June 15th, 2009 by KevinMD in Better Health Network
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A 90-year old man with a pancreatic mass, almost definitely pancreatic cancer, was admitted to a hospital.
Surgeon Jeffrey Parks does the initial surgery consult on this terminal case, and recommends hospice care.
The next evening, he’s shocked by the “astounding amount of medicine [that] had been practiced” during the day:
Consults had gone out to GI, oncology, and nephrology. The GI guy had ordered an MRCP and, based on some mild distal narrowing of the common bile duct, had scheduled the patient for a possible ERCP in the morning. A stat CT guided biopsy of the liver lesions had also been done. The oncologist had written a long note about palliative chemotherapy options and indicated he would contact the son about starting as soon as possible. The nephrologist had sent off a barrage of blood and urinary tests.
It’s often said that we spend the most money in the world on futile care, often with little benefit to the patient. The preceding account was that phenomenon in action, replicated thousands of times on a daily basis.
A microcosm of what’s wrong with American medicine indeed.
*This blog post was originally published at KevinMD.com*
January 29th, 2009 by Dr. Val Jones in Audio, Expert Interviews
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Billy Tauzin has spent most of his life in politics. He has been a member of the House of Representatives as both a democrat and a republican, though his recent experience with a rare and usually terminal cancer (duodenal adenocarcinoma) radically changed his career path and trajectory. I caught up with Mr. Tauzin by phone at the America’s Agenda conference in Miami. You may listen to our podcast conversation or read my summary of our discussion below.
[Audio:http://blog.getbetterhealth.com/wp-content/uploads/2009/01/billy-tauzin.mp3]
Dr. Val: Tell me a little bit about your intestinal cancer and how that changed the course of your life.
Tauzin: I was in the process of finishing up a 25-year career in Congress when one night I had a sudden, massive bleed. I was taken to the hospital and was diagnosed with a rare cancer with a poor prognosis: duodenal adenocarcinoma. There was a hole in my intestine, right next to my pancreas.
I went to Johns Hopkins to have a Whipple procedure – and as you know a Whipple procedure is one of the most aggressive types of surgery anyone can endure. They kind of split you open like a fish, pull out your innards and restructure you. They had to remove part of my stomach, intestines, and pancreas, and then reconnected it with new ducts and channels. The Whipple was supposed to cure me, but unfortunately I found out (at a follow up visit at MD Anderson) that there was still cancer in my body.
The doctor told me very frankly that I was going to die.
Dr. Val: Tell me about the experimental drug that you were introduced to at that point.
Tauzin: My doctor reviewed my options with me: I could undergo another surgery, but that would probably kill me and would be unlikely to cure the cancer. They had no approved protocol for people in my position, but there was a drug (called Avastin) that had been successful in treating colon cancer – but was not yet approved for duodenal adenocarcinoma. The drug works by cutting off the blood supply to tumors – which meant that the drug could either damage my healing process or kill the cancer. My wife and I decided to take the risk because we had very little to lose. It was really a choice between “going to die” (my current situation) and “might die” (Avastin could cure me).
It’s a good thing we tried Avastin because it worked like a miracle. By the end of my first round of chemotherapy, the radiologist couldn’t even find the tumor on my CT scans. It was gone. I completed several courses of chemo and radiation and I’ve been cancer-free for over 5 years now.
Dr. Val: Did this miraculous recovery influence your decision to become the CEO of Phrma?
Tauzin: After I recovered from cancer, I was fortunate to be offered many different job opportunities. However, my wife looked at me and said, “You know Billy, you really ought to go to work for the people who saved your life.” And I thought, “If there’s a meaning in why I’m alive today – then surely it must be to use my experience to help patients like me across the world.”
Dr. Val: So what are you hoping to achieve at the America’s Agenda conference in Miami?
Tauzin: This conference is unusual in that we’ve gathered together a group of very disparate voices from different perspectives – labor, business, health plans, trade associations, academic medicine, etc. hosted by Donna Shalala (former Secretary of HHS) at the University of Miami. We are trying to define our commonalities so we can influence health reform more effectively.
Washington is all about differences – it’s partisan, it’s mean, and I’ve been on both sides of the aisle. I can tell you that there are good people in both parties, but they’d never know it because they consider each other enemies. What we’re trying to say here is: patients don’t sign in as democrat or republican when they register at a hospital. They sign in as sick people. This is not a partisan issue. We have a sick care system that needs to be a health care system.
