- White House: Trump’s drug pricing plan will make the rest of the world pay its fair share (cnbc.com)
First, the president's plan would cut domestic drug prices by dismantling the burdensome government approval and reimbursement policies that inhibit healthy competition. Second, the plan would combat foreign government policies that devalue intellectual property rights and create unfair pricing systems that force drug manufacturers to sell to foreign buyers at unreasonably low prices...President Trump's plan would stop overpricing of drugs at home and underpricing abroad...Government policies that restrict competition...the lengthy drug approval process erects large entry barriers for both brand-name drugs and their cheaper generic counterparts. FDA's work to facilitate timely generic entry is estimated to have saved Americans billions of dollars...doctors are given precisely the wrong incentive when prescribing: the system reimburses them at higher rates when they prescribe more expensive drugs, ultimately funded by our tax dollars...There is no free lunch. If neither Americans nor foreigners pay for the R&D to develop new drugs, then soon nobody will receive new treatments...
- Fentanyl Billionaire John Kapoor To Plead Not Guilty In Opioid Kickback Case (forbes.com)
Fentanyl billionaire John Kapoor is set to plead not guilty this morning on charges of racketeering, mail fraud, wire fraud and conspiracy to violate the anti-kickback law...The founder and former CEO and chairman of ...Insys Therapeutics, Kapoor became a billionaire in 2013 because of the skyrocketing sales of that company’s Subsys, a form of the powerful opioid fentanyl that is sprayed under the tongue. He was arrested and charged on October 26 for allegedly leading a conspiracy to use fraud and bribes to market the drug and is set to appear in federal court in Boston...for his arraignment...Prosecutors...allege that Kapoor and six other executives...were arrested and charged...as part of a superseding indictment, offered bribes and kickbacks to doctors and nurses to get them to write large numbers of Subsys subscriptions to patients, most of whom did not have cancer.
- Drugmakers and distributors face barrage of lawsuits over opioid epidemic (washingtonpost.com)
The companies that manufacture and distribute highly addictive painkillers are facing a barrage of lawsuits for the toll their product has taken on communities across the country as the worst drug epidemic in U.S. history continues to escalate...Within the past year, at least 25 states, cities and counties have filed civil cases against manufacturers, distributors and large drugstore chains that make up the $13 billion-a-year opioid industry. In the past few weeks alone, the attorneys general for Ohio and Missouri, along with the district attorneys for three counties in Tennessee, filed suits against the industry — and the attorney general for Oklahoma filed suit on Friday...The strategy echoes the effort against major tobacco companies in the 1990s and is born of similar frustration over rising death rates and the increasing costs of addressing the continuing public health crisis. After years of government and pharmaceutical firms failing to control the problem, some lawyers say the suits have the potential to force the industry to curb practices that contribute to it...Representatives of the companies deny wrongdoing and vow to vigorously defend themselves. They said they have taken steps to prevent the diversion of their drugs to the black market. Stemming the epidemic, they said, will take a coordinated effort by doctors, the industry, and federal and local government agencies..."As we look to prevent abuse and misuse in the future, it will require a forward-looking, systemic approach that calls on greater coordination and collaboration between health-care, law enforcement, and state and federal regulatory authorities," said the Healthcare Distribution Alliance, which represents companies that distribute drugs...
- Suspected drug thefts persist at VA hospitals after ‘zero tolerance’ announced (abcnews.go.com)
Federal authorities are investigating dozens of new cases of possible opioid and other drug theft by employees at Veterans Affairs hospitals, a sign the problem isn't going away as more prescriptions disappear...Data...show 36 criminal investigations opened by the VA inspector general's office from Oct. 1 through May 19. It brings the total number of open criminal cases to 108 involving theft or unauthorized drug use. Most of those probes typically lead to criminal charges...Doctors, nurses or pharmacy staff in the VA's network of more than 160 medical centers and 1,000 clinics are suspected of siphoning away controlled substances for their own use or street sale — sometimes to the harm of patients — or drugs simply vanished without explanation...an IT specialist at the VA, says he's heard numerous employee complaints of faulty VA technical systems that track drug inventories, leading to errors and months of delays in identifying when drugs go missing. Prescription drug shipments aren't always fully inventoried when they arrive at a VA facility, he said, making it difficult to determine if a drug was missing upon arrival or stolen later...
- New Nevada law aims to tackle opioid epidemic (reviewjournal.com)
Doctors have additional protocols to consider when writing and maintaining opioid prescriptions under a new law that took effect on New Year’s Day...The Prescription Drug Abuse Prevention Act, passed by the 2017 Legislature, outlines safeguards for doctors before they prescribe controlled substances to treat pain and increases requirements necessary to continue a prescription after one month, three months and a year...The additional paperwork is meant to curb the state’s opioid overdose problem and track down doctors who overprescribe...“It just provides a platform by which the provider can really have an in-depth discussion with the patient as to whether the use of a controlled substance is truly necessary, or whether there are alternatives, ” said Daniel Burkhead, a pain management specialist in Las Vegas...The guidelines require every doctor to perform a patient risk assessment before prescribing a controlled substance to treat pain...Nevada is among 17 states that have enacted legislation limiting the number of days of an initial opioid prescription or capping prescription strength...
