Medical Blog Alert: Another new (for me, anyway) medical blog -The Bioethics Web Log by the editors of The American Journal of Bioethics. Are they the first editors of a medical journal to have a blog?
Caveat Emptor: Drug company stocks took a dive this week, as an FDA regulator spoke publicly about five drugs he considers unsafe:
The slides followed a claim by Dr David Graham, a regulator at the US Food and Drug Administration, of safety concerns surrounding AstraZeneca's Crestor anti-cholesterol drug and Serevent, an asthma treatment made by GSK.
"I can tell you right now there are at least five drugs on the market today that need to be looked at quite seriously to see if they belong there," Dr Graham told a committee of US senators.
The other drugs were Meridia, a weight-loss drug made by Abbott Laboratories, Bextra, a painkiller made by Pfizer, and Accutane, Roche's treatment for acne.
He said that the FDA, the US watchdog responsible for ensuring drug safety, had "case reports of people dying clutching their Serevent inhalers.
Dr Graham added that the FDA, as currently configured, was "incapable of protecting Americans against another Vioxx".
"It is important that the American people understand that what happened with Vioxx can happen again," he said. "We are virtually defenceless."
The cholesterol lowering drug Crestor has become a new favorite of our local cardiologists, and more than one patient has brought in ads for it asking me for the "best cholesterol medicine." But questions have been raised by the British medical establishment in the past about its safety. (Even though it's The Lancet, they make valid points. If it's safety profile is worse than other statins, why have it?)
Serevent is a problem because many patients with asthma forget or fail to understand that it isn't to be used as an emergency inhaler, but rather as a maintenance medicine that provides long-term, slow-acting asthma relief. I don't know why it's so hard to get that through to people, but I had too many experiences of patients who were using it inappropriately despite my best efforts at patient education, that I gave up on it soon after its introduction.
Meridia is a stimulant for weight loss. It's side effect profile is similar to other stimulants. I've always been wary that it could have the potential for side effects similar to other stimulants such as Redux and Fen-Phen which were removed from the market. (Not to mention, that once a person stops the drugs, they tend to regain their weight.) Long term use is definitely not recommended.
Bextra may end up having the same problems with clotting as Vioxx. (Although you can still make the argument that patients should be given the option of its use if it helps their pain, given the small risk of clotting associated with the class.)
Accutane, we know, has some serious side effects - among them birth defects. Most dermatologists who use it are extremely scrupulous about monitoring for side effects. They make girls go on birth control pills before they'll prescribe it, and they monitor lipid levels and liver enzymes very closely. It is a wonderful drug for treating recalcitrant, cystic acne, a condition which can leave devastating physical and emotional scars. I've never seen it used irresponsibly in any of the communities in which I've practiced. I have seen it used to great effect and with appropriate caution.
UPDATE: Comments from a Serevent user:
I was shocked to read that serevent has been attacked because some people can't, or won't, learn to use it properly. It was added to my preventive routine of albuterol and azmacort several months ago and has been very successful. My doctor wanted to get me off intermittent courses of prednisone in allergy season (suggested by prior physician.) Do you have the same problem with patients on azmacort? That doesn't stop attacks either. Are you suggesting that nobody should get preventive treatment for asthma because some people can't use it properly? That doesn't make sense to me.
No, but I'm suggesting that inhaled steroids are favored over Serevent for preventive therapy. For some reason, people don't mistake inhaled steroids for their rescue inhalers. Perhaps it's because Serevent is a bronchodilator, as are the rescue inhalers, and many people just carelessly figure one bronchodilator is pretty much like any other, despite warnings to the contrary. Acutally, the most popular - although expensive - preventive therapy seems to be Advair, a combination of inhaled steroids and Serevent. People don't mistake that one for a rescue inhaler, either.
Dr. Maher Saqqur of the University of Alberta and his colleagues tested an experimental combination of TPA and ultrasound to treat stroke before brain tissues are starved of a blood supply.
"What we find is that patients who receive the TPA plus the ultrasound do well compared to patients who get the TPA just by themselves," said Saqqur.
The study looked at 126 patients. After three months, 42 per cent of patients who received the experimental treatment were fully recovered, compared to 30 per cent who had TPA alone.
The study was limited to people who had clots in the middle cerebral artery, which is the only kind of stroke in which t-PA is recommended ( and even then, not without some controversy). The study did show improvement in outcome by combining ultrasound with t-PA compared to just using t-PA. But there's another question that needs to be asked. How would ultrasound alone compare to t-PA alone? A doctor in Scotland says he's seen it work wonders:
A SCOTTISH doctor has accidentally found a remarkable treatment to ease the crippling effects of a stroke.
