Holland & Hart Healthcare Law Blog

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 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. 

Stem Cell Research on Again, Time to Celebrate [Guest Editorial]

Among many other things that the Obama administration addresses --one of the most important far reaching actions in my opinion is the go-ahead to stem cell research. This was important scientific research that can help prevent diseases and in the development of better medicine to give a second chance at life to millions of human beings alive today.

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.

Evil In Contamination of Food and Medicine.

It is hard not to applaud the Chinese for their decision to execute officials for the contamination of milk sold domestically and abroad, even for those generally opposed to the death penalty. Unfortunately, the Chinese may have been motivated more by the impact of the unfavorable publicity than real concern about the larger moral evil lurking like a cancer in the cells of commerce. Two articles appearing in the New York Times today underscore the metastasis of that evil in the world community. One story involves Nigeria and the other the United States.

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.

FDA Review to “Pre-Empt” State Pharmaceutical Litigation?

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

PUBLIC CITIZEN SUES FDA TO "BLACK BOX" FLUROQUINOLONES.

In August, 2006 Public Citizen Health Research Group petitioned the FDA to require pharmaceutical companies to place "black box" warnings on their fluroquinolone antibiotics such as Levaquin, Cipro, Tequin, Norflexacin and others advising patients and physicians of high degree of danger to tendons, particularly of the potential of the rupture of the "Achilles" tendon. Public Citizen also requested the FDA to send "Dear Doctor" letters to physicians providing them with individualized warnings. Public Citizen reports that although there are current warnings about tendon damage from the use of the drug they are buried among a plethora of lesser potential reactions.

Ketek Attack At FDA.

In the April 19, 2007 edition of The New England Journal of Medicine, David B. Ross, M.D., Ph.D.,, a clinical assistant professor at George Washington University School of Medicine and Health Sciences took the FDA to task for its approval of Ketek, a ketolide antibiotic manufactured by Sanofi-Adventis, for use in respiratory tract infections.  The drug underwent three rounds of review by the FDA and followed an unusual structure of review and approval that may suggest outside interference in the process.

Will Drug Coated Stents Become The Next Vioxx?

This coming Thursday in Washington, D.C. the Federal Food and Drug Administration Center for Devices and Radiological Health will commence two days of hearings on the use of medicated stents to control arterial cardiovascular disease.  Drug coated stents first appeared in this country in 2003 in response to clotting problems that appeared from scar tissue forming around bare metal stents then widely in use.  The idea behind the use of stents is to provide a safe tube in the arteries that prevent their collapse or obstruction by cardiovascular disease, sort of like the "big dig" tunnel in Boston. Well, perhaps not exactly like that - they had problems there too didn't they.  The CDRH hearings are taking on the hype and pregame speculation of the Michigan-Ohio State Game.  '(Did Bo have a stent?) Some commentators are suggesting that their are legions of plaintiff tort lawyers lined up and ready to spring into action to represent the survivors of the roughly 2000 patients a year who expire from stent complications, not to mention the millions of patients with stents walking around with their miniature "time bombs" waiting for them to explode.