Drugs and Race

I write my column Drugs and Race in TCS Daily on 14 September 2004.

Get ready for ethnic pharmaceuticals

The first ethnic heart medicine is coming. That different groups of people are prone to certain diseases and react differently to the same medication is well known in medical research. Scandinavians have a higher tendency towards developing schizophrenia, while those of African descent have a higher risk of cardiac diseases.

Up until now the same medicines have been used for all types of patients who share a particular type of ailment. But recently findings in pharmacogenomics, which combine modern genetic testing with pharmaceutical development processes, have started to produce medicines that are specific for certain groups. This is sure to be controversial.

The pharmaceutical company NitroMed developed in the 1980s a new heart medicine, but discarded the project since it did not have an effect that was great enough with the test group. But recently, when the company did a closer examination of the data that were collected from the test, they discovered that the medicine seemed to have an effect among people of African descent but not among Caucasians.

NitroMed resumed the tests, now with solely African-Americans with cardiac conditions as test group. The results were so promising that test were finished before schedule. The drug, now named BiDil, was clearly more efficient than the regular heart medications. NitroMed is presently preparing to get BiDil approved and launched on the market next year.

The reason that people react differently to medications is that we all have different varieties of the enzymes that absorb, are affected by and break down the drugs. A person who quickly breaks down the medicine needs a bigger dose of it, or to take the medicine more often than a person who breaks it down less rapidly (and that could in fact get poisoned by a higher dose).

These differences depend on genetics, and different types of genes are common in certain ethnic groups and uncommon in others. There are already at present certain medications that carry warnings to physicians that they can be more or less appropriate for certain ethnic groups.

The downside with using ethnic origin as a criterion for choosing medication and treatment is that there are significant genetic variations in the ethnic groups themselves. It would be better to directly measure what variants exist through a gene test, which is also under development. But today it is far easier and less expensive for the physician to make an estimate based on the patient's ethnic origin.

Pharmaceutical corporations have started to develop certain medicines in conjunction with gene tests, in order to assess if they are suitable for the patient. One of the most famous examples is Herceptin, a metastatic breast cancer treatment that only works well against certain types of breast cancer, but works exceedingly well against them.

The problem is that often both the drug and the gene test must be approved by the authorities. That takes a lot of time, increases costs significantly and increases the risks for the corporation. What happens if only one of the two gets approved? Perhaps physicians will prescribe less of the medication if they only prescribe it to those for whom they know it really works well, thus reducing the corporation's profits.

Pharmacogenomics does not only promise safer medicines, with the right drug in the right dose to the right person, but also more efficient medicines against certain diseases. This constitutes the exact opposite to generic drugs that are assumed to be as efficient for everybody (ironically, BiDil is composed of a mixture of two generic medicines; it is the combination of the two that produces the drug's effect). This is sure to create a great controversy. New issues also arise for the pharmaceutical corporations, since up until now they have depended on developing blockbuster drugs (a prime example is Astra Zeneca's famous Losec). Blockbuster drugs are medicines that are efficient on very common diseases and ailments and thus produce large amounts of revenue. A small number of successful products must carry the costs for the many failed research projects or the medicines that failed to get the approval from the drug testing agencies. In fact, the average time required to develop a new drug has risen from 3 years in the 1960s to 10-12 years today; a significant reason for this are the much increased standards of the drug testing agencies to approve the use of a new medication.

To develop medicines for the more specific ailments of small groups in the population will thus present new problems for the pharmaceutical industry.

Many worry that race suddenly obtain a very real medical significance. One does not have to be a member of the Politically Correct establishment to share or at least understand some of those sentiments.

Maybe it would be better to use gene tests in order to determine relevant genetic differences than to use skin colour. English researchers have shown that it is possible to divide the population into four groups with genetic markers that predict the effect of drugs better than ethnicity. But until such tests are sufficiently proven and well understood, NitroMed is betting on its ethnic heart medicine. After all, as research leader Anne Taylor said in a recent interview in Nature magazine, they have the trump card: it works.