Singularity Health Law Blog

Digital Medicine - A LIFESAVER?

Robin Cook and Eric Topol had an interesting article in the Wall Street Journal today entitled “How Digital Medicine Will Soon Save Your Life.” They predict that digital medicine will arrive soon with “force of a hurricane. The promise of individualized “tailored” medicine’s advance with the prospect of cheap gene decoding, nanotechnology and smart phone’s playing the role of physician avatars, silently monitoring our body chemistry and organ functioning is certainly appealing and probably within the realm of near realization. They note the recent FDA approval of VISI, a device that monitors heart electricity, respiratory rate, blood oxygen, and blood pressure without a cuff and transmits the data to a medical office. They predict that the advent of digital medicine will democratize medicine permitting patients to own or control their medical data which they can transmit over the web. They see this as a shift away from the “medical - industrial complex.”

 

The authors see problems and unanticipated problems related to privacy, misuse of information and patients being overwhelmed by the information available to them. They suggest that the FDA will have to play a major role to ameliorate those issues. This is somewhat funny. The reality is that if the FDA plays a major role in this futuristic model it is far more likely to be the problem than the solution. It still clings to the 19th Century approach to approval of medicines that work for the majority, but not all of the public and to obstruct the access to drugs that work for a minority of patients, with appropriate molecular structures, but not for the majority.  To reach the great advances and lower costs that the author’s envision there will need to be a hurricane running through the FDA.

OVER THE COUNTER "DAY AFTER" DRUG: LOOSES TO UNDER THE COUNTER POLITICS.

Plan B One Step a controversial morning after drug that has been the subject of much litigation has been adjudged by the overwhelming majority of qualified reviewers at the FDA as being safe for women of all ages in an over the counter capacity. It is currently available OTC to women 18 years and older. Even that has been continually opposed by certain politicians who consider the drug an anti-abortion drug, which it is not. Access to the drug OTC has been obstructed in the past by interference by the Bush White House and Senior FDA officials.  In 2009, Hon.Edward R. Korman, a federal judge in New York, in the case of Tumino et al. v. Torti,  ordered the FDA to undertake a further review of providing access to women under 18 after finding a history of political interference with the FDAs findings. The FDA recently signaled its intent to offer OTC access to Plan B for all women, but today in steps Secty. of Health and Human Services, Katherine Sibilius to derail the plan claiming that more research is needed.

 

PARSING PARTS: COMPENSATION FOR BONE MARROW

Yesterday, a panel of the federal 9th Circuit Court of Appeals considered a challenge to the constitutionality of the National Organ Transplant Act (the “Act”) as it relates to restricting compensation to bone marrow cell donors whose cells are extracted through apherisis. The Act prohibits the compensation of donors of body organs including specifically, bone marrow, but permits compensation for blood, sperm,  and eggs. In Flynn et al v. Eric Holder, No. 10-55643 (9th Cir. 2011), the Plaintiffs, who included a variety of persons and entities adversely affected by the difficulty of obtaining donations of bone marrow, argued that there was no rational basis for distinguishing between the donation of blood plasma and the donation of hematopoietic stem cells which are excreted from the bone marrow itself into the blood stream in thus implicating the “equal protection clause” of the Constitution.

 

BRITS SAY MARGINAL LUPUS DRUG TOO EXPENSIVE.

Benlysta is a new Lupus drug developed by Human Genome Sciences and marketed by GaxoSmithKine.  It is the first new Lupus drug to come along in 50 years.  The others are aspirin approved in 1948 and Plaquenil, a malaria drug, and corticosteroids approved in 1955.  A United Kingdom regulator in Britain recommended that the health care system in Britain not pay for the drug because it is too expensive and marginally effective. The cost of the drug in the United States is about $35,000. per year.  In Britain, where big Pharma is a lot friendlier, it is about $15,600.

 

FDA TO REGULATE MINOR SUBSET OF SMARTPHONE MEDICAL DEVICE APPLICATIONS.

