Sclerotic Doctors Resist Change

(p. 177) Atherosclerosis, referring to a progressive and degenerative process of artery walls, is typically translated for a lay audience as “hardening of the arteries.” We’ve never needed a similar word to describe the medical community. It came with sclerosis built in. Of all the professions represented on the planet, perhaps none is more resistant to change than physicians. If there were ever a group defined by lacking plasticity, it would first apply to doctors.
(p. 178) The inherent “hardness” of physicians and the medical community suggests they will have a difficult time adapting to the digital world. Before the emergence of the Internet, physicians were high priests, holding all the knowledge and expertise, not to be challenged or questioned by the lowly consumer patient. “Doctor knows best” was the pervasive sentiment, shared by patients and especially physicians.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

AMA Resists the Democratization of DNA

The “Walgreens flap” mentioned below was the episode in 2010 when Walgreens announced that it would cell a genome testing saliva kit, but was pressured by government regulatory agencies, and withdrew the kit from the market within two days of the announcement.

(p. 119) . . . there will likely never be a “right time”—after we have passed some imaginary tipping point giving us critical, highly actionable, and perfectly accurate information—for it to be available to the public. The logical conclusion is that the tests should be made available. What’s more, the fact that they have been available has meant that democratization of DNA is real. Consumers now realize that they have the right to obtain data on their DNA. As a blogger wrote in response to the Walgreens flap, “To say that this information has to be routed through your doctor is a little like the Middle Ages, when only priests were allowed (or able) to read the Bible. Gutenberg came along with the printing press even though few people were able to read. This triggered a literacy/literature spiral that had incredible benefits for civilization, even if it reduced the power of the priestly class.”

The American Medical Association (AMA) sees things differently. In a pointed letter to the FDA in 2011, the AMA wrote: “We urge the Panel … that genetic testing, except under the most limited circumstances, should carried out under the personal supervision of a qualified health professional.” The FDA has indicated it is likely to accept the AMA recommendations, which will clearly limit consumer direct access to their DNA information. But this arrangement ultimately appears untenable, and eventually there will need to be full democratization of DNA for medicine to (p. 120) be transformed. Of course, health professionals can be consulted as needed, but it is the individual who should have the decision authority and capacity to drive the process.
The physician and entrepreneur Hugh Rienhoff, who has spent years attempting to decipher his daughter’s unexplained cardiovascular genetic defect and formed the online community MyDaughtersDNA.org, had this to say: “Doctors are not going to drive genetics into clinical practice. It’s going to be consumers …. The user interface, whether software or whatever will be embraced first by consumers, so it has to be pitched at that level, and that’s about the level doctors are at. Cardiologists do not know dog shit about genetics.”

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.
(Note: first ellipsis added; other ellipses in original.)

Personal Genomics Startups Struggle Under a “Circus” of Government Regulation

(p. 118) Government regulation of consumer genomics companies has been centerpiece (and the semblance of a circus) in their short history. Back in 2008, the states of California and New York sent “cease and desist” letters to the genome scan companies. State officials were concerned that the laboratories that generated the results were not certified as CLIA (Clinical Laboratory Improvement Amendments) and that the tests were being performed without a physician’s order. All three companies developed work-around plans in California and remained operational but were unable to market the tests in New York.
In 2010, the regulation issues escalated to the federal level. In May it was announced that 7,500 Walgreens drugstores throughout the United States would soon sell Pathway Genomics’s saliva kit for disease susceptibility and pharmacogenomics. While the tests produced by all four companies had been widely available via the Internet for three years, the announcement of wide-scale availability in drugstores (which was cancelled by Walgreens within two days) appeared to “cross the line” and set off a cascade of investigations and hearings by the FDA, the Government Accountability Office (GAO), and the Congressional House Committee on Energy and Commerce. The FDA’s Alberto Gutierrez said, “We don’t think physi-(p. 119)cians are going to be able to interpret the results,” and “genetic tests are medical devices and must be regulated.” The GAO undertook a “sting” operation with its staff posing as consumers who bought genetic tests and detailed significant inconsistencies, misleading test results, and deceptive marketing practices in its report.
All four personal genomics companies are struggling.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

“The Resistance from the Priesthood of Medicine Is at Its Height”

