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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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    Bye Bye, Bisphenol A

    Byoliveridley

    Canada is expected to formally declare on Saturday that the controversial chemical bisphenol A (BPA) is a hazardous substance.

    The move will make Canada the first country in the world to put the chemical on a list of toxic substances that will ban the material from being used in such products as baby bottles.

    via CTV.ca | Canada to put BPA on toxic substances list

    Good for Canada. Timing of when cans (the biggest potential source of adult exposure) will be BPA free is up in the air.

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    FDA Issues Dietary Supplements Final Rule

    Byoliveridley

    The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.

    Which ones?

    1. Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
    2. Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines.
    3. Adverse event reporting – Manufacturers/sellers will need to report adverse events. This is after the fact safety testing, wholly inadequate, but better than what we had previously.

    See something missing? Efficacy!! You do not have to prove that your product actually works! Basic safety? What is the overdose level? Interactions with other medicines/supplements? Is your dosing form actually bioavailable? Meaning, if you swallow a pill, will it actually get into your bloodstream and reach the intended target?

    Who knows, but standardizing, cataloging and auditing manufacturing processes is a start, I guess. 1.5 cheers for the FDA!

    I would be curious to find out how these companies are going to get audited by the FDA to prove that they’re following the quality control measures they’re supposed to implement. Guess I have to read the 815 pg bundle of joy that is the actual rule to find out more. A cursory word search on audits suggests that the manufacturers do audits on their suppliers, that the quality control unit of manufacturer perform audits on their manufacturing process, but nothing about the FDA conducting audits. Of course, calling yourself a GMP (good manufacturing processes) manufacturer is usually enough to trigger an FDA audit if you’re in pharma. I wonder how the FDA will deal with this one.

    FDA Issues Dietary Supplements Final Rule

    The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

    “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

    The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

    “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

    Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

    The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

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    Indian firms push down global vaccine prices – Lessons for Canada

    Byoliveridley

    Cheaper vaccines from India are forcing global giants to slash prices. GSK announced its rotavirus vaccines at $2.50 per dose — or $5 to fully immunise a child — in response to a current tender administered by UNICEF.The offer is a 67% reduction in the current lowest available public price.

    Hindustan Times

    This is good news for many reasons. Preventable diseases kill over a million people every year, and one of the biggest factors in getting vaccinated is cost. India’s healthcare spending was estimated at US$ 40 billion in 2008, going up to 300+ billion in 2023. Forty billion is less than $40 per person, so saving 7-8 dollars on vaccinations alone for every one of the 26 million children born every year is a huge deal.

    Development costs of vaccines and drugs are high and success is often uncertain. Pharmaceutical companies have used this to justify government enforced monopolies and per dose prices that are sometimes a 1000 times higher than the incremental cost of production. While this makes for good profits, it means severe lack of access in India, many African countries, and many excess deaths that could have been prevented. For years, India had what was called a process patent, not a product patent, which meant that if you could make a drug with a slightly different process, it would not get patent protection any more. How did this help India?

    1. Affordable drugs – Indian companies could make and sell drugs at a fraction of the cost without paying for drug development.

    2. Pharmaceutical Industry – This enabled the industry to grow and mature.

    Of course, this also meant that India was considered an outlaw, and Indian pharmaceutical industry came under great pressure from the WTO to tighten patent laws, which it did. At the time, the concern (rightly) was that tightening patent restrictions would harm India’s pharmaceutical industry and reduce access to drugs. Has this come to pass? In some ways, yes. But the Indian pharmaceutical industry has also matured, and with government help, has been able to do its own development, clinical trials and production (which it was always good at). The focus on tropical diseases like rotavirus also means that US, European Companies, which have since moved away to treating chronic conditions like high cholesterol, erectile dysfunction, etc., have much more competition in the tropical diseases area and cannot charge premium prices to poor people any more.

    So dear Canada, while you are negotiating with Europe about “free trade”, and trying to give European companies much greater patent protection for their drugs, know that this will very surely raise costs in the short term. Two important questions:

    1. Will Canada’s drug companies benefit?

    2. Will Canada’s consumers benefit?

    Um, let’s take a look at Canada’s top 10 in 2009:

     

    Rank Leading Companies Country Market Share (%)
    1 Pfizer US 13.4
    2 Apotex Canada 7
    3 AstraZeneca UK 6.6
    9 Merck US 6
    4 Johnson & Johnson US 5.3
    6 Novopharm (Teva) Israel 4.2
    7 Novartis Switzerland 4
    5 GlaxoSmithKline UK 4
    8 Abbott US 3.9
    10 Roche Switzerland 3.1
    Source: IMS Health

    There is one Canadian company in the top 10, and four European companies. Our pharmaceutical industry is not well positioned to be independent, or work to reduce Canadian drug prices, especially if laws strengthening patent protections for European companies come into effect. This will serve to weaken Apotex, and Canada does not have a big independent pharmaceutical company network born out of years of “isolation” to take advantage of any competition, or competitive advantages. So, while patent “reform” seems to not have hurt Indian industry as much as feared, it sure will hurt Canadian consumers.

