Performance enhancing drugs

Ryan Braun has come clean that he used banned substances classified by MLB as performing enhancing drugs in order to speed up his rehab for injury. I suspect he is not alone, but the question I have is what are performing enhancing drugs? What are certain agents selected for this forbidden category?

I am sitting in bed composing this piece, waiting for my Starbucks coffee to brew, knowing that after having my first morning cup my writing performance will be enhanced. I may very well play some tennis today, being sure to take a few doses of my NSAID of choice before to lessen the likelihood of pain and stiffness, thus enhancing my performance. Come to think about it, was is not a performance enhancing drug? Maybe only recreational drugs....

When a professional athlete has an injury, he or she is sent to some form health professional who intervenes in some way, presumably trying to restore and enhance their function. These interventions may involve medications, to enhance healing and function (performance). Why are some banned and others accepted? For some injuries injections or oral administration of glucocorticoids are prescribed to enhance healing. So tell my why these "steroids" are acceptable while anabolic steroids are not? 

Not infrequently athletes require surgery to address some issue. Is the surgery only allowed to restore where they were before their injury or is it allowed for the surgery to take them to a new state where their performance is enhanced? Take Tommy John surgery for an example. In these cases the surgeon leaves the athlete in an new anatomical state. Could or should this be viewed as performance enhancing surgery? What if surgical techniques and bionics progresses to a point to where implanted devices really give an edge?

What is it about certain medicinal interventions which is so disturbing that athletic regulatory bodies select them to be forbidden? Presumably all interventions which are not enhancing in their effects would and should not be of interest to any of the parties involved. Athletes will always be looking for anything that gives them an edge and enhances their performance, but that is really true for all of us. What constitutes a legal vs a unacceptable intervention is essentially impossible to define and attempts to define have to deal with the moving target phenomena. There are no clear lines which can be drawn and the ambiguous boundaries are constantly moving. There are no clearly defined principles to delineate the difference between banned substances and widely used ones. The designations appear to come about though whim and gestalt. 

Perhaps this is all part of a larger struggle we have with drugs in general. We understand that drugs can both impair and enhance our function and we seem to have a problem with both of these. Creating legal and regulatory boundaries on their use should yield more benefit than harm. I am not sure that's the case. Maybe we need to consider the possibility that fewer rules in this arena will lead to better outcomes.

Real team building in health care

We talk much about teams in health care and when it comes to completing short term tasks, we have built teams which can meet those goals. Where we have fallen short is in the building of teams tasked with addressing longer term issues, such as might be required to accomplish true coordinated care. This has been brought to my attention recently simply because we have fielded calls from patients with a variety of problems outside of our sphere of expertise. We were tagged with addressing these problems because we had people answering the phone.

The flippant answer is "Call your primary care physician". They take care of everything. That is really not fair to them but they tend to be the default choice in the eternal game of "Medical It". But who should a patient contact with a problem?

In order to have team care, one must first define who is on the team. Ask a patient who is on their medical team and you are likely to get blank stares. Ask them who is in charge and the stare continues. How can we have team care when no one knows who is on the team? In the rare circumstances where I get a list of various physicians who are involved in the care of a given patient I have no idea of what individual roles are played by these docs. Ask the patient who they call for particular problems and the likely answer is they will call whomever tends to respond to their queries. Talk about letting no good deed go unpunished.

In other industries there is a drive to find unmet needs and create products or services to meet those needs. In medicine, this is avoided like the plague. Unmet needs are likely markers for non-reimbursed or poorly reimbursed services.

Team building will require we define who is actually on health care teams, define which roles are filled,  making sure patients know who to turn to for specific issues, and striving to identify roles and tasks which need to be filled. Perhaps the first step is to do nothing more than to ask patients who is on their health care team and try to anticipate their needs, making sure they understand when it is appropriate to come to your window for help and when it is not.

Over time, this issue is going to be solved by patients recognizing where no one is stepping up to fill voids. At this point in time the voids are unrecognizable since no one's role is really defined and the team members are not defined either. Until then,we will simply pretend that we operate as a team with no roster and no positions.

