Healthy Skepticism Library item: 3905
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Fox M.
Lengthy drug testing not to blame for prices:study
Reuters 2006 Mar 7
http://www.nlm.nih.gov/medlineplus/news/fullstory_30690.html
Notes:
Ralp[h Faggotter’s Comments:
This article explodes a couple of myths. For example-
‘ “Out of 5,000 to 10,000 screened compounds, only 250 enter preclinical testing, five enter human clinical trials, and one is approved by the Food and Drug Administration,” PhRMA says in a statement.’
A common believe is, that modern drugs are largely designer drugs, where a researcher starts with a deep knowledge of human physiology and biochemistry and constructs a drug from scratch for a certain specific purpose.
The truth is, that useful drugs are still mostly discovered but a farily random process of trial and error as has always been the case. Hence, upto 10,000 chemicals must be screened to find one useful drug.
The truth is, that we still do not know enough about the human body ( and probably never will) to confidently predict which potential drugs will prove to be safe and effective.
Full text:
Lengthy drug testing not to blame for prices:study
Reuters Health
Tuesday, March 7, 2006
By Maggie Fox
WASHINGTON (Reuters) – Drug companies cannot blame long product testing times for the rising prices of medicines, researchers said on Tuesday.
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 very 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, 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 Center for the Study of Drug Development in Philadelphia that found the cost of developing a new drug is $802 million and that it takes an average of 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 $2,000 million ($2 billion), depending on the therapy or the developing firm,” the researchers wrote in their report in Health Affairs.
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 in 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.
SPEEDING TO MARKET
“The higher the annual sales on a drug, the faster it was developed,” 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, U.S. firms introduced 48 percent of first-in-class or novel drugs, 52 percent of biotech drugs and 55 percent 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 new compounds were introduced between 1982 and 2003. U.S. 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, or PhRMA, says drug development is risky.
“Out of 5,000 to 10,000 screened compounds, only 250 enter preclinical testing, five enter human clinical trials, and one is approved by the Food and Drug Administration,” PhRMA says in a statement.
Reuters Health
Copyright © 2006 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
