[e-drug] More essential drugs for cancer, HIV, Hep C added to India's EML

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E-DRUG: More essential drugs for cancer, HIV, Hep C added to India's EML
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Thu Dec 24, 2015 7:19am EST
India adds more cancer, HIV/AIDS drugs to essential medicines list

Reuters/Rupak De Chowdhuri/Files

http://www.reuters.com/article/india-medicine-pricecontrol-idUSKBN0U70W720151224

India has revised its list of essential medicines to add drugs for diseases ranging from cancer and HIV and AIDS to hepatitis C, in a move aimed at making them more affordable.

The update to the National List of Essential Medicines (NLEM) is just the third since it was compiled in 1996. It increased the list to 376 medicines from 348 and includes drugs ranging from analgesics and antivirals to contraceptives, cardiovascular and anti-tuberculosis drugs.

The list is posted on the Central Drug Standard Control Organisation's website. (bit.ly/1mBwpwD).

"The NLEM 2015 has been prepared adhering to the basic principles of efficacy, safety, cost-effectiveness; consideration of diseases as public health problems in India," a notice on the website said.

India had been criticised because the former list left out some life-saving drugs.

The new list takes cues from the World Health Organisation's 2015 list of essential drugs, which the United Nations agency defines as those that satisfy the priority healthcare needs of people and ensure affordability.

The revision comes after months of deliberations by a committee of experts formed by the central government last May. Views of the pharmaceutical industry and NGOs were also considered, the CDSCO said.

The committee recommended that the list, which is effective immediately, be revised every three years.

The Indian Pharmaceuticals Alliance, which represents large local drugmakers, did not respond to requests for immediate comment. It is likely that medicines in the new list will be brought under price control, as was done with the previous list, some in the industry said.

India contributes roughly 1 percent of its total gross domestic product to healthcare, among the lowest levels of funding in the world. India's drug pricing regulator has struggled in the past year to implement price caps and expand them to cover more drugs.

In initial thoughts, industry executives said they were yet to study the list's impact.
"We will be seeking clarification and a better understanding of its implications," said Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of India (OPPI) which represents large foreign drugmakers.

Drug pricing is a contentious issue in India, where about 70 percent of people live on less than $2 a day and health insurance is inadequate.

When the government fixed prices of about 100 medicines citing public interest last year, the industry fired back with lawsuits. The government soon curbed the NPPA's powers, restricting it from fixing the price of medicines not on the essential medicines list. (reut.rs/1Ocfo6n)

Industry executives say drug prices in India are also among the lowest in the world.

Price caps cover roughly 30 percent of the drugs sold in India.

(Reporting by Zeba Siddiqui in Mumbai; editing by Jason Neely)

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E-DRUG: Essential drugs for cancer- are they clinically effective and relatively safe?
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Are the essential drugs for cancer the exception to the rule — clinically effective and relatively safe?

How many of these cancer drugs have clear evidence of real clinical benefit to cancer patients?

A short assessment in the BMJ this spring [April 2015] found that the FDA, if not the EMA and other regulators, knowingly allow clinical trials for these drugs to often lack basic requirements for valid scientific results and then use those results, from trials designed to maximize evidence of benefits and minimize evidence of harms, to approve these drugs with a flourish of PR enthusiasm. Regulators allow most of these trials to substitute surrogate measures of clinical benefits.
A second BMJ editorial presented evidence that the new-generation monitoring for safety (risks of serious harm) has no evidence yet of being effective.

Both are at
http://www.pharmamyths.net/a_trio_of_short_critiques_of_the_fda_127980.htm

Hagop Kantarjian, among other leading oncologists, has published widely on how 90 percent or more of new cancer drugs provide few clinical benefits.

See
http://www.bloodjournal.org/content/121/22/4439?sso-checked=true

Are the essential drugs for cancer the exception to the rule — clinically effective and relatively safe?

Don

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E-DRUG: Essential drugs for cancer- are they clinically effective and relatively safe? (2)
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There is a lot that can be improved to maximize benefits for patients while still providing incentives for innovation. But this simplistic approach to attacking (in this case) anticancer drugs is not the way to go about it. I will not speak to the second BMJ editorial addressing clinical safety, as I believe this is an entirely separate issue.

Cancer drugs in my experience - and this is echoed by everyone who is a cancer specialist whereas I am not - are notoriously difficult to get approved and then to establish for optimal benefit.

Cancer drugs surprise us, we see that the critical trials for approval generally involve relatively small(ish) numbers of patients and we instinctively conclude that it's easy to bring a cancer drug to the market. It isn't. Early-phase cancer trials are conducted in patients who have few or no other options and whose immune systems are in very poor condition.

Very few cancer drugs are initially approved other than in combination trials with multiple other drugs, and in patients who are refractory to the best standard of care. Considering this, it is a wonder we ever have new cancer drugs approved.

Taxol (paclitaxcel) was approved by the FDA over 25 years ago with a dossier that was barely approvable. And yet, over a number of years it established itself as a mainstay of multiple treatment regimens. This is the norm, not the exception. The simple ethics of patient treatment for cancer make the approval process difficult.

Like many others, I cringe when I see television commercials promoting the short-term benefits of very expensive new cancer drugs. But, I also understand that regulatory agencies approve new drugs based upon clinical proof of non-inferiority, not superiority. To do otherwise would rob the public of the timely introduction of important new drugs. And, cancer drugs take a long time with lots of post-approval studies to establish optimal benefit. Most of this work comes AFTER regulatory approval, not before.

The root of this problem is a public discussion of fair pricing, not a knee-jerk rejection of the existing regulatory guidelines for marketing approvals.

Joseph Fortunak
Howard University DC USA
[Details added by moderator]
jfortunak@comcast.net