- MD Labs is part of a new industry called pharmacogenetics in Reno (nnbw.com)
Not everyone reacts to the same medication in the same way...Benedryl makes some people drowsy and others wired. Antidepressants have no affect on 38 percent of patients...Some people are more susceptible to addiction from pain medications while others get pain relief without getting hooked...MD Labs is part of a new industry called pharmacogenetics that uses genetics to map specific genes involved in the metabolism of and response to specific drugs...Ruttledge and Denis Grizelj, co-founder and CEO, began MD Labs in 2011 as a toxicology testing facility for physicians nationwide. They expanded to pharmacogenetic testing in 2014, with the development of their proprietary genetic test Rxight, which maps genes that affect more than 200 medications...Because it’s genetically based, Rxight is a once-in-a-lifetime test...Preemptive testing makes the patient’s genetically-based profile of drug reactions available to doctors and pharmacists before illness strikes and before a drug is prescribed...MD Labs contracts with Saint Mary’s Health to offer the testing and consultation at both Saint Mary’s Regional Medical Center and Saint Mary’s Medical Group Primary Care Northwest Reno...Pharmacists at those locations are Rxight Certified to administer the test and provide consultation...Nationwide the company has 100-110 employees total, which includes about 55 people in the Reno office plus a sales force in offices in Chicago and Pennsylvania...MD Labs owners see a future in which pharmacogenetics testing is routine.
- This Week in Managed Care: October 7, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.
- Humana, UnitedHealthcare join new value-based prescription drug model (modernhealthcare.com)
Humana, UnitedHealthcare, WellCare, Blue Cross and Blue Shield of Florida, Blue Cross and Blue Shield Northern Plains Alliance and CVS Health are among those participating in the Part D model that gives insurers financial incentives when they offer innovative programs that encourage seniors to take their medications...The experiment comes out of the Affordable Care Act…Evidence suggests that medication therapy services currently offered by Part D plans don't improve quality or reduce unnecessary medical expenditures. That's likely due to misaligned financial incentives and regulatory constraints…The focused approach is critical Medicare Advantage plans currently have more of an incentive than stand-alone Part D plans to work with patients to take their medications because they are on the hook for hospitalizations…The Medicare Advantage value-based insurance design model will begin Jan. 1, 2017, and run for five years…
- SEC charges former Puma biotech exec with $1.1 million in insider trading (statnews.com)
In the latest instance of alleged insider trading in the pharmaceutical industry, a former Puma Biotechnology executive was charged with illegally making more than $1.1 million by taking advantage of confidential information about clinical trials for a cancer drug...Robert Gadimian, who was senior director of regulatory affairs, bought and sold Puma stock after learning about favorable study results for a medicine that was being tested to treat breast cancer…This alleged episode of insider trading is only the latest instance involving the pharmaceutical industry or those working with drug makers. The issue has increasingly raised concerns in connection with clinical trial work, as well as deal-making and the drug approval process, which some fear can be distorted by such activities.
- To stop FDA inspector, workers at Japanese drug maker formed a human barricade (statnews.com)
Someone at Nippon Fine Chemical must have been very nervous when an investigator from the US Food and Drug Administration arrived last year...In an unusual display of chutzpah, the drug and ingredients maker refused to allow the investigator to inspect its quality control laboratory at its facility in Hyogo, Japan. Employees literally formed a "shoulder-to-shoulder" barricade to prevent the FDA employee from entering…the FDA investigator reviewed customer complaints that Nippon drugs contained glass, hair, cardboard, metal — and even a black spider. But Nippon employees refused to provide the investigator with copies of documents that detailed customer complaints. The FDA letter noted that Nippon uses the same equipment and processes for drugs sold in the Japanese and US markets...As a result of these foibles, the FDA declared Nippon products to be adulterated and issued an import alert two months ago, an action that means Nippon products can be detained from entering the US...Nippon could not be reached for comment...
- Pharmacy Week in Review: October 7, 2016 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Pharma industry should take a page from airline social media mavens, consultant says (fiercepharma.com)
Airlines are known for their quick and effective social media responses, often helping stranded and annoyed passengers in real time. But while pharma companies can’t solve problems instantly with a reroute or seat change, they can definitely look to airline’s social media savvy for inspiration, one industry consultant says...Pharma companies need to get over the mindset that social media is too difficult to do in the regulated industry…You have a social media manager who is actively monitoring public forums for complaints and seeking to address those complaints as quickly as possible...actionable intelligence...or...acting on the data to provide a benefit of some kind...becoming aware of discussions on social media…a "treasure trove of valuable patient insights"--and analyzing what percentage could be acted upon to the mutual benefit of the brand and the patient...
- Mylan to pay $465 million to settle claims of shortchanging Medicaid (statnews.com)
Mylan reached a $465 million settlement on Friday with the US Department of Justice and other government agencies over accusations that it shortchanged Medicaid...The move comes after a month of controversy over charges that Mylan improperly classified its EpiPen allergy device in reports to the Medicaid Drug Rebate Program. Under this program, companies must accurately report — and pay — a rebate on drugs paid for by the agency...Mylan, however, had been reporting EpiPen as a generic product for nearly a decade. And this is an important distinction, because classifications are used to determine the size of rebates that companies pay Medicaid. Rebates, which companies pay in exchange for having their products covered, are lower for generics — 13 percent versus 23 percent for a brand-name product.
- New center for kids with sickle cell disease aims to fill void in Southern Nevada (reviewjournal.com)
Children in the Las Vegas Valley who have sickle cell disease soon will be able to visit a one-stop hub for medical care and social services to help them cope with the painful, sometimes debilitating blood disorder...The new Sickle Cell Treatment Center will open at the Children’s Specialty Center of Nevada, 3121 S. Maryland Parkway, by the end of October, according to Dr. Nik Abdul Rashid, director of the sickle cell center...The center will provide patients with access to a multidisciplinary team, including doctors, a social worker and a clinical research associate, who can help with everything from psychological assessments to communicating with a child’s school about the impact of the disease, Rashid said...the new center will help ensure kids with sickle cell disease receive adequate care while also giving parents the information and resources they need to be the best caregivers they can be...
- The Patent Truth: The Access to Medicines Debate (realclearhealth.com)
Bill Gates and Abraham Lincoln are in agreement. Gates, whose foundation funds the development and distribution of new medicines in the developing world, said the U.S. system is better than most other systems one can imagine…. The drug companies are turning out miracles, and we need their R&D budgets to stay strong. They need to see the opportunity." It turns out that Mr. Gates is in good company. Lincoln, the only U.S. President to hold a patent, called the IP system, "the fuel of interest which fires man’s genius."...At the United Nation’s General Assembly...a group called the High Level Panel on Access to Medicines was working hard to extinguish that source of miracles. The UN’s HLP issued a report with recommendations that would disrupt medical innovation and potentially lower the health status of impoverished communities throughout the world. The report’s fundamental premise is that millions of people in low and middle-income countries have been denied access to medicines because patents have increased their prices...The UN’s HLP ignores...progress, and the evidence that innovation and its intellectual property laws can exist alongside the delivery of medicines and health services to people in need...Governments need to be aware of attempts by UN agencies to put the HLP recommendations into programs....Replacing the current system’s proven accomplishments with an untested system would endanger the astounding improvement in health conditions of the poor over the past half-century. Over time, it might turn a miracle into a tragedy...