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AstraZeneca Under Legal Fire Over Seroquel

British drug maker AstraZeneca has been subpoenaed by two states in conjunction with the sale, safety, and marketing of its antipsychotic Seroquel. Last month, the company received a subpoena from the California Attorney General’s office, this one coming shortly after the Alaska Attorney General’s office issued its own subpoena. They are also the subject of an informal inquiry by the U.S. Securities and Exchange Commission. The SEC is looking into allegedly improper payments made to doctors and government representatives outside the United States.

Last week, the company announced a 30 percent gain in third-quarter net profit to $1.59 billion, attributing its success in part to expanded use of Seroquel for the treatment of manic bipolar disorder. In 2005, sales of Seroquel totaled about $2.76 billion. Earlier this month, the FDA officially approved the drug for the treatment of bipolar depression. It had already been approved for schizophrenia, and now it is the only drug approved for both depressive and manic bipolar behavior. Seroquel and Nexium, an ulcer drug, account for more than half of AstraZeneca’s sales.
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KFC to Eliminate Trans Fats

Loaded with fat, salt, cholesterol, and calories, KFC’s chicken may never be considered a healthy eating option. However, the fast-food chain is taking steps to reduce the health risks of its products by eliminating artificial trans fat in its cooking oil. The overhaul is expected to be completed by April of 2007 in all of its 5,500 outlets.

The impetus for the conversion lies in large part with the New York City Board of Health. The board is considering whether to place an outright ban on artificial trans fats in city restaurants. In addition, the Center for Science in the Public Interest (CSPI) had sued KFC Corp. in June because of the company’s inclusion of trans fats in their foods. After KFC’s announcement, the CSPI decided to drop out of the lawsuit.
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Bayer: Who Knew What (and When) About Trasylol?

By Marc Greilsamer

Suppressed data? Secret informants? Fall guys? Welcome to the pharmaceutical industry, which is filled with enough mystery and intrigue to satisfy even the most demanding crime-drama aficionado. Yet, the issues that come into play in this gigantic, lucrative industry are quite real–and are certainly matters of life or death.

Questions and accusations are swirling around the German drug maker Bayer A.G., their heart-surgery drug, Trasylol (aprotinin), and the risk of potentially fatal side effects. But what distinguishes this case from most run-of-the-mill drug-safety controversies is the fact that Bayer may have withheld, either intentionally or errantly, pertinent information about Trasylol from the U.S. Food and Drug Administration.

On September 21, the FDA held a meeting of their Cardiovascular and Renal Drugs Advisory Committee specifically to discuss the safety of aprotinin injection, which is sold by Bayer under the trade name Trasylol. (Trasylol is used to reduce blood loss, prevent low blood pressure, and limit the need for transfusions in patients undergoing major heart surgery.) The main question at hand at the meeting: Is Trasylol usage associated with elevated risk of renal failure, myocardial infarction, heart failure, or stroke?

Present at that meeting were two Bayer executives: Michael Rozycki, Ph.D., director of U.S. regulatory affairs, and Pamela Cyrus, M.D., vice president of U.S. medical affairs. Joined by two outside professors, the Bayer group made a presentation to the committee that included an overview of the subject, a risk-benefit assessment, a review of clinical data, and a discussion of the methodology of two independent studies published in 2006–one in Transfusion and one in the New England Journal of Medicine–that called into question the safety of Trasylol. They were also asked to provide their own “recent safety and efficacy data” to the committee.
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New Study Pushes Lung Cancer Screening for Smokers

Early detection of cancerous lung tumors has a significant effect on a patient’s survival rate, according to a controversial new study. As a result, the study’s authors recommend a robust, annual CT screening process for smokers, claiming that early detection (and timely removal) of tumors gives patients a 10-year survival rate of 92 percent. The usual survival rate for people diagnosed with stage I lung cancer is about 70 percent.

The study was published in today’s issue of the New England Journal of Medicine and was supported by two dozen groups. Researchers screened 31,567 asymptomatic but at-risk patients between 1993 and 2005. Yet, many critics have questioned the results for a variety of reasons. For one, there was no control group with which to compare the results. For another, early screening, by definition, will lead to earlier detection and diagnosis, thereby extending the post-diagnosis survival time–even if a patient’s eventual death was not delayed or even prevented by the screening.
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Toy Company Mega Brands Settles Out of Court

Montreal-based Mega Brands, manufacturer of Magnetix toys, reached a $13.5 million settlement with 14 families, including one whose son died from injuries related to Magnetix products. A 22-month-old toddler from Redmond, Wash., Kenny Sweet, died on Thanksgiving Day, 2005, after ingesting eight kernel-sized magnetic pieces, which led to a perforation of his intestinal wall and, subsequently, blood poisoning.

