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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.

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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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Circumspection on Circumcision – Lessons for India

Byoliveridley

Circumcision May Help Protect Against HIV – washingtonpost.com

Getting circumcised may reduce men’s risk of acquiring HIV, according to a study conducted in Africa. “Our study shows that circumcised men had 53 percent fewer HIV infections than uncircumcised men,” lead study author Robert Bailey, professor of epidemiology at the University of Illinois at Chicago (UIC), said in a prepared statement.

This study, published in The Lancet (registration and kidney donation required!) adds to the growing body of research suggesting that circumcision significantly reduces the incidence of HIV infection. The doubts on circumcision as a protective factor against HIV are falling away.

But, is this a viable public health strategy? In context, the US health and human services reports an 85% reduction in HIV risk through condom usage. This is probably a conservative estimate. There’s no indication yet that the gains from circumcision and condom use together are multiplicative.

Let’s look at India, for instance. Circumcision is not practiced among Hindus. There is no history of circumcision, and when I was growing up, it was clear that circumcision was for Muslims and Muslims only. It was often laughed about and there was a sense of superiority about not having to mutilate. It was a clear distinction setting difference between “us” and “them”. This article by Jaishanker and Haldar provides some perspective on Hindu-Muslim identities.

Apart from that, the other important identity of Muslim males is circumcision. It is found in many riots that Muslims were victimized based on their religious identity. In the riots if the perpetrators or the police are not able to identify victims with their religion they forcefully remove the pants of the victims to check whether they are circumcised or not. Once they find that the victim is circumcised he is targeted without further analysing which community he belongs to.

For example in Bombay riot (1992) there is a case of man who was frisked by the police for assessing whether he was a Muslim. However, out of fear he gave his name as Raju (a Hindu name) the officer made him take out his trousers and, noticed that he was a circumcised Muslim, and fired at him.

No Hindu parent in their right mind would circumcise their male child. It’s that simple. It’s part of the ingrained Hindu psyche that having an uncut member sets us apart from our Muslim brethren.

Nothing has changed about AIDS prevention strategies. But it’s boring to study the same variables all the time, let’s recap them one more time, shall we!

Education and awareness: Look at this picture from India (from the NFHS Survey):
Now tell me that increasing awareness among women and empowering them is not the most important thing you can do!

Condom use = 85% risk reduction

Nothing more to say. Continuing to improve access to condoms is important. Avert indicates that condom use is very state dependent, especially among sex workers, with Tamil Nadu having an 80-90% use rate and Mysore in neighboring Karnataka having a 9% use rate.

Access to antiviral therapy

India is in a lucky position here with a very well established pharmaceutical industry. So, drugs are likely to be available (patent issues notwithstanding). The issue however is with infrastructure, getting the drugs to the right people at the right time. This 2004 paper from the Indian Journal of Medical Ethics indicates that coverage is spotty at best. India’s National AIDs Control Organization (NACO) recognizes this, but in my opinion does not go far enough to provide free/affordable drugs to infected people, especially to prevent mother-child transmission.

So, to cut a long story short, circumcision in India is not likely to be a factor in the pantheon of choices available. We have a long way to go with our other major AIDS prevention challenges, and I hope this circumcision issue does not become an increasing distraction.

Melamine – Now in Humans

Byoliveridley

Once again, there’s no evidence that melamine at such low levels would pose any threat to humans. (or pigs, I guess, they have other issues to worry about!). It is the lack of ingredients control, and the casual diversion of food considered unfit for pet consumption to animal feed. If you did this to some other, more dangerous contaminant, and I don’t see any reason why the same thing would not happen, we’d be in a lot more trouble. The U.S did not really learn any lessons from the mad cow scare.

In a way, I am glad this story has unfolded the way it did, slowly, and methodically up the food chain, finally reaching humans. It provides some insight into how the US government “regulates” food, and what needs to be done to shore up this program. (hint, better regulation, more money, more inspectors!). Of course, as a cat owner, (and one who had an unexplained trip to the hospital to treat said cat for puking and general stomach issues), I wish that cats were not the canary in this particular food safety scare, but I guess it really made people pay attention.

Report: Tainted hogs enter food supply – Yahoo! News

Several hundred of the 6,000 hogs that may have eaten contaminated pet food are believed to have entered the food supply for humans, the government said Thursday.

No more than 345 hogs, from farms in three states, that possibly ate tainted feed are involved, according to the Agriculture Department. It appears the large majority of the hogs that may have been exposed are still on the farms where they are being raised, spokeswoman Nicol Andrews said.

