June 3rd, 2008 by Dr. Val Jones in Expert Interviews
Tags: Alzheimer's, Caregiving, Geriatrics, Neurology, Pathology, Pharmaceuticals, Research
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The following interview with Alzheimer’s researcher, Dr. Jeffrey Cummings, is a continuation of part 1…
Dr. Val: Tell me about the comorbidities associated with Alzheimer’s and how caregivers can prepare for them.
Dr. Cummings: Being a caregiver is a real challenge. It’s so difficult to take care of someone who may be incontinent, agitated, psychotic or depressed. All of these symptoms occur with increasing frequency as the disease progresses, and can challenge even the most devoted caregiver.
There are educational programs that can help to explain to caregivers where these behaviors are coming from, and can teach them how not to exacerbate the symptoms. For example, it’s important to avoid confrontation with the patient. If he or she doesn’t want to take a shower in the morning, then it’s better just to let it go.
Reducing friction between the caregiver and the patient has been shown to delay the time to nursing home placement, so there are behavioral interventions on the part of the caregiver that can be very beneficial.
Dr. Val: What can online companies like Revolution Health do to support patients with Alzheimer’s disease and their caregivers?
Dr. Cummings: We’ve learned that there are things that people can do to protect themselves against getting Alzheimer’s disease. This includes physical exercise (at least 30 minutes per day 3 times per week), active engagement in leisure time activities, eating a diet high in anti-oxidants (such as salmon, green leafy vegetables, and blueberries), avoiding head trauma (e.g. wear helmets while cycling), controlling high blood pressure, and controlling cholesterol.
It would be great if Revolution Health included all of these healthy lifestyle strategies in a comprehensive Alzheimer’s prevention agenda.
Dr. Val: Is there a role for the “brain games” movement in Alzheimer’s disease?
Dr. Cummings: That’s an interesting question – though I’ve seen very little data supporting brain games in particular. We do know that active intellectual engagement reduces the risk of Alzheimer’s disease, but once one has the disease, it’s less clear whether these kinds of programs can actually reduce progression. At the very least they may reduce agitation by active engagement of the patient, leaving less time for them to be unoccupied. I’d really encourage the people who are developing brain games to test them in well controlled trials. The games could be tested in the same way that drugs are tested.
*Listen to the full interview here*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 30th, 2008 by Dr. Val Jones in Expert Interviews, True Stories
Tags: Disabilities, News, Obstetrics And Gynecology, Podcast, Reproductive Endocrinology
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Revolution Health expert, Dr. Rafat Abbasi, is a reproductive endocrinologist and fertility specialist in Washington, D.C. She told me this exciting story about a miracle baby that brought great joy to a young family. She hopes that this news will bring hope to other young men and women who have spinal cord injuries and want to have children.
Dr. Val: Tell me about the fertility success story that has you so excited.
Dr. Abbasi: A young couple was referred to me because they wanted to have a baby. They had been married for about a year, and had been through one miscarriage already. Sadly, the young husband (he is about 35 years old) was then involved in a freak mountain biking accident and broke his neck, severing his spinal cord. He was paralyzed from the neck down and confined to a wheelchair, unable to function sexually. His 29 year old wife and he were devastated.
They came to me wondering if there was any way that they could get pregnant under the current circumstances. And due to the amazing advances in fertility treatments, I was pleased to report to them that there was a chance that they could. I explained how we’d do it.
First we had to collect some sperm from the testes of the husband. We could do this by using an electric current to stimulate a spontaneous ejaculation reflex and then inseminate the wife with the fluid, or if that didn’t work, we could withdraw some immature sperm directly from the testes with a needle. I explained that if we retrieved the sperm with a needle we’d need to mature the sperm in a test tube incubator overnight, and retrieve eggs from her and then use in-vitro fertilization techniques to create embryos to implant into her womb. In order to get the eggs, we’d need to use egg-stimulating hormones (for about 10-12 days) and an ultrasound-guided needle retrieval technique (under local anesthesia).
As it turns out, we used the second method for this couple. We transferred three embryos and one of them took, and she gave birth to a beautiful baby girl. The couple is now interested in having a second baby.
Dr. Val: Isn’t it true that spinal cord injury can contribute to infertility? How does that work?
Dr. Abbasi: Over time, men who’ve had a spinal cord injury suffer from testicular atrophy which affects their hormone levels and can make it much more difficult to retrieve viable sperm. Fertility rates start to decrease substantially 5-7 years after a spinal cord injury.
Dr. Val: What made this story touching for you?