Terms of the settlement were not disclosed and are subject to court approval. However, Mega Brands did not assume any liability in the cases. Mega Brands is Canada’s largest toy company, but none of the health issues reported thus far have taken place in Canada.
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Big Pharma Backing Republicans, Says WSJ

The potential for a “Democratic revolution” in the upcoming midterm elections has created a palpable sense of fear in the pharmaceutical industry–and has spurred the industry to action. A front-page report in today’s Wall Street Journal noted that drug-industry political action committees had contributed around $8.7 million to political campaigns through September of this year, and a whopping 69 percent of these contributions have been earmarked for Republican candidates. The Journal based their report on data from the nonpartisan Center for Responsive Politics.

The big pharmaceutical companies have several reasons to dread a Democratic takeover in Congress. For one, Democrats are committed to allowing Medicare to negotiate directly with drug companies in order to secure more favorable pricing for consumers. (Currently, the Veterans Administration is allowed to negotiate directly with the drug companies, which has resulted in significant discounts for their medication–sometimes even 50 percent or more.)
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Heart Stents Reconsidered by Medical Community

For the better part of the last decade, heart stents have been celebrated as one of the most important developments in the medical field, and, with sales of heart stents reaching $6 billion annually, it’s also been one of the fastest-growing segments of the industry. Yet, it seems with each passing day that more and more questions arise regarding their long-term safety.

Recent evidence points to an increased risk of fatal blood clotting associated with a particular type of stent, the drug-coated stent. Drug-coated stents were virtually non-existent as recently as five years ago, but now they command more than 85 percent of the stent market. The FDA has scheduled meetings for this coming December in order to discuss the issue in more detail and perhaps call for further studies.
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Antidepressants Linked to Male Infertility

Researchers at New York’s Cornell Medical Center have found a major correlation between use of antidepressants and sperm count. Men who take selective serotonin reuptake inhibitors (SSRIs) are being urged to consult closely with their doctors in order to determine a proper course of action in light of the new study, the first of its kind. Cornell’s Peter Schlegel announced the results this week at the 62nd annual meeting of the American Society for Reproductive Medicine (ASRM) in New Orleans.

The Cornell study involved the careful monitoring of two male patients over the course of two years. Both men were treated with citalopram (Cipramil) or sertraline (Lustral) and were later found to have significantly decreased sperm counts; in fact, their sperm counts actually approached zero. Once taken off the antidepressants, both men’s sperm counts rebounded to normal levels. Researchers also found a similar connection in a dozen other patients, although not quite as dramatic as in the two featured cases.
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Recalled ReNu Lens Solution Still on the Market

The recalled contact-lens solution ReNu with MoistureLoc had maintained a 2 percent market share into the early weeks of September, despite the fact that distribution of the Bausch and Lomb product was halted by the company on April 9. Use of that solution has been connected to a serious fungal condition known as Fusarium keratitis, but recent market data call into question whether or not the company has been aggressive and diligent enough in alerting retailers, patients, and medical professionals to the product’s potential dangers.

In their announcement of Bausch and Lomb’s decision in April, the FDA said that the company was “voluntarily stopping shipment of the ReNu MoistureLoc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.” The following week, the company issued what they called a “voluntary market withdrawal,” which requested that retailers temporarily suspend sales while research was ongoing.

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Autism Association Questions Safety of Risperdal for Children

The Food and Drug Administration’s approval of Risperdal as a treatment for autistic children has been challenged by the National Autism Association (NAA) due to concerns about the drug’s side effects. According to the NAA, side effects of Risperdal, or risperidone, include lactation both in girls and boys, weight gain, and development of the often irreversible movement disorder tardive dyskinesia.

“Any medication that can induce lactation in boys is clearly a dangerous drug, and in my opinion should only be used when all avenues of biomedical treatments have been exhausted,” says National Autism Association executive director Rita Shreffler. “Parents are faced with extremely tough decisions when it comes to medicating their children, and extra caution should be used with Risperdal in particular given what we know about it.”
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