They'll miss Crawford because of his "openness."

"Despite various policy disagreements, we'll miss Dr. Crawford for his
openness, and because he's really one of the only FDA commissioners who
has had substantive experience with food safety," said Michael F.
Jacobson, executive director.

Then again maybe not.

"His time at the FDA has been a disaster for consumers," said Peter
Lurie of Public Citizen's drug safety project. "The scientific climate
has not been an open one."

Apparently he resigned because of a personnel matter. Er...or was that
a personal matter?

THE NATION
FDA Chief Crawford Resigns 2 Months After Confirmation

His first major action, delaying a decision on over-the-counter sales
of the 'morning-after' contraceptive Plan B, had stirred controversy.

By Ricardo Alonso-Zaldivar, Times Staff Writer

WASHINGTON - Food and Drug Administration Commissioner Lester M.
Crawford resigned Friday, a move that stunned agency staffers,
lawmakers, industry and the medical community.

Two months after winning Senate confirmation to a post he had sought
for much of his career, Crawford sent FDA employees an e-mail Friday
afternoon saying, "It is time, at the age of 67, to step aside."

The White House quickly announced that President Bush would nominate
Texas cancer surgeon Andrew C. von Eschenbach, head of the National
Cancer Institute, as acting FDA commissioner.

White House officials refused to comment on the reasons for Crawford's
departure, saying it was a "personnel matter." Crawford hastily met
with his senior staff to break the news but did not give any reason for
his departure, an FDA official said.

Congressional aides and some outside observers said the resignation
could be related to controversy over his Crawford's announcement last
month delaying a decision on whether to allow over-the-counter sales of
Plan B, the "morning-after" contraceptive.

The indefinite delay of the politically charged decision - Crawford's
first major action as permanent FDA chief - prompted a storm of
criticism in the scientific community. The head of the FDA's office of
women's health resigned in protest.

Although some social conservatives were pleased, other prominent
Republicans were dumbfounded because Crawford had promised the Senate a
firm ruling as a condition of his confirmation.

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor
and Pensions Committee, was among those who expected Crawford to issue
a clear decision.

"Enzi in particular felt he had been burned by the administration on
this," said a Senate staffer who works on drug policy issues and who
spoke on condition of anonymity. A spokesman for Enzi could not be
reached.

Crawford's mission as chief had been to help restore public confidence
in the FDA. Last year's recall of Vioxx, a painkiller, revealed flaws
in the agency's oversight of drug safety and prompted criticism that it
had grown too cozy with the pharmaceutical industry.

The Plan B delay led prominent academics to openly question the
agency's scientific integrity. The FDA's staff had concluded that the
drug was safe. But Crawford had said the delay was needed to determine
whether over-the-counter distribution could be restricted to those 17
years of age and older.

"You squander the public trust if you move away from a science-based
decision-making process," said Dr. Alastair J.J. Wood, Vanderbilt
University medical school associate dean.

Wood, who has advised the FDA on drug safety, co-wrote an article
highly critical of the agency's handling of the Plan B decision in this
week's New England Journal of Medicine.

"The recent actions of the FDA leadership have made a mockery of the
process of evaluating scientific evidence, disillusioned many of the
participating scientists both inside and outside the agency, squandered
the public trust, and tarnished the agency's image," it concluded.

On Capitol Hill, FDA critics said Crawford's resignation offers the
possibility of a fresh start for the agency.

"Dr. Crawford's ability to lead a strong and independent FDA was in
question from the start," Sen. Patty Murray (D-Wash.) said. "During his
tenure, the FDA's reputation as the gold standard in public health has
been tarnished."

Sen. Charles E. Grassley (R-Iowa) said: "Now is the time to reform the
FDA's culture and reassert that the agency's top priority is what's
good for John Q. Public."

Prior to his confirmation, Crawford underwent a two-month investigation
by the Health and Human Services inspector general into allegations
that he had had an affair with a subordinate. The inquiry found no
evidence to support the charges. Officials said Friday that his
resignation did not appear to be related to the investigation.