Salvaged pet food from companies known or suspected of using tainted ingredients was shipped to hog farms in seven states for use as feed. A poultry feed mill in an eighth state, Missouri, also received possibly contaminated pet food scraps left over from production. The fate of the feed made from that waste was not immediately known.

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NC smoking bill extinguished?

Byoliveridley

Laura Leslie has the scoop…

Monday: Snuffed Out? — North Carolina Public Radio WUNC

Looks like House Maj. Leader Hugh Holliman’s smoking ban may be in trouble. The first sign of trouble was that it didn’t come up for a floor vote in the few days following its 9-4 approval in J1 committee. Today, Holliman told NCNN’s Matt Willoughby he’s planning to pull the bill off the calendar when it comes up tomorrow.

It’s only a matter of time, they can fight it all they want, the smoking bans will pass throughout the country in a a decade or less, that’s a bold prediction!

Most critics say the legislation goes against private property rights in banning all workplace smoking, regardless of the context. But supporters point out the government has been regulating workplace safety on issues like asbestos for a long time, even on private property. Since secondhand smoke is an environmental toxin, they say, it should be regulated, too.

As I mentioned in comments on an earlier post, property rights is a catchall rhetorical tool that can defend just about anything, good bad or neutral. So, I am not surprised it is being used here. The obvious counter argument that property rights do not give you the right to pollute is apparently lost on this debate. But this is not really about property rights, is it? It is about protecting the tobacco industry, good old plut-prot-principle!

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Meanwhile, in the other India

Byoliveridley

While India prepares to spend many billions of dollars on fighter jets, it cannot provide clean water for its citizens.

Cholera-diarrhoea toll mounts to 164 in Orissa-India-The Times of India

Cholera and diarrhoea, having assumed epidemic proportions in three tribal dominated Orissa districts, have so far claimed 164 lives as officials confirmed five more deaths in worst-hit Koraput on Thursday.

The death toll, which had mounted to 159 on Wednesday, further rose to 164 with confirmation of five casualties in Dasmantpur block of Koraput district, Chief District Medical Officer (CDMO) R K Agarwal said.

While the toll in Koraput district went up to 73, the situation remained by and large unchanged in Rayagada with 64 casualties as the killer diseases claimed as many as 27 lives in Kalahandi, official sources said.

The water-borne diseases had assumed epidemic form in nine blocks of these three backward districts located adjacent to each other though separated by hills and the waterspread of the vast Indravati reservoir.

Despite state government’s claim to have effectively controlled the spread of the diseases, residents of the affected areas alleged that the administration had failed to provide adequate medical facilities to the patients.

This is disgusting and very symptomatic of the urban-rural divide that exists in India. Unless the government can provide basic infrastructure to its rural citizens, all those fancy malls and F16s mean little.

Potentially Incompatible Goals at F.D.A. – New York Times

Byoliveridley

The New York Times has an article on the FDA’s competing needs of safety and speed in drug approval.

Potentially Incompatible Goals at F.D.A. – New York Times

Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.

These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.

A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.

Safety and speed may be mutually incompatible. The biggest culprit is the Prescription Drug User Fees Act (PDUFA) which stipulated that in exchange for fees paid by pharma to the FDA for speedy approval, pharma would get a say in how that money was used. They used this say to cut down on post approval monitoring, weaken post approval data analysis and generally hide unfavorable results.

Do patients always benefit from speed? Again, you have to make distinctions between acute life threatening conditions and chronic, life management conditions. A delay in the approval of a cancer drug may result in the immediate death of the people affected with the cancer. But, a serious safety issue overlooked in this hasty approval would not hurt a healthy person. Yes, it would affect the cancer patient, but they would accept that risk. Something like Vioxx, or Avandia, on the other hand is a drug potentially consumed by millions of people to treat chronic conditions that can be managed in other ways. Since safety issues affecting these drugs could adversely affect otherwise healthy people, the approval process needs to be much more deliberate, involving more patients, and has to include lengthy post-approval monitoring, adverse event reporting, the availability of all data for meta-analysis, etc.

So why does this not happen? Because pharma makes much more money on that blockbuster “lifestyle” drugs taken by millions of otherwise healthy people. The pool of healthy people is much bigger than the pool of cancer victims. It is in their best interest to get a speedy approval.

The answer I guess is to make a clear distinction between these two different types of drugs and have completely different standards, somehow, I don’t think that will happen.