Medicine

Rating the FDA by Division

by on April 24, 2014 at 7:28 am in Economics, Law, Medicine | Permalink

In previous work, I have argued that asymmetric incentives make the FDA too risk averse with the result being excessive drug lag and drug loss. The FDA, however, is not a monolithic agency, it is divided into divisions which oversee different types of drugs. The divisions have different cultures, expectations histories and understandings. In my latest paper, written with Tufts researchers Joe DiMasi and Chris Milne, we put aside the question of global efficiency and ask a different question. How do the FDA divisions rate against one another? What we find is quite surprising: some of the FDA divisions appear to be much more productive than others. From the abstract:

After reviewing nearly 200 products accounting for 80 percent of new drug and biologic launches from 2004 to 2012, the authors find wide variation in division performance. In fact, the most productive divisions (Oncology and Antivirals) approve new drugs roughly twice as fast as the CDER average and three times faster than the least efficient divisions—without the benefit of greater resources, reduced complexity of task, or reduction in safety. The authors estimate that a modest narrowing of the CDER divisional productivity gap would reduce drug costs by nearly $900 million annually. The worth to patients, however, would be far greater if the agency could accelerate access to an additional generation of (about 25) drugs. Greater agency efficiency would be worth about $4 trillion in value to patients, from enhanced U.S. life expectancy. To reap such gains, this study encourages Congress and the FDA to more closely evaluate the agency’s most efficient drug review divisions, and apply the lessons learned across CDER. We also propose a number of reforms that the FDA and Congress should consider to improve efficiency, transparency, and consistency at the divisional level.

Andrew von Eschenbach a former Commissioner of the FDA and Director of the National Cancer Institute and now chairman of the Manhattan Institute’s Project FDA wrote a foreword to our paper. Eschenbach writes:

The authors of this report have taken a giant step…by assembling and analyzing a wide array of publicly available information about the relative performance of individual CDER divisions….Continuous, quality improvement measures routinely used by private industry could serve FDA leadership, sponsors, and patients by discerning factors that contribute to an optimal level of performance and, more important, disseminating such practices to ensure that all divisions achieve that performance. The payoff for such an effort could be enormous.

…Process improvement should not be a controversial proposal. An organization like the FDA—which is over a century old and which has maintained its current, basic organizational framework for decades—requires new tools to adapt to changing circumstances.

…I have enjoyed no greater privilege in my professional career than serving alongside the FDA’s talented staff. Today, the agency has more potential than ever to help the U.S. lead the world in advancing a biomedical revolution, one that will have an impact on every aspect of America’s economy and health-care system by improving health, increasing productivity, and reducing overall health-care costs.

…this report should be viewed as a positive, constructive contribution to a desperately needed dialogue on how to assist the agency in fulfilling this vital national goal.

Not a surprise to me but yikes nonetheless:

In the first comprehensive study of the DNA on dollar bills, researchers at New York University’s Dirty Money Project found that currency is a medium of exchange for hundreds of different kinds of bacteria as bank notes pass from hand to hand.

By analyzing genetic material on $1 bills, the NYU researchers identified 3,000 types of bacteria in all—many times more than in previous studies that examined samples under a microscope. Even so, they could identify only about 20% of the non-human DNA they found because so many microorganisms haven’t yet been cataloged in genetic data banks.

Easily the most abundant species they found is one that causes acne. Others were linked to gastric ulcers, pneumonia, food poisoning and staph infections, the scientists said. Some carried genes responsible for antibiotic resistance.

“It was quite amazing to us,” said Jane Carlton, director of genome sequencing at NYU’s Center for Genomics and Systems Biology where the university-funded work was performed. “We actually found that microbes grow on money.”

This was, by the way, a relatively frequent complaint in 19th century monetary writings, with the advent of banknotes.

British retirees may soon receive a novel kind of financial advice, courtesy of the state: They could be told when they are likely to die.

“People are living a lot longer, so we have to make sure they have up-to-date information,” the pensions minister, Steve Webb, said Thursday in an interview with the BBC.

