Tuesday, October 26, 2010

Almost $Billion Fine in DOJ GlaxoSmithKline Fraud Case, Whistle Blower Gets $96 Million

Bloomberg News By Justin Blum, David Voreacos and Andrew Harris Oct 26,2010
This is the complete Bloomberg article
GlaxoSmithKline Plc agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs.

Glaxo, the U.K.’s largest drugmaker, and the U.S. Justice Department announced the accord today, resolving a lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company.

“This is not something I wanted to do, but because of patient safety it was necessary,” Eckard, 51, told reporters following a Justice Department press conference in Boston. As a whistleblower, she will receive $96 million from the settlement money.

Glaxo was accused in court papers of selling tainted drugs under false pretenses. The medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to papers filed in federal court in Boston. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet.

The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement.

“We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers,” Carmen M. Ortiz, the U.S. Attorney in Boston, said at today’s news conference.

Guilty Plea

SB Pharmco Puerto Rico Inc., a Glaxo unit, agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs made at the now-shuttered plant, the Justice Department said. Glaxo said in July it had agreed in principle with the U.S. to pay 500 million pounds ($791 million) to resolve the investigation.

“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,” PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.

Eckard’s take is the largest ever for a single whistleblower, said Patrick Burns, spokesman for Taxpayers Against Fraud, a nonprofit Washington group that publicizes the use of legal means to combat fraud against the U.S. The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department said.

‘Serious Deficiencies’

Other drugs made at the plant include Kytril, an anti- nausea medication, and Bactroban, an ointment used to treat skin infections, the Justice Department said.

“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.

The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.

“We did not uncover any evidence that patients were harmed from these adulterated batches,” Ortiz said today. “It is critical we keep pressure on companies to follow FDA standards and play by the rules.”

Eckard’s complaint was joined by the states of California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New Mexico, New York, Tennessee, Texas and Virginia, as well as the District of Columbia, Chicago and New York City.

The case is U.S. v. SmithKline Beecham Corp., 04-10375, U.S. District Court for Massachusetts (Boston)

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Andrew M. Harris in Chicago at aharris16@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.

Monday, October 11, 2010

Who has the Number One U.S. Ranking in Criminal Fraud Cases? BigPharma of Course

This is a portion of the New York Times article Oct. 2nd 2010 by Duff Wilson “Side Effect may include Lawsuits”.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.
Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.
The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.
AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.
“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”
The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers despite recent crackdowns.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”
“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”
Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.” End of NYTimes exerpt.

The antidepressant pharmaceutical industry takes in $14.6 Billion in revenue selling these drugs that don’t work. If a firm is taking in this type of money it is easy to settle multi-million dollar fraud lawsuits. The media, government, and medical industry are all working together to cover up the facts that antidepressants don’t work at all so the public is just dumbed down and uninformed on the subject. We commend the NYTimes for doing the research for this article. A truely ethical and independent FDA could stop this madness.

Friday, October 1, 2010

Bad Science: Antidepressants Found to Lower Serotonin Levels and Increases Suicide Rates, Yet they are Marketed to Increase “The Feel Good Chemical"

Dr. Rene Hen is a professor of pharmacology at the Departments of Psychiatry and Neuroscience at Columbia University. She conducted a study on serotonin in mice earlier this year and it appeared in the January 15 issue of the journal Neuron.
One of her major conclusions was "The more antidepressants try to increase serotonin production, the less serotonin the neurons actually produce, and behavior in mice does not change," Dr. Hen was quoted.
Other studies have shown antidepressant drugs have been connected with an increased suicide risk and aggressive behavior. Natural News reported that Dr. Hen’s study found that antidepressants decrease the amount of serotonin in many patients' brains, instead of increasing it as they are meant to. Pharmaceutical Companies feel that serotonin in the brain makes a person feel good. So BigPharma’s drugs “supposably” increases serotonin levels in a patient so they are less depressed. According to Dr. Rene Hen’s study antidepressants have the opposite effect on about half the patients. Her findings indicate that half the patients who take antidepressants produce less serotonin. So, for half of the population, these drugs would actually be making the condition worse.

So the premise for these pharmaceutical companies drug approval was to increase this feel good chemical, but it now lowers serotonin in many patients. Lower serotonin according to BigPharma results in increased suicide rates. Hence, BigPharma is responsible for suicides in potentially fifty percent of the cases. 164 million antidepressant prescriptions were distributed in 2008.

It seems very strange to us why this study was not major news. Many studies have shown that antidepressants are no better than a placebo, but this study is even more alarming. It shows that Pharmaceutical companies and the FDA have blood on their hands. Their research is inadequate, rushed, or perhaps suppressed. There is an enormous population of lab humans taking drugs that show they cause far more harm than assistance. Recent news reports shows recalls of eggs, chicken, tomato’s and spinach because of signs of salmonella and e-coli. Car companies institute recalls for brake failures and many safety issues. Drugs companies don’t appear to be held to the same standard, and the FDA can’t enforce recalls. Hence, the J&J public relations debacle on their Tylenol recall, which gets broadly publicized, but not this alarming discovery regarding suicide and antidepressants.