Dr Paul Syme stumbled across the technique during routine examinations of stroke victims at Borders General Hospital in Melrose.
He realised that ultrasound equipment used to pinpoint strokes could also help patients make a recovery.
Dr Syme has used the technique, which sends sound waves through the body, to ease the symptoms of nearly 100 patients.
He is now confident it could help tens of thousands of sufferers in Scotland alone.
Speaking on BBC Radio Scotland’s Guinea Pigs programme, Dr Syme said: "This is a very exciting discovery, because we are encouraging the body to heal itself."
He obtained an ultrasound machine, called a transcranial doppler, to help him locate the source of strokes. To his surprise, the devastating physical symptoms appeared to improve while patients used the machine and the effects lasted long enough to allow sufferers to lead more normal lives again.
He's planning to collaborate with a couple of stroke centers in the UK to study it. Should be interesting. And it may be safer than using it with t-PA, which has the risk of devastating intracranial bleeding.
How does this work, anyway? An accompanying article in the New England Journal of Medicine offers some theories:
Ultrasound of sufficient amplitude, when applied to a fluid, causes the partly dissolved gases to form small bubbles. These bubbles then vibrate, absorbing the energy, and if enough energy is applied, they literally explode.
...However, this mechanism is unlikely to be responsible for the effect observed in the study by Alexandrov et al., because transcutaneous ultrasound devices are preset to prevent excessive deposition of ultrasound energy. Still, it is theoretically possible, although it is unlikely, that some gaseous bubbles trapped in the thrombus may be the right size and composition to meet the threshold for the onset of cavitation. The local effect would be to create gaps or symmetric "holes" in the fibrin mesh, thereby facilitating the permeation of t-PA into the thrombus.
Other effects depend on the level of ultrasound energy applied. At very low energies, ultrasound has been shown to promote the motion of fluid, an effect called microstreaming. It is possible that the application of ultrasound energy agitates the blood close to the occluding thrombus and promotes the mixing of t-PA, effectively increasing the concentration of the agent that is in contact with the thrombus. The pressure waves that are generated may also increase the permeation of t-PA into the interior of the fibrin network. This phenomenon, however, is unlikely to explain all the beneficial results observed in this study. At slightly higher energies, ultrasound waves can have direct effects on the binding of t-PA to the fibrin mesh that forms the occlusive lesion. The binding of t-PA to the cross-linked fibrin and fibrin elements within a matrix is enhanced, in vitro, by ultrasound energy, and the fibrin cross-links are weakened, further increasing the binding of t-PA. These two mechanisms probably play key roles in vivo.
Some authors have speculated that the heat generated by ultrasound is responsible for accelerating thrombolysis. Experiments have confirmed that the temperature elevation generated by ultrasound of sufficient power can increase the dissolution rate of thrombi.
A Matter of Trust: Arafat's nephew is going to Paris to retrieve his medical records in an attempt to put to rest the rampant rumors about his death. Privacy laws, at least in some societies, don't always work for the best:
The absence of conclusive information on the death has stoked rumors of poisoning. Mr. Arafat's own doctors and aides have helped fan speculation about a plot.
Last week the militant organization Hamas signed onto the conspiracy theory. In Gaza yesterday, the Al Aqsa Martyrs Brigade, the military wing of Mr. Arafat's Fatah party, circulated a leaflet threatening to avenge his death unless the Palestinian government disclosed the cause within two weeks.
Mohammad Yaghi, a columnist for the Palestinian Al-Ayyam newspaper, said the prevalence of state-controlled media in the Middle East had left ample room for speculation about conspiracy.
"Conspiracy theories have real roots inside the Arab world, not only Palestinian society," Mr. Yaghi said. "Before the electronic media, there was no access to information, and people don't trust the Arab media." posted by sydney on
11/19/2004 06:08:00 AM
A total of 102 soldiers were found to be infected with the bacteria Acinetobacter baumannii. The infections occurred among soldiers at Walter Reed Army Medical Center in Washington, Landstuhl Regional Medical Center in Germany and three other sites between Jan. 1, 2002, and Aug. 31, 2004.
...A. baumannii, which is found in water and soil and resistant to many types of antibiotics, surfaces occasionally in hospitals, often spread among patients in intensive care units.
The infection was also found in soldiers with traumatic injuries to their arms, legs and extremities during the Vietnam War.
Spread of the infection is often halted when health-care workers wash their hands and those of their patients with alcohol swabs, actively monitor those with wounds to the extremities and promptly identify the infected.
