Robert Kocher, Emmanuel Ezekiel and Nancy Ann Deparle have published an article in the August 24th edition of The Annals of Internal Medicine urging physicians to embrace the change in the health care system associated with the Affordable Care Act. The article describes the numerous changes to the practice of medicine. These changes include technological innovation and medical records, working in teams with a variety of non-physician providers, including payment mechanisms aimed toward such, proactively managing preventive care and incorporating patient-centered outcomes research into practice. The article emphasizes how the act removes barriers to care for our patients by improving information about the care of our patients and by providing incentives to improve care and to focus on preventive care. The article acknowledges many physicians’ disappointment in the continuation of the sustainable growth rate formula. However, despite this frustration, the Affordable Care Act provides much that we as physicians can use to improve the ability to provide quality care to our patients.

As physicians, we have taken an oath to protect our patients. This act provides a new way for physicians to focus their energies on delivery of care to populations and to improve care with this end in mind. The Affordable Care Act is just the first step in providing high quality and effective care for our patients. We encourage you to become more familiar with the ways that you can improve your patient outcomes through the Affordable Care Act.

The First Circuit Court of Appeals, a federal appeals court, upheld a Maine law restricting the use of prescription information by companies. The law allows doctors to opt out of having their prescriptions tracked by companies, who use the information for marketing purposes. The Court upheld a similar law in New Hampshire last year.

The plaintiffs challenged the constitutionality of 22 Me.Rev.Stat. Ann. tit. 22, § 1711-E(2-A), which allows prescribers licensed in Maine to choose not to make identifying information available for use in marketing prescription drugs to them.  Section 1711-E(2-A) does not directly prohibit marketing, but it prohibits certain entities from using or selling such information for marketing purposes if the prescriber has opted to protect the confidentiality of his prescribing data.

The ruling represents a defeat to the pharmaceutical companies, who use the data to market prescription drugs. This is a step forward for the Unbranded Doctor Campaign. Patterns and preferences in prescribing can be analyzed by companies, who then target doctors for particular prescribing patterns.

You can read the decision here.

NPA Board Member David Grande got a mention in this article in The Harvard Crimson discussing the recent changes to Harvard Medical School’s conflict of interest rules. The new rules prohibit faculty from accepting personal gifts and giving industry-sponsored talks at events where the material is prepared in advance by the company. In addition, when a faculty member is conducting research on technology owned or licensed by a particular company, compensation from that company to the faculty member is now limited to $10,000 annually.

A recent CNBC segment posed the question of whether healthcare is a right. They brought on commentators to argue in favor and against, one from the Cato Institute and one from the National Physicians Alliance. (you can see the clip at curethis.org)

The host started by posing the question to the conservative commentator, Michael Cannon. “I think it should be a right,” he replied. “And therefore I think physicians should work for nothing.” Sarcasm notwithstanding, his point was clear: healthcare cannot be a right because it involves payment. The exchange of goods and services for money equals capitalism, which puts healthcare squarely in the category of commodity.

Mr. Cannon backed up his point by contrasting healthcare with other things we commonly think of as human rights, like freedom of speech and religion. No one has to be paid in order to let us speak freely and worship freely, he implied, which is why they are rights and healthcare is not.

This argument is persuasive. We like to think that a human right is something you are born with, not something that has to be given. The very phrase ‘freedom of speech’ suggests its simplicity: just let people speak! It’s not that hard! Healthcare, on the other hand, is not accomplished by standing aside and letting citizens exercise their freedoms. For healthcare to be your human right, something has to actively be done to you.

But is it true that freedom of speech requires no involvement by the government? Let’s imagine taking a trip to place where there is very little government, for example Somalia. You might have the basic human right to freedom of speech there, but it’s not worth much. If you stand on a milk crate (assuming you can find one) and give a speech that others find disagreeable, those people may choose to gag you, stuff you in the trunk of a car, drive you 20 miles out of town, and perhaps kill you. The government has done nothing to take away your freedom of speech, but they haven’t done anything to protect it either.

We often ignore the role of infrastructure, such as our police force and civil and criminal court system, in allowing rights like freedom of speech and religion to flourish. The U.S. legal system is a highly complex bureaucracy, and it plays an important role in keeping the right to free speech alive.

The same principles apply in healthcare. We have a complex bureaucracy in place — doctors, nurses, hospitals — to protect our right to health. There’s no difference, in principle, between free speech and healthcare, so why is one an unquestioned human right while the other is relegated to a commodity?

