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Generic drugs

Long-term criminal fraud by Lipitor drugmakers exposed after years of selling adulterated drugs

Monday, July 01, 2013 by: J. D. Heyes
Tags: generic drugs, adulterated, Ranbaxy

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(NaturalNews) The evidence continues to mount that Big Pharma is little more than a massive criminal enterprise designed to maximize profits at the expense of your health. This story is a continuation on that theme.

Thanks to investigative reporter Katherine Eban, we now know that one Indian drug manufacturer, Ranbaxy, has been making substantial profits selling bogus drugs, including generic brands of Lipitor (which is prescribed to lower cholesterol levels), and generally engaging in widespread fraud.

From her Special Report:

On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties - the most ever levied against a generic-drug company.

Massive fraud

The huge fines and shocking revelations stemmed from a months-long review of every single one of Ranbaxy's products, production lines and every market by Dinesh Thakur, who was ordered to undertake the project by his boss, Dr. Rajinder Kumar, Ranbaxy's head of research and development, in 2004.

What led Thakur - an American-trained engineer and a naturalized U.S. citizen who had worked at Bristol-Myers Squibb in New Jersey for a decade before joining Ranbaxy - to conduct his investigation was just the tip of the iceberg, but in the end it produced "some of the most devastating allegations ever made about the conduct of a drug company," Eban wrote. Here is an excerpt:

Back in his office, Kumar handed him a letter from the World Health Organization (WHO). It summarized the results of an inspection that WHO had done at Vimta Laboratories, an Indian company that Ranbaxy hired to administer clinical tests of its AIDS medicine. The inspection had focused on antiretroviral (ARV) drugs that Ranbaxy was selling to the South African government to save the lives of its AIDS-ravaged population.

As Thakur read, his jaw dropped. The WHO had uncovered what seemed to the two men to be astonishing fraud. The Vimta tests appeared to be fabricated. Test results from separate patients, which normally would have differed from one another, were identical, as if Xeroxed.

In the end, Thakur's "information would lead Ranbaxy into a multi-year regulatory battle with the FDA, and into the crosshairs of a Justice Department investigation that, almost nine years later, has finally come to a resolution," said Eban.

In 2007 Thakur filed a confidential whistleblower complaint in federal court, alleging that the company falsified and fabricated its data in order to win Food and Drug Administration approvals. Under the whistleblower law, he will receive more than $48 million as part of the case's resolution.

What would make a Big Pharma giant become so careless (and callous) in the production of its products? The answer: Money - and lots of it.

'The whole house of cards will fall'

Eban notes that the global generic medicine market alone is worth $242 billion annually. What's worse for Americans, more "than 80 percent of active pharmaceutical ingredients for all U.S. drugs now come from overseas, as do 40 percent of finished pills and capsules," she says.

In the U.S., doctors and patients are trending heavily towards generic medications as a means of controlling costs. But, as the Ranbaxy case proves, this choice presents special hazards of its own.

Notes Eban:

As the Ranbaxy story makes vividly clear, generic-drug makers intent on breaking the rules - especially those operating abroad - can easily do so. Drug applications work on the honor system: The FDA relies on data provided by the companies themselves.

"We depend on that information to be truthful," Gary Buehler, head of the FDA's office of generic drugs for 10 years, said in December 2009.

The approval system "requires the ethical behavior of the applicant," he said. Otherwise, "the whole house of cards will fall down."

Sources for this article include:




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