Cardiac rehabilitation, or guided exercise under direction of a physical therapist, is a valuable yet underutilized therapy for patients suffering a heart attack. Importantly, in those patients with ongoing risk factors related to obesity and insulin resistance/diabetes, aggressive cardiac rehab was recently shown to be especially effective.
Specifically, two groups of patients were enrolled in high intesity (5-7 days weekly of 45-60 minutes exercise) versus standard (3 days weekly of 25-40 minutes exercise).
High intensity patients lost more than twice as much weight over 5 months as standard patients (18 pounds vs. 8 pounds and had significantly greater reductions in 2 major cardiac risk factors — waist circumference and insulin resistance. At 1 year, both groups had gained a couple of pounds over 5-month weights, but total body-fat percentages in the aggressive group remained significantly lower than initial readings. Other cardiac risk factors changed too – including decreased insulin resistance, increased HDL (good) cholesterol, and decreased measures of insulin, triglycerides, blood pressure, plasminogen activator inhibitor-1, and the ratio of total to HDL (good) cholesterol.
Overall then, patients who took advantage of their motivation after heart attack to aggressively address exercise goals reduced potential risk factors and set the tone for a healthier life. If you have been a heart attack sufferer, ask your doctor about cardiac rehab. If you are not a heart attack sufferer but have risks, ask your doctor about trying a program like this on your own.
Questions and comments welcome as always!
*This blog post was originally published at eDocAmerica*
On Friday 12th June, the US Senate voted in favor of a bill that gives the Food and Drug Administration the power to regulate tobacco products. President Obama (who as a Senator was a sponsor of the bill, as was John McCain) has indicated he will sign the bill into law.
Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides here.
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.
-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
– Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
– FDA also has the right to request any such industry document produced prior to the enactment of this law.
– FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
– Nicotine cannot be banned but it can be reduced to very low levels.
– FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.
Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these: Read more »
I have heard a lot of talk about ownership of medical information. Bloggers like e-Patient Dave, and Robin are strong advocates for patient ownership of their information. To be truthful, I get nervous when I hear people saying they own something I have in my possession (and I’ve blogged about this). The charts in my office are mine, right? How can I create something and have it not be mine?
I carried this unease with me into the exam room recently. Thinking about the ownership of medical information, I opened a patient chart. The vital signs were already in, and I started in on the HPI (the patient’s story as to why they are there). I do this by asking questions: When did it start? How long did it last? What did it feel like? What did you take? Did you have other symptoms with this? How bad was it? Have you ever had this before?
Hmmm…. Whose information is this?
Then I went on to the review of systems. We have the patients circle symptoms on a laminated sheet and I discuss what they circled.
“You have some chest pain?”
“Well, it was a sharp pain that happened when I coughed. Is that bad? Could it be my heart?”
We then go into a discussion about chest pain and what to look for.
I put down the information the patient has given me and think a little more. The patient’s information?
Then I get frustrated. The past medical history hasn’t been updated recently, she’s been in the hospital and most of the information about this is not in the chart. The medication list is not accurate. The information about her family, lifestyle, and habits are incomplete and I don’t know when they were last updated. I sigh, then try to fill in the gaps as best as I can by asking her questions without betraying my lack of confidence in our record.
We have a meeting of our IT team after this, and I am thinking about this encounter. We are about to roll out a patient portal where patients will be able to log onto our website securely and fill out patient demographics, request refills, and get appointments.
“What information in the record would the patient be best to be in charge of?” I ask. By being “in charge” I mean that the patients would have actual control of this information and we would read it. I tell them about my experience and frustrations and we make the following list:
Marital Status
# Children
Job/School info
Home DM monitoring, weight, BP
Address, phone, e-mail address
Family history
Then I ask, “What information in the record could the patient contribute directly to?” By this I mean that they would see the information as it is in there and be able to suggest changes or additions, but would not be able to actually change themselves. Here’s what we came up with:
Smoking, alcohol
Medication List
History of visits to other medical providers, consultant names, etc.
Review of systems prior to visit
Surgical history
We want to be able to assemble this information so that it is in a format that is readable to us and fits our needs, but the patient would have the ability to take this data information and perhaps download it to organize as they wish.
“So what information should they have access to?” I ask, referring to information they can see, download, and organize as they wish, but not add or subtract to. Here is that list:
Upcoming tests needed (Colonoscopy, etc)
Immunizations
Lab results
Visit schedule – past and present
Previous vital signs
Recommended schedule based on their diseases
Problem list?