Crawford had served as acting commissioner for more than two years
before winning confirmation to head the agency. He was known as a
low-key, affable boss. His background was unusual for an FDA
commissioner; he is not a physician, but holds degrees in veterinary
medicine and pharmacology.

Von Eschenbach, the proposed acting FDA chief, is a prostate cancer
specialist who performed surgery at the University of Texas M.D.
Anderson Cancer Center in Houston. As head of the National Cancer
Institute, he has worked with the FDA to develop medical imaging
techniques that can be used to deliver chemotherapy treatments more
precisely.

He has also been a cancer patient, having been treated for melanoma and
prostate cancer.

Academic experts said the FDA needs permanent leadership.

"Every day they go without permanent leadership, they lose some good
professional people at the agency," said Dr. Raymond Woosley, president
of the C-Path Institute, an Arizona nonprofit organization that seeks
to improve the process for developing drugs.

Dr. Brian L. Strom, chairman of the biostatistics and epidemiology
department at the University of Pennsylvania School of Medicine,
criticized the Bush administration for encroaching on the FDA's
independence.

"This should be one of the best jobs in American medicine, but at
present, I'm afraid it's become one of the most undesirable because of
the perception that science is secondary" in agency decisions, Strom
said.

Pharmaceutical Research and Manufacturers of America, which supported
Crawford's nomination to head the FDA, had no comment.

Several consumer groups critical of the agency said they were pleased.

"His time at the FDA has been a disaster for consumers," said Peter
Lurie of Public Citizen's drug safety project. "The scientific climate
has not been an open one."

"A fresh start is desperately needed," said Diana Zuckerman, president
of the National Research Center for Women & Families. "The Plan B
decision was a fiasco."

But the Center for Science in the Public Interest, which focuses on
food safety, said Crawford's departure would leave a void.

"Despite various policy disagreements, we'll miss Dr. Crawford for his
openness, and because he's really one of the only FDA commissioners who
has had substantive experience with food safety," said Michael F.
Jacobson, executive director.

fairuse
http://www.latimes.com/news/printedition/asection/la-na-fda24sep24,1,4752295,ful
l.story?coll=la-news-a_section&ctrack=1&cset=true

At the time low-dose ibuprofen (as Advil) went over-the-counter
(OTC), a nephrologist friend of mine shook his head and predicted
an enormous increase in patients predisposed to chronic kidney
disease (CKD) progressing to Stage 5 and life on dialysis.  He
was pretty much right.  The indiscriminate use of any medication -
Rx or OTC - has adverse consequences.  

But I think you're entirely wrong about the degree to which the
officers of the FDA have the lawful power to compel a manufacturer
to make a product available OTC if that manufacturer doesn't desire
to do so.  The last time I looked, a patented product was the exclu-
sive property of the patent's owner.  With regard to medicinal
products, the enabling legislation authorizing the FDA's actions
require them to receive from a patent holder a series of submission
documents leading up to a completed new drug application (NDA),
which outlines the purposes for which the patent holder is seeking
FDA marketing approval.  

If the patent holder wants the drug to be marketed as a prescription-
only product, they'll say that in the application process.  If they
want to be able to sell it OTC, they'll say *that*.  The FDA has
the duty to evaluate that request, and if the FDA's advisors and
administrators determine that a request for OTC marketing is in-
appropriate (and you honestly think that captopril [Capoten, old
Squibb, now Bristol-Meyers Squibb] ought to go OTC?), they'll
disapprove the application.  

I'm not saying that the FDA serves a beneficial purpose, or even
that the enabling legislation under which the FDA operates is in
any way constitutional.  Clearly, it's not.  But the statutes do not
even begin to empower the FDA's Vogon bureaucrats to tell a
patent holder what said property owner *must* do with the
goods in his/her keeping.  If the patent holder of a particular
pharmaceutical product doesn't want to have his/her intellectual
property sold over-the-counter, he/she is perfectly free to with-
hold it from that segment of the world market that is under the
unconstitutional control of the FDA.  

