December 19th, 2008 by Dr. Val Jones in Opinion
Tags: Abigail Burroughs, Cancer, Erbitux, FDA, Medical Ethics, Oncology, Pharmaceuticals
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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?
December 16th, 2008 by Dr. Val Jones in Opinion
Tags: Cigarettes, David C. Frederick, Fair Trial, Phenergan, Supreme Court, Wyeth vs. Levine
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For some reason, people just love to misrepresent the issues underlying the Wyeth vs. Levine case. I have written extensively about this case here and here because I found it so amazing that the media has bungled the story so badly – and that no one is really calling them on it.
In case you don’t recall – Ms. Levine was the victim of medical malpractice. An anti-nausea drug (phenergan) was injected into (or very near) her artery by accident (the potential consequences of such an error are clearly indicated on the drug label). Tragically, the resulting chemical reaction with the oxygen in her artery caused such severe tissue irritation that her arm eventually had to be amputated. Ms. Levine settled out of court for $700,000 with the clinic where the injection occurred. Unfortunately the story doesn’t stop there.
Ms. Levine’s attorney counseled her to sue the drug manufacturer for inadequate label warnings (the potential hazard is in fact mentioned on the label six times – though it does not forbid IV administration of the drug, though it recommends a low dose and slow push). In a precedent-setting judgment, a jury in Vermont decided that the FDA-approved label was inadequate, and that it should have fully contraindicated administration via IV push. The jury awarded Ms. Levine $6.8 million and Wyeth contested the judgment, bringing the case to the US Supreme court in November, 2008. The case has not yet been decided, though it has been compared to deceptive labeling of “light cigarettes.”
How on earth is a drug that has been successfully administered (without harmful side effects and with good efficacy) over 200 million times in the U.S. equivalent to cigarettes (a known carcinogen with no therapeutic value)? It’s an exceedingly poor analogy.
To put it another way, if a nurse took an insulin syringe and injected it into a diabetic’s eyeball, causing blindness, should I say that the insulin manufacturer (because it did not forbid the injection into the eye) was engaging in deceptive labeling and should be at fault for the patient’s loss of vision? The PA who injected the phenergan into Ms. Levine’s artery, and our hypothetical nurse who injected insulin into an eyeball are the ones to blame.
But wait, it gets worse.
The attorney (David C. Frederick) who is arguing Ms. Levine’s case in front of the Supreme Court is being considered by our President elect for the position of Solicitor General of the United States. Yes, this very man who is engaged in a law suit that could potentially set a precedent that would allow all 50 states to set up their own mini-FDAs with the lay public (i.e. juries) deciding what drug label language should say.
The pro-Levine camp argues that a court ruling in favor of Wyeth would preempt consumers from being able to sue drug companies for damages related to incomplete disclosure of risks (such as the Vioxx case) but in reality, the Wyeth vs. Levine case has no bearing on pharmaceutical non-disclosure, since Wyeth did not hide the irritant risks of phenergan from the FDA. They have been known for decades.
So Wyeth vs. Levine is NOT about deceptive labeling or non-disclosure of risks – it’s about whether medically uneducated juries should have the power to set arbitrary drug labeling language standards in order to facilitate litigation against deep-pocketed pharmaceutical manufacturers whenever a patient is harmed in a case of medical malpractice.
I understand that many folks are frustrated with pharmaceutical wrong doing (and there are many cases of it), but this is just not one of them. In America, we are not supposed to bring pre-conceived notions to bear on law suits, but objectively review the facts in each case, separate from our general feelings about those involved. I do think that Wyeth isn’t getting a fair shake in the media because of the general mistrust/dislike of Big Pharma. But everyone has a right to a fair trial. I sure hope they get it.
December 15th, 2008 by Dr. Val Jones in Opinion
Tags: Consumer Health World, Dr. Val Jones, Health 2.0, Health 3.0, Health 4.0
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The “Health 2.0” movement is about “consumer directed healthcare” and proposes to empower patients with online tools and technologies to help them manage their care and take control of their health. Some Health 2.0 initiatives have been quite popular – though many suffer from lack of participation on the part of consumers. Having your own personal health record sounds great – but when you’re the one who has to manually enter the majority of the data into it, only the most motivated patients will participate. Access to online physician ratings is appealing – but when everyone wants to read the ratings, but no one takes the time to complete the ratings questionnaire, the value of the tool is lost.
Over the past few years there have been a number of regularly repeating conferences created to unify key stakeholders around healthcare’s digital agenda – Health 2.0, Health Care Consumerism, The Healthcare Globalization Summit, Health 3.0, New Media Expo, Blog World Expo, Health 4.0, the AMA’s Medical Communications Conference, and more. Thankfully, these disparate groups with overlapping agendas are beginning to consolidate – offering new mega conferences that simplify the learning and relationship-building process.
