Holland & Hart Healthcare Law Blog

OKLAHOMA FEDERAL JUDGE AUTHORIZES SUBSTITUTE USE OF NEMBUTOL TO AID IN EXECUTIONS.

 

There has been a shortage of thiopetal sodium recently, the anesthetic of choice in executions by lethal injections, which has temporarily halted executions in a number of jurisdictions that unlike, Texas,  have not stocked up on the drug. The manufacturer of the drug Hospira, Inc. of Illinois has indicated that it has had manufacturing issues with the drug and replacement supplies would not be available until early 2011.  Hospira, which markets its drugs, under the tag line of “Advancing Wellness” has indicated that it does not favor the “off-label” use of its drug in state sponsored executions. Death penalty opponents have been objecting to the substitution of other drugs because of the potential for pain and suffering by the prisoner in potential violation of the Eighth Amendment prohibition against cruel and unusual punishment.

 

Physician Rebates on Pharmaceuticals Inducements or Volume Discounts?

 

    Can physicians be swayed in the prescription of drugs by volume purchase discounts that return substantial rebates to them on highly expensive drugs?  In an article in the New York Times this week, (Pollock, “Secret Rebates Offered on Costly Eye Drug, November 3, 2010”) a Times Reporter explored the practice of pharmaceutical companies providing “rebates” to physicians who purchase and use the drugs they sell on their patients.  Oncologists have long engaged in the purchase and resale of toxic agents used in the treatment of cancer. Recently  opthamologists have been provided the opportunity as well. Genetech’s Lucentis is a case in point.

 

PHYSICIAN FINGERED IN INSIDER TRADING FRAUD

 

Police arrested Dr. Yves M. Benhamou,  a French physician,  in Boston recently, charging him with leaking information to Front Point Partners a hedge fund owned by the investment bank, Morgan Stanley.  Benhamou, one of five physician overseeing a clinical trial of the drug Allbuferon developed by Human Genome Sciences, Inc. for the treatment of Hepatitis C. He  is alleged to have tipped off Front Point that there were problems involving the death of several patients in the trial.  Dr. Benhamou was apparently on retainer as a medical consultant to the hedge fund, while he was overseeing the clinical trials. Its kind of like having your mother on the jury. Chris Skowron, a doctor employed by Front Point to oversee its health care investments, is on administrative leave.

 

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART II)

    The FDA’s citation to Novartis last week for violations of Federal Law in its use of Facebook “Share” button on its Tasigna website without proper disclosures in the meta tagging, underscore recent concerns about big pharma use of social media and Internet technology to market product. On March 1, 2010, the Center for Digital Democracy an on-line consumer watchdog sent a letter to the FDA requesting that it join the FTC in developing rules for the use of behavioral targeting in on-line marketing and the undertaking of a comprehensive investigation into the use and impact of digital marketing techniques and technologies.

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART I)

    On July 29, 2010, the FDA issued its first social media traffic ticket to Novartis’ meta data link connected to the “share” button on its Tasigna web site. The feature allows consumers to send Novartis created information about its drug products such as Tasigna to “friends” of the consumers via the news feed. The FDA cited four separate violations  of the Federal Food, Drug and Cosmetic Act in the metadata.  First, the meta data omitted the risk factors with respect to the drug. Second, the meta data effectively broadened the indication for the use of the drug by not including its limitations by the the FDA (i.e. chronic phase and accelerated phase myelogenous leukemia resistant to prior therapy). Third, unsubstantiated superiority references (“ next generation”). Fourth, failure to submit form 2253 regarding the disclosure of promotional content.

HEALTH CARE REFORM BILL (II): MEDICAL DEVICE TAX - CONTROLLING COSTS OR STIFLING INNOVATION

There were not any easy choices in the Patient Protection and Affordable Care Act  (“PPACA”)as amended by the Health Care and Education Affordability Reconciliation Act (“HCEAR”), except perhaps the opportunity to stick it to the perpetually tanned Rep. John Boehner (R.Ohio), by imposing a 10 percent excise tax on tanning salons using ultraviolet lamps.  The Congress did impose a 2.9 percent excise tax on the sales of medical devices which is expected to raise $2OB in revenues to fund the expanded coverage of health care reform.  (The  original proposal was for $40B.) (See section 9009 of the PPACA and section 1405 of the HCEAR)  In addition new rules on proof of safety first and the implementation of “effective research” requirements are expected to further raise the cost of doing business in  the Medical Device field.

Fast track, "compassionate use," FDA approval bill for terminal patients filed.

Should the FDA provide “fast track” approval for curing edge drugs and devices that may help terminal patients?

Citing concerns that the current FDA approval processes may be too slow to help dying patients, ” Representative Diane Watson (D-CA) introduced H.R. 4732, the Compassionate Access Act of 2010, recently  The bill would amend the federal Food Drug and Cosmetic Act (“FDCA”) to create a new expedited review system for patients in need of compassionate access to tests that have not otherwise completed the FDA review process.

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.