Tuesday, January 23, 2007

Developing Countries Demand Share Of Bird Flu Drugs

 

# 348

 

An ethical dilemma, one with far reaching consequences for billions of people, has come to the forefront in the debate over how to deal with a possible avian influenza pandemic.

 

In a world of 6.5 billion people, how do you fairly allocated scare resources such as antiviral medications, antibiotics, and vaccines?

 

What surprises me about this widely reported story is not the demands being made on behalf of those who live in developing countries, but that it has taken this long for those demands to be made vocal.

 

First the reportage from Geneva, Switzerland - then some discussion.

 

Poor countries demand share of bird flu drugs

January 23 2007 at 07:54PM

By Stephanie Nebehay

 

Geneva - Developing countries from Asia to the Middle East demanded on Tuesday that they receive their "fair" share of limited bird flu vaccines and anti-virals if a deadly pandemic strain emerges.

 

Hard-hit China and Thailand promised to provide more virus samples from birds and humans - deemed vital for developing vaccines and diagnostic tests for the deadly disease.

 

The debate highlighting the gap between rich and poor countries was held in the Executive Board of the World Health Organisation (WHO), which warned of a "serious" threat that the H5N1 bird flu virus may mutate into a pandemic influenza strain.

 

"The pandemic will definitely occur in developing countries, not developed countries. But we are sending our virus (samples) to the rich countries to produce anti-virals and vaccines. And when pandemic occurs, they survive and we die," Thailand's representative Suwit Wibulpolprasert said in a blunt speech.

 

"It is unfair to let the poor die and the rich survive," said Suwit, a senior Thai public health officer.

 

Calling it a "national security issue", Suwit said: "We are not opposing the sharing of information and virus, but on the condition that every country will have equal opportunity to get access to vaccine and anti-virals if such a pandemic occurs."

 

 

Very blunt statements indeed, and they show just how worried some nations are as we face a potential pandemic.

 

There is more to the article than the excerpt I posted, and I’d recommend that my readers read it all. It illustrates what could become a major problem in the coming months as we attempt to stave off any pandemic threat, and an even bigger problem should a pandemic actually occur.   

 

While one could easily take exception to the Thai representative’s statement that, “The pandemic will definitely occur in developing countries, not developed countries.”, since the virus respects no borders and would affect every nation of the world, he is likely correct that poor, developing nations will suffer the most in a pandemic. That was the case in 1918, and it is likely to be the case again.

 

The death rates in some areas of India during the Spanish Flu were somewhere between 20 and 40 times greater than in some countries in Europe, and probably 10 times greater than we saw in the United States.

 

Thus far, among H5N1 human infections we know about, the survival rates have been dismal, even with treatment. The administration of antiviral medications and antibiotics, when done so early, appears to improve the patient’s chances of survival greatly.

 

The truth is, while the CFR (Case Fatality Ratio) hovers around 70% today, we really don’t know how much impact these drugs will have, since most patients today don’t receive them early in their illness. Questions over the virus developing resistance to these drugs have yet to be answered, clouding the issue even further.

 

The world’s supply of antiviral medications, particularly Tamiflu and Relenza, is very limited. Vaccines are all but non-existent, and are likely to remain so for some time. Most of the production facilities for both types of medications are controlled by developed nations, and should a pandemic erupt, most of these medicines would likely end up in the hands of western nations.

 

No, it isn’t even remotely fair.

 

To put this problem in perspective, it is helpful to look at actual numbers, for while they show that developed countries will have greater access to medications, they too will find them in woefully short supply.

 

The United States currently has a strategic stockpile of roughly 20 million 10-pill courses of Tamiflu; enough for 6.6% of its citizens. This assumes that the 10-pill course is adequate, and anecdotal reports from the field indicate that this may not be so. Should it require 20 pills, then we currently have enough of this antiviral to treat 3.3% of the country.

 

While there are plans to acquire enough Tamiflu to treat 80 million people, or 25% of the nation, it will be two years before we actually have those medications stockpiled. And once again, that supply could be cut in half, if a higher dosage is required.

 

With an annual global production of Tamiflu running around 500 million courses, it would take 12 years to produce enough of this antiviral to provide everyone with the minimum dose. Of course, since the shelf life of the drug is half that, in reality, unless we can produce more, we’d never reach that goal.

 

The truth is, no nation, whether developed or developing, is going to have an adequate supply on hand anytime soon.

 

The numbers for a vaccine are similar, with the exception that we can’t really begin to produce an effective vaccine until we see the pandemic strain emerge, and can tailor the vaccine to it. At least with antivirals, we can manufacture them now in anticipation of a pandemic.

 

The idea that developed nations will go unscathed is specious. At best, 10% to 20% of their populations may have some form of treatment.

 

That is cold comfort, of course, to nations that will have none.

 

Today, the H5N1 virus is predominately found in developing nations, and in order to create vaccines and drugs to combat it, we desperately need access to the genetic sequences and patient medical records for those afflicted. This access has not always been forthcoming, and in some cases, has been flatly denied.

 

Access to this crucial data can therefore be seen as leverage by these countries, as illustrated by the `conditions’ stated by the Thai representative.  And it is fair to say that facing a pandemic without medications or vaccines is an issue of National Security for these countries. 

 

They have a right to be worried. And were I in their place, I'd probably be trying to find ways to leverage this data for drugs, myself.

 

I’ve no idea what would be considered a fair and equitable distribution of vaccines and medications.

 

Currently the world’s production-capacity is concentrated mostly in nine countries: Australia, Canada, France, Germany, Italy, Japan, the Netherlands, the United Kingdom and the United States of America. The WHO (World Health Organization) estimates (pdf file) that they could ramp up and produce 500 million 15ug-dose inoculations a year.

 

Enough for 7% of the world’s people.

 

The combined population of these 9 nations is roughly 750 million, or 50% greater than they could currently produce vaccine for. Add in the EU nations, which with most of these nations have close ties, and you have well over 1 billion people in the developed world vying for 500 million shots.

 

In the United States, only four manufacturers are currently licensed to produced influenza vaccines (Sanofi Pasteur, Inc., MedImmune Vaccines Inc., Novartis Vaccine, and GlaxoSmithKline, Inc.), and so we import much of what we need each year. How far back in the line the United States will be when it comes to acquiring vaccines during a pandemic remains to be seen.

 

There are hopes that in a few years new vaccine cell growth technologies will allow for the rapid production of greater quantities of vaccines, but that is some time distant, and the results uncertain. Until that happens, the world’s supply of vaccines is desperately shy of what would be needed.

 

Obviously some solution for developing nations needs to be worked out, but until the numbers improve, I have a hard time seeing a solution here. It will be a hard sell convincing vaccine-producing nations to export badly needed vaccines to other countries when their own countries have an inadequate supply.

 

It is for these reasons that so much money is now being spent on new vaccine technology. Literally billions of dollars. For there to be a solution, we need to find new, better, and faster ways to produce vaccines. And we need to find them quickly.

 

Until then, no matter how you slice it, 500 million doses won’t cover 6.5 billion people.