Brazil offers AIDs drug factory to Mozambique

Byoliveridley

Brazil is positioning itself as a major manufacturer of generics, and offering to build this factory is a very good move because it will provide AIDs treatment options for Mozambique at affordable prices (well, better prices than the pharma giants would provide, at any rate). Is there expertise available in Mozambique to staff this factory and run it at the level of quality a pharmaceutical production facility needs? I don’t know the answer, but I sure hope so. Alternatively, is there any plan for Brazil to train and equip the personnel as well? It is good news, at any rate.
Brazil offers drug factory to AIDS-ravaged Mozambique – Yahoo News

Brazil has offered to build a $23 million pharmaceutical plant in Mozambique that will provide drugs to treat HIV/AIDS, malaria and other diseases, Mozambique’s national newspaper said on Tuesday.

Brazil, a leading pharmaceutical manufacturer, will monitor quality and transfer technology to the proposed plant, which would produce a range of drugs, including generic antiretroviral drugs (ARVs) to fight HIV/AIDS, Noticias reported.

The plan was presented to the Mozambique government by Brazil’s ambassador in the southern African nation.

Mozambique, one of the poorest nations on the continent, is struggling to find the money to rebuild its dilapidated health-care system, which was neglected during a 17-year civil war that ended in 1992.

The former Portuguese colony has been hard hit by the AIDS epidemic, with an estimated 1.6 million of its 18 million people infected with HIV. Only a fraction of those requiring ARVs are on treatment, with most of the drugs imported from India.

The offer to build the pharmaceutical plant was first raised by Brazilian President Luiz Inacio Lula da Silva during his 2004 official visit to Mozambique. Lula said he wanted drugs from the plant to be available to other African nations as well.

Brazil claims the use of generic anti-retrovirals has cut its AIDS mortality rate in half.

Mozambican Health Minister Ivo Garrido said the government would decide next month whether to approve the Brazilian proposal. “We will have to study it very carefully,” he was quoted as saying by Noticias.

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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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    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.

  • Drug makers and the FDA don't want you to find out about adverse trials

    Byoliveridley

    if you have not been following the Avandia story, an article published in the New England Journal of Medicine revealed that Avandia, a popular drug used in diabetes control significantly increased the threat of heart attacks and heart failure. A couple of things to note here, firstly, this fact was known to the FDA in 2002 per this memo obtained by Public Citizen. So, why the FDA (and GSK) thought that no one would notice, is beyond me. Secondly, when the drug was introduced in Europe, it was contra-indicated for people with heart disease. This fact must have been known to the FDA and GSK as well. It is one thing for GSk to not want to run long term epidemiological and safety studies on their drugs, but other people did the work, and the FDA just stood by and watched until the work was published in the US. The European Drug agency had acted on this information quite a while back.

    So, when I come across this article in the NY Times about a “downside” to full disclosure, I don’t really know what to say. I don’t care whether there is a downside to GSK or not. If I work as a waiter in a restaurant, there is a “downside” to reporting my tip income to the IRS (yes, higher taxes!). This does not mean I should not pay my taxes! This is a matter of life and death for people. Diabetes and heart disease go together in thousands of people, they needed to know if the drug they were taking to control one disease would kill them off with the other disease.

    For Drug Makers, a Downside to Full Disclosure – New York Times

    This week, GlaxoSmithKline learned what that greater disclosure could mean.

    A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

    “It was a treasure trove,” Dr. Nissen said about the Web site.

    GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.

    Also, note this “concern” from the FDA, no less:

    “I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.

    Yes, respond to results in a very prestigious peer reviewed journal by pretending that some dude with a computer in his basement (yes, all computers reside in basements) randomly picked up a couple of clinical trials and created “mass confusion”. The FDA should at least pretend to care…

    The risks and benefits involved with taking a drug to control a chronic condition are completely different from those you would take for an acute, immediately life threatening condition. If you are treating cancer, you expect side effects, and deal with them because the alternative is certain death. When you’re dealing with diabetes, you have alternatives that will not kill you. In addition, millions of people have diabetes and use Avandia. So, a small percentage increase in a side-effect can affect thousands. And, they need to know because there are alternatives that would work for them.

    GSK is not going to tell them because there is an obvious conflict of interest. They need to sell their new and expensive drug even if other alternatives work. This is why we have the FDA, and full disclosure of all clinical trials, not just the ones that worked for you.

  • Abbott Drops AIDS Drug Price in response to Thailand's hardball.

    Byoliveridley

    Moral of the story, you have to play hardball with the drug companies. Use your power as a sovereign country. You are a market to them, their threats to stop selling their drugs in your country cannot be taken seriously because if the drug is made unavailable in your country, that gives you even more right to make it yourself (or better, buy it from India!). I mean what are they going to do, invade you? The worst you will get is a scolding and lecture from the U.S ambassdor on patents and free trade, just ignore it, or better still, protest outside the embassy!

