The Washington Post (8/16, A1, Stein) reports that the FDA's debate on whether or not to rescind approval for Avastin as a breast cancer treatment "has become entangled in the politically explosive struggle over medical spending and effectiveness." The Post notes that many cancer experts, patient advocates and others are citing "a dearth of evidence of the drug's effectiveness, its potential toxic side effects, and its high cost," and are therefore "welcoming the prospect that Avastin's authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, women taking the drug, some members of Congress and advocates for giving patients as much access to as many treatments as possible." In addition, although the "FDA is not supposed to consider costs in its decisions," the agency also knows "insurers are likely to stop paying for treatment" if it's no longer approved for the indication.
Sunday, March 13, 2011
August 13, 2010 - FDA Approves New Five-Day Emergency Contraceptive.
The FDA announced approval of a new type of morning-after contraceptive, Ella from HRA Pharma. This medication is a prescription-only birth control approach that is said to reduce the chance of pregnancy up to five days after sex. The Los Angeles Times (8/14, Maugh II) "Booster Shots" blog said that the drug, "known generically as ulipristal acetate, is thought to inhibit or delay ovulation by interfering with the effects of the female hormone progesterone, which stimulates ovulation. ... Women with a known or suspected pregnancy or who are breastfeeding should not use the drug." The Washington Post (8/14, Stein) said that Ella "can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown." Supporters and opponents both said the FDA's decision "marked the clearest evidence of a shift in the influence of political ideology at the FDA. ... If the history of Plan B is any indication, Ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug." This story was also covered by the New York Times (8/14, A1, Harris), The Wall Street Journal (8/14, Mathews, Dooren), Bloomberg News (8/14, Waters, Peterson), AFP (8/16), and MedPage Today (8/13, Gever).
August 13, 2010 - FDA Warns Of Aseptic Meningitis Associated With Lamictal.
The FDA warned doctors and patients that GlaxoSmithKline PLC's anti-seizure drug Lamictal (lamotrigine) "can cause inflammation of the brain and spinal cord." New warnings are expected to be added to labeling. The FDA reported receiving reports of 40 cases of aseptic meningitis between 1994 and November 2009. Thirty-five "patients needed to be hospitalized." The symptoms usually emerged in the first month and a half of treatment, and resolved after the medication was stopped. The Wall Street Journal (8/13, Dooren) reported that the drug is used to treat seizures in children and bipolar disorder in adults. Russell Katz, director of the FDA's neurology-products division, said patients who experience symptoms of aseptic meningitis "should consult their healthcare professional immediately." MedPage Today (8/12, Gever), and Reuters (8/13, Heavey) also reported the story.
August 13, 2010 – Strattera Patent Ruled Invalid.
"Eli Lilly & Co.’s Strattera faces generic competition after the drugmaker lost a U.S. court case over the attention-deficit treatment, its second patent ruling setback in a month." The ruling means Lilly expects "'near-term entry' of generic versions" and has reduced its sales forecast. Lilly will appeal the ruling. Bloomberg News (8/13, Decker) reported the ruling "favors generic-drug companies including Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit."
August 12, 2010 - Drug Company Efforts To Outmaneuver The FDA Considered "Disturbingly Common."
Time (8/12, Park) reports that the FDA panel's recent decision to recommend keeping Avandia (rosiglitazone) on the market is "a move worth billions of dollars to GSK but that also may have put millions of patients at risk." The move is also an example "of the drug industry's outmaneuvering FDA regulators," which is "disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring." FDA critics and industry monitors "charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing."
August 11, 2010 - Bisphosphonates May Not Increase Risk Of Cancer Of The Esophagus Or Stomach.
Bloomberg News (8/11, Doherty) reported, "A group of medicines widely used to prevent bone loss doesn't increase the risk of cancer of the esophagus or stomach." In fact, the "combined incidence of the two tumor types was the same for osteoporosis patients given the drugs, called bisphosphonates, as for those not treated with the medicines," according to a paper in the New England Journal of Medicine. "Duration of treatment didn't have an impact on the risk of either cancer." About 18 months ago, the US Food and Drug Administration (FDA) reported 23 cases of esophageal cancer in alendronate treated patients from 1995 to 2008, and another 31 cases in patients using a variety of bisphosphonates in Europe and Japan. The researches analyzed data on more than 80,000 UK patients. During an "average follow-up of about 4.5 years, there were 37 cases of stomach cancer and 79 cases of esophageal cancer diagnosed in the bisphosphonate group, compared with 43 cases of stomach cancer and 72 cases of esophageal cancer after 4.4 years in the control group," HealthDay (8/10, Preidt) reported. Thus, the Belfast-based team concluded, "these drugs should not be withheld, on the basis of possible esophageal cancer risk, from patients with a genuine clinical indication for their use." However, as reported elsewhere, there may be other concerns about long-term use of these drugs.
August 9, 2010 - Some Stroke Patients Stop Taking Their Medications Within Three Months After Discharge.
The New York Times (8/9, Singer) "Prescriptions" blog reported, "Within three months of being hospitalized for an acute stroke, nearly one quarter of patients stop taking at least one of the drugs prescribed by their doctors to prevent further cardiovascular problems," researchers found after interviewing 2,598 individuals. "After their hospital stays, many patients had been prescribed several drugs such as anti-clotting pills, diuretics, cholesterol-lowering drugs and blood pressure medications," according to the paper in the Archives of Neurology. But, "three months after hospitalization, 75.5 percent of the patients were taking all of the medicines their doctors had prescribed to them when they were discharged." The research team examined characteristics of patients to see which ones are least likely to be on their medications, the Los Angeles Times (8/9, Healy) "Booster Shots" blog reported. "They found that younger patients and those who leave the hospital with the highest numbers of medications, those who suffered the severest disability after their strokes, and those without health insurance are more likely to be off their medications three months after a stroke." In contrast, "older patients who understand why their medications are prescribed, and are either employed or at home voluntarily, are more likely to remain on medication at that point."
August 9, 2010 – More Premarket Public Relations on Boceprevir For Hepatitis C.
Additional news stories appeared reviewing results of clinical trials for the Merck add-on Hepatitis C treatment. Placements included stories in The Los Angeles Times (8/9, Maugh) "Booster Shots" blog, HealthDay (8/9, Mozes), and MedPage Today (8/9, Smith). The "75% response rate occurred in the patients who got standard care for four weeks, followed by peginterferon alfa-2b, ribavirin, and boceprevir for 44 weeks." According to the paper in The Lancet, the "next best was a 67% response rate seen in patients who got all three drugs for 48 weeks." Both boceprevir and telaprevir another Hepatitis C drug in development add to the side effect burden. To date, no comparisons have been offered with metformin.
August 7, 2010 - Milwaukee Teachers Ask For Order To Cover Erectile Dysfunction Drugs.
The Milwaukee Teachers' Education Association (MTEA) filed suit to order the school board to cover the costs of erectile dysfunction drugs in its health benefits plan. The teacher’s union argued that excluding these drugs “constitutes sexual discrimination against male employees." Lawyers for the school board state the drugs were dropped in 2005 to save money. The Milwaukee Journal Sentinel (8/6, Randall) reported that the Milwaukee Public School System (MPS) "first agreed to cover drugs that treat erectile dysfunction in 2002. ... During negotiations with the union for its 2003-2005 contract, MPS tried to stop coverage of the drugs, citing rising costs," a decision which was upheld by an arbitrator in 2005.
August 9, 2010 - Questions About Statin Benefits For Patients Without Signs Of Heart Disease.
The Los Angeles Times (8/9, Healy) reports that "in recent months," statins' "touted medical reputation has come under tough scrutiny." While the drugs "certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease...it's not so clear they work that way in people who are healthy." In one study published in the Archives of Internal Medicine "last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack."
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