INdiana Systemic Thinking

February 16, 2008

FDA: Allowing Big Pharma’s Off Label Advertising

According to the Indianapolis Star this morning, the Food and Drug Administration will continue allowing pharmaceutical companies efforts to market a drug’s “off-label” uses, as long as the companies adhere to certain guidelines.  This “marketing” includes giving physicians articles describing “off-label” use.  In the past this practice has come under fire as the companies themselves sponsored the research and the articles were not published in peer reviewed journals.  According to the new guidelines;

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating that the FDA has not reviewed them.
Drug industry advocates said the proposal firmly establishes FDA’s role as a regulator of medicine — not information.

However, these “advocates” have a lot to gain by the ruling.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.

February 5, 2008

More Trouble for Zyprexa

In what is becoming more and more common, Eli Lilly’s Schizophrenia drug Zyprexa has run into a little more trouble.  From the Reuters, via the Indianapolis Star:

Excessive sedation is a “serious safety concern” with an experimental, long-acting form of Eli Lilly and Co.’s blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released Monday.

Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia, Reuters and Bloomberg both reported.

But risks include excessive sleepiness.

The analysis was released ahead of a meeting by a panel of outside advisers who will evaluate the drug Wednesday.”Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence – 0.07% of injections and 1.3% of patients,” FDA staff said.

Lilly officials, in a separate summary, said they thought the benefits of the long-acting formulation outweighed the risks.

“Although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities,” the company said, Reuters reported.

January 9, 2008

FDA Sets Meeting on Zyprexa Adhera

From the Indy Star

NEW YORK – The Food and Drug Administration has scheduled a meeting next month to review the safety and effectiveness of a long-acting version of Eli Lilly and Co.’s schizophrenia drug.

The agency’s panel of psychiatric drug advisers will meet Feb. 6 to assess Zyprexa Adhera, an injectable version of the company’s best-selling drug, which accounted for a quarter of Lilly’s sales last year.

FDA said it is particularly concerned about incidents of severe drowsiness among patients tested with the new formulation.
Zyprexa is currently available in pill form to treat schizophrenia and bipolar disorder. Sales grew 6 percent to $1.67 billion in the final quarter of last year.Shares of Lilly rose $1.03 to $55.57 in morning trading today.

December 20, 2007

Supreme Court Gets Zoloft Case

WTHR is reporting the Supreme Court will hear a case involving the antidepressant, Zoloft.  From the article:

Columbia, S.C. – Attorneys have asked the U.S. Supreme Court to hear the case of a teen sentenced to 30 years in prison for killing his grandparents when he was 12, arguing that the sentence is cruel.Christopher Pittman used a shotgun to shoot his grandparents Joe and Joy Pittman, and then set fire to their home in 2001. During his trial four years later, Pittman’s attorneys unsuccessfully argued the slayings were influenced by the antidepressant Zoloft –  a charge the maker of the drug vigorously denied.In the brief submitted to the high court late Monday, attorneys from the University of Texas School of Law argued that the 30-year sentence violates Christopher Pittman’s Eighth Amendment protection from cruel and unusual punishment.

Such a lengthy sentence is “unconstitutionally disproportionate as applied to a 12-year-old child,” according a copy of the petition provided by Juvenile Justice Foundation. It said Pittman “is the nation’s only inmate serving such a harsh sentence for an offense committed at such a young age.”

Zoloft is the most widely prescribed antidepressant in the United States, with 32.7 million prescriptions written in 2003. In 2004, the Food and Drug Administration ordered Zoloft and other antidepressants to carry “black box” warnings –  the government’s strongest warning short of a ban –  about an increased risk of suicidal behavior in children.

Zoloft is manufactured by Pfizer.

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