“There’s no point being all British and coy about it,” he said. Gender, age and “perhaps asking one or two basic questions, like whether you’ve smoked or not,” Mr. Webb said, should be enough to determine how long, on average, someone is likely to live. Having an idea of life expectancy would help retirees with private pensions manage their finances more efficiently, he said.

There is more here.

“We understand that we doctors should be and are stewards of the larger society as well as of the patient in our examination room,” said Dr. Lowell E. Schnipper, the chairman of a task force on value in cancer care at the American Society of Clinical Oncology.

In practical terms, new guidelines being developed by the medical groups could result in doctors choosing one drug over another for cost reasons or even deciding that a particular treatment — at the end of life, for example — is too expensive.

More from the NYTimes.

From the comments

by on April 17, 2014 at 2:17 pm in Current Affairs, Law, Medicine | Permalink

This is from John B. Chilton:

For those who don’t click through this is what Tyler wrote:

“6. The exchanges will be mostly working by March 2014, but by then the risk pool will be dysfunctional. In the meantime, real net prices will creep up, if only through implicit rationing and restrictions on provider networks. The Obama administration will attempt to address this problem — unsuccessfully — through additional regulation.”

The simple answer to Christian’s query (“I’m curious how you stand now given current enrollment numbers and your previous prediction about a dysfunctional exchange.”) is that it’s not the enrollment numbers that matter, it’s the risk pool.

The jury’s out on the risk pool — lots of opinions out there on whether exchange premiums will go up for 2015.

Here is Ross Douthat on how will we know if Obamacare is working?  It is the best post on this debate so far.  He closes with this:

I’ll lay down this marker for the future: If, in 2023, the uninsured rate is where the C.B.O. currently projects or lower, health inflation’s five-year average is running below the post-World War II norm, and the trend in the age-adjusted mortality rate shows a positive alteration starting right about now, I will write a post (or send out a Singularity-wide transmission, maybe) entitled “I Was Wrong About Obamacare” — or, if he prefers, just “Ezra Klein Was Right.”

The latest, uh, must-have appears to be positive pregnancy test results.

Women across the country are selling — and buying — them on Craigslist.

One post from Buffalo, New York, sums up the appeal for potential shoppers:

“Wanna get your boyfriend to finally pop the question? Play a trick on Mom, Dad or one of your friends? I really don’t care what you use it for.”

That particular test was going for the reasonable rate of $25 dollars. The tests in Texas seem to be slightly more expensive, at $30 a pop.

There is more here, via Marcela Veselková.

Department of Uh-Oh

by on April 16, 2014 at 12:31 am in Data Source, Economics, Medicine | Permalink

A four-year slowdown in health spending growth could be coming to an end.

Americans used more medical care in 2013 as the economy recovered, new reports show. Federal data suggests that health care spending is now growing just as quickly as it was prior to the recession.

“We’re at the highest level of growth since the slowdown began,” Paul Hughes-Cromwick, a senior health economist at the Altarum Institute, which tracks health spending. “You have to go back seven years to see growth like this.”

There is more here, from Sarah Kliff.  Note that is only from one quarter, however.  Kevin Drum remains more sanguine.

The Census Bureau, the authoritative source of health insurance data for more than three decades, is changing its annual survey so thoroughly that it will be difficult to measure the effects of President Obama’s health care law in the next report, due this fall, census officials said.

The changes are intended to improve the accuracy of the survey, being conducted this month in interviews with tens of thousands of households around the country. But the new questions are so different that the findings will not be comparable, the officials said.

An internal Census Bureau document said that the new questionnaire included a “total revision to health insurance questions” and, in a test last year, produced lower estimates of the uninsured. Thus, officials said, it will be difficult to say how much of any change is attributable to the Affordable Care Act and how much to the use of a new survey instrument.

“We are expecting much lower numbers just because of the questions and how they are asked,” said Brett J. O’Hara, chief of the health statistics branch at the Census Bureau.

