Who’s Afraid Of Sidney Wolfe? : GSK Tops Corruption Scales With 7.56 Billion In Penalties And Fines Since 1991


Corrupt and Criminal Pharmaceutical Companies

http://blogs.bmj.com/bmj/2014/04/15/the-bmj-today-gsk-and-paying-doctors-to-speak-on-its-behalf/

Not everyone is convinced by their public show of goodwill. In his regular column, Sidney Wolfe, founder and senior adviser in the Health Research Group at Public Citizen, in Washington analysed all civil and criminal penalties paid to the US federal and state governments by pharmaceutical companies from January 1991 through 18 July 2012.

“GSK topped the list of repeat offenders with total criminal and civil penalties of $7.56bn since 1991, comprised six different federal settlements and an additional number with states,” he wrote.

But it seems as though bad news follows the company as they try to build its image. Following investigations in China and Iraq, Shelley Jofre, BBC Panorama correspondent, has found that GSK is under investigation in Poland for allegedly bribing doctors there.

In a feature, she writes that it’s alleged that GSK sales reps in the region of Lodz, Poland’s third largest city, paid doctors as recently as 2012 to boost prescriptions of some of the company’s best known drugs.

A spokesman for the Lodz public prosecutor’s office, Krzysztof Kopania, said that one GSK regional manager and 11 doctors have been charged in connection with corruption allegations for offences committed in 2010-12.

In response, GSK said: “Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company,” the company added. “The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result. We continue to investigate these matters and are co-operating fully with the CBA [the anti-corruption bureau in Poland].”

Whilst such problems arise, GSK’s ability to shake off past reputation and build one of trust and scientific integrity, might be made that bit tougher.

Deborah Cohen is investigations editor, The BMJ.

Sidney Wolfe

150 Less ‘Rogue’ Employees At GSK… : GSK Sacks Over 150 Staff In China…


http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html

GSK cuts 150 China staff for improper sales practices
By Hui Zhi | Thursday, April 17, 2014 at 7:08AM

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).
 
The mass firing came ten months after bribery allegations emerged against the company.

Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions. 

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.



The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees.

“Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)
_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.
- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

GSK cuts 150 China staff for improper sales practices 

UK drug maker GlaxoSmithKline (GSK) has sacked over 150 staff in China amid a probe into allegations that the firm bribed doctors and government officials to boost drug sales, according to the 21st Century Business Herald (21CBH).

The mass firing came ten months after bribery allegations emerged against the company. Chinese authorities last year accused GSK’s sales staff of faking conference expenses and funneling about $480 million in bribes through travel agencies to doctors and officials for drug prescriptions.

After the bribery scandal broke out, GSK conducted internal investigation of expense claims. The company found that nearly 1,000 sales representatives had suspected compliance problems, resulting in the recent action against some of them, a GSK sales staffer told 21CBH.

The company has declined to specify the exact number of employees being dismissed, but the inside  source said at least 150 people were fired.

The termination has triggered protests from sales staff, who claimed the company failed to reimburse their expenses or pay their bonuses, and treated them unfairly.

The company admitted confiscating bonuses of some sacked employees. “Where we have found potential issues, we are thoroughly reviewing them and have withheld incentive payments where appropriate,” it said.

Some GSK employees were asked to sign a confession in return for a waiver from the company of penalties, the inside source alleged. However, the company later used the confessions as an excuse to sack them, the source reported.

The company announced a new global policy in December to stop paying doctors to attend medical conferences.

It is also investigating a fresh bribery allegation that its pharmaceuticals division in Iraq hired government physicians and pharmacists in Iraq as paid sales representatives to improperly boost its sales.

Sources: Wall Street Journal, Reuters, 21st Century Business Herald (21世纪经济报道)

_______________

Hui Zhi is the Senior Manager for Content with the China Compliance Digest, where a version of this post first appeared.

- See more at: http://www.fcpablog.com/blog/2014/4/17/gsk-cuts-150-china-staff-for-improper-sales-practices.html#sthash.9GJOcIX6.dpuf

Whistleblower Greg Thorpe: GSK Have Used Dangerous Tactics To Drive Sales To Treat Kids


Drug firms have used dangerous tactics to drive sales to treat kids

By Christopher N. Osher and Jennifer Brown
The Denver Post

Posted:   04/14/2014 12:01:00 AM MDT | Updated:   about 8 hours ago
Whistle-blower. Greg Thorpe, a former sales representative for GlaxoSmithKline, sits at a desk in Florida with papers from the case in which he alleged the
Whistle-blower. Greg Thorpe, a former sales representative for GlaxoSmithKline,
sits at a desk in Florida with papers from the case in which he alleged
the company encouraged doctors to prescribe antidepressants to
children when the FDA had not approved the drugs for pediatric use.
Glaxo agreed to pay $3 billion to the federal government to settle the case.
(Brian Blanco, Special to The Denver Post)

Pharmaceutical companies wooed academic leaders, ghostwrote articles, suppressed damaging health data and lavished doctors with gifts to make prescribing powerful psychotropic drugs to children a blockbuster profit center, a trail of lawsuits over the past two decades shows.

As a Colorado Springs sales representative for GlaxoSmithKline, Greg Thorpe tried to put a stop to the practice. His manager wrote him up for not being a “team player” after he objected to the free spa treatments and pedicures, hunting trips, tickets to sports games and skiing junkets that his supervisors expected him to give out to doctors and others.

“The sky was the limit,” said Thorpe, whose whistle-blower lawsuit against his former employer ended with a $3 billion settlement with the federal government. “Those who spent more money got rewarded because they were positioning the company for more business. And it did pay off.”

It was just one part of the massive effort by the pharmaceutical industry to drive sales of antidepressants, antipsychotics and other psychotropic drugs to treat poor children, often for uses never approved by federal regulators.

The push succeeded in reaching a particularly vulnerable group: foster children, who experts say often struggle to cope with trauma that psychotropic drugs don’t heal.

A Denver Post investigation into antipsychotic use found that foster children were prescribed the potent mood-altering drugs at a rate 12 times higher than that of other children on Medicaid in Colorado in 2012. Dosages and rates of multidrug prescriptions also were high among foster children in this state.

Colorado officials knew about rising prescription rates and dosages of psychotropic drugs, which include antipsychotics and antidepressants, as early as 2007 but didn’t convene a panel to address the issue for more than five years.

