[Ip-health] Novartis's Rebuttal: Glivec Controversy: Spanner In The Works

[Joana Ramos]

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Novartis's Rebuttal
http://www.businessworld.in/mar0507/news02.asp#[1]
Glivec Controversy
Spanner In The Works
Gauri Kamath
Businessworld Online ( Kolkata)
5 March 2007
Novartis has the Highest Regard for Patient Confidentiality
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When contacted by Businessworld, Novartis issued a point by point rebuttal of
the allegations made by Dr Purvish Parikh in his affidavit. Scroll down for
the details:
Why has GIPAP turned down Dr Parikh's patients, including the ones under the
ESIC scheme which does not reimburse patients for Glivec?
The Glivec International Patient Assistance Program (GIPAP) was instituted by
Novartis to enable access to Glivec for those patients who were medically
appropriate for treatment with Glivec, who were not insured or not reimbursed,
and who could not afford to buy the drug.
With reference to your specific query, we checked with The Max Foundation, the
administering body for GIPAP in India, and found that since inception of the
program in 2002, there were actually 8 patients under the care of Dr Purvish
Parikh and not 11 who were not enrolled onto the program as they did not meet
the eligibility criteria. Eight of them could not be enrolled as either they
or their spouse worked in government establishments with access to
reimbursement. As per GIPAP guidelines in India , patients who are eligible
for reimbursement but are unable to obtain it, must present documents stating
the same from their employer. The Max Foundation did not receive such
documents from any of these patients. There are several instances where
patients have come back to The Max Foundation with supporting documents and
got onto the program. Three of the cases reflected duplicate applications of
patients already on the program. As the treating physician, Dr Parikh was kept
informed of each case. The Max Foundation also informs us that there are
currently 594 patients under the care of Dr Parikh who are on GIPAP.
How do you respond to the allegation that Novartis is conducting a clinical
trial under the garb of GIPAP?
GIPAP is not a clinical trial but we have obligation to report serious adverse
events (SAEs) as part of normal post-launch pharmacovigilance activities aimed
at identifying any safety or other issues relating to approved and launched
drugs.
As the marketing authorisation holder (MAH), Novartis has obligations under
US, EU and other drug regulatory rules to provide prompt information on SAEs
(Serious Adverse Events). Under both the FDA CFR, ICH E2D and EMEA vol 9A of
Rules Governing Medicinal Products in the European Union: Guidelines on
Pharmacovigilance, the MAH is required to report cases from organised data
collection schemes including patient support and disease management
programmes. This is regardless of where in the world the program is operated.
The MAH is required to report serious adverse reactions arising from such
programmes to global regulatory authorities. GIPAP is one such patient support
scheme. So we collect serious adverse events to meet our regulatory
requirements.
The central Integrated Medical Safety (IMS) team, CTSO, database all the
serious cases coming from GIPAP and reported on the SAE form which only
collects a patient's ID number and initials. No full patient names are ever
collected. We are required to try and obtain identifierspatient number,
initials or date of birth for a patientto confirm the validity of such an
individual for reporting to regulatory authorities. The information is only
shared with health authorities as is permitted under the Data Privacy
legislation. As part of our regulatory obligations to perform due diligence,
each case is evaluated and assessed for the relevant follow-up information
required. As this site handles SAEs coming from all Novartis' interventional
and non-interventional studies and other organised data collection schemes,
they have developed a few standard forms to use for the request of required
follow-up information.
The Novartis CTSO Non-Interventional Clinical Trial SAE Query Follow-Up Form
was the selected standard template used on this occasion to ask for the cause
of death in Dr Parikh's patient. Although the title refers to a clinical
trial, it is merely the title of a standard template which is not specific for
GIPAP, and covers many different forms of non-interventional data collection
schemes.
Further, clinical trials are conducted for indications which are not approved
where data is needed to register the drug. In the case of GIPAP, the drug is
dispensed only to patients for indications approved by the local health
authorities. Glivec is being used entirely within scope of its licensed
indication.
What about the allegation that there is no patient confidentiality maintained
under the GIPAP programme, and that the identity and other details of patients
on the GIPAP programme are known to Novartis?
We are very surprised at this allegation as Novartis has the highest regard
for patient confidentiality and does not have any access to patient
identification. In fact, as recently as January 2007, Dr Purvish Parikh
approached Novartis for data on all patients on GIPAP to support a
retrospective analysis being conducted by him of data of CML patients from
India treated with Glivec on GIPAP. The rationale for his study was that
"GIPAP has been immensely successful and it is important to highlight its
advantages for the Indian oncology community as well as showcase it to the
world." Novartis directed him to The Max Foundation as it did not have access
to the requested data. We understand from The Max Foundation that Dr Parikh
was sent data only on patients under his care and refused data on other
patients unless Dr Parikh procured written consent from their treating
physicians. This was never received by The Max Foundation and the data never
shared with Dr Parikh.
In any communication with Novartis, patients are identified by The Max
Foundation by a Patient Identity Number (PIN) so as to maintain
confidentiality. This is clearly demonstrated in exhibits E, I and the form
following exhibit I attached to the affidavit, a copy of which you have. Going
by the affidavit filed by Dr Purvish Parikh, the only time when patient names
and PIN information are both present are in private communication between Dr
Parikh and The Max Foundation - see exhibits G and H of the affidavit. We are
concerned that patient confidentiality is breached by making this information
available in this affidavit which is now in the public domain.
It is clear that these allegations are absolutely baseless and it is indeed
disappointing that Dr Purvish Parikh lends his name to such an affidavit when
he should be aware of the true nature of GIPAP and its conditions of patient
confidentiality.

--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/[2]

===References:===
  1. http://www.businessworld.in/mar0507/news02.asp#
  2. http://ramoslink.info/