There’s been a small run of Diabetes-related items in the New York Times recently and not-so-recently. The one that caught my eye is the one in the New York Times by Jerry Avorn about clinical guidelines and how they can be influenced http://www.nytimes.com/2013/06/12/opinion/healing-the-overwhelmed-physician.html?hpw. That one made me think about some of the new diabetes drugs that have been getting press. Glaxo-Smith Kline, which makes Avandia, was very happy the other day when the FDA said it will re-open the question about whether it’s drug is responsible for increased risk of heart attack http://www.nytimes.com/2013/06/03/business/second-thoughts-on-safety-of-avandia-stir-a-dispute.html?pagewanted=all. I also noticed that a new injectable one-a-week drug called Bydureon from Amylin just got approved even though there are concerns about thyroid cancer, pancreatitis, and cardiovascular problems http://www.nytimes.com/2012/01/28/health/bydureon-a-diabetes-drug-from-amylin-wins-fda-approval.html. Victoza, by Novo Nordisk, is a similar drug. That got me thinking: “are the new drugs better? Which led me to Walecia Konrad’s article in 2011 about how the older drugs are better, safer, and cheaper http://www.nytimes.com/2011/05/28/health/28consumer.html.
Hmmm… Why all these recent new treatments for diabetes? Boys and girls, big big money. We spent 22 Billion dollars on diabetes drugs last year. Merck made 5.7 billion on the sale of Januvia and Janumet, it’s newest agents. Bydureon is estimated by the company to cost $4200 per person per year and make the company 1 billion dollars. By contrast Metformin and Glipizide, which have been around for a long time, will run you about $120/year. Avandia will run you $1,500/year.
Let’s look at effectiveness. Maybe the cost is justified by the awesomeness of the newer drugs. Your blood sugar is determined by four factors: the amount of insulin you make (insulin lowers blood sugar), how sensitive your insulin receptors are, how much glucagon you have (glucagon increases insulin production) and how much sugar your liver makes and your digestive system absorbs. You can see that there are many points at which you can interfere with blood sugar levels with various drugs. Metformin doesn’t increase insulin production. It works by decreasing the amount of sugar your liver makes, making your insulin receptors more sensitive, and decreases intestinal absorption of sugars. Avandia increases insulin sensitivity, and also doesn’t increase insulin production. Bydureon is what we call a GLP-1 receptor agonist. This means that it mimics the effects of the naturally-occurring hormone glucagon. Glucagon increases insulin production. So if your sugar is too high Bydureon will get you to release more insulin. Glyburide does essentially the same thing, but Glyburide also decreases the amount of sugar the liver produces and increases the sensitivity of the insulin receptors. Comparative effectiveness data tends to be surprisingly hard to find. Metformin and Avandia are roughly equally effective. Bydureon interacts at fewer regulation points than Glybyride, and comparison studies haven’t really been done.
OK, so the newer drugs are not more awesome. Are they safer? The Mayo Clinic does a really great job with this question on their website http://www.mayoclinic.com/health/diabetes-treatment. All have side effects. The older ones have sort of test-of-time safety profiles. The newer ones, as I’ve said above, have some problems that may or may not be significant. Why have companies spent so much money coming up with new versions of the same thing? It’s all about the money.
So, take home message: start with the cheap, move to the expensive. Unless you’re talking about shoes or husbands, you don’t get what you pay for. What bothers me about the new diabetes drugs is not their mechanisms or side effects or even cost. It’s that pharmaceutical companies are investing millions of dollars to come up with new drugs that do the same thing as old drugs, in order to get in on the market. AND that they spend millions more defending their products and promoting their products disingenuously. I would love to see those companies invest their R&D money on things that are really new and really helpful, regardless of market value. I would love to see them use all that lovely money to make more than shareholder returns.
Another extraordinary book. Victoria Sweet – “God’s Hotel”. It’s about her work in a facility in, I believe, San Francisco. It’s also about her work in medieval medical history, and how that study informs her work today. Laguna Honda is sort of a rehab facility or chronic care facility but is basically a dumping ground for the poor, the old, the indigent, the drug addict.