Finally, we discuss what is our own information that the patient only has access to if they request it. This is information that either will give them too much information (our thought process and remote concerns) or even things that we don’t want them to see (suspicions about truthfulness or worse). Here is this list:
Perhaps the problem list – if it contains things like anxiety, suspected abuse, or private things the patient has told us.
The HPI often has information that is potentially sensitive. People have to feel free to tell us things, and having that information be back in the face of the patient on the Internet (albeit a secure site) goes a bit too far. Who knows if a family member can access it? What about teens? It’s just too complicated.
Part of the assessment and plan is often conjecture and reminders to ourselves to pay attention to things in the future. If a person has weight loss, we may keep cancer in the back of our minds. If a person is asking repeatedly for narcotics, we may write down suspicions that bear watching in the future. We have to have a place where we can put things down and know they are for our own eyes only.
The last list is the shortest. Yet the current state of things is that the entire chart falls into the last category. This not only leaves the patient in the dark, it makes it so we have to do a whole lot of unnecessary work that the patient would do much better at (and without costing us a dime).
I think this is the sweet spot. This is the way the medical record should be in the future. It should be a shared venture – not just between PCP and patient, but also including other providers. For care to truly move forward we have to dream about what it could be. Our office now has this as the vision for where we want to head. I know my patients will be thrilled, and I am pretty sure I’ll have a lot less frustration in the exam room.
Like most of you, I’m continuing to watch the events unfold in Iran via Twitter and YouTube. Not surprisingly, given the escalating violence, doctors and nurses are caught in the crossfire. This video was posted on YouTube on June 16th. One woman who I’m guessing is a nurse is showing a sign that says that 8 people were martyred. Toward the end of the clip the young man (whose voice breaks down many times) is saying that he witnessed the brutal beating of women and children. He speculates that the attackers were Lebanese Hezbollah. Hat tip to Andrew Sullivan, The Daily Dish.
This story really upset me because I work with medical students at UGH (Undisclosed Government Hospital), and because I have children who are the same age as these victims. The eye witnesses reports come from medical students who hid when Iranian militia and police raided a Tehran University dormitory in the middle of the night. Hat tip to Nico Pitney of the Huffington Post. As we witness history, we will continue to witness the murder of innocent people.
“At the same time, Iran’s Interior Ministry ordered a probe into an attack late Sunday night on Tehran University students in a dormitory reported to have left several students dead and many more injured or arrested. Students say it was carried out by Islamic militia and police. Iran’s English-language Press TV said the ministry urged Tehran’s governor’s office to identify those involved. Iran’s influential speaker of parliament, Ali Larijani, condemned the attack.
Students’ Web sites reported mass resignations by Tehran University professors outraged over the incident. One medical student said he and his roommate blocked their door with furniture and hid in the closet when they heard the militia’s motorcycles approaching. He heard the militia breaking down doors, and then screams of anguish as students were dragged from their beds and beaten violently.
When he came out after the militia had left, friends and classmates lay unconscious in dorm rooms and hallways, many with chest wounds from being stabbed or bloody faces from blows to their heads, he said. The staff of the hospital where the wounded students were taken, Hazrat Rasoul Hospital, was so shocked that they went on strike for two hours, standing silently outside the gate in their white medical uniforms.”
Thanks to Dr. Wes for pointing us to a remarkable video of a 20-year old Belgian soccer player having his life saved by an implantable cardiac defibrillator (ICD). DrRich hopes you will view it.
As it happens, DrRich will be traveling to Europe imminently at the invitation of Dr. Pedro Brugada, whom some call Belgium’s King of Electrophysiology, and for whom the Brugada Syndrome is namesake. (DrRich is deeply honored to be one of the “masters” at Dr. Brugada’s “Meet the Masters” event, which gives him the opportunity to spend two days with a hand-picked group of top European and American electrophysiology fellows. DrRich will undoubtedly learn a lot from them, and will try very hard not to ruin these fine young physicians before they’ve even started out.) In any case, one must suspect that Dr. Brugada (being, after all, Belgium’s King of EP) must have been somehow responsible for placing the ICD in this young soccer player.
DrRich will be sure to ask him how that young man managed to receive an ICD. Because most high-risk patients, in the U.S. and elsewhere, have to do without.