Hoping for a different outcome

I watched one of my favorite movies yesterday, Groundhog Day. In this film the hero, Bill Murray, gets the opportunity to live a particular day over an over again until he can get it right. While he first becomes very discouraged that he is stuck in Punxsutawney, Pennsylvania reliving Ground hog day, over and over, he ultimately is able to realize that he is able to learn and adapt, ultimately getting it right and winning the girl, Andie MacDowell. 

In reading JAMA Internal Medicine this week, I feel like I am in Punxutawney. Sinsky and Dugdale (Sinsky & Dugdale) publish an article objectively demonstrate that those who do procedural work (cataract surgery and colonoscopy) are paid substantially more per unit time of work than those who do primarily cognitive work. (Table 4) They conclude yet again that a major reason our health delivery system is so focused on procedures is that the economic incentives drive the players in that direction. 

We have suspected this for a long time, perhaps 40 years or more. In the accompanying commentary titled "Using Science to Shape Medicare Physician Payment" by Paul Ginsberg, he notes that there have been repeated efforts to correct this bias in the payment system which have repeatedly failed (Ginsburg Commentary). Dr. Ginsberg seems to lack a certain sense of history by invoking science and price fixing in the same sentence. 

Dr. Ginsberg seems to view price setting as a simple accounting exercise, much as did earlier thinkers who embraced a similar use of science to set prices. I am referring to the application of scientific socialism which embraced the idea that economies could obtain better outcomes if they were intentionally planned, right down to using science to assign prices for goods and services. That did not go so well. 

In market systems, prices are simply information relating to value assigned by the public and scarcity. Items which are abundant and not viewed as valuable tend to command low prices while items more highly valued and scarce command higher prices. Prices set by market mechanisms send information to both consumers and to producers and are capable to responding quickly to both changes in demand and changes in supply. High or increasing prices flag what are unmet needs. No one needs to study such markets to identify where there are unmet needs. Just look where goods or services are expensive.

In contrast, scientifically set prices are essentially prices without any real information about supply or demand. Economies based upon administratively set prices may go years or decades without being to identify unmet needs.  Even when the unmet needs are recognized, the cycle time required for price adjustment is interminably long, much too long to have any meaningful allocative function. Ludwig von Mises recognized this over half a century ago.

Despite this recurring theme, authors such as Ginsburg repeatedly write suggesting that with just a bit more tweaking and application of scientific principles, the price mechanism in health care can be supplanted by administrative planning and controls. That is not the lesson I glean from the previous efforts. As the health care economy grows to engulf ever larger portions of resources, the administrative pricing approach dooms more and more resources to mis-allocation. We get to relive our experiences, much like Bill Murray in Ground Hog Day, the difference being he seems to learn from his experience while we are committed to the same mistakes.

The Emperor has no clothes?

Judge for yourself....JAMA Facial Plastic Surgery

Planning for acute unscheduled care

In the Annals of Internal Medicine, Kocher, et al published a piece titled: "What is our plan for acute unscheduled care" (Acute Unscheduled Care). This piece really resonated with me because we are in the midst of grappling with this very issue. Our management is encouraging us to use a model pioneered by the Cleveland Clinic where patients are spontaneously offered same day appointments. Their acute care model is built into their system. How they actually pull this off is another story. Perhaps it has to do with the fact they are based in a rust belt city where the demands for care are somewhat more modest.

For the rest of the world the reality of acute unscheduled care is Emergency Rooms, urgent care centers, Minute Clinics, and begging to get into your primary care provider's office. The burden is substantial since the authors of the article cite studies showing unscheduled care makes up about 30% of the 1.2 billion outpatient visits in the US annually. This data comes from the National Center for Health Statistics. The Rand Corporation published a fact sheet on this three years ago and I think their comments are spot on (Rand):

The results indicate that a relatively small proportion of doctors — emergency department (ER) physicians, who comprise only 4 percent of doctors — handle more than one-fourth of all acute care encounters and nearly all after-hours and weekend care. ER physicians also provide more acute care to the uninsured than all other doctors combined.

The main barriers to getting acute care in primary care settings are timeliness and complexity. Because the schedules of many primary care physicians are packed with 15-minute office visits, they have little or no time to see unscheduled patients, particularly those who have complicated problems. And primary care physicians have few incentives to offer extended hours of practice (only 40 percent do) or see patients on weekends.

