Articles Posted in Clinical guidelines

alexahhs-150x150Federal regulators may be on the brink of not only protecting but also advancing patients access and use of a key component of their care: their electronic health records. Or will bureaucrats fold up in the face of a muscle campaign by corporate interests and hospitals?

To its credit, the giant Health and Human Services agency has emphasized that it is moving forward in its announced plans to prepare new regulations on so-called EHRs, pressing patients’ rights and newer, and potentially more nimble tech firms’ abilities to make the information in the records more accessible and helpful.

But Epic, the giant software company that has installed electronic systems in hospitals and health systems nationwide — often for billions of dollars — is leading resistance to the new rules. It has convinced dozens of institutions and groups, some sizable, to lobby officials to oppose this federal intervention.

practicefusion-300x169Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system.

That’s because investigators have ferreted out “abhorrent” conduct by Practice Fusion, a San Francisco firm that specialized in electronic health care records software, according to the U.S. Attorney’s Office in Vermont.

“During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,”  Christina E. Nolan, U.S. Attorney for the District of Vermont, said in a statement. Practice Fusion, she added,  “illegally conspired to allow [a] drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”

darrow-300x168For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now:  “Some of them are really great,” the professor observed. “And some of them [are] not so great. And a lot of them are very expensive.”

That quote, by the way, comes from a news report by NPR on so-called reforms of the federal Food Drug and Administration prescription drug oversight process. Big Pharma has howled for some time now at politicians, regulators, and the public for fixes to the system — and the industry has gotten its way.

Now, as NPR reported, based on a new study posted online on the JAMA Network:

Clinicians drew in a postmortem conference a full portrait of patient K-0623, based on a detailed questionnaire and research they had conducted into his life. They learned all about the deceased’s happy childhood, his early high school graduation, and his athletic prowess, including his stardom in an elite collegiate football program.

ellisonmugThe neurologists, neuropsychologists, and psychiatrists also learned that the subject, known to them for now only by a number, had taken painkillers at one point, so he could keep up an all-too-brief NFL career.

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.”

samoa1-300x300The 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.

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.”

cardiacstent-300x169Tens 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.”

burkedbglobe-212x300A big Boston hospital has offered 13 million and one ways to try to make good with a former orthopedic surgeon who assailed the respected institution and colleagues for performing simultaneous operations in which doctors went from suite to suite, working for hours on multiple patients at once.

Massachusetts General Hospital insisted this practice was safe. Dr. Dennis Burke, a hip and knee specialist whose patients have included former Secretary of State John Kerry, disagreed. He told his bosses at the Harvard-affiliated hospital that simultaneous procedures put patients at risk, and, at minimum, they should be told that the surgeons they flocked to for surgery on them might pop in and out of their procedures.

Burke infuriated his bosses by taking his criticisms outside the hospital, including to investigative reporters for the Boston Globe. The newspaper dug into hospital surgeries, particularly in orthopedic cases where operations lasted for hours.

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