August 18, 2010 - Bayer AG Agrees To Pay $60 Million To Settle Some Trasylol Lawsuits.

Bloomberg News (8/18, Feeley) reports, "Bayer AG agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol [aprotinin injection], a drug used to control bleeding during heart surgeries, people familiar with the accords said." Specifically, "the settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient…” Trasylol was pulled off the market in 2007, around 14 years after it was approved in the US, and two years after research was published indicating a higher risk of death than competing drugs.

August 17, 2010 - Bariatric Surgery For Obese Patients Associated With Decreased Type 2 Diabetes Medication Burden.

Bloomberg News (8/17, Gale) reported, according to a study published Aug. 16 in the Archives of Surgery, "diabetics who undergo weight-loss surgery need fewer medications to control the condition and have lower health-care costs after the procedure." Specifically, "three-quarters of obese patients with type 2 diabetes were able to stop insulin and other blood-sugar controlling drugs within six months of undergoing bariatric surgery, researchers at the Johns Hopkins University School of Medicine said."

The study, was funded by the Department of Health and Human Services, and included 2,235 obese adults with type 2 diabetes who underwent bariatric surgery. The Wall Street Journal (8/17, D2, Dooren), the Los Angeles Times (8/16, Dennis) "Booster Shots", and HealthDay (8/16, Gordon) also covered the story.

Not surprisingly, the study published in a surgery journal concluded that insurers should cover the costs of bariatric surgery (median cost $30,959) despite that the three year average medical cost reduction seen in the study was only about $6,061. The study did not compare bariatric surgery to other intensive interventions for weight management among obese diabetics.

August 17, 2010 - Patients May Not Receive Useful Drug Information When Filling Prescriptions.

NPR (8/17, Fulton) reports that a study requested by the FDA at the University of Florida "showed that while 94 percent of patients are getting written information with their prescriptions, only 75 percent of them are getting information that's considered useful." The FDA's Medical Policy Office deputy director also assessed the “voluntary private-public sector agreement on principles for good drug information," as "a spectacular failure." The FDA is currently working on new rules to standardize patient drug information.

August 14, 2010 - Pharmacists Opportunity To Improve Patient Care.

The New York Times (8/14, A1, Abelson, Singer) reported on "the expanding role of the nation's pharmacists in ways that may benefit their customers and also represent a new source of revenue for the profession." Pharmacists are being enlisted to help address non-adherence to prescribed treatments. Poor adherence is estimated to cost “nearly $300 billion a year in emergency room visits, hospital stays and other medical expenditures." The Times also describes medication therapy management, which "typically involve face-to-face sessions between pharmacists and patients in retail stores or clinics,” and is paid for by some insurers and health plans.

Helm Benefit Design offers alternative strategies to encourage member medication adherence. While pharmacists can be very helpful in encouraging correct medication use, this can be a costly approach. Additionally, adherence programs must be focused on encouraging first-line medication use and guideline-supported medical treatments. Contact us, to learn more.

August 13, 2010 - Newer, More Costly High Blood Pressure Treatments Are Not Better Than Inexpensive, Generic Diuretics.

The Time (8/13, Blue) "Wellness" blog reported, "Pricey drugs to reduce blood pressure appear no better at preventing heart disease than cheap, generic diuretics, which have been around for decades," according to research presented at the China Heart Congress and International Heart Forum. In a follow-up report on the landmark Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) Trial, data after 8-13 years continued to support the use of chlorthalidone. Earlier evidence of an advantage of the diuretic over an ACE inhibitor in regard to stroke was no longer seen, though chlorthalidone continued to hold an advantage over amlodipine in respect to congestive heart failure.

HealthDay (8/13, Preidt) reported, "Data from (ALLHAT) released in 2002 showed that after four to eight years of follow-up, the diuretic was better than the calcium blocker in preventing heart failure and better than the ACE inhibitor in preventing stroke, heart failure and overall cardiovascular disease." MedPage Today (8/13, Phend) also covered the story.

August 13, 2010 - More Acetaminophen Use Associated with Greater Risk of Asthma

"Yet another new study...is showing a link between asthma and acetaminophen, the active ingredient in Tylenol," The Time (8/13, Blue) "Wellness" blog reported. The latest paper, from the American Journal of Respiratory and Critical Care Medicine reports, "13- and 14-year-olds who take acetaminophen are more than twice as likely to have asthma as teens the same age who never take the common over-the-counter painkiller."
The esearchers worked with data collected from 322,959 children, aged 13 to 14 years, from more than 100 centers in 50 countries. Data were collected by questionnaire on current symptoms of asthma, rhinoconjunctivitis, and eczema, as well as risk factors including acetaminophen exposure in the preceding 12 months.

The majority of the "teens (73%) reported using acetaminophen at least once in the previous year (medium use), and 30% said they had used it at least once a month (high use)," MedPage Today (8/13, Neale) reported. The investigators reported that heavy (monthly) users of acetaminophen had 2.5 times the asthma risk of nonusers.

However, because this and earlier findings derive from a cross-sectional study, it is impossible to conclude which, if either factor, may be the cause and which may be the effect. Additional reporting can be found at: the Los Angeles Times (8/13, Maugh) "Booster Shots" blog, CNN /Health.com (8/13, Mann) and the UK's Telegraph (8/14, Smith).

August 16, 2010 - FDA Considers Rescinding Avastin Approval For Breast Cancer.

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.

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."