Development of better drugs also is needed to help contain future outbreaks of the infection, Army officials said. In some cases, the only effective antibiotic is colistin, an older drug that is rarely prescribed today because of its high toxicity.
Health-care providers in the United States are urged to watch for A. baumannii infections among soldiers who have been recently treated at military hospitals, especially those who were in intensive care units.
Television Medicine: Caught the season premiere of Fox's new medical drama(?) "House." The protagonist, Dr. House, is a brilliant diagnostician who hates people. The premise is that each week he and his team will solve a baffling medical mystery. It's a hybrid of Becker and the New York Times Sunday Magazine "Diagnosis" column by Lisa Sanders. The show has its entertaining moments, mostly in the dialogue:
Junior Doctor: Isn't that why we became doctors, to treat patients?
Dr. House: No, we became doctors to treat illness. Treating patients is what makes most doctors miserable.
Unfortunately, that's the highest point of the show, which is extremely weak when it comes to medicine, and to human nature. A few minutes with Dr. House and you have to wonder why anyone would keep on staff, even if he is brilliant. Not only does he refuse to see patients, he stomps around insulting everyone and popping narcotics in plain site ("Because they're yummy," he tells a patient who's been unfortunate enough to be forced upon him by the head of the hospital.) Dr. House walks with a limp, supposedly caused by an illness that destroyed his thigh muscles. That's the only clue we have as to why he's a nasty piece of humanity. And truth to tell, you don't have to give a doctor a disability and a drug habit to explain his misanthropy - a beeper and a couple of nights on call would serve just as well.
But Dr. House's personality, as bad as it is, isn't the worst of the show. The entire medical establishment he inhabits will leave viewers familiar with the realism of shows like ER largely disappointed. Dr. House is head of "department of diagnostic medicine," whatever that is. Is he an internist who concentrates on diagnosis at the expense of treatment? Evidently not. He sees children as well as adults, and he prescribes treatment, too. And the entire department seems to be composed of Dr. House and his residents or fellows or whatever. (Their relationship to the great man is fuzzy, other than that their his subordinates.)
Dr. House and his team spend hours thinking over the one problem case they have. They defer diagnostic testing for other less conventional means of diagnosis such as breaking and entering. This week's case turned out to be neurocysticercosis, or tapeworm in the brain. This is certainly an uncommon ailment, and one that would require diagnostic acumen and doggedness, but the show goes over the top for drama. The case patient was allergic to the contrast that was needed for an MRI to make the diagnosis. So, instead of doing a lumbar puncture or performing lab tests that most would use in the situation to make a diagnosis, the team breaks into her house to search for clues. They find some deli ham in the refrigerator and - "bingo!" diagnosis made.
Not all of the show is bad. Hugh Laurie does a surprisingly good job playing an angry white male. It's safe to say he's put Bertie Wooster behind him for a long time. He could even have a future as movie villain. But his performance, alas, is the only good thing about the show.
And, the guy can't even use a cane correctly. Would someone please tell them that while a cane on the ipsilateral side as a defect looks impressive for TV, it's not the physiologically or mechanically correct technique. (See here.) posted by sydney on
11/17/2004 08:21:00 AM
Foot Dragging Mopes: I've had more than a few patients like this (with physical, not psychological, complaints):
When and if they do get therapy, psychiatrists say, people with strong passive-aggressive instincts are usually determined to fail: the therapist becomes the scorned authority figure. The patients will take their medications and then report with relish that they don't work. The patients will follow advice and then complain that it is senseless, useless. "They are not doing this on purpose; it's part of a deep-seated ambivalence about getting better," a determination to expose the authority as incompetent, said Dr. Marjorie Klein, a psychiatrist at the University of Wisconsin.
And I bet this will sound familiar to a lot of people:
The marriage seemed to come loose at the seams, one stitch at a time, often during the evening hour between work and dinner. She would be preparing the meal, while he kept her company in the sun room next to kitchen, usually reading the paper. At times the two would provoke each other, as couples do - about money, about holiday plans - but those exchanges often flared out quickly when he would say, simply, "O.K., you're right," and turn back to the news.
"Looking back, instead of getting angry, I was doing this as a dismissive way of shutting down the conversation," said Peter G. Hill, 48, a doctor in Massachusetts who has recently separated from his wife. Even reading the paper at that hour was his way of adamantly relaxing, in defiance of whatever it was she thought he should be doing.
"It takes two to break up, but I have been accused of being passive-aggressive, and there it is," he said.
