Will 21st Century Cures Act benefit hospitals?

captureFirst: The Globe is getting some attention for its five-part narrative about a family that helped  start a drug company to keep their son on an experimental cancer treatment.

Nicely written narrative with illustrations and audio. We won’t give away the ending. 

Also, here’s what people were saying a year ago about the “21st Century Cure Act.” It’s been amended since then, but much of what they have to say still applies. My take was: What’s in it for hospitals? 

The drug development and approval elements in the proposed legislation are the centerpiece of a gift basket that has something for everyone: engaged patients, drug makers, FitBit fanatics, NIH-funded scientists, those faced with rare diseases, and those fighting antibiotic resistance.

What do hospitals get out of it? Of course, it depends on whom you ask. One side says it will clear out bottlenecks that are delaying access to better drugs and new, effective antibiotics. That’s good news for hospitals struggling to improve patient outcomes and prevent readmissions. The other side says it will lead to unsafe drugs and a flawed approach to dealing with antibiotic resistance. That’s bad news for hospitals struggling to improve patient outcomes and prevent readmissions.

John Powers, MD, is a former head of the FDA’s Antimicrobial Drug Development and Resistance Initiatives. He is now a clinical professor at the George Washington University School of Medicine and one of the bill’s critics. If the bill’s provisions regarding FDA approval become law, hospitals should be worried that they will be held responsible for drugs that are ineffective or worse, he said.

“If you have a new drug and it doesn’t make the patient better, what you actually end up doing is spending more money in the long run because they stay in the hospital longer,” Powers said. “Or you may have to administer additional treatment to deal with the side effects of that medicine — which costs money.”

Two Boston meetings look at the role of patient advocates. They offer two very different perspectives.

patient-advocacy-summit-e4fb

Pharmaceutical manufacturers often  look to patient advocates for help winning approval for new drugs. Their most recent success in this area was the FDA’s approval of a new drug for Duchenne muscular dystrophy. That decision came despite recommendations against approval from FDA staff.

In an editorial, the Boston Globe questioned the FDA’s move while noting that eteplirsen’s “entry into the marketplace represents a major victory for the patient advocacy movement, and is bound to encourage more such engagement in the drug-approval process. Based on the infighting that went on over the Duchenne treatment, that’s going to be challenging for the FDA. It has to find a balance between public opinion and what’s truly in the public interest.” (The Globe also featured a story this week about one of those patient advocates.)

Today, drug makers in Boston are hosting a conference for patient advocates. The “Patient Advocacy Summit 2016 – Sharing Our Stories: Building a Patient-Centered Ecosystem” is underway at Novartis facility near MIT.

This event brings industry leaders together with patient advocates and other stakeholders to examine ways in which life sciences companies can more fully incorporate the patient voice into the work they do— not just approaching regulatory applications or at commercialization, but throughout the drug development cycle.

The day-long event will include panel discussions, case study presentations (spotlighting industry/patient partnerships), a keynote address, and awards ceremony, as well as a networking breakfast, lunch and cocktail reception. Expected attendance is 180 patient advocacy professionals, patient organizations and other stakeholders.

Worth noting that the same topic was the subject of  yesterday’s  panel at HUBweek, a  science/tech/arts series ongoing in Boston. The title: “The FDA and the Drug Approval Process: Is it Really Broken?”  Some made the point —  we should listen to the parents of sick children.  Others offered a different perspective: Patients might be better off in clinical trials with informed consent and free drugs,  rather paying  $300,000 per year for that same, unproven medication with unknown side effects.

Contacted after the panel, Zuckerman, president of the National Center for Health Research in DC,  offered these thoughts:

  1. Patient perspectives are crucial in helping us understand what scientific data mean, what the benefits and risks both mean to patients.  So patients should be part of the process – what should the outcome measures be and how can they be measured?
  2. The FDA is listening to patients who desperately want treatments but they are not listening well to patients who are harmed by ineffective or unsafe treatments.  That’s partly because the former are funded by Pharma to attend FDA meetings and to lobby Congress, but the latter are on their own, often don’t have the money to attend FDA public meetings, and wouldn’t even know about them if they don’t read the Federal Register, which is the only place they are announced in advance.

 A few more tweets worth noting.

 

Former NEJM editor Arnold Relman dies at 91

RelmanSee Storify for updates. 

Arnold Relman, the former New England Journal of Medicine editor, has died. From Bryan Marquard at the Globe: 

Eloquent and forceful on the page or the podium, Dr. Arnold Relman led the New England Journal of Medicine for more than 13 years, raising a sometimes lonely voice to warn about the dangers of for-profit medicine when many in politics and his profession raced to embrace a free market approach.

Dr. Relman also was one of the nation’s foremost writers about the rising cost of health care. Persistent to the end, he received the galleys of his final article just a few days before he died of cancer in his Cambridge home early Tuesday, on his 91st birthday.

 

When he suffered a catastrophic fall last year, he wrote about it in The New York Review of Books:

 

Since then, I have made an astonishing recovery, in the course of which I learned how it feels to be a helpless patient close to death. I also learned some things about the US medical care system that I had never fully appreciated, even though this is a subject that I have studied and written about for many years.

 

What he reported was not flattering to Spaulding Rehab, the hospitals that has won praise for working with so many marathon bombing survivors.