My observation as an attendee of several of these conferences is that providers and patients are still not coming together as they should. Online healthcare solutions tend to be created in a lopsided manner – either by consumer/patient groups without much provider input, or by providers/health plans/governmental agencies without much patient/consumer input. The result tends to produce two types of products 1) active online groups and tools that facilitate both helpful information and misinformation or 2) products that advance good concepts, but have low participation due to lack of user-friendliness.
The current conference version “arms race” (to attract the most powerful vendors and largest audience possible) is not terribly helpful. Whether you associate with Health 2.0, 3.0 or 4.0 – the bottom line is that the Internet is a powerful force in healthcare. It can provide many different kinds of tools that make valuable contributions to health education, care management, behavior modification, emotional support, and improved quality outcomes. In the wrong hands it can also mislead patients, promote snake oil, sensationalize health news, confound research efforts, misinform, and mislead.
There is no more critical time than this for providers and patients to join forces to guide the development of new online health initiatives. The successful execution of digital health platforms requires a patient-provider partnership – I can only hope that upcoming conferences will embrace this view more fully.
In my next few blog posts, I’ll provide you with some fascinating interviews with key opinion leaders from the recent Consumer Health World mega-conference in Arlington, Virginia. The interviews are as follows, so stay tuned:
1. Skip Brickley, founder of Consumer Health World
2. Joseph Heyman, M.D., Chair, Board of Trustees, the American Medical Association
3. Emme Levin Deland, Senior Vice president, Strategy, New York Presbyterian Hospital
4. Joseph Kvedar, M.D., Director, Center For Connected Health, Partners Healthcare
December 11th, 2008 by Dr. Val Jones in Opinion
Tags: Children's Health Insurance, CHIP, Dr. Val Jones, Galen Institute, Grace-Marie Turner, Health Policy, SCHIP
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Some thoughts to chew on from Grace-Marie Turner:
But expanding SCHIP to cover all children would be a mistake, for four reasons:
1. First, Congress should make sure poorer, uninsured children are covered first. At least two-thirds of uninsured children already are eligible for SCHIP or Medicaid but aren’t enrolled. If SCHIP were expanded to cover children in higher-income families, their parents would rush to the head of the line to get the taxpayer-subsidized coverage. When a “free” government plan is offered, it’s nearly impossible to resist. Poorer children would be left behind as states focus on enrolling higher-income kids.
2. Second, expanding the program would “crowd out” the private insurance many higher-income kids already have. Hawaii offers proof. Earlier this year, the state created a new taxpayer-financed program to fill the gap between private and public insurance in an effort to provide universal coverage for children. But state officials found families were dropping private coverage to enroll their children in the government plan. When Gov. Linda Lingle saw the data, she pulled the plug on funding. With Hawaii facing budget shortfalls, she said it was unwise to spend public money to replace private coverage children already had.
3. Third, putting many millions of children on a government program will quickly lead to restrictions on access to care. A young boy died in Baltimore not long ago from an untreated tooth infection, even though he was enrolled in SCHIP. Few dentists can afford to take SCHIP patients because the program’s reimbursement rates are so low. The boy’s mother couldn’t find a dentist to see him. In Massachusetts’ move toward universal health coverage, more people have insurance, but they are finding that physicians’ practices are often filled, with waiting lists for a new patient appointment at 100 days and counting. Putting more children on SCHIP will add to the program’s financial pressures, making it harder for poorer kids to get care.
4. Finally, government insurance means that politicians and bureaucrats, not parents, make decisions about the care children receive and about what services will or will not be covered.
December 5th, 2008 by Dr. Val Jones in Opinion
Tags: Dr. Val Jones, Finishing School, Manners, Medical Ethics, Physician, Physician Behavior
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Thanks to KevinMD for pointing out a recent NYT article about “etiquette-based medicine.” The author, a psychiatrist, suggests that physicians should use a check list to ensure courteous behavior and that this sort of thing should be taught in medical school. His suggestions were also published in the New England Journal of Medicine:
• Ask permission to enter the room; wait for an answer.
• Introduce yourself; show your ID badge.
• Shake hands.
• Sit down. Smile if appropriate.
• Explain your role on the health care team.
• Ask how the patient feels about being in the hospital.
If this sort of thing isn’t intuitively obvious to a physician then I’d say the blame should rest with his parents not his medical school. I mean, do we really need to teach doctors to knock on doors and smile on cue? Aren’t those sorts of things taught in pre-school?
It grieves me that some of my peers do not display what some might call “normal behavior” when interacting with patients. But I don’t think that’s related to their medical school curriculae – it’s the sad result of a broken healthcare system that wears thin our common human decency. Doctors are exhausted by clinical volume, henpecked by bureaucracy, delirious from lack of sleep, and stressed out by the daily grind of bad news, disease progression, and death. When well-groomed adults of sound mind require a checklist in order to smile appropriately, you know something’s terribly wrong.
Now, I don’t excuse disrespectful behavior – we docs must rise above our natural urge to be irritable at times, and remember that our patients are vulnerable and need our help. But for heaven’s sake… let’s drop the smug check lists and finger pointing. We’re all in this together, and it ain’t pretty.
