Study says testing time can't be blamed for rising drug costs

Drug companies cannot blame long product testing times for the rising prices of medicines, researchers said yesterday.

They said that in fact, the time it takes to get a drug from idea to the market is not increasing and some potential blockbuster drugs are tested and approved quickly.

"Our research shows that long development times are an unlikely factor in rising drug prices," said Dr Salomeh Keyhani, an assistant professor of health policy at Mount Sinai School of Medicine in New York who led the study.

"Drug companies will price new drugs at the highest price that the market will bear, not based on drug development times."

Writing in the journal Health Affairs, Dr Keyhani and colleagues said they used published cost estimates along with information on success rates from publicly available data such as Food and Drug Administration reports.

They started with the widely cited 2001 study by the Tufts Centre for the Study of Drug Development in Philadelphia that found the cost of developing a new drug is $802 million ($1.2 billion) and that it takes an average of from 10 to 15 years to bring a new compound from the laboratory to the pharmacy.

"However, our estimates vary from around $500 million to more than $2000 million, depending on the therapy or the developing firm," the researchers wrote in their report in Health Affairs.

Dr Keyhani's team searched published reports on drug testing times for 168 drugs entering human clinical trials for the first time between 1989 and 2002.

They found the median clinical trial period was 5.1 years and the median regulatory review period was 1.2 years. Clinical trials are trials on people, as opposed to tests done in laboratories.

Drugs with annual sales over $100 million took one year less to develop than drugs that did not sell as well.

"The higher the annual sales on a drug, the faster it was developed," Dr Keyhani said in a statement.

"Does that mean that if a drug was potentially more profitable, that a pharmaceutical company would get it out on the market faster?

"We don't know, but it's one theory."

Keyhani's team also found that drugs to treat rare diseases, called orphan drugs, take longer to develop, a median of 5.8 years. The first drugs in a new class also tend to take longer to develop.

Drugs with huge markets such as those sold for allergies, stomach acid and incontinence were tested in clinical trials for less than 2.5 years.

A second study in the same journal shows that the United States dominates the new drug industry, introducing close to half of all the major new drugs in the global market.

Between 1993 and 2003, US firms introduced 48 per cent of first-in-class or novel drugs, 52 per cent of biotech drugs and 55 per cent of orphan drugs that treat rare diseases worldwide, according to Henry Grabowski, a Duke University professor of economics.

"The industry is spending more and getting fewer drugs out, but the drugs are higher quality," Grabowski said in a statement.

His study found that 919 compounds were introduced between 1982 and 2003. US firms accounted for more than half of biotech products during that time, and most of the new agents targeted cancer.

The drug industry lobby group, Pharmaceutical Research and Manufacturers of America, says drug development is risky.

"Out of 5000 to 10,000 screened compounds, only 250 enter pre-clinical testing, five enter human clinical trials, and one is approved by the Food and Drug Administration," the drug group said.

- REUTERS