    Chemical & Engineering News: Latest News – Abbott Drops AIDS Drug Price

    Abbott Drops AIDS Drug Price, move follows compulsory licensing decision by Thailand

    Jean-François Tremblay

    Abbott Laboratories will drop its price for Kaletra, a protease inhibitor used to treat AIDS, to the equivalent of $1,000 per patient per year in 40 developing countries.

    The move, facilitated by the World Health Organization, is apparently Abbott’s response to a decision by Thailand earlier this year to resort to compulsory licensing of Kaletra, a practice that reduces health care costs in a way that pharmaceutical companies view as patent infringement (C&EN, Feb. 5, page 11).

    Following Thailand’s decision, Abbott announced that it would stop selling Kaletra and other patented drugs in Thailand, a move that the nongovernmental organization Doctors Without Borders called “a major betrayal of patients.”Abbott had already been under fire for not supplying Kaletra to several other low-income countries.

    The price of $1,000 per year per patient, Abbott says, is 55% less than the average price at which the drug is now sold in the 40 countries. The company says it wants to increase drug affordability while “preserving the system that enables the discovery of new medicines.

    Compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies (AIDs is a national emergency, isn’t it?). More importantly, governments in poorer countries really should invoke this provision as much as they can. Because every time they invoke it, they make big pharma come to the bargaining table.

    $1000 per patient per year is still a lot of money, though, I would encourage Thailand to play even more hardball!

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    What can the U.S learn from homeopathy?

    Byoliveridley

    Homeopathy was all around me growing up in India, so I read this article with interest as it jogged many memories of visiting the family homeopath with my parents.

    Faith Healing with Homeopathy — In These Times

    Homeopathy rests on three unproven tenets: First, “Like treats like.” Because arsenic causes shortness of breath, for example, homeopaths prescribe its “spirit” to treat diseases such as asthma. Second, the arsenic or other active ingredient is diluted in water and then that dilution is diluted again and so on, dozens of times, guaranteeing—for better and worse—that even if the dose has no therapeutic value, it does no harm. And third, the potion is shaken vigorously so that it retains a “memory” of the allegedly curative ingredient, a spirit-like essence that revives the body’s “vital force.”

    Fooey, the description of the science is hilariously pseudoscientific, but homeopathy is no laughing matter in India. It is estimated to be a Rs. 250 Crore (that is 2.5 billion rupees or about $58 million) industry as of 2002-2003.  I do not think this includes doctors and clinics. This website lists 158 colleges in India offering the  valid (it is like an MD!) degree of Bachelor of Homeopathic Medicine and Surgery, or BHMS. My parents swear by it, most of my family living in India has either visited, or regularly visit one. It is hugely popular for hepatitis and liver disease, more so than conventional medicine in India.

    What’s the deal? Why is it so popular? I think Terry Allen is on the right track, this sentence here, buried in the middle, hits the nail on the head…

    Part of the effect comes from the ritual of consultation with a practitioner who treats the patient like a person rather than a body part on an assembly line.

    Allen does not quite grasp the significance of this sentence and tracks away into placebo effects and evil pharma. But here’s the deal: A lot of Indians (who can afford $4-$5 consultation fee) visit their homeopath every month. When I tagged along with my parents, we would go on a Sunday afternoon at 2 PM to this homeopath’s office, which was a wing of his house (a big house, I might add!). It was a relaxed and leisurely time, he spent 10-15 minutes with each of us (yes, my parents made me!) talking about the previous month, what we were up to, how stressed we’d been, how our ailments from the previous month were doing, had we noticed any changes to our health over the month, etc. We would be interrupted occasionally by his little kid, or his assistant relaying a message from his wife, it was as far removed from a doctor’s visit as possible. And yes, he would take your blood pressure, run simple blood tests, etc. At the end of it, he would give you little sugar pills/sugar coated powder formulations to take home. The formulations were individually dosed, it was all categorized and labeled for you.

    This is like having a mini physical every month. Surely, just the act of talking to someone made you feel better, the act of ritually opening up little packets of “medicine” and following detailed instructions for 5 days helped, surely the homely and relaxing atmosphere of visiting a family friend helped, I don’t know.

    Metrics? both my parents occasionally had their hypertension treated with homeopathy. This worked as long as they were borderline, and simple stress management would get the numbers down. This doctor was/is very good at stress management because he talked calmly, yet firmly, he would listen and tease their little everyday stressors out of them and that was probably good for a 10 point reduction. But I remember the homeopath sending mom off to a doctor for a more conventional treatment regimen as soon as she hit 160.

    It never ever worked for me because I was way too sceptical to buy into the process, so I would not listen, or relax enough to talk. I would take my pills, but it would make absolutely no difference whatsoever. Of course, he was trying to treat me for severe sinus related issues probably brought on by pollution, and by sleepless nights spent on a beach looking for turtles!

    I am sure that for every good homeopath, there were two bad ones who just handed out pills of sugar. But my parents’ homeopath was, and continues to be part Dr. Phil, part candyman, part cheerleader!

    Homeopathy probably “works” because it makes people take the time to think about their life and what’s ailing them. It’s a lesson that American primary care providers could do well to learn.

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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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