What did this experience teach me about the current state of medical care in the US? Quite a lot, as it turns out. I always knew that the treatment of the critically ill in our best teaching hospitals was excellent. That was certainly confirmed by the life-saving treatment I received in the Massachusetts General emergency room. Physicians there simply refused to let me die (try as hard as I might). But what I hadn’t appreciated was the extent to which, when there is no emergency, new technologies and electronic record-keeping affect how doctors do their work. Attention to the masses of data generated by laboratory and imaging studies has shifted their focus away from the patient. Doctors now spend more time with their computers than at the bedside. That seemed true at both the ICU and Spaulding. Reading the physicians’ notes in the MGHand Spaulding records, I found only a few brief descriptions of how I felt or looked, but there were copious reports of the data from tests and monitoring devices. Conversations with my physicians were infrequent, brief, and hardly ever reported.

What personal care hospitalized patients now get is mostly from nurses. In the MGHICU the nursing care was superb; at Spaulding it was inconsistent. I had never before understood how much good nursing care contributes to patients’ safety and comfort, especially when they are very sick or disabled. This is a lesson all physicians and hospital administrators should learn. When nursing is not optimal, patient care is never good.

More on that piece from The NYTimes. 

 

Relman often commented on the influence of money on medicine. In 20o9,  he crashed the inaugural meeting of the Association of Clinical Researchers and Educators (ACRE) “an organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts.”

So, we asked for his thoughts about the presentations. Here they are:

“I sat through the whole program, which was a sustained diatribe against conflict-of-interest regulations rather than a scholarly, balanced discussion of the issues. There was practically no time for audience questions or comments, but instead an almost unrelenting barrage of ideological and anecdotal criticism of what was said to be a misguided “belief system” that worries excessively over relations between industry and the medical profession. There was an occasional informative and reasonable contribution, but for the most part sarcasm and anger prevailed.
 
The heavily industry-related audience loved the performance, but the obviously biased, self-serving, and often grossly flawed presentations should have embarrassed the organizers. Although neither Harvard Medical School nor the Brigham & Women’s Hospital sponsored or formally endorsed the meeting, the HMS Dean did give the initial welcoming remarks, and the Hospital offered its facilities for the event. One can only hope that they are now having second thoughts.”
More here:

How the Supreme Court same-sex marriage rulings will impact health care #DOMA #SCOTUS

Profoundly, it seems. The decisions to uphold same-sex marriage are just coming out.  Since lots of people get health insurance through their spouses, the impact will be huge. Here is New England, where same-sex marriage is legal, HR offices for federal agencies should expect a spurt in family coverage.

Kaiser Health News posted a what-if story on DOMA in April:

According to a report published by two think tanks, the Center for American 

Progress and the Williams Institute, which conducts 

Screen Shot 2013-06-26 at 11.19.48 AM

research on gender identity and sexual orientation, an employee who buys health insurance for a domestic partner of the same or opposite sex pays $1,069 more a year in federal taxes, on average, than a worker in a heterosexual marriage would pay for the same coverage.

Nine states and the District of Columbia currently permit same-sex mar

riage, according to the National Conference of State Legislatures.

The Gay and Lesbian Medical Association filed a brief in the DOMA case.

BHN looked at gay health issues during the 2009  gay pride events in Boston.

Does Berwick have a fix for Massachusetts that he didn’t get to try in DC?

berwickIn addition to the rest of the state’s problems, would-be Governor Don Berwick would inherit the post-mandate struggle to contain health care costs. Does he have any solutions for  Massachusetts that he didn’t get a chance to try in DC?

Last summer, the former Medicare chief gave a talk before a film about the failures of U.S.  health care.  Instead of demonizing doctors and drug companies , he said they are just working within the system as it stands.

They’re just doing what makes sense,” he said. “We have to change what makes sense.”

Read full post here. 

For more on Dr. Berwick see:

#Medicare boss Berwick for Massachusetts governor? Changing what makes sense #hcr #mapoli

Sure sounds like it from the Globe story.

Berwick, a Newton pediatrician and longtime Harvard faculty …has been contemplating a run for the past two or three months, meeting with 40 or 50 people, including political veterans and consultants. …“I’m strongly considering it,” said Berwick, whose interest in the office was first reported by State House News Service.  While he would bring deep policy knowledge to a governor’s race, it is unknown whether Berwick can mount a serious candidacy, as a newcomer to politics who has never raised money or glad-handed voters at a strip mall.

More from Politico.

BHN caught up with Dr. Berwick on Martha’s Vineyard this summer, where he introduced a health care documentary. There, he talked about the people who came to see him during his short tenure in Washington:

Instead of demonizing doctors and drug companies, he doesn’t blame any of the players, who are working within the system as it stands.

“They’re just doing what makes sense,” he said. “We have to change what makes sense.”

 For more on Dr. Berwick see:

Hounded ex-Medicare chief Berwick back in Boston

Donald Berwick, who was hounded out of Washington for saying something nice about the UK health system, is back in town and on WBUR today.

Also check out today’s NTYimes op/ed by Joe Nocera:

Dr. Donald Berwick was already in Massachusetts when I spoke to him Sunday afternoon. He was back in the Newton home where he’d lived for 30 years, being pleasantly interrupted during our conversation by his 2-year-old grandson. His last day in Washington as the administrator of the Centers for Medicare and Medicaid Services had been Thursday. Friday was packing day. Saturday was moving day. And, by Sunday, he was already talking about his too-short, 17-month tenure as the nation’s top Medicare official in the past tense. Which, alas, it was.       

Dr. Berwick, I’m here to tell you, was the most qualified person in the country to run Medicare at this critical juncture, and the fact that he is no longer in the job is the country’s loss.
%d bloggers like this: