Medicare Rebutted May 3, 2006
Posted by barelymd in Health Policy, Pharmaceuticals.add a comment
Hear Hear! (NEJM – free full text)
While Medicare Part D continues to generate more problems than it solves, the medical community has no qualms about speaking to the disaster that has unfolded. In this correspondance piece that responds to a cheery article on Part D, Dr. Cooper decries what has undoubtedly become a nationwide phenomenon.
“… although the authors believe that “physicians are uniquely suited to helping their patients . . . to identify plans that provide substantial savings,” I would argue that busy physicians, already overwhelmed by paperwork, are in no such position. Physicians are trained to provide medical care, not to navigate government Web sites and insurance companies’ formularies. The best advice physicians can provide to their patients is to call the offices of their elected officials. Perhaps when these officials are swamped by calls from perplexed seniors, Congress will find a way to fix the mess they have created.”
See Over My Med Body for an excellent discussion on the solution to this mess.
Magic Cancer Bullet April 30, 2006
Posted by barelymd in Health Insurance, Health Policy, Pharmaceuticals, Public Health.add a comment
Drug companies deserve their billions in profit.
The outspoken public is largely united against the pharmaceutical industry and the cut-throat economics that govern drug sales – and with good reason. As health spending in the United States quickly approaches 20% of GDP, it seems perfectly justified to ask why the ten drug companies listed on the Fortune 500 far exceed all other sectors in net return. Couple that corporate image with documentaries about patients who cannot access lifesaving medications and you have an image of an evil, soulless corporatocracy. Of course, it is of little help that Medicare Part D, in all of its convoluted bureaucracy, was conjured up by PhRMA lobbyists to squeeze every last dollar out of public health coffers.
Granted, it is difficult to sympathize with businesspeople who treat lifesaving compounds as “products” and make billions in the process, but who is really to blame? Or does the current state of affairs even merit assigning someone the blame?
Daniella Vasella, the author of Magic Cancer Bullet and the CEO of Novartis makes a compelling case for the stance of his industry. Gleevec, a magic bullet used to treat chronic myelogenous leukemia (CML) is made by his firm and costs around $30,000 USD per year. It is unclear whether Gleevec can cure CML, so for now, patients undergoing treatment can expect to stay on the drug for the entire course of their natural lives. As one might imagine, public outcry over the exorbitant cost of this drug has been loud, relentless and, given the stakes, emotionally charged. In his book, Vasella notes that prior to the introduction of Gleevec, CML therapies using interferon and Ara-C were similarly expensive. Moreover, so few people suffer from CML in the United States (no more than 8,000 at any given time) that prices must be high to justify the resources invested in drug research and development. To broaden the argument, Genzyme was recently granted approval to sell Myozyme, a treatment for Pompe disease, for $300,000 USD per year.
Indeed, it currently takes an average of 12 years and $880 million to bring a drug to market, and the entire process is prone to collapse at any point in the process. One poor trial result, one acutely adverse reaction, or one unexpected toxicity study and a potential drug can become trash. Aside from the high risk involved, the industry experiences tremendous failure as only 1 of 10,000 compounds actually makes it to the market. It would seem logical in any other industry that such poorly stacked odds should promise tremendous reward to those rare few who do manage to succeed – but in medicine things are different. When a “miracle cure” is discovered, the patient population feels a right to benefit from the innovation. That one’s life can hinge on ingesting a single pill is such an abstract and wonderful notion that it is difficult to grasp how market-theory and econometrics may become barriers to life.
The U.S. government has taken some action in alleviating the market pressures by legislating the Orphan Drug Act. This piece of legislation allows for the speedy and relatively inexpensive approval of drugs that treat rare diseases. Without this law, drug companies would have little incentive to develop products to treat CML and similarly rare diseases. The problem, however, is that the savings do not appear to filter down to the consumer. Orphan drugs are still exorbitantly priced and patients are still pressured out of the market.