High rates of psychotropic drug use among poor and foster children didn’t occur by mistake, government investigators say. Court documents filed in health care false-claims lawsuits show that drug companies closely tracked the prescribing habits of doctors in the Medicaid program, which pays the health care of the poor, including foster children.

In Colorado, nine of the top 10 most prescribed drugs for foster children in the Medicaid program are psychotropics, according to the most recently available data. In contrast, for non-foster children, only one psychotropic is among the top 10 most prescribed drugs in Medicaid.

Pharmaceutical companies in 2008 alone spent nearly $800 million on sales representatives making visits to health care professionals for antipsychotics and antidepressants, a December 2009 report from the nonpartisan Congressional Budget Office found.

And that’s not counting additional money paid to health care providers for speeches, consulting and research, some of which went to Colorado doctors.

John T. Hardy, an adolescent and child psychiatrist in Pueblo, received about $400,000 from 2009 through 2011 in travel, consulting and speaking fees and meals from drug companies, including antipsychotic manufacturers Eli Lilly and Pfizer, according to a ProPublica database.

A variety of psychotropic drugs — some simultaneously — are used by many children in the foster-care system. Olanzapine, sold under brand names

A variety of psychotropic drugs — some simultaneously — are used by many children in the foster-care system. Olanzapine, sold under brand names including Zyprexa, is used to treat schizophrenia and acute mixed or manic episodes, while Seroquel, or quetiapine, is used to treat nervous, emotional and mental conditions such as schizophrenia and symptoms of bipolar disorder, or manic-depressive illness. All of these drugs are atypical antipsychotics. (Helen H. Richardson, The Denver Post)

A Colorado panel studying the high use of psychotropics among foster children in Colorado reviewed Medicaid drug prescriptions and found that in 2012, Hardy was one of the highest volume prescribers in the state of mental health drugs.

“I do what’s best for my patients,” said Hardy, adding that pharmaceutical money doesn’t influence his prescribing decisions. The number of psychotropic prescriptions Hardy wrote could not be obtained by The Post.

Lucrative drugs

Far from the niche market they originally served, antipsychotics these days are some of the most lucrative drugs, with sales topping $18 billion in 2011, more than sales of vaccines and triple the amount spent on antipsychotics in 2002, national drug-sales data show.

More than 1 million children in America take antipsychotics annually, and tens of thousands of those are younger than 5, a 2009 Food and Drug Administration advisory committee study found.

One in 25 children in the nation between the ages of 12 and 17 took antidepressants in 2011, according to a study by the Centers for Disease Control and Prevention that also found that use of the drugs in Americans of all ages increased by 400 percent in the past two decades.

Pharmaceutical firms say the explosive growth has filled an important need and deny that the growth was driven by inappropriate marketing. Officials with those companies say many more people whose symptoms haven’t yet been addressed and aren’t taking the drugs could benefit from taking antidepressants and anti-psychotics.

But many child health experts warn that the increase comes at a tremendous cost to public health programs and at great risk to children. Antipsychotics have been linked to weight gain and diabetes in children and growth of breasts in boys. The FDA has warned that antidepressants increase suicidal behavior and thinking in children and adolescents.

“We really don’t know enough about the safety and effectiveness of these drugs,” said Dr. Tobias Gerhard, an assistant professor at Rutgers University who has studied the growth in prescribing antipsychotics to children and adolescents.

While antipsychotics’ effectiveness and safety remain hotly debated, the prescription of them has become standard practice for treating children for “off-label” uses that have never been approved by federal regulators.

At least three-quarters of the children prescribed antipsychotics through Medicaid took them for issues beyond FDA-approved uses for the drugs, a Rutgers University study found. The drugs often are prescribed for attention-deficit hyperactivity disorder, conduct disorder, anxiety or depression, none of which is a condition the FDA has approved for treatment by antipsychotics in children, the study found.

“It’s an issue that’s getting a lot of attention, but it’s very difficult for payers to impact the prescribing behaviors of clinicians in America,” said Dr. Stephen Crystal, who led that research team. “Major manufacturers of these drugs have paid fines in the hundreds of millions of dollars for alleged improper marketing, in some cases for use in kids.”

Doctors are free to prescribe drugs for any symptom, even if that results in a drug use that has never been approved by the FDA. But it’s against the law for pharmaceutical firms to encourage doctors to prescribe off-label.

$13 billion paid

Since 2008, pharmaceutical companies have agreed to pay more than $13 billion to resolve U.S. Department of Justice allegations of fraudulent marketing practices. Among the cases:

• Eli Lilly distributed videotapes to doctors titled “The Myth of Diabetes” when marketing its antipsychotic Zyprexa, despite being aware of studies showing those taking the drug had a higher rate of diabetes, government investigators say. The government accused the company of pressing doctors to prescribe Zyprexa to children and collected a $1.4 billion fine.

• Pfizer, which paid a $2.3 billion fine to settle a whistle-blower lawsuit, hired 250 child psychiatrists to help market its antipsychotic Geodon despite there being no approved pediatric use for the drug from the FDA. As part of the settlement, Pfizer denied any wrongdoing.

• AstraZeneca paid a fine of $520 million to resolve allegations that it promoted the antipsychotic Seroquel to treat aggression, sleeplessness, anxiety and depression when the FDA had approved the drug only to treat schizophrenia and, later, bipolar mania. Government investigators said the company targeted child physicians.

• Johnson & Johnson targeted what it called key opinion leaders to help promote the use of anti-psychotic Risperdal in children, the government alleged in another lawsuit that resulted in a $2.2 billion fine to resolve criminal and civil allegations.

The GlaxoSmithKline whistle-blower case in which Thorpe was a plaintiff included allegations the company encouraged health care providers to prescribe antidepressants to children when the FDA had not approved the drugs for pediatric use. Glaxo agreed to pay $3 billion to the federal government to settle the case, the largest health care false-claims act settlement ever.

Government investigators found that Glaxo aggressively marketed Paxil off-label as curing everything from depression to shyness in children. Increasing pediatric prescriptions of the drug was a key business strategy for the company, one that helped propel Paxil to $2.7 billion in sales in the United States in 2003, documents show.

Between 1994 and 2001, the company conducted three trials using Paxil to treat depression in those under 18. None of the trials showed the drug helped depressed children, the government asserted. But the trials showed that Paxil had harmful effects and increased the likelihood of suicidal thinking and behavior in children.

Despite those damaging findings, the company hired a firm to help it publish a favorable article about Paxil in the Journal of the American Academy of Child and Adolescent Psychiatry.

