imitrex went on the market in 1995, Mother Jones reported on Dianne Riley, a 41-year-old mother of four who died from a heart attack that seemed to be the result of an adverse reaction to the drug.

GSK, Save The Children, Yemen, And How Glaxo Behaves In Developing Countries…


“…..Teaming up with Save the Children to market a product could boost your sales, profile and customer base’ – Save the Children’s assurance to potential corporate partners….”

http://newint.org/features/2014/12/01/charities-and-transnationals/

GSK yemen

“….In Yemen and across the developing world, GSK is committed to finding new and innovative ways to ensure access to medicines,” said Mr Omar Mulhi, Country Manager, GSK Yemen. “We are collaborating with government, NGOs and other private-sector companies to improve people’s health and well-being no matter where they live, while continuing to expand our business and invest in research.”

Over the past five years, GSK has made fundamental changes to its business model including re-investing 20 per cent of all profits in the least developed countries to help communities strengthen their local health infrastructure.

For example, in cooperation with Save the Children, GSK is funding the building of a Health and Nutrition Workforce for vulnerable communities in Yemen. The programme will benefit 45,000 children under the age of five; 30,000 children aged six and over; and 30,000 women of child bearing age….”

For full article see here

Over the last few months I have been in correspondence with a whistle-blower from Yemen who claims that GSK  have been involved in various unethical shenanigans there (see here). I have in my possession some pretty damning information however I cannot publish yet, but I will hopefully be able to- by the end of the month (so stay tuned).

Allegations of corruption by GSK are nothing new- back in 2012 they paid the biggest healthcare settlement fine in US history (a staggering 3 Billion dollars) and as recently as 2014 they paid half a million dollars to settle a big corruption case in China.

So what’s the big deal if GSK are behaving badly, or unethically, in Yemen -or other countries?

Well, in a developing country like Yemen, perhaps it’s fair to say that GSK can get away with a little more than they would in say- the US or UK?

Personally, I think that the GSK culture is riddled with corruption, and despite claims by GSK Andrew Witty that this kind of behavior is from another ‘era’ and not current GSK policy, the corruption in GSK doesn’t seem to be stamped out, and it’s arguable that it is more widespread globally..

Why is this?

GSK have built their business model on corruption, it’s how they have generated their vast profits. Without lying and deceiving they wouldn’t have had a blockbuster like Seroxat/Paxil for example. If they had told the truth about that drug- they wouldn’t have made billions on it. You could say the same for Avandia- another controversial GSK drug- or even how they marketed Advair (their asthma drug at the center of the GSK department of Justice investigation- see Greg Thorpe’s complaint here).

Their profits generate profits.

They have infiltrated, and leveraged influence- on- governments, academia, universities, NGO’s, healthcare policy, regulation etc.

Even the legal bribery that goes on is dodgy. When GSK sponsors a charity, or a prize, or an academic department or a university, this causes undue influence. It curry’s favor…

Corruption and bribery (both legal and illegal) is rampant wherever GSK goes because that’s a successful business model that evidently works for them.

But perhaps the most disturbing aspect of GSK’s ‘influence’ is upon charities such as ‘Save The Children’

If the Yemen whistle-blowers allegations are true then it seems that Save the Children should be concerned also about off label prescribing of GSK owned drugs in Yemen to- (you guessed it)- children..

However,  the ‘Save The Children’ organization are already aware of Seroxat study 329 and the off label prescribing of Seroxat/Paxil to children and they don’t seem that bothered about it so maybe they won’t see much of a problem with any future allegations either?…

Only time will tell..

http://newint.org/features/2014/12/01/charities-and-transnationals/

“…….No mention on Save the Children’s website, however, of one of GSK’s less child-friendly products – the antidepressant Paxil (Seroxat/paroxetine). In 2012 the company was fined $3 billion by the US government after pleading guilty to criminal charges, including bribing doctors and encouraging the prescription of Paxil to children, even though the drug was unsuitable and unapproved for this use.2

‘We would never refrain from speaking out on an issue because we had a partnership with a particular company. That would clearly compromise our values,’ claims Save the Children.

When contacted for a response, it admitted it was ‘aware of reports on the historic issues relating to Paxil… but our belief is that the risks are outweighed by the benefits of the partnership.’3….”

..Dear Bob,

Many thanks for getting in touch with Save the Children about our partnership with GlaxoSmithKline. I believe you have contacted us before on this, and we thank you for your interest.

