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.

MANDELA: ARTIFACTS FROM 8115 VILAKAZI ST.

To my sorrow I never met Nelson Mandela, but in a visit to his modest home on Vilakazi Street in Soweto in the 1990s there were a number of artifacts remaining that voiced much about the man.  The one bedroom brick home was small with a brick wall between the kitchen in the rear and the living room in the front.  The living room was a dangerous place. One can still see the ridge of higher ground blocks away where state security service officers regularly fired high power rifles into their living room. (The outside bricks are still chipped from target practice.) The Mandelas were forced to sleep on the kitchen floor in the back of the house in order to assure that they would wake up in the morning.

 

JUSTICE ROBERTS AND A BRIDGE TOO FAR

In holding with the minority liberal wing of the court that the Affordable Care Act is constitutional as a tax, Justice Roberts seems to have concluded that the wholesale sinking of the Act by the Supreme Court was “a bridge too far” for the conservative majority which stopped the vote recount in Florida before it was completed, effectively anointing George W. Bush President of the United States on legal grounds not used before or since. That of course brought us 2 middle east wars on a credit card that we are just beginning to pay and the worst financial crash since the Great Depression.

 

Comment on "Eight Reforms To Medical Peer Review Post."

Until my retirement three years ago I was Associate Director for Research and Disputes for HRSA's National Practitioner Data Bank.  For over 10 years I read every Secretarial Review request, assigned every case to staff reviewers, and approved every decision before forwarding it for final approval and signature by the Director.  In other words, I have great familiarity with this matter. 

Before turning to the eight suggestions, I must take issue with the implication that a report to the NPDB can destroy a career.  It is the underlying actions that hurt careers, not reports to the Data Bank.  Applications for licensure, privileges, etc., require physicians to disclose more than is required to be reported to the Data Bank.  For example, the Data Bank does not require reporting of pending cases; applications do.  Honest physicians have nothing to fear from Data Bank reports; they have to disclose the same information regardless of the Data Bank.

It also should be noted that there are thousands of physicians with multiple reports in the Data Bank who continue to practice and, often, to have even more actions taken against them and reported.  If the Data Bank ended careers, physicians would not continue to have action after action taken against them.

THE PROBLEM WITH PEER REVIEW.

Peer review is the process of evaluation of individual professional performance, by qualified peers as part of a system to maintain standards and improve performance within the profession. If misused, peer review can be a powerful weapon to constrain competitors, to eviscerate political rivals and to energize personal egos through the diminishment of other professionals. In medicine, under the shelter of near absolute immunity provided by the Health Care Quality Improvement Act of 1980 (“HCQIA”) and state peer review counterparts, the system of review and accountability as enacted by the legislatures and reviewed by the courts assumes a level of good faith and fair treatment by professionals of one’s colleagues. Like any system with a concentration of unaccountable power to destroy the professional reputation and livelihood of one’s colleagues, there are bound to be abuses.

 

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.

 

SANTORUM DISPUTES STUDENT ON NO INSURANCE COVERAGE MORTALITY

In a small upstate Christian School, Droat College, in Northwestern Iowa, presidential candidate challenged a student’s concern about a December 2009 Harvard University Study appearing in the American Journal of Public Health, that suggested that 45,000 Americans died each year as a result of a lack of insurance coverage. 

"With all due respect Sen. Santorum, I don't think God appreciates the fact that we have 50-100 thousand uninsured Americans dying due to a lack of healthcare every year," said Ryan Walters

 

"SNOW" BACHMANN AND THE SEVEN FOOT DOCTORS.

It was to say the least startling to watch the Utube video of Rep. Michele Bachmann holding forth in another otherworldly tirade against “Obamacare” in Webster City, Iowa. It was even more scary to see the audience sitting their calmly, politely and acceptingly as if “chewing the cud” while her fantasies poured fourth.  This is no joke. She told her audience that a seven foot plus doctor told her that he waited on the phone for 2 hours and 15 minutes with the IRS awaiting for approvals of care for “a little lady in my office,” while patients stacked up in his waiting room.

 

HEALTH MANDATE, RON PAUL AND THE COLLAPSE OF COMMUNITY VALUES.

The Republican Candidate’s debate last week with all of the emphasis on who is and will be the darling of the Tea Party graphically underscored the American value creep of the past four decades away from what used to be community responsibility. Rep. Paul, a physician, continues to rail against the “individual mandate” in the Health Reform legislation enacted by Congress and signed by Mr. Obama in 2009.  He views it as a slap in the face of individual rights, because it curtails personal freedom by removing the personal freedom to choose to remain uninsured, whatever the consequences.  Moderator, Wolf Blitzer, posed the question to him that if a healthy 30 year old chose not to obtain insurance but was suddenly confronted with an unexpected need for medical assistance, should be be denied treatment?  

 

PERSONAL ELECTRONIC MEDICAL RECORDS ESSENTIAL

Dying is a messy business.  Having watched my father endure the process involving three hospitals and a SNF in the final month, I have been impressed with the primitive nature of medical record keeping today even in the most efficient and effective of medical institutions.  My father had a long history of problems with bleeding ulcers resulting in extreme surgery to remove most of his stomach.  Lately he had been under the care of an HMO with a Medicare plan. There was no central depository of his medical records.  One of the facilities, the Henry Ford Hospital in Detroit, sought valiantly to locate all of his recent records, but limited staff in other facilities resulted in significant delays in obtaining vital information.