It wasn’t until 2006, two years after the FDA ordered all manufacturers of antidepressants to provide cautionary warnings on their labels, that Glaxo changed Paxil’s label to note the suicidal risk and sent letters to doctors alerting them of the risk.

Glaxo officials say the company has made broad changes to its drug-marketing policies. It no longer provides bonuses to sales representatives for increasing prescription volume. Glaxo also has begun publishing all drug-trial results and says it will stop offering to pay doctors to give speeches touting drugs.

Industry trade groups also have adopted new policies restricting the gifts that drug sales representatives can offer physicians.

But Thorpe said the changes come too late. The public still is left struggling with high prescription rates to treat the very young, he said.

“An off-label script is a script that keeps giving whether you stop promoting the drug or not,” he said. “A doctor will keep prescribing the drug if he’s become comfortable with it. The patient likes the drug, so they will want it. It becomes a profit for life.”

Thorpe said he became disgusted with Glaxo’s all-expense-paid trips to Jamaica and Hawaii for physicians and their guests to train them how to give speeches touting the drugs.

Some speakers were paid more than $500,000 annually to talk up the benefits of treating children with antidepressants when the FDA had never approved the drugs for such uses, documents show. The company budgeted as much as $6.8 million annually to entertain doctors in luxury sky-box suites at sporting venues, according to the documents.

Thorpe left the company where he had worked 24 years and later filed his lawsuit. It took nine years for government prosecutors to join the suit.

In 2012, Glaxo agreed to settle. Thorpe’s cut for helping the government recuperate money drained from the Medicare, Medicaid and veteran programs was $20 million.

Off-label uses pushed

Glaxo was not the only company to use such tactics. Other firms pushed for off-label uses of newer antipsychotics, known as atypicals, contending they worked better than older versions.

During the 1990s, Johnson & Johnson received FDA approval for its new antipsychotic drug, Risperdal, to treat schizophrenia in adults. But the agency repeatedly rejected J&J’s efforts to obtain approval for children.

The company had not proposed any child or adolescent psychiatric disorders that Risperdal would treat, the FDA noted in one denial letter. In one meeting, FDA officials worried that using the drug to treat conduct disorder in children would amount to creating a “chemical straitjacket.” It was not until 2006 that FDA officials approved the drug for the limited use of treating autism in children.

Still, the company trained its sales force to market the drug to primary-care doctors and child psychiatrists well before that 2006 approval. More than 1,500 child psychiatrists, targeted due to their antipsychotic prescribing history, each received at least 12 calls from J&J sales representatives in 2000 , documents show.

In 2003, when Risperdal still had no FDA-approved use for children, the company developed a “Back to School Bash.” The marketing plan aimed to increase prescriptions of Risperdal to children and adolescents with ice-cream parties and free snacks and lunches.

One district manager praised a sales representative for promoting a new, faster-dissolving version of Risperdal by providing starter kits to child psychiatrists. The kits included free Risperdal samples, coupons for the drugs, lollipops and small toys, a performance review shows.

Other initiatives that J&J launched for Risperdal created problems for the company.

A research partnership with a prominent child psychiatrist backfired when it was revealed that the psychiatrist and two others had accepted $4.2 million from pharmaceutical companies from 2000 to 2007.

J&J hired a marketing firm to ghostwrite articles attributed to academicians who had done little to no work, according to a report from Dr. David Rothman, a Columbia University professor who studies medical industry ties. Rothman was an expert witness for the Texas Attorney General’s Office in a lawsuit against J&J.

Along the way, the company kept from the public key health data showing troubling risks of Risperdal.

In the pediatric market, the company downplayed the risk that the drug would cause the growth of prolactin in boys, which can cause them to develop lactating breasts, said David Kessler, a former FDA chief who was an expert witness in personal-injury lawsuits filed against Janssen Pharmaceuticals Inc., a J&J subsidiary.

Kessler found the company was responsible for medical-journal articles that gave misleading information about the results of studies into the prolactin issue.

In fact, the company’s studies showed breasts developing in about 10 out of 100 children taking the drug, Kessler reported.

“Janssen’s promotion of Risperdal, a powerful drug, for nonapproved uses in the most vulnerable children is deeply troubling,” Kessler stated in his report.

Janssen officials said those activities are in the past.

“Janssen is committed to ethical business practices and has policies in place to ensure its products are only promoted for their FDA-approved indications,” said spokesman Robyn Reed Frenze. “In fact, the company’s policies meet and often exceed the legal requirements of all jurisdictions it operates within and all local industry codes of which it is a member.”

While the court settlements seem big, they don’t compare to the profits the sales of the drugs generate, said Stephen Sheller, a Philadelphia lawyer who worked with the justice department on a whistle-blower lawsuit involving Risperdal.

J&J generated $4.55 billion in annual sales of Risperdal, 18 percent of its pharmaceutical sales, according to financial reports the company filed with federal regulators in 2008.

Meanwhile, lawsuits against pharmaceutical firms alleging violations of the federal false-claims act continue to be filed at a rapid pace. The justice department says 500 health care fraud act lawsuits were filed last year, the most ever in a year.

“Nothing is going to change significantly until a few top people go to jail,” Sheller said. “There is too much money to gain by marketing the drugs illegally.”

Christopher N. Osher: 303-954-1747, cosher@denverpost.com or twitter.com/chrisosher


About the drugs

Psychotropics: A broad class of medications made of chemicals that alter brain function, including mood and behavior; these include antidepressants, anti-anxiety drugs and attention-deficit-disorder drugs.
Antipsychotics: The most powerful drugs in the broader class of psychotropics; have been linked to diabetes and weight gain in children, and growth of breasts in boys.
Atypicals: The latest generation of antipsychotic medications, with brand names such as Abilify, Zyprexa and Risperdal.


About the seriesThis investigation by The Denver Post into psychotropic drug use by foster children stems from The Post’s “Failed to Death” series on Colorado’s child-welfare system that ran in 2012.
The overprescription of powerful psychotropic medication to foster children is a national epidemic — yet in Colorado, efforts to curb the problem lag some states.
The Post obtained unpublished state data and reports, interviewed foster families and children, reviewed other states’ efforts and examined promising new therapies.

Sunday: Foster kids are prescribed powerful drugs that alter brain function at rates far higher than other children. A growing number of experts say this is not only unnecessary, but harmful.

