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unixronin: Galen the technomage, from Babylon 5: Crusade (Default)
Unixronin

December 2012

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Friday, March 30th, 2007 09:39 am

We all know about the problems of antibiotic resistance, frequently aggravated by over-prescription and improper use of antibiotics.  MRSA, methicillin-resistant staphylococcus aureus, has been the bane of hospitals for a decade or more.  Other potent pathogens have emerged in MDR (multiple drug resistant) and XDR (extensively drug resistant) forms over recent years.

The latest to join the club is mycobacterium tuberculosis.  Tuberculosis, "the white plague", used to be a major killer before antibiotics.  In large part, the public health systems of the western world were put together to fight tuberculosis, and for a long time, TB was on the run.  But now it's back, worse than ever.  One fifth of TB cases worldwide are now multi-drug resistant TB, defined as resistant to both of the main first-line drugs.  For MDR-TB, four other drug families exist, but they are much more expensive, have severe side effects — starting with nausea and diarrhoea, and extending to convulsions and kidney failure — and must be taken for as long as two years to effect a complete cure.  XDR-TB strains may be resistant to as many as six of the available antibiotics, and since mycobacterium tuberculosis is lwo-growing, it currently takes several weeks to grow enough of a culture to test it for drug-resistance to find a drug to which it is susceptible — by which time the patient may well be dead.  In one South African clinic, out of 53 patients infected with XDR-TB since 2001, only one survived; the remaining 52 all died within weeks of infection.  Even in the US, out of one group of 64 XDR-TB patients, one third died.  Studies conducted to date appear to show that 2% of TB cases are XDR — in other words, one in five TB infections is MDR, and one in ten of those is XDR.

And it doesn't stop with MDR or XDR.  Since the magnitude of the drug-resistance problem became clear, doctors worldwide have dreaded the emergence of a virulent pathogen strain with complete drug resistance.  Last month in Italy, it finally happened:  a patient developed a strain of tuberculosis resistant to all currently known antibiotics.

It is estimated that one third of the world's population carries mycobacterium tuberculosis.  It is dormant in most carriers, but if the immune system is weakened or compromised by injury or other sickness, or by HIV, it can flare up and go active.  TB is the largest single killer among the HIV-positive.  On average, about one in ten people who carry mycobacterium tuberculosis will eventually develop the active disease.

One of the biggest problems here — and one of the reasons why there are no new drugs — is because TB is widely seen as a disease of the poor.  It is comparatively rare to find active TB in the western world, but in the world's poorer quarters, where sanitation is frequently poor, many patients cannot afford to see a doctor, and hospitals are frequently under-funded and under-equipped, it is widespread and becoming more so.  In 2006 there were nine million diagnosed cases of TB worldwide; 1.6 million of the patients died.

But there's little or no profit to be made in treating the diseases of the poor ... so drug companies, on the whole, aren't interested.

In recent years, an international agreement has been passed which allows poorer countries to issue "compulsory licenses" allowing them to make or import generic versions of patented drugs upon payment of a fee to the patent holder.  This program was designed to make front-line drugs available to countries that cannot afford to buy them over-the-counter from the manufacturer.  Thailand, where AIDS is now claimed by some to be the leading cause of death, recently issued such compulsory licenses for Sanofi-Aventis' heart drug Plavix and for two HIV drugs, Merck Sharp and Dohme's Stocrin and Abbott Laboratories' Kaletra, the most widely-prescribed anti-retroviral agent worldwide in its class.

[...] the Thai government has tried to talk to the companies but prices have not been reduced sufficiently.  “For the lopinavir/ritronavr we have tried several times to negotiate with Abbott in the last two years. They have reduced the price down but [it is] still too high to be affordable by our universal access to antiretroviral drug scheme,” [an official of the Thai government] said.

Abbott recently developed a new tablet formulation of Kaletra that needs no refrigeration — but, in retaliation for Thailand's compulsory-license issuance, Abbott is withholding the new formulation from Thailand, along with six other drugs.

Not all drug companies respond so poorly.  When Thailand issued its compulsory license for Stocrin, Merck Sharpe & Dohme responded with an offer to cut the price of Stocrin by two thirds.  Overall, the pharmacentical industry as a whole needs to get the message that profit is not the primary consideration when it comes to treating disease.  XDR and CDR pathogens put us all at risk, and there's no profit at all to be made from antibiotics if none of them work any more.

