- China says 202 detained in vaccine scandal (reuters.com)
A total of 202 people have been detained in connection with a scandal over an illegal black market vaccine ring, the Chinese government said...as it vowed to improve supervision of the market...The case, involving millions of illegal trades of vaccines through a black market drugs ring, has ignited public ire and underscored regulatory weaknesses in the world's second largest pharmaceuticals market...The State Council...said in a report 202 people had now been detained, with 357 health and regulatory officials receiving administrative punishments...The supervision and regulatory system would be tightened, the State Council said, with better record keeping for the production, storing and transport of vaccines and tougher punishments for lawbreakers...The scandal has stirred angry debate, casting a shadow over government ambitions to bolster the domestic drug industry and underlining the challenge it faces to regulate a widespread and fragmented medicine supply chain.
- Federal Reclassification of Marijuana Could Have Major Impact on Medical Uses (abcnews.go.com)
Federal authorities have announced that they are reviewing the possibility of loosening the classification of marijuana, and if this happens, it could have a far-reaching impact on how the substance is used in medical settings...Marijuana is currently classified as a Schedule I drug, meaning it is listed alongside heroin and LSD as among the "most dangerous drugs" and has "no currently accepted medical use and a high potential for abuse."...The Drug Enforcement Administration announced last week that it is reviewing the possibility of reclassifying it as a Schedule II drug, which would put it in the same category as Ritalin, Adderal and oxycodone...There are thousands of people who are using medical marijuana for a whole host of medical conditions...where the efficacy has yet to be thoroughly studied...By changing the classification of the drug...researchers and doctors could find out how effective marijuana is in other conditions...We could move toward a more evidence-based use of medical marijuana... For too long schedule I status for marijuana has been a barrier for necessary research...
- HHS Proposes Expanding Prescriptions for Opioid Addiction Treatment (pharmacytimes.com)
The Department of Health and Human Services has proposed allowing physicians to prescribe buprenorphine for twice as many opioid-addicted patients as they do now...Buprenorphine is a medication-assisted treatment for opioid use disorder, and certain physicians are permitted to prescribe or dispense the drug in their offices because it has low potential for abuse...Under current usage guidelines, physicians looking to prescribe and dispense buprenorphine must participate in training before receiving a special Drug Enforcement Administration number. Physicians certified to prescribe buprenorphine for opioid use disorder are currently permitted to prescribe it to up to 30 patients in their first year and then request authorization to prescribe it to up to 100 patients—a cap that HHS said "limits the ability of some physicians to prescribe to patients with opioid use disorder."...If the HHS proposal is adopted, then qualified and currently waived physicians will be able to prescribe buprenorphine for up to 200 patients.
- Cashing In on Opioid War: Alkermes and Its $1,300-a-Month Shot (bloomberg.com)
A decade-old drug that was once seen as a commercial flop is getting a second chance to thrive as the fight against the opioid abuse epidemic shifts toward medical treatment in the U.S...Alkermes Plc’s Vivitrol, a $1,300-a-month shot that helps kill the high from painkillers and heroin, is poised to get a sales boost after President Barack Obama’s recent push to give millions of Americans better access to addiction medicines through expanded Medicaid coverage and extra budget funding...Alkermes is getting support from governors, police chiefs and judges who helped start more than 100 programs offering Vivitrol with counseling across 30 states...Nobody steals Vivitrol. Nobody traffics it unless they want to get sober...Vivitrol’s sales revival 10 years after its introduction is unusual in the pharmaceutical industry...The active ingredient in Vivitrol, naltrexone, binds to the same receptors in the brain as opioids and blocks the pleasurable feelings associated with taking narcotics...Designing drugs for addicts comes with thorny challenges: How do you prevent addicts from becoming addicted to the addiction treatment, and how do you prevent them from selling it to other addicts?
- Federal court reverses dismissal of class-action suit against Pfizer over pain drugs (biopharmadive.com)
A federal appeals court reversed a previous dismissal of a class-action lawsuit against Pfizer, ruling the case was wrongfully dismissed...The verdict, from the 2nd U.S. Circuit Court of Appeals...sends the shareholder lawsuit back to the district court judge who originally heard the case...The lawsuit alleges Pfizer mislead shareholders about the safety of the company's Celebrex and Bextra pain-relieving drugs. A group of Pfizer investors initiated the suit in 2004, claiming the company concealed cardiovascular risks associated with Celebrex and Bextra, two COX-2 inhibitors approved as anti-inflammatories. In the mid-2000's, evidence mounted showing that COX-2 inhibitors significantly increased the risk of certain CVD events...In dismissing the case, the federal appeals court also ruled U.S. District Judge Laura Taylor Swain erred in refusing to allow expert testimony from a former Univeristy of Chicago Law School dean, Daniel Fischel, about potential damages to shareholders.