Fortunately, it seems some drug makers do have a soul. Novartis has enacted a patient access program whereby those CML sufferers earning less than $43,000 per year are offered Gleevec for free. Not even for the minimal production cost – for FREE. As reported by Novartis, there are currently over 10,000 patients receiving this benefit and more are enrolling each year. Other firms have similarly arranged programs where patients who cannot afford lifesaving treatments are subsidized by the companies themselves. Indeed, the programs are probably not perfect and one can be certain that many patients fall between the bureaucratic cracks, but the numbers do speak loudly. There are impoverished, uninsured, very sick patients who are getting their drugs for free, solely because some drug companies are aware of their responsibility to society. The argument could be made that this goodwill is, in effect, a public relations campaign to ensure that the firms are not derided for withholding live-saving treatments – and this may very well be true. A company that willingly allows people to die or economic reasons will not have a very happy consumer base. It will also not hold as much sway in government and will certainly have few friends in its own industry. But how many other private sectors offer their products for free when consumers are in dire need?
The pharmaceutical sector in the United States certainly makes large profits, sometimes to the point of obscenity, but is that its fault? Profit-minded shareholders ultimately run all of these firms and the actual people on the lab floor have little to do with pricing and marketing. The existence of drug access programs run by the firms themselves seems a cry for help directed at legislators and regulators – they are the only ones poised to do something about the ludicrous state of healthcare economics in this age.
Grand Rounds – 4/4/06 April 4, 2006
Posted by barelymd in Technology.add a comment
Grand Rounds is up for this week in form of a patient history.
… and who said medical blogs were dwindling?
Medicine, Upside-Down April 1, 2006
Posted by barelymd in Health Policy, Pharmaceuticals, Public Health.7 comments
Sorry about the extended hiatus over the past few weeks – had a bit of excitement going on and couldn't find the time to post. Barely, MD will try his best to be a little more regular in the future (maybe some prune juice is in order?)
Anyhow, that past few weeks have been huge in terms of large cohort studies. At least three major epidemiological findings rattled the medical community and changes to treatment guidelines are likely to affect almost every patient in the developed world.
Vitamin D and Calcium – A gargantuan study involving 36,282 women between the ages of 50 and 79 sought to determine whether supplementation with vitamin D and calcium correlated with a reduced risk of bone fracture. After decades of expounding on the benefits of these two supplements in post-menopausal women, it seems the data are less enthusiastic than the medical community has been. The study concluded that:
Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones.
The authors of the study won't go so far as to recommend a change in treatment guidelines, but far be it for this blog to ignore such compelling data. Given that Americans spend hundreds of millions of dollars to supplement their diets with calcium and vitamin D, it might be time to re-evaluate this excess and see if that money might be put to better use elsewhere… say, perhaps, in gym memberships.
Glucosamine and Chrondroitin – As if the vitamin D bombshell weren't enough to rattle aging Americans and their blind trust of the medicine cabinet, a second study was sure affect the supplement landscape. Glucosamine and chrondroitin have long been used to treat osteoarthritis under the belief that these two molecules are essential structural components of the joints. The working hypothesis was that worn-down joints in osteoarthritis sufferers could be restored by supplementation with the exact components that appear to have been degraded. To study the efficacy of these two supplements, researchers recruited 1583 patients with symptomatic knee pain resulting from arthritis and followed progress of their symptoms. Again, the double-blind placebo controlled trial prevailed:
Overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent. As compared with the rate of response to placebo (60.1 percent), the rate of response to glucosamine was 3.9 percentage points higher (P=0.30), the rate of response to chondroitin sulfate was 5.3 percentage points higher (P=0.17), and the rate of response to combined treatment was 6.5 percentage points higher (P=0.09)…
Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee.
This study may have revealed that Americans have been spending inordinate amounts on molecules that have little to no activity in the body:
Osteoarthritis is the most common form of arthritis in the United States and has a major effect on the health-related quality of life. In 2004, the estimated direct and indirect medical costs associated with all forms of arthritis exceeded $86 billion. Glucosamine and chondroitin sulfate are the most widely used dietary supplements for osteoarthritis, with estimated sales in 2004 approaching $730 million.
Moreover, the authors also gave us some clues as to why glucosamine and chondroitin may be not be functioning as previously believed. It seems that these two molecules are not terribly stable and after passing through the digestive system, not much is left of either to reach the joints. So despite the results of this trial, maybe our friends in pharma can find a novel way to protect these compounds from being degraded in the GI tract.
Third Party Prayer – "Prayer? What does prayer have to do with cold, hard data?" you might be wondering. Well, in a science that used to subject people to mustard gas and blistering hot instruments for the 'rebalancing of the humors', no health intervention can remain unexamined. The American Heart Journal just reported that having a third-party pray for a patient has absolutely no effect on patient outcome. Complete with its own major-drug-trial-acronym, STEP, the Study of the Therapeutic Effects of Intercessory Prayer (should it be STEIP?) concluded not only that prayer doesn't improve outcome, but that the knowledge of someone praying for you may actually increase the likelihood of complications… yikes!
Intercessory prayer itself had no effect on complication-free recovery from CABG, but certainty of receiving intercessory prayer was associated with a higher incidence of complications.
I can't say for certain that this study really tells us anything about anything. What conclusions can we draw? Do we tell families not to pray for loved ones going into surgery? Do we stop believing in the supernatural because hey, if well-controlled, experimental prayer increases complications just think what actual religiosity might do! Or do we go about our existence, content in the knowledge that we do what we can and believe in what we trust? I for one am thoroughly confused by this trial and am not entirely certain what these researchers set out to prove. Were the results overwhelmingly in favour of prayer, or overwhelmingly against prayer, would anything really change?
Next time, let's have a study on how many patients we could have saved using the resources that STEP just wasted.
Grand Rounds March 8, 2006
Posted by barelymd in Technology.add a comment
Grand rounds is graciously being hosted this week by Emergiblog.
Check it out – the best of the medical blogosphere.
Of Flipped Cars and Brain Bleeds March 6, 2006
Posted by barelymd in Clinical Cases, EMS.3 comments
If EMS has taught me anything it’s that appearances can often be deceiving.
On this particular Monday morning, I happened to be covering for a friend who decided it was a good day to skip town and go camping. Around 9am we got a call for a motor-vehicle accident (MVA) with one patient.
Alright, fair enough.
We take the local highway to get to the scene, and along the way, we meet up with three police cars, two rescue trucks and a fire truck. Hmm… interesting – this much attention for an ordinary car accident?
Our entourage of seven emergency vehicles is barreling down the highway much faster than it should be (typical guys, we like to show off our engines). And the sound of all our sirens must be deafening, as pedestrians on the sidewalk visibly cringe in pain when we pass. Finally, after twenty minutes of concocting all sorts of interesting theories about this call, we see the scene and gasp.
When you approach an overturned car sitting in the middle of the road a few things start going through your mind, not the least of which is how you can safely stage the ambulance on a major roadway. The real problem will be getting this patient out of the car (extricated) because he will obviously be stuck (entrapped) in an awkward position. His spine has also likely taken quite the jolt so it is imperative to keep him straight and move him gently lest our movements sever the chord and paralyze him. So my partner and I unload all of the rescue equipment and rush over to the car ready to provide life support and extricate this victim.
We anxiously approach the car and look inside, afraid of what we might find – and hey, there’s nobody in there. A heavy-set man comes up behind us and is furious, “I’m not paying for a trip to the hospital. Go home! Let me sort this out with the police.”
Needless to say, I was absolutely shocked: “Sir – you just crawled out of an overturned car on a major highway. You could be bleeding in any number of places, your brain could have been bruised, bones could have broken and, frankly, you could drop dead at any second!”
This was one stubborn dude. He cursed and yelled and swore until he was red in the face. Not only did he wreck his car, but now he’d have to pay for medical treatment.
Poor guy.
After nearly 20 minutes of begging him to come to the hospital, he finally relented and we put him in a collar, backboarded him and took off driving faster than when we had arrived. There were no symptoms or signs on scene. The patient felt completely fine, complaining of no pain at all. When we started transporting, however, things got a little shady.
A minor headache turned into nausea, which became difficulty breathing, which finally escalated to loss of consciousness (LOC) just as we entered the emergency department.
As it turns out, this gentleman, who at first refused to be transported, had a major subdural bleed (bleeding in the brain) and had fractured several vertebrae.
To be sure, when I said he could have died on the spot, ’twas not hyperbole.
Book Review: The Great Influenza March 5, 2006
Posted by barelymd in Book Review, Infectious Diseases.add a comment
John Barry’s The Great Influenza chronicles the violent upheaval of American medicine that occurred around the time of the 1918 influenza pandemic. The book does an excellent job of introducing how modern medicine had truly yet to emerge as a means of treating the ill. Patients would routinely undergo blood-letting, and doctors frequently prescribed irritants that caused boils and cysts to form – all the in the name of re-balancing the “humours” whose disequilibrium was causing disease.