Monday: Over decades, the pharmaceutical industry pushed aggressively to market psychotropics to children and tap into the lucrative Medicaid system.

Tuesday: New therapies to repair developmental delays in children’s brains caused by abuse and neglect are taking hold. Proponents advocate for more therapy and fewer medications.

Wednesday: Other states have been more aggressive and more effective than Colorado in establishing policies to reduce prescriptions of psychotropics to foster children.


Read more: Drug firms have used dangerous tactics to drive sales to treat kids – The Denver Post http://www.denverpost.com/investigations/ci_25561024/drug-firms-have-used-dangerous-tactics-drive-sales#ixzz2zHEJfrM5
Read The Denver Post’s Terms of Use of its content: http://www.denverpost.com/termsofuse

Silly Man Of The Day (or possibly of the year): Stephen Whitehead of the ABPI (Association of the British Pharmaceutical Industry)


stephen-whitehead-200

SWJust watching Panorama’s recent documentary (for the second time) on how the pharmaceutical industry influences doctors and the medicines they prescribe, and I think that Mr Stephen Whitehead (of the ABPI)- speaking on behalf of the UK pharmaceutical industry- definitely deserves the accolade of Silly Man Of The Day..

There are many other adjectives which others might use to describe Stephen Whitehead, but personally I think he is just a very silly man. His comments in defense of the corruption of doctors by pharmaceutical companies are absolutely ridiculous and you would have to wonder who was coaching Whitehead? Did he not get advice? Did he not watch previous BBC  Panorama documentaries? Did he not know he was dealing with Shelley Jofre? (One of the best investigative journalists of the pharmaceutical industry in the UK).

How’s about this for a dialogue?

(from appox the last 10 mins of “Who’s paying your doctor?”)

Stephen Whitehead :”We should never fool ourselves that doctors will be overly swayed by some of this commercial activity given that they have seen a lot of other information”..

Shelley Jofre: “Why on earth would these drug companies spend all this money on doctors if it didn’t sway their prescribing?”

Stephen Whitehead:  “Well..  that’s an interesting question isn’t it..

Shelley Jofre: “But why would they?”

Stephen Whitehead : “Well…My view is.. it should sway their prescribing”.. “and I will absolutely categorically say that”…It’s absolutely appropriate for doctors to prescribe medicines for patients that need them.. .it is up to the doctor to decide what is right… “

What exactly is Stephen Whitehead on about? He seems to be contradicting himself..

Basically it seems that Mr Whitehead begins by saying that doctors would not be ‘overly’ swayed by drug company symposiums (or sponsored conferences, exhibits, lectures etc)

but then in the next breath he says that they should be swayed and that drug companies should be able to influence their prescribing!… So which is it Whitehead?… Are doctors not influenced by drug companies? Or are they? (I think we all know the answer to that one)

At least get your script right before you are interviewed.. Whitehead you Silly Man!…

It seems that Whitehad is so far indoctrinated into the greedy industry he so eagerly defends, that he has lost the ability to make sense..  he absolutely failed to defend the industry on Panorama and his gibberish proves that he doesn’t know his arse from his elbow!…

We all know the pharmaceutical industry is corrupt, we all know that doctors have been corrupted by the industry that the ABPI supports, so stop with the silly PR crap Stephen, nobody believes it- it’s getting boring- and your lame attempt at defending the industry was thoroughly pathetic, not to mention -incoherent.

http://www.quitam-lawyer.com/sites/quitam-lawyer.com/files/02.03.12%20-%20GSK%20–%20Exhibits%20to%207AC%201-752.pdf

People often say that, 1% of the human population are sociopaths and that it is these callous, devious individuals, with no empathy, or regard for others- who rise to the top of multinationals, banks, politics etc…  I am inclined to agree somewhat in the sociopath theory( how else could you explain GSK for example?), but I also reckon that there is a sizable percentage of the population who are just silly, idiotic, moronic, easily led, and utterly gormless, and it’s these individuals who also end up in jobs which require them to be just that…

… mindless corporate minions to the cleverer sociopaths further up the greasy ladder…

Stephen Whitehead You Are A Very Silly Man!…

And once again, you have missed the point completely!…

From Seroxat Secrets 2012 :

http://seroxatsecrets.wordpress.com/2012/10/22/stephen-whitehead-abpi-missing-the-point-completely/

Stephen Whitehead, ABPI – missing the point completely

I read this article in the New Statesman today and made me really quite annoyed…

It featured a letter written to the New Statesman by the CEO of the Association of the British Pharmaceutical Industry (ABPI), Stephen Whitehead, as a response to issues Ben Goldacre’s new book, Bad Pharma.

It’s amazing just how stupid a response it is – in fact I have to ask if Stephen has actually bothered to read the book at all or if the’s just gone into classic big Pharma knee jerk mode (after all, Stephen did spend 10 years of his career working at Glaxo and Eli Lily).

But no matter, as the New Statesman has printed Ben’s reply to the response.

However the comment I really found strange from Stephen Whitehead was this “…references to companies (GSK, Lilly, Pfizer) being fined are all examples from the US and simply not relevant to the UK market…”

GSK’s fine was, to remind you, the largest healthcare fraud settlement in history at $3bn.

How it isn’t relevant to the UK is beyond me – because what we’re talking about here is not just illegal marketing of drugs – not just bribing doctors to prescribe GSK products – what we’re talking about here are dead people.

Patients died because they were taking drugs that weren’t safe, drugs that weren’t even approved for their treatment.

In the case of Avandia, the drug is so dangerous that it can no longer be prescribed in Europe – it had to be withdrawn from the market because of high levels of heart attack, heart failure and stroke in patients. It had to be withdrawn from the market because it killed too many people.

How’s that “simply not relevant” to patients in the UK, Stephen?

mySuperLamePic_61c1d71a19e745397aec3a499b16167a

The Great Glaxo Transparency Swindle… Prof. David Healy says ‘now is the time of greatest peril’…


ben-gBlcxjvbCUAA0GQW-1BGGSK amazing

MasssivehistoricMedSkepbobShellejofre

http://davidhealy.org/welcome-to-troy/#comments

Trojan Horse

The press coverage of AbbVie’s withdrawn legal action suggests that most major companies have now embraced an option for transparency pioneered by GSK.

All Trials are among those taking credit for pressuring AbbVie into submission. They have aggressively welcomed the offer by GSK to make clinical trial data available with no questioning of the terms on which the data is being produced.