In fact, no matter what human right you can name, there is an infrastructure in place to protect and defend it. And the professionals who manage that infrastructure need to get paid. So it’s foolish logic to argue that since doctors are paid a salary, healthcare cannot be a right.

Now, an opponent of the idea that healthcare is a right could argue that sure, the legal system keeps freedom of speech alive. But it also does other things. We would need cops and judges around to deal with violent crime, even if society had no right to free speech. So the added cost to society from having freedom of speech is pretty minimal.
But the same argument could be made for healthcare. The medical industry has to exist regardless of whether healthcare is a right or not. Once again we can see that healthcare and freedom of speech are identical.

Still, let’s be generous. Let’s say we do accept the distinction that Mr. Cannon was trying to make when he drew a bright line between healthcare and freedom of speech. I think what he was trying to get at was that there are two types of rights. And actually, he’s correct. Philosophers and ethicists commonly refer to them as “positive” rights and “negative” rights.

In the U.S., we are very comfortable with the latter category. Negative rights are when a person has the right not to have something done to him. For example, the right not to be tortured, not be persecuted for your religion, and not to be thrown in jail for disagreeing with the government.

Healthcare falls into the category of positive rights, for obvious reasons. (i realize, by the way, that i’m not using the strict philosophical definition of these terms. If you really care, check out Wikipedia.) We Americans, when polled on this subject, have always been uncomfortable with positive rights. Positive rights seem to imply whininess, laziness, petulantly asking others for help.

But positive rights are actually a strong part of our tradition. Universal public education was introduced in the U.S. in the late 1800s, and today it is as American as apple pie. Ask any fourth-grader if she has a right to go to high school, and you’ll get a quizzical look because the answer is so obvious. We still fight about ways to improve education in the U.S., but no one has seriously proposed abolishing the public school system. Why? Because we understand what an incredible boon to our country it has been to have a well-educated workforce.

So we’ve established that healthcare, from the standpoint of principles, is no different than other accepted human rights. And from a practical standpoint, we see that Americans already support rights that are very similar to healthcare, like education.

So it seems to me that healthcare is a right. Other people, of course, can disagree. What they can’t do is pretend that there are objective, empiric differences between healthcare and other accepted human rights.

Ok, eye catching title, but I admit this has nothing to do with Sex, Lies and Videotape, other than what we need for healthcare may be what this movie did for independent film (to revolutionize it).

Nor do I want to suggest any of the described below are lies…. this is for readers to decide….

This just in from the New York Times: Richard L. Scott, a conservative that ran a company convicted of defrauding the government of hundreds of millions of dollars in the 1990′s (yes, he is still filthy rich), and whose investment firm claims “integrity” as one of its principles, now is embarking on a campaign à la Swift Boat Veterans against the Obama health plan. Which health plan? The one currently being developed by Congress, aka The People?

Hard to believe that someone with such a history will be taken as credible, so many of us who want affordable health care for all may welcome his attempt to influence the public…. Richard Kirsch, campaign manger for HCAN, of which the NPA is a partner, is quoted as saying: “We cannot have a better first person to attack health care reform than someone who ran a company that ripped off the government of hundreds of millions of dollars.”
Scott’s mantra “Choice, Competition, Accountability and Personal Responsibility” hardly disguises his “businesslike approach to health care” which is “bottom-line-driven”, and has seems to have helped make him a very wealthy man. And calling his organization “CPR” just seems too corny.

It is easy to offer urgent care services for “respiratory illness, headaches, sore throats, sprains or fractures, cold or flu symptoms, burns, cuts, ear and eye infections, pulled or strained muscles, coughs, and childhood illnesses; and physicals, including school or sports, pre-op, and basic check-ups“, as Scott’s company Solantic does, and leave true, costly emergencies for hospitals to deal with. This will not fix our healthcare system, nor have choice and competition taken care of the 46 million uninsured and many more underinsured people stuck with high deductible plans so far (of course Scott is quick to tell you its the governments fault).

Rick, we all agree our healthcare system is too expensive and not sustainable. Other than that, you seem to have little in common with me. I would suggest we all work on a solution that puts more money in people’s pockets, not in yours or mine. Let other, more credible folks (patients, health care professionals and dedicated law makers such as Kennedy come to mind) worry about how to fix healthcare.

I have a new plan for healthcare reform. Take HMO and pharma executives on mandatory tours of the ER.

How did I come up with this brilliant plan, you ask? Let me talk you through it…

Last night I admitted a 23 year-old woman to the hospital. Let’s call her Marisa. Her only medical problem, diagnosed when she was fourteen, was Crohn’s disease, which is an inflammatory condition of the bowel that causes unpleasantness like chronic diarrhea, vomiting and abdominal pain.

