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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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  • Melamine – The FDA Says the Right Things

    Byoliveridley

    But can it follow up?

    FDA limits Chinese food additive imports – USATODAY.com

    The Food and Drug Administration is enforcing a new import alert that greatly expands its curtailment of some food ingredients imported from China, authorizing border inspectors to detain ingredients used in everything from noodles to breakfast bars.

    The new restriction is likely to cause delays in the delivery of raw ingredients for the production of many commonly used products.

    Inspectors are now allowed to detain vegetable-protein imports from
    China because they may contain the chemical melamine. Melamine, used in
    the manufacture of plastics, was found in the wheat gluten and rice
    protein concentrate that has led to the recall of 5,300 pet food
    products.

    Good, and about time. The FDA cites “control issues” in issuing this alert.

    Now for the products to reach U.S. foodmakers, the importers will have
    to prove to the FDA that they are safe. The ingredients restricted
    include wheat gluten, rice gluten, rice protein, rice protein
    concentrate, corn gluten, corn gluten meal, corn by-products, soy
    protein, soy gluten, mung-bean protein and amino acids.

    Excellent stuff, exactly what was needed, to put the onus on the manufacturer to prove safety. Here’s the FDA’s press release.

    The onus, of course, is on enforcement. Can the FDA identify every item on this list, and quarantine it until a certificate is produced? Can it subject a random number of these products to independent verification to avoid cheating? Does it have the resources? Does it have the inspectors? Stay tuned.

  • | |

    Circumcision and AIDS – Revisited

    Byoliveridley

    condom.jpg

    A post I wrote quite a while back on circumcision and AIDS remains my most commented post ever. In it (if you’re too lazy to click) I said that while research indicating a reduction in HIV infection in circumcised men was promising, there were a couple of concerns. One, that this could be a distraction from the single most effective prevention measure (no, not abstinence!), condom use. And two, that in certain cultures, especially among Hindus, this would be an absolute no no because circumcision is identified with being Muslim.

    Anyway, in a review article, the Cochrane Centre in South Africa summarizes results from a meta analysis of a number of trials indicating a 50% reduction in HIV incidence among circumcised males. At this point in time, it is clear that circumcision is effective in reducing HIV incidence among heterosexual males. Based on this, the institute encourages the widespread use of circumcision as an AIDS prevention strategy.

    So, am I still circumspect? Absolutely. I am still concerned that this research will be misinterpreted in a way that discourages condom use. In fact, the authors note that circumcised men indulged in more risky behaviour. Also, the incidence of HIV in the women these men were sleeping with increased from 9.6% to 13.8%, a 40% uptick. This increase was not statistically significant. No arguing with that, though the study was stopped early once it was clear that the men were helped, never mind the women, or reaching statistical significance in their case.

    Given that it is very unclear what the effects of circumcision are on anything other than circumcised penises, which are only one half of the equation (or less!), I don’t think it is responsible to call for widespread use of circumcision as a public health strategy for the prevention of HIV until its effects on the other parties are known. While people are aware of this issue, I don’t think the science or the cultural landscape promote the use of circumcision as a HIV prevention strategy until its proven that women are not at risk from increased HIV incidence either biologically from a yet unknown mechanism, or socially from increased risk taking.

    Men have more power in most societies to demand and receive sex on their terms. So the male centric nature of this research, and the conclusions drawn are disturbing. How irresponsible is it to encourage a public health strategy that appears to increase risk taking behaviour among men when the effects on the women are yet unknown, with only a statistically “insignificant” 40% increase in HIV incidence among women being observed?

    I am. for very good reason, still circumspect on circumcision.

    Whisky flavoured condoms courtesy bruno  girin’s photostream used under a creative commons license. Now how’s that for a turn on, whisky!

  • |

    South Asians: Watch your Heart

    Byoliveridley

    Seems like us South Asians die earlier from heart attacks.

    ScienceDaily: South Asians Have Higher Levels Of Heart Attack Risk Factors At Younger Ages

    Deaths related to cardiovascular disease occur 5 to 10 years earlier in South Asian countries than in Western countries, according to background information in the article. This has raised the possibility that South Asians exhibit a special susceptibility for acute myocardial infarction (AMI; heart attack) that is not explained by traditional risk factors.

    But why?

    The prevalence of protective risk factors (leisure time physical activity, regular alcohol intake, and daily intake of fruits and vegetables) were markedly lower in South Asian study participants compared with those from other countries.

    Um, it is mainly behavioral, not genetic according to the authors, and hence can be mitigated by lifestyle changes.

    Well, I guess it is time to take a personal stock as of 1-18-2007:

    • Weight – Well, I am in the lower end of the healthy BMI.
    • Exercise – 4-5 days of 45 minutes – 1 hour per day, pretty good.
    • Food – Well, mostly good, especially if the candy can be avoided. I need to eat more vegetables, but I eat a lot of high fibre, and whole wheat food, probably not enough protein, mostly vegetarian.
    • Alcohol (1-2 drinks is apparently a heart protector) – Amen, I am a religious one drink a day partaker, more on weekends :-;
    • Smoking – Well, gave that up a while back, now to quit that occasional “party” smoke.
    • Stress – Well, not so good, this is probably the area I would need to work on the most.
    • Hypertension – Well, I am borderline on my blood pressure readings 🙁 Need to work on that.
    • Cholesterol – Still waiting for results on my physical.

