May 27th, 2008 by Dr. Val Jones in Expert Interviews, Health Policy
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I attended the STOP Obesity Alliance press conference on May 22, 2008, in Washington, D.C. During the conference a new strategy to reduce obesity rates was announced — which provides employers with an obesity management benefit for their employees. I asked Carl Graziano, the vice president of communications for DMAA: The Care Continuum Alliance, to explain what this new benefit is and how it works. (DMAA was formerly known as the Disease Management Association of America.)
Dr. Val: How does the DMAA “prototype obesity benefit” work?
Graziano: The prototype is just that — a suggested approach based on the best available evidence on effective obesity interventions. While we provide a template for possible covered services and suggested pricing, it will be up to individual end users to tailor this benefit to their particular budgets, corporate cultures and values. Generally, we recommend three tiers of coverage, starting with enhanced primary care services, nutritional counseling and pharmaceuticals. A second tier would add treatment by an obesity specialist, and a third level would provide coverage for bariatric surgery and associated supporting services. Plan participants could be subject to an additional premium and co-payments for these services, as with other “riders,” such as vision and dental benefits.
Dr. Val: Which employers are planning to offer this benefit?
Graziano: We’re pleased to have the support of the Service Employees International Union (SEIU), which will consider our benefit approach as it develops coverage for its members. We expect that as experience with the benefit design and awareness grows, other employers will tailor it to their specific needs. As the STOP Obesity Alliance survey shows, while most employers believe in the appropriateness of obesity-related services, less than half say their companies devote enough attention to the problem of obesity. We believe this reflects a lack of guidance on how to provide obesity benefits, and that’s why we developed our suggested approach.
Dr. Val: What can people do to make sure that their employer offers this benefit or something similar?
Graziano: Because this benefit prototype will be freely available from and promoted by DMAA, we expect growing awareness of it among benefits managers over the next year — both through their own efforts to stay current on benefit design trends and recommendations from employees and others.
Dr. Val: How do we know that this program works? What outcomes have you demonstrated so far?
Graziano: Designing a formal approach to obesity benefits is largely uncharted territory, which is precisely the reason why DMAA saw a need to initiate research in this area. That said, our benefit design is strongly rooted in the best available evidence that interventions deliver high-value, positive outcomes. We are breaking new ground here, but we believe the benefit’s value-based approach offers the best chance of positive clinical and financial outcomes in a real-world setting.
Dr. Val: What’s the most important aspect that the public should know about the DMAA obesity benefit?
Graziano: It’s important that the public understand that personal behavior — eating healthfully, exercising and making other lifestyle changes — is essential to the success of any overweight or obesity intervention. While our benefit approach may ultimately contribute to new and expanded care options for the overweight and obese — a change that’s much needed in the face of a growing obesity epidemic — the commitment of plan participants to these interventions will play a large part in reversing the overweight and obesity trend.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 26th, 2008 by Dr. Val Jones in News, Opinion
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American physicians are appropriately frustrated about the high cost of medical malpractice insurance, and the frequency with which false and/or exaggerated claims are filed against them. In the Philadelphia region, a spine surgeon must pay upwards of $300,000.00 a year in malpractice insurance. The law allows Obstetricians to be sued for mishandling the birthing process until the “child” is 20 years old. In many states, there is no cap on the amount of money awarded in a true case of negligence, and juries set the pay out – which can exceed 20 million dollars per verdict.
Interestingly, Texas instituted a new policy in which firm caps were placed on malpractice claims. The cost of medical malpractice insurance dropped precipitously, and over 7000 physicians flooded into the state.
I recently interviewed Canadian Senator Michael Kirby about the medical malpractice process in Canada, and he laughed at how litigious the American system is. He said that keeping the malpractice system from being abused is quite simple: fine plaintiffs who bring forth frivolous suits, set caps on pay outs, and allow awards to be set by judges, not juries. You can listen to our discussion here.
However, there is a flip side to this coin – when providers are permitted to practice without any real legal recourse. I was astonished to learn (from my blogging colleague across the pond, Dr. John Crippen), that in New Zealand midwives are permitted to practice without any form of malpractice insurance. In fact, a recent case demonstrated obvious negligence resulting in the death of a newborn baby. What recourse did the mother have? Apparently, her legal actions resulted in a payout of $2,000.00 and a promise of closer oversight of the practices of midwives.
Wow.
On the spectrum of “reasonableness” for medical malpractice policy, I believe the Canadians win, followed perhaps by Texans. What do you think?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 24th, 2008 by Dr. Val Jones in True Stories
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One of my colleagues at Revolution Health has a daughter who is a freshman in college (we’ll call her Julie). Julie has been struggling with a very sore throat for many months, and her mom would occasionally ask my opinion about her care.
