Articles Posted in Testing

pretomanid-300x122Rare good news on destructive infections is emerging from Africa: Medical scientists, Good Samaritans, and public health officials are hailing the successes of powerful new therapies in treating a deadly and extremely drug-resistant strain of tuberculosis and Ebola, a killer viral hemorrhagic fever that spreads like wildfire.

Americans may skip over dispatches about these “foreign” news developments. They would be wise not to do so, because they have heightened importance these days, domestically, including in providing key lessons to be learned about how to safeguard the public health.

The TB care that is winning great attention overseas requires patients to take three drugs in a regimen in which they take five pills a day for six months. That already is a boon compared with other, now common therapies in which they might need 40 pills a day for as long as two years, or daily antibiotics shots with bad side effects like deafness, kidney failure, and psychosis.

zolegensma-300x225Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard.

The concerning incidents involve “pay to play” clinical trials and “manipulated” data submitted to the federal Food and Drug Administration by maker Novartis as part of the approval process for a gene therapy drug with a sky-high price.

Neither instance, officials insist, had immediate effects in endangering patients. But both show extreme practices and conduct that regulators should slam to a halt.

fdagottlieb-240x300Consumers may want to think long and hard about whether the federal Food and Drug Administration protects the interests of the vulnerable public or profit-raking Big Pharma and medical device makers.

As a scrutiny of data by Science magazine  shows:

“From monitoring clinical trials and approving medicines and vaccines, to ensuring the safety of blood transfusions, medical devices, groceries, and more, the U.S. Food and Drug Administration (FDA) is one of the nation’s most vital watchdogs. By several measures, however, FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office … The agency’s ‘warning letters’—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1,033 warning letters, compared with 1,532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half. Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.

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:

Spending’s askew when billions go for unproven surgical robots while lack of affordable care leads thousands of poor, black, and brown patients to need diabetic amputations

amputations-300x171If U.S. health care leaders look ahead to 2020 and wonder why their sector of the economy will be one of the key concerns of presidential candidates and voters, they can only blame themselves for allowing the public to conclude that the industry’s big money and big profit drives have gone haywire.

eyefocus-300x278Although experts estimate medical over-testing adds more than $200 billion in wasted spending in the U.S. health care system, reducing  it can be hard, as we can see from one example in eye surgery.

Let’s zoom in on cataract surgery, a procedure in which eye surgeons (ophthalmologists) aim to relieve the visual clouding that many patients experience as they age, taking out the natural lens and putting in an artificial replacement. The surgery isn’t without risks, but it goes swiftly and with minor inconvenience for most patients, who get to go home the same day.

For healthy seniors undergoing cataract surgery, the professional consensus has seemed clear for not quite two decades: preoperative testing—which may include a complete blood count, chemical analysis, coagulation studies, urinalysis, electrocardiography, echocardiography, cardiac stress tests, chest radiography, and pulmonary-function tests—is unnecessary. This has been established by rigorous studies (see here and here), as well as by the stringent Cochrane review. The American Academy of Ophthalmology has made this a guideline or clinical statement and spread the word, notably through the public Choosing Wisely initiative that counsels patients on key procedures they need to ask their caregivers about if they’re ordered.

breastimplantUncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

vamps-300x169Funny the mischief that can happen with a little blood and spit. Seemingly unrelated medical stories last week brought home the lesson of the law of unintended consequences. Those consequences abound everywhere, in health care most especially. So with blood, we’re learning about a bizarre new fountain-of-youth treatment, with echoes of vampires, for seniors who ought to know better.   And with spit, we’re learning how seemingly harmless genetic tests can raise from the dead some disturbing revelations about our deceased family members.

Bunk about blood transfusions

The federal Food and Drug Administration has warned older Americans about a new kind of anti-aging bunk flying out of the Silicon Valley: blood transfusions. Companies, dancing on a fine legal line, have hinted that seniors could benefit by getting transfusions of young people’s blood and blood products.

headmri-300x300When patients experience bad headaches, severe chest pain, back or neck aches, or even when kids come in with gut pain that likely is appendicitis, doctors too readily push them into and through what may be hospitals’ over-sized cash-generating machines. It’s past time to end wasteful use of high-powered imaging systems, experts from the Mayo Clinic and Stanford University say.

Drs. Ohad Oren, Electron Kebebew, and John Ioannidis have called out their medical colleagues in an opinion piece published in the medical journal JAMA over excess computed tomography (CT) and magnetic resonance imaging (MRI), saying conditions can’t justify why Americans undergo these costly scans at many times the rate, for example, that Finns do.

Research shows diagnoses don’t improve with many more MRIs and CTs. Instead, they may lead to yet more costly, invasive, and unnecessary tests and procedures, some of which can harm patients.

dirtydrugs-300x143Even as Big Pharma launched the new year with yet another round of profiteering price hikes for prescription medications, a new investigation has uncovered how drug makers get away with nasty manufacturing practices, which, combined with lax oversight, send billions of doses of tainted products to market each year,  imperiling patients’ health.

Sydney Lupkin, writing for the independent, nonpartisan Kaiser Health News Service (KHN), has done the public a service in exposing the weak, irregular, and risky oversight of drug making by the federal Food and Drug Administration. This is a significant problem, Lupkin reported:

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient. Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection…

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