Save the Children is aware of the reports on the historical issue of Paxil. As an organisation we take our reputation and our role to protect children very seriously and assess all our partnerships within this context.  We acknowledge there are risks associated in working with a pharmaceutical company such as GSK, but our belief is that these risks are outweighed by the benefits of the partnership in helping us achieve our ambitions for children.

As part of our partnership we continue to have open dialogue with GSK and monitor their business practices, in order that we respond appropriately should future issues arise.

Private sector partnerships are instrumental in enabling Save the Children to realise our vision and our partnership with GSK will have a lasting impact on global mortality rates. The focus of the partnership is to help to save a million children’s lives in the developing world and it combines GSK’s relevant skills, expertise and resources across its business with the funding of healthcare programmes for the poorest children in developing worlds.

For further information on our partnership, please visit: http://www.savethechildren.org.uk/about-us/who-we-work-with/corporate-partnerships/our-partners/gsk

Kind regards…”

(Bob Fiddaman Blog 2015)

http://fiddaman.blogspot.ie/2015/10/save-children-respond-re-partnership.html

GSK’s Seroxat/Paxil Drug Among Drugs Now Tied To Changes In The Brain


Ever wondered why you feel brain damaged after taking Seroxat/Paxil?  Or why you felt brain fog on it? Or maybe you have memory loss and just never felt the same since?

This might explain it…

http://in.reuters.com/article/us-health-brain-otc-drugs-idINKCN0XH1Y8

(Reuters Health) – Commonly used drugs for problems like colds, allergies, depression, high blood pressure and heart disease have long been linked to cognitive impairment and dementia. Now researchers have some fresh evidence that may help explain the connection.

The drugs, known as anticholinergics, stop a chemical called acetylcholine from working properly in the nervous system. By doing so, they can relieve unpleasant gastrointestinal, respiratory or urinary symptoms, for example.

The list of such drugs is long. Among them: Benadryl for allergies, the antidepressant Paxil and the antipsychotic Zyprexa, Dimetapp for colds and the sleep aid Unisom.

In the new analysis, researchers looked at brain scans and cognitive test results from 451 older adults – including 60 who had been taking anticholinergic drugs for at least a month. The study participants were about 73 years old on average.

None of them had been diagnosed with cognitive problems like Alzheimer’s disease or dementia.

But brain scans of people who used anticholinergic drugs showed lower levels of glucose processing in the brain – an indicator of brain activity – in a region of the brain associated with memory that’s also affected early in the course of Alzheimer’s disease.

In addition, patients who used these medications had reduced brain volume and thickness in some regions linked to cognitive function, the researchers report in JAMA Neurology.

People who used these drugs also scored lower on tests of immediate memory recall and executive function compared to people who weren’t using these drugs, researchers found.

“There are definitely medical benefits to all of the anticholinergic medications we looked at, which could outweigh the cognitive risks,” said lead study author Shannon Risacher of the Indiana Alzheimer Disease Center at the Indiana University School of Medicine in Indianapolis.

“But if alternative therapies are available that provide effective treatment of these conditions, patients and doctors might want to consider avoiding anticholinergic medications,” Risacher added by email.

The study can’t prove the anticholinergics were the cause of participants’ brain and memory differences.

The authors also acknowledge limitations of their study. In addition to the small number of participants taking anticholinergic drugs, another problem is that the study relied on participants to accurately recall and report on drug use, which wasn’t verified by medical records or prescription data.

This study and others like it are limited as well by a lack of specifics about what dosage of anticholinergic drugs people took or how long they used the medications, noted Alain Koyama, an outcomes researcher at Health Advocate, a consultancy in Los Angeles.

“Therefore, it is yet unclear if lower doses or shorter durations of use can in fact mitigate risk of cognitive harm,” Koyama, who wasn’t involved in the study, said by email.

Still, the study adds to a growing body of evidence connecting anticholinergic medicines to cognitive problems later in life and offers new evidence to explain why this link exists, Koyama added.

The findings should encourage doctors and patients to discuss the drugs, and to consider whether the potential risk of cognitive decline merits avoiding or limiting use of these medicines.

Not every patient will arrive at the same answer, however.

“Since the pathology underlying any effect of anticholinergic drugs on cognitive function likely takes years to manifest, if a patient is clearly benefiting from a drug in the short-term, but may not survive in the long term, any cognitive harm from the drug may be inconsequential,” Koyama said.