And if the FDA won't approve the marketing of a patent holder's
product within the FDA's statutory but constitutionally illegiti-
mate jurisdiction, the manufacturer is perfectly free to sell it else-
where.  Note that sanofi (now sanofi-aventis) peddles a second-
generation "atypical" antipsychotic drug called amisulpride (trade-
marked as Solian in several countries) just about everywhere in
the world other than in these United States.  To the best of my
knowledge, they've never even waved the molecule under the
noses of the boys down in Rockville.  

And the FDA did not "keep claritin and nicorette off OTC
status" at all.  While Claritin (loratadine) was under patent,
Schering Plough did its very damnedest to maintain its
status as a prescription drug.  The same goes for the patent
holders of Nicorette gum (SmithKline, now GlaxoSmithKline),
who kept it as a prescription-only product until it had neared
the end of patent exclusivity in 1996, whereupon they took the
product OTC in exchange for a three-year extension of market-
ing exclusivity (i.e., an effective extension of the product's
patent life) while conducting pharmacovigilance studies on the
product's safe use under OTC access.  

Schering Plough could not manage such a dicker with their
loratadine products (they'd spent years proving that Claritin
- although a pretty weak and commonly ineffective antihista-
mine - *is* astonishingly safe), and so the rug came out from
under Kogan and Kenilworth when the patent life of Schering
Plough's "blockbuster" drug died an ignominious but perfectly
anticipatable death a few years ago.  Exeunt Kogan and his
merry crew of cement-headed wreckers, and bring on Fred
Hassan and all those Pharmacia-like rumors about Schering
Plough as an acquisition target.  

----------------
The only good bureaucrat is one with a pistol at his head.
Put it in his hand and it's good-bye to the Bill of Rights.

       -- H.L. Mencken

What you had originally written was: "....one HMO company (Wellpoint)
actually petitioned the FDA to make ANOTHER company's drug avail-
able OTC."  How else can that phrasing and emphasis be taken except to
indicate that you had mistakenly ranked Wellpoint as a drug manufac-
turer?  

What Wellpoint attempted was an effort to violate the property rights
of several patent holders.  What if a big retailer like Best Buy were
to petition a federal agency to impose by fiat some sort of change in
Apple's marketing plan for their patented iPod product line?  Sure,
Best Buy has the right to petition government (the full phrases is
"for redress of grievances," isn't it?).  The question now devolves
into consideration of private property rights, the appropriate powers
of civil government, and standing.

In Wellpoint's case, the grievance is: "I want to buy this manufac-
turer's goods at a cheaper price than the greedy bastard is willing
to charge!"  In the course of their push to get the Federal govern-
ment to violate the patent rights of the manufacturers of the "second
generation" (less-sedating) antihistamines, you say they argued that
"...the average American should be just as tired of [tired of paying
a lot of money for non-sedating antihistamines as Wellpoint was],
if they didn't happen to have a health plan that covered all prescrip-
tions."

It was hardly a question of concern for people who "...didn't hap-
pen to have a health plan that covered all prescriptions."  As I'd
said, Wellpoint had (and still has) a contractual relationship with
many of its clients to cover the costs of certain prescription drugs.
That contract doesn't give Wellpoint or its corporate officers any
standing whatsoever to utter a petition wherein they claim to be
acting on behalf of the general public - i.e., "...the average Ameri-
can...[who] didn't happen to have a health plan that covered all
prescriptions."  And, of course, Wellpoint wasn't.  Their purpose
was entirely self-dealing.  Wellpoint was taking boatloads of money
out of the pockets of their clients, and they wanted - quite naturally
- to keep as much of it as they possibly could.  

Do I have to explain this in detail?  

The Wellpoint goniffs made this outrageous move at a strategically
opportune moment, when the first of the safer less-sedating drugs in
this therapeutic category was approaching the end of its patent life.
Note that there was nothing in their petition to encourage the FDA
to grant OTC status to several other prescription drugs in this
category that were already off-patent.  

