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 19th, 2008 by Dr. Val Jones in Patient Interviews
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I met Patty Smith and her husband Jay at the Alzheimer’s Association gala in Washington, DC. Patty was diagnosed with early onset Alzheimer’s at the age of 51, and has devoted her life to raising awareness of her condition. She agreed to deliver a short message to the large audience, including political celebrities like Nancy Pelosi, Chris Matthews (of Hardball) and Newt Gingrich. I was able to spend some 1:1 time with Patty in a quiet press room prior to the event.
What struck me most about Patty was her courage and determination. Although her symptoms were troublesome to her (she had some difficulty concentrating, remembering details of her past, and couldn’t offer robust answers to questions) she was prepared to be vulnerable in a very public way. I was moved by Patty’s bravery, and her willingness to sacrifice personal comfort for public education. Of all the important donors and benefactors at the event, Patty was (in my opinion) the one who sacrificed the most- because she was the one who was willing to expose her frailty to us all. I became quite misty-eyed during this interview, as I witnessed a beautiful and brilliant woman slowly being robbed of her faculties (as was my own grandmother) by a relentless disease. I am honored that Patty took the time to tell me a little bit about what it felt like to be living with Alzheimer’s. My prayers are with her and her family.
Dr. Val: How were you first diagnosed?
Patty: I was working downtown on K Street for BB&T as one of their top consultants (I was 49 years old). But I slowly started missing some things and forgetting to follow through with my work. I remember being devastated when I was written up by my superior for poor performance. I decided to take some time off to figure out what was going on with my brain.
I went to see a neurologist who ordered an MRI. The MRI was normal because it was too early in the disease process to see changes. The neurologist then sent me to a psychiatrist to check me for depression. After several sessions, the psychiatrist sent me back to the neurologist saying “If this woman doesn’t have a neurological problem, I’ll eat my hat.” Then I had a PET scan which showed the Alzheimer’s disease. It took a really long time to get the diagnosis because no one thought of Alzheimer’s as a possibility for someone so young. Also there’s no history of Alzheimer’s in my family and my father is one of 17 kids.
Dr. Val: Did you undergo any genetic testing to find out if you carry a gene for Alzheimer’s?
Patty: Well, the neurologist ordered some tests on my spinal fluid, but unfortunately the person who tried to do the spinal tap missed so many times that we gave up because it was painful. [Patty’s husband adds: In the end the test results don’t make that much of a difference. You either have it or you don’t.]
Dr. Val: What is the most difficult part of being diagnosed with early onset Alzheimer’s?
Patty: The thing that frustrates me the most is that I lose my thoughts for a moment. They come back relatively quickly still. It’s hard to see it affecting my children. They’re 22 and 20. My diagnosis has been difficult for them but they’re taking it pretty well I think.
Dr. Val: If there’s one thing you’d like others to know about early onset Alzheimer’s disease, what would that be?
Patty: I’d like doctors to consider it as a possibility when they’re seeing patients with complaints like mine. It shouldn’t take years to get diagnosed. We have to break the stereotype of Alzheimer’s being exclusively a disease of the elderly. Younger people with Alzheimer’s get diagnosed with “stress” or depression, even though the symptoms are the same whether you’re 85 or 50 years old.
Also, I’d like more research funding for drug development. I’d like the FDA to move a little faster on getting the drugs out as well. I’m willing to volunteer for clinical trials, but I’m afraid that I’ll be placed in the placebo group, and I’d really like to get the drug.
Dr. Val: Are you taking any drugs now?
Patty: Yes, I’m on Aricept, Wellbutrin, and Namenda.
Dr. Val: Are you bothered by any side effects?
Patty: At the beginning we had to adjust the dosage of the Aricept because I was getting “night terrors.” I’d wake up in the middle of the night and sit bolt upright in bed and scare my husband half to death. Of course I didn’t remember any of it because I was still asleep. We cut the dosage of Aricept in half and the problem resolved.
Dr. Val: What are your plans going forward?
Patty: I’m going to continue helping the Alzheimer’s Association to raise awareness about the disease. Our healthcare system is not equipped to handle all the additional people who will be diagnosed with Alzheimer’s in the near future. We must get the message out so that we can prepare better. I’ll continue on giving speeches across the country for as long as I can do this.
*USA Today profiled Patty and Jay in an article published last year.*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 13th, 2008 by Dr. Val Jones in Patient Interviews
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Therese Borchard is a vibrant author, editor, and mother of two. She writes a critically aclaimed blog called “Beyond Blue” at beliefnet.com, which is devoted to supporting people who are living with bipolar disorder. Therese’s writing is engaging and humorous, as she normalizes the experience of mental illness through her own lens of motherhood. Revolution Health salutes Therese for her compassion, and I hope you enjoy getting to know her through this interview:
*Listen to Podcast*
Dr. Val: Tell me about the circumstances surrounding your diagnosis of bipolar disorder. What was it like when you received the diagnosis for the first time?
Therese: I’ve struggled with depression most of my life, though college was when I first started taking medication and came to terms with the diagnosis of major depression. However, I had a much harder time when I realized that what I had was actually bipolar disorder. This was really difficult for me because my aunt was the only person I knew with bipolar and she took her own life when I was 16. So I had a lot of resistance to that diagnosis.
In fact, I ended up seeing 7 different psychiatrists, went through 2 hospital stays, and tried a total of 23 different medications.
Dr. Val: What’s the story behind the 7 psychiatrists? Were you not connecting with them?
Therese: I strongly advise people with bipolar or anyone struggling with depression to find the right doctor. For me it was going to Johns Hopkins, an academic center that has the best research and an outstanding team of doctors. My bipolar symptoms were not clear cut or “textbook” so it took a team of specialists to really help me find the best treatment path.
Dr. Val: What have you found to be most helpful (therapeutically) to keep you feeling balanced and in control?
Therese: My three staples are diet, exercise, and sleep, because I think that with any illness you just have to make those a priority. Obviously, finding the right doctor and the right medication is important too. Another key component to my recovery was connecting with a greater mission – I see that as my blog. Reaching out to others gives back to me every day. When I read a biography of Abraham Lincoln (he struggled with major depression, but didn’t have meds back then) I was struck by the fact that he focused on the emancipation of slaves as a positive way to get through his depression.
Obviously, a good therapeutic relationship with your doctor is important, as well as finding the right medications for you when/if needed.
I’ve found Dr. David Burns’ book, “Ten Days To Self Esteem” to be really helpful. It’s a work book that you can use as a journal. He asks you to list all your distorted thoughts, how they’re distorted and then how you can think differently. For example, we sometimes engage in mind-guessing, like “Oh he hates what I just said…” when the person isn’t thinking that at all. This book is really good for people with mood disorders.
I also regularly engage in prayer, and as a Catholic it’s really important to me and my healing.
Dr. Val: What advice do you have for people living with bipolar disorder?
Therese: You have to surround yourself with people who understand your illness because it’s so easy to be hard on yourself and adopt an attitude of “I should be able to get over this problem” and then feel deflated when it doesn’t magically disappear. It is so much easier when you have friends around to remind you that bipolar disorder is an illness like arthritis or diabetes – that it can be disabling and it’s not your fault.
Bottom line: Work as hard as you can on your diet and exercise, use light therapy as needed to help elevate your mood, and educate yourself as best you can about your illness.
Dr. Val: You mention diet as an important factor. Do you follow a special diet or do you just mean ‘healthy eating’ in general?
Therese: Mostly I’m talking about a healthy diet with lots of fiber, fruits and veggies, lean protein and whole grains. Caffeine and sugar are dangerous and alcohol can really mess up psych meds. Everything nowadays seems to have high fructose corn syrup in it. I try to stay away from highly processed foods and white flour.
Dr. Val: Do you believe that there is a stigma associated with bipolar disorder? How can that be reduced/removed?
Therese: The stigma does exist. I read a recent article about celebrities basically saying that antidepressants sap your personality, creativity, and sex drive. They make it sound as if people with bipolar disorder are doomed to live a dull and mediocre life. Other articles, like those about Britney Spears, are so negative. They make you think, “Oh God, this woman is never going to be normal.” The media really does bipolar disorder a disservice. Why not say that 70-80% of people with bipolar recover completely and do beautifully? They live very fruitful and productive lives. I have a hard time with how the media presents mental illness in general.
I also find that when I tell people that I have a therapist appointment their eyes sort of bug out. But it shouldn’t be shameful, it’s no different than going to a doctor’s appointment. We have to continue to work on tolerance and acceptance for mental illness.
Dr. Val: What role can online communities play in the management of daily life with bipolar?
Therese: Online groups have proven to be beneficial to those suffering from depression. Sharing your story is therapeutic in itself. Also the anonymity offered by online groups can make sharing stories and struggles more comfortable. For people who live in remote areas or who don’t have access to transportation, online groups offer the best way to connect with others.
Dr. Val: How do your coping mechanisms change when you’re struggling with mania versus depression?
Therese: Some of them are the same, like getting good sleep, eating healthy foods and exercising. I have two little kids so I watch the movie Cars a lot with them. And I like what one of the characters says in response to a question about steering around curves. He says, “in order to go left, you need to turn right, and in order to go right, you need to turn left.” I always remember this when I’m manic or depressed because it’s counter-intuitive.
When you’re depressed, the last thing you want to do is to get yourself involved in life, and get up and get moving – but that’s exactly what you need to do. When you’re manic it’s so easy to say, “This is so great, I’m on a roll, let’s go all night!” It’s hard to shut down your computer and say, “No, I’ve worked enough, now it’s time for bed.” But that’s what you need to do.
Dr. Val: Is there any bipolar-related information or service that you’ve always wished you could get from the Internet but doesn’t exist yet?
Therese: I wish there were an Amazon.com type directory online where you could find therapists, doctors, partial stay hospital programs, and support groups in your zip code, and read reviews from others about them. A one stop resource center would be great!
Dr. Val: You work at Belief Net – tell me a little bit about what the spiritual side of the bipolar journey. How has spirituality played a role in your healing?
Therese: I grew up as a very religious kid and my “OCD” made itself manifest at a young age. I remember that when I was in fourth grade I wrote a book for my mom and her prayer group friends about how to get to heaven. I look back and laugh at that now because it probably listed things like looking at the sacred heart and praying the rosary 15 times.
But on a more serious note, when I was deeply depressed and feeling suicidal the thing that kept me from taking my life was the thread of hope that God was there. If I didn’t have that I don’t think I’d be here. I often asked God for signs of His presence during that horrible times, and believe it or not, I always received them.
*Full Interview Available Via Audio Podcast*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 12th, 2008 by Dr. Val Jones in News
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I’ve been following this story with interest and concern. A little birdie told me that Katie Couric has prepared a special report about the potential link between vaccines and autism for the CBS news tonight (May 12th). Sharyl Attkisson will be interviewing Dr. Bernadine Healy, former head of the National Institutes of Health, about her perspective. The CBS website has a 5 minute video clip now available on their site.
While I certainly agree with Dr. Healy that science must not be stifled, and that it’s fair game to research any environmental factor that could plausbily be related to autism, I am deeply concerned that the potential harm induced by vaccines (on kids with rare genetic disorders) will be generalized inappropriately and parents will refrain from vaccinating their children. We are already beginning to see Measles make a comeback (a disease with that can be fatal or cause irreversible brain damage) due to lower vaccination rates, and this trend may continue. Unvaccinated kids are not just a threat to themselves (because they’re at much higher risk for developing preventable diseases) but a threat to vaccinated kids as well, since vaccines are not 100% effective.
What do you think about the CBS segment? Watch it with me and we can discuss it here on my blog. Robin Morris, mother of a child with autism and a patient advocate at Revolution Health, will weigh in as well.
*Update: the full script is here*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 9th, 2008 by Dr. Val Jones in Uncategorized
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Revolution Health is always looking for creative ways to bring important health information to the public. This week, in honor of Mother’s Day, we’ve created a virtual women’s health expo – and we’ll donate to the featured non-profit organizations for every click you make.
So why not do some good for the following non-profits by visiting their booths at the virtual expo? This is the easiest way for you to support your favorite non-profit – you can even visit them in your pajamas. 
Y-Me National Breast Cancer Association
Depression and Bipolar Support Alliance (DBSA)
National Healthy Mothers, Healthy Babies Coalition
National Alliance on Mental Illness (NAMI)
National Women’s Health Resource Center
The Wellness Community
Women’s Sports Foundation
Go Red For Women
Healthy Weight For Life
Society for Women’s Health Research
*Go to the Women’s Health Expo*
This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
