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Monday, July 1, 2019
Sunday, June 30, 2019
Key events this week – healthcare
Noteworthy events during the week of June 30 – July 6 for healthcare investors.
TUESDAY (7/2): Jazz Pharmaceuticals (NASDAQ:JAZZ): Sunosi update webcast.
WEDNESDAY (7/3): ESMO World Congress on Gastrointestinal Cancer, Barcelona. Celyad (NASDAQ:CYAD): Phase 1 data on CYAD-101 in colorectal cancer. Array BioPharma (NASDAQ:ARRY): Updated data on BRAFTOVI + MEKTOVI + Erbitux in BRAF V600E-positive metastatic colorectal cancer.
SATURDAY (7/6): International Society on Thrombosis and Hemostasis Congress, Melbourne. Bayer (OTCPK:BAYRY): Long-term data on Jivi antihemophilic factor (recombinant) PEGylated-aucl.
Time to Jettison Nearly 400 Medical Practices, Review Says
With hindsight, the folly of trying to cure with mercury or an “ice pick” lobotomy is clear, but there was a time they reigned and patients were harmed. A new study takes aim at today’s ineffective medical practices, with an eye toward shortening their transition to obsolescence.
After reviewing 3017 randomized controlled trials (RCTs) published in the past 16 years in three high-impact medical journals, the investigators identified 396 medical reversals or practices found through RCTs to be no better than a previous or lesser standard of care. In 53% of cases, a systematic review confirmed the device, procedure, or practice was indeed a medical reversal.
“Large, well-done randomized trials are essential in helping to determine whether an intervention is effective or not. Studies that are poorly conducted or small in sample size produce spurious results, and these types of studies, because of their nature, can lead to the adoption of ineffective practices or medical reversals,” authors Alyson Haslam, PhD, and Jennifer Gill, MSc, Knight Cancer Institute, Oregon Health & Science University, Portland, told theheart.org | Medscape Cardiology via email.
Senior author Vinay Prasad, MD, Knight Cancer Institute, has published extensively on the topic, including a previous report of 146 medical reversals published in the New England Journal of Medicine (NEJM) from 2001 to 2010.
In the present study, 13% of all RCTs were medical reversals; 29% of reversals were found in the Lancet, 33% in NEJM, and 39% in the Journal of the American Medical Association.
Most studies (92%) were conducted in high-income countries, with the remainder done in low- or middle-income countries, such as China, Ghana, and India, according to the report, published online June 11 in the open-access journal eLife.
Reversals were found in every specialty, with cardiovascular disease (CVD) was the most common medical category (20%), followed by public health/preventive medicine (12%) and critical care (11%).
CVD examples include the still-debated use of off-pump coronary-artery bypass surgery and the reversal of pulmonary artery catheterization as a therapy for congestive heart failure, identified via the ESCAPE trial and a 2013 Cochrane review.
Interventional cardiologist Robert W. Yeh, MD, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, who was not involved in the study, said the concentration of reversals in cardiology reflects the nature of the specialty.
“What it means to me is that we are willing to subject our therapies to the test; we’re willing to do the hard work of conducting randomized trials,” he told theheart.org | Medscape Cardiology. “That really is the foundation of cardiology in many ways. It is, I think, if not the most evidence-based disciplines in medicine, certainly one of them.”
The finding also likely relates to the fact that heart disease is the number one killer globally and in the United States.
“Our denominator of therapies is probably larger, so that’s another reason I think we have a number of therapies showing up in this list,” Yeh said. “I don’t view it as a condemnation. I sort of wear it as a badge of honor.”
Direct and Indirect Costs
The study does not address how often the 396 medical reversals continue to be used. This can be very complex because some of the reversals are practices that patients or family can self-prescribe, such as vitamin A supplementation to improve newborn mortality or use of graduated compression stockings to reduce deep vein thrombosis after stroke, Haslam and Gill note.
Use of various practices is also inconsistent or they are being used off-label. Other reversals can be tracked more easily, such as breast cancer screening in women 40 to 49 years of age, but will likely continue because of discordant recommendations.
Although it also was outside the scope of the study to determine whether the implementation of practices later identified as reversals was financially motivated, most reversals (63.9%) were identified because of a nonindustry funded study.
As for why some physicians may be slow to de-implement ineffective practices yet quick to adopt therapies without a strong evidence base, Haslam and Gill observe that it can be hard for physicians to keep up with the published literature because of time constraints. And it takes time to conduct a good randomized study, and “sometimes there isn’t the luxury of time when you have a very sick patient with few good options (e.g., patients with cancer).”
Nevertheless, continued use of low-value practices can erode trust in the medical system and means patients spend time and money on practices that are ineffective, they note. For example, bevacizumab (Avastin) was approved in 2008 for metastatic breast cancer under the accelerated approval program, at a cost of about $88,000 per patient, but the indication was withdrawn in late 2011 after it was shown not to improve overall survival.
