Testing

October 8, 2019

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of the prescription blood-pressure medications losartan, valsartan and irbesartan.

The actions occurred after cancer-causing chemicals known as nitrosamines — N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, and N-Nitrosodimethylamine, or NDMA— were detected in them.

They were yanked in an abundance of caution, and doctors and public health experts have told patients to consult with their pharmacists and doctors to ensure they do not suddenly halt their use of needed treatments, especially because there are ready options.

October 1, 2019

Health care plagued by cases of a persistent pathology — unmitigated gall

by Patrick A. Malone

There seems to be a never-ending outbreak of a certain kind of pathology in the United States. Big Pharma has it and spreads it around, a lot. So, too, do public health figures. Let’s call this scourge what it is — unmitigated gall.

The problem with this nasty condition is that it afflicts the rest of us. Just consider how stomach-churning these shenanigans can be:

Penalties for bogus prescribing of ‘little red pills’ on elderly dementia patients

August 28, 2019

U.S. task force refines guidelines for women’s genetic cancer screening

by Patrick A. Malone

Many more women would benefit if their doctors took time to put them through a relatively easy screening using readily available questionnaires to determine if they might need further specialist assessment and a medical test for a genetic mutation linked to breast and other forms of cancer.

Women, however, should not routinely be subjected to the assessment, counseling, and testing for the BRCA 1 and BRCA 2 mutation, the influential U.S. Preventive Services Task Force has recommended, based on its blue-chip review of medical evidence. The task force gave the broad, routine approach its D grade, as in it should not be done.

The panel gave the careful and appropriate BRCA screenings its “B” grade, meaning they have moderate to significant benefits. The screening by primary care doctors is best suited for women with “a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations.”

August 23, 2019

To fight smoking and drug abuse, Uncle Sam will try gross images and screenings

by Patrick A. Malone

fda3smokewarns-300x166 The U.S. government will try to tackle two of the toughest health care challenges around with new pushes involving graphic imagery and smoking prevention and the encouragement for doctors to screen their adult patients to better detect, avert, and treat drug abuse.

Both initiatives have their soft spots.

But officials say they must act in as many ways as they can. That’s because 480,000 people in the United States die each year from illnesses related to tobacco use, the American Cancer Society reports, adding, “This means each year smoking causes about 1 out of 5 deaths in the US.” Drug abuse and overdoses, meantime, killed more than 68,000 Americans in 2018 alone, exceeding the nation’s peak annual deaths from car crashes, AIDS or guns, the New York Times reported, based on data from the federal Centers for Disease Control and Prevention (CDC).

August 22, 2019

Do health care’s perverse incentives lure MDs into deliberate misdiagnosis for profit?

by Patrick A. Malone

When doctors become medical outliers, shouldn’t hospitals, colleagues, insurers, and the rest of us ask how and why an individual practitioner diverges so much from the way others provide care?

Olga Khazan details for the Atlantic magazine the disturbing charges involving Yasser Awaad, a pediatric neurologist at a hospital in Dearborn, Mich. As she describes him, for a decade he racked up hundreds of cases in which he is accused by patients of “intentionally misreading their EEGs and misdiagnosing them with epilepsy in childhood, all to increase his pay.” Khazan says his case “shines a light on the grim world of health-care fraud—specifically, the growing number of doctors who are accused of performing unnecessary procedures, sometimes for their own personal gain.”

In the malpractice cases that are unfolding against him, Awaad’s pay has become a central issue, with evidence showing his hospital contract rewarded him for boosting the number of screenings he ordered and diagnoses he made. Jurors have been told that Awaad, whose salary increased from 1997 to 2007 from $185,000 annually to $300,000, “turned that EEG machine into an ATM.” He earned bonuses exceeding $200,000, if he hit billing targets.

August 21, 2019

Glimmers of hope in new therapies to battle killer Ebola and lethal TB strain

by Patrick A. Malone

Rare 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.

August 14, 2019

For patients’ sake, U.S. must slap down Big Pharma chiseling on tests, trials

by Patrick A. Malone

Big 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.

July 10, 2019

Critics fear a key watchdog’s decline as FDA eases up its regulatory actions

by Patrick A. Malone

Consumers 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.

June 4, 2019

Can we avoid getting dopey about hype, use, regulation of dope-derived CBD?

by Patrick A. Malone

The 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:

May 10, 2019

Modern medicine may be great at making money but not at making sense

by Patrick A. Malone

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

If 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.

How unbalanced have the nation’s health care priorities become that, on the one hand, surgeons and hospitals keep pushing to spend billions of dollars more for robotic surgeries that doctors themselves are doubting, while, on the other hand, researchers blame economic and racial disparities for playing a big role in requiring tens of thousands of patients — especially those who are black and brown and poor — to undergo diabetic amputations?