The Survive and Thrive Boomer Guide

States sue 20 generic drug companies and 15 executives for allegedly conspiring to fix prices for more than 100 drugs

A 44-state coalition of attorneys general is suing Teva Pharmaceuticals and 19 of the nation's largest generic drug manufacturers alleging a conspiracy to increase prices and reduce competition for more than 100 generic drugs.

The lawsuit, filed in federal court, also names 15 individual senior executive defendants, leaders of the conspiracy, who were responsible for sales, marketing, pricing, and operations. The drugs make up billions of dollars of sales in the United States, and the alleged schemes increased prices affecting the health insurance market, taxpayer-funded healthcare programs such as Medicare and Medicaid, and individuals who had to pay artificially-inflated prices for their prescriptions drugs.

All types of drugs were included – tablets, capsules, suspensions, creams, gels, and ointments – as well as many classes of drugs – statins, ace inhibitors, beta blockers, antibiotics, anti-depressants, contraceptives, and non-steroidal anti-inflammatory drugs. The drugs treat a range of diseases and conditions from basic infections to diabetes, cancer, epilepsy, multiple sclerosis, HIV, ADHD, and more. In some cases, the coordinated price increases were more than 1,000 percent.

Founder and executives of opioid company convicted of bribing doctors and lying to insurance companies to increase sales

The founder and four former executives of Insys Therapeutics Inc. were convicted Thursday by a federal jury in Boston of bribing medical practitioners to prescribe Subsys, a highly-addictive, fentanyl spray intended for cancer patients, and for defrauding Medicare and private insurance companies.

John Kapoor, Insys founder and former chairman, and other executives of the Arizona-based company could face prison sentences for the felony convictions that run as long as 20 years.

From May 2012 to December 2015, the defendants bribed practitioners, many of whom operated pain clinics, to get them to prescribe Insys’ Subsys to patients often when it wasn’t medically necessary. Subsys is a powerful, under the tongue, rapid-onset opioid used to treat cancer patients suffering intense breakthrough pain.

Drugs that cause uncontrollable behaviors like binging and gambling need stronger labeling, citizens group says

Public Citizen sued the U.S. Food and Drug Administration in federal court Monday over its failure to act on a nearly three-year-old petition seeking a boxed warning in the product labeling for widely used dopamine agonist medications, which can cause compulsive or uncontrollable behaviors.

The 2016 petition called for black box warnings on six dopamine agonist medications – apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rotigotine – that are used to treat Parkinson’s disease, restless leg syndrome, and several other conditions. It also called for the FDA to require that letters be sent to doctors and patients to warn them about the potential risks.

Patients taking a dopamine agonist drug may have up to a 20 times greater risk of impulse-control problems and compulsive behaviors, including pathological gambling and insatiable shopping or eating, than patients not using these medications. In severe cases, these behaviors can have devastating, life-altering effects. Divorces, financial ruin, criminal charges, and suicide attempts have been reported in patients using these medications, according to the petition.

FDA should ban widely used, deadly gout medication, consumer group says

The U.S. Food and Drug Administration should immediately ban the widely used gout medication febuxostat because it poses unique, serious risks – including the risk of dying from cardiovascular disease – and provides no unique benefit, Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Friday. Public Citizen petitioned the FDA to ban the medication in June 2018.

The FDA convened advisory committees in response to a request from Takeda Pharmaceuticals America, maker of the brand name febuxostat product Uloric, for approval to update the medication’s labeling to include results of a recently completed clinical trial. The trial, which involved more than 6,000 gout patients, showed that patients taking febuxostat were significantly more likely to die from cardiovascular causes compared with those receiving the much older gout medication allopurinol.

Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious cardiovascular outcomes, including heart attack, stroke, and death. The FDA rejected the medication twice due to these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market clinical trial to further evaluate the cardiovascular risks.

Two more blood pressure medications recalled due to possible cancer risks

Teva Pharmaceuticals is recalling all lots of combination tablets featuring the drugs amlodipine and valsartan and another combination drug featuring amlodipine, valsartan, and hydrochlorothiazide due to an impurity detected.