“In countries like the US, where there was a 20% increase in spending between 2013 and 2015, and drug prices alone surpassed the increase in aggregate healthcare spending, the identification and disuse of costly and ineffective (or possibly harmful) medications and practices are especially important,” the authors write.
Keeping interventions without a sufficient evidence base from becoming common practice will require systemic changes at all levels — from government to individual practice — and starts with holding treatments to higher standards when granting market approval, Haslam and Gill say.
“Practitioners can critically evaluate treatments, new and old, and choose what to adopt and how to practice to best serve their patients,” they add. “This is happening already but through this research, we hope that more develop critical eyes and demand well-done randomized trials before accepting treatments into their practice. While this may not directly affect systemic changes in companies and governmental agencies, it may influence future decisions and put pressure on these powers to come up with stronger evidence for new practices.”
Haslam and Gill report no relevant financial interests. Prasad reports receiving royalties from his book, Ending Medical Reversal; funding for his work from the Laura and John Arnold Foundation; honoraria for Grand Rounds/lectures from several universities, medical centers, nonprofit groups, and professional societies; serving as a writer for Medscape; and hosting the podcast Plenary Session, which has Patreon backers.
Elife. Published online June 11, 2019. Full text
3 Tricks to a Telephone Patient Assessment
Nursing assessments are taught thoroughly in nursing school and used at the bedside every day. Nurses use their senses to gather important information regarding the status of their patients. They are trained to pick up on seemingly insignificant changes in the patient’s status and incorporating it into their overall assessment. Whether it is a change in the patient’s complexion, swelling in their ankles, the new onset of a cough, or the slightest change in a patient’s vital signs, nurses process more information that can be caught by a keen observer.
With an increase in technology use, nurses are more commonly taken away from the bedside. Telehealth is becoming more common for nurses in a variety of care settings. Whether you are looking to improve your assessment skills or are considering a job that requires telehealth, here are some tips to help you assess patients over the phone.
Nurse Out Loud
Nurses often don’t understand how much of their assessment relies on visual cues at the bedside. Given the fact that you are on the phone, you must translate the normal assessment at the bedside to a verbal conversation. When using telehealth, start to verbalize your assessment to your patient over the phone, especially regarding assessments of things that you would otherwise be able to see in person, such as appearance, behavioral changes, and swelling.
Be Descriptive
When assessing a patient over the phone, you must be descriptive. Often patients have difficulty describing things. As a nurse, you have many adjectives that you use that are helpful. Plus, you need to get into the details. You cannot settle for vague generalities such as, “I had a loose bowel movement” or “I’m in pain.” You can facilitate the conversation by asking things like, “Was your pain sharp and stabbing or was it dull and achy?” and “When you passed blood in your stool was it black and tarry or bright red?” The better you can describe common descriptors relating to what the patient is telling you, the better you can accurately assess what they are actually experiencing.
Let the Patient Talk
Listening intently can uncover many valuable details that otherwise might get overlooked. Since patients can have difficulty explaining their symptoms, giving them space and time to get out what they are trying to say can go a long way in understanding what is actually going on. Remember, you are the assessment expert, not the patient.
You are completely dependent on what you can get from the patient during a telehealth assessment. To get a thorough assessment, remember to verbalize your assessment to your patient, be descriptive, and let the patient speak.
Opioid trial in Oklahoma has national implications
With billions of dollars and historic legal precedent on the line, attorneys nationwide are paying close attention to Oklahoma’s ongoing public nuisance trial against opioid manufacturer Johnson & Johnson.
The verdict that comes out of Judge Thad Balkman’s Cleveland County courtroom, although likely to be appealed no matter the ruling, is expected to impact more than 1,600 city, county and local municipality lawsuits against opioid manufacturers that have all consolidated before a federal judge in Ohio.
Cleveland jurors will hear arguments in two of these lawsuits during a bellwether, or test, trial scheduled for Oct. 21. U.S. District Judge Dan Polster is encouraging plaintiffs and drug manufacturers to reach a settlement quickly.
A win for Oklahoma — complete with a large payout from Johnson & Johnson — would give plaintiffs involved in this multidistrict litigation increased bargaining power in settlement negotiations.
A defense victory could embolden the drugmakers to fight more cases in an attempt to cut back on their losses, according to University of Kentucky law professor and liability law expert Richard Ausness.
“However it turns out, the Oklahoma trial is a bellwether that gives some indication as to where these other cases are going,” he said. “Both sides are going to be watching it with great interest.”
While every state but Nebraska is pursuing some kind of legal action against opioid manufacturers, Oklahoma was the first to reach the trial stage. Attorney General Mike Hunter alleges Johnson & Johnson caused a public nuisance by using deceptive opioid marketing techniques that led to a statewide health epidemic.
Originally expected to try three drug companies, Oklahoma settled with Purdue Pharma for $270 million on March 26 and Teva Pharmaceuticals for $85 million two months later.
Legal questions
Opioid litigation arose around the turn of the century, when some people addicted to the painkillers unsuccessfully sued drug makers.