    On the whole, I seem to be in decent shape. It’s good to take stock once in a while.

  • |

    Brazil successfully hardballs Abbott on AIDs drug

    Byoliveridley

    I mentioned in May that Brazil had introduced compulsory licensing on a Merck AIDs drug Efavirenz, and heartily recommended that Brazil and other third world countries continue to play hardball with big pharma whenever they could. It looks like Merck decided to not bargain, but Abbott did on Kaletra. Note that Abbott got into a similar controversy with Thailand, and agreed to drop the price when Thailand rejected the Kaletra patent.

    Keep it coming, third world countries. Bargaining is perfectly acceptable in the marketplace!

    Brazil says Abbott to cut price of AIDS drug | Health | Reuters

    razil’s health ministry said Wednesday that Abbott Laboratories Inc. agreed to cut the price of its Kaletra AIDS drug by 29.5 percent.

    The lower price for the drug, also known as lopinavir and ritonavir, will help Brazil supply free drugs for its AIDS treatment program.

    In May, President Luiz Inacio Lula da Silva authorized Brazil for the first time to break the patent on an AIDS drug, one made by Merck & Co.. It then started importing a generic version of the drug Efavirenz from India.

    Under WTO rules, countries can issue a “compulsory license” to manufacture or buy generic versions of patented drugs deemed critical to public health.

    Drug makers often reduce prices to keep countries as clients and avoid compulsory licenses.

  • China Food Quality Questioned

    Byoliveridley

    I mentioned briefly that I would not trust anything coming out of China at this point in time, the Post runs with it this morning.

    China Food Fears Go From Pets To People – washingtonpost.com

    The scandal, which unfolded three years ago after hundreds of babies fell ill in an eastern Chinese province, became the defining symbol of a broad problem in China’s economy. Quality control and product-safety regulation are so poor in this country that people cannot trust the goods on store shelves.

    China has been especially poor at meeting international standards. The United States subjects only a small fraction of its food imports to close inspection, but each month rejects about 200 shipments from China, mostly because of concerns about pesticides and antibiotics and about misleading labeling. In February, border inspectors for the U.S. Food and Drug Administration blocked peas tainted by pesticides, dried white plums containing banned additives, pepper contaminated with salmonella and frozen crawfish that were filthy.

    China’s development in many areas has been remarkably rapid, but one has to remember that basic infrastructure such as food safety standards, environmental controls, etc. follow along a little later. China being what it is, the U.S government really needs to be more careful and comprehensive with its food testing and safety programs. There’s no sense in blaming China for this, the Chinese government can’t possibly control all this activity. It takes both buyer beware, and seller beware to ensure safety. The U.S should take the European Union’s approach on this issue.

  • |

    Common chemicals are linked to breast cancer

    Byoliveridley

    The LA Times features a study arising from the Silent Spring institute.

    Common chemicals are linked to breast cancer – Los Angeles Times

    More than 200 chemicals — many found in urban air and everyday consumer products — cause breast cancer in animal tests, according to a compilation of scientific reports published today.

    Writing in a publication of the American Cancer Society, researchers concluded that reducing exposure to the compounds could prevent many women from developing the disease.

    The research team from five institutions analyzed a growing body of evidence linking environmental contaminants to breast cancer, the leading killer of U.S. women in their late 30s to early 50s.

    Experts say that family history and genes are responsible for a small percentage of breast cancer cases but that environmental or lifestyle factors such as diet are probably involved in the vast majority.

    “Overall, exposure to mammary gland carcinogens is widespread,” the researchers wrote in a special supplement to the journal Cancer. “These compounds are widely detected in human tissues and in environments, such as homes, where women spend time.”

    The scientists said data were too incomplete to estimate how many breast cancer cases might be linked to chemical exposures.

    The resources to come out of this study include two databases, one that summarizes animal mechanistic studies, and one that summarizes human epidemiological studies. It’s a good start and I hope these databases are continually expanded. The study was essentially a big lit review and data organization project.

    There are two major issues with the way carcinogenicity is studied. Firstly, animals other than humans are dosed at high levels to test for possible cancer outcomes. This leaves most researchers vulnerable to the charge that these high dose studies do not translate well to humans because the dose-response relationship at ambient levels is not well studied. So, the obvious criticism is that just because cancer endpoints were seen at high levels does not mean that the same thing will happen at low levels. This cuts both ways, though. We’re seeing with bisphenol A that low doses can cause more harm than intermediate doses. Another issue is the additivity of the interactions. Does 1 “dose” of PAH + 1 “dose” of PCB = 2 “doses” of PAH? We’re exposed to a whole host of chemicals all our lives, who knows which ones add, which ones subtract, which ones multiply, etc.

    Of course, as with most diseases, some macro variables dominate. For instance, the US has seen 8-9% decline in breast cancer incidence recently due to a decreased use of hormone replacement therapy. So, as with all diseases, taking care of some of these big ticket items is very important. One discouraging story I read today reported on a four percentage point decline in mammograms (70 to 66%) in women age 40 and older. Why? decreased access to health insurance and dropping the ball on promotion.

    The depressing fact of the matter is that the boring basics of good preventative healthcare, screening, good lifestyle and diet are the most important factors, and if we take care of these factors, we will make most health issues easier to deal with.