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Drug trials

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.

 

 

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On Tuesday The Supreme Court heard opening arguments in a case that, at it’s resolution, will set a strong precedent regarding corporate liability for civil suits brought by foreign nationals for human rights violations committed abroad.

The case, Kiobel v. Royal Dutch Petroleum, involves a civil suit filed by 12 Nigerian Plaintiffs who allege that Royal Dutch Petroleum, a.k.a. Shell, “aided and abetted, and were otherwise complicit in, violations of international law;” specifically that the corporation “collaborated closely with Nigeria’s then-military government as it carried out a campaign of intimidation and violence” against the Ogoni people who opposed the development of their land for oil. At this stage the suit, filed under the umbrella of the Alien Tort Claims Act of 1789, is immediately concerned with whether foreign nationals have any right to try such claims through the United States Judicial System at all.

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In Madhya Pradesh, India, a controversy is raging over clinical drug testing, after a government report concluded that a number of patients participated in clinical trials without their knowledge or informed consent.

The husband of one such patient explained: “The doctor told us that the medicines will be given free and that they were going to be launched soon by a foreign company. Not once did he say it was an experiment or a trial. If I knew, would I have taken the risk?”

In 2005, India loosened the guidelines that regulate clinical drug testing.  As a result, participation in such trials rose precipitously, as numerous international pharmaceutical companies decided to take advantage of the country’s lower costs.

C.M. Gulhati, editor of the Monthly Index of Medical Specialities journal, summed up the trend in blunt terms: “India is emerging as a hub for drug trials, and Indian patients are like guinea pigs.”