Dr. Sweet has a couple of things in common with Dr. Paul Farmer, about whom I wrote last week. First, she has a world view that sees every single human as just as valuable and deserving of treatment as every other, regardless of what they have done or how much they contribute or don’t contribute to society. A lot of people SAY they believe this but these two REALLY DO believe it. My father is a bit like this as well. It is so easy and so natural to write off the drug addict after the 5th hospital admission for a drug-related problem. It is so easy to look at the obese diabetic and judge him as less worthy of care because of what he puts in his mouth. Dr. Sweet does not see things this way. She will treat the drug addict just as aggressively the 5th time as the first. Expensive? Yes. Frustrating? Of course. Cost-effective? Nope. A true expression of what being a doctor is? Absolutely.
The second is the focus on the individual. Just as Dr. Farmer will walk 7 hours to see one TB patient and consider that a job well done, Dr. Sweet will treat a drug-addicted prostitute with a bed sore for 2 1/2 years until the wound is healed and consider that time well spent. Dr. Sweet calls it TIME. Unlimited and unpressured time. The pre-modern medical practitioners understood this, maybe in part because they couldn’t intervene much anyway: given time, a body will heal itself. Also given the right surroundings. Isn’t it extraordinary that today the hospital setting is the environment in which we think people should get better when in fact it is the least therapeutic environment you can think of? For example, Dr. Sweet points out the simple fact of the therapeutic value of good food. Healthy, fresh, tasty, well-made food. Dr. Farmer says the same thing: yes the patient has tuberculosis, but his real problem is he’s hungry. But what do we feed people in the hospital or even in rehab facilities? Either nothing or a “diet” deemed suitable, but nothing fresh and nothing that encourages appetite. Such a simple thing.
Doctors are under pressure to be more cost-effective and efficient, to move patients along faster and do more with less time. I think doctors and nurses should be the last people to have to consider these things. Their focus should be on the individual. It is not the doctor’s job to dole out “care” in a cost-effective way. It’s her job to care for the patient in front of her, in every way that patient needs help. Not the most expensive care or the recommended treatment or the latest thing, but what the patient needs. Another example: Dr. Sweet tried to discharge someone but he had no shoes. Shoes had been ordered from central supply but the order had gotten lost. He was still cheerfully waiting for shoes. She went out and bought him a pair of shoes. He went home. It’s not efficient. You have to get in your car, go to the local mall, buy the shoes, come back, try them on the patient, etc etc. Takes longer than writing out a requisition for shoes. You have to pay for the shoes yourself; you can’t be reimbursed by your insurance company. You might pay more for the shoes than the insurance company would have contracted them for. But it’s what the patient needed. Time and care for the individual. That’s what medicine used to be.
OK all you loyal readers. You know what I’m going to talk about. Anyone who reads this blog for more than five minutes knows that articles like the one written in the New York Times on Sunday by Elisabeth Rosenthal are like crack for people like me. If you haven’t read it here’s the link, but take your medication before reading:
Where do I start with this??? I’m going to let Ms. Rosenthal tell you about how many unnecessary colonoscopies we do. I’ll let her tell you how much more it costs here than anywhere else. I will address the anesthesia bit. Let me tell you a little story. When I was a baby anesthesiologist my hospital sent anesthesiologists “downstairs” to do anesthesia for GI procedures maybe once a week for a few hours. This was in 2004 or so. Now we send three board certified anesthesiologists to various GI units every day all day. We do maybe 25 cases a day on average. Now, some of this is due to the aggressive expansion of the advanced GI procedures unit as well as the addition of an outside private group that was recently folded into the greater hospital system. It’s also because we’re there. It’s no accident that as soon as we committed troops to the GI battle all of a sudden everybody needed anesthesia.
The NYT article uses Dierdre Yapalater as an example, a healthy 60-something. Putting aside the ridiculous cost for the overall procedure, she was billed $2,400 for anesthesia. But she didn’t need anesthesia. There is absolutely no reason for her to have an anesthesiologist involved for that case. None. Anesthesia care used to be limited to very sick patients, not because they are harder to sedate (they’re actually often easier) but to monitor them closely because of their tenuous physiologic status. Now everybody is getting it. Why did she get anesthesia, why did the anesthesiologist give it, why does insurance pay for it?
