Process and Product

Some years back, I worked with the former Dean of the Yale Medical School on a foundation project.  We good naturedly drove each other crazy.  We agreed on strategy and the content in a report.  Let’s go with it, I urged.  “Not yet, he said, I want so-and-so to approve it and ten vet it in the group.  You are a creature of process, I said a bit derisively.  I am a journalist.  We are creatures of product and want to get it out there.

I found the man a bit condescending and asked if he knew how I could be sure he was a doctor.  He looked at me blankly.  You are arrogant, I said, and I can’t read your writing.  He loved it and has repeated the exchange over the years.  Clever, perhaps, but there is a point. One reason medical research moves with the speed of molasses on a cold day is that oversight is carried to ridiculous ends.

The sick are impatient and want trials and treatment instantly.  That is not going to happen.  On the other hand, the FDA never makes a decision in a week, month or year if they can extend it out to double that.  They are risk averse to the tenth power, unable, it seems, to distinguish between reasonable risk and recklessness.  Suffering patients chomp at the bit , and  bureaucrats go to lunch.

Oversight is important.  Few question that.  But many would like to see a streamlined system where FDA and IRBs (investigational review boards, which examine safety and liability) swallow hard and put us out of our misery.  There is no such thing as being one hundred percent, guaranteed safe.   Get real, and think of the waiting patient.  We are going to die of old age before regulators make a decision.

22 Responses to Process and Product

  1. Kate Aquilino March 3, 2014 at 9:15 am #

    Old age isn’t the worst thing to die of!!! They approve all the really expensive pharmaceuticals when often vitamin d is more effective. I see you haven’t read the power of patience yet. How aboutmy book? Have you even looked? Link at my name.

  2. Matt March 3, 2014 at 11:47 am #

    Vitamin d is interesting because this has been around forever and overlooked. We are so worried about manufacturing a treatment that often overlook an obvious cure or treatment right in front of us ie stem cells. I know for a fact stem cells work because I had a stem cell procedure for my ms. Still not perfect but miles from where I was! It’s all about making money from our cells that is holding up the process. Charge what you want for my cells if that’s what it takes! Just let me use them as I want!!!

    • Lori March 3, 2014 at 12:40 pm #

      Sometimes it seems “they” just want control. Here in Canada you do not get any testing/scans unless you’re Doc agrees you need them. We now have private pay MRI’s….but still need our Doc to refer….huh? If I’m paying…why do you get to decide whether I should waste my money…or not? I have had some troubling symptoms – neurological…for several months…and had to convince my Doc to refer me for the private pay MRI. It’s no skin off her nose… waiting 6 months for a specialist appointment – and no option for private pay….sucks! I believe stem cells will be the answer for many illnesses – they just need to hurry it up already!

      • Richard M. Cohen March 3, 2014 at 8:34 pm #

        You are even more cynical than I. But you are right. Fingers in every pie.

        R.

    • Richard M. Cohen March 3, 2014 at 8:31 pm #

      You are evenmore cynical than I.

      R.

  3. Steve March 3, 2014 at 12:49 pm #

    Vitamin is not the magic bullet that some seem to think it is. I have been taking it for years and still walk like a drunken sailor. Really we are at the mercy of the insurance companies and the drug companies who run the FDA as they see fit. We sit on and wait for something that may help. I will probably die of old age before I will get a chance to use my stem cells. I can only hope my daughter will be able to use hers. It all comes down to money and we are just a way for them to make it with no real regard to our health.

    • Richard M. Cohen March 4, 2014 at 7:43 am #

      Steve-

      I am as cynical as it gets. I agree the FDA is controlled bt big pharma. Watch in the next years. Drug companies will acquire cell therapy enterprises. The business of America is business.

      R.

    • Don Brabston March 6, 2014 at 12:17 pm #

      I, too, have been taking Vitamin D (4000 IU per day) for a couple of years and have seen no change in my MS symptoms. It was recommended by my neurologist. OTOH, I don’t need a prescription for the vitamin D, I’ve not seen any negative aspects of taking it, and it’s not expensive.

  4. Nancy Cincotta March 3, 2014 at 2:46 pm #

    I don’t understand the FDA I know they have a very careful concern for safety which usually falls short for those off us suffering with chronic illness.
    I watched the Dallas Buyers Club last night and loved the way the lead character dealt with the FDA. This was a true story, a man fighting for his life against the aids epidemic.
    We are desperate and willing to fight, please give us some hope for a future.

    • Richard M. Cohen March 3, 2014 at 8:36 pm #

      I saw it, too. Be cynical.

      R.

      • Chris Weller March 15, 2014 at 9:29 am #

        Come on Richard..we don’t need anyone encouraging us to be more cynical. I believe it is one of the stages of acceptance. Anger, bitterness, cynicism and succumb.

    • Richard M. Cohen March 4, 2014 at 7:47 am #

      Nancy-

      I believe in oversight, I also believe the FDA should get out of the way and let progress come. Motives are unclear, though the FDA is controlled by industry. What do you think?

      R.

  5. Michelle Rafanelli March 4, 2014 at 5:43 pm #

    No kidding. If pharma was involved in this study there would not be an issue. approval would be quick(er). Such a bunch of (insert word here).

    • Richard March 4, 2014 at 7:16 pm #

      Too much a gentleman.

      R.

  6. Lori March 5, 2014 at 4:29 pm #

    I just read an article about a possible new treatment for MS – The patient had SPMS and had 6 weeks of treatment – which reduced pain and boosted energy levels. Brain scans showed reduced disease, and there was a reduction of antibodies in the spinal fluid. It is based on the theory that the EBV is responsible for MS and this treatment boosts the body’s ability to fight the virus. I don’t know if this is “old news”….There is a plethora of research being done…and I believe the next 5-10 years, MS sufferers will have many options to help fight this nasty chronic and progressive condition.

    • Richard March 7, 2014 at 8:52 am #

      Lori-

      Thanks. I will believe it when I see it. I have hers about a multitude of treatments, if not cures, across the years.

      R.

  7. Steve March 6, 2014 at 5:51 am #

    It will be too late for a lot of us.

    • Richard March 7, 2014 at 8:54 am #

      Not clear what you are referring to.

      R.

  8. Lori March 10, 2014 at 3:10 pm #

    I think Steve is referring to my comment about the next 5-10 years MS sufferers will have many options to help fight the disease.

  9. Lori March 10, 2014 at 3:14 pm #

    Richard – Has there not been any treatments since you’ve been fighting MS that have helped slow down the progression at all? Or have all the treatments been for the relapse/remit form only? (Please pardon my ignorance on the subject)

  10. proteins May 9, 2014 at 2:19 am #

    Hello would you mind letting me know which web host you’re using? I’ve loaded your blog in 3 different internet browsers and I must say this blog loads a lot quicker then most. Can you recommend a good hosting provider at a reasonable price? Kudos, I appreciate it!

  11. roses lyrics meaning July 27, 2014 at 7:21 pm #

    I think this is among the most vital info for me.
    And i am glad reading your article. But wanna remark on some general things, The
    web site style is ideal, the articles is really excellent
    : D. Good job, cheers