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.
April 23rd, 2008 by Dr. Val Jones in Expert Interviews, News
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Imagine that you were diagnosed with cancer, and were told that you had one of two treatment options: 1) you could receive a one time dose of a medicine that will go directly to the tumor cells and kill them only, having very few noticeable side effects or 2) you could undergo months of exposure to toxic chemicals that will kill the tumor cells and many other healthy cells as well, resulting in hair loss, bowel damage, nausea, and vomiting. Which would you choose?
Unfortunately, choice number one may no longer be an option for lymphoma patients due to government funding cutbacks, and the development of such treatments for other cancers is in jeopardy as well.
Radioimmunotherapy (RIT) is a relatively new approach to cancer treatment, new enough that the government is having difficulty categorizing it correctly. (RIT involves targeting cancer cells with special antibodies that carry tiny, lethal radiation doses to individual cells.) In fact, drugs like Bexxar and Zevalin have been misclassified by CMS as “supplies” rather than medications, and so the reimbursement allowed doesn’t come close to covering the cost of the therapy. Although there are many new targeted therapies under development, investors are worried that the drugs will never be used in patient care because the country’s number one payer (Medicare) is unwilling to cover their costs. Other health insurers often follow the government’s lead when it comes to treatment coverage policies. If no one will pay for the cost of the drug, then ultimately no one can afford to make it available.
Similar funding problems are beginning to limit access to diagnostic nuclear imaging modalities like PET scans, PET CT, cardiac SPECT scans, and bone scans. Reimbursement levels that do not cover the cost of the imaging drugs means that facilities cannot afford to offer these diagnostic technologies to patients, and centers are slowly reducing the number of tests they offer. Nuclear imaging studies are often critical in diagnosing heart problems, infections, and early detection of cancer. Senator Arlen Specter had his cancer recurrence diagnosed at the very earliest stages thanks to PET scanning technology. Early treatment offers him the best possible prognosis, but he is in a dwindling group of people who have access to this imaging modality.
I spoke with Dr. Peter Conti, professor of radiology at the University of Southern California, and former president of the Society of Nuclear Medicine, from Spain this week – as he is attending the 6th International Workshop for Nuclear Oncology, a lymphoma conference where the crisis in reimbursement for targeted cancer therapies is being discussed, along with exciting advances in treating patients with lymphoma. The two different RIT drugs (Bexxar and Zevalin) for non-Hodgkin’s lymphoma are in jeopardy of not being available to Medicare patients due to proposed cuts in reimbursement. Recent plans to cut payment for these drugs have been halted by a temporary moratorium from Senator Kennedy. Here’s what Dr. Conti had to say:
“Let’s face it, lymphoma is not as high profile as other cancers such as breast, colon, or prostate. However, we’ve found a fantastic treatment option for it, and there are implications for the more common cancers, but that treatment option is being denied to lymphoma patients because facilities cannot cover the costs of offering it. I’d like the entire cancer community to rise up in support of lymphoma patients so that Congress will tell Medicare to fix the funding problem. If this doesn’t happen, it’s only a matter of time until novel RIT treatments are no longer an option and we’ll be stuck in the dark ages of non-specific chemotherapy and radiation treatments that harm the good cells with the bad. Personalized, targeted therapy is the future – and we’re missing the opportunity to further develop these novel therapies due to budget cuts.”
I reached out to the current president of the Society of Nuclear Medicine, Dr. Alexander J. McEwan, for comment:
“Molecular imaging offers critical tools for the early detection, diagnosis and treatment of many life-threatening diseases, including cancer. SNM recommends that CMS establishes appropriate reimbursement for all forms of nuclear and molecular imaging and radioisotope therapies at levels that allow optimum access and improved outcomes for all patients.”
Denial of RIT to lymphoma patients may be the first sign of a new trend limiting the development of high tech therapeutic innovations. Will America’s research engine run out of gas before we figure out how to treat cancer without side effects? Should we buy one more tank to get us over the crest of the targeted therapy hill? This is a judgment call that affects all of us at a time of great need and limited resources. What’s your take?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
April 22nd, 2008 by Dr. Val Jones in Medblogger Shout Outs
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Welcome to Grand Rounds 4.31, Dr. Val’s edition of the weekly rotating carnival of the best of the medical blogosphere. There are many approaches to summarizing submissions to Grand Rounds, and I have chosen one that has never (to my knowledge) been used before.
