[Ip-health] Glivec Controversy : Spanner In The Works

[Joana Ramos]

http://www.businessworld.in/mar0507/news02.asp#

Glivec Controversy
Spanner In The Works


Gauri Kamath
Businessworld Online ( Kolkata)
5 March 2007


CHALLENGER:
Purvish Parikh has alleged that Novartis refused access to GIPAP to some

The $2.6-billion cancer treatment drug Glivec is proving to be an
albatross around Swiss MNC Novartis=92 neck in India. Aid groups have
flayed a lawsuit in the Madras High Court, in which Novartis has
challenged the rejection of its patent application on the drug for its
potential to take cheaper copies of Glivec off the market, and tighten
India=92s patent law.

The latest blow to Novartis is an affidavit filed by a Mumbai-based
oncologist that makes serious allegations about GIPAP. The scheme
provides Glivec, which costs Rs 14 lakh a year, for free to needy patients.

Purvish Parikh, professor and chief of medical oncology, Tata Memorial
Hospital, has alleged that 11 of his patients have been denied access to
free Glivec. Some of the patients were poor workers covered under a
government health scheme that did not reimburse expensive medicines, he
says. When asked why they were rejected, Parikh says, =93I wish I knew the
answer.=94 Tata Memorial sees about 325 new cases a year of chronic
myeloid leukaemia (CML), the cancer that Glivec treats.

Novartis says patients who are eligible but unable to obtain
reimbursement must present documents stating as much from their employer
which these patients did not do. It also says that only eight of the
doctor=92s patients were not enrolled into GIPAP and Parikh was informed
of each case.

Parikh has also made a startling suggestion, denied by Novartis, that it
may be running an unauthorised clinical trial under GIPAP. He alleges
this on the basis of serious adverse event (SAE) reporting forms that
Novartis circulates to doctors with GIPAP patients. These forms are
labelled as being for a =91non-interventional clinical trial=92. The
affidavit claims that The Max Foundation (TMF), an NGO that administers
GIPAP, shares information about beneficiaries and their status with
Novartis, thus violating confidentiality.

But the company says that it is obliged under US and other drug
regulatory rules to provide prompt information on SAEs including in
patient support schemes =93regardless of where the programme is operated=94=
.
The SAE form is =93a standard template which is not specific to GIPAP and
covers many different forms of data collection schemes=94, it says. No
full names are collected and data is shared with regulators under
privacy legislations, it says. It adds that Parikh had himself sought
data from Novartis on all GIPAP patients but was sent data only on his
patients as he did not provide written consent from other physicians.

Parikh is one of the first doctors that Novartis approached in 2002 to
explain GIPAP. He is one of 87 physicians that TMF has authorised to
refer patients to it. Novartis says Parikh has over 594 patients on
GIPAP. Yet, as the affidavit shows, the doctor seems dissatisfied about
the way GIPAP is run. Parikh believes that a patent on Glivec will deny
access to the life-saving medicine to many including those currently
using the copycats, some of them subsidised or free.

Novartis says 6,700 patients in India get free Glivec, but where 20,000
are diagnosed for CML every year, many too poor to afford treatment, it
clearly has a long battle ahead of it.

--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/