Aids to recovery

The $800 Million Pill: the truth behind the cost of new drugs

Merrill Goozner <em>University of Ca

Imagine if something as essential as air or water cost every user tens of thousands of dollars each year. This is the case with anti-Aids drugs. The disease is incurable; patients can keep the virus at bay only by constantly consuming chemicals. For drugs companies, however, Aids is a curious blessing: its victims are for ever dependent on their products.

In the past few years, pitched battle has ensued between Aids patients and their representatives, fighting for cheaper drugs, and the drugs industry, which is determined to keep prices high. Why do drugs firms insist on extorting high sums for essential medicines? This is one of the questions that Merrill Goozner attempts to answer in his fascinating expose of the pharmaceutical industry.

For more than a decade, I have been seeking a cure for sleeping sickness, a tropical disease caused by parasites, injected into your body by tsetse flies that bite. The parasites pass from the bloodstream to the brain. They disrupt sleep patterns, drive you mad and then kill you. Scientists have dissected the inner workings of the parasites. We know how to kill them, and even have the chemicals that can do just that. However, every time we ask a drugs company to convert these chemicals into useable medicines, they flatly refuse. After all, they insist, it costs $800m to develop a new drug. How can a return on that investment be made from the half-million victims of sleeping sickness, who are among the poorest people in the world and live exclusively in sub-Saharan Africa?

It is undoubtedly expensive to make drugs. You need money to clear the regulatory hurdles blocking access to licences required to sell pharmaceuticals. These barriers are essential in guarding against the potential harmful side effects of new drugs - no one has forgotten the thalidomide catastrophe. In some cases, entire factories must be built to manufacture new compounds. But is it true to say that it costs $800m to develop every new drug?

Goozner describes an industry that has lost its way - and its moral purpose. The most powerful companies aim above all to have a share of medicine's most lucrative markets: anti-indigestion tablets, anti-cholesterols, blood pressure-reducing agents, antidepressants, erection assistants. Expenditure on anti-infectives (even essential antibiotics to fight ubiquitous bacteria) is in sharp decline - their problem is that they actually cure patients.

Cancer is a western plague, but it is proving remarkably hard to find new drugs for it. This is because cancer cells are nearly identical to our other cells, so it is difficult finding targets to attack. The same is true for other conditions where particular variants of our own receptors or enzymes go wrong. Curing infections is much easier. Microbes differ genetically from humans. They are full of "target" molecules, not shared with us, that provide opportunities to develop selective toxins, free from side effects. So while drugs against infectious agents may yield lower profits than, say, Viagra, this should be offset by substantially lower development costs.

Most drugs firms, however, are in a battle of diminishing returns to provide treatments for the chronic diseases of the west. According to Goozner, a "me-too" mentality has taken hold, whereby the drugs companies set out to mimic the lucrative products of competitors. Imitative drugs are seldom better than those that already exist. It requires intense marketing to persuade doctors to prescribe new drugs over those of competitors; to support the claims of this marketing requires ever larger and more costly clinical trials. As a result, development costs have risen to absurd levels.

In recent years, hope has emerged in the form of not-for-profit consortia established to pursue drugs for malaria, tuberculosis and Aids. Bill Gates, through the foundation he established with his wife, Melinda, has become the world's most generous benefactor in the field of neglected diseases. In 2003, a group of gritty pragmatists at the medical charity Medecins Sans Frontieres launched the Drugs for Neglected Diseases Initiative (DNDi). They aim to bring to market new drugs against those diseases, including sleeping sickness, for which hopes of a profit are non-existent. Led by Bernard Pecoul, a kind of Jose Bove for small pharmas against the global giants, DNDi has just appointed Simon Croft, an adroit Yorkshireman, to direct its research. Croft believes that by focusing on tractable medical problems, using innovative approaches and not worrying about marketing, the "not-for-profits" could develop a multitude of drugs and still get change from $800m. The challenge will be to raise the money. If they can, they are certain to prove that drug development costs need not be exorbitant.

Michael Barrett researches into drugs for tropical diseases at Glasgow University