Medical Device Safety

December 12, 2019

Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

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.

December 8, 2019

Investigations rip FDA for laxity on asbestos-tainted talc and medical devices

by Patrick A. Malone

When 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.

December 6, 2019

Samoa, a Pacific speck, provides a big and sad lesson about vaccinations

by Patrick A. Malone

The distant nation of Samoa may have more to offer the United States than prominent athletes and warm Pacific Islander culture. Its deadly experiences with a raging outbreak of an infectious disease underscore a timely and important message: Vaccinations matter and we should all get them.

A confluence of unfortunate events has led to a measles epidemic in Samoa, news organizations reported, with more than 40 deaths and 3,000 illnesses among the nation’s 200,000 people. Schools and colleges have been shut due to the illness.

International health organizations, including the U.S. Centers for Disease Control and Prevention, are flying in medical experts to assist with the dangerous and growing epidemic, which has hit children on the island hard.

November 17, 2019

Drugs are better for heart patients than surgery (except in mid-heart attack), study finds

by Patrick A. Malone

Tens of thousands of patients with serious but stable heart disease soon may see themselves treated more with prescription drugs and less with rushed surgeries, especially bypass procedures or operations that seek to open clogged blood vessels with wire cages called stents.

A possible shift away from stents — which have come under question for some time now — may be accelerated by the just-announced findings of a $100 million, multi-year study of more than 5,000 heart patients at 320 sites and in 37 countries. The research, the New York Times reported, sought to provide rigorous and more incontrovertible evidence on procedures that now are a bulwark of heart care:

“[The study dubbed] Ischemia is the largest trial to address the effect of opening blocked arteries in non-emergency situations and the first to include today’s powerful drug regimens, which doctors refer to as medical therapy. All the patients had moderate to severe blockages in coronary arteries. Most had some history of chest pain, although one in three had no chest pain in the month before enrollment in the study. One in five experienced chest pain at least once a week. All participants were regularly counseled to adhere to medical therapy. Depending on the patient’s condition, the therapy variously included high doses of statins and other cholesterol-lowering drugs, blood pressure medications, aspirin and, for those with heart damage, a drug to slow the heart rate. Those who got stents also took powerful anti-clotting drugs for six months to a year. Patients were randomly assigned to have medical therapy alone or an intervention and medical therapy. Of those in the intervention group, three-quarters received stents; the others received bypass surgery. The number of deaths among those who had stents or bypass was 145, compared to 144 among the patients who received medication alone. The number of patients who had heart attacks was 276 in the stent and bypass group, compared with 314 in the medication group, an insignificant difference.”

November 4, 2019

Secrecy in drug and medical device lawsuits can imperil patients, experts say

by Patrick A. Malone

The 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.”

October 27, 2019

As FDA warns of implant perils, new questions arise about 3D mammograms

by Patrick A. Malone

Angry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution. The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients:

September 20, 2019

Nursing homes and long-term care facilities may be infection ‘cauldrons’

by Patrick A. Malone

The battle to reduce the sky-high cost of hospital care may have created its own unforeseen and harmful consequence: By hastening to get patients out of traditional hospitals and into skilled nursing facilities and long-term care centers, doctors and policy-makers may be contributing to a medical nightmare — serious infections acquired in health care institutions.

The New York Times reported that “public health experts say that nursing facilities, and long-term hospitals, are a dangerously weak link in the health care system, often understaffed and ill-equipped to enforce rigorous infection control, yet continuously cycling infected patients, or those who carry the germ, into hospitals and back again.”

Hospital-acquired infections (HAIs) pose significant risks to already ill and injured patients, as well as adding to the fearsome costs of institutional care, the Leapfrog Group, an independent patient safety and advocacy group has found. As Leapfrog has reported:

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.

July 30, 2019

Voluntary recall of textured device raises more alarms about breast implants

by Patrick A. Malone

An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.

U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:

“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”

July 28, 2019

Can lives be saved with lessons learned from a space pioneer’s botched care?

by Patrick A. Malone

Neil Armstrong served as a naval aviator, test pilot, federal administrator, and a university professor. He earned his place in history as space pioneer — the first astronaut to walk on the moon. The American hero, who spoke the legendary phrase about “one small step for man and one giant leap for mankind,” also now offers a textbook case about nightmares in health care. Can others avoid these by learning about what happened to him?

As the nation celebrates the 50^th anniversary of Armstrong’s Apollo 11 flight, an anonymous tipster has disclosed information to two news organizations that his death was due to botched care. His family, which included a lawyer who represented their interests, reached a $6 million settlement with the community hospital involved.

Armstrong was known for keeping out of the media and public glare. His family kept that tradition in keeping private how he died in 2012, why, and the tense negotiations that resulted in the sizable payment to them by the hospital. Full information about his case may never be fully disclosed. But it already provides a possible series of check points for patients to protect themselves and their loved ones in dealing with doctors and hospitals: