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Pharmaceutical companies

A trial for an HIV vaccine had to be stopped before the trail could be completed because the vaccine was doing the complete opposite of what it was supposed to do. A number of 1,836 were followed and 172 of them contracted the virus.  It was found to be making some men MORE LIKELY to get HIV.  Men that were uncircumcised and received the vaccine were more vulnerable to acquiring the virus after getting the vaccine even when not participating in risky behaviors.  This higher susceptibility however, lessen after 18 months.

Why is it that when researchers realized that the vaccine was not protecting anyone from getting HIV and when they had suspicions hat it was making some men more susceptible to HIV that this faulty vaccine being administered?  Did this pharmaceutical company figure that their profits would be worth more than the lives of these men that were put in danger?

This is an example of a human rights violation because Merck, the pharmaceutical company, should have been a guardian of health and stopped administering this vaccine once they had suspicions that the drug was failing men.

http://www.nytimes.com/2012/05/18/health/research/trial-vaccine-made-some-more-vulnerable-to-hiv-study-confirms.html?_r=1&ref=health

Many drugs being used to treat Malaria in disease ridden areas could be substitutes, or could even be fake.

The Lancet Infectious Disease Journal reported that up to 42% of the Malaria drugs used in Southeast Asia or Sub-Saharan Africa could be ineffective, being either counterfeit medication, a substitute medication or just a placebo.

The governments of the countries where these ineffective drugs were discovered are being urged to regulate drug production more strictly.

People along the borders of Thailand and Myanmar have been found to carry a Malarial parasite that is immune to the best anti-Malarial drugs available, called artemisinin combination therapy, or ACT.  In Cambodia, drug resistant Malarial parasites were also discovered.  These new cases showing up along the borders of Thailand and Myanmar are different in the fact that it is a different parasite these patients are carrying.

“Anti-malarial control efforts are vitally dependent on artemisinin combination treatments,” says  Anne-Catrin Uhlemann and David Fidock of Columbia University.  “Should these regimens fail, no other drugs are ready for deployment, and drug development efforts are not expected to yield new antimalarials until the end of this decade.”

AFP reports that the Indian drug manufacturer Cipla will drastically reduce the price of three important cancer drugs — each of them under patent to one of the big western pharmaceutical firms.  With Cipla’s new pricing scheme, the drugs will be purchasable for about 25% of the price charged by the patent holders, Bayer, AstraZeneca, and Schering.

As the Wall Street Journal reports, the break point came when the Indian patent office required Bayer to grant a license to an Indian manufacturing firm (not Cipla, actually) for its liver/kidney cancer medication Nexavar.

The head of the European Federation of Pharmaceutical Industries and Associations said that the companies would prefer to make drugs affordable through so-called tiered pricing schemes, wherein the price of a drug varies from country to country in regard to local cost of living.

In a 2009 article in Global Health magazine, Andrew Jack notes that some big pharmaceutical companies have lowered their prices to try to compete in the huge Indian market, including selling the diabetes drug Januvia (Merck) for one-fifth its US price.  GSK, Jack notes, even has different prices in different parts of India.

Tiered pricing or patent busting — a big problem remains unresolved:  even when prices are lowered to $100 per dose, many people can’t afford them.  Last year, an article in The Economist showed results of surveys by Abhijit Banerjee and Esther Duflo:  over 90% of respondents in rural India (and about 80% of Pakistanis, 70% of Bengladeshis, etc.) live on $2 a day or less.  For such households, the cost of a single dose of cancer medication — even at the Cipla price — is equivalent to weeks worth of food.

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On April 11th 2012, the FDA finally took a step in the direction of protecting humans from the build-up of drug resistant bacteria.

Many don’t like to admit that bacteria are often smarter than even our best scientists. But the truth is that for every antibiotic we create, a stronger and more drug resistant strain of bacteria is generated.

NYTimes journalist Gardiner Harris writes, “Using small amounts of antibiotics over long periods of time leads to the growth of bacteria that are resistant to the drugs’ effects, endangering humans who become infected” (The New York Times). The New York Times also gives the estimate that 99,000 people die each year from infections they contracted at a hospital, and that the majority of these are due to resistant strains of bacteria.

Despite all of the research and data that has been collected, the US has done very little to cut back on the unnecessary use of antibiotics, specifically in the meat industry. Are we naively allowing industries interest to threaten the health of our entire population and especially of future generations?

The meat industry has been routinely including antibiotics in healthy livestock’s feed and water since the realization that it induced phenomenal growth.

One of the reasons antibiotics are not sold over the counter for human use is to reduce unnecessary use of such drugs that can create resistant strains of harmful bacteria. Until this April, however, there was hardly any regulation of antibiotic use for livestock.

The FDA announced on April 11th that in order for livestock to be given antibiotics, the antibiotics would need to be prescribed by a veterinarian. This was a victory in helping to preserve humans right to health. However, many more steps towards eliminating unnecessary antibiotic use are needed. Some are also concerned that both the meat and antibiotic industries will hold off making any changes in hope that the administration after the upcoming election will change the policy.

I am curious to see if people think this is a human rights issue where the government is failing to protect our right to health, or if people feel this is simply a policy issue.

Read more at http://www.nytimes.com/2012/04/12/us/antibiotics-for-livestock-will-require-prescription-fda-says.html

Yesterday’s New York Times had an article that described how pharmaceutical companies are dragging their heels on a drug that could save thousands of lives annually. The drug’s problem?  It’s cheap.

As the article explained

[I]ts very inexpensiveness has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings and stabbings — up to 4,000 Americans a year, according to a recent study.

Because there is so little profit in it, the companies that make it do not champion it.

A Reuters article today describes the problem of access to cancer medications for India’s poor.  Even though India has allowed local manufacturers to make a cancer drug that is elsewhere patented by Bayer, and might allow the same to happen with Novartis’s Gleevec, many Indians are too poor to afford even the generic medications.

With around 40 percent of the population living below the poverty line, healthcare is an upper-middle-class luxury in much of India where spending in private clinics is four times the amount of that in government hospitals. The poorest would-be patients literally beg for treatment on the outside of a chronically underfunded and overstretched health system.

If compulsory licensing still leaves millions of people untreated, what else should be done?

A briefing paper issued by Doctors Without Borders (Médecins sans Frontières) takes issue with Novartis’s response to the contention that the company should not be granted a patent on the leukemia drug Gleevec in India.

Basically, the humanitarian organization disagrees with Novartis’s claim that there’s no connection between patent protection and drug cost/availability.  They explain their own experience, for instance with patent protection on AIDS meds:

When AIDS treatment first became available in the late 1990s, the price of first line patented AIDS medicines was—even after discounts—US$10,439 per patient per year. Millions died in developing countries, particularly in Africa, as prices were too high. Generic competition brought prices down, making treatment possible.

And, whereas Novartis argues that it should be able to have a monopoly on Gleevec in India because 40 other countries have recognized its patent, MSF says

Although the World Trade Organization’s (WTO’s) … TRIPS Agreement obliges all WTO members, including India, to grant patents on medicines, nothing obliges developing countries to replicate the patent systems of wealthy countries.

The Gleevec suit will be decided by an Indian court at the end of March.  Meanwhile, there’s a new development in a related case:  This week, India used compulsory licensing to grant the right to make a different cancer drug, sorafenib tosylate (used for kidney and liver cancers), breaking Bayer’s monopoly.

The director of MSF’s Access campaign said

When drug companies are price gouging and limiting availability, there is a consequence: the Patent Office can and will end monopoly powers to ensure access to important medicines. If this precedent is applied to other drugs and expanded to include exports, it would have a direct impact on affordability of medicines used by MSF and give a real boost to accessing the drugs that are critically needed in countries where we work