With the new questions, “it is likely that the Census Bureau will decide that there is a break in series for the health insurance estimates,” says another agency document describing the changes. This “break in trend” will complicate efforts to trace the impact of the Affordable Care Act, it said.

Obviously with a big new law you need new questions too, I suppose, plus the old questions ought not to hang around.  You can read more here.

As a side note, I have been reading far too many blog posts about “numbers enrolled” as a metric of success for Obamacare.  That has never been a good test of the serious criticisms (and defenses) of ACA.

I thank Megan and Garett for the pointers.

Addendum: You should read this update from Vox, though I am not satisfied with the Administration’s response.

Hi Professor Cowen,

I am a loyal MR reader and I wondered if you could comment on the following situation:

I am a 3rd year medical student, and for the purposes of this question, let’s assume I have equal interest and ability in the various medical specialties.  In order to create the greatest good for the greatest number of people through my work in medicine (i.e., the highest return to society), what specialty should I pursue?  I should add that, although I intend to practice in the U.S., I am open to devoting as much of my free time/vacation as possible to pro bono medical activities, and further, that I wish to do the interventions myself (instead, for example, or just making lots of money and then donating the proceeds to some other charitable activity).  In attempting to answer this question, I’ve been looking at DALYs and QALYs associated with various medical interventions (e.g., cataract surgery).  Am I going about answering this question the right way?  Any thoughts?

An interesting corollary would be asking what job, in any field, has the highest return to society.  Is there any literature on this?

The fundamental institutional failure to overcome is that many lives “out there” are pretty happy, and very much worth living, but those individuals do not have enough money to afford reasonable doctors.  If you are seeking to maximize social welfare, look to step into some of these gaps.

But which gap in particular?

The second binding constraint, in my view, is that most people won’t in fact go through with their plan to do a lot of social good.  That means you too.  So you wish to seek out a form of do-gooding which is incentive-compatible over the long run, or in other words which is fun for you or rewarding in some other way.  This second consideration is likely to prove decisive.

For instance you might decide the fight against dengue (just an example to make a point, not an actual net assessment) is the way to go, based on a narrow cost-benefit analysis.  But it is hard as a field worker to really, fully protect yourself against dengue.  And getting dengue can be very bad indeed.  As you age, the pressures not to go into the field will mount.  You might do more good by pledging your efforts to fight a malady which you can help fix without so much direct risk or exposure to yourself, let’s say infant mortality.

You will note a difference here between pledges of individual effort and pledges of money.  A money pledger, thinking in game-theoretic Nash terms, will realize that effort pledgers will resist the fight against dengue.  That is all the more reason why throwing money at the fight against dengue may bring high returns, namely that at the margin not enough is being done from the side of volunteer and quasi-volunteer labor.  (In general this distinction creates a problem with talking up one kind of cause over another, namely that labor and money face differing incentives and should hear different messages of encouragement.)

You will note also that in a second best optimum, field workers will appear to be “consuming too many perks.”  At the same time, donated funds should be trying to push field workers out of their comfort zones, at least on the margin.

I would add two final points.  First, if you have a reasonable chance of being a research superstar, that may be the path to follow.

Second, if you are not already attached, spent time cultivating social circles (aid work, World Bank, vegetarians, etc.) where you are likely to meet a partner or spouse who will support a similar vision to help the world.

Addendum: David Henderson adds comment.

