Drug development for TB: an innovative collaboration

A landmark collaboration could see the development of the first new-action tuberculosis drug in 40 years.  Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership, and Tibotec, a Johnson & Johnson company, have joined forces to focus on the development of the new experimental drug TMC207.

Forbes reports that if the drug is approved, it could be the first of its kind on the market and the first tuberculosis drug in more than four decades to take a new approach to treating the condition. A cocktail of antibiotics is the mainstay of treatment and there has been no major advancements since the antibiotic Rifampicin hit the market in the 1960s.

The drug candidate, now in midstage clinical trials, works by inhibiting an enzyme responsible for fueling tuberculosis cells, thereby cutting off the cell’s energy supply. Midstage study results have so far shown the drug is effective as part of a combination treatment when compared with a placebo. Results from a second stage of the midstage program are expected in 2010.

If it were approved, the parties involved will establish an access program for developing countries. The TB Alliance will have a royalty-free license on the drug for drug-susceptible forms of tuberculosis.

Tuberculosis remains one of the world’s deadliest diseases and has harshly impacted developing countries as the drug-resistant form of the condition gains ground. The World Health Organization estimates approximately one-third of the world’s population is infected with bacillus that causes tuberculosis and the disease is responsible for nearly 5,000 deaths each day worldwide.

Online pharmacies and patient safety

A recent article by the San Diego Union-Tribune raises concerns over online pharmacies.  According to the piece, a vast majority of online pharmacies may not be compliant with US Federal standards.   Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP), was quoted as saying, “We have found that 92 percent of Web-site pharmacies are illegal or in violation of FDA regulations.”  In order for online pharmacies to be considered legitimate by the FDA they must be located within the US, licensed within its home state, and not fill orders without a written doctor’s prescription.

Moreover, the article warns that the quality and efficacy of drugs purchased at illegitimate online pharmacies can be questionable at best.  Common issues include counterfeit, expired, mislabeled, adulterated, or contaminated drugs.   The majority of such online pharmacies are located outside of the US, and though they claim to be importing mostly Canadian drugs, this is likely not the case.  An FDA investigation in 2005 revealed that nearly half of the imported drugs used to fill online pharmacy orders originated from India, Israel, Costa Rica, and Vanuatu —not Canada. Additionally, 85% of the imported drugs claiming to be Canadian actually came from 27 separate countries.

It is important to keep in mind that not only is it illegal for US citizens to import prescription drugs, despite indications from some online pharmacies, but many of these imports stem from developing nations with more lax prescription drug regulations and enforcement, leading to an increased probability that what you receive may not be what you ordered.  In addition to these concerns, FDA spokesman Christopher Kelly was quoted as saying, “The FDA will detain or refuse entry (into the U.S.) of illegal, unapproved products that it finds.”

The moral of the story is do not play with your health; avoid illegitimate online pharmacies with prices too good to be true.    For a list of NABP accredited online pharmacies or to report online pharmacies you suspect could be unlawful please visit their website at: http://www.nabp.net/.

GAVI announces innovative approach to developing vaccines for developing nations

At the end of last week, the GAVI Alliance partners (the World Bank, WHO and UNICEF), five national governments and the Bill & Melinda Gates Foundation formally announced the first-ever Advance Market Commitment (AMC) designed to accelerate access to vaccines against pneumococcal disease.

The Wall Street Journal reports that the $1.5 billion program marks a departure from previous charitable efforts to increase poor countries’ access to vaccines. Instead of buying existing drugs and giving them away, the donors will guarantee pharmaceutical companies a future market big enough to justify developing and manufacturing new vaccines needed in nations too impoverished to afford them on their own.

This innovative new model will mean faster access to vaccines for millions of children in poor countries. It’s a great example of how innovation and technology together can produce life-saving advances and make them available to people who need them around the world.

— Bill Gates, co-chair of the Bill & Melinda Gates Foundation

This innovative financing mechanism will ensure that children in the world’s poorest countries receive life-saving vaccines 15-20 years before they might otherwise have been available and at prices their governments can afford.

“It’s a great step for global health,” said Orin Levine, associate professor of international health at Johns Hopkins University and a longtime backer of the so-called advance-market commitment concept. He projects the funding mechanism could prevent between five million and eight million child deaths by 2030.

Although a pneumococcal vaccine has existed since 2000 and is part of regular immunisation programmes in developed countries, there is not a suitable and affordable vaccine for developing countries.

This pilot AMC aims to address this challenge by stimulating the late stage development and manufacture of suitable vaccines at affordable prices.

Through an AMC, donors commit money to guarantee the price of vaccines once they have been developed, thus creating the potential for a viable future market. These commitments provide vaccine makers with the incentive to invest the considerable sums required to conduct research and development and build manufacturing capacity.

The currently existing pneumococcal vaccine is sold at over US$70 per dose in industrialised countries. But thanks to the AMC, the long term price for developing countries will be US$ 3.50.

