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.
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.
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.
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).
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.
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.
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.
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.
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.
How about a popular movie on market based health care reform? There is actually one out there although it hasn’t yet penetrated the cloud over the current health care debate, and surprisingly didn’t score well in the box office count over the weekend. On the first day after the House passage of the Obama Administration’e Health Care Reform Bill as approved by the Senate and following passage by the house of a bill to amend it, it might be interesting to review a future that is at least equally as bleak as the “Tea Party” people and their surrogates have been painting the likely affects of health care reform. The movie presents a society in which high pressure sales people use guilt, guile and outright fraud to coerce people to purchase very very expensive electronic organ replacement devices such as hearts, kidneys. livers, eyes, knees,, etc. (called “artiforgs” ) The artiforgs can provide an electronic read out to various patrolling repossession gleaners, the status of their credit accounts.