For many years Marisa’s disease was well-controlled with Azathioprine, meaning she had very few of the disagreeable symptoms i just listed. Then a year ago her insurance (which was chosen by the university she attended — none of that mythical free-market “choice”) decided that they weren’t going to cover azathioprine, because for most patients cheaper medicines would do the trick just as well.

There’s a problem with basing overall policy on how most patients react. I’ve never met someone named Most Patients. Every real human being is a little bit different than the composite they create from research. It may be true that in a study of 4000 people, the average Diarrhea Symptom Index score (i just made that up) was not significantly different between Azathioprine and another medicine. But what does that matter to Marisa? For her the “average” patient is meaningless. She needs exactly this medicine to treat her disease.

We have a gargantuan, multi-billion dollar profit-making pharmaceutical industry in this country. The industry is constantly pumping out new drugs, each of which does almost exactly the same thing as its predecessor. Most of the time, it doesn’t matter which of the ten available drugs is chosen. But in the rare cases where it does matter — like now, with Marisa lying on a stretcher in front of me — shouldn’t the patient have access to the drug? Why do we have this massive pharmaceutical industry otherwise?

Marisa couldn’t get her Azathioprine six months ago, so she was forced to try inferior alternatives, none of which have done the trick. She came to the ER last night because things had gotten so bad she’d begun to experience rectal bleeding. Not just blood in her stool, mind you: this is blood dripping from her rectum at random intervals without her control. She’s twenty-three and she has to wear a diaper.

I could almost justify a system of huge profits, shameless marketing, and ridiculous unnecessary drugs, if at least that system gave this one 23 year-old the relief she was crying out to me for.

But it didn’t. I had nothing to offer her.

The dinosaurs who believe in free-market healthcare carry around a certain fantasy — something akin to elementary school civics class. Remember “How a Bill Becomes a Law”? We learned that there are three branches of government, and each branch provides checks and balances to the other two. None of them can get too strong, because the others are watching.

The free-marketeers think the same thing will happen in healthcare. They are deluded into thinking that although the pharmaceutical industry will ply us with expensive new medicines, the HMOs will keep them in line. In turn, consumers will keep the HMOs in line by demanding that they cover the medicines that work. Checks and balances.

But in the case of Marisa, we have an example of how the checks and balances only serve to slam every door and leave the patient out in the cold. The patient has no voice. It’s not a coincidence that they call them for-profit entities, not for-patient entities.

You might think I’m naive to expect a giant HMO or pharmaceutical company not to pursue profit. And it’s true, I would not expect otherwise. But that’s why situations like Marisa’s make me want to cry: corporations may be evil, but the human beings inside them aren’t. If any of the people working for Aetna or Merck met this poor girl, and heard her story, I know they would do everything they could to get her the medications she needs. They would be touched, they would see her as a human being, and they would act compassionately.

But the people who work for Aetna and Merck haven’t met Marisa. They don’t know her story. They are are blissfully removed from her life, and from the lives of millions of other people they affect daily. For them, this 23 year-old Crohn’s patient exists only as an account payable, a number to be spindled and manipulated and shifted into the proper column. If enough of these faceless numbers move in the right direction, the workers get a healthy year-end bonus. Hey, they’re just doing their job. Nothing cruel or heartless about that.

Which is why it’s time for the mandatory ER tours. Sign-up sheets will be posted soon.

(cross-posted to whyitstime.blogspot.com)

There’s a great article in the last NYT of 2008 about the new “restrictions” that the pharmaceutical industry is imposing on itself. No mugs, no pens, no trinkety free goodies.

Sounds great, right? Pharma is policing itself.

Well, first of all, these restrictions are all voluntary, which means no penalty for breaking the rules. And rule-breakin’ penalties is one of the reasons we have laws.

Then if we read a little further, there’s some fine print down in grafs eleven and fourteen:

The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” — which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

Cutting out the pens but leaving the rest is like going on a diet where you only eat Big Macs. They’ve cut out the cheapest and least effective part of their marketing campaigns, while doing nothing about the most expensive and deviously influential elements.

Drug reps can still buy lunches for doctors in their offices; they can still take docs out to dinners, as long as there is some educational component. (I went on one of these “educational dinners” long ago… the talk lasted 5 minutes and then we ate for two hours…)

Also, the companies can still pay “consulting fees” that generally run in the tens of thousands. Some of these consultancies are real. But do you think most of the doctors who receive these consulting payments would continue to get them if those doctors banned drug reps from their offices, banned all lunches and dinners, and stopped prescribing the manufacturer’s drug?