I've done some things that are passive-aggressive in my time, such as giving a tie I knew to be ugly as a gift. But, I'm relieved to discover, it's no longer considered a personality disorder. Does that mean it's now considered acceptable behavior?
Real Life: Princeton professor of ethics Peter Singer took his class on a field trip to a neonatology unit where they came face to face with those Singer considers life unworthy of living:
Singer had brought his students to the ward to show them the living faces of a medical debate featured prominently in his scholarship and his seminar: whether it is ethical to end an infant's life when medical data predict she has a low chance of surviving.
The students, excited as they entered the hospital, turned somber as they walked through the ward.
... "Everyone came in very bouncy and energetic, and I thought, 'Wow, these people have no idea what they're getting into,'" said Jennifer Calise, a young mother cradling her one-year-old daughter, a former ward patient who had come for a checkup. "Now they all look a little shell-shocked."
...Calise was forced to confront the viability-of-life issue abruptly in February 2003, when her water broke early and doctors told her the fetus had a low chance of surviving. When Calise gave birth to her first child several days later, the newborn's prognosis was not good.
"What we call viability is 24 weeks," said Dr. Denise Hassinger, who oversees Calise's care. "[Calise's first baby] came out at 23 weeks. And she could move, she could breathe and everything, but it was 23 weeks. So is it a person, is it not a person? There's a lot of legal and ethical issues involved."
Calise had instructed the doctors to resuscitate the baby if it showed any chance of survival, but its premature birth, and a severe prenatal infection, suggested little use in trying to keep the baby alive. The baby, named Simone, died after support was withdrawn.
"[My husband and I] have seen the miracle babies, and everyday we ask ourselves, did we do the right thing?" Calise said.
Calise gave birth again in September 2003 to a baby named Ava. Though her second baby was also premature at 25 weeks, it was relatively healthy otherwise and doctors started care immediately. Calise proudly showed the class her cheerful, healthy daughter.
When Hiatt encouraged students to ask Calise questions, they were hesitant. "I could see with the students, everyone was thinking 'Oh my God, is she going to have a nervous breakdown if I say her first child wasn't a person?'" Calise said later.
After about 30 seconds, the first question came from Faruk Colakoglu '08.
"Are [underdeveloped babies] children?" he asked.
"What makes them a child?" Calise replied. "I mean, is it the fact that they breathe, or is there something else that tells you there's a life?"
The article doesn't say if anyone had an answer to that.
More Race-Based Medicine: Journal Club expounds on the genesis of the heart failure pill for patients of African descent:
Isosorbide dinitrate and hydralazine have been used for the treatment of heart failure in the past. The isosorbide-hydralazine combination pill was patented (in the 1980’s) for the treatment of congestive heart failure, but failed to provide significant benefits in large trials; as a result, the FDA would not approve it as a new medication. Subgroup analysis of the original trials, however, suggested benefit in black patients. The company NitroMed, which had acquired the rights to the combination, then applied for and received a new patent for it specifically for the treatment of heart failure in black patients. Unlike the original patent, which expires in 2007, the new one for the same medication is valid until 2020. Armed with this new patent, NitroMed sponsored the current trial. With the positive results just reported, the FDA is likely to approve BiDil for use in black patients.
My initial reaction to this whole story was that it represents a typical interaction between industry, the patent system and the FDA. There is a one-two punch with the patent system prolonging the drug company’s monopoly by granting a new patent for use in a subpopulation, which the FDA then protects by limiting approval of the medication to that subpopulation.
The other side of this coin, however, is that precisely this system led to a potential profit for NitroMed, which made sponsoring the trial financially attractive. The result is likely to be of benefit to many African Americans. A prime example of the strengths and problems with the pharmaceutical industry’s ties to regulatory agencies.
Attention Sufficit: So this is why I've had a spate of college-age students (and their parents) insist that they've suddenly realized they have ADD:
Kevin Ngo, a Baylor University graduate now studying for the law school entrance exam, isn't leaving anything to chance. He is seeking help from a pill that's meant to treat attention deficit hyperactivity disorder.
"There is something about Adderall that makes you concentrate, focus and makes whatever you're studying more interesting," he said.
A Yale University junior said Adderall helped him read the 576-page novel "Crime and Punishment" and write a 15-page paper — all in 30 hours.
Amending Amendments: A judge in Florida has put a hold on the "three strikes and you're out" malpractice amendment that Florida voters passed this month:
The amendment, known informally as the "three strikes for bad doctors" measure, was approved by 70 percent of voters earlier this month.
Circuit Judge Janet E. Ferris agreed in part with hospitals that sued to block the amendment from taking effect until some aspects of it can be clarified, most likely by the Legislature or by the courts.