(p. 77) In December 2010 in Milwaukee, Wisconsin, Nicholas Volker, a five-year-old boy with a gastrointestinal condition that had not previously been seen, who had undergone over a hundred surgical operations and was almost constantly hospitalized and intermittently septic, was virtually on death’s door. But when his DNA sequence was determined, his doctors found the culprit mutation. That discovery led to the proper treatment, and now Nicholas is healthy and thriving. Even though this was only the first clearly documented case of the life-saving power of human genomics in medicine, (p. 78) few could now deny that the field was going to have a vital role in the future of medicine. Some would argue that the treatment led to an even bigger breakthrough: health insurance coverage of sequencing costs for select cases.
It took the better part of a decade from the completion of the first draft of the Human Genome Project for genomics to reach the clinic in such a dramatic way. To make treatment like Volker’s common will likely take more time still. Even if that’s the ultimate prize, the creative destruction of medicine still has various other, less comprehensive, genomic tools for us to use, based on investigations of things like single-nucleotide polymorphisms, the exome, and more. The material can be a bit heady, but it’s worth pushing through: these tools could effect not just dramatic corrections of faulty genes but a better, more scientific understanding of disease susceptibility and what drugs to take. Moreover, as they empower patients and democratize medicine, they make medical knowledge available to all and deep knowledge of ourselves available to each of us. Nevertheless, at this level, perhaps more than anywhere else in this ongoing medical revolution, the resistance from the priesthood of medicine is at its height. The fight might be tougher than the material, but in neither case can we afford to give up.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

Health Inefficiencies Free-Ride on “Home Run Innovations”

The article quoted below is a useful antidote to those economists who sometimes seem to argue that health gains fully justify the rise in health costs.

(p. 645) In the United States, health care technology has contributed to rising survival rates, yet health care spending relative to GDP has also grown more rapidly than in any other country. We develop a model of patient demand and supplier behavior to explain these parallel trends in technology growth and cost growth. We show that health care productivity depends on the heterogeneity of treatment effects across patients, the shape of the health production function, and the cost structure of procedures such as MRIs with high fixed costs and low marginal costs. The model implies a typology of medical technology productivity: (I) highly cost-effective “home run” innovations with little chance of overuse, such as anti-retroviral therapy for HIV, (II) treatments highly effective for some but not for all (e.g., stents), and (III) “gray area” treatments with uncertain clinical value such as ICU days among chronically ill patients. Not surprisingly, countries adopting Category I and effective Category II treatments gain the greatest health improvements, while countries adopting ineffective Category II and Category III treatments experience the most rapid cost growth. Ultimately, economic and political resistance in the United States to ever-rising tax rates will likely slow cost growth, with uncertain effects on technology growth.

Source of abstract:
Chandra, Amitabh, and Jonathan Skinner. “Technology Growth and Expenditure Growth in Health Care.” Journal of Economic Literature 50, no. 3 (Sept. 2012): 645-80.

When Bibliometrics Are a Matter of Life and Death

(p. 51) . . . it is essential, if at all possible, to have a go-to physician expert and authority when one has a newly diagnosed, serious condition, such as a brain or, neurologic conditions like multiple sclerosis and Parkinson’s disease, heart valve abnormality. How do you find that individual doctor?
In order to leverage the Internet and gain access to state-of-the-art expertise, you need to identify the physician who conducts the leading research in the field. Let’s pick pancreatic cancer as an example of a serious condition that often proves to be rapidly fatal. The first step is to go to Google Scholar and find the top-cited articles for that condition by typing in “pancreatic cancer.” They are generally listed in order by descending number of citations. Look for the senior, last author of the articles. The last author of the top-listed paper in the Journal of Clinical Oncology from 1997 is Daniel D. Von Hoff, with over 2,000 citations (“cited by … ” appears at the end of each hit). Now you may have identified an expert. Enter “Daniel Von Hoff” into PubMed (www.ncbi.nlm.nih.gov/sites/pubmed) to see how many papers he has published: 567. Most are related to pancreatic cancer or cancer research.
(p. 52) Now go back to Google Scholar and enter his name, and you’ll see over 24,000 hits–this number includes papers that cite his work. There are some problems with these websites, since getting citations by other peer-reviewed publications takes time; if a breakthrough paper is published, it will be years to accumulate hundreds, if not thousands, of citations. Thus, the lag time or incubation phase of citations may result in missing a rising star. If it is a common name, there may be admixture of citations of different researchers with the same name, albeit different topics, so it is useful to enter in all elements including the middle initial and to scan the topic list to alleviate that problem. For perspective, a paper that has been cited 1,000 times by others is rare and would be considered a classic. In this example, the top paper by Von Hoff in 1997 is a long time ago, and he is no longer at the University of Texas, San Antonio-he moved to Phoenix, Arizona. How would you find that out? Look for Daniel D. Von Hoff using a search engine such as Google or Bing, and look up his profile on Wikipedia. Without any help from any doctor, you will have found the country’s leading authority on pancreatic cancer. And you will have also identified some backups at Johns Hopkins using the same methodology.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.
(Note: initial ellipsis added; parenthetical ellipsis in original.)

FDA and ACS Wrongly Endorsed Sunscreen with Retinyl Palmitate

Some consumers let their guard down on medical issues, assuming that the government Food and Drug Administration (FDA), and large incumbent bureaucratic non-profits, like the American Cancer Society (ACS), will protect them—it ain’t necessarily so. Caveat emptor should remain the rule for consumers.