The FTC has dipped its toe in the water of smartphone and ipad technology by announcing that it intends to regulate a “narrow subset” of smartphone medical devices that meet the definition of a “device” under Section 201(h) of the FD&C Act, 21 U.S.C. 321.  In a recent news release it indicated that it intended to regulate those applications meeting the definition of device and 1) used as an accessory to an already regulated medical device or 2) that transforms a mobile platform into a regulated medical device. See 76 Fed. Reg. 43689. In its news release the FDA noted a study that indicated that 500 million smartphone users will be using health care applications in the near future. The FDA indicated that it intended to regulate those applications that create great risk when they do not work as intended. An example of a device that would be regulated is a smart phone that is converted to an ECG heart monitor.(i.e. Smartheart,  a self service heart monitor).

Regulatory Ricochet - a Peril of Multi-State Licensure For Physicians.

The rise of the internet, telemedicine and on-line communication technology have led to a greater federal government interest in improving the cost and quality of medicine by promoting the cost-effective patient access to consulting or even treating physicians across state lines. Earlier many states had loose regulations permitting limited consultation by in-state physicians with out of state physicians. With the proliferation of communications technology many, if not most, states have tightened up their vigilance and regulatory requirements for out of state physicians consulting on or treating patients located in the state. Most states have adopted standards to deal with and in varying degrees permit telemedicine. They provide various forms of limited licensure and of course require the payment of fees and the submission of the physician to the jurisdiction and authority of the state medical board which regulates and imposes discipline on the practice of medicine.

THE PROMISE AND PERIL OF EVIDENCE BASED CLINICAL STANDARDS.

 

A key component of the governments efforts to bend the cost curve for health care is the use of technology and new health delivery structures to introduce “evidence based” clinical standards for the treatment of patients.  Technology will be useful in determining the most clinical effective modalities of treatment and in monitoring the implementation of the guidelines across the spectrum of health car providers. It is an idea that on the surface makes a great deal of sense.  Providers should be held accountable to implement those methods of treatment that have shown themselves to be the most effective and cost efficient in the treatment of chronic disease disease syndromes.

 

THE END OF MEDICINE: How Silicon Valley (and Naked Mice) Will Reboot Your Doctor by Andy Kessler, Collins 2007.

    Andy Kessler is an irreverent, flip and highly readable writer who poses an interesting single question and than doggedly pursues an answer, with a lot of biting asides to entertain the reader. The question is, given the exponential decline in cost of technology in Silicon Valley and its exponential increase in power and effectiveness, why hasn’t medical technology turned over the same returns to deliver more effective health care at a cheaper cost. There are a number of reasons including the inherent slowness of the treatment and study process, the FDA, entrenched economic interests and the focus on treatment rather than prevention.

    

THE SINGULARITY IS NEAR: When Humans Transcend Biology. by Ray Kurzweil, Viking Press, 2005.

    Recent developments in brain scanning through technological refinements of SPECT, fMRI and PET scans that monitor water, blood and/or glucose movement in the human brain to observe actual brain functioning as opposed to structure are providing a wealth of new information concerning its organization, complexity and integration.  Ray Kurzweil believes that exponential improvements in the temporal, spatial resolution and bandwidth of the human brain which is doubling each year, will successfully enable us to reverse engineer the human brains principals of operation  in the first half of this century.  This will result in that he calls the “Singularity” where machine based intelligence surpasses that of all humans combined, creating a disruptive transformation in human capability.  This capability he believes will be a billion times more powerful that all of human intelligence today.

Within several decades information based technologies will encompass all human knowledge and proficiency, ultimately including the pattern recognition powers, problem solving skills, and emotional and moral intelligence of the brain itself.

NEW MEXICO BODY PARTS CAPER.

It came up “heads” when an employee at a medical waste disposal facility called Stericycle in Kansas noticed a partially burned head and torso at disposal site.  Stericycle normally disposes of dead tissue, but this was more like raisins in the oatmeal and he quickly perceived something was wrong.  Further investigation led to the discovery of 6 additional roughly severed heads and a number of torsos in a truck outside of the facility. Shades of Alistair Cook! Cook you will remember as the genial host of Masterpiece Theater on PBS whose body was dismembered and proliferated by a gang of New Jersey body snatchers a couple of years ago.