But GSK’s offer is a manoeuvre worthy of Ulysses himself. You’d never guess from company self-congratulation that it was forced on GSK by a New York Court as part of the resolution of a Fraud action. The Fraud Action happened because GSK had written up a positive portrayal of a trial when in fact the company itself thought the trial had shown their antidepressant, Paxil, did not work.

The trial – Study 329 – was test of Paxil in children. As mandated by the Courts in the wake of Study 329, GSK put up company study reports for all of their trials, Paxil and other drugs including the diabetes drug Avandia. These could be downloaded. Steve Nissen of the Cleveland Clinic did just this for the Avandia reports and was able to show that Avandia killed.  A company blockbuster was stopped in its tracks.

Poacher turned Game-Keeper?

Putting study results up on the web must have seemed like a very bad idea to GSK. So why are they now championing data access?

GSK and other companies are reaping kudos for apparent transparency. And they can say with a straight face to any TV anchorman or Congressional committee that they are making data available.

But in fact here is what is happening. Having seen what happened with the Avandia study reports GSK now know what to do when writing a Study Report to avoid a repeat. Suitably Doctored Study Reports for other drugs will go up on their website.

The Study Reports however do not contain the data. A first approximation to the data in the case of Study 329 comes in a series of 7 appendices to the 329 Study Report – something GSK did not put up on the company website until the omission was spotted nearly 10 years later by Peter Doshi and New York State required them to do so.

In the case of Study 329, the ghostwritten article that led to GSK being sued for fraud, is 11 pages. The Study Report is over 700 pages. There are then 7 appendices that between them come close to 5500 pages. Even this however is not the raw data.The raw data lies in Clinical Report Forms.

You can Look but you cannot See

As things stood before GSK’s offer of transparency, the 5,500 page of appendices and 700+ pages of the Study Report could be downloaded and printed off. Finding what went on in a clinical trial from paperwork like this is a bit like playing Memory – where there a bunch of cards with faces or plants or whatever turned face down and if you turn one up you have to remember where the matching face you turned up before is. It can be done with 5,500 pages printed off.

But playing Memory is much harder to do now with the new improved access GSK is offering.

If you apply to access a GSK trial now you are forced to submit an analytic plan which essentially stops an applicant from accessing any adverse events on the drug. Adverse events are the material the company tries hardest to hide.

Should you get access to the full set of appendices that contain company listings of adverse events, there is almost no way to play the Memory Game because access is through a remote desktop. It may be that a younger generation used to playing Digital Memory will be able to work the system, but it’s not easy. It takes multiple passwords to access the desktop. You are logged out regularly. And while on the desktop, GSK can monitor your every keystroke.

Nightmare in Harlow

But here’s the rub. To really nail down what’s going on, you need access to the approximately 70,000 pages of patient level data. Through a remote desktop this becomes a nightmare.

This scheme to deliver frustration cloaked in the appearances of transparency was devised several years ago. 

The history of the idea was outlined two years ago in May Fool’s Day. Last year the details of GSK’s scheme were outlined in April Fool in Harlow.

- See more at: http://davidhealy.org/welcome-to-troy/#comments

Neil1Neil2

 For more on The Ben Goldacre/GSK/Data Debacle See My Previous Posts Here:
http://truthman30.wordpress.com/tag/ben-goldacre/

And They Call Us “Conspiracy Theorists”…


From CNN MONEY 2005.

http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld/

Rumsfeld’s growing stake in Tamiflu
Defense Secretary, ex-chairman of flu treatment rights holder, sees portfolio value growing.
October 31, 2005: 10:55 AM EST
By Nelson D. Schwartz, Fortune senior writer

NEW YORK (Fortune) – The prospect of a bird flu outbreak may be panicking people around the globe, but it’s proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that owns the rights to Tamiflu, the influenza remedy that’s now the most-sought after drug in the world.

Rumsfeld served as Gilead (Research)’s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.

The forms don’t reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead’s stock from $35 to $47. That’s made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.

Rumsfeld isn’t the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead’s board, has sold more than $7 million worth of Gilead since the beginning of 2005.

Another board member is the wife of former California Gov. Pete Wilson.

“I don’t know of any biotech company that’s so politically well-connected,” says analyst Andrew McDonald of Think Equity Partners in San Francisco.

What’s more, the federal government is emerging as one of the world’s biggest customers for Tamiflu. In July, the Pentagon ordered $58 million worth of the treatment for U.S. troops around the world, and Congress is considering a multi-billion dollar purchase. Roche expects 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004.

Rumsfeld recused himself from any decisions involving Gilead when he left Gilead and became Secretary of Defense in early 2001. And late last month, notes a senior Pentagon official, Rumsfeld went even further and had the Pentagon’s general counsel issue additional instructions outlining what he could and could not be involved in if there were an avian flu pandemic and the Pentagon had to respond.

As the flu issue heated up early this year, according to the Pentagon official, Rumsfeld considered unloading his entire Gilead stake and sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics.

Those agencies didn’t offer an opinion so Rumsfeld consulted a private securities lawyer, who advised him that it was safer to hold on to the stock and be quite public about his recusal rather than sell and run the risk of being accused of trading on insider information, something Rumsfeld doesn’t believe he possesses. So he’s keeping his shares for the time being.

http://www.smh.com.au/comment/tamiflu-is-the-new-snake-oil-20140416-zqvj8.html

Tamiflu is the new snake oil

Date
April 16, 2014

Dr Joe Kosterich

Millions has been wasted on Tamiflu.Millions has been wasted on Tamiflu. Photo: fairfax

In days of old when the snake oil salesman came to town folks would gather round to hear of miracle cures. Those who were sufficiently impressed would buy some of the salesman’s wares to cure colds, sore toes or a myriad of other ailments. The snake oil salesman would then get back onto his cart and go to the next town.

Times change. Today we have scientific channels, advisory panels and rigorous process to make sure that whatever claims are made are verifiable.

So surely governments around the world could not spend billions of dollars stockpiling a drug which does not actually do anything?

Tamiflu has been a big waste of money.Tamiflu has been a big waste of money.

Could doctors, advisory panels, and health departments have been sold modern day snake oil?

Unfortunately, the answer is yes!

The anti viral drugs Tamiflu (oseltamvir) and Relenza (zanamivir) have been promoted as a treatment for influenza. But most specifically, they have been claimed to reduce transmission of influenza and reduce complications such as pneumonia. Governments have bought them so that they can be released in the event of an epidemic.