Ferris barred the amendment from going into effect while she considers arguments presented by the hospitals and the state, which is charged with enforcing the measure, and by a group called Floridians for Patient Protection, which pushed to get the issue on the ballot.
An industry group representing hospitals argued that the amendment's requirements are not clear. It is seeking clarification of questions such as whether its effects are retroactive for doctors who already have had "three strikes," what doctors are included and what agency is responsible for revoking licenses.
Ferris said her injunction will expire at the end of the upcoming legislative session in the spring, meaning that if lawmakers don't pass a law putting more specifics into the measure and if there hasn't been a court ruling in the interim, the amendment could then go into effect.
It should be interesting to see what effect this amendment will have on the supply of obstetricians, neurosurgeons, and trauma surgeons in the state. Those specialties all have high rates of suits not because they're full of bad doctors but because they handle risky situations - situations in which people die no matter how good the care. And no matter how good the care, when someone dies young and unexpectedly, a lawsuit follows.
Will lawyers who justify such lawsuits by saying "well, that's why the doctors have insurance" file fewer lawsuits knowing the consequences will be ruined careers? Of course not. As long as the ruined career isn't theirs. posted by sydney on
11/16/2004 06:29:00 AM
The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all. posted by sydney on
11/16/2004 06:14:00 AM
Children with autism have inflammation in their brains, although it is not yet clear whether the inflammation actually causes the condition, researchers said on Monday.
Tests on the brain tissue of 11 patients with autism who had died and spinal fluid from six living children with autism showed the activation of immune system responses, the team at Johns Hopkins University School of Medicine in Baltimore and the University of Milan found.
"These findings reinforce the theory that immune activation in the brain is involved in autism, although it is not yet clear whether it is destructive or beneficial, or both, to the developing brain," said Dr. Carlos Pardo-Villamizar of Johns Hopkins, who led the study.
Bioterrorism Preparedness Watch: Evidently, there are people who think that altered smallpox virus is already out there in the world. Here's one former Soviet scientist on the WHO's decision to consider allowing genetic alteration of the virus to investigate disease treatment:
'It's absolutely the right decision,' said Dr. Ken Alibek, a former top scientist in the Soviet biological weapons program who said the Soviets covertly developed smallpox as a weapon in the 1980's.
Alibek, who defected to the U.S. in 1992 and now teaches at George Mason University, said it's now possible to genetically engineer smallpox to render current vaccines useless.
'The bad guys already know how to do it,' Alibek said. 'So why prohibit legitimate researchers to do research for protection.'
Given the trade in weapons we now know to have existed between the Soviets and Iraq, could it be that some of those smallpox samples made it there, too? If so, where are they now? posted by sydney on
11/15/2004 06:50:00 AM
Good-bye to All That: While I was away, the governor of Tennessee announced he was going to shut down TennCare, the budget eating state-funded healthcare program that bore many similarities to the Kerry/Edwards plan for the nation. The governor is in a show-down with advocates who have fought tooth and nail to keep the benefits generous. How generous is it? Here's a letter from a man that describes one of their forms of generosity. Evidently, once you were on it, they kept you indefinitely, no matter what your income. posted by sydney on
11/15/2004 06:32:00 AM
Ashraf al Kurdi, who was a friend and doctor to Arafat for 25 years, also said he was 'disappointed' in the care that French doctors gave Arafat.
'They did not care even to phone me and ask for his medical history,' al Kurdi told Knight Ridder Newspapers by phone from his home in Jordan. 'They did not even phone. I am very disappointed in their care for him, and I cannot understand this lack of an explanation for his death.
Join the club, buddy. Every primary care doctor who has ever referred a patient to a tertiary care center for further care gets the same treatment.
posted by sydney on
11/15/2004 06:04:00 AM
Reaching Out: One of my patients brought a program to my attention that offers savings on generic drugs for people who make up to 250% of the poverty level. Called RxOutreach, it's run by the pharmacy benefits management company, Express Scripts. I've since recommended it to one of my other patients who lost his insurance coverage. I added their button to the right if anyone is interested in checking them out or recommending them to a friend. Here's a list of the medications they offer. posted by sydney on
11/15/2004 05:57:00 AM
Fruits of Bias: By now, everyone's heard of the wonderful new drug combination that will save the lives of many people of African descent:
A two-drug combination pill dramatically reduced deaths among blacks with heart failure, a landmark finding that is expected to lead to government approval of the first medication marketed for a specific race.
Black cardiologists hailed this form of racial profiling after years in which minorities got short shrift in medical studies. Others complained that the drug also might help whites and should have been tested in them, but wasn't for business reasons.