Another little story. About 6 months ago there was a midazolam shortage. Midazolam is a valium-like drug given intravenously for sedation, often used by nurses and non-anesthesia providers very safely, and frequently used in colonoscopies. One of my hospital’s affiliates, which does a hundred colonoscopies a day, didn’t want their revenue stream interruped by this so instead of delaying these completely elective cases they asked my department to come give the anesthesia for all their cases until the midaz shortage was over. So we sent 2 or 3 doctors over there everyday for a while to give propofol. Increased the cost of each case by a couple of thousand bucks. Why did we have to send fully-trained anesthesiologists over there? Because the anesthesia lobby has been powerfully persuasive about limiting the use of some drugs to our docs only. Propfol, the sedative used in the above example in place of midazolam, is a powerful drug but it’s use is not rocket science. It has been used in other developed countries by non-anesthesia personnel safely for years.
And even without propofol, the vast majority of colonoscopies can be done easily with midazolam and fentanyl. An anesthesiologist is just not necessary. Apologies to my colleagues. Protecting our jobs looks great from our 4 bedroom houses in the suburbs, but not so great for the longevity and integrigy of our healthcare system.
I just finished reading the most fantastic book. Entitled “Mountains Beyond Mountains” it is written by Tracy Kidder and follows the life (thus far) and work of Dr. Paul Farmer. This book has renewed my faith in humanity and in medicine, which I didn’t think was possible. Farmer is, well in simplest terms he’s an infectious disease doctor and Brigham and Women’s hospital in Boston. This job title does not begin to describe the work he does in treating HIV, AIDS, TB and MDRTB (Multi-Drug Resistant Tuberculosis) in Haiti, Peru, Russia, and Boston and the influence he and his organization Partners in Health have had on global health and poverty. Much has been written by him and about him and I’m not going to write about specific things he has done. I’m going to write about why I can’t shake the impression his world view has had on me.
In Haiti he’s Doktor Paul. My dear Haitian friend, when I ask him if he has met Farmer, says “Of course! He is Haitian!” And that is how the people of Haiti feel about him. He is, to quote my friend again, “Beyond words.” You see, Paul Farmer really thinks that all humans are interconnected, that one life is not worth more than another, that cost-effective strategies for the global war on poverty don’t apply to the patient he’s looking at right now. That we SHOULD be uncomfortable with the disparities between rich and poor. That we SHOULD be ambivalent about our places in life. But it’s not just that he “cares about poor people” in some general way. Plenty of people wave their hands around and spout about how “something needs to be done in x third world country and how we have so much and they have so little and isn’t it awful why don’t I send Mr. Farmer 50 bucks for his wonderful work”. Farmer’s interest is ultimately in the individual, and focusing on the individual gives him the drive to intervene in a concrete way in places like Haiti.
Here are two examples of this philosophy. Farmer will walk 11 hours to follow-up on a single TB patient that hasn’t been seen in the clinic recently. He doesn’t view this as a waste of time. He once approved a $20,000 flight to the US for a Haitian boy dying of a rare but treatable form of cancer. When asked if he didn’t think this money might have been better spent on a larger number of people in a smaller way, and why this boy and not another, he will say something like “Because this boy and his mother were in my clinic. They needed help and I could help.” He doesn’t view this as a waste of money. The general consensus among world health experts is that it isn’t cost-effective to aggressively treat HIV and MDRTB in poor countries. Farmer disagrees. I did anesthesia for a week in the jungle in Mexico where the anesthesia machine had holes and little old ladies re-sterilized gloves and hung surgical drapes on clotheslines. It was hard not to think “What’s the point? This is such a drop in the ocean”. Farmer would view that week as a great success because 20 people who needed my help got it.
