May 10, 2010 - Patients Not Taking Medicine As Directed Is A National Problem.
The Boston Globe (5/10, Smith) highlights the problem of poor medication adherence reporting on a VA study of cholesterol lowering medications. The study examined the relationship between increased co-payments and other factors and affect regular medication use. Without regular use of medications for chronic conditions, patients are unlikely to receive long-term benefits in health improvement.
May 11, 2010 - Studies Link PPIs To Increased Risk Of Bacterial Infection, Bone Fracture.
The CBS Evening News (5/10, story 6, Couric) reported on proton pump inhibitors (PPIs), which are "very popular drugs used to treat acid reflux and ulcers," and generate "$13.5 billion in sales." According to the Wall Street Journal (5/11, Dooren), approximately 119 million PPI prescriptions were written in the US in 2009, making PPIs the third-largest selling class of drugs. CNN (5/10, Gardner) reported on physician concern for overprescribing and the "the risks" of taking PPIs "may outweigh the benefits for people with less serious conditions, experts say." PPIs "can have rare but serious side effects, including an increased risk of bacterial infection and bone fracture, according to several new studies in the Archives of Internal Medicine." Researchers suggest that PPI medications should be used only by patients with conditions which require these treatments.
In a large trial of postmenopausal women without a history of prior hip fracture researcher found that "over eight years of the study, there were 21,247 bone fractures" as reported in Bloomberg News (5/10, Ostrow). Even though no differences were found in the rate of hip fractures, women taking PPIs had “a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures," the Boston Globe (5/10, Cooney) "White Coat Notes" blog reported.
A number of studies and large pooled analysis associate PPI use with an increased risk of a potentially serious bacterial infection which causies diarrhea. These include: MedPage Today (5/7, Bankhead) reporting "Pooled data from the [nine] studies showed almost a threefold increased risk of C. difficile-associated diarrhea among patients taking PPIs;" HealthDay (5/10, Goodwin) reporting on analysis including more than 100,000 hospital discharges over five years – abstract here; and MedPage Today (5/10, Bankhead) reporting that a study revealed "PPI use was associated with a 42% increase in the risk of recurrent C. difficile infection, with the greatest risk among patients older than 80 and in patients treated with antibiotics that were not targeted to the bacterium."
Meanwhile, a paper written by Taiwanese scientists indicated that "high-dose PPI therapy proved to be no more effective than lower doses for controlling bleeding ulcers," while Harvard data revealed that "introduction of a standardized guideline for prescribing practices reduced inpatient use of PPIs, but only among patients who were not on PPIs at admission."
PPI medication use was previously reported to be associated with an increased risk for developing pneumonia. The Los Angeles Times (5/11, Maugh), Reuters (5/11, Steenhuysen), and WebMD (5/10, DeNoon) also provided additional coverage.
May 11, 2010 - GlaxoSmithKline Reported To Agree To Settle Some Avandia Lawsuits For $60 Million.
Bloomberg News (5/11, Feeley, Kelley) reports, "GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company's Avandia [rosiglitazone] diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say." The report stated that this will resolve 700 Avandia suits. So far, GSK faces approximately 4,000 Avandia-related lawsuits. Reuters (5/11, Hirschler) also covered the story.
May 14, 2010 - FDA Rejects Teva's Citizen Petition To Deny Approval Of Generic Copaxone.
Dow Jones Newswire (5/14, Gryta) reports the Food and Drug Administration has rejected a citizen's petition filed by Teva Pharmaceutical Industry Ltd. Seeking to halt FDA approval of generic versions of Copaxone (glatiramer), a multiple sclerosis medication. Teva has sued drugmakers Mylan Inc. and Momenta Pharmaceuticals Inc., both of which have filed to produce glatiramer. In its effort to protect its own Copaxone brand, Teva, the largest producer of generic drugs in the world, is challenging other drugmakers' ability to create a generic drug.
May 14, 2010 - Mylan Seeks To Sell Generic Version Of Sutent.
Dow Jones Newswire (5/14, Gryta) reports that Mylan Inc. is seeking FDA approval to produce a generic version of Pfizer’s cancer drug Sutent (sunitinib). Sutent is approved to treat certain types of kidney cancer and gastrointestinal tumors and generated sales of $964 million in 2009.
