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Switzerland-based drug giant Roche announced today that it plans to reduce its worldwide job force by 6% over the next few years. This would mean a loss of approximately 6300 positions globally, with around 3550 of these coming from the United States.
The program, which was first hinted to in September, will attempt to save the company $2.4 billion by 2012. Most of the cuts will come from sales, marketing and commercial operations in the U.S. and Europe.
The company blames the decision largely on delays in the launch of its diabetes drug taspoglutide and losses from healthcare reform in the United States. It was recently announce the drug would be released 12 to 18 months later than expected. The recent healthcare changes are also expected to cost the company in upwards of $500 million annually.
Many Accutane attorneys also point to the fact that the drug maker faces thousands of lawsuits for alleged side effects from its popular Accutane drug which was sold between 1982 and 2009. Experts have linked the drug to serious bowel disorders such as Inflammatory Bowel Disease, Crohn’s Disease and Ulcerative Colitis. Check back with AccutaneRisks.com for more updates.
The only problem is the study was funded by one of the generic manufacturers of Accutane, who along with Roche, are facing thousands of lawsuits from those who took Accutane, Amnesteem, Claravis or Sotret and later developed the bowel disorders. It is believed that approximately 16 million people took Accutane to fight their acne after the drug was introduced in 1983.
Roche pharmaceuticals discontinued sales of Accutane in June of 2009 due to decreasing market share from generic pressure and mounting lawsuits over its severe side effects.
The four drug firms are searching for something to break the link between their products and the gastrointestinal conditions, after numerous experts have stated that the isotretinoin is related to the disorders. So far, in every one of the six lawsuits that have gone to a jury trial, the patients have won and have been awarded a total of $56 million.
The recent study was published in the American Journal of Gastroenterology on August 10. It discusses the fact that several of the people who eventually took Accutane to treat their severe acne and later developed severe bowel problems first took one of the tetracycline-based oral antibiotics. The researchers, who were funded by one of the generic Accutane drug manufacturers, stated there could be a link between antibiotic drugs for acne treatment and an increased risk of inflammatory bowel disease.
Critics of the study, however, point out that it studied a broad sample of 94,000 people in the U.K. who had acne as teenagers between 1998 to 2006, but only looked for the ones who took antibiotics such as doxycycline, minocycline or tetracycline and developed IBD. 152 people in the study met that criteria, with most of those developing Crohns disease.
Researchers familiar with Inflammatory Bowel Disease, Ulcerative Colitis and Crohns Disease say the results of this study certainly dont clear Accutane from its links to the diseases, but more studies should be performed.
Experts have linked Accutane to harmful bowel conditions such as Inflammatory Bowel Disease, Ulcerative Colitis and Crohns Disease. Although it was discontinued in June, 2009, the drug was sold to over 13 million people worldwide since 1982. Thousands of people have now filed claims alleging the drug caused their injuries.
The decision come after a ruling by the European Ombudsman in April that the European Medicines Agency (EMA) failed to adhere to the E.U.s transparency regulations which were put in place in 2001. Liam Grant, who has filed a lawsuit against Roche over his sons death, had sought the records but was initially denied.
In a very biased opinion, the EMA originally stated that the transparency laws didnt apply to adverse event reports for drugs, and that the drug safety information would be misleading to the general public and cause undo alarm.
Ombudsman Nikiforos Diamandouros disagreed, and ruled that the transparency rules applied to all of the EMAs documents, with few exceptions. He suggested the EMA provide additional context to go with any documents they thought may be misleading.
AccutaneRisks.com applauds the decision of the E.U.s actions and believes the United States FDA should operate with the same transparency to protect its citizens from future negative drug side effects.
Kamie Kendall, from Utah, filed her Accutane lawsuit in 2007 and was awarded $10.5 million after a jury ruled that her gastrointestinal disorders were due in part to side effects from the drug, and that Roche pharmaceuticals, the maker of the drug, had failed to warn users of its dangers.
The verdict has been overturned for now, however, after an Appellate court found that the trial judge improperly prohibited Roche from using evidence about how many acne sufferers had used Accutane over the past several decades. The appeals court commented that this ruling failed to give a full and fair opportunity for Roche to present and advocate the relevant numbers evidence,.
The decision to retry the Kendall case resulted in a decision by an Atlantic City judge to delay another trial which has received far more attention in recent months. Hollywood actor James Marshall, best known for his role as private Downey in the film A Few Good Men has sued the makers of Accutane charging that the drug caused him to develop inflammatory bowel disease which led to surgery to remove his colon.
The Marshall trial, which was set to start this week, will feature a number of A-list Hollywood players who are expected to testify that the condition sidelined Marshalls successful acting career. The judge hasnt indicated when the trial will be scheduled to start again.
Researchers in recent years have linked the use of Accutane with an increased risk of developing Inflammatory Bowel Disease, Ulcerative Colitis or Crohns Disease. Some experts also charge that Roche, the maker of the drug, knew of the dangers as early as 1986, but failed to issue any warnings. Roche discontinued sales of Accutane in June, 2009, after mounting pressure of litigation over the side effects.
As Roches patent on Accutane expired around 2002, however, several companies introduced generic versions of the drug. These versions are still available on the market. After Roche stopped sales of its drug last year, the FDA undertook an investigation to determine if a complete recall was warranted.
In its recent decision, which was posted as a notice in the Federal Register, FDA regulators ruled that the recall by Roche was not due to problems with the safety or effectiveness of the drug. This came as a shock to the thousands of people who have been affected by or filed lawsuits for inflammatory bowel disease, Crohns disease or ulcerative colitis after taking the drug.
Although the name brand Accutane is no longer available, the generic versions known as Claravis, Sotret and Amnesteem are. Under FDA regulations, the manufacturers of these drugs may continue to sell them by simply showing that they are bioequivalent, or mostly the same formula as, the original Accutane that was approved by the FDA decades earlier. If the FDA had determined that the decision to stop selling Accutane amounted to a full recall, then the generics would have been left to obtain their own FDA approval with a full application and extensive testing.
In a recent study released in the April edition of the American Journal of Gastroenterology researchers concluded that the severe side effects of Accutane increased the risk of developing Ulcerative Colitis four-fold. Drug safety advocates are now hoping that people will heed this warning and stop using the generic versions on their own, despite the questionable ruling by the FDA.
Marshall is best known for his role as Private First Class Louden Downey in the 1992 hit A Few Good Men. He also starred in the movie Gladiator. Accutane, which was sold by Roche Pharmaceuticals until June of 2009 has been linked to several bowel conditions including Inflammatory Bowel Disease, Ulcerative Colitis and Crohns Disease. In the most sever of these afflictions patients may have to have parts of their bowels removed.
The lawsuit filed by the 43 year old actor alleges that the eventual surgery he had to undergo as a result of the severe side effects from Accutane ruined a successful acting career. Several industry insiders and fellow actors such as Martin Sheen, Brian Dennehy and Rob Reiner are expected to testify to that effect during the trial.
More than 1,000 Accutane lawsuits have been filed so far against Roche alleging that the drug manufacturer did not properly warn patients of the risks of severe bowel disease side effects associated with the drug. Although only 7 of the cases have reached a jury decision, all of those have resulted in verdicts against Roche totaling approximately $56 million.
It is expected that even more people suffering from conditions like Inflammatory Bowel Disease, Ulcerative Colitis and Crohns Disease who took Accutane but do not know of the connection will learn about their legal rights because of this high profile case.