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One of my favorite BaldingBlog contributors (who shall remain nameless) sent in some great insights about FDA advisory committees. We’ve previously posted his thoughts on the LaserComb, clinical trials, and FDA trials. This post will be used in the future as a point of reference:

    Dr Rassman,
    Given the many questions related to consideration of FDA expansion of the finasteride label for prevention of prostate cancer, your readers may wish to access the data themselves and better understand the process (which becomes more transparent and less “conspiratorial”).

     
    The recent finasteride and dutasteride opinions noted in the Dec 3 Balding Blog posting are not from the FDA, but are from an independent group termed the Oncologic Drugs Advisory Committee. The committee is composed of 18 voting members (and several non-voting members) – mainly oncologists, with some statisticians, epidemiologists, and a patient representative, the former mainly from academic institutions.

    The FDA eventually considers the committees opinion in approval or withdrawal of drugs (or “expansion” of a drug label for a new indication). The FDA usually follows the recommendations of advisory committees, as the committees’ recommendations are presumably “data-driven” and the FDA typically comes to similar conclusions. However, as in the case of many decisions that are split or where significant differences in interpretation of risk-benefit exist, the FDA has occasionally approved or rejected a drug against the recommendation of an advisory panel. Examples of split Advisory decisions (where a majority vote did occur) are the opinions this year related to several weight loss drugs.

    The Oncologic Drugs Advisory Committee voted 17-0 against expanding the label for finasteride to include prevention of prostate cancer. A unanimous vote by FDA Advisory Committees is rare. I have no special knowledge of the meeting. This decision was based in part on data from the 19,000 patient Prostate Cancer Prevention Trial and the belief that the data did not support the risk benefit profile (i.e. possibility of increased aggressiveness of tumor did not outweigh reduced risk of low-grade tumors). As with all such committee meetings, which are open to the public (including listening via live webcasts), the transcript will be published and available within a few weeks at the FDA’s web site.

    However, interested readers can go to the FDA web site now and access the Briefing Document and presentations given to Committee members from the drug company seeking approval. This information is public and typically posted several days before the meeting. The meeting was held on Dec 1, but the date of posting was Nov 26 (see under Oncologic Drugs Advisory Committee). The info can be found at the following links [note – all are PDF files]:

  1. Draft Agenda for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
  2. Briefing Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
  3. Draft Questions for the November 30, 2010 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
  4. Merck Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
  5. FDA Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
  6. GlaxoSmithKline Briefing Information for the December 01, 2010 Meeting of the Oncologic Drugs Advisory Committee
  7. Draft Questions for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
  8. Draft Meeting Roster for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
  9. Webcast Information for the December 1, 2010 Meeting of the Oncologic Drugs Advisory Committee
Tags: fda, dutasteride, finasteride, proscar, avodart, merck, glaxosmithkline, prostate, cancer

 

A couple months ago I was invited to speak before the Anderson School of Business at UCLA about entrepreneurship, and I was able to talk about the diversity experienced in the multiple careers I’ve held since receiving my Doctor of Medicine degree from the Medical College of Virginia. So from time to time I’ll share some of these personal tidbits that I spoke to the Anderson School about so you can learn more about me.

I was encouraged by the feedback I received after posting about my short-lived farming career, so I’ll continue to post these as long as there’s an interest. For those of you who do not know much about my background or Dr. Pak’s background in various fields, you can find those here. So without further ado…

HeartThe Intra-Aortic Balloon Pump:

In medical school, I was fortunate to find a number of faculty who stimulated the inquisitive mind. I developed an interest while I took a job on the inhalation therapy team and the university hospital. I worked nights and was usually the first person to be called when a patient went into extremis or had a cardiac arrest. I quickly became an expert on cardiac resuscitation. I wondered why some of the patients survived and some did not, so I set up experiments, first in the VA hospital (under Dr. Yale Zimberg) where I started to develop cardiac pumps and then eventually in the research lab of the cardiac surgeon, Dr. Richard Lower. The dean of the school of medicine eventually funded my projects. That got me to eventually work at the University of Minnesota under the famous surgeon Dr. C.W. Lillehei, the father of open-heart surgery. Funds for my ideas eventually came from an endowment fund under Dr. Lillehei’s trust and when I moved from Minnesota to Cornell Medical Center, I eventually came up with the first commercial bedside assist pump, the Intra-Aortic Balloon Pump (see: demo video). The medical cardiology community initially opposed the application of the technology, so the only patients I had a chance to work on were those patients who would not come off of the heart lung machine after cardiac surgery. Dr. Lillehei was clearly my sponsor and not only paid for this work, but encouraged me in developing further improvements. I believe that cardiologists were intimidated by the technology, particularly because some minor surgery was required in the leg to insert the balloon, something that in those days cardiologists were averse to.

