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Judge Says State of Georgia to Pay for Makena Rather than Compounded 17P
U.S. District Judge Charles Pannell granted a victory to K-V Pharmaceutical Co. by ordering the state of Georgia to provide Medicaid coverage for their pricey drug, Makena. State officials had argued that readily available compounded 17P costs far less and has no major safety issues. They accused K-V of seeking a court order that would let the company gouge taxpayers and consumers, as the compounded drug costs up to $20 per injection and K-V has said it has agreements for Makena's use in other states for rebated rates of less than $300 per injection.
Pannell said the key difference is that Makena has FDA approval and the compounded drug does not. "Because the court finds that the FDA drug approval process means something," Pannell wrote, the state has an "upside-down policy" because it is covering a drug that is not FDA-approved and not covering one that is. Pannell also ordered K-V to post a bond to cover the cost difference between Medicaid coverage of Makena and the compounded drug, in case his ruling is overturned on appeal.
http://www.ajc.com/news/atlanta/judge-orders-drug-for-1496467.html
Study: Aspirin and Cancer
Low- or medium-dose aspirin taken daily may help protect against cancer, but the effect seems weaker than previously thought, according to a U.S. study that included a decade's worth of data from more than 100,000 people.
"News about the cancer potential of aspirin use has been really encouraging lately," said Michael Thun of the American Cancer Society, who worked on the study that appeared in the Journal of the National Cancer Institute. The effect was strongest for gastrointestinal cancer, such as colon cancer and stomach cancer.
http://www.reuters.com/article/2012/08/13/us-aspirin-idUSBRE87C01620120813
FDA Clears New Flu Vaccine for Production by 6 Manufacturers
The new flu vaccine that will be manufactured by six companies, including GlaxoSmithKline, Sanofi, and Novartis, has been approved by the FDA, beginning this year.
According to the CDC, between 5% and 20% of Americans get the flu each year, leading to 200,000 hospitalizations. Flu-related deaths vary each year and can range from 3,000 to 49,000. The CDC recommends that everyone older than six months receive an annual flu vaccine.
http://www.washingtonpost.com/business/fda-clears-new-flu-vaccine-for-production-by-6-manufacturers/2012/08/13/634a7c6a-e584-11e1-9739-eef99c5fb285_story.html
Illinois Elderly Struggling with Rx Costs
Joanne Capretti, a 78-year-old widow needs an inhaler to breathe well enough to continue working part-time as a restaurant hostess, which supplements her Social Security retirement benefits. However, she's worried she can't afford her medication anymore as her out-of-pocket cost has more than doubled since July 1 when Illinois ended a program that helped her and thousands of other seniors buy prescription drugs. "I can't quit working because then I won't be able to eat," said Capretti, who lives in the Chicago suburb of Lynwood. "I don't understand it. The older people don't get [nothing] and now they're getting less...What am I going to do?"
The Illinois Cares Rx program ended just weeks after the governor signed legislation to cut it in an effort to save $72 million and help fill a $2.7 billion hole in the Illinois Medicaid budget, giving seniors and the disabled, who also qualified for the program, little time to plan.
http://www.stltoday.com/news/state-and-regional/illinois/ill-elderly-struggle-with-prescription-drug-costs/article_f4d1895a-be2c-5470-a385-6901ed80453d.html
4-Aminopyridine, Fampridine, Dalfampridine, Ampyra, Neurelan Not as Good
as Projected
Acorda Therapeutics Inc. said on Monday that a low-dose version of its multiple sclerosis (MS) drug, 4-Aminopyridine, did not work in a clinical study. A post-marketing study of Ampyra failed to show an improvement in patients' walking speed when 5 mg of the drug was given twice a day. If the 5-mg version worked, generic rivals could have entered the market in 2017 or 2018, but the 10-mg version is patent-protected until 2027.
More than 55,000 patients have used the drug, and, in the latest trial, two patients, each from the 5-mg and 10-mg treatment group, experienced serious adverse events, including the loss of consciousness in the 10-mg group, Acorda said in a statement. In July, the FDA issued a warning to patients and physicians about the increased risk of seizures from the drug in MS patients with kidney impairment.
http://www.reuters.com/article/2012/08/13/us-acorda-study-ampyra-idUSBRE87C0FD20120813
Ointments, Creams, and Gel Prices Drastically Increasing!
Many physicians prescribe ointments, creams, and gels without a second thought. But increasingly, some dermatologists say, patients are complaining about a recent, mysterious and rapid rise in price of the generic versions. For example, in 2008, betamethasone dipropionate cost $18.17; the medicine now costs $71.28, according to Red Book. Permethrin cream cost $29.25 in 2008 but has jumped to $71.08 today.
The phenomenon illustrates the murky and often illogical world of drug pricing, where prices are not always driven by the usual rules of supply and demand. Some doctors said the prices were unacceptable. "Patients complain about it at every office visit," said Dr. Mark G. Lebwohl, chairman of the National Psoriasis Foundation's medical board and of dermatology at Mount Sinai Medical Center in Manhattan. "I think it's outrageous that the cost of a generic cream—or any cream—exceeds the cost of a doctor's office visit." Most generic creams and ointments in the U.S. are made by three companies: Perrigo, Taro, and Fougera.
http://www.nytimes.com/2012/08/10/business/prescription-skin-creams-jump-in-price.html?_r=1&partner=yahoofinance
Make Your Own!
We may be one step closer to producing drugs in the right place at the right time in the body, avoiding the collateral damage of untargeted treatments. The new method involves packaging the molecular machinery for making proteins into a membraned capsule and controlling the generation of a protein at any time with a trigger of light.
They nano-sized "protein factories" use lipids to encapsulate polymerase and other substances necessary for protein production from E. coli, along with a DNA plasmid containing a gene of interest. To block transcription until the right moment, they added a DNA "photo-labile cage" to the plasmid that is cleaved by exposure to UV light.
http://the-scientist.com/2012/08/13/next-generation-in-vivo-drug-factories/
Canton Pharmacist Convicted on Healthcare Fraud Charges
A Canton pharmacist and five associates were convicted on 26 counts of conspiracy, healthcare fraud, and controlled substance distribution; they stole money from the Medicare and Medicaid programs. Pharmacists and healthcare providers should be aware that we are scrutinizing records to detect and prosecute healthcare fraud said the investigators.
The investigators stated that from January 2006 through August 2011, Babubhai Patel owned and controlled over 20 pharmacies in the metro Detroit area, turning a profit based on a large-scale healthcare fraud. Investigators on the case included those from the DEA, DHHS, OIG, and the FBI.
http://www.wxyz.com/dpp/news/canton-pharmacist-convicted-on-health-care-fraud-charges
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