Maybe the Jig Is Up

Yesterday Reuters reported that, in comments at a Financial Times conference in London, a top executive at Roche Pharmaceuticals condemned direct-to-consumer advertising as a disaster. “Direct-to-consumer promotion [of drugs] was the single worst decision for the industry," said William Burns, Roche’s head of pharmaceuticals, to conference attendees. "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility,” he continued.

Burns’ despondency is understandable: if ever there was a time that the prescription drug industry needed credibility, it’s now. For the first time in recent memory, drug companies are facing the prospects of an end to their free ride of unregulated profiteering. There are already rumblings that both the Obama Administration and the Democratic Congress want to stack up a series of clean legislative victories by going for “low-hanging fruit”—bipartisan, popular initiatives that will pass easily—and there are few juicier targets than Big Pharma. 


A few days ago, The Chicago Tribune reported that President Obama will likely push for “cheaper copies of expensive drugs derived from biotechnology,” will let Medicare “negotiate drug prices directly with drug companies,” and will try to make “it legal for pharmaceuticals to be imported into the U.S.” In other words, Obama wants to make drugs cheaper for patients, and thus impact drug companies’ bottom line. According to David Dranove, professor of health industry management for Northwestern University's Kellogg School of Management, these changes have been “hanging there [in Congress] for some time and will be easy sells and easy to get through."

For its part, the industry knows that it’s got a big, fat target on its back. During the presidential election, drug companies were torn over which candidate to support, mostly because they couldn’t decide who hated them less. Even John McCain boasted—not untruthfully—that he repeatedly “took on the drug industry” over the course of his career.

The comparable distastefulness of both candidates led to a development that hasn’t happened in almost twenty years: the prescription drug industry gave to the Democratic and the Republican presidential candidate in almost equal amounts (usually pharma goes for the GOP). “Both [Obama and McCain] blame big drug companies for high prices and reduced innovation,” sighed one industry insider. “In either case, we should expect more price negotiation and re-importation [of drugs].” Translation: the honeymoon is over. 

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Inside the Imaging Boom

Much of the newest issue of Health Affairs is dedicated to putting hard numbers to the rapid proliferation and over-use of diagnostic imaging technology like computed topography (CT) and magnetic resonance imaging (MRI) scans. This research warrants special attention:  quantifying the “imaging boom” provides an important contribution to understanding  America’s health care woes.

The Scope of Growth

The lead article from Health Affairs comes from Laurence Baker and Scott Atlas at Stanford and Christopher Afendulis at Harvard. The research team notes the explosion of imaging machines in recent years, estimating that “the number of CT units [in the United States] grew more than 50 percent between 1995 and 2004” and that “the estimated number of MRI units more than doubled.” As this technology has become more widely available, it’s been used more often: the number of MRI procedures per 1,000 Medicare beneficiaries increased from 0.3 in 1985 to 173 in 2004. Use of CT scans more than doubled from 235 per 1,000 in 1995 to 547 per 1,000 in 2005. Baker et al. crunch the numbers to find that, over the years, each new MRI unit on the market led to 733 additional MRI procedures, adding $550,000 to Medicare spending annually. Each new CT unit on the market prompted 2,224 additional CT scans and tacked on $685,000 to the yearly Medicare bill.

These are striking numbers, and the shock persists when you put diagnostic imaging in the context of other medical services. In another Health Affairs study, Ariel Winter and Nancy Ray from the Medicare Payment Advisory Commission (MedPAC) note that between 2000 and 2005, the volume of services per Medicare beneficiary grew by 31 percent (in other words, the average Medicare patient in 2005 received 31 percent more care than she did in 2000). In contrast, the volume of diagnostic imaging (including MRI and CT scans, x-rays, and ultrasound) grew by 61 percent—twice as fast as broader physician services. More services means more payments, and this increase has been coupled with a doubling of Medicare spending on imaging services, from $6.4 billion in 2000 to $12.3 billion in 2006.

