Tuesday, November 11, 2008

By February 2006 more than five million children had died from HIV/AIDS, and another 2.3 million children were infected. (UNICEF)
85% of them lived and died in sub-Saharan Africa.
Two- months later I arrived on my first trip to Swaziland.
I was so naïve.
For years I’d heard about HIV treatments, -ARVs and cocktails that added quality and quantity of years and drugs that would prevent the transmission of the virus from mother to unborn or nursing babies.
I thought they were everywhere.
In my lifetime we’ve seen a rapid decrease in the US infection rate.
But at the same time, there’s an outrageous increase of infection and death throughout the rest of the world.
Why?
In the year 2003 the number of childhood infections from mother to baby:
United States: 59
Ethiopia: 60,000
80% of those Ethiopian children died before the age of two.
How is that possible?
No access to these life saving drugs.
I asked my teachers the other day, “Do you remember when I came in 2006 to visit? I know the people had ARVs then… how long had you had access to them?”
“Oh, not long… I don’t remember, but not very long… they are new to Swaziland… just a short time.”
How is it that we Americans have watched a healthy happy Magic Johnson talk about his ARV since the early 90’s, and yet tens of millions of Africans have only recently received them?
I’ve recently read there’s no me without you by Melissa Fay Greene, a wonderful biography of a woman who has cared for orphans in Ethiopia. It’s a touching story filled with history of the country, but also history of the pandemic and its spread.
The role that our pharmaceutical companies played (or refused to play) was shocking. This is just a tiny, tiny, tiny excerpt, but enough for you to understand what I didn’t. Perhaps you are just as naïve as I was.




“Exclusivity is the lifeblood of the industry, “ writes Dr. Marcia Angell in her best-selling book, The truth about drug companies, “Because it means that no other company may sell the same drug for a set period. After exclusive marketing rights expire, copies (called generic drugs) enter the market and the price usually falls to as little as twenty percent of what it was.”
“But,” writes Angell, “Industry lawyers have manipulated some of its provisions to extend patents far longer than the lawmakers intended…
“Drug companies now employ small armies of lawyers to milk these laws for all they’re worth,- and their worth a lot.
“The result is that the effective patent life of rand-new drugs increased from 8 years in 1980 to about 14 years in 2000. For block-busters-usually defined as a drug with sales of over a billion dollars a year (like Lipitor, or Celebrex, or Zoloft)-those six years of additional exclusivity are golden. They can add billions of dollars to sales.”


…The big drug makers weren’t focused on keeping lifesaving medicines away from the poor; the millions of people dying of AIDS (6.4 million by 1994; and 22 million were HIV-infected) were not of specific interest. What the drug companies wanted to avoid was seeing a generic drug-identical to a pricy brand name drug-sold at rock-bottom prices. There were two big problems with this. The first was that the comparison could prove uncomfortable if a person in Brazil or India could purchase an exact copy of AZT for $1,000 a year a customer in Sweden, France or the Us might question why he was paying $10,000 or $15,000 for the branded version…
...The second problem was that if generic-drug companies began churning out knockoffs, the cheap versions of the drugs would surely make their way in to the rich markets of the northern hemisphere…
…So global patent protection was the new frontier…
…The cost of fighting the AIDS pandemic in the 1990 with brand-name drugs was estimated at $3 billion a year. The US government subsidized the cost for some Americans. African governments were too poor. And their AIDS sufferers were too numerous, to contemplate doing the same. The drugs were not expensive; the patents were. The patented drugs cost $15,000 per patient per year, although the production costs might have been closer to $200. This led to sticker shock among the world’s governments: universal treatment would not be an option for Africans..
…By the mid-1990s it was evident that South Africa was the hardest-hit country in the HIV/AIDS pandemic 4.3 million South Africans were infected with HIV; a quarter of a million South Africans would die of it by 2000; and it was estimated that , by 2010, life expectancy in SA would have fallen by more than twenty years…
…In 1997, taking advantage of a legal exception in Trade-Related Aspects of Intellectual Property Rights (TRIPS) the South African government passed the Medicines and Related Substance Control Amendment Act. Theoretically, under TRIPS, in a public health emergency, a government was permitted to suspend the patent protection on a brand-name drug within the country (this was called “compulsory-licensing”) and was permitted to shop for the cheapest versions available of brand-name drugs, rather than buying them directly from their manufactures. (This was called “parallel importing”) Less than three months after Nelson Mandela signed the “medicine Act” into law, the Pharmaceutical Manufacturers’ Association of South Africa, representing 39 pharmaceutical companies, filed suit in South Africa’s Constitutional Court, barring the amendment from taking effect. Plaintiffs included Alcon, Bayer, Bristiol-Myers Squibb, Boehringer-Ingelheim, Eli Lilly, Glaxosmith-Kline, Merck, and SmithKlein Beechem…
“…what drug companies are concerned about ,” James Love, executive director of the Consumer Project on Technology, testified before the US Congress Subcommittee on Criminal Justice, Human Resources and Drug Policy, Committee on Government Reform, “is the embarrassment of seeing a drug like Fluconazole selling for $23.50 in Italy but only $.95 in India. In this sense it is a public relations issue. But how many millions should literally die of this embarrassment?”…
…But the US government …pressured SA to repeal the Medicines Act. Congress temporarily cut off foreign aid…US trade Representative Charlene Barshefsky denied SA certain tariff breaks and place the country on a “Watch list”…
…The big drug companies took a thorough drubbing in the press over their lawsuit against SA, which had to be one of the worst public relations missteps of all time. Two years later still sheepish about the poor judgment, and industry representative addressed a health and human rights conference. He opened with a joke: “People ask me how we could have been so stupid as to sue Nelson Mandela.
I tell them we had to. Mother Teresa was already dead.”…
…At the waning of the 20th century, the major drug makers were presented with a historic opportunity. Crisis beckoned to them to recast the industry along ethical as well as profitable lines, to bring their medicines to the front lines of humanity’s gravest health emergency.
Instead they sued South Africa….
…In 2005 GlaxoSmithKline (formerly Burroughs Wellcome) saw the expiration of it patent on zidovudine (AZT) Generic drugmakers in China, India, and Africa applied to the US Food and Drug Administration with requests to manufacture generic versions and four American drug makers applied as well. GSK’s Retrovir cost $3,893.64 for a year’s supply; between 1987 and 2005, Retrovir generated $4billion in sales.
The generic version costs $105 for a year’s supply…

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