Thursday, May 9, 2013

GSK And Merck Are Certainly To Be Commended, Here [With A Footnote]


This morning's coverage of Whitehouse Station1 is dominated by the joint Glaxo-Merck announcement, with GAVI, of a very-low cost HPV vaccine initiative in the developing world -- some 40 countries by 2020. The aim is to vaccinate over 30 million girls -- and thus prevent the burden of the disease of cervical cancer -- at least the strains of cervical cancer caused by chronic HPV infections. At $4 to $6 per, as compared to over $100 per, here in the States, this is a very generous, humane and charitable endeavor.

As The Guardian noted over this past weekend, though -- I'd be less than candid if I didn't mention that cervical cancer is not a "top five" cause of mortality in most of these 40 countries. It is true that most of those women who do die of cervical cancer tend to live in the developing world, because -- as a rule -- the disease goes undiagnosed for many many years, in most cases. But that is not the same as being a "leading" cause of death, in these countries.

At least in Africa, one of the first countries to benefit from the initiative, women are far more likely to die from complications in childbirth (primarily sepsis from infections, and ruptured-uterus related bleeding), than cervical cancer. Data also suggest that men are far more likely to die of hypertensive disease, diarrheal disease and HIV/AIDS. And, candidly, each of these public health burdens would be far more expensive to widely address -- than a three-shot regimen of vaccines.

No doubt abut it, the HPV vaccines will save thousands of lives. But the vaccine is highly unlikely to save the lives of millions of women, primarily because they are likely to die of other causes, related to inadequate access to basic health care. That is, we should not expect a one-to-one correlation in doses administered, connecting to an equal number of lives saved.

UPDATED: Noon | 05.09.13 EDT -- I should have noted specifically that I think the New York Times' "275,000 deaths/year from cervical cancer in the developing world" figure. . . is not helpful, and perhaps a little misleading.

There is no evidence that these cervical cancer deaths in Africa, for example, are from the small handful virally-induced cervical cancers the vaccines prevent. [No one is paying for the tests needed to do a truly-precise post-mortem analysis, on the specific strains of virus/types of cancers these women are dying of  (it's all just likely listed as "cervical cancer" to the extent it is reported at all, in Sub-Saharan Africa, of that much I am certain.] There is also no evidence that the HPV vaccines on sale at deep discounts, are as effective against the most common strains which cause cancer, in Africa, for example. My understanding is that there are over 20 strains in Europe and North America alone. As is often true, mutations are likely to have occured, by geography -- and so, we cannot assign one-for-one results in Africa, for example, to North American data.

Surely, there will be some hefty number of saved lives, but I'd guess-timate the figure at closer to 10,000 than any figure over 100,000 -- especially in this, the pilot phase, with only a few hundred thousand doses being made available -- for all the above reasons. [END, UPDATED PORTION.]

Here is the Wa Po on today's news -- in any event:

. . . .Starting with pilot programs in eight Asian and African nations, the ambitious project ultimately is intended to inoculate more than 30 million girls in more than 40 countries by 2020. Given that most women killed by cervical cancer live in developing countries, the project could have a huge impact. . . .
Do not misunderstand, this is a very good thing -- no two ways about it -- we just need a whole lot more of it, in many many more disease states. Primarily in the truly heaviest burden of disease-states -- now. The "we" I refer to, is the "we" -- of the peoples -- all peoples, as a planet. We can do it -- the question is do we have the will to do it?

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1. You may generally assume, as I've written in the past, that if I don't mention a set of Merck press releases, it is because they are either puffery, or definitively immaterial to Merck's prospects and financial condition. Exhibit A for that proposition, would be yesterday's ragweed FDA BLA filing announcement. Here endeth my reminder.

4 comments:

Anonymous said...

and your thoughts for this?

http://www.drugstorenews.com/article/merck-submits-fda-filing-ragweed-allergy-drug/

Condor said...

Smile -- Didja' see/read my footnote (1) -- at the bottom of this same post? I was apparently a little to abtuse. . .

I do not think it will matter.

Sublingual tabs for ragweed allergy sufferers are only a slight improvement over currently available standard regimens.

It will be a nice little line -- but only a little one -- it cannot move the $50 billion needle at Merck very much, no matter what FDA decides.

On the main topic of this post, I should have noted specifically that I think the NYT's 275,000 deaths/year from cervical cancer in the developing world figure. . . is misleading.

There is no evidence that these cervical cancer deaths are from the small handful virally-induced cervical cancers the vaccines prevent. There is also no evidence that the HPV Vaccines on sale are effective against the most common strains which cause cancer, in Africa for example.

Surely, there will be some saved lives, but I'd guess-timate the figure at closer to 10,000 than 100,000 -- for all the above reasons.

Sorry to prattle on -- thanks for stopping by -- and, do stop back!

Namaste

Anonymous said...

sorry, missed the footnote...my bad.

I agree, just wondering~

thanks

Condor said...

Not a problem at all, Anon.!

Do stop back -- Namaste