Flu Shot Linked to Child Narcolepsy – Reuters Reports

Reuters reports that GlaxoSmithKline’s Pandemrix H1N1 swine flu vaccine has caused 800 cases of narcolepsy in children.  Taking under-reporting into account, this could amount to between at least 5,600 cases or a figure around up to 40,000 in the countries concerned. Cases have been recorded in children from Sweden, Finland, Norway, Ireland and France. Narcolepsy is a serious condition which can debilitate a child for life.  Sufferers can fall asleep on the spot any time without warning.

To gain an idea of the potential extent of this adverse reaction in children caused by this vaccine and to adjust for under-reporting it is necessary to multiply by up to 50 times.  [Under-reporting in all drugs and not just vaccines is 98 in every 100 adverse reactions – hence multiply by 50: Spontaneous adverse drug reaction reporting vs event monitoring: a comparison: Journal of the Royal Society of Medicine Volume 84 June 1991 341.]

Read the Reuters’ report here:

Insight: Evidence grows for narcolepsy link to GSK swine flu shot – By Kate Kelland, Health and Science Correspondent, Reuters, STOCKHOLM | Tue Jan 22, 2013

See also our CHS article today:

Piers Morgan Very Sick Days After USA TV Flu Shot Stunt Backfires – Piers Told “Don’t Ever Take A Flu Shot Again”

And these selected CHS articles:

Flu Vaccine Doesn’t Work

New York Times – Flu Vaccine Does Not Work – Yet More Research Says

Flu Vaccine Caused 3587 US Miscarriages & Stillbirths

Flu Vaccine Cripples Healthy US Cheerleader for Life

Most UK Medics Refusing Flu Vaccines

EU Flu Vaccine Bans Still Unreported – Medics Sick After Vaccine Refuse More

UK Fakes Flu Death Numbers

CBS News Investigation – Forced Swine Flu Vaccination Under Obama’s “National Emergency” Based on Wildly Exaggerated Statistics

Call for FDA Ban on Glaxo Weight-Loss Drug – Public Citizen Group Petitions FDA

April 14, 2011

Weight-Loss Drugs Alli and Xenical Should Be Removed From the Market, Public Citizen Tells FDA

Xenical and Alli Can Cause Severe Injury to Liver, Pancreas, Kidneys

WASHINGTON, D.C. – The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately because they not only can damage the liver, but also, based on new information obtained from FDA adverse reaction files, have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones, Public Citizen said today in a petition to the Food and Drug Administration (FDA).

 Both drugs are forms of orlistat; Xenical has 120 milligrams (mgs) and Alli has 60 mgs. Their serious risks greatly outweigh their benefits, which are questionable, because neither has been shown to be much more effective than diet and exercise.

“Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients. For this reason, the FDA should tell the manufacturers of these drugs, Hoffman-LaRoche and GlaxoSmithKline, to pull Xenical and Alli, respectively, from the market immediately.”

This is Public Citizen’s second petition to have Xenical taken off pharmacy shelves. In April 2006, Public Citizen urged a ban of Xenical because research in rats had demonstrated that orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected that petition.

U.S. physicians have been writing fewer prescriptions for Xenical, even long before over-the-counter Alli was available, because of its serious risks and marginal effectiveness. Prescriptions for Xenical in the U.S. declined 81 percent from 2.6 million in 2000, when Xenical first became available in the U.S., to just 490,000 in 2007. By 2009, the number of Xenical prescriptions in the U.S. further decreased to 110,000 prescriptions, representing only 4 percent of its peak in 2000, but still exposing tens of thousands of patients to a drug with serious risks that greatly outweigh its meager benefits.

Meanwhile, sales of Alli plummeted from $145 million in the first year of marketing (mid-2007 to mid-2008) to $84 million between mid-2009 and mid-2010, the latest years for which data are available.

The weight lost by users of both prescription and the over-the counter-strength orlistat was minimal, Public Citizen said in the petition. For example, people taking Xenical while dieting and exercising for one year (in contrast to those just altering their diet and exercise) lost only 5.6 additional pounds from the 60-mg dose and seven additional pounds from the 120-mg dose compared to the group that engaged only in diet and exercise. Similarly, those in a four-month study of Alli lost only two to four more pounds than those who solely changed their diet and exercise routines.

But the biggest problem with the drugs is their potential to cause serious injuries and death.

On May 26, 2010, the FDA issued a warning about “severe liver injury” resulting from using orlistat. The agency identified 12 foreign reports of severe liver toxicity associated with Xenical and one domestic case for Alli. Two of the patients died of liver failure and three required liver transplants.

Another serious adverse effect of taking Xenical or Alli is acute pancreatitis, which may be especially difficult to diagnose since orlistat’s most common side effects, including abdominal pain and nausea, are also typically symptoms of pancreatitis. Public Citizen’s research of FDA MedWatch adverse reaction reports found 47 cases of pancreatitis associated with Xenical or Alli. Thirty-nine of those patients required hospitalization and one died.

 Public Citizen’s analysis of FDA’s MedWatch reports also identified 73 cases of kidney stones associated with Xenical or Alli use, of which 23 required hospitalization. In a review of the medical literature, Public Citizen also identified at least three patients taking orlistat who developed acute kidney failure because tiny calcium salt crystals formed throughout the kidneys. In one reported case, the patient required dialysis and ultimately died.

Other risks of these drugs include interference with the absorption of fat-soluble vitamins and drugs, fecal urgency, gas with discharge and abdominal pain.

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Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

British Medical Journal fails to disclose commercial conflicts in Wakefield attack

I have submitted the following letter to BMJ this morning:-

What about BMJ, Merck and GSK (and Andrew Wakefield)?

BMJ is a part free journal. In view of the recent renewed attacks on Andrew Wakefield (which were all free of access) what are we to make of the fact that BMJ Learning is in partnership with Merck under the alias of Univadis [1,2], or that MSD and GSK sponsor BMJ awards [3]? Should not these competing interests be openly declared?

[1] Vera Hassner Sharav ‘BMJ & Lancet Wedded to Merck CME Partnership’ (including Martin J Walker ‘Merck’s Medical Media Empire’), http://www.ahrp.org/cms/content/view/766/9/

[2] Univadis log-in page, http://www.univadis.com/RH/UK_loginpage/

[3] http://groupawards.bmj.com/sponsors