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Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

Byoliveridley

As I mentioned previously, compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies for governments to authororize the bypassing of drug patents. Thailand threatened to do it recently, Brazil goes one better.

Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

President Luiz Inacio Lula da Silva took steps Friday to let Brazil buy an inexpensive generic version of an AIDS drug made by Merck & Co. despite the U.S. drug company’s patent.

Silva issued a “compulsory license” that would bypass Merck’s patent on the AIDS drug efavirenz, a day after the Brazilian government rejected Merck’s offer to sell the drug at a 30 percent discount, or $1.10 per pill, down from $1.57.

The country was seeking to purchase the drug at 65 cents a pill, the same price Thailand pays.

This story fits the script in every possible way. Here’s the drug company’s “disappointed” response:

Amy Rose, a spokeswoman for Whitehouse Station, N.J.-based Merck, said earlier that the company would be “profoundly disappointed if Brazil goes ahead with a compulsory license.”

“As the world’s 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease,” Merck said in a statement after Silva’s announcement.

Ah, the irony of a large pharma company appealing to Brazil’s sense of fairness!

The usual US government/chamber of commerce type’s scold and threat to withold further foreign investment:

But the U.S.-Brazil Business Council said the decision was a “major step backward” in intellectual property law and warned it could harm development.

“Brazil is working to attract investment in innovative industries … and this move will likely cause investments to go elsewhere,” the council said in a statement.

Who are the US-Brazil Business Council? It is an affiliate of the U.S Chamber of Commerce. Its website reveals it to be a lobbying and networking group of high powered U.S executives “fostering” U.S-Brazil trade relations. Hmm, I wonder who’s side they will take!

But, we forget what this is about, the health of thousands of AIDs patients (and the money it costs to treat them).

Brazil provides free AIDS drugs to anyone who needs them and manufactures generic versions of several drugs that were in production before Brazil enacted an intellectual property law in 1997 to join the WTO.

But as newer drugs have emerged, costs ballooned and health officials warned that without deep discounts, they would be forced to issue compulsory licenses.

Efavirenz is used by 75,000 of the 180,000 Brazilians who receive free AIDS drugs from the government. The drug currently costs about the government about $580 per patient per year.

Brazil is doing absolutely the right thing by bargaining and playing hardball. it wants to pay the same prices Thailand pays, and should continue to bargain till it gets there. There’s no sense in being a sovereign powerful nation if you can’t shakedown a pharma company, is there!

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    Stalking my walking.

    Byoliveridley

    image

    Google Now tells me I have walked 74 km in February (one of the last meaningful acts of my phone before it passed away). That’s mostly me walking from my bus stop to work and back, 3.6 km everyday, something I don’t consider exercise to the point that I undergo serious bouts of self-criticism about “not exercising enough”. I post this because I, like many around me, am very concerned about the amount of digital surveillance in our society. Everyday, Snowden’s document dump brings new revelations. Yahoo webcam images, anyone? But the benefits of benign surveillance are potentially big. I would like my phone to remind me that I am exercising, that my bus is scheduled to arrive in 5 minutes (of course, BC Transit does not have real-time information, so this is theoretical), that I am near a grocery store that has my favourite cereal on sale (this would need open data on retail prices), that my neighbour on the bus is reading the same book that I am (okay, too much!).

    Cellphones are now intelligent, location and context aware. They can do a lot of good. Hell, I’ll even tolerate the use of some of my metadata for advertising and information gathering as long as it is transparent. But the data is also used by governments non-transparently to track my movements and actions, and I am deeply uncomfortable with it. Till now, my gee-whizness and fairly high belief in the value of a trust-based open information commons keeps me from closing off these data streams. If we stop trusting in the good of an open internet and stop contributing, the internet is seriously harmed.

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    Feds punt on Bisphenol A

    Byoliveridley

    By studiously ignoring all the subtle hormone disruption effects of bisphenol A and concentrating on easily observable neurological effects, the CERHR essentially does the industry’s bidding.

    Some risk linked to plastic chemical – Los Angeles Times

    A federal panel of scientists concluded Wednesday that an estrogen-like compound in plastic could be posing some risk to the brain development of babies and children.

    Bisphenol A, or BPA, is found in low levels in virtually every human body. A component of polycarbonate plastic, it can leach from baby bottles and other hard plastic beverage containers, food can linings and other consumer products.

    Culminating months of scientific debate, the decision by the 12 advisors of the Center for the Evaluation of Risks to Human Reproduction — part of the National Institutes of Health — is the first official, government action related to the chemical. Their recommendation will be reviewed for a federal report that could lead to regulations restricting one of the most used chemicals.

    The scientists ranked their concerns about BPA, concluding they had “some concern” about neurological and behavioral effects in fetuses, infants and children, but “minimal” or “negligible” concern about reproductive effects. The findings put the panel roughly in the middle — between the chemical industry, which has long said there is no evidence of danger to humans, and the environmental activists and scientists who say it is probably harming people.

    For a detailed look at how bisphenol research has been corrupted by industry sponsored “focused counter research” – where the goal is to show no effects and the experiment is tiled to ensure this goal, read this excellent article in the The Public Library of Science Biology Open Source Journal. Note, because it is Open Access, you can actually read it without selling a kidney! Some highlights…

    The moment we published something on bisphenol A, the chemical industry went out and hired a number of corporate laboratories to replicate our research. What was stunning about what they did,” vom Saal says with a mix of outrage and bemused disbelief, “was they hired people who had no idea how to do the work. Each of the members of these groups came to me and said, ‘We don’t know how to do this, will you teach us?’”