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The Front Lines of Primary Care, Part 2

In my previous post, I discussed how the realities of primary care—the “hamster wheel” of 15-minute visits with sometimes-difficult patients suffering from complex, chronic conditions—can burn out idealistic primary care physicians (PCPs). Increasingly, disillusioned PCPs are leaving the field. A recent survey from the Physicians’ Foundation reports that one-half of PCPs would leave medicine if they thought they could do so. 


Well-intentioned doctors choose primary care because they love the idea of working closely with patients and building lasting relationships over time. But the low reimbursement rates force them to see as many patients as possible in a given day, and the frantic pace of their work often de-humanizes their practice. They are pushed to practice “assembly line” medicine.  Understandably unhappy with this state of affairs, many think to themselves, “this is not why I wanted to become a doctor.”

Ideally, as Thomas Lee, an associate editor of the New England Journal of Medicine, recently put it, PCPs should go home every night thinking “this is what I was meant to do.” This seems like a high bar to reach, but we’d be a lot closer to it if our system recognized one simple fact: no physician is an island.

The Importance of Teamwork

Primary care can’t be a one-man (or a one-woman) show. There’s simply too much to do. In a recent commentary for the New England Journal of Medicine¸ Dr. Thomas Bodenheimer of the University of California-San Francisco notes that “it would  take a primary care physician 18 hours per day to provide all recommended preventive and chronic care services to a typical” cohort of patients.

Making the time-crunch even worse is the fact that PCPs often take on duties that have little to do with the actual practice of medicine. In a recent comment over at Theresa Chan’s Rural Doctoring blog, a PCP named “Doctor Jen” describes the diversity of responsibilities that she faces over the course of a day. “Today,” she begins, “I saw a young woman who brought a list with 17 issues to be addressed…I also saw a newly diagnosed cirrhotic gentleman who is really struggling emotionally with his diagnosis, an 88 yr old lovely woman who needed medical clearance to take a driver's test, and a poorly controlled bipolar client who can't get a psych appt for 3 [months] because he's not suicidal.”


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The Front Lines of Primary Care: The Stories Behind the Crisis (Part I)

In a recent post, Health Beat described the policy strategies that must be employed in order to address the primary care crisis in the United States.  Here, I’d like to focus to the human side of the primary care crunch by highlighting the personal experiences of doctors. Moving from the policy to the personal adds an all-important qualitative element to our understanding of just why American primary care is in such dire straits. 


The Basics

That said, numbers still help set the stage: in 1990, 9 percent of graduating medical students planned to work in primary care/internal medicine; today just 2 percent are choosing primary care. Meanwhile, we know that primary care can help patients avoid expensive, unnecessary medical procedures; obtain regular preventive care; and manage the chronic illnesses that make up between 75 and 80 percent of our $2.3 trillion national health care bill. We can’t afford to run out of PCPs.

The usual reasons cited for the dwindling ranks of PCPs are money and time. Many PCPs make only 1/5 as much as the best-paid specialists. Lower salaries mean that PCPs need to see more patients to have incomes that are comparable to those of their peers. This imperative creates a “hamster wheel” as PCPs frantically cycle through patients who often are suffering from complex, chronic diseases.

No Time to Learn

It’s generally agreed that primary care is unpopular because medical students see the money/time crunch and tell themselves, “no way is that going to be my life.” But the Over My Med Body! blog, which until recently had been maintained by a medical student named Graham, offers a slightly different perspective. According to Graham, students aren’t necessarily mapping out their whole lives when they select a field and apply for residencies—they just want the chance to develop their analytical acumen and grow as doctors. The hamster wheel doesn’t give them that opportunity. 

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“Spread the Wealth” Controversy Hits Doctors

Niko Karvounis and Maggie Mahar

By now you know that Senator Max Baucus (D-MT) has offered a “Call to Arms” for health care reform by way of a 98 page policy document. There is much to think about in Baucus’ proposal, so you might have missed the section where he talks about increasing payments to primary care providers at the expense of compensation for specialists. But in the future, keep your eyes peeled for developments around this proposition—because supporting primary care is going to be a complex and controversial undertaking.