“On the other hand, a healthier patient particularly concerned about future dementia risk, whether because of family history or other reason, may consider alternative treatments,” Koyama added.

SOURCE: bit.ly/1WcH6Dt JAMA Neurology, online April 18, 2016.

 

Robert West (University College London Professor Of Health Psychology) And His Competing Interests With GSK And Others


Smokers die after taking Zyban cure

by RACHEL ELLIS, Mail on Sunday

Eighteen smokers have died after taking Zyban – the new ‘wonder cure’ for nicotine addiction, The Mail on Sunday reveals today.

The deaths, reported by GPs to the Department of Health, have occurred in the seven-and-a-half months since the drug was launched. Those who died were mainly in their 40s and 50s – although one was aged just 21.

Health Department figures also show that 3,457 Zyban users have suffered a disturbing range of suspected side effects – from chest pains to fits, seizures and depression.

Manufacturers GlaxoSmithKline and health officials last night insisted there was no evidence that Zyban was unsafe. But Ministers are under pressure to launch an urgent investigation into the drug, which has been prescribed to some 270,000 smokers in Britain.


You could be forgiven if you were duped by some of the headlines the last few days about a new study which apparently exonerates GSK’s Zyban and Pfizer’s Champix/Chantix (both marketed as stop-smoking drugs) of any serious neuro-psychiatric side effects.

GSK’s Zyban (and Pfizer’s Champix) have long been linked to suicide, and other neuro-toxic effects.

Zyban is just GSK’s ‘anti-depressant’ Wellbutrin (Bupropion) marketed under another name for the stop-smoking market. GSK’s CEO Andrew Witty was once involved in Wellbutrin marketing, and you’d have to wonder what he knows about these neurotoxic side effects? (see here).

On face value this article about the study looks above board doesn’t it?

That’s until you see who’s really behind it.

The Study is funded by Pfizer and GSK

(As the old adage goes- follow the money)

The Lancet

 


“...The EAGLES study – published in The Lancet – backed the safety and efficacy of Pfizer’s Chantix/Champix (varenicline) and GlaxoSmithKline’s Zyban (bupropion) as well as nicotine replacement therapies in helping people quit smoking.

Questions about the safety of Champix and Zyban first came to the fore in 2009, when the FDA ordered Pfizer and GSK to include box warnings on their products to warn of their possible link to “changes in behaviour, depressed mood, hostility and suicidal thoughts”.

However, what the article does not state are the competing interests of one of the lead authors of this study- Mr Robert West of UCL (University of London).

“…Robert West of University College London – one of the authors of the paper – said the results “should reassure regulatory authorities, doctors and patients about the safety and effectiveness of medicines to help smokers to stop, whether or not those smokers have a history of a psychiatric disorder”…

Mr West’s competing interests include:

“…..research and consultancy for companies that develop and manufacture smoking cessation medicines (Pfizer, GSK and J&J)….”

Robert


Mr West does not state exactly how much he is paid for the research and consultancy for work he does for companies like GSK, Pfizer and J and J, but you can be sure that he doesn’t work for peanuts- he is a Professor after all and I’m sure he would expect a nice fee after all those academic years of attainment.

Furthermore, considering Professor West’s admitted conflict of interests with the companies that make the drugs which his research is based upon- does this mean that we should take his study into Pfizer’s Champix and GSK’s Zyban with a generous pinch of salt?

I think that would be wise, don’t you?

It seems someone has already requested (under a FOI mechanism) to see what links Mr West has to Pharmaceutical companies already (see here).


From: RT Freud

19 April 2016

Dear Department of Health,

Please provide all correspondence over the past 5 years between DH and Robert West, Editor-in-Chief of Addiction Journal, Professor of Health Psychology and Director of Tobacco Studies at the Cancer Research UK Health Behaviour Research Centre, University College London, co-director of the National Centre for Smoking Cessation, co-author of the English National Smoking Cessation Guidelines and consultant to numerous pharmaceutical conglomerates that develop and manufacture smoking cessation medications including GSK, J&J and Pfizer.

Given that Prof Robert West is a paid consultant for the pharmaceutical lobby, please advise how his conflicts of interest are handled, and how the DH ensures that his evaluation of pharmacological and behavioural aids to smoking cessation and his training programmes for medical staff are free of conflicts of interest.

Many thanks

Yours faithfully,

RT Freud


Mr West is not the only author of this study with links to Pharma, if you click on the names of each author on the Lancet page where the study is published (here) you will see that many of the other authors also have various links to pharmaceutical companies.