About a decade later, local governments seeking monetary relief to combat opioid addiction in their region started filing lawsuits against drug manufacturers. Several of these claims are now part of the multidistrict litigation in Ohio.
It remains to be seen if a public nuisance argument against drugmakers in a trial setting can be successful, according to Ausness. Lawyers in the 1990s won large settlements from tobacco companies using the claim, but were unsuccessful arguing public nuisance against firearms and lead paint makers.
“Even though I think public nuisance is a weak theory, it resonates well,” Ausness said. “Anybody can be negligent, but only really bad people can commit public nuisances. That’s sort of the way it looks to somebody who isn’t an expert in the area.”
A former opioid addict turned church pastor, as well as family members of an OU football player who died from an opioid overdose, were among the state witnesses called during the first two weeks of the trial. While their testimony may have been powerful, its relevance is questionable, according to Ausness. To win a public nuisance argument, a plaintiff must establish that a collective public right has been violated and the defendant had control over the offending activity or condition.
“Bringing in people who were addicted and whose relatives were addicted, it doesn’t really go to any of the elements of a public nuisance,” he said. “After all, the state is suing for economic loss and not personal injuries. I don’t want to criticize the parties, because I have not been following the trial on a day-to-day basis, but it sounds like while the state has been vigorous, they may not be persuasive at this point.”
Johnson & Johnson could also be bolstered by a recent court ruling in favor of an opioid manufacturer in North Dakota. On May 16, a North Dakota judge dismissed a state lawsuit seeking damages against Purdue Pharma, saying the drug maker does not control the product after it enters the market.
“At the very least, the North Dakota ruling provides opioid defendants some leverage in settlement negotiations,” product liability attorney Cameron Turner said in an opinion piece on Law360.com. “Even if they proceed to trial and take an adverse verdict, they now have a potentially dispositive appellate argument that has been accepted by at least one judge.”
A similar ruling occurred in January, when Connecticut Judge Thomas Moukawsher dismissed lawsuits brought against Purdue Pharma by 37 cities and towns in the state. Moukawsher claimed the plaintiffs could not directly show that Purdue caused the opioid problem in their region.
“They (opioid manufacturers) really haven’t lost a case yet. It’s sort of 2-0 at this point,” Ausness said. “I think a victory for the defendants in the Oklahoma case would perhaps be more significant than a victory for the plaintiffs. Nobody likes to lose, but I think they would say we won a few, so now we can afford to lose a few.”
Potential outcomes
Johnson & Johnson’s low overall opioid market share in Oklahoma, combined with the fact that the case is being tried in front of a judge rather than a jury, limits the likelihood of a substantial judgment should Balkman rule in favor of the state, according to Ausness.
“Trial judges can be political, but I think they’re a little less swayed by the emotional stuff that is certainly being generated by the plaintiffs in this case,” he said.
In April, Balkman ruled he, not a jury, would decide the case. Hunter requested a bench trial on the basis that the state is not seeking monetary damages, but rather equitable relief, and therefore is not entitled to a jury trial. Drug manufacturers were mixed on the issue.
While this case may soon influence settlement amounts in Ohio as well as legal strategy in trial cases against drug makers, the battle won’t stop once Balkman delivers a verdict later this summer.
“Whichever way it goes, the losing side is going to appeal,” Ausness said. “There are no intermediate courts in Oklahoma, so it’ll go right to the Oklahoma Supreme Court. So who knows when they’ll render a decision. It’s going to take awhile for the full effect of the case to be realized.”
How obesity re-wires the brain’s neurological food suppression system
Overeating, by cutting the brain’s natural brakes on food intake, may result in neurological changes that continue to fuel pathological eating and lead to obesity, reports a new study in mice. The results demonstrate how diet-induced obesity alters the function of a crucial neurological feeding suppression system – findings that could help identify novel therapeutic targets for eating disorders and obesity in humans. Obesity, a disease that affects more than 500 million adults worldwide and is a large factor in the increased incidence of a myriad of other serious health issues, is often considered to be one of the most pressing global health concerns. While obesity can be linked to a few, rarely occurring medical causes, unhealthy eating habits are widely recognized as the largest determinant. However, little is known about how obesity impacts the brain or underlying neurological mechanisms, to contribute to these adverse eating behaviors. Previous research suggests that the lateral hypothalamic area (LHA), a brain region that mediates physiological functions related to survival, plays a crucial role in controlling eating behavior. In a mouse model of obesity, Mark Rossi and colleagues used a combination of single-cell RNA sequencing and two-photon calcium imaging to identify obesity-related alterations in particular cells within the LHA. The results identified a discrete class of cells – glutamatergic neurons – that functionally put the brakes on feeding to suppress food intake beyond satiation, in ideal conditions. However, in mice fed high-fat, obesogenic diets, Rossi et al. found these neurons to be highly and uniquely modified in a way that disrupted this natural feeding suppression system to promote overeating and obesity. In a related Perspective, Stephanie Borgland discusses the study in more detail.
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