Dr. Val: What should the Obama administration choose as their top priorities for health reform?
Tauzin: First of all we need to recognize that we spend 75 cents of every dollar on the damage done by 5 chronic diseases (including diabetes, heart disease, mental health, cancer, and lung disease). We must focus our system on early detection and prevention of these diseases, so that we manage them well and avoid the costly toll they take when untreated. We’re destined to be a poorer, sicker society if we don’t get insurance coverage for every American. We need insurance to provide early detection, prevention, and good management of our chronic diseases. How we do that is debatable. But we need to get there.
December 27th, 2008 by Dr. Val Jones in Announcements
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My dear friend Seton Holt passed away on Christmas eve. She was 42 years old, and surrounded by family at home. I wrote about Seton’s battle with cancer – and how she faced adversity with an inspirational courage.*
When you lose someone you immediately wish you’d had the chance for one last conversation – to make sure they knew how much you loved them, and what they meant in your life. I didn’t have that final conversation with Seton, but I suspect that she knew how I felt.
Seton was a devout Catholic. She leaves behind a nearly two-year-old son, Damian, her husband David, and a large loving extended family.
I’ll be attending her wake tomorrow. May she rest in peace.
*These are some of my previous posts about Seton:
Cancer Isn’t Fair
Unencumbered By Prognosis
Strawberry Shortcake In Central Park
The Lucky One
December 19th, 2008 by Dr. Val Jones in Opinion
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I was reading a good blog post about ethics violations in clinical trials in India, and was reminded of an interesting case in the U.S. Several years ago a 21-year-old woman (Abigail Burroughs) with terminal cancer (who had exhausted all treatment options) was denied the option of purchasing a drug that was in the final process of receiving FDA approval. The FDA ruled that terminally ill patients should not be permitted to purchase drugs until the drugs have completed the approval process, citing safety concerns. Their arguments also included that:
1. Patients cannot make a truly informed decision regarding whether or not to try a medicine that has not yet been fully tested.
2. Allowing access to drugs before they are FDA approved would undermine the clinical trial process.
3. If terminally ill patients could buy treatments, others would soon expect health plans to cover these costs for others.
4. Allowing access to drugs before they were proven effective would add to the public’s general confusion about evidence-based medicine and promote magical thinking.
I don’t know how you feel about this, but it makes me squirm a little bit. Although I appreciate the FDA’s position (and my colleague Dr. Jim Sabin has blogged about his support for the ruling) it just seems a little heavy-handed, especially in light of the details of the Abigail case. Here’s what I wrote to Dr. Sabin:
About the Abigail case… I think they were trying to get access to Erbitux for Abigail, and it was in phase III trials at the time (so there was mounting evidence for its efficacy – their request to purchase it wasn’t scientifically unreasonable.)
I have very mixed feelings about the FDA ruling. I understand that we don’t want to 1) set a precedent that would lead to insurers having to pay for expensive experimental therapies 2) discourage people from entering clinical trials 3) allow drug makers to profit from “false hopes” in terminal cases. However, couldn’t we add enough caveats to make it reasonable to allow patients who have exhausted all other options to purchase (with their own money) drugs that have shown promise but are not yet FDA approved?
What if we said that the drugs had to be in phase III trials, with enough evidence to suggest a plausible benefit for the patient? Terminal patients are rarely good candidates for clinical trials (I don’t think we’d be poaching from the CT pool), few can afford to buy monoclonal antibodies (and the like) on their own so if there were trials for terminal patients, they’d still have great incentive to join, and I’m not sure that just because a patient can buy a treatment that insurance will HAVE TO follow suit.
Something about limiting personal choices (for those who have the means to make them) seems un-American to me. There are very low risks of harm in monoclonal antibody treatments (so the argument that the FDA must err on the side of patient safety doesn’t really fit the Abigail case). Yes, it’s sad for those who can’t afford to buy every possible therapy – but why should we deny access for those who can? With the right caveats, I think we could allow people like Abigail to try every remaining option. But of course I agree that phase I drugs are just not far enough along the research pipeline to make educated choices about them.
Maybe Abigail was a casualty of the one-size-fits-all, population-based rules that are appropriate most of the time, but fail in exceptional cases. I predict that this sort of thinking (where evidence-based protocols are applied in a cook book manner to all patients with a given disease) will dominate the healthcare landscape in the coming years as we seek to reign in costs and do the best thing for most. I just wish there were a way to bend rules on the edges a bit. What do you think?