Despite the fact that ICDs are dramatically effective and dramatically life-saving in people who have dangerous cardiac arrhythmias (please do watch the video to see the drama for yourself), they are still used in only a tiny fraction of the identifiable patients who are at risk for sudden cardiac death. Consequently, in the United States alone, almost 1,000 patients each day die suddenly from cardiac arrhythmias who could have been saved by an ICD.
DrRich has written before about the covert rationing of ICDs, which is done so openly that one is tempted to drop the modifier “covert,” and has even written about how a former government official has admitted that he had no choice but to juggle the statistics of a randomized clinical trial (i.e., to bastardize the science) in order to avoid having to pay for ICD therapy in broader categories of patients. That’s old news, and there’s no reason to beat it to death again here.
Instead, DrRich would like to explore another question – Why are ICDs still so damned expensive?
Having worked closely with ICD manufacturers since the early 1980s (which, DrRich knows, makes him a very bad person), he perhaps more than most appreciates the engineering magic that has gone into making and improving these devices over the years. It is a truly remarkable thing that one can build a tiny implantable device that a) houses a computer that runs an extraordinarily sophisticated heart rhythm analyzer that, from beat to beat, accurately diagnoses the heart rhythm in real time; b) can deliver a tiny electrical pacing impulse to the proper cardiac chamber at the proper time, from beat to beat, to coordinate and optimize cardiac function; c) then, if a fatal arrhythmia develops, to deliver a very big shock to the heart within 10 – 15 seconds, to restore the rhythm to normal (please do see the video); d) wirelessly communicate via the Internet to tell the doctor (and anyone else who needs to know) its own condition and the condition of the patient; e) all the while surviving in a hostile, high-temperature, salt-water environment (i.e., the human body), for 5- 7 years, without (for the most part) corroding, leaking, rusting, blowing up, or otherwise malfunctioning.
Try to get your iphone to do that.
At this point, most of DrRich’s regular readers are likely expecting him to say: No wonder these beasts cost $15,000 to $25,000 apiece. Just look at the sophisticated technology that is built into them!
And it is indeed true that over the past 27 years, hundreds of millions of dollars have been invested in making ICDs smaller, more reliable, longer lasting and safer. It is also true that the companies that make these devices ought to be fairly rewarded for their efforts in this regard. And for many years (DrRich estimates that the “right” number of years was about 18) the high cost of ICDs was easily justifiable, given the steady, remarkable, important and meaningful improvements in technology that took place during that time, improvements that were being funded by the cost of the devices.
But DrRich argues that by the turn of the millenium, ICD technology had become largely mature, and that since that time improvements (while still happening) have been merely incremental. “Gingerbread” might be too strong a term, but nonetheless that’s the term that pops into DrRich’s mind. The fact is that by the year 2000, all ICD manufacturers were building reliable, safe devices that were really good at preventing sudden death, and improvements since then have not altered (or materially improved on) that fact.
Here’s a truth that ICD manufacturers would not like us to know: It only costs them a couple of thousand dollars to build an ICD. DrRich does not know the precise dollar amount (very few people even in ICD companies know these precise amounts) but based on his experience he cannot see how it could be much more than about $3000 per unit. Now, lest you think that the roughly $22,000 difference between the cost to manufacture and selling price is pure profit, it’s not. ICD companies continue incurring expenses as long as an ICD remains in service. These “lifetime” expenditures include monitoring of device function; maintaining expensive, rigorous quality and reliability processes; and backing up every implanted device with a large force of highly-trained and expensive field clinical engineers who are available to electrophysiologists 24/7, anywhere and everywhere, for “troubleshooting” and even for routine follow-up. All this “extra” stuff must be fully accounted for in the initial price of the device.
Still, ICD manufacturers make a very, very nice margin on every device they sell. Few businesses in the world enjoy this kind of price margin.
With all that “room” to play with, one might think market forces would by now have brought the price down for a mature technology like this, especially since over the past few years the growth of the ICD market has flattened, and ICD companies now must compete with each other for more market share if they want to grow their businesses.
But classic market forces usually do not work in healthcare, and that is especially true when it comes to ICDs.
It all begins with Medicare reimbursement, which sets the price for ICDs, and consequently the cost of ICDs is likely to remain at $15,000 – $25,000 forever.