Julie initially believed that she had a viral throat infection and tried to wait it out. Several weeks later the pain was quite severe and worsening instead of improving, so she sought help at the student health service at her university. The nurse reassured her and told her to wait a little bit longer and come back in a couple of weeks if things weren’t improving.
Two weeks later Julie was back, and was offered a monospot test (which was negative). The nurse practitioner gave her some samples of Keflex to treat her presumed strep throat, and was told to return in 2 weeks if her symptoms hadn’t resolved. Julie’s mom asked me if I thought that was ok, and I mentioned that drug resistance was not uncommon to Keflex, but that it was really cheap. I explained that Julie’s throat had been sore for an awfully long time, and that if the Keflex didn’t improve her symptoms within a few days, she might want to try something stronger.
Guess what? A week later Julie went back to the student health service with continued symptoms, and their response was to continue the Keflex for a full 10 days. Julie asked if a different antibiotic might be appropriate, and they simply replied that the health service only carried Keflex.
Julie completed the full course of antibiotics with no improvement. She called her mom to ask what she might do next and I suggested that she consider seeing a physician about an antibiotic with a lower resistance profile (like azithromycin). She was unable to get an appointment for a couple of weeks. The student health service nurse said that Julie’s throat did not appear concerning.
As it happened, Julie began having difficulty swallowing, was unable to sleep because of her throat pain, and had a low grade fever. I worried about a peritonsillar abscess (pus trapped in the deep tissues of the throat) and counseled Julie’s mom to get her to a physician right away. Julie flew to DC to be with her mom for the weekend, and was able to get an appointment with a primary care physician who gave her some azithromycin and steroids and said that there did not appear to be any visible signs of a peritonsillar abscess.
Again, Julie’s pain continued unabated. Her throat became even more swollen – and at that point I encouraged them to go to the ER to rule out an abscess. Julie was seen by an affable young ER physician who promptly ordered a CT scan of her neck. Several hours later the diagnosis was confirmed: Julie had pus trapped in the deep recesses of her throat. The ER doc numbed up the tonsil area and inserted a needle into the pus and pulled out several cc’s of thick green goo.
Man I wish I could have been there. (I know that’s a weird response, but docs LOVE pus.)
As I thought about this case, I wondered if we’ve gone too far in withholding antibiotics from deserving patients in our quest to reduce resistant bacterial strains. For every Julie there’s probably 100 others receiving (quite inappropriately) azithromycin for a viral throat infection… but Julie’s case may represent a new kind of provider problem: their own resistance to antibiotics.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 23rd, 2008 by Dr. Val Jones in Expert Interviews, Health Policy
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Sen. Sam Brownback (R-Kans.) and Rep. Diane Watson (D-Calif.) held a press conference on May 21 to announce the introduction of the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act. The ACCESS Act seeks to increase terminally ill patients’ access to promising treatments in the investigational phase of Food and Drug Administration (FDA) approval.
I had the chance to interview one of the speakers at the press conference, Emil J. Freireich, M.D., the director of the Adult Leukemia Research Program at M.D. Anderson Cancer Center at The University of Texas. His opinions are quite provocative.
Dr. Val: You’ve expressed frustration with the FDA’s cancer drug approval process, especially as it pertains to terminally ill patients and investigational drugs. What’s the source of your frustration?
Dr. Freireich: The problem with the FDA and the research process in this country is that it’s too risk-averse. Twenty-five thousand Americans die in car accidents each year, but we don’t ban cars. Five-hundred thousand Americans die of cancer each year, and the FDA makes it impossible for many of them to get the drugs they need. What’s the sense in that?
The excessive red tape [slowing down the research pipeline] is caused primarily by legislation created at the time of the thalidomide disaster [1957-1961]. They made a mistake in marketing a sedative to an untested population group of pregnant women, and that resulted in the alarming birth-defect consequences. However, because everybody panicked, now the FDA regulates the earliest development of a drug. The whole process of drug approval changed.
Treatment of human beings for disease is the only area of research where the scientists who know about it have to petition the government to begin to do research. I can do research in physics, chemistry, astronomy or any science. But if I’m going to do medical research, I have to petition the government first — even for animal studies.
The FDA should not have power over the Investigational New Drug (IND) process. Scientists should not have to petition nonscientists to do research. The FDA is always seeking more scientists to work for them — but they’ll never get enough because what kind of scientist wants to sit behind a desk and approve someone else’s research? If you’re creative and innovative, you want to do your own research.
Dr. Val: Let me ask you about funding. The health care system has a limited amount of money — how can you justify spending it on investigational drugs for the terminally ill?