That’s right – I’m taking my inspiration from the limbic system, and have organized the posts according to the dominant emotion they elicit from readers. And because Dr. Val was one of those annoying medical students who brought 10 different colored highlighters to study class, I will also label some of the posts with the following tagging system (in brackets) to offer advanced readers an additional nuance:
[:-)] = A post that demonstrates literary excellence
[{] = Early bird – an author who got his/her submission in early, which is really convenient for the host(ess)
[:-/] = Naughty – an author who forgot to submit an entry to Grand Rounds but who was included nonetheless
So without further ado, here’s the Grand Rounds that will make you laugh, cry, stomp your feet, and become enlightened in the process.
Amusing
The fun begins with the Clinical Cases and Images Blog, featuring a hilarious blogger “sweat shop” video to illustrate the heart attack-inducing stress that bloggers face on a daily basis. His post is called: “Death by blogging?”
Dr. Rob Lamberts from Musings of a Distractible Mind has some parenting tips (including pole vaulting avoidance strategies) in his post called “The Sins of the Father.”
Happy, the Happy Hospitalist offers his perspective of what it would mean if physician satisfaction surveys (rather than patient satisfaction surveys) mattered.
Allen Roberts of GruntDoc describes how one misspoken word can result in unexpected innuendo.
[:-/] Dr. Wes predicts an upcoming hospital “performance Olympics” after one patient receives a record fast, door-to-balloon cardiac intervention.
Touching
[:-)] Laurie Edwards of A Chronic Dose tells the touching and amusing story of how one sick young girl was ostracized at summer camp – and how new camps designed for chronically ill children are revolutionizing the camping experience. Her post is called, “Summer Camp: Sick Style.”
Barbara Kivowitz, from In Sickness and in Health, describes a husband who knows just the right thing to say in a stressful time. Her post is called “Mars/Venus Who Cares?”
Lisa Emrich, from Brass and Ivory describes what it’s like to experience a relapse of Multiple Sclerosis and an MRI to evaluate the progression of her disease. Her post is called “Surfing the Magnetic Tube.”
Dr. A from Doctor Anonymous wonders if peace and contentment come from accepting one’s lot in life. His post is called, “With Age Comes Happiness?”
Infuriating
ER Nursey relays the tragic story of a baby that died of a preventable illness. His mom decided not to vaccinate him against pertussis and was trying to treat the infection with “natural methods.” Her post is entitled simply: “Whooping Cough.”
[:-/] Abel Pharmboy at Terra Sigillata explains that since 1994, dietary supplements cannot be removed from the market until there is evidence for lack of safety, meaning that consumers must first be harmed before FDA is authorized to intervene. His post is called, “Must People Die Before DSHEA is Repealed?”
[:-/] David Gorski at Science Based Medicine takes a critical look at the claims of a popular alternative medicine practice: colon cleansing. His post is called, “Would You Like a Liver Flush with that Colon Cleanse?”
[:-)] John Crippen from NHS Blog Doctor explores the difference between a young doctor’s “gallows humor” and a senior physician’s deep and abiding concern for patients in this reflection on death certificates in Britain. The post is called “Ash Cash.”
A Canadian Medical Student and author of Vitum Medicinus tells the story of how a patient asked her doctor a question that she already knew the answer to, just to see if he was current in his knowledge of recent health news. The post is “What Trickery Is This?”
David Williams of The Health Business Blog points out the fallacies inherent in one writer’s attempt to vilify the health insurance industry. His post is called, “There is no Health Insurance Mafia.”
Enlightening
This large group of posts may be further organized by the topic of enlightenment. First up we have practical health tips.
Health Tips
[{] We begin this section with an anonymous psychiatrist blogger at How to Cope with Pain. She has captured my little Rehabilitation Medicine heart with her three-part series describing office ergonomics, therapeutic exercises, and how to avoid computer-induced postural strain. Her very practical post (that will be very useful to you readers) is called: “How to Sit at Your Computer to Avoid Pain.”
Ramona Bates at Suture for a Living explains what to do if you’re bitten by a cat – she does a wonderful job describing the treatment options and possible infections that can result. Her post is aptly named, “Cat Bites.”
Paul Auerbach at Medicine for the Outdoors teaches us everything we need to know about preventing and treating foot blisters caused by hiking/walking. His post has the shortest name of this Grand Rounds: “Blisters.”
Jeff Benabio at The Derm Blog offers a comprehensive analysis of the dangers of tanning salons with some tips for safe sun exposure. His post is called, “Is The Tanning Industry The New Big Tobacco?”
