Articles Posted in Medications

pacemaker-300x186Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.

But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.

The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.

cdccancer-271x300Those carrying around a few pounds extra, or maybe even a lot more, may want to get moving and to drop that excess weight for yet more compelling health causes: That’s because more than 630,000 Americans were diagnosed in 2014 with cancers linked to obesity or overweight, the federal Centers for Disease Control and Prevention has reported.

The CDC says 40 percent of all diagnosed cancers were associated with obesity. At a time when the nation is seeing some success in reducing overall rates of diagnosed cancers, a baker’s dozen of overweight-related cancers increased 7 percent between 2005 and 2014. Two out of three of the cancers occurred in those 50- to 74-years-old.

Federal officials have found that more than half of Americans don’t know there’s a connection between 13 kinds of cancers (see diagram) and excess weight. It took public health officials decades to persuade the public that smoking posed cancer health risks and people needed to stop—and Big Tobacco still resorts to unceasing, deceptive tactics to undermine this awareness.

pills-drugs-300x215The epidemic of opioid drug abuse, which increasingly is claiming children’s lives, has plenty of blameworthy causes. Here’s a new one: health insurers which steer patients to cheaper, more addictive painkillers while playing Scrooge for less addictive but pricier alternatives.

Pro Publica, a Pulitzer Prize-winning investigative journalism site, and the New York Times get credit for their expose of  penny-wise and pound-foolish prescription management practices.

By analyzing “Medicare prescription drug plans covering 35.7 million people in the second quarter of this year,” the news organizations say they saw repeated patterns in which insurers and the spin-off businesses that run their drug payment plans (so-called pharmacy benefit mangers or PBMs) easily and quickly approve opioids for patients in pain, medications that cost relatively little. They throw up all kinds of obstacles, however, to doctors and patients who try to use less potent but more expensive drugs, including patches containing Butrans (a lesser opioid) or lidocaine. They also drag their feet on approving payments for addiction-fighting medications like Suboxone.

ravensLet’s give a hurrah for Maryland health officials — they threw a red flag at a high-tech startup that planned with the Baltimore Ravens football team to serve up a mass genetic screening test at a recent game. The blunt reality is this would have been genetic malarkey.

This incident should serve as a reminder, caveat emptor, to consumers, even in settings of good cheer. It should offer a caution to those who stage big public events, like sports leagues, that health matters and highly personal and confidential medical information isn’t handled well at spectacles.

Shall we also offer a Bronx cheer for Orig3N, a Boston company that offers direct-to-consumer “genetic testing,” and talks on its web site about everything from organ donation to regenerative and personalized medicine as well as its commitment to public service? The company, a new Ravens sponsor, planned a recent promotional Sunday when it would offer its mouth swab tests to 55,000 fans flocking to the contest against the Cleveland Browns.

paxil-300x300Psychiatric medications, which doctors have prescribed freely and patients have taken dutifully, not only may have demonstrated risks for the young but also under-considered problems for adults older than 40 — 1 in 7 of whom has filled a script, for example, for an antidepressant.

The New York Times has done a service by bringing to the fore some lesser known issues of psych meds by reporting on a successful lawsuit involving a 57-year-old Chicago lawyer. He apparently suffered from severe physical and mental agitation after he started taking paroxetine, the generic form of the brand-name drug Paxil. His anxiety became so acute, a jury found, the lawyer threw himself fatally in front of an oncoming train.

Antidepressants, including Paxil, long have been controversial for the young, especially after reports cropped up describing serious issues with their use. All such meds have carried a “black box” warning label, reviewed and approved by the federal Food and Drug Administration, warning that they increase the risk of suicidal thinking and behavior in children, teens, and those younger than 25.

kaiser-drugs-300x225Big Pharma and medical device makers have mastered the art of crying “Poor me!” complaining without end about the time and costs of getting products to the market and the need for regulators to lighten up. New information, however, undercuts this industry whine—and it reminds that the nation’s watchdogs need, if anything, to be tougher and more vigilant.

Let’s start with new research, published in JAMA Internal Medicine, that calls into question Big Pharma’s long-espoused position that its whopping prices (which the public wants official action on—see graphic) are warranted because a new drug costs upward of $3 billion to research and develop. But based on a scrutiny of public information about expenses to develop 10 new cancer drugs—among the most costly to get to market—researchers found drug makers’ R&D costs were far less — closer to $650 million.

Although independent experts praised the new study, drug makers challenged the cheaper R&D estimates, with backing from Tufts researchers’ who had set the earlier, pricier benchmark. It’s difficult to make apples and oranges comparisons. That’s because Big Pharma wants any tally of its drug development expenses to include its costly failures.

Heroin-Fentanyl-vials-NHSPFL-1600x900-300x169A Missouri  Senator has accused Insys Therapeutics, a major drug maker, of conducting a sneaky campaign to get more pain-wracked cancer patients to use its synthetic and super powerful opioid drug, thus helping to fuel the wildfire spread of increasingly lethal and debilitating prescription pain killers.

Sen. Claire McCaskill and investigators from a Senate committee, as well as federal prosecutors, have painted a harsh picture of how Insys created a special unit to boost sales and use of Subsys, its spray form of the potent painkiller fentanyl.

Through an elaborate ruse—which included carefully crafted scripts and bogus phone numbers—Insys workers contacted prescription benefit management (PBM) firms, making them believe they were patients seeking a required pre-approval for their doctors to prescribe them Subsys.

CAR-T-image-300x274Drug makers have just shown not only their verve in pursuing new ways to treat cancer and heart disease but also their nerve in pricing these novel therapies as if sick patients had the wealth of mega lottery winners. Just look at what Novartis is doing with the medications Kymirah and canakinumab, a drug now marketed under the brand name Ilaris.

One the one hand, it’s hard not to admire the medical science behind both, notably first Kymirah. The drug has been newly approved by the federal Food and Drug Administration to treat children and young adults for B-cell acute lymphoblastic leukemia, a “devastating and deadly” form of the blood cancer that has resisted standard treatment and often resulted in disheartening relapses.

But Kymirah, regulators agreed, offers a treatment “milestone” because it “genetically alters a patient’s own cells to fight cancer,” converting them into a “living drug,” and training them “to recognize and attack the disease.” This Chimeric Antigen Receptor (CAR) T-Cell Therapy (see illustration) “is part of the rapidly growing field of immunotherapy that bolsters the immune system through drugs and other therapies and has, in some cases, led to long remissions and possibly even cures,” as the New York Times has reported.

jjbabypowder-150x150What exactly causes cancer? That may be, recent news reports indicate:

syphillis-150x150The myriad problems tied to the nation’s opioid drug abuse epidemic seem only to worsen and grow more complex by the day. They are, recent news reports say:

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