The impurity is N-nitroso-diethylamine or NDEA, which has been classified as a probable human carcinogen, according to the U.S. Food and Drug Administration.

The combination tablets are used for treating high blood pressure. Teva hasn’t received any reports of adverse events signaling a potential link or exposure to valsartan, according to a statement from Teva posted by the FDA.

Blood pressure medication recalled due to impurities that could cause cancer

ScieGen Pharmaceuticals Inc. is recalling some lots of Irbesartan tablets because they may be contaminated with an impurity.

The impurity, N-nitrosodiethylamine, is classified as a probable human carcinogen by the International Agency for Research on Cancer.

The Irbesartan tablets recalled include 75 mg., 150 mg., and 300 mg. dosages and were manufactured by Aurobindo Pharma Limited.

Baby boomers focus on autumn opportunities

The weather here is changing, with temperatures dropping and brightly colored leaves beginning to pile up sidewalks so you can swish through them when you walk. 

There's a fall nip in the air, foreshadowing Halloween and the Day of the Dead – just around the corner.

Our boomer bloggers are writing about fall activities – how to cut a white pumpkin in memory of your loved ones, how to decorate for Halloween, and how a candidate meeting for the U.S. House of Representatives turned out.

Other topics include lottery fever, the routine use of antibiotics in livestock, and one way to slow atrial fibrillation.

Meryl Baer of Six Decades and Counting writes about these articles on the Best of Boomer Blogs #569. Click here to get the links to the articles. And be sure to leave a comment. Boomer bloggers love to hear from readers.

Copyright 2018, Rita R. Robison, Consumer Specialist

FDA considering approval of a super-potent opioid medication that will be abused and kill people, consumer group says

A U.S. Food and Drug Administration advisory committee has recommended approval of AcelRx Pharmaceuticals’ application for use of sufentanil sublingual tablets to treat moderate-to-severe acute pain in a medically supervised setting. It’s five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The committee voted 10-3 last week for the medication to be approved.

However, Raeford Brown, M.D., chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee that made the recommendation, joined three Public Citizen staff in urging the agency to reject the application. Public Citizen is a consumer advocacy organization.

“I predict that we will encounter diversion, abuse and death within the early months of its availability on the market,” Brown said, adding strong opioids often are abused by medical personnel. “Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”

Burger chains make little progress in serving beef raised without antibiotics

Two burger chains, Shake Shack and BurgerFi, are serving beef raised without the routine use of antibiotics. They were the only restaurants to earn an “A” in the fourth annual Chain Reaction scorecard developed by six consumer and environmental groups. The vast majority of hamburger chains – 22 of the top 25, including top sellers such as McDonald’s – received an “F” grade because they lack established policies restricting antibiotic use in their beef supply chains.

“We should all be worried that so many restaurants are failing when it comes to antibiotic stewardship,” said Elise Orlick, director of the WashPIRG Foundation. “We need more burger chains to follow the lead of BurgerFi and Shake Shake and commit to protecting our life-saving medicines. Antibiotics are too important to lose and these companies can use their purchasing power to protect our health.”

The scorecard shows the lack of progress in the beef industry, the largest buyer of medically-important antibiotics among food animal sectors, in addressing antibiotic overuse. Public health experts warn that the widespread overuse of antibiotics for meat production is making these medications less effective by contributing to the creation and spread of drug-resistant bacteria called superbugs.

Corporation to pay $625 million for distributing contaminated drugs, including cancer drugs

Forty-four states and the federal government have reached an agreement with drug distributor AmerisourceBergen Corp. for illegal distribution of adulterated and misbranded drugs. ABC will pay the states and the federal government $625 million, of which $99.9 million will go to the states’ Medicaid programs.

“ABC placed corporate profits over patients’ needs, endangering the health of vulnerable cancer patients,” said U.S. Attorney Donoghue.

The settlement came after ABC’s AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs in September 2017. ABSG agreed to pay $260 million in fines and payments.