Dr. Abbasi: I think the whole story is incredibly touching because this young man, who was in the prime of his life, had a freak accident that took away his hope of ever having kids. His rehabilitation medicine physician thought to refer him to a fertility specialist (because he’d heard about the technique we use to retrieve sperm from patients who’ve had spinal cord injuries) and now he’s blessed with a family. Until then he mistakenly believed that there was no hope for a pregnancy after his injury. His life is different now due to his physical limitations, but he is full of joy because of his baby daughter. It gives me goose bumps just thinking about it.
To listen to the full interview (with a step-by-step clinical account of how the fertility procedure was managed), click here.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 28th, 2008 by Dr. Val Jones in Expert Interviews
Tags: Cancer, Chronic Disease, Complementary And Alternative Medicine, Food and Nutrition, News, Vaccines, Weight Loss
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Dr. Val: Dr. Carmona, I recently met you at the Partnership to Fight Chronic Disease conference in Washington, D.C., and now you’re here with the STOP Obesity Alliance. You are certainly one busy guy. What are you doing with your life these days?
Dr. Carmona: My life is certainly very full and very fulfilling. After completing my four-year term as surgeon general, many good people in the private sector offered me opportunities to continue my life’s work. All of my endeavors are geared toward improving the public’s health —that is, the health, safety and security of a person, a population, a nation —and sometimes even globally through partners that we work with.
As I surveyed the various opportunities to engage in public health service, I wanted to choose initiatives that gave me the biggest bang for my buck. In other words, I wanted to support programs that would have maximal impact in improving the lives of Americans. The chronic disease burden caused by a preventable condition —obesity — seemed like a really logical place to start.
We have to figure out how to reverse obesity in more than 9 million children, and we need to help the two out of three adults who are overweight or obese. Obesity has a huge impact on diseases across the board —asthma, cardiovascular disease, diabetes, cancers and a whole host of chronic diseases. Obesity either causes or is a comorbid [simultaneous and independent] factor in each of these.
In addition to my involvement in the Partnership to Fight Chronic Disease and in the STOP Obesity Alliance, I am involved in the National Foundation for Infectious Diseases, where I chair the Childhood Influenza Immunization Coalition — which endeavors to ensure that our children get their full complement of vaccines.
In a country where we spend more on health care than any other nation in the world, our metrics put us somewhere between 25th and 40th in terms of life expectancy, childhood vaccinations, maternal child mortality and things like that. We have to step back and ask: “Where are we missing the boat here?” I think part of the answer is that many of our children don’t complete their immunization series. In Arizona just recently, we had a measles outbreak. That shouldn’t happen in this country.
When I was a child, every mom worried about her son or daughter getting polio. We don’t have to worry about that any more because of vaccines. In a global economy where people move freely across geopolitical borders, vaccination has never been more important —both here in the U.S. and internationally.
Dr. Val: Tell me a little bit about what you’re doing at Canyon Ranch. People may have some misperceptions about the population that Canyon Ranch exists to serve (i.e., wealthy spa-goers). But I know there’s a lot more to it than that.
Dr. Carmona: I’m the vice chairman and CEO of Canyon Ranch [resorts in Arizona, Massachusetts and Florida], and I am always looking for opportunities for the organization to contribute to health policy issues. Our goal is to help the people who come to us to find a path to optimal health and wellness through prevention strategies based on a true integration of the mind, body and spirit.
The Canyon Ranch Institute is the nonprofit arm of our organization that takes our best practices at Canyon Ranch and translates them to underserved populations around the country. So we serve the upper echelons of society, but we also have a strong social responsibility to “give back” to underserved communities and to help eliminate health disparities. Through the institute, we partner with [for example] the Urban Health Plan in the South Bronx [in New York City] — which is in one of the poorest congressional districts in the United States. We’ve committed to helping some of the poorest Hispanic people in America because they struggle with disproportionate disease burden as a group.
Essentially, we’re building a Canyon Ranch Institute Life Enhancement Program in a federally qualified community health center to change the health metrics of that population. And we’re going to focus on disease prevention and an integrative approach to health and wellness. We’re going to measure our impact scientifically. We do everything in peer partnership in a way that honors the culture of the community, and we respect what they’re already doing to serve their population. With everything we do, we plan and act as consultants to the local community leaders. In this case, we took the local community physician and other health leaders and brought them to Canyon Ranch on a scholarship program. We trained them and then sent them back to the Bronx with a small team of staff to help them put together a life enhancement program. And now, we’re building a curriculum with them.
