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.

Peter W. Huber. The Cure in the Code.

Book Review: Peter W. Huber. The Cure in the Code: How 20th Century Law is undermining 21st Century Medicine.Basic Books (Nov. 2013).

Mr. Huber provides an intense guide to the exploding scientific developments in molecular medicine and the legal and regulatory impediments that threaten to cripple its promise of cheaper and more effective medicine through individualized treatment applications. Modern molecular and genomic advances in medicine, coupled with the exponential increases in computing power and attendant increase in algorithmic data analysis capability opens up the potential for great leaps in medical knowledge and treatment effectiveness.

Standing in the way, however, is the federal Food and Drug Administration with an antiquated system of approvals for new developments in medicine. Mr. Huber argues that the gold standard for FDA approval, the double blind based studies of broad effectiveness against a placebo, are too expensive, too time consuming, too unethical and too narrow. They are too narrow in the sense that they are too broad, requiring a demonstration of effectiveness in a large population, dealing with a specific medical issue, without focusing on the drugs applicability to specific molecular potential in individual cases.

The author refers to this as the “old magic bullet” model, with a single simple cause directly linked to a single effect. He asserts,

 

[A] high level of complex and statistically elusive biochemical diversity likewise makes it impossible to judge a drug’s efficacy or most of its potential side effects using a conventional, one dimensional statistical analysis of data in biochemically indiscriminate Trials.

 

Mr. Huber notes that the FDA relaxed the reins somewhat in dealing with the multi-virus issues inherent in HIV treatment, speeding drugs to market like AZT and the creation of “drug cocktails” for attacking the virus, when one drug alone was insufficient.  Since then, the FDA has retreated to a more regressive pattern of focus on testing large scale applications of individual drugs to broad populations rather than providing support for wider experimentation by doctors and patients based upon biomarkers and molecular diversity to generate the type of success and failure information that can provide meaningful advances in medical knowledge. The answer he suggests requires a radical reorientation of the FDA, with the focus of Baysean statistical analysis on a broad range of evidence.

 

ON LINE PRODUCTS HELP OFFENDERS PASS DRUG AND ALCOHOL TESTS.

Late last month in St. Charles, Missouri, a 34 year old man named Sydney Levin, on probation for illegal substance possession and felony stealing, was discovered using a prosthetic product known as the Whizzinator to pass synthetic medical grade urine in lieu of his own. He was charged with possessing a “forging instrument” and released on a $25,000. bond. The Whizzinator contains an artificial penis connected to a 4 oz. bag to contain the synthetic urine.  There are heating elements in the apparatus that elevate the temperature to human body levels.  The device comes in three colors, white, black and brown. The product is advertised at $149.95 plus shipping and handling. Rapid Clean Clean Pee is advertised at $15.95 a pack.

WHEN WILL COMPUTERS THINK?

The Obama Administration recently announced the formation of the “Brain Activity Map Project” to be funded by the National Institutes of Health and other public and private foundations and organizations to undertake a ten year study of the human brain. The effort, which is similar to the organized effort to map the human genome is expected to cost at least 300 million dollars a year over the ten years. It is anticipated by scientists that it will be much for complex and difficult to undertake than the genome project. The hope is to develop a complete model of brain activity and the process of neuron firings that lead to cognition.

 

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.

 

PREGNANT DRIVER TASER CASE ZAPPED.

The full eleven judge panel of the 9th Circuit Court of Appeals reversed a 2 to 1 decision of an earlier panel of the Court which found claims against police officers for excessive use of force subject to immunity defenses.  Malaika Brooks, then obviously 7 months pregnant, was stopped by police in Seattle for traveling 32 MPH in a 20 MPH zone and issued a ticket. They demanded she sign for the ticket and she refused saying she never had to sign for tickets before and apparently thought she was being asked to plead guilty. She stiffened in the car and grabbed the steering wheel when officers tried to arrest her.  They tasered her several times in the leg. In Maui, Jayzel Matos tried to defuse an altercation between her drunk husband and police was dropped by a taser with “dart mode” which produces a more severe shock than the “touch mode” used on Ms. Brooks.

OBAMA BLUE BUTTON INITIATIVE PUSHES PHR DOWNLOAD PROGRAMS

 Recognizing the critical health care need for accurate historic  patient health records, the Obama administration has developed what it calls a “Blue Button” download initiative at the Department of Veteran Affairs, CMS and HHS. These are all programs that permit patients to go on-line and download their own medical records that they can share with their providers, caregivers and trusted others.  Some of these programs are now operational.  In the lead is the VA ( www.myhealth.va.gov ) where approximately 60,000 veterans have already accessed their records.  Medicare recipients can also access their records now at www.mymedicare.gov . Only about 5,600 have done so. There are about 47 million medicare recipients and 1 million veterans.

STANFORD HIPAA BLUES.

Are business associate contracts enough protection against a vendor’s negligence with respect to the public disclosure of patient medical information?  Stanford Hospital in Palo Alto is about to find out. One of its vendors, Multi Speciality Collection Services, LLC apparently posted the names and diagnosis codes of approximately 20,000 patients seen in the hospital’s emergency room in a six month period in 2009. One of the patient’s found his or her name on line in August of 2011.  It had been posted along with the others since September 9, 2010 on an on-line site called Student of Fortune.

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).

INSTITUTE OF MEDICINE JOLTS FDA BY RECOMMENDING IT SCRAP 510(K) APPROVAL PROCESS.

In 2009 the FDA requested the Institute of Medicine (“IOM”), a part of the National Academy of Sciences, to undertake a study of its 510(k) approval process to determine its effectiveness and to make recommendations to improve and strengthen it.  It hardly imagined that the recommendation out last week would be to dump it altogether. The 510(k) clearance process for moderate risk devices such as hip replacement devices, external heart defibrillators and hospital based pumping devices provides an easier road for medical device manufacturer’s to obtain regulatory approval of new technological advances in medical devices without going through the more cumbersome, comprehensive and expensive PMA or premarket approval process required for higher risk products.