Which leads me to my main point: drug companies should not be allowed to track in precise detail exactly which doctors are prescribing their medicines. They should be allowed to know the rough outlines — by zip code, for example — but allowing them to buy databases with the exact number of prescriptions each doctor has given out for each medicine. . . . there’s too much potential for an unspoken quid pro quo to exist between doctors and drug reps.

I am heartened by one aspect of this: the fact that Pharma is imposing these restrictions voluntarily means that they see the writing on the wall. They are trying desperately to prevent the kinds of laws that New Hampshire passed from spreading across the country. They want to give opponents of reform some ammunition, something to let them point to and say “See? The drug companies have cleaned up their act! Everything is fine now!”

Except in four or five years, when we’re paying attention to something else, the pens and mugs will come creeping back. They’ll come back slowly, a trickle at a time, without the big press release and glowing article in the New York Times.

The time has come to reject the hidden intrusion of Pharma into our lives. Prescriptions belong to doctors and patients, no one else.

(p.s. I’ve started a blog dedicated to this issue: www.prescriptionprivacy.blogspot.com)

It seems that a certain Dr. Goodwin, host of the popular NPR program “The Infinite Mind”, has received over $1.3 million in compensation from pharmaceutical companies for giving lectures about their products. He served as both a journalist and prominent psychiatrist in his role on the NPR show. The show’s since been canceled, after NPR found out about the compensation. But it continues to bring up so many questions. First and foremost: Who can you trust? Here are two examples where things get very sticky:

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

“But as we’ll be hearing today,” Dr. Goodwin told his audience, “modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.”

Supposedly Dr Goodwin received $2,500 that same day by a pharmaceutical company to promote it’s drug for bipolar syndrome. And…

He said that he had never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled “Prozac Nation: Revisited.” which he introduced by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.”

That same week, Dr. Goodwin earned around $20,000 from GlaxoSmithKline, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.

Check out the article — “Radio Host has Drug Company Ties” — in the New York Times. The good news, though, is that this conflict-of-interest information was revealed by a formal investigation by Senator Charles Grassley (R-Iowa), who has also sponsored the Physician Payments Sunshine Act (S. 2029) of which there is also a version in the House. S. 2029 looks to increase transparency and accountability by requiring drug and medical device companies to publish all gifts and payments over a certain dollar amount, given to physicians.

The National Physicians Alliance is in support of this legislation as part of its Unbranded Doctor campaign. It hosts an informative webpage on this legislation. The legislation is gaining support among legislators, media makers, and conscientious physicians and health systems. It’s music to my ears, because as a health care provider, I believe that I (and the public) have a right to know where conflicts of interest exist. I’d really like to know who I can trust.

(cross-posted at Cure This)

Generally, I lack the time to follow much TV, so it’s been a while that I watched Lost, but I thought the show’s basic and primordial premise – being lost on an island, where no one really knows how they got there, or how to get away (ok, for those who are up to date on this, people seems to have gotten off the island in Season 4) – seems so befitting our current economic situation. Now, I am a physician and not a economist, but most analysts seems to agree with me that the current world economic situation is quite similar to the TV series: we seem utterly lost, every day brings a new turn (together with a 500 up or down in the Dow), no one fully undertsands how we got here (some of the villans, subprimes, clearly not being everything), no one really knows how to get out of the hole.

But that is not the only thing lost. Although I just learned that Ed Kennedy is working on comprehensive heallth care reform (bless him, I wish him well but this may be his parting gift to Congress and the American People), I think that people like Bean, Gingrich and Kerry, who just out forward a suggestions to run medicine like baseball, should do a reality check. Here are some things they wrote that bug me:

Studies have shown that most health care is not based on clinical studies of what works best and what does not, be it a test, treatment, drug or technology. Instead, most care is based on informed opinion, personal observation or tradition (…)  We can do better if doctors have better access to concise, evidence-based medical information (…)  Evidence-based health care would not strip doctors of their decision-making authority nor replace their expertise. Instead, data and evidence should complement a lifetime of experience, so that doctors can deliver the best quality care at the lowest possible cost.