I was intrigued by the new paper by Adam Leive, called “Dying to Win? Olympic Gold Medals and Longevity.”  The main results are these:

This paper investigates how status affects health by comparing mortality between Gold medalists in Olympic Track and Field and other finalists. Due to the nature of Olympic competition, analyzing performance on a single day provides a way to cut through potential endogeneity between status and health. I first document that an athlete’s longevity is affected by whether he wins or loses and then detail mechanisms driving the results. Winning on a team confers a survival advantage, with evidence that higher mortality among losers may be due to poor performance relative to one’s teammates. However, winning an individual event is associated with an earlier death. By analyzing the best performances of each athlete before the Olympics, I demonstrate that an athlete’s performance relative to his expectations partly explains the earlier death of winners in individual events: on average, Olympic Gold medalists expected to win, but losers exceeded their expectations. Conversely, athletes considered “favorites” but who fail to win die earlier than other athletes who also lost. My results are robust to estimating a range of parametric and semi-parametric survival models that make different assumptions about unobserved heterogeneity. My central estimates imply lifespan differentials of a year or more between winners and losers. The findings point to the importance of expectations, relative performance, surprise, and disappointment in affecting health, which are not highlighted by standard models of health capital, but are consistent with reference-dependent utility. I also discuss potential implications for employment contracts in terms of a trade-off between ex post health and ex ante incentives for productivity.

The paper is here, and for the pointer I thank the excellent Kevin Lewis.

There is a new NBER Working Paper by Mark Duggan, Amanda Starc, and Boris Vabson, here is the abstract, with the bold emphasis added by me:

Governments contract with private firms to provide a wide range of services. While a large body of previous work has estimated the effects of that contracting, surprisingly little has investigated how those effects vary with the generosity of the contract. In this paper we examine this issue in the Medicare Advantage (MA) program, through which the federal government contracts with private insurers to coordinate and finance health care for more than 15 million Medicare recipients. To do this, we exploit a substantial policy-induced increase in MA reimbursement in metropolitan areas with a population of 250 thousand or more relative to MSAs just below this threshold. Our results demonstrate that the additional reimbursement leads more private firms to enter this market and to an increase in the share of Medicare recipients enrolled in MA plans. Our findings also reveal that only about one-fifth of the additional reimbursement is passed through to consumers in the form of better coverage. A somewhat larger share accrues to private insurers in the form of higher profits and we find suggestive evidence of a large impact on advertising expenditures. Our results have implications for a key feature of the Affordable Care Act that will reduce reimbursement to MA plans by $156 billion from 2013 to 2022.

There is an ungated version here (pdf).

Still Burned by the FDA

by on March 21, 2014 at 7:30 am in Economics, Law, Medicine | Permalink

Excellent piece in the Washington Post on the FDA and sunscreen:

…American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade.

That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.

…The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere.

If you want to understand how dysfunctional regulation has become ponder this sentence:

“This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation,”

Who said it? Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research! Or how about this:

Eleven months ago, in a hearing on Capitol Hill, FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”

If this is high priority what happens to all the “low priority” drugs and medical devices?

The whole piece in the Washington Post is very good, read it all. I first wrote about this issue last year.

Addendum: See FDAReview.org for more on the FDA regulatory process and its reform.

Sentences to ponder

by on March 19, 2014 at 12:01 pm in Data Source, Medicine, The Arts | Permalink

Artists grew up in households w/typically higher incomes than doctors did…

There is more information here, along with a picture, and the original story here.

Addendum:  Cowen and Tabarrok once wrote on this topic.

Crack cocaine estimate of the day

by on March 18, 2014 at 5:55 pm in Law, Medicine | Permalink

At present, no more than about 200 young people start using crack-cocaine each day. Ten years ago, the corresponding estimated daily rate was 1,000.

That is from this paper, via Kevin Lewis.

That is a new paper by Susan F. Lu & Huaxia Rui, here is the abstract:

Despite heated debate about the pros and cons of online physician ratings, very little systematic work examines the correlation between physicians’ online ratings and their actual medical performance. Using patients’ ratings of physicians at RateMDs website and the Florida Hospital Discharge data, we investigate whether online ratings reflect physicians’ medical skill by means of a two-stage model that takes into account patients’ ratings-based selection of cardiac surgeons. Estimation results suggest that five-star surgeons perform significantly better and are more likely to be selected by sicker patients than lower-rated surgeons. Our findings suggest that we can trust online physician reviews, at least of cardiac surgeons.

The pointer is from Andres Marroquin.