Indeed, the turn of the century was not that long after Darwin proposed the theory of evolution, and the Germ Theory of Disease was still a cotentious issue. For those seeking a good grounding in the history of medicine, or specifically, in how America came to be part of the scientific revolution that gave birth to modern medicine, Barry has done an excellent job in this text.
A remarkable history has been compiled here, combining the intricate politics, bureaucracy and history that established America’s medical schools, along with clear and succint explanations regarding the epidemiology and pathology of the influenza virus. Specifically, this history is written as a story in which the protagonists emerge initially with too few tools and without the institutional support necessary to attack a global health threat.
As the story progresses, the heroes believe they have found the cause of influenza to be a bacteria that seems ubiquitous in infected patients. By the time science discovered that influenza was caused by a virus however, the pandemic was over and the death toll had already reached millions.
Truth be told, we still know relatively little about the influenza that caused the 1918 pandemic and are not much better equipped to handle it than we were 100 years ago. Hence the concern over our H5N1 friend.
Scientific Humanities March 3, 2006
Posted by barelymd in Medical School.add a comment
Dr. Campo of the Beth Israel in Boston wrote a reflective piece in JAMA last week concerning the dehumanization of medicine.
… here we were, scientists and artists from across the globe, all deeply concerned about the growing dehumanization of medical care, yet quite unsure about under which inspiring banner, exactly, we might most effectively unite to combat it. “So, what are the medical humanities, anyway?” asked a savvy medical student during a break as we nibbled on cookies, neatly summing up the vast yet unspoken problem we had posed to ourselves from the outset.
The student clearly hit on an issue that many recognize, but few are equipped to address. Combining a humanistic approach with the cold, hard science that has proven statistical outcomes to back it up just seems a contradiction of terms.
My initial reaction to his question enacts the very difficulty of even attempting to conjure up such a definition. On the one hand pour in all the emotions of knowing intuitively that the way medicine is now taught and practiced is simply wrong, that the humane is being supplanted by unfeeling science and uncaring economics—the incalculable distress I feel when I hear an intern refer to her patient as “the breast cancer in room 718,” the ephemeral sadness in cutting short a visit before we can delve into my patient’s grief at the loss of her husband because I have three others waiting…
So knowing that the the physician-patient relationship is headed for ruin, what are we going to do about it? In my experience, the most useful practice has been to simply pause the assessment algorithm for a moment and consider what the patient is going through.
Whether it be on the ambulance, in the waiting room, or on the operating table – consider yourself in the patient’s position and try to empathize with the fear, anger and anxiety that patients regularly feel. Sure, you may be rushing to get through a procedure or you may even be scared yourself if the patient presents with something serious that you may not think you can handle, but stopping for a moment to think is the best thing you can do for both patient and yourself.
Great words were once uttered by a physician who made humanistic medicine his calling: “If you treat the disease, you win some and you lose some. But if you treat the patient, I guarantee you’ll win every time.”
The High Cost of Health Care March 3, 2006
Posted by barelymd in Health Insurance, Health Policy, Public Health.add a comment
The delivery of health care in America needs help. Following none of the rules that govern supply and demand, deviating from every conceivable market predictor, and continually swallowing more of the national GDP, the medical system is acutely ill. The figure most often cited in raising this issue is that medical spending in America now accounts for 16% of the national GDP ($1.7 trillion). By comparison, the next-highest spending country is Switzerland, which spends 10.9% of its GDP on medical care.
So why the disparity?
Though there are numerous answers to this question, none is being adequately addressed – medical spending is projected to reach 20% of GDP within a decade. That means 1 of every 5 dollars spent in the US will be going towards some form of health care. The medical community may see that this bodes well for the future of the profession, but in actuality, most of this money is leaking out of the system into overhead costs such as insurance administration, patient record-keeping, political lobbying, and of course, malpractice settlements/fees/insurance.
Among the most surprising questions raised by the American system is how privatized medicine came to be more expensive than the single-payer, socialized system found in most of the developed world. By all measures, Americans enjoy neither the highest quality of life, nor the longest lifespan despite their unquenchable spending habits. Some argue that high costs are a natural result of the unequalled rate of innovation in the US. This camp contends that American companies spend more on research and development than other countries. The resulting drugs and medical products are then exported for a fraction of what they cost to develop, and voila – foreign nations enjoy the medical benefits of American innovation without the hassle of years-long investment costs.