    More…

    The HCRA report, commissioned before Schwartz’s tenure, concluded that “the weight of the evidence for low-dose effects is very weak” [15]. Industry groups hailed the report as a comprehensive review by independent experts and quickly disseminated its findings. Yet the “comprehensive” report reviewed just 19 of 47 studies available in April 2002, and when it was published more than two years later, three panelists asked not to be listed as authors.

    What the hell, just read the whole article, especially the bit about the Harvard Center for Risk Analysis and its well documented industry shillness.

    The key to understanding bisphenol research is to realize that it is a hormone disruptor that works at low doses. At high doses, normal toxicological testing doses that is, it floods the hormone receptors and slows down the receptor pathways. So, the usual technique of testing in rats and mice at high doses and extrapolating will not work.

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    Endocrine Disrupting Chemicals – A new Resource

    Byoliveridley

    Critical Windows of Development is a timeline of how the human body develops in the womb, with animal research showing when low-dose exposure to endocrine disrupting chemicals during development results in altered health outcomes.

    Critical Windows of Development

    This promises to be an easy to use database showing development timelines of infants, and the documented effects of endocrine disrupting chemicals at these timelines. The prime focus is bisphenol A and phthalates at this point in time. The Environmental Health News has more about the program here. It is not out for public consumption yet, so stay tuned…

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    Tuesdays with Turtles – Travel Edition

    Byoliveridley

    sm_mapping.jpgIt’s travel all the time for sea turtles. Of course, the great turtle race is finally on, and windy’s in the lead, my pick billie’s in second place, a mere 30 miles behind. There’s a new turtle in the race, Colbertia, named in honor of Stephen Colbert, in third place.

    Anything that gets turtles some attention is good.

    But this is only a 500 mile sprint. PBS’ nature series had a one hour documentary on an 8000 mile, one plus year journey of a loggerhead turtle from her juvenile feeding grounds in Mexico to her adult breeding ground in Japan. It’s great to spend an hour at that close proximity to a turtle. But to me, the other animals, the dolphin pods, the giant fish swarms, the hammerhead sharks, the other sharks, the jelly fish, those little fish that eat parasites off the turtles and sharks kinda stole the show. There is something about thousands of animals of the same species doing something in concert. 

    Anyway, nothing more to say, except that 8000 miles is a long way at a mile an hour. I don’t think any of us can appreciate the mindfulness and sense of purpose (do turtles have these qualities, or do they just keep on chuggin’?), not to mention the huge amount of luck it takes to get it done.

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    India Rejects Obvious Patents

    Byoliveridley

    Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for the elite?

    Setback for Novartis in India Over Drug Patent – New York Times

    Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday.

    Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies’ efforts to improve their products.

    At issue is the degree of innovation required for a drug to be regarded as truly “new”, where there is a significant enough chance for failure that the company would never develop it unless afforded monopoly rights for 10 years. A very well known tactic by drug companies is to make a slightly different formulation of an existing drug, say an extended release form of a drug which takes a little longer to dissolve, and hence is available to the body at a different time. Under US patent law, this qualifies for full patent protection on the extended release form. By now, the science of making an extended release tablet is well known, it’s just a question of formulating the drug with a different set of inactive ingredients that take longer to dissolve, or sometimes, through a differently engineered tablet. The chemistry of this change is predictable, published and not really innovative. Why should these small changes have patent protection?

    Bonus Note: Madras is my home city, so I’m glad it was decided there!

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    Ethanol significantly worse than gasoline for air pollution

    Byoliveridley

    So, Mark Jacobson from Stanford, an accomplished atmospheric chemist and modeler from Stanford, puts ethanol into his modeling mix as an automobile fuel and comes up with increased ozone, peroxyacetyl nitrate (PAN, an ozone precursor) and acetaldehyde, leading to a possible increase in mortality. Without reading his paper, I cannot comment on the assumptions used, but this is an additional issue to be concerned about as our politicians continue to binge on alcohol. It’s weird, almost as if there’s something intoxicating and addictive about this fuel :-;

    Effects of Ethanol E85 versus Gasoline Vehicles on Cancer and Mortality in the United States

    Ethanol use in vehicle fuel is increasing worldwide, but the potential cancer risk and ozone-related health consequences of a large-scale conversion from gasoline to ethanol have not been examined. Here, a nested global-through-urban air pollution/weather forecast model is combined with high-resolution future emission inventories, population data, and health effects data to examine the effect of converting from gasoline to E85 on cancer, mortality, and hospitalization in the United States as a whole and Los Angeles in particular. Under the base-case emission scenario derived, which accounted for projected improvements in gasoline and E85 vehicle emission controls, it was found that E85 (85% ethanol fuel, 15% gasoline) may increase ozone-related mortality, hospitalization, and asthma by about 9% in Los Angeles and 4% in the United States as a whole relative to 100% gasoline. Ozone increases in Los Angeles and the northeast were partially offset by decreases in the southeast. E85 also increased peroxyacetyl nitrate (PAN) in the U.S. but was estimated to cause little change in cancer risk. Due to its ozone effects, future E85 may be a greater overall public health risk than gasoline. However, because of the uncertainty in future emission regulations, it can be concluded with confidence only that E85 is unlikely to improve air quality over future gasoline vehicles. Unburned ethanol emissions from E85 may result in a global-scale source of acetaldehyde larger than that of direct emissions.