Now, to be sure, the government does not directly determine what companies get paid for ICDs. Rather, they indirectly determine the price by deciding what hospitals and physicians will be reimbursed for implanting ICDs. Those reimbursement rates apparently vary substantially from region to region and hospital to hospital (who knows how the government determines these things?), and the rates are not publicly available to DrRich’s knowledge. But ICD manufacturers, at worst, can impute the reimbursement rates by figuring out the top price specific hospitals are willing to pay for ICDs (hence the range in prices).
Having determined the top price they can possibly get paid for ICDs, the only logical strategy for manufacturers is to figure out how they can always get paid that top price for every device they sell. They do this by making ICDs specifically aimed at keeping the decision makers happy. And the decision makers, by and large, are the electrophysiologists.
Electrophysiologists decide who gets ICDs, and they decide which ICDs to implant. So, to keep prices at the highest possible level, ICD companies must cater to the wants and needs of electrophysiologists (their true customers), and so must produce a steady stream of new, improved ICDs whose novel features are requested by these very high-end, high-maintenance physicians.
Electrophysiologists have a clear agenda in this regard. Their “demands” on ICD companies, expressed in rigorously conducted marketing surveys and focus groups, inexorably lead to ever more complex devices. This complexity helps electrophysiologists (a small community whose growth is tightly controlled) to maintain a professional stranglehold over the implantation and management of ICDs.
It’s a matter of turf protection.
Since ICDs are already exceedingly complex devices, and grow more complex with each succeeding generation, then “obviously” one must be a high-end specialist like an electrophysiologist to understand and manage all their nuances. (In real life, ICDs have become so complex that not even a majority of electrophysiologists can keep up with them any more, thus necessitating armies of “clinical engineers” in the employ of ICD companies who can do troubleshooting in the field.)
All the ICD manufacturer needs (and wants) to know is: what gingerbread do I need to add to my next generation of ICDs to make them even more stupefyingly complex, so as to maintain the loyalty of my electrophysiologist customers? If they can answer this question manufacturers will continue to be paid top dollar for their product (again, as determined by regional reimbursement rates set by the government).
And this is why, despite the fact that ICD technology has been fully mature (says DrRich) for most of a decade now, which in a functional market would cause the price to plummet, the cost of ICDs remains so high. Whatever has developed in the complex interplay between ICD manufacturers, electrophysiologists, hospitals and the government, it’s not a functional market.
Among other things, this dysfunctional economic model (if that’s what it is) utterly precludes ICDs ever becoming available to a large proportion of individuals whose lives could be saved by them. They’re simply too expensive and complex for widespread usage.
Covert rationing, of course, thrives on opacity, obfuscation, confusion, inefficiency and complexity, and the convoluted ICD “business model” provides many, many avenues for covert rationing. So while the price remains high, relatively few ICDs actually end up being implanted (compared to the number of patients who have clear, FDA-approved indications for ICDs). In fact, the growth curve for ICD implantation has been successfully flattened for almost five years now (despite projections earlier this decade for 20% annual growth for years and years) – and it is likely to stay flat.
If we were to have a system of fully transparent, open rationing, then the ICD business model would rapidly be seen as the travesty of confusion that it is. Furthermore, a system of open rationing would quickly goad ICD manufacturers away from catering to the turf-based requests for more complexity by electrophysiologists. They would quickly develop ICDs that are simple, reliable, effective, easy to implant, long-lasting and cheap, and which could be safely implanted and managed by non-electrophysiologists.
The technology to do that exists today.
This is an example, DrRich believes, where open rationing would ultimately lead to more usage of a life-saving technology, by driving industry to put their development efforts into reducing the cost and increasing the simplicity and reliability of their products, and thus making them more cost effective, rather than striving to make them more attractive to high-end-physician decision makers. If they did this, then videos like the one Dr. Wes has shown us would no longer merit mention on blogs or on any other form of media, as ICD rescues would become very common.
DrRich has been telling all this to ICD companies for many years to no measurable effect. Of course, it has been well documented that DrRich is more than willing to tell his clients stuff they may not particularly want to hear. (It’s truly amazing that he can still make a living as a consultant.)
In any case, here’s DrRich’s investment advice for this week: The growth of the ICD market is destined to remain flat as long as high-priced, gingerbread-laden ICDs that only an electrophysiologist can love remain the norm. Avoid companies whose growth depends on these devices. On the other hand, the ICD market is ripe for a major disruption, if one of these outfits ever figures it out.
DrRich will now fade into quietude here for a week or so, as he entertains those nice people in Europe with his crazy ideas about healthcare.
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