Nancy Brown at Teen Health 411 warns that outdoor tanning is also not safe. Her post is called “Sun Safety.”
Jolie Bookspan, The Fitness Fixer, tells the story of how a woman living in the Yukon learned that “doing exercises” doesn’t heal an injury if you go back to bad movement habits the rest of the day. The post is called, “Fixing Herniated Disk and Reclaiming Active Life.”
[:-/] TBTAM at The Blog That Ate Manhattan has practical tips for patients preparing for a new patient visit with an Ob/Gyn. Her post is called: “TBTAM’s Healthcare Team Tips for New Players.”
[:-/] Dr. David at Musings of a Pediatric Oncologist teaches us that HPV can predispose people to oral and throat cancers as well as cervical cancer. All the more reason to vaccinate boys as well as girls. His post: “HPV and Cancer Revisited.”
Kenneth Trofatter, at Fruit of the Womb offers a detailed analysis of when it might be appropriate to use Fondaparinux to reduce the risk of clotting in pregnant women. His post: “Use of Fondaparinux During Pregnancy.”
Joshua Schwimmer at Tech Medicine offers some tips for doctors. Practice makes perfect, and this new teaching mannequin has some nifty bells and whistles. His post is: “The iStan Medical Mannequin: it Sweats, Bleeds, and Breathes.”
More healthcare for dummies is offered by Jan Gurley of Doc Gurley Blog. Her post is called: “Playing Surgeon.”
Next up, a series of posts about Web 2.0 principles.
Web 2.0
Allergy Notes describes a small study in the BMJ demonstrating that text message reminders can improve compliance with asthma medication regimens. The post is called, “Text Messaging Can Help Young People Manage Asthma.”
[{] Sam Solomon of Canadian Medicine describes a new trend in Canadian medical research – using blog tools to analyze public opinion. His post is called, “Putting Clinical Depression under the Microscope and on the Blogosphere.”
Mic Agbayani at GeekyDoc, suggests that patient privacy is violated by YouTube when a video is posted of healthcare professionals laughing during a surgical procedure to remove a foreign body from the rectum. His post is called, “Patient privacy and YouTube.”
[:-/] Richard Reece at Med Innovation Blog explains that doctors get a bad rap when it comes to EMRs and IT in general. See his post: “Bad Rap on Physician IT Use Not Deserved.”
[:-/] A counter-point argument for the mandatory use of EMRs (at his hospital) is made by John Halamka at Geek Doctor. His post is called: “Accelerating Electronic Health Record Adoption.”
Health Policy and Medical Ethics
This is our largest and final subgroup of enlightening posts. You’ll find some great reasoning here (and Dr. Val is partial to reason).
First up we have the inimitable Sandy Szwarc of Junk Food Science. She takes a close look at the numbers and shows that the current Student Nutrition Policy Initiative is failing to stem the tide of childhood obesity and poor eating habits. Her post is called, “JFS Special Report: Major Findings on Childhood Obesity Programs.”
Amy Tenderich at Diabetes Mine has a terrific post about the need to revise the Americans With Disabilities Act. As a physiatrist, I cheer her on. Her post: “Disability and Diabetes Revisited.”
[:-/] Dr. Rich at The Covert Rationing Blog explains the financial incentives behind Medicare’s new “never event” initiative and how it will impact care for the elderly, obese, and those with bleeding disorders. His post is called, “Never Events? Never Mind.”
Bob Coffield at Health Care Law Blog writes that some argue that preventing disease does not decrease health costs. Bob disagrees, but isn’t sure if he can prove his case. His post: “Is prevention cheaper than treatment?”
[:-/] #1 Dinosaur of Musings of a Dinosaur explains that reducing expenditures in a patient’s last year of life requires perfect foresight into his or her life expectancy. His post: “End of Life Care Costs: A Logical Fallacy.”
Maurice Bernstein at the Bioethics Discussion Blog argues that, over the past 50 years, the ethics of medicine has changed more than any other aspect of it. Technological advances and the advent of medical consumerism have changed the way medicine is practiced. His post is: “50 Years of Medical Practice: Changes, Benefits, Costs, Dilemmas.”
Louise Norris at the Colorado Health Insurance Insider would rather be treated by a salaried physician who has no incentive to order additional and perhaps unnecessary tests and treatments. Her post: “More Care Does Not Mean Better Care.”
[:-/] Charlie Baker at Let’s Talk Healthcare offers a nice summary of a recent NEJM article about how to cut healthcare costs in the US. See his post: “Partners HealthCare Weighs In On Health Care Costs.”