November 8th, 2008 by Dr. Val Jones in Celebrity Interviews, Expert Interviews
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Dr. Gawande
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Kaiser Permanente sponsored a special event in DC today – Charlie Rose interviewed Dr. Atul Gawande about patient safety in front of an audience of physicians. Dr. Gawande is a young surgeon at Harvard’s Dana Farber Cancer Institute, has written two books about performance improvement, and is a regular contributor to the New Yorker magazine. I had heard many positive things about Atul, but had never met him in person. I was pleasantly impressed.
Atul strikes me as a genuinely humble person. He shifted uncomfortably in his chair as Charlie Rose cited a long list of his impressive accomplishments, including writing for the New Yorker. Atul responded:
I’m not sure how my writing became so popular. I took one fiction-writing class in college because I liked a girl who was taking the class. I got a “C” in the class but married the girl.
He went on to explain that because his son was born with a heart defect (absent aortic arch) he knew what it felt like to be on the patient side of the surgical conversation. He told the audience that at times he felt uncomfortable knowing which surgeons would be operating on his son, because he had trained with them as a resident, and remembered their peer antics.
Atul explained that patient safety is becoming a more and more complicated proposition as science continues to uncover additional treatment options.
If you had a heart attack in the 1950’s, you’d be given some morphine and put on bed rest. If you survived 6 weeks it was a miracle. Today not only do we have 10 different ways to prevent heart attacks, but we have many different treatment options, including stents, clot busters, heart surgery, and medical management. The degree of challenge in applying the ultimate best treatment option for any particular patient is becoming difficult. This puts us at risk for “failures” that didn’t exist in the past.
In an environment of increasing healthcare complexity, how do physicians make sure that care is as safe as possible? Atul suggests that we need to go back to basics. Simple checklists have demonstrated incredible value in reducing central line infections and surgical error rates. He cited a checklist initiative started by Dr. Peter Pronovost that resulted in reduction of central line infections of 33%. This did not require investment in advanced antibacterial technology, and it cost almost nothing to implement.
Atul argued that death rates from roadside bombs decreased from 25% (in the Gulf War) to 10% (in the Iraq war) primarily because of the implementation of check lists. Military personnel were not regularly wearing their Kevlar vests until it was mandated and enforced. This one change in process has saved countless lives, with little increase in cost and no new technology.
I asked Atul if he believed that (beyond check lists) pay for performance (P4P) measures would be useful in improving quality of care. He responded that he had not been terribly impressed with the improvements in outcomes from P4P initiatives in the area of congestive heart failure. He said that because there are over 13,000 different diseases and conditions, it would be incredibly difficult to apply P4P to each of those. He said that most providers would find a way to meet the targets – and that overall P4P just lowers the bar for care.
Non-punitive measures such as check lists and applying what we already know will go a lot farther than P4P in improving patient safety and quality of care.
Atul also touted the importance of transparency in improving patient safety and quality (I could imagine my friend Paul Levy cheering in the background). In the most touching moment of the interview, Atul reflected:
As a surgeon I have a 3% error rate. In other words, every year my work harms about 10-12 patients more than it helps. In about half of those cases I know that I could have done something differently. I remember the names of every patient I killed or permanently disabled. It drives me to try harder to reduce errors and strive for perfection.
Atul argued that hospitals’ resistance to transparency is not primarily driven by a fear of lawsuits, but by a fear of the implications of transparency. If errors are found and publicized, then that means you have to change processes to make sure they don’t happen again. Therein lies the real challenge: knowing what to do and how to act on safety violations is not always easy.
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Charlie Rose
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Charlie Rose asked Atul the million dollar question at the end of the interview, “How do we fix healthcare?” His response was well-reasoned:
First we must accept that any attempt to fix healthcare will fail. That’s why I believe that we should try implementing Obama’s plan in a narrow segment of the population, say for children under 18, or for laid off autoworkers, or for veterans returning from Iraq. We must apply universal coverage to this subgroup and then watch how it fails. We can then learn from the mistakes and improve the system before applying it to America as a whole. There is no perfect, 2000 page healthcare solution for America. I learned that when I was working with Hillary Clinton in 1992. Instead of trying to fix our system all at once, we should start small and start now. That’s the best way to learn from our mistakes.