Dr. Freireich: Of the $50 million used to bring a drug to market, $49.5 million is used to satisfy regulators. That’s where the money goes. If you are in a pharmaceutical company and you want to get approval for your drug, you have to hire people who used to work at the FDA to figure out what hoops they’re likely to require you to jump through.
And how does the FDA decide how the drug should be developed? By consulting the world’s leading scientists and researchers? No. Regulators make up the rules on a whim. They stipulate things like: “Before you can do human trials, you have to kill 1,000 monkeys in Africa, and then 4,000 rats in China. And if you bring home that data, we’ll be sure to approve the drug. Then pharma goes to venture capitalists to pay for the monkey and rat trials, and the FDA approves the drug for human trials. But to make sure that the maximal benefit is observed in the trial, participants have to be young Olympic athletes with normal kidneys, livers, a full head of hair, nice teeth and a small cancer. Meanwhile all my patients are dying as they’re ineligible to participate.
Take Gleevec for example. Chronic myelogenous leukemia (CML) used to have a median survival rate of 3 1/2 years (90 percent of people were dead in five to six years). Today 90 percent of people with CML have a 10-year survival rate. And that’s the result of just one drug. When we gave Gleevec to the first 10 patients, it was obvious how powerful it was. But we were required to do a randomized trial that took two years, and half the patients were given interferon — which we knew wouldn’t cure them. I had a patient who was on the board of directors of Novartis. He had CML, and he had all the data, and he knew he needed Gleevec. He entered the trial and happened to be randomized to the interferon arm and died. This shows you that the venture capitalists and administration of pharma are powerless. They can only do what these powerful FDA regulators allow.
Some of the regulators are 25-year-old college graduates, and they essentially control the lives of millions of people. All they have to do is sit at their desk and say “no” all day long to trials. Regulators have no incentive to approve drugs for trial because of risk aversion. I could create a cure for cancer, but if one person dies in a trial, then they’d fire the FDA guy who approved it. Then if they’re really smart, they go over to the industry side and get a tenfold pay raise and make more than the researchers and doctors who are trying to save the lives of cancer patients.
Dr. Val: What about all the research that is unregulated? The research in alternative medicines, for example?
Dr. Freireich: The tragedy is that the FDA can’t touch alternative medicine practices. FDA regulation only hinders the legitimate scientists, while the quacks get off scot-free. This is due to the “consequence of the unintended.” The legislation wasn’t intended to control quacks, but it controls legitimate scientists. Why? Because the government funds 30 percent of all research in this country. If I say to my research lab director: “I have a drug that can cure leukemia, but the FDA won’t let me test it — let’s just do test it without their approval.” He’ll respond: “Guess what? Thirty percent of our budget will disappear in five minutes.”
At the same time that I can’t get FDA approval to test promising drug therapies, there’s a quack in Houston who sells urine extracts to cure cancer. Why doesn’t the FDA touch him? He doesn’t accept federal funds, so he can do what he wants. In a sense, the quack movement is indirectly fed by the FDA. If patients could get legitimate treatments from doctors, they wouldn’t be turning to quacks. The problem is that they come to me and I have to tell them that they’re not qualified for clinical trials. The patients we turn away from M.D. Anderson go straight to the quacks. What else can they do? You can either pray, go to a quack or go on the Internet to look for miracle cures.
Tragically, if it takes 10 years to develop a cancer drug, 5 million people die while waiting for it to be approved. That same drug could be developed in one year, but we’re being regulated in areas where it’s not needed. The FDA should be worrying about the drugs we give to healthy people, not worrying about sick people — that’s the doctor’s job.
Dr. Val: Well, what do you suggest we do about this?
Dr. Freireich: The solution is legislation. Why does the public put up with the current IND process? Because most of the public is healthy. Healthy people never envision themselves getting sick. If you’re healthy, you don’t think about cancer happening to you. We need to wake up and support the ACCESS Act legislation.
***
Addendum: I spoke with Selma Schimmel, the CEO of Vital Options International, a cancer advocacy group, about her perception of the investigative drug process. She said that while she is sympathetic to cancer patients’ eagerness to gain access to drugs, she wouldn’t want them to be harmed by investigative drugs either. Schimmel says that the FDA is in a difficult position in which staff are held accountable for an incredibly high standard of safety — and yet the agency is being asked to push things through quickly.
This ACCESS Act has been a topic of debate for some time and was discussed here.
Another article of interest about FDA and Medicare joining forces to form an early warning drug network was published in the LA Times today.
What do you think of this issue?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 22nd, 2008 by Dr. Val Jones in Humor
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My husband said this after contemplating his accidental role as softball captain for his work team:
“I think I’m a closet extrovert.”This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