[:-/] Kevin Pho at KevinMD has a series of posts called “My Take.” This one on legitimate malpractice lawsuits and anti-aging is very interesting.
Kerri Morrone at Six Until Me raises her voice for Type 1 Diabetes awareness. Her post: “My Raised Voice.”
[{] Ian Furst from Wait Time and Delayed Care wonders if visual cues could be developed to reduce patient wait times. His post is called, “Clutter of the Brain.”
And finally, an anonymous medical student at a blog called From Medskool argues that there is no primary care shortage, that incomes are fine, and that PCPs won’t abandon Medicare. Anyone wish to debate this with him? His post: “Four Myths of the Primary Care Crisis.”
***
And here’s a special message from next week’s Grand Rounds hostess, Jan Gurley:
Grand Rounds in medicine often means a morgue-cold auditorium, a sea of starched white coats, and staccato squeaks from irritable chairs. Doc Gurley is hosting April 29th’s Grand Rounds of the medical blogosphere with a more WWF-type approach: Grand Rounds Smack Down Week. Do you want to take on a behemoth topic with some chest-beating frenzy? Or just climb into the Internet ring wearing your most outrageous verbal-costume? Here’s your chance to go for it.
Thanks to all who sent me submissions, and many thanks to Nick Genes our fearless leader. Let me know how this Grand Rounds made you FEEL!This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
March 29th, 2008 by Dr. Val Jones in Medblogger Shout Outs
2 Comments »
Interesting thoughts from The Happy Hospitalist:
How do you define quality care?…
If preventing 90% of in-hospital DVT’s with a medicine that cost $30 a day was quality, so be it.
What if you could prevent 99% of in hospital DVT’s with a medicine that cost $300 a day. Would the 90% be quality or the 99% be quality? What if it cost $3,000 a day to prevent 99.99% of in- hospital DVT’s?
Which effort would be considered quality? Who defines the cut off, and at what price?
Here’s what he has to say about Pay for Performance measures, and why they won’t add up to significant savings:
Unfortunately, the measures being undertaken for quality initiatives are, from my stand point, minuscule in terms of the overall potential cost savings to the system.
And the reason is simply, at least in my part of the medical physician spectrum, a very large chunk of health care expenditures comes in the form of evaluation, and not management…
In the medical profession, there exists a sense of universal freedom to order tests, xrays, labs, and procedures with a sense of unlimited funding. Somebody will pay for it. My patient sitting in front of me is the center of my attention and their needs supersede all other needs from a social/financial point of view of the nation…
Where are the government incentives for quality medicine in the evaluation of disease?
Where is your bonus payment for not ordering the heart cath?
For not ordering the CT Angiogram?
Where is your physician bonus payment for not ruling out a low probability DVT?
Or not ordering an EGD?
For choosing watchful waiting.
Where are your quality bonus payments for evaluation of illness?
They simply don’t exist. Because doing so would overtly ration the public and create a firestorm.
Is the storm coming nonetheless?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
February 24th, 2008 by Dr. Val Jones in Book Reviews, Health Policy
5 Comments »
Dr. Richard Fogoros wrote a fascinating book called Fixing American Healthcare: Wonkonians, Gekkonians, and the Grand Unification Theory of Healthcare. In the first two thirds of the book, he explains why our healthcare system is broken, and describes its dysfunction with exasperating accuracy.
One of the most important concepts in his book is that of “covert rationing.” As Dr. Rich explains, we Americans cling to two fundamental beliefs:
1. Everything that can be done for a sick person must be done, as long as there’s some small hope of beneficial outcome. (The belief in no spending limits).
2. Healthcare is an entitlement for all Americans. (The belief in universal access).
Since science and technology have provided us with incredible (and expensive) advances over the last several decades, doing all that’s possible for all who are sick is simply not financially possible. However, Americans are fundamentally opposed to rationing care, so the rationing occurs covertly, including cost-savings achieved by people being uninsured, by certain chemo drugs not being covered by Medicare, by physicians being coerced by HMOs to ration care, and countless other subtle and capricious ways.
Covert rationing is a little recognized but fundamental flaw of the current healthcare system, and it results in untold inequities in care. Dr. Rich believes that a fair system requires open rationing of resources, with rules agreed upon by tax payers. Would you agree?
In my next post I’ll discuss Dr. Rich’s thoughts on what’s really driving up healthcare costs…This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
