Holland & Hart Healthcare Law Blog

INTERNET MEDICINE: PART VII – PUBLIC, PROPRIETARY AND PRIVACY TENSIONS IN MEDICAL DEVICES.

The front page of the New York Times today carried a story by Pam Belluck on a hospital’s promotional webcast of Shila Renee Mullins’s brain surgery to extract a malignant tumor, which raised conflicting opinion is about the wisdom, benefit and ethics of the public dissemination of personal medical information, even if consensual, and the public access to dramatic interventional medical procedures. Some hospitals are featuring twittering during operations in order to apprise relatives and others of the progress of thee procedure in real time.

INTERNET MEDICINE: PART VI –CHALLENGES TO DATA SECURITY IN INTERNET MEDICAL DEVICE INFORMATION LINKS.

The growing interoperability between medical devices and electronic medical records gives rise to new opportunities in the transmittal and collection of vital medical data. New vulnerabilities arise as well. Last month, the Internet Storm Center sponsored by SANS (SysAdmin, Audit, Network, Security Institute) warned that the Conflicker worm had infected approximately ten million internet devices including MRIs. SANS is a cooperative research and education organization that since 1989 has specialized in information security technology training and awareness.

The Conflicker worm attacks holes in Windows OS with advanced malware techniques. It is the largest worm infection since the SQL Slammer worm. Many of the infected devices were not designed for internet connectivity. The efficacy of the infection repair is complicated by a FDA regulation which limits the ability to issue an internet “patch” for 90 days, and apparent triumph of law over common sense in crisis with a unique and unanticipated need.

Internet Medicine Part IV: “Health 2.0.”

“Health 2.0” or “Medicare 2.0” relates to a new paradigm in the relationship between patients and physicians, in particular the application of Web 2.0 interconnectivity tools or social media technology to the provision of health care.  One of the ironies of this movement is the emphasis on sharing rather than protecting or hiding health care information.  The www.patientslikeme.com  website sponsors  patients as partners with their physicians in assembling and sharing information related to specific diseases.  Patientslikeme assembles and aggregates patient information related to 5 chronic illness categories: Amyotrophic Lateral Sclerosis (ALS); Parkinson’s Disease, HIV/AIDS, Multiple Sclerosis and Mood Disorders.  Participants share treatment experiences, drug side effects, new treatment regimens and even organize and participate in their own clinical trials. 

BOOK REVIEW: Ray Kurzweil and Terry Grossman, M.D., FANTASTIC VOYAGE: LIVE LONG ENOUGH TO LIVE FOREVER, Rodale 2004.

Aubrey de Grey, the British biomedical gerontologist who recently appeared on 60 Minutes and gave a lecture on “Why We Age and How We Can Avoid It” on TED is convinced that we now have the resources to repair metabolically damaged tissue so as to be able to live for 1000 years.  He believes that it is possible for a 50 year old to “pull out of the dive” of aging based on current and immediately anticipated technology.

INTERNET MEDICINE PART II: PHYSICIAN CHAT ROOMS

One of the growing phenomena related to the practice of medicine and the internet is the introduction of physician chat rooms in real time on the web. In new forums like Sermo, approximately 90.000 physicians can currently log on line and discuss clinical issues in real time and obtain broad based input and support and advice from other physicians with respect to clinical issues. This is a form of social networking for physicians. Among the potential benefits of the forum is the ability to compare notes and to alert others to sudden distortions in the health of local populations due to flu or other causes, and the sharing of what works and doesn’t work in clinical practice. 

"Socially Assistive" Robots: New Care Givers?