But recent research has found that these drugs are little more than today’s snake oil potions. A review of 46 studies on more than 24,000 people has shown that they do not prevent people catching the flu. They do not reduce the rate of complications or hospitalisations. At best, they might reduce the length of the illness by about half a day.

Let me repeat that- it shortens the course of influenza by half a day, at best!

How could so much money get spent on something of so little value? That is because the drug manufacturers refused to release most of the data that is now available.  Only information from drug trials, which showed a positive effect from the drug, was previously published.

The British Medical Journal and independent Cochrane Collaboration had been fighting for four years to get hold of all the data so that it could be independently examined and to answer the very basic question – does it work?

Obviously the manufacturers are keen to put the best spin on their products. But they are not the only ones culpable here. There are numerous problems to fix.

Between 48% and 89% of researchers involved in clinical trials of new treatments have been found to have undeclared conflicts of interest. This occurs  where the company that has a new drug being studied may pay them directly or indirectly.

Medical research needs to be cleaned up.

Governments look to advisory panels for independent advice. Some 75% of doctors on panels, which make recommendations about disease definitions and management, have ties to the pharmaceutical industry.

Any advisory board must have totally independent members.

 The facts show that every influenza “epidemic” since 1918 has had fewer deaths than the one before.  Predictions about millions of deaths from, Avian flu, SARS and Swine flu all turned out to be completely wrong.

Each year in Australia there are around 2500 deaths associated with influenza. Some 98% of these are due to secondary pneumonia in people of an average age of 87(which is older that the average life expectancy).

The annual “killer flu” hype needs to be toned down.

Is the flu really so fearsome? For the vast majority of people it will be up to a week of feeling unwell followed by a full recovery. There are exceptions and whilst tragic, they are very rare and are not always understood or preventable.

Governments like to be seen to be doing something. Wendy Barclay from Imperial College London best summed this up telling Reuters: “If another pandemic came tomorrow, and the government had no drug to treat thousands of influenza infected patients, I imagine there would be public outcry”.

She sums the situation up very well – the public expects the government to provide a medication, which does not work for an illness, which will go away by itself.

Maybe deep down we still want to buy the snake oil and the salesman is still ready to assist us.

Read more: http://www.smh.com.au/comment/tamiflu-is-the-new-snake-oil-20140416-zqvj8.html#ixzz2z76m6aXj

Apart From Dealing With The GSK Global Bribery Scandal… What Will GSK Do To Help The Narcolepsy Sufferers Damaged From Their Pandemrix H1N1 Swine Flu Vaccine?


Probably nothing…

They usually get away (scot-free) with damaging the public with dodgy, ineffective, defective and dangerous drugs and vaccines..

They’ve been doing it for decades

and they almost always get away with it…

 

http://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122

Insight: Evidence grows for narcolepsy link to GSK swine flu shot

STOCKHOLM Tue Jan 22, 2013 7:26am EST

Emelie Olsson falls asleep as he watches television in her apartment in Stockholm, January 17, 2013. Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised in 2009 with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline. Picture taken January 17, 2013. REUTERS-Ints Kalnins
Emelie Olsson shows her paintings in Stockholm January 17, 2013. REUTERS-Ints Kalnins

 

 

 

 

 

 

 

1 of 13. Emelie Olsson falls asleep as he watches television in her apartment in Stockholm, January 17, 2013. Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised in 2009 with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline. Picture taken January 17, 2013.

 

Narcolepsy diagnosis in Sweden and Finland

(Reuters) – Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she’s often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.

Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.

Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.

Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden’s vaccination campaign calls a “medical tragedy” that will demand rising scientific and medical attention.

Europe’s drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK’s vaccines division, Norman Begg, says his firm views the issue extremely seriously and is “absolutely committed to getting to the bottom of this”, but adds there is not yet enough data or evidence to suggest a causal link.

Others – including Emmanuel Mignot, one of the world’s leading experts on narcolepsy, who is being funded by GSK to investigate further – agree more research is needed but say the evidence is already clearly pointing in one direction.

“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries – and probably in most countries,” says Mignot, a specialist in the sleep disorder at Stanford University in the United States.

30 MILLION RECEIVED PANDEMRIX

In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.

GSK says 795 people across Europe have reported developing narcolepsy since the vaccine’s use began in 2009.

Questions about how the narcolepsy cases are linked to Pandemrix, what the triggers and biological mechanisms might have been, and whether there might be a genetic susceptibility are currently the subject of deep scientific investigation.

But experts on all sides are wary. Rare adverse reactions can swiftly develop into “vaccine scares” that spiral out of proportion and cast what one of Europe’s top flu experts calls a “long shadow” over public confidence in vaccines that control potential killers like measles and polio.

“No-one wants to be the next Wakefield,” said Mignot, referring to the now discredited British doctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps and rubella (MMR) shot with false claims of links to autism.

With the narcolepsy studies, there is no suggestion that the findings are the work of one rogue doctor.

Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.

“We really do want to get to the bottom of this. It’s not in anyone’s interests if there is a safety issue that needs to be addressed,” said GSK’s Begg.

LIFE CHANGED

Emelie’s parents, Charles and Marie Olsson, say she was a top student who loved playing the piano, taking tennis lessons, creating art and having fun with friends. But her life started to change in early 2010, a few months after she had Pandemrix. In the spring of 2010, they noticed she was often tired, needing to sleep when she came home from school.

But it wasn’t until May, when she began collapsing at school, that it became clear something serious was happening.

As well as the life-limiting bouts of daytime sleepiness, narcolepsy brings nightmares, hallucinations, sleep paralysis and episodes of cataplexy – when strong emotions trigger a sudden and dramatic loss of muscle strength.

In Emelie’s case, having fun is the emotional trigger. “I can’t laugh or joke about with my friends any more, because when I do I get cataplexies and collapse,” she said in an interview at her home in the Swedish capital.

Narcolepsy is estimated to affect between 200 and 500 people per million and is a lifelong condition. It has no known cure and scientists don’t really know what causes it. But they do know patients have a deficit of a brain neurotransmitter called orexin, also known as hypocretin, which regulates wakefulness.

Research has found that some people are born with a variant in a gene known as HLA that means they have low hypocretin, making them more susceptible to narcolepsy. Around 25 percent of Europeans are thought to have this genetic vulnerability.

