TCS Daily


Trials in Error

By Roger Bate - November 17, 2003 12:00 AM

Last month an appeals court in New York re-opened a case brought by several Nigerian families against the drug company Pfizer. They allege that the company violated their human rights by administering Trovan, an experimental drug, without adequately informing them of the risks.

 

This lawsuit has very little merit and will probably be thrown out like the original one two years ago. But it may do long run damage. Health campaigners have been asking for drugs for developing country diseases for decades, but how are drug companies expected to test their new drugs on poor country diseases if, when they do so, they are sued because someone dies, or someone wasn't properly informed that a new drug might be dangerous? The incentive for the companies is obvious: work in the West on the financially lucrative diseases of cancer, baldness, hypertension, and yes, erectile dysfunction, and forget things like cholera, meningitis and malaria.

 

Activist Attacks

 

There have been numerous attacks on the pharmaceutical industry in the past two years. Overly expensive medicines in the US and aggressive patent protection of AIDS drugs in poor countries, have been the favorite two targets of activist campaigns. But although the industry as a whole has been attacked, Pfizer, the world's largest drug company, has taken most of the beating. Two and half years ago The Washington Post discussed the distressing 1996 meningitis epidemic in Nigeria and attacked Pfizer for using the epidemic as an opportunity to test a new meningitis drug called Trovan.

 

The Post echoed activists' claims that Pfizer's Trovan trial on children sick with meningitis may have led to more deaths than would have been expected. Six months ago The British newspaper The Guardian attacked Pfizer's profits and drug prices, and then British TV's Channel Four broadcast a program called Dying for Drugs, which attacked Pfizer's Trovan trial.

 

The program interviewed family members of children who had been involved in the trial, Western activists who oppose drug company patents, doctors from international health agencies who obviously dislike the influence of corporations, lawyers representing "victims" of Pfizer's activities who are suing the drug company, bitter ex-employees of Pfizer, and other opinionated commentators.

 

The only party missing from the debate was anyone currently employed by Pfizer (or anyone who could put a drug trial in a corrupt third world country into perspective). Pfizer's public affairs representatives say they were never asked to take part.

 

Without including Pfizer officials or providing a counter voice, the program seriously lacked balance. But balanced journalism was never its intention. The program was really a campaign, aimed at making an emotive case against drug companies, rather than investigating the challenges of healthcare in the developing world. In a similar vein the re-opened New York case will be used primarily to embarrass the company.

 

Various reports on the Trovan drug trial, from The Washington Post and other news and academic sources, suggest that it is unclear whether Pfizer's activities cost lives or saved them. Pfizer insists that it furthered knowledge about Trovan, which was subsequently approved for use in the US. The fatality rate for the Trovan trial was about 6pc, the same as those children treated with other drugs.

 

Perhaps the Trovan drug trial was conducted under less than ideal conditions, with slack trials regulations. But even so, meningitis is a rare disease in wealthy countries and it's impossible to perform adequate trials on such low numbers. So testing in Nigeria probably made sense, and even if mistakes were made, none appeared to have been willful or from negligence.

 

Trovan Litigation

 

There is ongoing litigation in Nigerian and US courts, but the most famous case was dropped this summer. Nigerian plaintiffs filed their statement of claim in Zango v. Pfizer on March 7, 2001 at the Federal High Court in Kano, Nigeria.

 

Yet many of the claims were for unnamed "ghost" plaintiffs: the gender of many plaintiffs, names of plaintiffs who allegedly died, and hospital records were all missing. Court requests for full information apparently fell on deaf ears. Although the New York case that re-opened yesterday has, at least, "real" plaintiffs, claims of harm are hard to substantiate.

 

The legal and media attacks will likely result in fewer drug trials in poor countries, but it will also reduce research on drugs for diseases that primarily affect them. How could drugs for leprosy, malaria or leishmaniasis be tested in Geneva, London or New York when no one has the disease in those locations?

 

Drug companies are not in the business of testing drugs they know do not work, or of avoiding testing regulations because they want to harm the poor. To make a profit they need successful drugs. They clearly benefit from swifter testing regimes abroad -- but so do consumers. Greater profits mean more research and development.

 

Over time, the developed world drug approval process has slowed, with bureaucrats scared to approve anything that might be the new thalidomide. This overly cautious approach denies thousands the benefits of new treatments. It is the single largest cost companies bear, encouraging them to look overseas.

 

The media and the courts should focus on the real scandal: the time it takes to bring a new drug to market.

 

Dr. Roger Bate is a visiting fellow of the American Enterprise Institute and a Director of health advocacy group, Africa Fighting Malaria
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