'At times you can't win,' said Dr. Augustus Grant, past president of the Association of Black Cardiologists, which supported the study. 'Here we have a wonderful trial that shows a clear result and the issue is raised, 'Why was this trial only done in African Americans?''
Good question. If what you were really looking for is a drug that would work better in blacks than in whites, wouldn't you compare the impact of the drug on the two groups? Why, yes, you would. But that's not what the researchers did. Perhaps it was because the researchers know there's a great demand and interest in research that's conducted on people of African descent, and focusing their research on that population is more likely to result in publication. Perhaps it was because the researchers who conducted the study have a genuine interest in only studying people of African descent. Or, perhaps it's because one of the researchers holds two patents on the drug combination used in the study and he had a vested interest in making the combination look good. Or, perhaps it was because the company sponsoring the study, NitroMed, has applied for a patent that specifies the drug for use specifically in patients of African descent. Either way, there's an obvious inherent bias in the study.
And by the way, the results weren't all that impressive. Certainly not "dramatic." The study followed patients for an average of ten months. Of those who took the drug combination, 6.2% died by the end of the trial compared to 10.2% of those who took placebo, for a difference of 4 percentage points. The two groups also differed in the incidence of heart failure exacerbations by about four percentage points. But the incidence of side effects was much higher in the treatment group - 47.5% experienced headaches, compared to 19.2% in the placebo group; 29.3% experienced dizziness compared to 12.3% in the placebo group. You've got to wonder if it's really worth taking.
The idea of finding drugs that work best within a genetic make-up is a good one. An one day, when the science of genomic medicine is better developed, we may be able to choose drugs that will work best for an individual genetic make-up. But this study is no nowhere near that level. And it bears all the marks of spinning the data to fit the researchers - and their sponsors's -best interests, rather than those of patients.
UPDATE: A reader takes me to task:
I agree with the thrust of your comment that we need to watch out for vested interests in designing studies, etc., and in this case, there is an extra angle associated with race. But I think that you have the details of this particular story a bit wrong, despite the fact that you are generally right about such things. I speak particularly of your comment to this effect:
"perhaps it's because one of the researchers holds two patents on the drug combination used in the study and he had a vested interest in making the combination look good."
Now, I occasionally have reason to do things professionally with Jay Cohn, the cardiologist here at U Minnesota whose brainchild is the therapeutic combination of hydralazine and isosorbide compounds.... I don't see where that says anything about his motives for this project.
I would bet my wife and daughters- well, not them, but you get the idea- that his presence on patent 6,784,177 has exactly zero to do with conflicts of interest to get big dollars from the combination drug. For starters, he doesn't need the money- if he was driven by cash, he would not still be in academia as a very well-known practitioner with a CV 8 miles long, he would be in big deal practice out there working for famous and rich CHF patients like Richard DeVos.
Cohn has been crusading for 20 years to find anyone who will test the two drugs together to get the therapy qualified for on-label scripts, but no one had any interest because the compounds themselves were/are generic and out of patent coverage. The patent itself is a method patent- meaning that it is essentially unenforceable; anyone who reads the clinical studies can just go use the therapy with no one paying any attention at all. The only
reason to patent the thing at all is PR for the company that finally took up the cause. Cohn frankly admits that he is in the African-American application solely because it was the only way he could get this tested at all. Anyone who challenged the claims of that patent or was challenged by an enforcement attempt would have it killed so fast your head would spin. In the real world, the patent is about as financially useful as Bayer patenting the idea of women over 50 taking 80mg a day of aspirin to reduce the possibility of MI. Cohn frankly tells anyone that he wants nothing more than for everyone to prescribe those drugs together in appropriate dosages for HF, wherever they get them. If the company makes some money on a convenient single pill, fine.
And I find the motives of those decrying the study on "ethical" grounds pretty suspect; the Jonathan Kahns of the world are more concerned that African Americans will start to see health care redlining or the rebirth of the old IQ controversy as part of the eugenics debate than they are about treating patients.
We Have Met the Enemy, and They Are Us: Dr. John Abramson is somewhat of an anomaly. For starters, he's a family physician on the faculty of Harvard Medical School - an institution not known for its warm embrace of the family medicine concept. (In its place, they have something called the Department of Ambulatory Care and Prevention, staffed largely by internists and pediatricians and masters of public health, and oddly enough, funded by an HMO.) Which brings us to his other claim to anomalism - the publication of his book, Overdosed America : The Broken Promise of American Medicine. While other academics and health policy analysts point directly to the pharmaceutical industry as the root of all evil in our current healthcare system, Dr. Abramson correctly notes that the real roots of our problems lie in our culture - from the academic and health policy system to the professional and popular cultural mileau.