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FarmingMy bother-in-law is one of the most brilliant men I have ever known. I do not mean the Einstein type, but rather, he’s incredibly practical, creative, and clever. He ran a dairy farm passed down from his father in Ireland’s lush countryside, and gave me the opportunity to experience farming firsthand. Enthralled with his inventiveness with solutions to his daily problems on the farm, I realized the creative opportunities in farming. So in 1976, while running one of the busiest surgical practices in Vermont, I decided to enter the farming business. I really knew nothing about farming, but felt deep in my heart that this was a venture I would prosper in and enjoy the rewards of manual labor, something that the surgical practice did not offer. So… I bought a farm. With the agreement of my surgical partner, I took off enough time to set up the farm I purchased, which already had almost 100 dairy stock cows. My wife grew up in Ireland and as a child had to milk 7 cows each day by hand before going to school, so I figured that the difference between milking 7 cows by hand and 100 cows by a set of milking machines could be made up by just hiring a few farmhands. I purchased the farm in May and almost immediately had to plant my corn to feed the herd, so I was off and running right from the start.

It was a marvelous experience and I really fell in love with being a farmer. I felt invigorated after a day’s work and I put on muscles I did not know I had. I even bought a horse and broke it, and she only threw me once before we became bonded and I felt like a true horseman. I was really living the life, but things weren’t always so rosy. There were lots of problem with the farm, economics being the first one I never sensed I would have. Like any company, one needs a business plan that would anticipate the potential problems, but in the autumn of that first year, 40 cows developed pneumonia. I went to the hospital, got lots of IV solutions, and created an intensive care unit in the barn. I asked the drug reps for antibiotics, which they freely gave me, and used the hospital lab to help me treat the cow’s infections. So I now had two medical activities: my busy surgical practice and a fill-in veterinary practice. All of the sick cows never recovered their milk production and this failure almost lead me into bankruptcy. I learned that the pneumonia was caused by not allowing free circulation of air in the barn, so when I tried to regulate barn temperature I then created a situation where the cows easily became overheated. That was a costly lesson. I had to repurchase an entire herd.

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Dr William RassmanThis isn’t a hair transplant related post, but it is a trip down memory lane for me. Allow me to indulge myself…

I was recently talking with a friend, and I was asked to think back on a case where I had a patient that I simply did not like. While I do get along well with all of my patients today, I thought for a few moments and remembered an experience I had in my first year in surgical practice (before my life as a hair transplant doctor). The chairman of the hospital board of trustees, a very fat, nasty, and ugly man, was an obstructionist to everything that the doctors, nurses, and local politicians wanted to improve, not only the physical facility, but he was also against changing policies that would make the hospital a more patient-friendly place. He was a political person with strong prejudices and he was despised by most of the doctors as he exercised power over them by vetoing everything they asked for. I remember wondering how I’d react if he came into the emergency room bleeding to death from some type of accident and I was be the surgeon on duty. Then one day, that wonder became reality as he was rolled into the emergency room with internal bleeding from a really bad car wreck.

There was no question how I was going to behave, how I must behave — that I would do my best to save this man’s life. This was no ordinary effort, as he had major bleeding from his liver and a ruptured spleen. By the time I got him to the operating room, his blood pressure was barely detectable. We pumped many units of blood into him, got his blood pressure up a bit, opened his abdomen, removed his spleen, and sewed up his liver. I got him out of the operating room barely alive. If he had died, his injury would have justified it… but not for me. I thought that my subconscious might have tried to work against him. I remember staying at the hospital for 2 days and nights, barely sleeping. I stayed at his bedside and did not go home for over 50 hours. Slowly, he got out of shock, remaining very sick for some days until eventually he recovered. When he came back to his chairman duties months later, he was changed. Anything I would say would become his cause célèbre, so when I endorsed various hospital agenda issues like any improvements in hospital policies, in the hospital’s physical plant, etc… he became an advocate.

This experience was unique for me. I knew if he died, I somehow might be responsible for his death. I did not give him any better care than I would give any of my patients, but my prejudices towards him made me so aware of how vital and important it was for me to be impartial.

Tags: healthcare, doctor, patient, medical, surgical

 

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