Home »

Untreatable tuberculosis (TB) Spreading: As a new deadly strain is discovered.

As a new, deadly, strain is discovered, funding for new medications remains slow to materialize.

September 7, 2006

The most common infectious global disease on earth, tuberculosis (TB) kills more than 50 percent of its victims within a few years, left untreated.

This week, a new strain of the disease called extreme drug resistant tuberculosis (XDR-TB) was discovered in KwaSulu-Natal in Africa. According to a spokesperson from the Department of Health there, a total of 53 cases were identified and 52 of the patients died. The co-infection rate of HIV and TB was reportedly high.

Although drug resistant TB exists in other parts of the globe, the outbreak in Africa is the first to demonstrate a deadly synergy between XDR-TB and HIV.

The World Health Organization?s Dr. Ernesto Jaramillo, told international health experts Thursday, ?There is no time to wait before we embark on decisive action.?

Dr. Ken Castro, of the U.S. Centers for Disease Control and Prevention (CDC) echoed his concern, ?The emergence of XDR-TB in the world poses a threat everywhere.?

Experts from the WHO and the CDC convened in Johannesburg, South Africa on Thursday to discuss ways to deal with XDR-TB and put together a seven-point strategic plan to contain the disease. Finding out the global extent of the infection was identified as a top priority.

Politics and poverty responsible for the spread

TB is most prevalent amongst the poor and disenfranchised. About 8.9 million new cases of TB are registered each year, but the rate of the disease is likely much higher.

Drug-resistant TB first came to light in Haiti, Peru and in the former Soviet Union in the 1980?s. Authorities didn?t treat the disease with any of the regimens that emerged after 1950. Nor was anyone particularly interested in saving prisoners and poor people.

Immigration has exacerbated the problem. California has more cases of drug-resistant TB than anywhere in the U.S. Those infected are from outside the U.S. They are usually very poor, frightened, and hard to track.

According to a recent article featured in FDANews Drugs, ?a recent survey of 18,000 TB sample by the CDC and WHO between November 2004 and November 2005 found that 20% of them were multi-drug resistant and a further 2% were extreme drug resistant.?

Treatment for regular TB requires six months of antibiotics. The cost is about $2,000. If the disease mutates into a strain that resists drugs, the length and cost of treatment skyrockets. As much as $1.2 million is required to treat a single patient.

According to the American Lung Association, some of the factors that have contributed to the rise in numbers of people infected with drug-resistant TB are:

· Delayed diagnosis and delayed determination of drug susceptibility which may take several weeks

· Susceptibility of immuno-suppressed individuals for not only acquiring DR-TB but for rapid disease progression, which may result in rapid transmission of the disease to other immuno-suppressed individuals

· Inadequate respiratory isolation procedures and other environmental safety conditions, especially in confined areas such as prisons

· Noncompliance or intermittent compliance with anti-tuberculosis drug therapy

Lack of adequate funding stalls the cure

Today, four drugs are used to treat regular TB?all of them more than 40 years old.

The first antibiotic to treat TB was streptomycin, developed in 1946. In the following years, a slew of TB drugs emerged: p-aminosalicylic acid (1949), isoniazid (1952), pyrazinamide (1954), cycloserine (1955), ethambutol (1962) and rifamipicin (1963). By combining two or three of these drugs with streptomycin, doctors were able to keep the resistant strains at bay.

The incidence of TB dropped so significantly in developed countries by 1980 that the disease went off the radar screen and no new drugs have been developed since. That, however, is changing at last.

The Global Alliance for TB Drug Development in May received $104 million from the Bill & Melinda Gates Foundation to advance a number of new drugs over the next five years. The non-profit TB Alliance has established a significant pipeline of novel treatments including four compounds from GlaxoSmithKline.

While that may sound like a lot, well over $1 billion has been invested in the development of vaccines for anthrax since October 2001.

Dr. Carol Nacy, CEO of Sequella, Inc., a privately held biopharmaceutical company focused on treating diseases of epidemic potential, has struggled for years to raise funds for TB treatments. ?Lots of government money is spent to combat TB but the resources are diverted to other things like building roads,? she said.

Although on August 23, Sequella was awarded a Small Business Innovation Research grant to develop a novel class of drug to treat the TB and pneumonia, the money, $228,000 is just a drop in the bucket. But Dr. Nacy says it has thus far been very discouraging to get investors behind a cure.

?We spend an enormous amount of time educating people about TB and the need for new products, but I honestly believe no one wants to be the very first VC to fund a TB-focused company,? said Dr. Nacy.

Central to Sequella?s business plan is making money on products that change the paradigm of TB diagnosis. Even in the U.S., it takes 2 to 6 months for TB to be diagnosed. The company has a TB patch test and a ?bronchs box? to identify pulmonary TB in late stage clinical trials. If approved, those products could collapse the TB diagnosis timetable down to about a week. There are other drugs and devices in Sequella?s pipeline and most are being tested in humans.

?The stressing thing is that everything is in clinical trials and you know what that requires?vast amounts of money,? said Dr. Nacy.

Contact the writer: crispin@saber.net