Baucus rightly recognizes that primary care is “undervalued” in our health care system. The Medicare reimbursement schedule—which is the model for private insurers rates—pays a lot more for removing a wart than it does, say, for talking to patients about their medications. Doing something to a patient (procedural care) is compensated much more than is doing something with a patient (cognitive care). The result is that generalists, including family practitioners, internists, primary care providers (PCPs), geriatricians and palliative care specialists make a lot less than proceduralists.

Today the average annual salary of a radiologist is $354,000, and at the high end they make $911,000.  Orthopedic surgeons pull in $459,000 to $1.352 million; cardiovascular surgeons average $558,719 to $852,000.  By contrast, internists report average salaries of $176,000; after years of experience, they can hope to make $245,000.  In the middle of her career, the typical pediatricians can expect to earn $175,000; later, she may move up to $271,000.  The average family practitioner may gross $204,000, at the high end he can look for $299,000. 

Following the recommendations of an April Medicare Payment Advisory Commission (MedPAC) report, Baucus wants to restructure the reimbursement system to place more value on primary care. Part of this plan is to offer bonus payments to PCPs by making a list of services that qualify as primary care services (“evaluation and management visits”) and boosting payments to doctors who deliver these services. These increased payments would be “budge-neutral”—meaning that hikes in PCP payments would be coupled with corresponding cuts in some specialists’ payments.

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FDA Priority Vouchers: Less Than Impressive

Some facts to chew on: The prescription drug industry is projected to reach $842 billion in global sales in 2010. Over the last ten years, 80 percent of the drugs that have entered the U.S. market are “me too” drugs that are no more effective than those we already use. Meanwhile, across the ocean, Sub-Saharan Africa accounts for 60 percent of the world’s 250-500 million malaria cases every year and 75 percent of the global population that goes blind from the infectious eye disease trachoma.  Both diseases can be treated through various drugs and antibiotics which pharmaceutical companies have the capacity to manufacture.

The billion-dollar question: how can we get drug companies to focus more of their formidable resources on producing drugs to combat these tropical diseases? The Food and Drug Administration (FDA) thinks it has the answer: a “priority voucher” program which grants drug companies accelerated approval for products targeted at wealthy countries as a reward for developing drugs that address tropical diseases. The program, established through a 2007 Congressional amendment to FDA legislation, essentially offers drug makers a deal: prove that you have, say, a new anti-malarial drug, and get your next blockbuster antidepressant fast-tracked for FDA approval. At first glance, this may seem like a sly bargaining chip to help the Third World; but in reality, the priority voucher program leaves much to be desired.

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The Dangers of Do-It-Yourself DNA Testing

Recently, Time magazine listed the retail DNA test as its best invention of 2008 (thanks to Kevin M.D. for the tip). The best?  Maybe one of the most worrisome.

Time specifically highlights the do-it-yourself DNA testing kit from 23andMe, a California-based corporation named after the 23 pairs of chromosomes in each human cell.  The company sells $399 DNA kits that consist of a test tube in which you spit and send to the company’s lab. There, over the next 4-6 weeks, researchers extract DNA from your saliva and map your genome, putting the results online. You can access the results through the web and navigate a guide to your genes that estimates “[genetic] predisposition for more than 90 traits and conditions ranging from baldness to blindness.” 

Admittedly, this sounds pretty cool. As Time gushes, “in the past, only élite researchers had access to their genetic fingerprints, but now personal genotyping is available to anyone who orders the service online…” But look closer at the commoditization of DNA testing and the novelty wears off pretty quickly.

By pinpointing specific genes associated with certain diseases, a 23andMe gene read-out can inform a user of his or her susceptibility to those conditions. It turns out this is a lot less useful than it might seem. For example, Time reports that one test showed that the husband of 23andMe’s founder has a rare mutation that gives him an estimated 20 percent to 80 percent chance of getting Parkinson’s disease. The couple’s child, due later this year, has a 50 percent chance of inheriting this mutation, and thus his dad’s risk of Parkinson’s.

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The Bipartisan Merits of a Public Competitor

Long-term, Health Beat still expects that President-elect Barack Obama will reform healthcare. Originally (before the economic melt-down) he said that he hoped to roll out reform by the end of his first four years in office. Now, as Maggie indicated yesterday, he seems to be signaling that full-scale reform will have to wait until his second term. But there are steps that he can take to begin paving the way for reform in 2009.