Lisa St. Aubin – Pfizer.

Thomas McRae- Pfizer.

David Lawrcence- Pfizer.

John Asher MD- GSK.

Christina Russ- Pfizer.

Alok Krishen- Paraxel internatinal on behalf of GSK.


It looks to me that this Lancet study is little more than a product placement for Pfizer and GSK and also a PR move in defense of Champix and Zyban.

I would trust an independent (non pharma-biased) opinion over someone like Mr West’s and rightly so…

The articles below illustrate the long documented problems with drugs like Zyban..

And its information from links like this (from real people’s online experiences of Zyban and Champix) which Pfizer, GSK- and perhaps even Dr West and his associates- would likely (conveniently) dismiss as merely ‘anecdotal‘.

 


http://www.vancouversun.com/health/Smoking+cessation+drug+more+harmful+than+previously+thought+report/10392954/story.html

VANCOUVER – Use of a popular smoking cessation and depression medication led to 64 hospitalizations — including 22 cases admitted to critical care — last year in B.C., according to the province’s Drug and Poison Information Centre.

The centre handled 95 calls last year about bupropion overdoses, including 22 cases where the wrong dosage was taken, 47 cases of suspected suicide attempts and nine cases of misuse or abuse. There was one death. Burpropion is marketed under the brand names Wellbutrin and Zyban.

Since not all cases of overdoses or abuse are reported to the centre, it is likely there are far more cases in B.C., said Dr. Roy Purssell, an emergency room physician who is also medical head of the drug and poison centre, an agency affiliated with the Provincial Health Services Authority.

“We’re on edge about this medication and we want doctors and the public to be aware of our concerns. It has the propensity to cause serious, toxic effects. And I don’t think there is awareness about how big the risks are,” Purssell said in an interview.

http://america.aljazeera.com/watch/shows/america-tonight/america-tonight-blog/2013/11/21/fda-anti-smokingdrugchantixlinkedtomorethan500suicides.html

Shows America Tonight The Flagship

Nov 21 12:08 PM

FDA: Anti-smoking drug Chantix linked to more than 500 suicides

After being approved by the FDA in 2006, Chantix was given a black-box warning by the FDA for the serious adverse effects caused by the drug.

After being approved by the FDA in 2006, Chantix was given a black-box warning by the FDA for the serious adverse effects caused by the drug.
America Tonight

Tina Hurst was living what she considered a perfect life in her quiet neighborhood in suburban Chicago. She was happily married, the mother of two teenage girls and an executive at an insurance company.

Hurst also had a secret. She was a closet smoker, an on-again, off-again, pack-a-day habit she’d hidden from her family.

“I would quit for a couple of months and then I would start back again, so it was one of those periods where my family thought I was still not smoking, and I had started again,” Hurst said.

Hurst called her doctor, who suggested a prescription drug called Chantix, which is designed to help smokers quit by curbing the desire to light up. Hurst thought she’d found an easy fix. Wiithin a week, she quit smoking.

“I thought it was a miracle drug, you know?” she said.

As Hurst continued taking the drug as prescribed, her well-ordered life started coming unhinged and she began acting erratically. After her husband convinced her to throw the pills away, Hurst said she went over the edge.

“It was just like, boom! Something went wrong,” she said.

Hurst, who said she’d never been depressed or suffered from any other mental illness, started experiencing hallucinations and suicidal thoughts. Hurst threatened to jump out of a moving car, forcing her parents called 911.

Hurst wound up spending five days in a locked-down psychiatric ward at a local hospital, a nightmarish experience she blames on Chantix.

Chantix, approved by the U.S. Food and Drug Administration in 2006, has a long history of users – and their next of kin — reporting troubling, sometimes deadly, side effects they blame on the drug.

In the last five years, 544 suicides and 1,869 attempted suicides have been reported to the FDA as “adverse events” in connection with Chantix, according to documents obtained by America Tonight under the Freedom of Information Act.

Adverse events are side effects reported to the FDA by patients, doctors or health professionals, or the drug makers themselves. The reports don’t prove cause and effect but serve as an early warning system of sorts for the FDA, which monitors federal drug safety.

Side effects ‘off the charts’

In 2008, Thomas J. Moore, senior researcher with the Institute for Safe Medication Practices, was testing new software to analyze adverse events when he made a startling discovery.

“Here, basically going off the charts, was this new smoking-cessation drug called Chantix,” Moore said.