Now, as healthcare systems go, ours isn't too shabby. We have the luxury of taking clean water and cheap, unspoiled food for granted. We live our lives free of the threat of death by bacteria. Most of us, no matter how poor, can find a doctor to take care of us in our hour of need. We don't wait for months for CAT scans or heart surgery, or to get an appointment with a doctor. We have a medical establishment that believes strongly in the importance of practicing medicine only with scientifically proven treatments - aka "evidence-based medicine." We have third party payers who monitor the quality of care by our physicians based on guidelines written by experts in their fields. However, as Dr. Abramson points out - an awful lot of the healthcare we get isn't the worth the money we pay. If our healthcare system were a car, it would be a Jaguar - fast, expensive, and beautiful on the surface, but little to offer for the long-haul.
Part of the problem is the elusive nature of this thing called health. Like happiness, it's difficult to nail down. That's why our founding fathers claimed a right to the pursuit of happiness rather than the state of happiness. If only we were so wise when it came to defining our goals for health. Today, health and disease have much broader meanings than they did fifteen years ago. Fifteen years ago, disease meant illnesses caused by a malfunctioning of the body or outside invader, such as cancer or infections; today, disease includes the normal changes of aging, such as osteoporosis and thickening waist lines. Twenty years ago, to be healthy meant to be of sound mind and body; today it means a fine obsession with various biomedical measures of the body - from cholesterol level breakdowns to bone density values. What's more, we have a pill or a procedure to treat each of those biomedical measures of health. Is your LDL cholesterol a smidgen above the recommended guidelines? We can bring it down for just over a hundred dollars a month. Is your body mass index forever over 25? We can readjust your stomach to bring it down. Even better, we have insurance companies who are willing to pay for all of this. And if they don't, we'll pressure them until they do.
Dr. Abramson doesn't spare the pharmaceutical companies any criticism. Our system of drug-financed medical reasearch and medical centers, corporate-sponsored professional organizations and medical education, and consumer advertising corrupts the decision making process of doctors, patients, and expert panels. The evidence central to evidence-based medicine can't be trusted because it's financed by drug companies. The practice guidelines that expert panels such as the American Heart Association publish which are supposed to guarantee we all practice high quality medicine can't be trusted because they're funded by drug companies. But that's only part of the problem. As Dr. Abramson says at one point in his book - "we have met the enemy and they are us."
The problem can be traced back to the late 1980's and early 1990's when Medicare, Medicaid, and the baby boom population reached maturity. There was much hand-wringing at the time about the "crisis in American medicine," just as there is now. Then, as now, the crisis was the cost. The solution, which enjoyed wide support from all sectors of society - from the public, the medical profession, and politicians on both sides of the aisle - was the adoption of managed care, or HMO's. The public loved it because it meant they no longer had to pay for healthcare, at least not directly. For a minimum co-pay, and the price of their monthly insurance premiums, they would get unlimited access to their doctors and all the preventive care they needed - pap smears, mammograms, immunizations, and yearly physical exams, and drugs. The medical profession loved it because they believed passionately in the power of prevention and they also believed that by providing unlimited preventive care they could conquer disease. The insurance companies loved it because it shifted the inherent risk of their business to the medical profession. Politicians loved it because it meant that once Medicare and Medicaid beneficiaries were shifted to managed care programs, someone else would make the painful and unpopular decisions about rationing that are inevitably needed to rein in costs. It was win-win all around.
Except it didn't quite turn out that way. The gatekeeping nature of HMO's turned out to be immensely unpopular - so much so that the insurance companies pretty much gave up on limiting benefits, lest they be accused of corporate malfeascence. Instead, they just raised premiums. The emphasis on prevention, and the willingness to pay for it, encouraged doctors and the public to accept expanded definitions of health and disease. Doctors could promote with impunity the necessity of having bone densitometry tests or fasting lipid panels done - and the necessity of treating values outside the defined norm - without giving much scrutiny to the actual benefit. And the public could accept it without much thought, since they didn't have to pay for it directly. Add to this mix the expansion of pharmaceutical advertising directly to the patient - who no longer had to worry about the cost of the product they were consuming, and you've got a recipe for unlimited demand, and unlimited spending. (The drug industry marketing departments knew a golden opportunity when they saw it. What other product has the luxury of advertising directly to a consumer who doesn't have to pay for it?)