One thing that strikes me about Farmer is that he still loves his work at the Brigham. He either does not see or is immune to the many hassles, waste, and general BS that have become part of daily life in high-tech hospitals. I don’t understand this. I would think that someone who has seen as much suffering as he has would be angry and offended by the excesses of American medicine. I spent 4 hours sitting in an OR yesterday giving anesthesia to a beautiful 19-year-old who wanted a nose job. That makes me crazy. And maybe he is angry. But it is channeled in such a way that he is able to use the resources of his hospital to further his work elsewhere. And he still manages to keep the focus on the individual. Duke, Harvard, the Brigham, professorships, Fulbrights, Gates foundation grants, all his intellectual and societal gifts are channeled toward the individual. Most of the frustrations with health care reform, health insurance, computerized records, etc. comes from the elimination of the importance of the individual. Protocols and Meaningful Use requirements deny the uniqueness of the individual. Cost-effective quality measures consider populations, not people. If we can keep the focus on the patient in front of us, the world can change.
Doktor Paul. Beyond Words.
One of the things that used to make physicians different from other providers is the ability to prescribe drugs. This is not true anymore, but the majority of prescriptions are stil written by doctors. Prescribing practices of physicians vary widely across different populations and specialties. If a doctor takes medicare patients, his prescribing patterns are part of the mountains of data medicare collects about it’s patients. In 2003 the government passed an expansion of medicare called Part D. This program pays for prescription drugs. 35 million people have medicare Part D.
Propublica, the non-profit investigative reporting organization, says there’s a problem with medicare part D. It’s not that it was a bad idea, or that it costs too much. The intention was good and it has cost less than it was expected to. The problem seems to be that doctors are prescribing too many dangerous or inappropriate drugs to patients, mostly the elderly. Propublica looked at Medicare’s data and found 70 physicians with outlying prescribing records, including abnormally high prescriptions per day, or high numbers of prescriptions for sedatives, narcotics, and antipsychotics. The article says that the Center for Medicare Services, or CMS, is not monitoring doctors closely enough.
Now, I don’t know how many doctors prescribe to patients who have Medicare Part D, but I bet it’s a much larger number than 70. Propublica pulled out some of the most egregious examples to illustrate their point. There are doubtless some charlatan physicians out there and some unscrupulous ones, but not many. Let’s forget the doctors who prescribe for cash or to game the system. Everybody else might be trying to do the right thing in a misguided way. For example, Propublica cites one physician who prescribes too many antipsychotics for demented patients. The thing about dementia is that it causes people to do things that are dangerous to themselves. In some cases the drugs can help decrease the disordered thinking that leads to dangerous behavior. The best thing for a demented patient is to have someone who cares about them watching them or very near them all the time, to prevent harm. This doesn’t happen of course. A bunch of demented people get put in a big ward with one or two nurses. If no one can watch them, the solution is to medicate them. A nursing home medical director may be doing the best he can in a bad situation.
Other doctors prescribe too many narcotics. There are multiple reasons for this, some having to do with patient population or specialty, others having to do with path of least resistance, yet others having to do with patient and family demands. And yes, some doctors would rather just prescribe something to get you out of their office than try to deal with what’s really wrong with you.
Physicians prescribe things that aren’t approved by the FDA for specific uses. For example, Haldol, an antipsychotic, has well-known anti-nausea properties. I don’t believe it is FDA approved for this use. Propofol, a powerful sedative, also has anti-nausea properties not approved by the FDA. Decadron, a steroid, also has anti-nausea properties. Sometimes it’s voodoo, sometimes it’s placebo, sometimes it might actually work. When someone is really sick, you might try all of them. Most of the time the doctor is making an effort to help.
Are there unscrupulous or dangerous physicians out there? Absolutely. Should those physicians be stopped. Absolutely. The problem is that you have to scrutinize everyone all the time to find these 70 guys. It becomes kind of like Homeland Security guys at the airport; everybody has to take their shoes off cuz one guy had a bright idea. How many terrorists has that system caught? More regulation is not the answer. If you make more rules, you burden the honest folks while the dishonest ones will find a way to work around them. Let’s look at WHY this is happening. Do demented people need more supervision? Do doctors need more time to evaluate pain? Do medical schools need to teach pharmacology better? Do residency programs need to evaluate young physicians in their pharma usage?
There will always be bad actors. Let’s not punish everyone else for their behavior.