Wednesday, December 09, 2009

Bizarre! Phrma Doing Biz As Usual. As Usual it Qualifies as Moral Terpitude

The New York Times
December 4, 2009
Questioning a $30,000-a-Month Cancer Drug
By Andrew Pollack

A newly approved chemotherapy drug will cost about $30,000 a month, a sign
that the prices of cancer medicines are continuing to rise despite growing
concern about health care costs.

Critics, including many oncologists, say that patients and the health system
cannot afford to pay huge prices for drugs that, on average, provide only a
few extra months of life at best.

And Folotyn (made by Allos Therapeutics) has not even been shown to prolong
lives ? only to shrink tumors. The drug was approved by the Food and Drug
Administration in late September as a treatment for peripheral T-cell
lymphoma, a rare and usually aggressive blood cancer that strikes an
estimated 5,600 Americans each year.

(James V. Caruso, the chief commercial officer for Allos) said the price of
Folotyn was not out of line with that of other drugs for rare cancers.
Patients, moreover, are likely to use the drug for only a couple of months
because the tumor worsens so quickly, he said.

In a note to clients in October, Joshua Schimmer, an analyst at Leerink
Swann, estimated that a typical treatment would last 3.5 months and cost
$126,000, or about $36,000 a month.


Allos Therapeutics, Inc.
Prescribing Information for Folotyn (pralatrexate injection)
Issued: September 2009

Indications and Usage:

Folotyn is indicated for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). This indication is based on
overall response rate. Clinical benefit such as improvement in progression
free survival or overall survival has not been demonstrated.

Adverse reactions (list includes only those events occurring in 10 percent
or more of patients treated):

Pharyngolaryngeal pain
Liver function test abnormal
Abdominal pain
Pain in extremity
Back pain
Night sweats
Upper respiratory tract infection

Percent of patients experiencing any adverse event: 100 percent

Forty-four percent of patients (n = 49) experienced a serious adverse event
while on study or within 30 days after their last dose of Folotyn.


The Library of Congress, THOMAS
Patient Protection and Affordable Care Act (Amendment in Senate)

Title VII - Improving access to innovative medical therapies
Sec. 7002, (a), (2), (k)
(7) Exclusivity for reference product
(A) Effective date of biosimilar application approval - Approval of an
application under this subsection may not be made effective by the Secretary
until the date that is 12 years after the date on which the reference
product was first licensed under subsection (a).

Comment: Fotolyn is a new miracle drug brought to us by our highly revered
pharmaceutical industry. This new drug has no demonstrated clinical benefit,
though all patients have adverse reactions, almost half of them serious -
including death.

In an astonishing moment of candor, James Caruso, chief commercial officer
for Allos, provided reassurance that the very high monthly cost of Fotolyn
would not be protracted since the tumor worsens so quickly.

What makes this drug a miracle only the investment community can understand.
Desperate patients will spend an average of $126,000 for this worthless
drug. On Wall Street that's a miracle, but within the health policy
community, that's a tragedy.

You can be assured that, in crafting health care reform, Congress has
responded to the very high prices of newer patented therapeutic agents, but
in a perverse way. Recognizing the great potential of genetically-engineered
biologics, Congress has included in the legislation an unprecedented 12 year
exclusivity, protecting the firms from competition of biosimilar products.

Maybe the biotech firms will be able to parley this into seven-figure
treatment programs for the desperately ill. The soak-the-sick policies may
not work for patients, but they certainly work well for Wall Street. And
doesn't that seem to be where Congress's loyalties lie these days?
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