Articles Posted in Medications

ucipic-300x245
Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential professional conflicts of interest, notably the significant sums they get from Big Pharma and medical device makers.

ProPublica, the Pulitzer Prize-winning investigative organization, and the Los Angeles Times jointly scrutinized the experts’ required disclosures, finding they not only fall short. They may fail to give the public a fair view of the credibility of their findings. And, in California, they may be a unique rip-off of the state’s top university system. The “UCs” provide research faculty with costly facilities and other support, as well as sharing its global renown — in exchange for revenue the experts may earn outside the system.

In total, after examining records on tens of thousands of university scholars and NIH experts, ProPublica not only has made public its “Dollars for Profs” database, it also quotes federal watchdogs as estimating that with the NIH alone, conflicts of interest with agency grants amounts to $1 billion.

lacasamhrc-300x200With mental health services stretched thin and failing to fill significant need, it may be more distressing still for the public to confront growing evidence of big problems in existing facilities that try to treat those with serious psychiatric ills.

The Los Angeles Times, based on its investigation, has found “nearly 100 preventable deaths over the last decade at California psychiatric facilities, including at La Casa Mental Health Rehabilition Center  (shown here). It marks the first public count of deaths at California’s mental health facilities and highlights breakdowns in care at these hospitals as well as the struggles of regulators to reduce the number of deaths.”

The newspaper said it “submitted more than 100 public record requests to nearly 50 county and state agencies to obtain death certificates, coroner’s reports and hospital inspection records with information about these deaths.” Reporter Soumya Karlamangla said she had to look far and wide for data on problems in psychiatric facilities because, “No single agency keeps tabs on the number of deaths at psychiatric facilities in California, or elsewhere in the nation.”

FDA-logo-300x129When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury.

The federal Food and Drug Administration has taken a double hit in recent news reports, with an investigation by Reuters news service raising big doubts about the agency’s oversight of products  with supposedly safe talc — but that long may have been tainted with disease-causing asbestos. The Kaiser Health News service, meantime, has followed up on the wave of lawsuits and research that has resulted from its discovery that the FDA for years allowed device makers to hide from public view a million complaints about medical devices.

The scathing findings in these two reports, combined with other deep digs into agency work, might well prompt members of Congress to conduct hearings into whether the FDA is acting as the watchdog that the public deserves or as a lap kitten beholden to the rich, powerful, and booming medical device industry.

cannabisleaf-281x300Fans of marijuana and its related products may want to take careful note of developments regarding their health and safety effects.

Federal researchers are racing to trace thousands of cases of lung damage and dozens of deaths to so-called smokeless consumption of tetrahydrocannabinol or THC, the ingredient that produces the marijuana high. Other federal officials also are warning about cannabidiol or CBD — a derivative of marijuana or its cousin hemp — and its burgeoning and unapproved use in an array of products on the market.

To be sure, because blue-nose attitudes blocked rigorous research on marijuana and other drugs, medical scientists have been scrupulous in declining to make sweeping declarations about grass and its potential benefits or harms.

clostridioides_difficile_369x285-300x232Federal officials have put out some scary new findings about the state of patients’ health in the 21st century: Superbugs may be more common and potent than previously believed. And we may now have plummeted into what experts are calling the perilous “post-antibiotic age.”

This all amounts to far more than a hypothetical menace. It could affect you if you get, for instance, a urinary tract infection. Or if you undergo a surgery, say, for a joint replacement or a C-section. Depending where and how you live, you may see the significance of this health problem if you contract tuberculosis or some sexually transmitted diseases.

As the news website Vox reported of the startling new information from the federal Centers for Disease Control and Prevention: “Every 15 minutes, one person in the U.S. dies because of an infection that antibiotics can no longer treat effectively.”

drugtruvada-300x200When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers:

Expensive brands may not be manufactured by name firms, and instead, may be cranked out in dirty and risky secondary facilities. And the research that leads to expensive products may have been ripped off from federal scientists funded by taxpayers who aren’t getting paid back.

Sydney Lupkin of the independent, nonpartisan Kaiser Health News service deserves credit for expanding public attention on growing concerns over the safety and quality in drug manufacturing beyond generics and on to costly, blue chip branded prescription medications. As she reported of the Federal Food and Drug Administration:

blindjustice-300x200The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special communication” published in a noted medical journal.

The online article in JAMA Internal Medicine argues for greater transparency and disclosures, with a table of examples that includes how:

  • With the Prempro hormone therapy drug for women, the “Manufacturer hired vendors to publish ghost written reviews and commentaries that promoted estrogen replacement for several off-label uses, including prevention of dementia, Parkinson disease, and visual impairment, and downplayed risks of hormone-associated breast cancer.”

biogenlogo-300x104With as many as 14 million Americans potentially suffering from various forms of dementia by 2040, including the common  Alzheimer’s disease, and with the costs of the care for them forecast to soar soon to more than $500 billion, a frenzied race is on for ways to deal with the debilitating cognitive syndromes. But will individual initiative or Big Pharma products matter most for seniors and their loved ones in the days ahead?

Industry analysts and patient advocates alike were stunned when drug maker Biogen reversed itself and announced that it would seek federal Food and Drug Administration approval for aducanumab, which the New York Times reported “is a monoclonal antibody, an expensive type of drug that attaches to specific proteins in order to disable them. The drug clears a key protein in Alzheimer’s disease — beta amyloid — that accumulates in plaques in patients’ brains. Aducanumab is given as an intravenous infusion once a month.”

Biogen had spent heavily on multiple tests of this drug, suddenly pulling the plug on it last spring, declaring with the counsel of an independent advisory board that the prospective prescription medication — and possibly the line of inquiry about beta amyloids and Alzheimer’s that had led to its creation — was a failure.

fallhospitalIt’s the 21st century, and excellent information is more available than ever due to communication and technology advances. But doctors and hospitals keep harming patients by testing and treating them in ways that are unsupported by rigorous medical evidence, and by carrying out safety recommendations in extreme ways.

Just consider:

drugbottles-300x200Tens of billions of dollars. Those sound like hefty sums. But will it ever be enough? Will, say, $50 billion offer justice and appropriate recompense to a nation wracked by an opioid and overdose crisis?

These figures aren’t pulled from thin air. They’re part of the reported settlement under negotiations to resolve more than 2,300 lawsuits, all bundled up now and under the sway of a federal judge in Ohio. He will launch a landmark opioids’ trial this week, starting with claims by two Ohio counties, unless Big Pharma firms remaining as defendants and the plaintiffs — including states, counties, cities, and Indian tribes — can strike a deal and settle.

The claimants, of course, themselves represent huge and diverse interests: their millions of individual constituents. And they disagree on how much money is fair, how it should be divided, and more. The drug makers and distributors, having seen some of their peers bail already for significant sums, assert they have reached their negotiating ceiling, somewhere around that magic $50 billion.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information