I run a specialty practice which is essentially all outpatient based. We make our margins by consistently having appointment utilization at greater than 95%. The practitioners in our practice have also been impacted by the deployment of the electronic medical record. We have no place to put unscheduled acute care other than in places which guarantee that they will create waits and delays.  

It used to be said, better, faster, cheaper; which two do you want? I am afraid the choice is which one do you want, that is unless we change the payment and licensing systems to allow for real innovation in health care delivery.

Regulation without integrity is doomed to failure

Every year there are a handful of stories which really shake my confidence. Today, I read one . (Ranbaxy)  An investigative story published on the CNN Money website attributed to Fortune Magazine describing a truly sordid tale entitled "Dirty medicine" (by Katherine Eban).

Ranbaxy is a veritable generic drug giant in which the Japanese Pharmaceutical Company Daiicho Sankyo has a controlling interest. They purchased this in 2008. However, four years earlier employees of Ranbaxy publicly drew attention to the fabrication of drug testing reports within the company. The fraud did not appear to be isolated, but affected perhaps every drug and market that Ranbaxy was involved with.

As noted in the Fortune piece, 80% of the active pharmaceuticals used in the US come from outside of the country. The level of oversight is inherently less in countries such as India than it is in the US or Europe. The lesson of the story is clear as noted in the Fortune piece:

As the Ranbaxy story makes vividly clear, generic-drug makers intent on breaking the rules -- especially those operating abroad -- can easily do so. Drug applications work on the honor system: The FDA relies on data provided by the companies themselves. "We depend on that information to be truthful," Gary Buehler, who headed the FDA's office of generic drugs for 10 years, said in December 2009. (Buehler has since taken a position at the U.S. unit of the Israeli generic-drug company Teva.) The approval system "requires the ethical behavior of the applicant," he said. Otherwise, "the whole house of cards will fall down."

The particulars were described in detail in the article. Rajinder Kumar and Dinesh Thukar were Ranbaxy employees previously employed by brand name pharmacuetical firms who were lured back to India and Ranbaxy to assume leadership posts. They had little idea of what they were getting into.

In August 2004, as he confronted his assignment to investigate possible fraud at his own company, Thakur gave each of his project managers a part of the world and asked them to compare Ranbaxy's manufacturing data against the claims made to regulators. His own efforts began with a visit to a company regulatory official.

It was a depressing conversation. The official explained, Thakur says, that the company culture was for management to dictate the results it wanted and for those beneath to bend the process to achieve it. He described how Ranbaxy took its greatest liberties in markets where regulation was weakest and the risk of discovery was lowest. He acknowledged there was no data supporting some of Ranbaxy's drug applications in those regions and that management knew that, according to Thakur...... 

The entire article is worth reading. I don't think it makes sense to copy it in its entirety into the blog post. Each section is simply remarkable in terms of the reported brazenness of Ranbaxy management. For example:

Lying to regulators and backdating and forgery were commonplace, he says. The company even forged its own standard operating procedures, which FDA inspectors rely on to assess whether a company is following its own policies. Thakur's team was told of one instance in which company officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a "steam room" overnight to fool regulators.
Company scientists told Thakur's staff that they were directed to substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results.

I don't even know where to begin. A complex world and the human interactions required to make this work are so based upon trust. When you go into a restaurant for a meal, there is a large degree of trust. Yes, there is a health department inspection report somewhere but that can only go so far. When patients see a physician or dentist, there is trust that medications are correct and instruments are clean. Every few years there are revelations about this practice or that where operations are substandard. They may reach a few hundred or perhaps a few thousand people. The Ranbaxy situation was orders of magnitude worse, perhaps affecting tens if not hundreds of millions of people, many of whom are the most vulnerable in the world.

Within the US  we are strongly encouraged to prescribe generic drugs. This behavior is now assigned the priority as a "quality" metric placing physicians in a position where they are strongly encouraged to write for generics. Talk about unintended consequences. I am very tempted to prescribe with the qualifier that  generics are OK but to avoid Ranbaxy products until they can restore my trust. Good luck to them.