Friday, March 30th, 2007 05:08 pm (UTC)
And when people do catch forms of drug-resistant TB, what shall we do with them?

Why, let's lock them up in solitary quarantine: http://www.azcentral.com/arizonarepublic/local/articles/0329tb0329.html (http://www.azcentral.com/arizonarepublic/local/articles/0329tb0329.html).

(I figured you'd be interested in reading about that.)
Friday, March 30th, 2007 05:23 pm (UTC)
California has also forcibly quarantined at least one XDR-TB patient who would not stay on the antibiotic course and refused to wear a breath mask in public.

As far as what to do medically with XDR-TB patients, apparently doctors in some parts of the world are resorting to excising the infected parts of the lung or even removing entire lungs.
Friday, March 30th, 2007 10:02 pm (UTC)
Of course, one of the biggest problems is 19th century standards of hygene in some countries, who are unclear on the concept. (I believe it was Mike who relayed that they thought washing needles with soap would remedy the spread of AIDS in Thailand.)

Russia has...well, a very Russian way of treating its nasty TB cases. They lock those who have it away in a remote sanitarium, push food under the doors occasionally, and wait for those inside to die. I hope we don't come to that.
Friday, March 30th, 2007 11:53 pm (UTC)
A company is not a welfare agency. If Thailand needs the drugs they can pay for them, take the years needed to develop them or take them by force.

There are subsets of those options, negotiation, appeal to public sentiment or appeal to civil authorities. They chose the latter option authorized by civil authorities when they did not get what they wanted.

Since that agreement allows them to take what they want the system as designed worked for them.

I can understand why any company would not feel all warm and fuzzy at the prospect of losing more of their shareholders money. I suppose that force can be used against them again.

Eh, why not just take the company and all of it's property for public use? That would solve things very nicely.
Saturday, March 31st, 2007 01:28 am (UTC)
Nobody said a company was, or had to be, a welfare agency. But that's not what the compulsory-license law is about. Which of these scenarios makes Company X more money?

  1. Country Y desperately needs Drug Z, but can't afford it at Company X's prices, so has to go without and doesn't buy any.

  2. Country Y desperately needs Drug Z, but can't afford it at Company X's prices, so issues a compulsory license allowing its own pharmaceuticals industry to manufacture it, or allowing import from a foreign generic manufacturer, and pays Company X the mandated license fee per dose.


The point you appear to be overlooking is that a country eligible to use the compulsory-license agreement can't afford to buy the drugs at the manufacturer's retail, or even wholesale, price in the first place. The company isn't losing any sales, because a full-price sale wasn't going to happen anyway. So it's not as though the company is losing money, and they do get some compensation in the form of the license fee under the agreement. Sure, it's a small percentage; but many of these countries are manufacturing a lot of doses. It adds up. Meanwhile, maybe a whole lot of people who didn't choose to be born where they were don't die miserable deaths.

And ultimately, that's what health care should be about: providing health care on the basis of where it's needed, not that of where the greatest profit can be made. It's the whole idea that The Bottom Line Is Everything that creates a lot of the problem in the first place -- too many pharmaceuticals companies aren't interested in developing drugs to treat diseases that principally occur in countries too poor to be able to provide the profit margin the company's stockholders want to see on the quarterly balance sheets. So the diseases are inadequately treated, or left to run wild.

The compulsory-license scheme isn't perfect. But it's a lot better than saying, "This disease is endemic in your population and you can't afford our standard retail price for the drug to treat it? Sucks to be you." Thailand isn't importing a few thousand doses of generic Kaletra, or a few tens of thousand; they're importing tens of millions of doses. A half percent of the generic price on ten or twenty million doses of any drug is real money. In retaliating by refusing to sell the improved version of Kaletra and the other six withdrawn drugs in Thailand, thus throwing away whatever full-price sales they were getting in Thailand for those drugs, Abbott Labs is cutting off its own nose to spite its face.
Saturday, March 31st, 2007 01:54 am (UTC)

Since Abbott is so evil just take everything they have. I'm sure it will all work out fine.
Saturday, March 31st, 2007 04:14 am (UTC)
Now you're just being ridiculous.
Saturday, March 31st, 2007 08:30 pm (UTC)
*sigh* I know.