- Discrepancy between trial goals, results may mask treatment risks (reuters.com)Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications (jamanetwork.com)
Scientists often fail to publicly register plans for clinical trials or to publish the results, and the outcomes they do share may mask instances when new treatments are unsafe or ineffective, a small study suggests...One goal of asking scientists to register clinical trial plans in public research databases is to highlight the main objective of experiments and make it easy to see whether a tested treatment achieved this goal when results are published, the study authors note in JAMA...But more than one-third of the 113 clinical trials researchers examined for the study were never registered. Only 64 of the trials, or 57 percent, were published...One in five trials didn’t define a primary outcome, or clear protocols for determining if the tested treatment had achieved its main goal...Doctors rely on published evidence to guide patient care decisions, while researchers use the published literature to guide which promising areas of inquiry to pursue...Unpublished trials tend to be the ones that found treatments didn’t work or weren’t safe...Published results, meanwhile, tend to highlight successful experiments...
- Praxsyn Corporation Acquires Nevada Pharmacy (finance.yahoo.com)
Praxsyn Corporation is pleased to announce that it has purchased through a newly formed subsidiary, Nevada Health Rx, Inc., the pharmacy license and all of the assets of Meds Direct Rx, a pharmacy located in Las Vegas, Nevada. The new pharmacy is about 8,000+ square feet of pharmacy and warehouse space, and includes a large loading dock and a secured yard to hold delivery vehicles...The total purchase price for the acquisition of the pharmacy was $120,000...This acquisition will allow us to sell a broader mix of products from a much larger facility than we have had in the past. Our focus is on filling prescriptions that have a 30 day pay cycle...Our focus...is on customer service to our patients, their doctors, the surgery centers and hospitals that will serve our patients...Headquartered in Las Vegas, Nevada, Praxsyn Corporation is a holding company that finds solutions to fit the needs and goals of medical professionals and their patients...
- CRISIS MEDICINE: Health professionals review what worked and what didn’t (businesspress.vegas)Homeland security officials praise Las Vegas shooting response (reviewjournal.com)
Southern Nevada and the world watched as Las Vegas hospitals and doctors operated and cared for the wounded on Oct. 1 and subsequent days, and they’re getting high marks for their performance for handling the worst mass shooting in modern U.S. history...While 58 were killed — nearly all succumbed to their wounds at the scene of a country music concert on the Strip — more than 500 people were injured, and most passed through nine of Las Vegas’ 14 hospitals. More than 200 went to Sunrise Hospital and Medical Center, and more than 100 went to University Medical Center — the city’s two main trauma centers for handling emergency cases...The hospitals and the medical community are evaluating their performance for a wider report about lessons learned. That information will be disseminated across the country as doctors, nurses and administrators appear at panels in the coming months to share with professionals in their fields...Once hospitals complete their internal review, they will be shared with one another how they responded and what the challenges were...They will look at what they did well and how they would do something differently in the future...Las Vegas will share with the rest of the world the “best practices” it learned from the mass shooting, just like it did after the MGM Grand fire...
- Doctors, nurses among hundreds charged with defrauding U.S. health programs (reuters.com)Sessions to Unveil Health-Care Fraud Crackdown This Week, Sources Say (bloomberg.com)
A total of 412 people, including almost 115 doctors, nurses and other medical professionals, have been charged in the sweeping enforcement action, the biggest ever by the multi-agency Medicare Strike Force, the Justice Department said...More than 120 people were accused of illegally prescribing and distributing opioids and other dangerous narcotics...Amazingly, some have made their practices into multi-million-dollar criminal enterprises...Those charged participated in schemes that billed Medicaid, Medicare and TRICARE...for unneeded drugs and treatments that were often never provided...In many cases, healthcare providers paid cash kickbacks to patients and others in exchange for medical data that would allow them to file fraudulent bills to Medicare...In addition to the hundreds charged, the Department of Health and Human Services has launched suspension procedures against almost 300 medical service providers, including doctors, nurses and pharmacists...
- Shortages of Simple Drugs Thwart Treatments (wsj.com)ASHP - Drug Shortages List (ashp.org)
The scarcity of a simple medicine is complicating treatment for patients...Chronic drug shortages have burdened U.S. medical care for several years. Studies have estimated drug shortages add more than $400 million in annual U.S. health-care costs because hospitals and doctors are forced to seek more expensive alternatives, and health-care workers must spend extra time managing shortages...The shortages of low-cost medicines have been caused by a decline in the number of suppliers for certain products and failures by companies to build enough production capacity or meet manufacturing-quality standards...also...thinner profit margins for many older drugs reduce incentives for companies to invest in them...As a result of the shortage, doctors and hospitals are resorting to riskier and sometimes costlier treatments...FDA...said the agency works closely with manufacturers of drugs in short supply to help restore stocks, and asks other companies to increase production if they manufacture the same drug. The FDA says such efforts has helped cut the number of new shortages but can’t prevent all of them...