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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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When most Americans imagine Tuberculosis, they think of a disease that was active over 100 years ago.  They imagine people coughing, becoming frail and being sent to warm, dry climates as the disease progressed.  It was then often called “consumption” or “white plague”.  It is a bacterial infection that invades the lungs and destroys the lung tissue.  The bacteria can be spread when people cough, and is airborne.  

Bacille Calmette Guerin (BCG) is the vaccine that is now in use to protect against tuberculosis. It was first used in 1921.  BCG was first used as a vaccine in 1921. It was given to infants orally. Since 1921, this has been the standard treatment against TB and has been used extensively.  Today, it is estimated that more than 1 billion people have received BCG.  

A startling new finding has many people concerned:  Documentation of a “totally drug resistant strain of TB” has been found in India.  Last week, the World Health Organization convened to discuss these findings and to determine if a new classification must be added to the first TB description:  this new classification would be ‘totally drug-resistant TB,’ or TDR-TB. This means the disease has changed from one that could be treated with a six month course of antibiotics, to the emergence of MDR-TB, then extensively drug-resistant TB (XDR-TB). The most disturbing aspect of these new discoveries, says Lucica Ditiu of the WHO’s Stop TB Partnership, is the fact that drug-resistant TB ‘is a totally man-made disease.'”

Bacteria, while simple creatures, are highly adaptable and can evolve to resist the drugs meant to destroy them. Mycobacterium tuberculosis is no exception.  In many areas of the world, TB is a major problem due to lack of vaccination and inability of the people of certain countries to obtain the antibiotics needed to cure them.  To explain this new strain of TB as being man made:  if a person has access to the TB antibiotic, and begins taking the recommended course, then stops for whatever reason—lack of access to the medicine, becoming too ill to travel to obtain the medicine, or simply feeling better and stopping the course of treatment on their own—the bacteria still present in their bodies begins to adapt to fight the antibiotic introduced.  This leaves the person uncured of the original infection, and now able to transmit a new strain of the adapted bacteria to others. 

 Dr Zarir Udwadia, a specialist in TB at the Hinduja National Hospital in Mumbai, recently published a paper in the Clinical Infectious Diseases journal examining four cases of TDR-TB. He told Reuters that he has now seen 12 cases of TB where all known TB drugs were applied and none were successful. Three of the 12 cases are already dead.

The powerful TB drugs he tested on each patient, one after another, were first line treaments–isoniazid, rifampicin and streptomycin, and then a range of second line drugs like moxifloxacin, kanamycin and ethionamide. Each medicine did not work.

“If you add it all up, they were resistant to 12 drugs in total,” said Udwadia.

TB can lie dormant in a patient for many years before showing signs of infection.  As TB can now be considered an untreatable disease, the world needs to gear up for epidemic that may be crippling.

 

 

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

 

 

Today’s New York Times offers a long article on the case before India’s Supreme Court regarding licensing of off-patent versions of the leukemia drug imatinib.  Currently Novartis sells this under patent as Gleevec.  The article mentions the potential implication for availability not only of this effective cancer medication, but also for AIDS medications worldwide.  For the pro-patent case, the website IP Watch gives extensive coverage to the industry contentions and intellectual property aspects.

The economics of supply and demand have allowed drug companies to reap exorbitant profit from the market, but what are the effects when the supply does not meet the demand? The United States is currently wheeling from a shortage of two drugs used to combat cancer, this shortage has prompted the FDA to seek drugs from foreign markets, such as India. The two drugs are Doxil and methotrexate, which is known by the trade names Rheumatrex and Trexall. Pharmaceutical companies have a market interest in providing their products to consumers. After the introduction of a product, should companies be mandated to ensure a consistent supply chain? As patients/consumers what assurance do we have that life saving drugs will be available if we need them? In some way I can see situations such as this manifesting a loosening of international trade agreements. If India did not have a readily available supply of a drug similar to Doxil this would have undoubtedly affected the lives of a larger number of people. The intellectual property rights of drug developers are protected through trade agreements, what is the impact of these protections in critical shortage situations? The loosening of patent restrictions may improve the health of consumers by ensuring access to needed drugs, while keeping costs lower.