For one, he needs to give Americans a chance to understand why a public sector health care plan, open to all Americas under 65 years of age, would be a good idea.  This plan would serve as a voluntary alternative to private insurance. People who didn’t want to enroll in the public plan could stick with their private insurer or move to one contracted with the National Health Insurance Exchange—the new government organization which, in addition to managing the public plan, would help to connect people with plans that adhere to certain government-specified regulations.

This so-called “public competitor” model, in which the government (a) introduces a new health care plan to compete with private insurers, and (b) tightens regulations on the health insurance market, has made its share of enemies on both the Left and the Right. Staunch single-payer advocates bristle at a reform package that still includes a role for private insurers, while conservatives view an expansion of the government’s role in health care as evidence of “socialism.”

Given the orthodoxies at work on both sides here—More government! Less government!—these complaints aren’t surprising. But both camps should understand that the National Health Insurance Exchange (NHIE) is a means of giving both single-payers and free-marketeers a health care system close to their cherished principles—without making health care reform an unnecessarily daunting and divisive endeavor.

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Paging Dr. Mario

Over at The Health Care Blog, Douglas Goldstein wrote a post earlier this month on “health eGames,” a category of video games “that deliver measurable health benefits” to patients who play them. iConecto, a developer of such games, recently reported that there are already over 300  health eGames available—and that the size of this market over the next year will be $7 billion+. Consumers definitely seem open to the idea of healthy gaming: Wii Fit, Nintendo’s fitness video game, is poised to become the best selling title of the year, having already sold 8.7 million units.

This got me thinking: what about video games for doctors?

Kevin M.D. began to answer my question on Tuesday when he posted this YouTube clip on his blog:

This video simulates emergency room situations; surgeons can use it to train themselves in particular operations. This is a pretty cool idea: test the skills of a surgeon, but in a context where his slip-ups won’t cost lives.

What’s more surprising is that even conventional video games can play a role in training surgeons. In January, the BBC reported that a British hospital asked “eight trainee surgeons to spend an hour playing [non-medical video games] before performing ‘virtual reality’ surgery” through the program in the YouTube clip above. The hospital found that “game players scored nearly 50% higher on tool control and overall performance than other trainees.” The game that was most effective at improving their skills was Marble Mania, in which the player rolls a marble through a maze and obstacle course.

This isn’t all that weird when you consider how the technical skills you need for most video games—spatial awareness, fast reflexes, dexterity, and precision—are also vital to successful surgery. If a video game can help a surgeon brush up on these skills, it doesn’t matter whether it’s about a marble or a monkey.

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The Case of Patients v. Big Pharma

On November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the “business case of the century”—and with good reason. In essence, Monday’s ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks.

First, the details of the case: In the spring of 2000, Diana Levine of Vermont received treatment for migraines which consisted of the painkiller Demerol and Phenergan, an antihistamine manufactured by Wyeth Pharmaceuticals. Phenergan is typically injected directly into the muscle or dripped into the vein through steady doses (a procedure called an “IV drip”). When administering the drug, clinicians must be careful not to expose it to blood in the arteries; doing so causes “swift and irreversible gangrene,” to use an evocative phrase from a September New York Times article on Levine’s case.

Unfortunately, the physician assistant who attended to Levine administered Phenergan neither through muscular injection nor IV drip, but through a process called “IV push”—a direct intravenous shot in the arm. The assistant missed and hit an artery. Over the next few weeks, Levine, who was an avid guitarist, saw her right hand and forearm turn purple and then black—until both were finally amputated.

The court battle is over whether or not Wyeth Pharmaceuticals sufficiently warned against the dangers of IV push on its packaging for Phenergan—packaging that had been approved by the FDA. The drug’s labeling did warn that it was preferable to give Phenergan through IV drip, and warned that “inadvertent intra-arterial injection”—accidentally injecting the drug into an artery—could cause “gangrene requiring amputation.” But nowhere on the Phenergan label was there an express warning that the method of IV push is extremely risky for this very reason.   

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