- Doctor tells U.S. court drug not suitable for Arkansas executions (reuters.com)
A surgeon told a federal court in Arkansas...that a sedative the state plans to use in its lethal injection mix is not suitable for surgery and should be prohibited when Arkansas holds an unprecedented series of executions later this month...Arkansas plans to kill eight prisoners in dual executions...Death penalty opponents have said the rushed schedule is reckless and increases the chance of errors...The convicted murderers scheduled to die have asked U.S. District Judge Kristine Baker in Little Rock to halt their executions, saying the state's rush to the death chamber was unconstitutional...Lawyers for Arkansas, have told the court that the drug in question, midazolam, has been used in executions in other states and its lethal injection protocols pass constitutional muster...Arkansas Governor Asa Hutchinson...set the schedule, saying the state's midazolam supply expires at the end of April and it was in the interest of justice to hold as many executions as possible while Arkansas has the difficult-to-obtain drug.
- Greece’s corruption prosecutor quits, citing pressure over Novartis bribery probe (fiercepharma.com)
Novartis is embroiled in a soap opera in Greece, complete with bribery allegations and a suicide threat. Now the plot is thickening. The country’s chief corruption prosecutor, Eleni Raikou, has resigned—and she’s blaming the Swiss pharma giant’s legal issues for her decision...Raikou...sending a letter to Greece’s Supreme Court claiming she was targeted by "unofficial power centres" over her investigation of Novartis...Greek authorities raided Novartis’ offices...after one of the company’s local managers reportedly made a suicide threat...The executive was one of the employees the authorities were interviewing...The probe began after media reports appeared alleging that Novartis had paid bribes to local "functionaries,"…Raikou’s resignation letter said that the bribery probe turned up "substantial and crucial evidence" that doctors and some politicians in Greece had received €28 million ($30.4 million) worth of bribes from a Novartis bank account...some of the evidence was linked to the prosecution of a local businessman and former minister of defense Yiannos Papantoniou...
- FDA scolds Indian API maker for not ensuring river water it uses is safe (fiercepharma.com)
The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river is sanitary before using it to make its products...In a warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 without scientific evidence that the system is capable of producing water that meets quality standards...plant employees knew the water for months was out of spec for total aerobic microbial counts when it was used in production, but they didn’t investigate or even seem to understand the process that the plant’s water system relies on to kill microorganisms...water was only one of the problems FDA investigators found...Records were found in trash bags behind a building that showed test results that were different from what had been officially recorded...
- AP Exclusive: Drugs vanish at some VA hospitals (bigstory.ap.org)
Federal authorities are stepping up investigations at Department of Veterans Affairs medical centers due to a sharp increase in opioid theft, missing prescriptions or unauthorized drug use by VA employees since 2009…Doctors, nurses or pharmacy staff at federal hospitals — the vast majority within the VA system — siphoned away controlled substances for their own use or street sales, or drugs intended for patients simply disappeared...Aggravating the problem is that some VA hospitals have been lax in tracking drug supplies...Reported incidents of drug losses or theft at federal hospitals jumped from 272 in 2009 to 2,926 in 2015, before dipping to 2,457 last year, according to DEA data...The GAO review...found the most missed inspections at VA's hospital in Washington, D.C...Monthly checks were missed there more than 40 percent of the time, mostly in critical patient care areas, such as the operating room and intensive care units…Responding to the findings, the House Veterans Affairs Committee planned a hearing on the inspection issue. Its chairman, Rep. Phil Roe, a physician, said failing to follow protocol is serious and "should not be tolerated within VA."
- Ex-New York assemblyman, doctors charged in illegal opioid prescription scheme: officials (reuters.com)
A former New York assemblyman and a dozen pain clinic workers were arrested on Friday, accused of operating some of the largest "pill mills" in the northeastern United States and illegally prescribing more than 6 million opioid pills...Alec Brook-Krasny, who served in the New York State Assembly from 2006 to 2015 representing South Brooklyn, was charged with conspiracy and scheming to defraud by unlawfully selling prescriptions…Also arrested in the sweep of three pain clinics were at least one nurse practitioner, three physician's assistants, and two doctors including Dr. Lazar Feygin, who owned two of the clinics...They were accused of over-prescribing oxycodone...to clinic patients who showed signs of selling pills or abusing other narcotics...in exchange for oxycodone, the defendants also pressured patients to undergo unnecessary medical tests and procedures, then billed Medicare and Medicaid for millions of dollars...
- Physician And Medical Assistant Convicted Of Conspiracy To Distribute Large Quantities Of Oxycodone For Non-Medical Necessity (justice.gov)Las Vegas pharmacist testifies at his federal drug trial (reviewjournal.com)
Dr. Henri Wetselaar, MD, 93, and David A. Litwin, 58, were found guilty of conspiracy to distribute and distribution of oxycodone and other controlled substances, announced Acting U.S. Attorney Steven W. Myhre for the District of Nevada…Wetselaar was a Nevada physician practicing as a specialist in pain management. Litwin was...his medical assistant...(they) conspired with each other and local drug dealers to distribute the prescription drugs in and around Las Vegas. Wetselaar prescribed large amounts of...oxycodone, hydrocodone, Xanax and Soma, to persons for no legitimate medical purpose...Wetselaar and Litwin were found guilty of conspiracy to distribute controlled substances,...distribution of controlled substances,...money laundering and structuring of money transactions.
- NFL abuse of painkillers and other drugs described in court filings (washingtonpost.com)
National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...
- Disregarding federal laws
- Reliance on pharmaceuticals
- Lining up for the ‘T Train’
- The government’s struggle to hold opioid manufacturers accountable (washingtonpost.com)
Sixty-six percent of all oxycodone sold in Florida came from this company. But the DEA’s case against it faltered...Mallinckrodt’s blue 30-milligram oxycodone tablets became so popular among drug users and dealers that they acquired a street name — "M’s," for the company’s distinctive block-letter logo…the Drug Enforcement Administration trained its sights in 2011 on Mallinckrodt Pharmaceuticals, one of the nation’s largest manufacturers of the highly addictive generic painkiller oxycodone. ..It was the first time the DEA had targeted a manufacturer of opioids for alleged violations of laws designed to prevent diversion of legal narcotics to the black market. And it would become the largest prescription-drug case the agency has pursued…But six years later, after four investigations that spanned five states, the government has taken no legal action against Mallinckrodt. Instead, the company has reached a tentative settlement with federal prosecutors…Under the proposal…Mallinckrodt would agree to pay a $35 million fine and admit no wrongdoing.
- EU recommends suspending hundreds of drugs tested by Indian firm (reuters.com)
Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...
- Pfizer Subpoenaed in DOJ Investigation of Drugmaker Charity Connections (bloomberg.com)
Pfizer Inc. said that it received two subpoenas from the U.S. Attorney’s office in Massachusetts related to charities that help Medicare patients afford co-payments for drugs, the latest company to disclose involvement in the probe...The...subpoenas...requesting documents related to the Patient Access Network Foundation and other organizations that provide financial assistance to Medicare patients. Pfizer donated more than $10 million to the PAN Foundation in 2016...including for funds related to kidney cancer and...acromegaly...A long list of drugmakers have now received subpoenas about their relationships with patient assistance charities, some related to how they help people in the Medicare drug program for the elderly afford the co-payments for drugs...As drug prices have surged, pharmaceutical companies’ large contributions to charities have given them a public-relations foil against backlash and helped keep patients from seeking lower-priced medicines. The seven biggest co-pay charities, which cover scores of diseases, reported combined contributions of $1.1 billion in 2014...