WHO set to declare flu pandemic

The BBC reports that UN health officials are expected to declare the first global flu pandemic in 40 years, after holding emergency talks on the swine flu crisis.

WHO poised to declare first flu pandemic in 40 years

Flu experts expected to recommend move to phase 6

Expected to urge finishing seasonal flu vaccine production

Spread of virus in Australia triggering declaration

The last global flu pandemic came in 1968 over the Hong Kong flu.  That pandemic killed about one million people.  A disease is classed as a pandemic when transmission between humans becomes widespread in at least two regions of the world.

The latest virus emerged in Mexico in April and since then thousands of cases have been confirmed throughout North and South America.

The H1N1 strain has spread to 74 countries but the WHO has so far resisted labelling the outbreak a full-blown pandemic.

WHO chief Margaret Chan talked to officials from eight countries with large flu outbreaks on Wednesday in an attempt to confirm the spread of the disease.

The WHO’s move follows Australia’s confirmation of more than 1,200 cases – a four-fold increase in a week.

Although most sufferers experience normal flu symptoms and make a full recovery, the WHO has confirmed 141 deaths from 27,737 cases.

The BBC’s health correspondent, Jane Dreaper, says classifying the virus as a pandemic does not mean that the virus has suddenly become more deadly.

But it does send a clear signal to health officials and businesses to continue planning for the possibility of large numbers of people catching the virus, she says.

Japan, China Start Group on Intellectual Property Rights

Bloomberg reported that Economic ministers from Japan and China will start a working group on protecting intellectual property rights as part of an effort to tighten economic ties during the global recession.

Asia’s two largest economies agreed to set up a working group to discuss intellectual property, implement economic measures pledged at the Group of 20 meeting in April and cooperate on development in Africa and other poorer regions.

Counterfeits and drug resistance: the global concern of malaria

Many health experts are concerned that the growing resistance to artemisinin drugs in western Cambodia could result in a repeat of the fate of chloroquine, which became largely ineffective. Counterfeit drugs can contain insufficient amounts of active ingredient, failing to cure the disease parasite and allowing it to mutate and resist the drug.  With half the world’s population at risk of malaria, it is important to prevent the spread of drug-resistant strains of this disease.

According to a recent article by Julian Harris from IPN, fake drugs are a leading cause of resistance.  Unfortunately, the proposal to simply supply cheaper artemisinin drugs is no silver bullet.

Too often, western health activists focus narrowly on the cost of drugs, as if this were the sole (let alone primary) barrier to treatment. But as explained by former US President Bill Clinton, the environment in which drugs are dispersed is vitally important: “You just can’t get the medicine, ship it into a country, and drop it from the sky. If it is going to save people’s lives, the medicine must be accompanied by instructions, monitoring, by follow-up, and changing the medicine if necessary.”

He could have added that poor storage and the degradation of drugs in transit have been shown to be major causes of substandard drugs – a problem exacerbated by pharmaceuticals being held up in tropical ports due to excessive red tape and tariffs.

Lower prices would be good, but only good drugs can save the world from a resistant strand of malaria that would claim millions more lives.

A historical view of flu pandemics: a reason to remain vigilant

Global H1N1 fears are subsiding, but as a recent Wall Street Journal article pointed out this may be premature.  The article illustrates how the number of countries with confirmed H1N1 cases has risen from four on April 27th to 48 as of Wednesday, with the number of individual cases increasing from 73 to 13,398.  However, the central question remains whether or not the virus will make a resurgence in the coming fall flu season, and if it does how virulent will it be.  As you can see from the chart below, the 1918 flu pandemic struck in 3 separate phases, with the most severe occurring in the fall of that year.  Similar to now, in 1918 after the initial outbreak, the world experienced a spring and summer with relatively low fatalities, despite rising infection rates. Nevertheless, by the fall of 1918 this trough culminated with a significant surge in fatality rates, leading to an estimated 500mn deaths.  The 1918 scenario is by no means guaranteed to reoccur; nevertheless, it is certainly a reason to remain vigilant.

A time series of deaths per 1,000 during the 1918 flu pandemic

Interesting to point out is that according to the article 64% of the current H1N1 cases have occurred in the 5-24 age bracket, with only 1% of cases occurring in people older than 65.  This distribution could theoretically be due to existing immunities within that age bracket from exposure to past H1N1 outbreaks.  This pattern again parallels the 1918 pandemic.

Not all is fire and brimstone.  Flu-detection and prevention technology has improved exponentially from 1918.  An article by the NY Times, points out pharmaceutical companies have begun preliminary work on an H1N1 vaccine. The new vaccine could be ready as early as October, after clinical trials this summer.  Nevertheless, given the parallels between now and the 1918 flu pandemic, it is important the public does not become over-complacent.  It is good advice to remain aware of your environment and report any potential infections to the proper authorities for treatment and tracking purposes.