     

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    PFOA emissions from Non stick cookware and Popcorn Bags

    Byoliveridley

    Important research coming out of NY. See here for previous PFOA posts. Perfluorinated compounds are used in the manufacture of Teflon, and are bioaccumulative. The theory is that the salts left over in the manufacture (residuals) are offgassing during use, and exposing consumers to bioaccumulative compounds.

    Cast Iron, anyone!!

    Quantitation of Gas-Phase Perfluoroalkyl Surfactants and Fluorotelomer Alcohols Released from Nonstick Cookware and Microwave Popcorn Bags

    Fluoropolymer dispersions are used for coating certain cookware products and food-contact packaging to impart oil and water repellency. Since salts of perfluorooctanoic acid (PFOA) are used as a processing aid in the manufacture of many fluoropolymers, it is necessary to determine if these compounds are still present as residuals after the process used to coat nonstick cookware or packaging, and could be released during typical cooking conditions. In this study, we identified and measured perfluoroalkyl carboxylates (PFCAs), particularly PFOA, and fluorotelomer alcohols (FTOHs; 6:2 FTOH and 8:2 FTOH), released from nonstick cookware into the gas phase under normal cooking temperatures (179 to 233 C surface temperature). PFOA was released into the gas phase at 7-337 ng (11-503 pg/cm2) per pan from four brands of nonstick frying pans. 6:2 FTOH and 8:2 FTOH were found in the gas phase of four brands of frying pans, and the sources of FTOHs released from nonstick cookware are under investigation. We observed a significant decrease in gas-phase PFOA following repeated use of one brand of pan, whereas the other brand did not show a significant reduction in PFOA release following multiple uses. PFOA was found at >5 ng during the fourth use of both brands of pans. FTOHs were not found after the second use of either brand of pans. PFOA was found at 5-34 ng in the vapors produced from a prepacked microwave popcorn bag. PFOA was not found in the vapors produced from plain white corn kernels popped in a polypropylene container. 6:2 FTOH and 8:2 FTOH were measured in the vapors produced from one brand of prepacked microwave popcorn at 223 ± 37 ng and 258 ± 36 ng per bag, respectively, but not measured at >20 ng (LOQ) in the other two brands. On the packaging surface of one brand of microwave popcorn several PFCAs, including C5-C12, 6:2 FTOH, and 8:2 FTOH, were found at concentrations in the order of 0.5-6.0 ng/cm2. This study suggests that residual PFOA is not completely removed during the fabrication process of the nonstick coating for cookware. They remain as residuals on the surface and may be off-gassed when heated at normal cooking temperatures.

    More later.

  • American feed makers used melamine as well

    Byoliveridley

    Well, turns out all that China baiting was for naught, because right in America’s heartland, Ohio, some feed manufacturer was using melamine as a binding agent.

    Melamine From U.S. Put in Feed – New York Times

    Ever since pet food contaminated with an industrial chemical was traced to shipments of wheat flour from China, American officials have concentrated on cracking down on imports.

    It turns out the problem was closer to home, too.

    Yesterday, federal officials announced that a manufacturing plant in Ohio was using the same banned substance, melamine, to make binding agents that ended up in feed for farmed fish, shrimp and livestock.

    Apparently, it is Tembec, a Canadian company with a plant in Ohio. I am sure the effects to humans are not significant, but where’s the control? Where’s the list of things you can’t put in food. More importantly, where’s the list of things you’re allowed to put in? Food being a very easy mode of pollutant ingestion, the ingredients list must be exclusionary, that is, only approved ingredients are allowed. If something is not approved, it is not allowed…

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    Soda = Fat

    Byoliveridley

    Sodat Fat

    From The New York Department of Health

    Try this experiment at home: Take two and a half cups of water, add 15-20 teaspoons of sugar and stir to dissolve. If you haven’t broken your wrist with all this action, take a sip or two, or gulp it down. No worries, you’ve just had all the nutrition in a typical soda!

    That’s the message the NY Department of health is sending out with its new PR campaign against soda. Pretty gross and effective, I must say, though I would go one further and put it on every label of Coke, now wouldn’t that be nice!