On Tue, 08 Jan 2013 08:59:25 -0800, Joseph J. Horton wrote:
I am not particularly disturbed by this ruling depending upon just what
claims
are being made. If it is clear the claim is based on a collection of
anecdotes
rather than empirical study informing physicians that others have found a
drug
useful seems fine.
I suggest reading the following blog entry from a legal firm that maintains
the blog as a source of information on legal issues involving the FDA:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/12/a-deep-dive-into-the-second-circuits-caronia-decision-potential-next-steps-and-potential-enforcement.html
I say this as one who regularly takes a drug for off label use.
I am not sure how this is relevant since mere personal experiences do not
constitute data, only anecdote (at best a case study if done systematically
but case studies are not scientific studies). That being said, I too have
had conditions where there was no established treatment and have received
numerous drugs off-label, none of which worked (you don't know how
much I hoped for a good placebo effect). A major problem with off-label
drug treatment are the side-effects which can be significant. Sometimes
one thinks one is taking a step forward but winds up taking two steps back.
It is a generic drug and has been for a very long time. Thus it costs very
little. No one would invest the time and money to conduct a clinical trial
for
my issue. Yet the drug has dramatically improved my quality of life. Were
the
FDA to take away my physician's ability to prescribe it for me, I would be
quite disappointed.
With all sincerity, I am glad that the drug has done you good but I hope you
realize that if it is being used off-label: (a) there is no empirical
research evidence
that the drug is the cause of the improvement (that is one of the major
problems
with using a drug in an off-label manner though there may be various crappy
"open label" studies -- studies where participants and researchers know who
is receiving the drug, possibly with no placebo control) and (b) even if the
"Caronia case" goes in favor of the FDA on appeal, your doctor can still
treat
you with the off label drug because the FDA's focus is on the marketing of
the
drug.
Below I quote from the legal blog I cite above but I give warning that the
quote
is long. It does, however, provide much significant context:
NOTE: the FDA prosecutes off label marketing as a violation of
interstate commerce law; see the blog for details
|On November 30, 2009, a jury found Alfred Caronia guilty of misdemeanor
|conspiracy to introduce misbranded drugs into interstate commerce. His
|conviction was based on off-label statements he made while employed
|as a pharmaceutical sales representative for Orphan Medical, Inc.
("Orphan").
|Specifically, Caronia verbally promoted the drug Xyrem, a central nervous
|system depressant approved only for the treatment of certain categories
|of narcolepsy patients, to treat a variety of other conditions including
insomnia,
|fibromyalgia, and Parkinson's. He also promoted Xyrem for use in an
|unapproved patient population - individuals under the age of 16.
|
|The government began its investigation of Orphan in 2005, when former
|Orphan saleswoman Shelley Lauterbach filed a qui tam suit against the
|company. During the course of the investigation, Caronia was recorded
|on two occasions discussing off-label uses of Xyrem. On both occasions,
|Caronia was recorded speaking alongside Dr. Peter Gleason, a doctor
|that Caronia had engaged to participate in "speaker programs" intended
|to educate other physicians about Xyrem. Caronia and Dr. Gleason
|discussed off-label uses for Xyrem with Dr. Jeffrey Charo, an undercover
|informant for the government. In 2006, the government filed charges
against
|Orphan, Dr. Gleason, Caronia, as well as David Tucker (a former Orphan
|sales manager) for conspiring to promote Xyrem for off-label uses, and
|thereby introduce a misbranded drug into interstate commerce.
|
|In March 2007, David Tucker pleaded guilty to a single felony misbranding
|charge. In July 2007, Orphan pleaded guilty to felony charges, and its
|parent company, Jazz Pharmaceuticals, Inc., agreed to pay $20 million and
|enter into a Corporate Integrity Agreement to resolve both criminal and
civil
|charges. In August 2008, Dr. Gleason also pleaded guilty to criminal
misbranding
|charges.
|
|Caronia, however, did not plead guilty and filed a motion to dismiss his
case
|based inter alia on First Amendment grounds. The District Court denied his
|motion, but noted that the allegations against Caronia included First
|Amendment-protected speech. Nevertheless, the District Court concluded
|that the government's interpretation of the FDCA was constitutional under
the
|commercial speech doctrine because it did not limit speech more than was
|necessary to achieve the government' objectives. On appeal of Caronia's
|criminal conviction, the Second Circuit disagreed.
It is the Second Circuit's judgment that served as the basis for the Nature
Med
article. The blog entry goes into what possible follow-up actions that the
FDA may engage in.
-Mike Palij
New York University
[email protected]
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