Wednesday, February 24, 2010

Congress Doth Protest Too Much

Vera Sharav of the Alliance for Human Research Protection asks why the discovery of defective cars are front page news while defective FDA-approved prescription drugs are accepted as part of life's risk:

According to the database maintained by the National Highway Safety Administration there were 34 deaths alleged to be attributable to defective Toyota cars (13 of those deaths occurred between 2005 and 2010). Toyota has recalled 8.5 million cars.

Yet, defective FDA-approved drugs that kill thousands of people every week!

The latest QuarterWatch Report by the Institute for Safe Medication Practices… found that the number of consumers harmed and killed by FDA-approved prescription drugs keeps rising.

"In the third quarter of 2009 the steady increase continued in reported serious, disabling and fatal adverse drug events. Cases meeting the QuarterWatch criteria totaled 29,065 cases, an increase of 2,256 cases (8.4%) from the same quarter in the previous year. For the first three quarters of 2009, combined case reports increased by 8.1% from the first three quarters of 2009."

GlaxoSmithKline's diabetes drug, Avandia, and AstraZeneca's, antipsychotic, Seroquel, are the two worst drugs--if one considers the magnitude of harm produced by these drugs, coupled with these drugs' controversial (at best) clinical value.

According to QuarterWatch analysts:

"Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.

In February 2010 the FDA announced it was conducting an overall safety review of rosiglitazone and would present its findings to a special advisory committee meeting in July."

Quetiapine (SEROQUEL, SEROQUEL XR). In the third quarter of 2009, quetiapine, a drug approved for several severe mental disorders, was the suspect drug in more possible cases of diabetes than all other drugs combined. AstraZeneca, which manufactures this best-selling antipsychotic drug, told us it believed most of the diabetes cases were related to lawsuits. The mandatory Medication Guide to warn patients about the risk of diabetes does not primarily use the word "diabetes" but rather describes the disorder as "high blood sugar (hyperglycemia)," potentially minimizing this serious risk."

The FDA has been shown to be complicit in its failure to act--despite a mounting epidemic of drug-induced catastrophes.

A mountain of evidence documents the harm these drugs have produced--and internal documents confirm that manufacturers used corrupt practices to market these hazardous drugs.

Healthcare overhaul must include a shift at the policy level: FDA's drug safety policy must be geared toward effectively reducing preventable drug-induced deaths.

Vera forgot to mention that competent drivers could easily avoid accidents by placing their car in NEUTRAL and parking at the side of the road before turning off the ignition. If someone crashes it’s not because of a stuck accelerator but because of their failure to control a car that malfunctions.

Nevertheless, the Congressional hearings likely stem not from a few incompetent drivers who frightened or injured themselves but from the fact that Congress is now a part-owner of Toyota’s competitors. If Congress was concerned about public safety they would ask why Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and criminal penalties since 2004 because of drugs that kill or injure hundreds of thousands of patients annually.

If Toyota was a union operation that kicked back as much as GM, Pfizer and Glaxo has over the years they wouldn't be grilled like this.

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