Moore found that Chantix was responsible for more adverse events – including the type of serious psychiatric episodes such as Hurst’s – than any other drug on the market. They fell into four categories: suicidal behaviors, depression, psychosis and aggression.

“There were side effects that made it look like it was unsafe for pilots and people in critical occupations because there were seizures, blackouts, temporary blindness, blurry vision,” he said.

Based on Moore’s research, the Institute for Safe Medication Practices issued a report saying the group had “immediate safety concerns” about Chantix “among persons operating aircraft, trains, buses and other vehicles.”

The Federal Aviation Administration and Defense Department took heed and banned Chantix use among pilots and air traffic controllers. The military also banned Chantix for missile crews.

The Federal Motor Carrier Safety Administration, the federal agency that governs truckers, said Chantix may “adversely affect the driver’s ability to safely operate a motor vehicle.” And the Department of Transportation sent a memo to the Federal Railroad Administration warning of “the potential threat to public safety caused by the anti-smoking drug Chantix.”

In July 2009, the FDA slapped a so-called black-box warning on Chantix – the most serious warning possible – saying the drug “has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.”

Prospects for violence?

Moore continued digging into adverse event reports, particularly those involving violence. He co-authored a 2010 study in the Annals of Pharmacotherapy analyzing 26 acts of violence reported to the FDA as adverse events associated with Chantix. The study called them “inexplicable and unprovoked”: “A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car…A 42-year-old man punched a stranger at a bowling alley…A 24-year-old started beating her boyfriend in bed because ‘he looked so peaceful’ and she later attempted suicide.”

“These cases had three striking characteristics,” Moore said in an interview at his Alexandria, Va., office. “First, the violence was absolutely unpredictable and senseless. Second, the victim was anybody who happened to be nearby. It could have been a fiancé. It could have been mother. It could have been a police officer. And third, these people had no history of violence and were unlikely prospects for a violent act.”

Clinical trials of Chantix have failed to turn up suicidal behavior or the type of aggression and violence reported to the FDA as adverse events.

“Pfizer believes in and supports Chantix as an important treatment option for adult smokers who want to quit and takes the safety of all of its medicines seriously,” Pfizer said in a statement to America Tonight, adding that the drug has been prescribed to more than 20 million people worldwide.

The future of Chantix

Smoking remains the largest cause of preventable death and disease in the United States, and the FDA is standing behind Chantix, which has a 12-month quit rate of 22 percent, slightly better than counseling or nicotine-replacement therapy such as the patch or gum.

The FDA declined to an interview for this story, but gave a statement to America Tonight: “Although Chantix, like any medication, is associated with a number of adverse effects, appropriate patient monitoring and selection can reduce the likelihood of these adverse events occurring.”

Dr. Michael Siegel, a professor at Boston University’s School of Public Health who has studied smoking for 25 years, said it’s unrealistic to ask doctors to monitor for attempted suicide.

“The use of a black box warning is to help physicians identify early symptoms that so that you can prevent the adverse event from occurring,” Siegel explained. “In the case of Chantix, the black box warning is basically telling physicians, ‘Be careful because your patients might die taking this.’ What use is it to monitor patients for suicide? Once they commit suicide, it’s over.”

Tina Hurst thought Chantix was a "miracle drug."

Tina Hurst thought Chantix was a “miracle drug.” Now, she’s still paying the price.
America Tonight

For that reason, Siegel has called for Chantix, which made $670 million in sales last year, should be pulled from the market.

Moore doesn’t go that far. He said more restrictions should be placed on Chantix.

“People who carry weapons for a living such as police officers and military should not take a drug, which can cause – and this is well-documented – uncontrollable rage,” he said.

The FDA has asked Pfizer to investigate reports of violence by Chantix users and report back by 2017.

Earlier this year, Pfizer spent close to $300 million to settle 2,700 Chantix lawsuits, and the judge in the case says the black box warning is sufficient, meaning future litigation is unlikely.

Tthe company has stepped up advertising the drug, offering testimonials from happy customers able to quit a pernicious habit. But for Chantix users like Hurst, life took an unexpected detour, even as Pfizer continues to make hundreds of millions of dollars on the drug.

“Pfizer is making a killing on this drug, but I took it. There were warnings at the time,” said Hurst, whose life is back to normal. “But there’s always this ‘It won’t happen to me. It could happen to somebody else. It’s not going to happen to me

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 and it just might take a pending court case in the UK to reveal the full truth about GSK’s sinister Seroxat drug.

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.

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