(p. 39) Of note, one of the reasons for the lack of updating the rules and acknowledging UVA rays has been heavy pressure from sunscreen manufacturers, which include Johnson and Johnson (Neutrogena), Merck-Schering Plough (Coppertone), Proctor and Gamble (Olay), and L’Oreal. Interestingly, in Europe products that provide solid UVA protection have been available for years. The concerns run even deeper because many of the products (41 percent in the United States) contain a form of vitamin A known as retinyl palmitate, which has been associated with increased likelihood of skin cancer. There are, however, no randomized studies, but biological plausibility and the observational findings of a rising incidence of basal cell (p. 40) carcinoma and melanoma, despite the widespread use of sunscreens. In mid-2011, the FDA finally unveiled some new rules about sunscreen claims.

This issue really hit home when my wife brought out a tube of Neutrogena Ultra Sheer Dry-Tough SPF 30 Sunblock. It claims “Broad Spectrum UVNUVB Protection” despite repeatedly failing UVA tests. But the real eye-opener is to find the American Cancer Society logo on the front of the tube with the message “Help Block Out Skin Cancer.” Now what is the American Cancer Society logo doing on the tube of Neutrogena? The fine print on the bottom reads: “The American Cancer Society (ACS) and Neutrogena, working together to help prevent skin cancer, support the use of sunscreen. The ACS does not endorse any specific product. Neutrogena pays a royalty to the ACS for the use of its logo.”

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

The Kairos of Creative Destruction in Medicine

Wikipedia tells us that “Kairos” “is an ancient Greek word meaning the right or opportune moment (the supreme moment).”

(p. x) With a medical profession that is particularly incapable of making a transition to practicing individualized medicine, despite a new array of powerful tools, isn’t it time for consumers to drive this capability? The median of human beings is not the message. The revolution in technology that is based on the primacy of individuals mandates a revolution by consumers in order for new medicine to take hold.

Now you’ve probably thought “creative destruction” is a pretty harsh term to apply to medicine. But we desperately need medicine to he Schumpetered, to be radically transformed. We need the digital world to invade (p. xi) the medical cocoon and to exploit the newfound and exciting technological capabilities of digitizing human beings. Some will consider this to be a unique, opportune moment in medicine, a veritable once-in-a-lifetime Kairos.
This book is intended to arm consumers to move us forward.

Source:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.
(Note: italics in original.)

Instead of Fixing “Inadequate Schools,” Adderall Is Prescribed to “Struggling” Students

RocafortAmandaAndSonQuintn2012-10-12.jpg “Amanda Rocafort and her son Quintn in Woodstock, Ga. Quintn takes the medication Risperdal.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A1) CANTON, Ga. — When Dr. Michael Anderson hears about his low-income patients struggling in elementary school, he usually gives them a taste of some powerful medicine: Adderall.

The pills boost focus and impulse control in children with attention deficit hyperactivity disorder. Although A.D.H.D is the diagnosis Dr. Anderson makes, he calls the disorder “made up” and “an excuse” to prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.

For the full story, see:
ALAN SCHWARZ. “Attention Disorder or Not, Pills to Help in School.” The New York Times (Tues., October 9, 2012): A1 & A18.

Openness to Creative Destruction Will Speed Health Care Progress

CreativeDestructionOfMedicineBK2012-10-11.jpg

Source of book image: http://si.wsj.net/public/resources/images/OB-RQ412_bkrvme_DV_20120202132402.jpg

Eric Topol has bucked the medical establishment before. In entries on August 20, 2006 and on December 26, 2006 on this blog, he was quoted as arguing that stents were being overused. Now he argues that the medical establishment is slowing progress that could reduce disability and extend life. He advocates the sequencing of each of our genomes and a medical revolution that will fine-tune treatment to our genomic differences.
Many agree with Topol’s view of the future of medicine, but many medical schools are neglecting teaching future doctors about the therapeutic implications of individual genomics.
Topol calls for the creative destruction of medical education and other medical institutions.
The early part of the book is weak because it discusses subjects on which Topol is not an expert—such as the history and applications of information technology. In these sections, he too often tediously explains the obvious and widely known. Sometimes in this section of the book, he is just wrong, as when (p. 14) he claims that Werner Sombart originated “creative destruction.”
After the early chapters the book comes into its own when Topol discusses medical advances and challenges. While his early prose may be aimed too low, his later prose may be aimed too high—but it is better to be talked up to than down to, and the best of the later chapters contain some fascinating descriptions of what is happening on the frontiers of medicine, and what could be happening if we change policies and institutions to make medicine more open to creative destruction.
In the following few weeks, I will be quoting several of the more important or thought-provoking passages.

Book discussed:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.