First, apart from the fact that a baseball player can hardly be compared with a doctor, it is not like Evidence Based Medicine is a new concept. It has been around for decades. And the barrier to findings new evidence is not primarlily the lack of will of doctors to accept it, it’s the lack of evidence, caused by a lack of studies, especially unbiased studies. The US government and public have sat back, NIH funding has been insufficient, and we have left it to the drug industry to go and find the evidence. Thus there is a lot of (often biased) evidence of the most lucrative conditions (although the FDA’s orphan drug program has made some difference), like the new diseases everybody seems to have (restless legs, social anxiety, ADHD). Meanwhile, it has become more and more expensive to get a medical education, there is a shortage of physcians, particularly in primary care, the doctors that do work often have no time, and sometimes no funds, for continuing education. Furthremore,  the number of un- and underinsured people is at an alltime high. Although I think it is a great idea, adequately funding the NIH, or some new institution, to run large unbiased clinical trials will have no immediate impact on clinical care: evidence will take years to accumulate and be transplated into practice and it will cost billions that Americans unfortunately are not willing  to pay (more taxes, anyone?).

Everyday I deal with the checkbox mentality of doctors: patient has condition X, so I must check Y and order Z. If I don’t, my hospital gets poor marks on the statistics used to judge their performance, and soon will determine their reimbursement. Furthermore, doctors are trained to think that if they do yet another test, they will not get sued and risk their livelihood and job as a result. Meanwhile, they have not time to talk to the patient, take a good history and review the chart. There is little, if any, evidence that increaseing the ‘batting average” of a doctor to run test Z does anything to make a patient better.  What we need NOW (notn in 5 to 10 years), is to get off the island. Not mb checking boxes, or more tax breaks, but by comprehensive health care reform. Let’s get Un-Lost!

America’s Children are too fat. You cannot deny it (just look outside). They develop diabetes at an alarming rate. There is no doubt that many of them will develop into unhealthy adults and suffer of the  consequences: premature coronary artery disease, chronic pain, disability etc.

16 months ago, the American Academy of Pediatrics endorsed a guideline developed with the AHA in 2006 on how to treat children with disorders that have been shown to put them at risk for prematrue coronary artery disease. The highest risk catergory, which would receive medicines early in the course of treatment, featured conditions fairly rare in childhood (including Diabetes Type I). As recently as July 2007, the US Preventive Services Taskforce concluded that

Several key issues about screening and treatment of dyslipidemia in children and adolescents could not be addressed because of lack of studies, including effectiveness of screening on adult coronary heart disease or lipid outcomes, optimal ages and intervals for screening children, or effects of treatment of childhood lipid levels on adult coronary heart disease outcomes (emphasis added)

Now we are reading that children as young as 8 may be candidates for medications if they have a LDL concentration (“bad cholesterol”) above 160 mg/dl. These risk factors include:

obesity, hypertension, or cigarette smoking or a positive family history of premature CVD (cardiovascular disease)

So maybe the above Task Force – and I  – have missed a recent large outcomes trial that shows that treating an overweight child with a Statin (presumably that, because as the article points out most other medicines are poorly tolerated) will prevent adult heart disease. Furthermore, this articles hopefully compared it with the standard of care… if you find it, let me know. What is the standard of care? Here are a few suggestions by the American Heart Association:

Cholesterol and Atherosclerosis in Children

AHA Scientific Position

There is compelling evidence that the atherosclerosis (…) begins in childhood and progresses slowly into adulthood. Then it often leads to coronary heart disease (…)

Elevated cholesterol levels early in life may play a role in the development of atherosclerosis in adults.

Eating patterns and genetics affect blood cholesterol levels and coronary heart disease risk.

Lowering levels in children and adolescents may be beneficial.

(…)

To reduce fatty buildups in arteries in children (and adults):

Cigarette smoking should be discouraged.

Regular aerobic exercise that lasts at least 30–60 minutes on most days of the week should be encouraged.

High blood pressure should be identified and treated.

Obesity should be avoided or reduced.

Diabetes mellitus should be diagnosed and treated.

Children age 2 years and older should be encouraged to eat at least five servings of fruits and vegetables daily as well as a wide variety of other foods low in saturated fat and cholesterol. Doing this will help them maintain normal blood cholesterol levels and promote cardiovascular health.

No mention of drugs…..

I do not doubt that some children, particulary those with extremely elevated LDL (above 500 or so), may benefit from Statin drugs. But every obese child with a LDL above 160? That may be hundreds of thousands if not millions of young people swallowing expensive pills, with rare but serious side effects, and no proven benefit. It may help (prove it!), but the problem of obesity among children is not one of pill deficiency. How about spending the billions of health care dollars that such a treatment program will presumably cost, and getting more education, physical ed and better nutrition to our kids!

 And then when you read that the lead author Stephen Daniels has a conflict of interest (undisclosed by the journal), you may get nauseated… hey, there is a pill for that, too!

Read more in the New York Times, or LA Times.