Weight Cutoffs for Elective Surgeries: Bias or Economics?

Is access to elective surgeries a human right? For patients with severe obesity, this isn’t simply an interesting philosophical question. Rather, the answer is one that could change the trajectory of their lives. From breast reductions to knee replacements, fertility treatments, and more, weight as an exclusion criterion is a regular reality. But is it good medicine?
Defenders of weight-based denial of care will often point to increased surgical risks or complications as the rationale for a BMI cutoff. But increased risks can be covered by obtaining informed consent, as is done with other conditions and circumstances that increase risks but—unlike obesity—don’t preclude consultation, let alone surgery.
Some studies actively refute the presumptive risks. Multiple publications have suggested that weight-based restrictions for breast reductions should be abandoned, and others have found that the degree of pain relief after knee replacements is greater in those with obesity, while functional improvements are comparable. And finally, at least here in Canada, national recommendations have called for an end to BMI-based cutoffs for fertility treatments.
Recently, this question led to a legal challenge in the Canadian province of Nova Scotia. Melody Harding was seeking a breast reduction but was told that because her BMI was above 27, she was ineligible for provincial coverage. Frustrated, she wrote to the Nova Scotia Human Rights Commission, and 2 years later, their intervention led to the removal of Nova Scotia’s BMI cutoff for reduction mammoplasty. Whether other cases and similar outcomes in other provinces will follow remains to be seen, but given the evidence and the precedent, I suspect they are inevitable.

Surgical Economics

But what drives the cutoffs? If it’s not surgical outcomes, is it old-fashioned weight bias and paternalism, with doctors thinking that these cutoffs will motivate people to lose weight? Or worse, that people with obesity should not receive care because they have brought their miseries onto themselves by not moving more and eating less? That might be true for some, but a conversation I had with a plastic surgeon has me thinking that there are far more mundane considerations afoot.
We chatted about human rights, obesity, and elective surgeries. When I suggested that weight bias might be behind the cutoffs, he very quickly dismissed that as unlikely. More likely, according to him, are the boring realities of operating on patients with severe obesity: The surgeries take longer; may be more technically difficult or demanding; may require specialized equipment, training, or knowledge; and though not life-threatening, may also involve the surgeon spending more time dealing with complications or medical management postoperatively. He argued that weight-based cutoffs are about simple, dispassionate, surgical economics. And at least in regard to increased operative time and postoperative superficial skin infections, the medical literature is in agreement.

No Clear Answers

When it comes to strategies for improvement, there are some obvious considerations, including reevaluating the evidence for and validity of existing weight-based cutoffs; ensuring surgical remuneration is commensurate for longer, more technically difficult cases and follow-up courses; improving clinical training to ensure that surgeons are comfortable dealing with common comorbidities associated with these more medically complicated patients; and recognizing weight bias as a subject worthy of careful attention in medical education.

Without robust medical evidence to the contrary, obesity alone should never preclude a patient from the consideration of surgery, and informed consent is the tool with which to handle risk increases that are comparable to those of other conditions that don’t themselves preclude conversation. Anything less is weight-based discrimination.
But if the basis of that discrimination is logistical, can surgeons be required to take on more complicated or lengthy cases, or to buy equipment specifically to work with patients with obesity? Is there a precedent for that in any other area of medicine? I don’t know the answers to these questions and would love to hear your thoughts in the comments.
Yoni Freedhoff is an associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work.
https://www.medscape.com/viewarticle/919792

Cerner to acquire AbleVets

Cerner (CERN +0.2%) to acquire strategic IT consulting and engineering firm AbleVets for undisclosed terms.

The companies expect to complete the transaction in the Q4.

Travis Dalton, president, Cerner Government Services. “Integrating the team into our business is a natural next step of our relationship. We expect AbleVets’ technical expertise and execution in solving complex problems will accelerate Cerner’s success in providing integrated, seamless care for Veterans, Service members and their families.”

https://seekingalpha.com/news/3506926-cerner-acquire-ablevets

PTC strikes out in Europe in bid to expand use of Translarna

The European Medicines Agency’s advisory committee CHMP has confirmed its negative opinion issued in June against approving PTC Therapeutics’ (PTCT +1%) Translarna (ataluren) for non-ambulatory patients with nonsense mutation Duchenne muscular dystrophy (DMD).

The product is currently approved in the EU for ambulatory DMD patients.

https://seekingalpha.com/news/3506937-ptc-strikes-europe-bid-expand-use-translarna

Novartis strikes out on expanded use of Revolade/eltrombopag in Europe

The European Medicines Agency’s advisory committee CHMP has confirmed its negative opinion issued in June against approving Novartis’ (NVS -0.5%) Revolade (eltrombopag) as add-on treatment in previously untreated patients at least 12 years old with severe aplastic anemia who are not candidates for autologous stem cell transplant.

CHMP stated that the clinical study supporting the application was inadequate to show a treatment effect in these patients since there was no direct comparison between Revolade + immunosuppressive therapy and immunosuppressive therapy alone.

Revolade is currently approved in the EU for adults with severe aplastic anemia, patients at least one year old with primary immune thrombocytopenia and HCV-positive adults with thrombocytopenia.

https://seekingalpha.com/news/3506932-novartis-strikes-expanded-use-eltrombopag-europe

FDA OKs expanded use for Amgen’s Nplate

The FDA approves Amgen’s (NASDAQ:AMGN) Nplate (romiplostim) for use in newly diagnosed adults with immune thrombocytopenia (ITP) (low blood platelets) who have not responded adequately to corticosteroids, immunoglobulins or splenectomy (spleen removal).

The agency approved the thrombopoietin receptor agonist in August 2008 for the long-term treatment of adults with chronic ITP and in December 2018 for pediatric ITP patients.

https://seekingalpha.com/news/3506910-fda-oks-expanded-use-amgens-nplate

J&J to recall single lot of baby powder as FDA finds traces of asbestos

Johnson & Johnson said on Friday it would recall a single lot of its baby powder in the United States after the Food and Drug Administration found trace amounts of asbestos in samples taken from a bottle purchased online.

The recall is limited to one lot of Johnson’s Baby Powder produced and shipped in the United States in 2018, the company said.
The company’s shares fell 2% to $133.01 in premarket trade.
J&J also said it has started an investigation and is working with health regulators to determine the integrity of the tested sample as well as the validity of test results.
The FDA test indicated the presence of no greater than 0.00002% of chrysotile asbestos in the tested sample, the company said.
The company’s consumer unit said it was too early to confirm whether cross-contamination of the sample had caused a false positive, whether it was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
It also added it could not confirm whether the product was authentic or counterfeit.
J&J faces around thousands of lawsuits related to products containing talc. The company has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.

https://www.marketscreener.com/news/J-J-to-recall-single-lot-of-baby-powder-as-FDA-finds-traces-of-asbestos–29416568/

Judge’s unorthodox approach has huge opioid settlement within reach

From the start of the sprawling U.S. litigation seeking to hold drugmakers and distributors liable for the country’s opioid epidemic, Judge Dan Polster has made one thing clear: he never wanted a trial.

On Friday, Polster will make his most dramatic bid yet to avoid a landmark trial that is scheduled to start on Monday. The federal judge has summoned the top executives from several large healthcare companies to his Cleveland court to try to hammer out a settlement that could be worth around $50 billion.
Polster has a knack for getting bitter adversaries into a conference room, making them feel understood and reaching a resolution, said Seema Saifee, a law clerk for the judge from 2004 to 2006.
“There would be times when I would be working on a draft opinion and he would come out of a conference room and say ‘settled that one.’ And I would take the draft and duly throw it out,” said Saifee, a senior staff attorney with the non-profit Innocence Project in New York.
“A colleague said he could probably settle the Palestinian-Israeli conflict,” said Saifee.
If no deal is reached, Polster will play the part of the reluctant trial judge, guiding what promises to be some of the most complex litigation in U.S. history.
“We don’t need a lot of briefs and we don’t need trials,” said Polster at an initial hearing last year, after a federal panel assigned him to coordinate federal opioid cases from around the country. “None of those are going to solve what we’ve got.”
Polster is overseeing more than 2,300 lawsuits by towns, cities, counties and tribal governments that seek to hold drugmakers, distributors and pharmacies liable for their role in a U.S. public health crisis that has taken a terrible toll.
Opioids were involved in around 400,000 overdose deaths between 1997 and 2017, and have cost the country hundreds of billions of dollars in emergency services, addiction treatment and lost worker productivity.
The lawsuits allege that drug manufacturers aggressively marketed their painkillers while downplaying the risks of addiction, and claim drug distributors failed to halt and report suspicious orders for opioids. The companies deny the allegations.
In a last-ditch effort to avoid a trial, Polster asked the chief executive officers of McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – the three largest U.S. drug distributors – and Israel-based drugmaker Teva Pharmaceutical Industries Ltd to meet on Friday to discuss a proposal they have made to settle the cases.
‘REALLY INNOVATIVE’
Polster, a native of his northern Ohio jurisdiction who has said he cycles 10 miles (16 km) to work, has taken an aggressive approach to getting a deal on opioids.
He invited state attorneys general, whose cases were not before him, to participate in settlement talks, and he ordered the federal government to turn over confidential data showing where each manufacturers’ opioids were distributed in the United States.
He also recently endorsed a novel “negotiation class” framework that could be used to allow thousands of local governments to vote on potential settlements.
“If it looks like he is doing things that are really innovative, he is,” said Mary Davis, the interim dean at the University of Kentucky College of Law.
If talks fail, Monday will mark the start of a two-month trial that will pit Ohio’s Cuyahoga and Summit counties against some companies in a bellwether, or test, trial that allows parties to see a jury’s reaction to the allegations.
The outcome will be watched closely by plaintiffs and defendants in future trials, including U.S. healthcare conglomerate Johnson & Johnson, to help them reach what is known as a global settlement of all opioid litigation.
“Maybe this isn’t what a court should do,” Polster told a gathering at Harvard Law School in April 2018 about aggressively pushing settlements. “The courts didn’t ask for this … This one cried out for some effort to come together.”
The judge has his critics.
A Reuters investigation showed that Polster has been more willing to seal documents than other judges involved in opioid litigation, raising concerns that important information about the crisis remains secret. Polster declined to comment on that report.
The major drug distributors and retailers, including CVS Health Corp and Walmart Inc , took the rare step of trying to remove the judge from the case based on his appearance of bias, in part due to his unusual habit of discussing the case in the media and his push for a settlement. An appeals court backed Polster.
“Publicly acknowledging this human toll does not suggest I am biased; it shows that I am human,” Polster wrote in a court filing.

https://www.marketscreener.com/news/Judge-s-unorthodox-approach-has-huge-opioid-settlement-within-reach–29416669/?countview=0