[Ip-health] Deborah Cohen in BMJ: US trade rep pressing Indian gov consortium says

Elizabeth Rajasingh elizabeth.rajasingh at keionline.org
Wed Nov 5 08:32:19 PST 2014


US trade rep is pressing Indian government to forbid production of generic
cancer drug, consortium says
BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6593 (Published 04
November 2014)
Cite this as: BMJ 2014;349:g6593

Deborah Cohen

The US government’s opposition to the generic manufacture of a cancer drug
has been described as an “endorsement of excessive pricing, a rejection of
the goal of access to medicine for all, and a death sentence for leukaemia
patients” in a letter from an international network of people affected by

The letter, written by the Union for Affordable Cancer Treatment to Michael
Froman, the US trade representative, alleged that he is using his position
to pressure the Indian government to deny patients access to affordable
generic versions of dasatinib.

Made by US firm Bristol-Myers Squibb, dasatinib (marketed as Sprycel) is
used to treat both Philadelphia chromosome positive acute lymphoblastic
leukaemia and chronic myeloid leukaemia when patients do not respond to
other treatments.

Bristol-Myers Squibb charge Rs6627 (£68; €86; $108) a day for a daily dose
of 100 mg in India—a country where the average annual per capita income is
$1570 and “where most patients pay for cancer drugs out of pocket,” the
letter said.

“Companies seeking a compulsory license have offered to supply generic
versions of dasatinib for $4 a day, and that price would likely fall if
competition was permitted,” it added. The letter said that the Indian
Ministry of Health had requested that the Department of Industrial Policy
and Promotion issue a compulsory license for dasatinib. But the department
is reportedly opposing the compulsory license, motivated primarily by
concerns that it would create trade and foreign policy problems with the
United States.

Moreover, it was not just the price in India that the consortium had
concerns about. They said that the price was “excessive everywhere.” In the
US Bristol-Myers Squibb has increased the price per milligram of dasatinib
threefold since the introduction of the drug in 2006. “Today the average
wholesale price for dasatinib [in the US] is a rapacious $367 per day,
roughly twice the price [of the drug] in other high income countries—and
this for a drug developed with extensive US government subsidies,” the
letter said.

The consortium alleged that although Bristol-Myers Squibb tried to justify
high cancer drug prices on the grounds that research and development was
expensive, the company spent little on the research and development of
dasatinib, as the funds came mainly from the public purse. “[The company]
benefited extensively from US government research subsidies, including NIH
[National Institutes of Health] funded research and clinical trials, and a
50% tax credit on the BMS [Bristol-Myers Squibb] funded trials,” the
consortium wrote.

In England and Wales the National Institute for Health and Care Excellence
did not recommend the use of dasatinib because it did not provide enough
benefit to patients to justify its high cost. The Cancer Drugs Fund
subsequently approved its use. The Scottish Medicines Consortium has
recommended its use for people with chronic myeloid leukaemia but did not
recommend it as a treatment for people with acute lymphoblastic leukaemia.

Although their letter focuses on one drug, the consortium said that “the
dasatinib dispute illustrates the shortcomings of US trade policy and its
impact on cancer patients.” The letter said that the US trade
representative had “a simple policy regarding cancer drugs to make them as
expensive as possible everywhere in the world” and that such an approach
was “flawed.” Patients could not “continue to be held hostage in a system
of threats” to ration life saving drugs because of the high prices charged,
the consortium said.

“Are we willing to acknowledge the high cost of the current system, that
returns just 8 cents per dollar of global sales in R&D [research and
development], and which often wastes much of that 8% on medically
unimportant R&D projects?” they asked.

Cite this as: BMJ 2014;349:g6593

thebmj.com Feature: Patent wars: affordable medicines versus intellectual
property rights (BMJ 2014;348:g1533, doi:10.1136/bmj.g1533)

Elizabeth Rajasingh
Perls Fellow, Knowledge Ecology International
1621 Connecticut Ave. NW, Suite 500
Washington, DC 20009
*elizabeth.rajasingh at keionline.org <elizabeth.rajasingh at keionline.org>* |

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