Re: Rational Use of ARV and ARV Regulation.(2)

[Guest guest]

Rational Use of ARV and ARV Regulation.

Dear Forum,

Re: /message/7881

Hope you will find this news article interesting, published in Times of India in

2003. On our previous posting many people preferred to call up on the cell phone

and shared what is happening around them on ART and needed more time to come

forward to share their observations and concerns.

Government must frame policy on use of ARV therapy for AIDS: Experts

12 Feb 2003, 0001 hrs IST , Rupa Chinai , TNN

timesofindia.indiatimes.com/archive/year-2003,month-2,starttime-37664.cms - 65k

-

MUMBAI: On the surface, it would seem like an effective way to guard against the

new Black Death. Across India, doctors and pharmaceutical companies are

encouraging HIV patients to start on Anti-Retroviral (ARV) therapy and urging

others to be tested for the virus. But many public health experts warn that this

strategy is fraught with danger and potentially catastrophic consequences.

Community-based NGOs such as Sankalp or Committed Communities Development Trust

say it is dangerous to advocate unwarranted HIV testing without counselling

patients, or without warning them about the drawbacks of ARV treatment.

Both these organisations have found that many poor and middle-class HIVpositive

persons are consuming ARVs in “fits and starts’’ because of their unstable

financial condition.

Although doctors know this, they have not counselled their patients about the

dangers of irregular therapy. Before starting on the regimen, patients were not

told of the hidden costs associated with ARV therapy: apart from the cost of the

drugs, expensive and regular laboratory tests are required.

Neither were patients informed that ARV could cause severe side-effects in many

people—and does not promise a cure. Meanwhile, an initial HIV- positive test

result could turn out to be false, as has often been shown in subsequent

testing.

Official policy in Mumbai’s public hospitals does not encourage HIV testing

unless there are clinical symptoms warranting suspicion of AIDS. Although the

National AIDS Control Organisation now stipulates three Eliza tests before a

person can be confirmed as HIV positive, the positive result from a single test

is still projected to be a death sentence by doctors.

AIDS specialist Nagesh Shirgoppikar said that there is a strong case for ARV to

be taken by patients if their CD4 count (a laboratory test which measures their

immune status) falls below 225.

Confirming that this approach adheres to current international recommendations,

experts at a recent workshop to promote responsible ARV use by city doctors

said, such patients have experienced a life-saving reversal of symptoms. But a

nexus of pharmaceutical companies and doctors appear to be promoting a much

wider use of ARVs.

HIV positive persons are being encouraged to start the therapy before they need

it, several Mumbai doctors have reported. Qualified doctors—not just quacks— are

also experimenting with their own dosage and drug combinations.

Lack of adherence to standardised therapy, and improper monitoring of toxic

side-effects could lead to drug resistance in patients, they warned. If drug

resistance were to develop, access to new and more effective AIDS drugs will be

expensive for Indian AIDS patients, once patent protection comes into force in

2005, says Vivek Diwan, from Lawyer’s Collective.

Ranbaxy, an Indian multinational is reported to have been indulging in

“door-step’’ selling of ARVs directly to HIV persons, bypassing usual retail

channels that dispense prescription drugs. Having a close nexus with public and

private hospital doctors treating HIV/ AIDS patients, the company is believed to

service around 350 patients in and around Mumbai. The drugs are delivered by the

company courier, on terms of cash on delivery, and a discount of nearly 20 per

cent on market rates. Ranbaxy confirmed that it offered courrier delivery of

ARV’s to “some’’ patients.

A company representative said this direct marketing was done on the basis of a

doctor’s prescription, and the company did not make enquiries into the

prescribing practices of doctors.

The company stonewalled further enquiries, despite the submission of written

questions at their request, and a personal visit by appointment to their Andheri

office.

According to Mumbai doctors, the pharmaceutical industry’s push to market ARVs

is an effort to get Indian patients started on the drug in the hope that the

medical profession will ultimately generate a demand forcing the Indian

government and global donors to supply free ARVs through the public health

system. Says Sanjay Nagral, an editor of ‘Issues in Medical Ethics’, “We need a

strong national policy on ARV use.

Steps to prevent drug resistance cannot be left to the whims of private

practitioners or the pharmaceutical companies, whose record in public health is

not encouraging. The chaotic prescribing of TB or antibiotic drugs provides

ample example of a weak health system that cannot monitor or prevent wrong

practices and ethics. Such abuse with ARV drugs can only lead to a more

dangerous and chaotic situation’’.

The race to cash in on India’s AIDS drugs market is resulting in a price war

amongst companies, with the recognition that even at steep discounts, the market

promises a healthy revenue, recent press reports reveal.

Currently there are five companies already in the Indian market and more are set

to enter.

With the Indian government estimating the number of HIV positive cases in India

at 3.5 million, and international agencies projecting 25 million, the Indian

market is estimated to be worth Rs.100 crores. (This is the fourth and

concluding part of a series on India’s donor driven health agenda).

_________________________________________________________________

With regards,

Sanjeev Jain

e-mail: sanj1966@...