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 20th, 2008 by Dr. Val Jones in Expert Interviews
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I had the chance to attend a recent press conference announcing the expansion of a nationwide effort to help U.S. veterans. The American Psychiatric Foundation, the Lilly Foundation, and Give an Hour Foundation joined forces to provide free mental health care for Iraq and Afghanistan war veterans and their families.
This innovative program allows mental health professionals to donate at least one hour a week of their professional time to serve the needs of the military. Collectively, this donated time adds up to a large improvement in access to services beyond the current reach for many of our nation’s heroes.
I am also hoping that the Give an Hour Foundation will join forces with Revolution Health to provide a therapeutic online community for military personnel and families who need support.
An interview with Barbara V. Romberg, Ph.D., founder and president of the Give an Hour Foundation
Dr. Val: Tell me about the Give an Hour initiative. Who came up with the idea, what does it involve, and how is the concept being promoted?
Dr. Romberg: I grew up in the post-Vietnam era and watched my brother’s friends go to war — and they either never came back or they returned as completely different people. So about three years ago, I was watching the Iraq war unfold and I became more and more aware that people were returning home with some very significant mental health issues. I began worrying about whether there were enough mental health services available to meet their needs, and I wondered if we in the mental health community should step up to provide additional services.
The thing that really pushed me to do something about this, as a busy private practitioner, was when I was driving in Bethesda [Md.] with my 9-year-old daughter. We passed a homeless veteran on the street and she said to me, “Mom, how can we?” It was the use of the word “we” that touched me. “How can we let this happen to these men and women who serve our country?”
And I thought, I can’t let her grow up and look to me and say, “Why didn’t your profession do something?” So I said, “OK, I’ve got to do this.” And that was the beginning of the Give an Hour initiative.
The Give an Hour initiative is a national network of mental health professionals — psychiatrists, psychologists, social workers, licensed counselors and therapists — who volunteer an hour of their time per week to serve the needs of the military. Participants are collected in an online database. Military personnel can come to our website at www.giveanhour.org, and enter their ZIP code and the services they seek, and we’ll return a list of providers available in their area. If there is no one listed in the database in the search area, we offer phone support.
Dr. Val: In your opinion, how is the health care system failing Iraq and Afghanistan war veterans who need mental health services?
Dr. Romberg: I’m not sure that it’s failing so much as it’s just being overwhelmed. The Department of Defense and the VA [Veterans Administration] are working really hard, but they’re just overwhelmed. It’s our duty, honor and opportunity to step up as mental health professionals and give back to the military. Regardless of what you think of the war, it’s a wonderful opportunity for our country to heal. The work is also therapeutic for the therapist.
Dr. Val: In terms of access to mental health services, where are the largest shortcomings: 1. Access to psychiatrists? 2. Access to psychologists? 3. Access to affordable therapies? 4. Community support?
Dr. Romberg: Yes. [Laughing.] All of the above. Many of the National Guard and Army Reserves staff return to rural communities after their tours of duty. There often aren’t providers who accept TRICARE [military health care insurance] in rural communities, so access to mental health services is limited. The VA is doing a lot of good work, but there are long waits and not enough therapists for regular ongoing visits. Continuity of care really suffers.
Dr. Val: What’s the most important message that you’d like to relay to a general public audience about mental health services and veterans returning from Iraq and Afghanistan?
Dr. Romberg: These men and women are put in situations that are sometimes horrific and excruciatingly stressful for long periods of time. If you put any of us into those situations, it would affect how we experience ourselves and the world. What we want to do is educate the public so that they understand this and know how to talk to their neighbors and co-workers. When people don’t understand an illness, they can become uncomfortable and fearful that they may say the wrong thing. But by normalizing mental health issues through public education efforts, we can reduce the associated stigma of mental illness.
Military personnel need to be comfortable in accessing services when they need them. For starters, they can visit the Give an Hour website. We’re also affiliated with many other Veterans Affairs associations like the Wounded Warriors program, National Military Family Association, and TAPS. These organizations can offer assistance or put people in touch with us as needed.
*See a continuation of this conference reporting here.*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
May 19th, 2008 by Dr. Val Jones in Uncategorized
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People come from all over the nation (and the world) to speak their mind about health issues in Washington, DC. I work at a DC-based online media company (Revolution Health) devoted to enhancing awareness of medical issues and empowering patients to take control of their health.
A few weeks ago I put 2 and 2 together and realized that I could practically tip a microphone out my window and get some really important and compelling health information straight from America’s most influential leaders and organizations. I began attending local meetings, and before I knew it, I was embraced as the local physician-journalist who provides press coverage for an online health audience.
I’ve gotten terrific feedback about my recent blog interviews with former Surgeon General Rich Carmona, and Governor Mike Huckabee, among others. So I figured – hey, maybe this is something I should do more often? Maybe the medical blogosphere would like to receive regular updates on the “goings on” in Washington? Someone’s gotta keep an eye on them, and why not a local “voice of reason?”
So I’ll continue interviewing my little heart out – and point my virtual microphone at groups and people who have something interesting and important to say about health issues. I hope you enjoy them!
Up Next: I just met with a group of mental health professionals (from the American Psychiatric Association and American Psychiatric Foundation) about an exciting new volunteer effort (Give an Hour) to serve the psychological needs of military personnel returning from Iraq and Afghanistan. I hope to post about this initiative today or tomorrow here on my blog.
Later this week: Dr. Val covers the Campaign for Tobacco-Free Kids update. I’ll find out what we’re doing to break the smoking cycle at the earliest stages.
Much later this week: Dr. Rich Carmona gets a second visit from Dr. Val. As an unsuspecting victim of “round two,” our former Surgeon General is speaking at the Strategies to Overcome and Prevent (STOP) Obesity Alliance.
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.