At the same time, the shift of Medicaid and Medicare patients to managed care plans meant less money for academic medical centers, who relied on these patients for their operating revenues. To remain competitive, they turned to private industry for funding, which in most cases meant the pharmaceutical industry. This relationship skewed the inherent bias in all research even further toward the positive, and meant that the emphasis would be placed on drug development rather than non-pharmacological management of disease and disease prevention. Those same researchers end up sitting on the expert panels that then write the guidelines that are supposed to guarantee quality care.
It doesn't help that medical journal editors are by and large undiscriminating in the papers they publish. They, too, have their biases, and publishing papers that show positive results is one of them. So is publishing papers that suggest a revolution in treatment - such as reducing heart disease by treating cholesterol. They don't give the data much scrutiny in the process. And they never question the spin the authors give their data. Even worse, they press release that spin to the media for direct consumption by the consumer.
And so we have our current system. A paper is published that suggests taking cholesterol lowering drugs cuts the risk of heart disease by 50%. In actuality, their data find that without the drug, 2 out of 100 people have a heart attack, while with the drug, only 1 out of 100 do. Their claim to a 50% reduction in risk is technically true, but misleading. The majority of people in both categories will do fine without the drug. But the authors have chosen to concentrate on the more impressive sounding relative risk reduction rather than the absolute risk reduction. It gets them more attention that way. The medical journal, and perhaps the author's institution as well, sends a press release to the media about these stunning findings. That week, the news is full of the amazing benefits of the drug. The company makes up television and print ads touting its benefits, too. Within the week, patients are asking their doctor about the cholesterol lowering drug that works saves so many lives. And the doctors? With any luck they'll read the abstract of the paper and conclude the drug must be beneficial, without ever noting the devil in the statistical details. And even if they did, they would have trouble convincing most people of the inadequacy of the drug given all the favorable publicity it's gotten. As a result, new drugs and treatments become accepted much more quickly than they otherwise would - and with much less scrutiny than they deserve.
Dr. Abramson sees the solution to our cunundrum as more government oversight of the healthcare industry. He suggests we set up an impartial body, along the lines of the Federal Reserve Board, to monitor the quality of medical research and recommendations. In addition, he suggests that there be government funded universal healthcare coverage, which would pay only for those benefits deemed worthy by the oversight board. Dr. Abramson puts too much faith in the impartiality of government bodies. Even the Federal Reserve Board comes under criticism for being entirely a creature of the finance sector. The Institute of Medicine, which he also mentions as a model, is no less subject to bias. Their report on racism, for example, was written by people whose careers depend on the presence of racism. Their personal bias was to see racism even where it doesn't exist. Similarly, their report on errors in medicine was written by people who make their living selling safety systems and consulting on error reduction. Not surprisingly, the racism panel claimed racism was rampant (later debunked) and the error panel claimed more errors than statistically reasonable. Imagine what they would do with something like drugs and therapuetics which are much more subject to lobbying influence.
History tells us that there's very little reason to expect our government to be immune to industry lobbying. As we've seen with Medicare spending and NIH research funding, all it takes is a celebrity or a Congressional relative with a disease to earmark money for its treatment. They're even more prone to influence from those advocacy groups and lobbyists who have the money for campaign donations.
A better solution would be to move the decision making process, especially for preventive care, back where it belongs - between a patient and his physician. The only way to do this is for the patient to share at least some of the financial responsibility for their care. As long as someone else is paying the bill, the sky will be the limit. It's just human nature. A patient who has to pay for cholesterol lowering medication is going to be much more likely to question its benefits, and the doctor who has to justify the expense to his patient it is going to be much more willing to critique the evidence. This, of course, flies in the face of all that is politically correct in medicine. But, as Dr. Abramson so ably points out in his book, we aren't really getting very much in return for all of this very costly prevention. Isn't it about time that we all took responsibility for our share of the mess?
ADDENDUM: For another take on the book, click here. Dr. Abramson's blog can be found here.
Bravo to you and Abramson both. Having been in family practice since it was called 'general practice' (I interned in a 'general practice' program; when I got out of the Navy two years later, I went back to the same hospital to do my 'family practice' residency), I'm amazed anyone's even listening to the guy.
Every year I note the 'normal' weight/cholesterol/blood pressure/blood sugar, etc keeps getting defined lower and lower by the stroke of a pen, thus creating a whole new class of sick people. They now are trying to sell 'pre-hypertension'!
My daughter was a detailer for the old Upjohn Corp in the early '90s and quit in disgust after a few years. The relationship between doctors and pharms is way out of line. posted by sydney on
11/14/2004 06:32:00 PM