Another compounding factor is how much is spent on end-of-life care. It is well known that one percent of the population accounts for thirty percent of health spending in the United States. Meanwhile, a third of Medicare’s budget is spent on patients in their last one year of life. It seems that other countries may have learned to embrace the end of life as a natural event, not be fended off tooth-and-nail in the face of all that medical science has say. Certainly, patients should have the option to pursue aggressive treatment, but it is the physicians’ role to prevent cases of gross misjudgement from allowing to proceed.
There are 45 million uninsured Americans who sit at the brink because the system cannot afford to support them. Perhaps a re-allocation of resources is in order.
… and of course, there will always be malpractice to keep physicians’ costs high and others’ pockets well-lined.
Oncology and the Decline of Childhood March 2, 2006
Posted by barelymd in Clinical Cases, EMS, Oncology, Pediatrics.add a comment
The other day I learned what childhood is all about. Or at least, what it’s supposed to be about.
To introduce this case, I should tell you that my spare time is spent working as an Emergency Medical Technician. The work gives me a refreshing view of the medicine that rarely makes it through hospital doors and that few professionals get to see. This is the dirty medicine; the medicine that involves rushing into someone’s bedroom to find them clutching their chest; the medicine that involves climbing into car wrecks and choosing between driver and passenger; the medicine that too-often makes one wonder how the world ever became like this.
But this call was nothing like that. This call was more about humanity than it was about medicine and that’s why it is so memorable.
Around 11.30pm we were dispatched for a 6 year old complaining of “acute pain.” We arrived on scene to find Emma (sorry, not her real name) curled up in her parents’ bed screaming in pain at the top of her lungs. She was apparently a non-Hodgkin lymphoma patient who had undergone such torturous treatment that it gave rise to neuropathies and chronic uncontrollable pain.
Well, Emma clearly needed to go to the hospital, but any time somebody touched her the pain would get worse. By now she had been screaming for so long that her lips were beginning to turn blue and her face was pale. This was not your ordinary tantrum. So we made a decision. Emma’s mother scooped her up, put her on our stretcher and out we went.
The amazing thing about kids is how quickly they go from incomprehensible misery to complete indifference. Once we got into the ambulance I guess there were enough distractions that Emma stopped crying and just starting pressing all the buttons, undoing all the buckles, opening all the cabinets, and generally making a mess of the place. To say the least, we were relieved that the colour was now coming back to her face.
Normally, our patients go to the local hospital that’s no more than 5 minutes from anywhere in town (yes, small town). The short transport means that EMTs rarely get to know their patients very well before the trip is over. Pediatric oncology cases, however, get driven to an academic center that’s thirty minutes away (even when driving with lights and sirens) so Emma got to tell me her whole life story before it was time to say goodbye.
Diagnosed with her lymphoma almost immediately after birth, Emma was forced to endure the oscillating success and failures that all oncology patients experience. The cancer is in remission. Uh oh, it relapsed. Remission again. Relapse once more. The emotional trauma is distressing enough for an adult, let alone a child who hasn’t a clue what life is like without chemotherapy.
Emma told us all about her ordeals – about how she can’t play with other children because her “immune system is broken” and about why she can’t go to the local hospital because only “special doctors can fix a special girl.”
As it turns out, her birthday was just the week before, but she didn’t have a birthday party. “Remember?” she asked, “I can’t play with the other kids because I’m neu- neu- neut- neutropenic.” And there it was. This six year old was going through unspeakable pain, enduring a suffering that nobody should ever have to conceive, and in the back of a speeding ambulance she saw the puzzled look on the EMT’s faces and began to explain what neutropenia was.
No sooner was she done with her explanation than she asked specifically for an “N-95 NIOSH approved mask” to “keep the germs away.” My partner put the mask over Emma’s face and immediately observed that it looked like a duck-bill. And so, for the rest of our ride to the hospital, the wail of the sirens was drowned out by Emma’s going “quack, quack, quack.” Perhaps she was child after all.
Now, when I think back, I have trouble remembering how Emma explained neutropenia. All I can picture is a duck.
