The Cellar - The Pharmaceutical Industry

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FDA does not have something equivalent to the NTSB or NTHSA to perform technical analysis. As has been proven repeatedly, FDA discovered threats to human life even get diminishes, quashed, or downplayed due to FDA politics and their association with big Pharma.

Not that a separate investigation unit by itself would fix the problem. The NTSB has a 30 year criticism of the FAA for its 'dead body' attitude. FAA will not fix things until someone dies. Even Fox News is now reporting how corrupt the FAA oversight has been.

We also have a separate agency to analyze vehicles failures and deaths. Not that it stopped 37 Toyota deaths. But it has eliminated many such failures by reporting the public - not to some auto industry oversight board.

FDA desperately needs its entire investigation board be spun off and separate from the FDA management. Big pharma has massive profits, gets much if not most of it basic research paid for by government, and has a history of keeping prices high by consolidating and by getting government protection. The most recent and perfect exact is George Jr's Medicaid prescription law that protected a 40% higher profit for drugs in America.

FDA needs to have all investigations separate and reported publicly. The FDA has a long history of protecting big Pharma – especially the cash cow drugs - at the expense of the public. FDA tends to backtrack only when reports are leaked. Too many news investigations have exposed this cozy relationship to be deniable. The reason for separate investigation agencies in other industries has long been understood.

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Originally Posted by jinx (Post 636286)

Senate report links diabetes drug Avandia to heart attacks

Sounds like another cox-2 (Vioxx) cover-up.

Feds found Pfizer too big to nail

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Pfizer, the world's largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns. When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. "It sends a clear message" to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI's Criminal Investigative Division.
But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It's a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.
Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.
But an internal marketing plan called for training physicians "to serve as public relations spokespeople."
According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, "They pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."

But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.
Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.
Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

In all, Pfizer lost the equivalent of three months' profit.
It maintained its ability to do business with the federal government.

We're living in the 30s all over again. Too big to fail = too big.

Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing

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AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA)
...

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.
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The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

US prescription drug sales hit $300 bln in 2009

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Antipsychotics top drug category by sales

guess who bought the most antipsychotics

Pfizer pulls leukemia drug from U.S. market

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Drugmaker Pfizer Inc is pulling a decade-old leukemia medicine off the U.S. market after a study found a higher death rate and no benefit for patients.
Mylotarg won approval under an abbreviated process to help bring treatments for serious diseases to patients more quickly. Medicines cleared in that way must pass follow-up tests to confirm they work.
The Food and Drug Administration said on Monday it asked Pfizer to withdraw the drug after a recent clinical trial raised new concerns about the product's safety and the drug "failed to demonstrate clinical benefit to patients enrolled in trials."
Mylotarg's first-quarter sales were $8.8 million, making it a small product for the world's largest drugmaker. The company reported first quarter revenue of $16.8 billion. Pfizer acquired Mylotarg when it bought Wyeth in October 2009.

The trial also showed more deaths in the first couple months of treatment. The fatality rate was 5.7 percent for Mylotarg patients, compared with 1.4 percent without the drug, Pfizer said.

The FDA cleared Mylotarg for sale in 2000

Once again, the evidence shows that when it comes to protecting OUR health and well being, the US government agencies tasked with that responsibility should not be your first choice. Nor second, third, or fourth.

no need to limit their ability to do anything to health, but I totally agree with you.

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Originally Posted by squirell nutkin (Post 668942)

Who should be first through fourth?

Ignorant cartoonists of course.

I support a fasttracked process for drugs for terminal diseases, as long as the patients are well informed that the drug is more experimental than one that went through the full process. It's a tough call; on one hand you're allowing companies to exploit desperate people for drug tests, but on the other hand you're allowing desperate people to have the choice of trying something experimental.

On the third hand, a drug with a 1.4% fatality rate does not seem to be a good candidate for the fasttrack process.

5.7 percent. 1.4 was those NOT on the drug.

Sorry, typo; I meant a DISEASE whose fatality rate is 1.4% under normal treatment doesn't seem to merit a fasttrack drug approval process.