- Medicare ‘hospital star rating’ may correspond to patient outcomes (reuters.com)
The Centers for Medicare and Medicaid Services has been letting patients grade their hospital experiences, and those "patient experience scores" may give some insight into a hospital’s health outcomes...Some people have been concerned that patient experience isn’t the most important factor to measure...Medicare has been putting a lot of data out for a long time, but the broad consensus has been it’s very hard for consumers to use this info...CMS responded by giving out star ratings that consumers can understand easily...The five-star rating system is based on patients’ answers to 27 questions about a recent hospital stay...If you use the star rating you’re more likely to end up at a high quality hospital...But I wouldn’t use only the star rating to choose a hospital...
- California bill would require drug makers to report 10 percent price hikes (statnews.com)Pharmaceutical Cost Transparency Act - AB 463 (leginfo.ca.gov)
In the latest effort to push back against drug costs, the California legislature will hold a hearing on Wednesday to review a bill that would require companies to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would have to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move...The legislation, which would also require insurers to provide regulators with spending data on prescription medicines...The...bill "will bring prescription drugs in line with the rest of the health care sector by shedding light, for the first time, on those drugs that are having the greatest impact on our health care dollar," said state Senator Ed Hernandez...The Pharmaceutical Research and Manufacturers of America...in its own letter opposing the bill, argued that the reporting requirements are "extraordinarily broad" and would potentially apply to many drugs for which the impact of a price hike on insurance premiums would be "essentially" minimal and "would reflect an imperceptible change in the total cost of care."...BioCom maintained that the bill fails to require payers and pharmacy benefits to similarly disclose their reasons for increasing copayments, deductibles, and out-of-pocket expenses for consumers...
- CMS reportedly proposes 2-year ban of Theranos founder Holmes, revocation of lab’s license (biopharmadive.com)Walgreens Is Reportedly Taking Steps to Dump Theranos (fortune.com)
Centers for Medicare and Medicare Services is reportedly proposing to ban Theranos founder Elizabeth Holmes from owning or operating a laboratory for two years, along with revoking the license of Theranos' Newark, CA lab...Theranos had ten calendar days from receiving the notice to explain to CMS why the sanctions should not be imposed on Holmes and the company...The proposed sanctions stem from a number of key deficiencies CMS found in inspections last fall. Theranos had sent in a correction plan for the deficiencies but the regulator found it to be not credible.
- CMS Diabetes Prevention Program Reduces Medicare Spending, Improves Care (specialtypharmacytimes.com)
...Office of the Actuary in the Centers for Medicare & Medicaid Services certified that the Diabetes Prevention Program reduces net Medicare spending and improves patient care...the Diabetes Prevention Program...enrolled Medicare beneficiaries at high risk of diabetes. The goal was to decrease the risk of developing serious diabetes-related illnesses...Over a 15-month period, Medicare estimated that participants in the program each saved $2,650...This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers and private insurers can use to help 86 million Americans live healthier...We are now working to determine the best strategies for incorporating the Diabetes Prevention Program into Medicare...
- Former Parker Doctor, Office Manager, and Two Pharmacists Indicted for Conspiracy and Illegal Distribution of Prescription Medication Resulting in Patient Deaths (dea.gov)
Dr. John Alan Littleford, and three others were indicted by a federal grand jury in Denver last week on charges related to the illegal distribution of prescription medication and money laundering...Littleford...Dianna L Smithling...Stanley G. Callas and Scott Alan Eskanos were arrested this morning...defendants are alleged to have dispensed and distributed controlled substances to individuals in quantities and dosages that would enable the individuals to abuse, misuse, and develop or maintain dependencies or addictions to controlled substances. Littleford routinely wrote new prescriptions for opioids when the individuals for whom he was writing the prescriptions should have still had opioids left from a prior prescription...Callas and Eskanos knowingly filled these "early refill" prescriptions written by Littleford. The indictment specifically alleges unlawful distribution of controlled substances to seven individuals who presented as patients at the Pain & Injury Clinic and filled their prescriptions at Crown Point Pharmacy, Sky Ridge Pharmacy...The indictment alleges that Littleford’s unlawful distribution of Oxycodone to two of the individuals resulted in their respective deaths. Finally, the indictment alleges the defendants committed money laundering with the intent to promote the carrying on of their unlawful distribution of controlled substances.









