Wednesday, June 6, 2007

Part 3 of the Personalized Medicine Revolution

The third post of the conference at Brown will cover a round table. This forum was moderated by Professor Charles Ogletree of Harvard Law School. The following persons were involved in the forum:

  • Healthcare Translation – Daniel J. Wattendorf, MD, MAJ, MC, USAF, Keesler Air Force Base
  • Ethics – Thomas H. Murray, PhD, President & CEO, The Hastings Center
  • Patient Advocacy – Sharon F. Terry, MA, President & CEO, Genetic Alliance
  • Privacy – Joy L. Pritts, JD, Research Associate Professor, Health Policy Institute, Georgetown University
  • Research – FrancisS. Collins, MD, PhD Director, National Human Genome Research Institute
  • Institutional Review Board – P. Pearl O’Rourke, MD, Director, Human Research Affairs, ESCRO Chair, Partners Healthcare; Associate Professor, Harvard Medical School
  • Legal – Richard A. Johnson, JD, MS, Senior Partner, Arnold & Porter LLP
  • Economics – Edward Abrahams, PhD, Executive Director, Personalized Medicine Coalition
  • Media – Jonathan D. Rockoff, Reporter (Washington Bureau), Baltimore Sun
  • Insurance – James E.Purcell, JD, President, Blue Cross Blue Shield, RI
  • Hospital – Joseph F. Amaral, MD, FACS President and CEO, Rhode Island Hospital
  • Pharmaceutical Industry – Patrice M. Milos, PhD, Executive Director, Pfizer
  • Politics – Paul T. Kim, AB, MPP, JD, Partner, Foley Haog LLP

Professor Ogletree posed the following situation. "Terry is a 25 year old woman who has just used Google's Health Kit and searched her family's history. She finds 2 maternal aunts with heart attacks in their forties. Who does that matter to?"

First he asked her PMD. "Does this matter?" The PMD representative was a physician from the Air Force. He said-"I don't have any guidelines on second degree relatives. I don't know what to do" Obviously he didn't read Maren Scheuner's articles.

Next Dr. Ogletree asks what other tools might she have used. Dr Collins answers that there is a study going on at Harvard where all employees were encouraged to input and utilize a family history tool. There will be an evaluation of pedigrees and risks.

Dr Ogltree then asks "What are the discrimination risks?" That is when the panel caught fire. Joy Pritts starts by stating that each state have different regulations, and that these regulations are filled with loopholes. She also states that Rhode Island has some of the best protections available. "Don't ever move! Because your protections don't follow you!" "I hope she doesn't work for Wal-Mart she says" Mr Kim then chimes in...."What's in the google box? What are they doing with your data? How protected is it?"

Professor Ogletree then shifts gears "This 25 year old woman receives an email from a Pfizer clinical trial coordinator offering enrollment. Should she join? What about protections?"

It is becoming evident that the existing legislation throws you to the wolves. Patrick Kennedy seated quietly in the crowd can barely contain himself and starts shouting at the crowd. He says HIPAA doesn't protect you. In fact if your provider or company utilizing your data (i.e. for research) goes bankrupt that your data is no longer protected.

Dr Milos of Pfizer then chimes in....."I don't think Pfizer is going bankrupt any time soon. She should enroll." Then Dr Collins quips "Who wants to place bets on that?" The crowd erupts into laughter.

The Sherpa Says: The moral of this roundtable was that there are online companies offering services. Who is to say that they won't go bankrupt and put your info out there. Only medical practices actually have the kind of protections a patient needs. No DTC company can be held liable for "losing/selling" your data, especially if they go bankrupt. In addition we learn that most PMDs are unaware of the significant role family history plays. The take home point is that the medical infrastructure is ill suited for this next transformation in medicine and Google is likely to give you more information about genetics in medicne.


Keith Robison said...

What happens if a medical practice goes bankrupt? Aren't the same issues around records present, or has the law covered that case well?

Steve Murphy MD said...

THere was almost a throw down at the round table discussion about this precise topic. Representative Kennedy felt it was not protected. However, Ms Pitts the specialist in HIPAA and public policy stated that case law actually mandates health practices to be held to a higher standard than regular corporations. Of note, healthcare practices can only be owned by physicians, who must be licensed in the state that the practice is formed. So they are held to the same standard as the singular physicians.

mvic said...

Wow, big can of genetically modified worms... It's probably too narrow to focus merely on companies that become custodians of sensitive Personal Health Information. There are lots of ways an employer, law enforcement agency, insurer, journalist or friend might obtain PHI, which could then be the source of a harmful disclosure. Just one example: "Blended records." You go to your doctor and give all kinds of genetic information on other people (i.e. family) when you give "your" history. Whose privacy is involved? Burlesque: "Well doctor, my headache began when my airline pilot husband knocked a lamp over in a drunken stumble. My daughter with Down Syndrome, started crying. When the EMTs got to my house, one of them mentioned that I might have epilepsy, because his sister has the same symptoms..." etc.

- Michael Victoroff, MD

Steve Murphy MD said...

I totally agree. Blended records are a huge issue. I don't know how we can ever hope to protect every situation. I think we need some sense and sensibility in these areas. Sometimes I feel that people often forget "the spirit" of the law.......Especially litigators....
Send me an email, I'd love to chat.