When results of Emelie’s hypocretin test came back in November last year, it showed she had 15 percent of the normal amount, typical of heavy narcolepsy with cataplexy.

The seriousness of her strange new illness has forced her to contemplate life far more than many other young teens: “In the beginning I didn’t really want to live any more, but now I have learned to handle things better,” she said.

TRIGGERS?

Scientists investigating these cases are looking in detail at Pandemrix’s adjuvant, called AS03, for clues.

Some suggest AS03, or maybe its boosting effect, or even the H1N1 flu itself, may have triggered the onset of narcolepsy in those who have the susceptible HLA gene variant.

Angus Nicoll, a flu expert at the European Centre for Disease Prevention and Control (ECDC), says genes may well play a part, but don’t tell the whole story.

“Yes, there’s a genetic predisposition to this condition, but that alone cannot explain these cases,” he said. “There was also something to do with receiving this specific vaccination. Whether it was the vaccine plus the genetic disposition alone or a third factor as well – like another infection – we simply do not know yet.”

GSK is funding a study in Canada, where its adjuvanted vaccine Arepanrix, similar to Pandemrix, was used during the 2009-2010 pandemic. The study won’t be completed until 2014, and some experts fear it may not shed much light since the vaccines were similar but not precisely the same.

It all leaves this investigation with far more questions than answers, and a lot more research ahead.

WAS IT WORTH IT?

In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, Goran Stiernstedt, a doctor turned public health official, has spent many difficult hours going over what happened in his country during the swine flu pandemic, wondering if things should have been different.

“The big question is was it worth it? And retrospectively I have to say it was not,” he told Reuters in an interview.

Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It got Pandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake of the vaccine to 59 percent, meaning around 5 million people got the shot.

Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden’s 21 regions.

The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.

While estimates vary, Stiernstedt says Sweden’s mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.

With hindsight, this risk-benefit balance is unacceptable. “This is a medical tragedy,” he said. “Hundreds of young people have had their lives almost destroyed.”

PANDEMICS ARE EMERGENCIES

Yet the problem with risk-benefit analyses is that they often look radically different when the world is facing a pandemic with the potential to wipe out millions than they do when it has emerged relatively unscathed from one, like H1N1, which turned out to be much milder than first feared.

David Salisbury, the British government’s director of immunization, says “therein lies the risk, and the difficulty, of working in public health” when a viral emergency hits.

“In the event of a severe pandemic, the risk of death is far higher than the risk of narcolepsy,” he told Reuters. “If we spent longer developing and testing the vaccine on very large numbers of people and waited to see whether any of them developed narcolepsy, much of the population might be dead.”

Pandemrix was authorized by European drug regulators using a so-called “mock-up procedure” that allows a vaccine to be authorized ahead of a possible pandemic using another flu strain. In Pandemrix’s case, the substitute was H5N1 bird flu.

When the WHO declared a pandemic, GSK replaced the mock-up’s strain with the pandemic-causing H1N1 strain to form Pandemrix.

GSK says the final H1N1 version was tested in trials involving around 3,600 patients, including children, adolescents, adults and the elderly, before it was rolled out.

The ECDC’s Nicoll says early warning systems that give a more accurate analysis of a flu strain’s threat are the best way to minimize risks of this kind of tragedy happening in future.

Salisbury agrees, and says progress towards a universal flu vaccine – one that wouldn’t need last-minute changes made when a new strain emerged – would cuts risks further.

“Ideally, we would have a better vaccine that would work against all strains of influenza and we wouldn’t need to worry about this ever again,” he said. “But that’s a long way off.”

With scientists facing years of investigation and research, Emelie just wants to make the best of her life.

She reluctantly accepts that to do so, she needs a cocktail of drugs to try to control the narcolepsy symptoms. The stimulant Ritalin and the sleeping pill Sobril are prescribed for Emelie’s daytime sleepiness and night terrors. Then there’s Prozac to try to stabilize her and limit her cataplexies.

“That’s one of the things that makes me feel most uncomfortable,” she explains. “Before I got this condition I didn’t take any pills, and now I have to take lots – maybe for the rest of my life. It’s not good to take so many medicines, especially when you know they have side effects.”

(This story has been corrected to insert full name in first paragraph)

http://www.independent.ie/lifestyle/health/learning-to-live-with-the-nightmares-of-narcolepsy-30179896.html

Alex Lawless, who developed narcolepsy after taking Pandemrix, with his mum Mairead. Picture: Ronan Lang

Terrifying hallucinations, aggressive behaviour, and threats of self-harm – the nightmare of narcolepsy has devastated the life of Dublin schoolboy Alexander Donovan.

The nine-year-old must take a 20-minute nap in school each morning at 10am, and another 30-minute doze in the afternoon when he returns to the family home in Rathgar.

This is despite the strong medication which his mother, Mairead Lawless, says, is actually licensed for use by adults, but which is crucial to keep Alex alert in the mornings, and provide the deep night-sleep denied him by his debilitating condition.

“It’s a struggle to keep him awake enough to do his homework.He struggles to concentrate and focus, and finds it difficult to pay attention in school. He can be very bad-tempered when he’s tired and he’s a very different child to what he was.”

Her son, she says, can no longer find the energy for the sports he once adored – while other boys of his age are out kicking footballs and getting into mischief, his mother says all Alex wants to do is sit on the sofa.

Once an active, outgoing child, who was full of energy and had lots of friends, Alexander has become quiet, lacking in energy and unable to participate in activities with his pals.

He pushes himself to do Cub Scouts and plays hockey once a week at school, says his mum, but it’s a major effort.

“He cannot go on public transport on his own – he has to be with someone or he will fall asleep,” she reveals.

Alex was just five years old when he received the Pandemrix vaccine (for swine flu) in January 2010. His mother, father Ray and older sister Eleanor were also vaccinated.

About three months later, at the beginning of April, Lawless, a bank manager, started to notice that Alex was falling asleep at odd times – even on very short car journeys.

She brought him to the family GP. Blood tests showed only a slightly lowered iron and white blood cell count.

By mid-May there was no improvement.

Still falling asleep at peculiar times, Alex was now also enduring horrifying nightmares. “He became very scared of the dark and said he was seeing things – and it started to get a bit scary.

“He was sleeping for up to three hours in the afternoon after coming home from school. He’d become very aggressive and irrational after waking up. Sometimes he’d start screaming while sleeping – but his eyes would be open,” she recalls.

Alex, she says, repeatedly asked her why she couldn’t see the terrifying things he was seeing.

