Articles Posted in Product Safety

covervf-300x210As the nation’s opioid and drug overdose crisis deepens, it can be hard to watch as the “Not My Fault” crowd clucks about its blamelessness in pushing potent painkillers that have played a part in killing more Americans in 2016 and 2017 alone than lost their lives in the Vietnam War.

The latest NMF protagonists include:

insys-300x141Insys Therapeutics, a drug maker that peddled powerful and addictive painkillers in sordid ways, entered yet another phase of its penalties for its criminal conduct: The firm in quick fashion agreed first to pay $225 million to resolve federal bribery charges, then promptly sought bankruptcy protection.

Federal prosecutors, who earlier had won criminal racketeering convictions against the firm’s CEO and other Insys executives, emphasized that the Big Pharma firm hasn’t declared itself insolvent in its bankruptcy action and will pay up for damages caused by Susbsys, its chief product.

Subsys is a liquid containing the super potent painkiller fentanyl. It is administered as a drop under the tongue and was supposed to benefit cancer patients with grueling pain. Instead, Insys CEO John Kapoor “used speaker’s fees and lap dances to lure doctors into prescribing Subsys for far more patients than the drug was approved for and cheated insurers into covering prescriptions for the costly medication,” the Washington Post reported. Kapoor and other Insys execs await sentencing after their federal felony convictions.

carsandkids-300x114As the weather turns toasty, it’s worth remembering that common sense and a bit of caution can save the lives of children and pets: Please don’t forget they are in your vehicle’s back seats, and don’t lock them in there with the windows rolled up — even for the briefest moment.

The New York Times reported this, in a timely news article:

As the summer months heat up across America, advocates are hoping to draw attention to the issue [of children dying in locked vehicles] as well as their push for legislation to help address the problem. Dozens of children die of heatstroke each year in cars whose temperatures, even on relatively mild days, can quickly soar past 100 degrees. Many of those children were left behind by a distracted caregiver.

dangersign-192x300As the nation slips into summer and the statistical 100 deadliest days for kids, there are some timely reminders about keeping youngsters safer around swimming pools and the chemicals used with them and protecting them from the harms of riding mowers when the devices are run in reverse.

The Red Cross, of course, reminds that “10 people die each day from unintentional drowning, and on average two of them are younger than 14. Drowning is responsible for more deaths among children ages one to four than any other cause except birth defects. And among those 1-14, drowning is the second-leading cause of unintentional injury-related death behind motor vehicle crashes. For every child who dies from drowning, another five receive emergency care for nonfatal submersion injuries.”

The safety group, which urges parents to supervise kids closely near water and get them swimming lessons and instruction in ways to prevent water-borne mishaps, underscores that little kids drown most often at home — in pools, hot tubs, and spas, but also buckets, bath seats, wells, cisterns, septic tanks, decorative ponds, and toilets. Youngsters 5 and older drown more often in ponds, lakes, and the ocean.

cbdThe federal Food and Drug Administration has waded into its potential oversight of a substance that already is becoming wildly popular. The process of figuring government rules for cannabidiol, aka CBD, well could be called Confusion By Design.

The New York Times and Washington Post both reported on the parade of dozens of parties, pared from hundreds of aspirants, wanting to influence the FDA’s path with the agency’s first hearing on CBD. It already is sold in thousands of products on the market now. These include pet foods, soft drinks, bath salts, and oils and solutions that users add to food and rub on themselves.

Of great concern to the FDA are the extreme and proliferating claims that vendors are making for unproven health-related benefits of use of CBD, which is a nonintoxicating extract that can be derived from hemp and marijuana. As the popular health information WebMD site reported:

FDA-logo-300x129Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the greatest risk. With certain heart pumps and defibrillator units, both implanted in patients, the Federal Food and Drug Administration deserves criticism for putting the interests of device makers ahead of patients, excellent stories by the Kaiser Health News Service and Axios show.

KHN reporter Christina Jewett followed up her investigation into how FDA bureaucrats let device makers  file 1.1 million reports of injuries or malfunctions with their products to a little-known internal agency database, discovering how this practice contributed to what one cardiologist described as “the worst cardiac device problem” he has seen in a quarter-century of practice.

The incidents involved the Sprint Fidelis, a small device surgically installed in hundreds of thousands of patients to monitor and supposedly to administer small shocks to deal with their irregular heartbeat. Instead, the device — especially due to problems with its corroding and cracking electrical leads — gave patients random jolts, failed to perform in genuine emergencies, and led to a torrent of complaints and deaths. Doctors, medical researchers, and patients forced into wide public view the substantial defects of the defibrillator, including in congressional hearings.

lyrica-300x248Patients’ struggles with medical pain are a major problem. So, too, is the proclivity of Big Pharma, doctors, hospitals, insurers, and many others to respond to pain not only by pushing more prescription pills but also by overstating their benefits and downplaying their costs and potential harms.

As the nation grapples with an opioid painkiller crisis, New York Times columnist Jane E. Brody deserves credit for drilling down on gabapentin, “taken by millions of patients despite little or no evidence that it can relieve their pain.”

The drug won approval from the federal Food and Drug Administration a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” Brody wrote.

pills-300x200With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes, however, may be dying out by the day.

The attorneys general of dozens of states have sued major generic makers including Teva, Pfizer, Novartis and Mylan, accusing them of conspiring to inflate generic drug prices by as much as 1,000%, the New York Times and other media organizations reported.

The makers’ price-fixing affected more than 100 generics, including “lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants,” the New York Times said.

baronmunchhausen-223x300For all the benefits that the cyber world has bestowed on billions of users, it also has brought out trolls and bullies aplenty. It also potentially has created a new category of sick people. They use online forums to fake illnesses and gain sympathy and even money. There’s even a new term for it:  Munchausen by internet.

To be sure, this is not yet a formal and widely accepted medical or psychiatric diagnosis but a description of a phenomenon that appears to be rising and has gotten media attention when exposed through the experiences of patients with serious and chronic illnesses who band together in online chat groups, writer Roisin Lanigan reported in the Atlantic magazine.

Lanigan says that patients with cancer, for example, find the cyber forums invaluable. They not only allow those with the disease to discuss their fears, emotions, and experiences, they can allow individuals to share tips and ideas on how to cope with situations that patients have never encountered and may be overwhelmed by.

jj-300x112If consumers ever considered Johnson and Johnson just to be a family friendly health brand, the conglomerate’s legal challenges on three fronts—with problematic medical devices and drugs—may disabuse them of warm and fuzzy views.

As Bloomberg News Service reported, J&J will pay $1 billion to try to extricate itself from 95% of 6,000 lawsuits against it over defective metal-on-metal hip implants that not only caused patients great pain but also had to be surgically removed and replaced. The company still must resolve thousands of suits with patients who haven’t had replacement operations or whose implants were only partially metal.

J&J has battled over its Pinnacle implant from its DePuy unit for at least four years, losing sizable cases in Texas to patients who convinced judges and juries that the medical device maker had misled them about their artificial hips’ durability and risks, including assertions that it caused metal poisoning.

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