Maunder on all you like about having "...been THERE..." when
Claritin was selling for $3 a pill (that wasn't the *Redbook* price,
of course, but you're polemicizing and therefore not expected to
bother taking into account the uncontrolled mark-ups charged by
pharmacies at the point of sale), but how much experience have
you had in prescribing Hismanal (astemizole, Janssen Pharmaceutica)
or Seldane (terfenadine, Hoechst Marion Roussel) before these two
supposedly safe "non-sedating antihistamines" - both of which had
gone successfully through the FDA's and various other national
governments' approval processes - were pulled off the market in
the late '90s?  

Did Wellpoint also petition for OTC sales of astemizole and ter-
fenadine?  Except for certain nasty drug-drug interactions (which
have been well-defined and can easily be incorporated in product
labeling), both Hismanal and Seldane were effective low-sedating
antihistamines.  Aspirin and ibuprofen have worse track records
insofar as drug safety issues go.  So why wasn't Wellpoint including
those older, off-patent drug products in their petition?  

Might it have been because there actually *was* a safety issue
coloring the use of the "non-sedating" antihistamines as a class?  
And that this issue took a few years to thrash out, during which
time we discovered a whole lot of patients whose predispositions
anent life-threatening cardiac re-entrant arrhythmias had not been
anticipated until they took Seldane?  Retrospectroscopy is a
great diagnostic procedure, but it's not available IRL.    

Schering Plough *did* charge what the market would bear on
their Claritin product line.  I didn't write for Claritin all that
much (as I've said, it's a pretty weak and relatively ineffective
antihistamine), and I prefer Zyrtec (cetirizine, Pfizer) both for
its greater potency and for a pharmacokinetic profile that
predictably apes its precursor drug (Vistaril [hydroxyzine, also
Pfizer]), which I first learned to employ when I was on clinical
clerkships in medical school.  But Schering Plough pumped a
lot of money into marketing the Claritin products, and that had
an impact on patient demand for Schering Plough's loratadine
goodies.  

Now, the pliability (indeed, the stupidity) of the general public
has been a thoroughly execrable characteristic of the market-
place ever since the division-of-labor economy was first con-
ceived.  We have many wonderful bad examples to take as
object lessons, and one of them is the witlessness of patients
who come into doctors' offices and specifically request certain
prescription drug products.  But "Stupidity cannot be cured
with money, or through education, or by legislation. Stupidity
is not a sin, the victim can't help being stupid. But stupidity is
the only universal capital crime; the sentence is death, there is
no appeal, and execution is carried out automatically and
without pity." (Robert A. Heinlein)  

When Schering Plough petitioned the FDA for permission
to take loratadine OTC toward the close of the product's
patent life, it was not out of embarrassment (pointy-haired
bosses like Kogan don't *get* embarrassed when you accuse
them of price-gouging) but rather because they were ready to
introduce a successor product line - Clarinex (desloratadine,
licensed from drug developer Sepracor) - to the prescription
market, and they wanted to cut the legs out from under the
generics manufacturers who had gotten their own "me-too"
ANDAs into Rockville well in advance of the Claritin patents'
expiration.  

Y'see, the moment that generic prescription loratadine
became available, there would be little reason for doctors
to write for Clarinex products.  The difference between
loratadine and desloratadine from a clinical point of view
is effectively nil.  

I won't go into a detailed discussion at this point about pharma-
ceuticals pricing in Canada and the whole drug re-importation
issue except to observe that your naïveté on this subject proves
that Heinlein's observation about stupidity is still wonderfully
robust.  You really don't know squat about it, do you?

More I will not say about the Wellpoint petition, except:

---------------
Government is the great fiction through which everybody
endeavors to live at the expense of everybody else.

    -- Frederic Bastiat, "Government" (1848)
      http://bastiat.org/en/government.html