Dr. David Satcher and I are discussing a new initiative in Atlanta, perhaps through his institute — the Satcher Health Leadership Institute. We also have a partnership with the Lance Armstrong Foundation, in which we’ve come together with other surgeons general to bring forth a collective call to action on cancer prevention and survivorship — which we’ll announce this summer here at the National Press Club. This is the first initiative to include all the past surgeons general, so it’s really exciting.
We’re doing many innovative and entrepreneurial things that we can initiate quickly with a lot of smart and willing people. You can move a little more nimbly in the private sector than you can in the federal government, so it’s a joy to be able to pull all these people together to address the unmet needs of various populations at all levels of society.
Dr. Val: How do you incorporate the “mind, body, and spirit” approach to health without getting too far afield from science?
Dr. Carmona: At Canyon Ranch and the Canyon Ranch Institute, we believe that achieving optimal wellness involves taking an integrative and holistic approach to the many dimensions of health and well-being —enhancing the physical, mental, emotional, social, spiritual and environmental aspects. We’re also helping to translate this integrative approach to underserved communities through the Canyon Ranch Institute.
I have a small group of integrative health doctors and other health professionals who meet on a regular basis at Canyon Ranch. Their job is to read their scientific literature and meet periodically with me to present the new and emerging science in health and wellness. Then we review the science together and ask ourselves if there’s anything applicable that we could use as a product to improve the health of those we serve at Canyon Ranch or through the Canyon Ranch Institute’s nonprofit efforts.
So, for example, we’ve been taking a close look at the brain fitness movement in order to see what we could apply to older adults. When you and I went to medical school, we were taught that when you hit 60 or 70, you couldn’t really learn anything new and you need to be put out to pasture. The fact of the matter is that the science is now very clear that not only can you learn, but you can grow your knowledge and ability in many areas — even when you’re into your 90s and 100s. So at Canyon Ranch, we combine physical fitness with brain fitness, and we have holistic programs to develop cognitive skills through nutrition and mind exercises to increase intellectual capacity.
We have also been investigating whether or not touch can be healing. I believe it’s a gray area — some of it may be hocus-pocus, but some may also have scientific merit. So we’re working with Gary Schwartz, Ph.D., an expert in energy medicine, to take a closer look at this and to conduct some trials to see what works. I know this is pushing the envelope, but it’s not implausible that the comfort and stress reduction one experiences from gentle touch might improve immunity.
I recognize that holistic medicine is a very dynamic and challenging field to be in, but we vet everything and make sure that we have some scientific validity before we move forward with anything as a product. We try to stay open-minded as we study these so-called complementary and alternative medicine practices to see what works. And if we find a benefit, we incorporate it. If not, we reject it and move on.
Dr. Val: And do you practice what you preach? How are you taking care of yourself?
Dr. Carmona: I get about an hour to an hour and 15 minutes of exercise five to six times a week. I even have staff meetings while working out at the gym sometimes. I’ll say: “I have 24 hours a day, and you guys get 23. But I need one for exercise. If it’s so important that you need to see me during that hour, then you have to work out with me. We can swim or walk, and you can debrief me while we’re doing that.” Sometimes they’ll take me up on it, but not always. Last night we didn’t finish our business dinner until 11 pm. Everybody went to bed, but I went to the gym.
I do a lot of cross-training. I don’t run that much anymore because my knees are getting sore. I use elliptical machines and the StairMaster. I swim, and then I do a weight training circuit every other day.
Just keep moving. I think that’s the important thing.
Dr. Val: And what do you do nutritionally?
Dr. Carmona: I’m careful about what I eat. I eat a little bit of beef, but not much. I do eat a lot of chicken. I have fish allergies so, unfortunately, I can’t eat seafood. I eat a lot of whole grains, nuts and fruits, and I control my portions. My typical breakfast is oatmeal, fruit and a glass of skim milk. For lunch, I have a sandwich and some salad, and then I have a full but portion-controlled dinner. I allow myself some vices. I used to joke with my staff all the time about not being able to pass a Baskin-Robbins without stopping in to get a vanilla ice-cream cone.
Dr. Val: Baskin-Robbins has 31 flavors … and you pick vanilla?
Dr. Carmona: That’s right. I told them they’re wasting their time on the other 30. There’s only one flavor that I need: vanilla. Every once in a while, I’m really risqué and I’ll try French vanilla.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 27th, 2008 by Dr. Val Jones in Expert Interviews, Health Policy
Tags: Finance, Food and Nutrition, News, Pharmaceuticals, Research, Surgery, Weight Loss
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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 23rd, 2008 by Dr. Val Jones in Expert Interviews, Health Policy
Tags: Cancer, FDA, Medicare, News, Pharmaceuticals, Research
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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.