“I became afraid that he had psychological issues,” Lawless recalls. “He was seeing things that I could not see and became angry when I couldn’t see them.”

She later discovered that her child was having what are called hypnogogic hallucinations which is a symptom of narcolepsy.

“You’re effectively awake, but still dreaming and not distinguishing between dream and reality,” Lawless explains.

More consultations and tests followed, but by February 2011 Alex put on a lot of weight – another symptom of narcolepsy as Lawless was to discover.

A formerly slim child, Alex, now aged nearly six, was wearing trousers for a nine-year-old.

At one point Lawless did suggest the possibility that Alex had narcolepsy but was told that this was extremely rare in children and that she should rule it out.

The tests continued, but nothing showed up.

Then, in February 2011 Alex started to talk about self-harm. “I was finding red marks down his arm, where he’d been scratching his nails along the inside of his arms.”

One day after he had misbehaved, she put him on ‘time-out’ and instructed him to sit on the bottom step of the stairs:

“He said he didn’t want to be alive anymore and was very distressed – he said that he wanted to strangle himself.”

His energy levels plummeted. “He had to give up the Gaelic football, because he was too tired and emotional for it – and he was not able to play games with his friends. It was an horrific time,” she says.

“Alex was acting so out of character that we knew there was something going on. At times he’d have been behaving like somebody possessed; he was so aggressive, argumentative and irrational in the afternoons.

“This was a complete change from the gentle, placid and happy child he used to be.”

Then, in March 2011 the breakthrough came – another mother showed Lawless a newspaper article about a girl who seemed to be displaying similar symptoms.

“My hair stood up on end,” she recalls. “The article was about a girl who had all of the same symptoms as Alex – falling asleep, nightmares and so on.”

Things moved very quickly after that – following more tests Alex was officially diagnosed with narcolepsy in August 2011.

“Soon afterwards we got in touch with other children who had had the vaccine, and they all had symptoms like Alex and they were getting a diagnosis of narcolepsy.”

In 2011, Lawless joined other parents in establishing the organisation SOUND, (Sufferers of Unique Narcolepsy Disorder) which supports families affected by narcolepsy and also received the Pandemrix vaccine. There are currently more than 60 such families in the group.

It’s now believed more than 70 children in Ireland developed narcolepsy after receiving the swine flu vaccine.

Sound has four members who were adults when vaccinated, says Lawless. “Adults have also been affected although so far the numbers making themselves known to Sound are small in comparison with the number of children to date.”

The group successfully campaigned for supports to be put in place for the affected children, though Lawless emphasises, these are on a temporary basis.

“We got a number of supports put in place for the children and adults – these include discretionary medical cards which can be reviewed annually, as well as expenses for narcolepsy-related medical expenses.”

The medication is very expensive – the night-time medication alone can cost up to €25,000 a year, she says.

“In addition to that, we organised for the children attending to be assessed for education needs – there is now an allowance for extra tuition,” she says.

“Our children have a life-long condition which not only affects their childhood but will affect their work and study for the rest of their lives.”

Health Minister James Reilly recently detailed the services being provided to people with narcolepsy following pandemic vaccination, but Lawless says these have not yet been confirmed to SOUND as permanent supports: “These are not permanent and there is a concern that they could be withdrawn at any time,” she says.

She also questions the minister’s interpretation of research carried out by renowned US narcolepsy expert Dr Emmanuel Mignot.

Referring to a paper by Dr Mignot, which was published online in October 2012, Mr Reilly said that in the majority of narcolepsy cases, appropriate medication and lifestyle modifications could see functioning restored to about 80pc of normal.

According to Dr Mignot, a return to close to normal functioning was possible in about 80pc of cases through a combination of lifestyle changes and pharmaceutical treatment tailored to each individual.

His study advised that many patients with narcolepsy benefited best from combined drug therapy and behavioural modifications – scheduled napping one to three times a day, for example, while certain drug treatments had found to be of benefit to patients.

However, Ms Lawless points out, the treatments alluded to by the minister when quoting from Dr Mignot’s research are actually not deemed suitable for children

“The issues we have with the minister’s interpretation is that the therapeutic treatments that are referred to by Mignot are not licensed/recommended for use by children,” she says.

Referring to another piece of research published in December 2012 by experts at Stanford Medical Centre, with which Dr Mignot was also very closely associated, Dr Reilly said it indicated that narcolepsy was an autoimmune disorder, and that it was now possible to explore new therapies which may have more beneficial effects.

However, Ms Lawless said SOUND believed that the fruits of the research referred to by the minister were “so far in the future” that the children would be grown up by the time such therapies were available.

As a result, she believed they would be disadvantaged both educationally and career-wise.

“As our children go through education, they face huge difficulty maintaining focus and concentration which in turn will impact on exam results.

“We fear they will be discriminated against in job applications and employment due to their requirement to take naps and a propensity to lose focus/attention.

“They will likely be limited in operation of machinery including driving a car which curtails independence in itself, let alone ruling out many types of employment.”

Lawless also pointed out that although the research indicated that the majority could reach up to 80pc of normal function, that still left a sizeable number who would not reach that level of functioning.

“Furthermore,” she asks, “should we be happy about our children functioning at 80pc of normal capacity?”

GlaxoSmithKline, the makers of Pandemrix said: “Patient safety is our number one priority and we are actively conducting research on the observed association between Pandemrix and narcolepsy and on the interaction this vaccine might have had with other risk factors in affected individuals.

“Whilst people vaccinated with Pandemrix have been shown in several published studies to be more likely to develop narcolepsy than those who were not, further research is needed to confirm what role Pandemrix may have played in the development of narcolepsy among those affected.

“Narcolepsy is a complex disease and has a number of different potential contributory factors.

“The causes of narcolepsy are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.

“It is crucial that we learn more about how narcolepsy is triggered.

“We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.

“We are also supporting ongoing work from other experts and organisations investigating reported cases of the condition.”

(Reporting by Kate Kelland; Editing by Will Waterman)

 

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Zack Hunter | Phenomenological Fiction

Zack Hunter is the pseudonym of a Californian poet, author, artist, musician, and researcher. He lives on a farm and spends his free time reading and writing about whatever it is he is passionate about at the time.

seroxat secrets...

...and let's not forget GlaxoSmithKline & the MHRA

medicaments : nos médecins nous tuent

"COMMENT EMPECHER VOTRE DOCTEUR DE VOUS TUER"

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