On March 10, the Washington Post ran a stimulating piece by Anita Slomski “I’m here to Make You Feel Better,”  about the development of interactive robots that have the potential to assist in the care of patients afflicted with autism, stroke, dementia, Alzheimer’s and other conditions that require a caretaker or a companion. Ms. Slomski’s article appeared earlier under the title of the “Sociable Robot” in the Winter, 2009 edition of Proto, a publication of Massachusetts General Hospital. Ms Slomski underscores that people become attached to robotic personalities. Consider the people who worry that when they send in their Roombas, a robotic vacuum cleaner, in for repair, they might not get their original back.  They have become attached to a particular vacuum personality. I for one have tried to disassociate myself from our vacuum cleaner for just that reason. Helps maintain the old objectivity you know.

Clink Awaits Record Shirking Shrink.

Maria Carmen Palazzo, M.D., PhD., MMM, will soon have some numbers to add to the letters behind her name as she likely will find herself behind bars for Medicare Fraud and for criminal failure as a clinical investigator to maintain records of clinical drug studies.  The New Orleans psychiatrist contracted with SmithKline Beecham to participate in clinical drug studies related the safety of Paxil in the treatment of children and adolescents with major depressive disorders and obsessive compulsive disorders. She failed to comply with the study protocols and failed to personally review all of the information in the patient charts. She apparently accepted about $5000.00 per study, for some patients at least who were never diagnosed with the conditions.

Pfizer's "Double Blind" Bextra Bind -The Value of Clinical Data

Shortly before Christmas a Santa Clara County, California jury entered a $38 Million Dollar Judgment Against Pfizer, Inc. for allegedly stealing clinical data from the Ischemia Research and Education Foundation ("IREF"), concerning its acute arthritic pain drug, Bextra. Pfizer pulled Bextra from the market in 2005, followig concerns about its safety for heart patients. Not long ago Pfizer entered into a $900,000,000.00 product liability settlement for Bextra and for Cerebrex, both Cox 2 inhibitor drugs that raised safety concerns. IREF filed its suit in 2004, claiming that Pfizer obtained access to the clinical data developed by IREF after its negotiations with IREF collapsed through the device of a contract with an IREF employee and statistican, Ping Hsu. IREF is a non-profit research organization founded by Dr. Dennis Mangano, PhD, M.D., in 1987.IREF has developed a substantial data base of clinical information through the cooperation and participation of over 300 research centers around the world in the twenty plus years of its existence. There was apparently some evidence presented to the jury that Pfizer and Mr. Hsu destroyed or otherwise attemped a coverup of the use of the IREF information. Pfizer asserts that it has been unjustly caught up in the dispute between Mr. Hsu and IREF and denies any theft of the IREF information. It will likely appeal.

California Nixes Medical Discrimination By Religous Doctors.

The California Supreme Court has ruled that physicians may not discriminate and withhold  non-emergency medical care based upon their religious beliefs in violation of the California Unruh Civil Rights Act, which prohibits discrimination by businesses based on sexual orientation.  In North Coast Women's Care Medical Group, Inc. et al. v. San Diego Superior Court, a lesbian, Guadalupe T. Benitez brought suit against the physician group and two individual doctors for refusing to provide intrauterine insemination using unfrozen semen from a friend to assist her obtaining pregnancy. This is a medical procedure in which a physician threads a catheter through a patient's cervix and inserts semen through the catheter into the patient's cervix. One of the physicians claims that her religious belief's in question have more to do with the patient being unmarried than a lesbian, but that is disputed by the plaintiff.

Supreme Court Pre-empts State Medical Device Litigation.

.  The U.S. Supreme Court issued its long awaited opinion in Riegel v. Medtronic, Inc. ____U.S.___  (2008) as to whether the Medical Device Amendments of 1976 passed by Congress to provide federal oversight for medical devices pre-empted state product liability tort actions. It does. The Plaintiff, Charles Riegel suffered a myocardial infarction in 1996 and underwent a coronary angioplasty. His right coronary artery was diffusely diseased and heavily calcified. When his physician inserted the Evergreen Balloon Catheter into the artery it ruptured and Riegel developed a heart block requiring emergency coronary bypass surgery.  The use of the catheter was contraindicated for the artery according to label warnings and the catheter was over inflated during installation.