Posted on April 17, 2011 by BioJobBlogger

Looking Back: The Largest Big Pharma Drug Settlements in the Past Two Years

Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!
 

 

Tags: , , , , , , , , , , , , , , , , , , , , , ,
Posted on October 30, 2009 by BioJobBlogger

Another Pharmaceutical Company Settles Illegal Marketing and Promotion Lawsuits

The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Tags: , , , , , , , , , , , , , , , ,
Posted on December 21, 2007 by BioJobBlogger

Once Again Merck Chooses Sales Over Patient Safety

There is a storm brewing around Zetia, Merck and Schering Plough’s blockbuster cholesterol-lowering drug. However, let me preface this post by reminding everyone that all drugs have side effects and if a drug’s benefits outweigh its risks then it will likely be prescribed to patients. That said, new evidence has been uncovered which shows that Merck, and  Schering Plough, conducted  at least 8 clinical trials from 2000 to 2003– to evaluate Zetia’s risk to the liver when taken with other cholesterol-lowering drugs (statins) – but chose to not publish the results of those studies. This is what we know about Zetia:

  • Zetia has annual sales of over $ 5 billion
  • Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. A 10,000 patient Zetia clinical study called ENHANCE is currently underway to determine whether the drug’s ability to lower cholesterol really translates into a reduction in heart attacks and strokes
  • Millions of people who take Zetia also take statins such as Zocor, Lipitor, Pavachol, Crestor and Mevacor to lower cholesterol (Vytorin, Merck’ new cholesterol-lowering drug contains Zetia and Zocor in a single pill)
  • From 2000 to 2003 Merck and Schering Plough conducted 8 long-term safety studies of Zetia in combination with a variety of statins but only published the results from 3 of the 8 studies. Also, the unpublished studies were not listed on industry websites where companies are supposed to register by law the results of all ongoing clinical trials after 2002 (because some of these trials were initiated before 2002 the law does not apply to them)
  • FDA supposedly reviewed the results of the unpublished studies and approved Zetia use with statins anyway
  • Prior to its approval in 2002, at least one internal FDA reviewer recommended that Zetia not be approved for use with statins because the combination caused liver disease in animals. Also, since 2006 a number of case reports have been published in medical journals that suggest the combination of Zetia and statins has caused severe liver damage in some patients
  • In the US, Zetia’s product label only contains mild warnings about the drug’s potential to cause liver damage. However, since 2005, product labels in Canada and Australia have carried strong warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression—warnings that have seemingly been ignored in the US
So what do Merck and Schering Plough have to say about the results of the unpublished safety trials? According to the New York Times, Dr. Robert J. Spiegel, Schering Plough’s Chief Medical Officer said “The companies had not considered the studies scientifically significant enough to publish their findings. Some may eventually be published.” Similar statements were made by Merck executives about Vioxx’s safety after they pulled it from the market! Not surprisingly, most of the safety studies that were published by Merck and Schering Plough generally played down the liver problems associated with Zetia and statin combination therapy.

Although many physicians still think that Zetia is safe, I believe that the failure of Merck and Schering Plough to promptly and openly disclose all research about the drug may be leaving the American public with a misleadingly favorable view of Zetia’s safety and efficacy (sort of like Vioxx). For the past 8 years or so, FDA has been slow in issuing safety warnings and demanding label changes for many widely used drugs like Merck’s pain killer Vioxx, GSK’s diabetes medication Avandia and Lilly’s anti psychotic drug Zyprexa that have turned out to carry serious safety risks. I think that it is time for FDA to “step up to the plate” and do its job—provide Americans with SAFE and efficacious medicines. Also, I hope that pharmaceutical companies are beginning to realize that they must be more forthcoming about the safety of their products if they want Americans to use them. Finally, and perhaps most importantly, drug company profits should never come at the expense of patient safety—NEVER!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!
Tags: , , , , , , ,