April 21, 2009

Citizens or Subjects II

A great friend whom I had better not identify does cancer research and sent along some comments on my post about Provenge approval. When I said that only me and the Wall Street Journal Ed Page cared, I think I left a few folks out. There are a lot of caring MDs and technicians who work on these trials.

> I read your Three Sources post regarding the FDA denial of approval
> for Provenge with great interest. A few years back I conducted a few
> trials with Dendreon's vaccine against multiple myeloma.

> Getting FDA approval was an
> expensive and cumbersome process and, as a small biotech start-up,
> Dendreon desperately needed to get something to market.
> Unfortunately, due to economic pressures
> Dendreon eventually made a business decision to
> abandon their myeloma program. The prostate cancer vaccine program
> was farther along and frankly would have a much bigger market, so they
> put their eggs in that basket. A few months ago, I decided to
> re-look at our data. We compared all the patients enrolled in our
> trial to all the patients with myeloma who were not enrolled in the
> trial and had a stem cell transplant during the same time interval.

> Patients in the vaccine trial have lived an average 2 years longer
> than the patients who did not get the vaccines.
> Alas, because the FDA made the approval process so
> cumbersome, the vaccines are no longer available. So we cannot do the
> larger confirmatory trials to see if the vaccine really works.

> Feel free to excerpt anonymously as an example
> of how FDA policy costs lives. Multiple myeloma is a fatal cancer
> with life expectancy of 3-5 years. If our findings hold up, two years
> is a huge advance.


Beyond the Martha Stewarts and Sam Waksals, it has been my main point that the FDA scares capital out of the pharmaceutical sector. Here, its sluggishness and capriciousness cause a firm to abandon a promising treatment.


Pharmaceuticals Posted by John Kranz at April 21, 2009 7:24 PM

Indeed. We look at President Historical and Speaker Business Jet's promises to nationalize healthcare and wonder where Canadians will then go when they really need a critical medical procedure. Free-market medicine is more advanced, medically and scientifically, than that in a controlled market. But since the U.S. economy is mixed there are doubtless many potential advances that never occurred, even here, as a result.

Posted by: johngalt at April 23, 2009 12:29 PM | What do you think? [1]