Linda...
Below is a very interesting story concerning the testing of drugs, the associated costs, etc., etc. It came from the May 17 issue of Forbes. Well worth reading. I knew drug testing was expensive but I never realized the magnitude and cost of testing drugs.
I also have a friend who works for a major Drug company and he tells me that only 1 in 10 ever get approved. I cannot prove that but nonetheless it is a very costly process.
Regards
Bob T.
forbes.com
Drugs
Forbes Executive Compensation Database
The drug revolution could run into a brick wall: not enough guinea pigs.
Trials and tribulations
By Alexandra Alger
HUGE ADVANCES IN molecular design, high-speed robotic drug analysis and genetic mapping have spawned hundreds of new drugs in the lab, but the march of science is stumbling over a low-tech problem: a shortage of human volunteers to try them out.
There are more trials these days, and they need more patients. Landing enough subjects adds months of delay to the lengthy clinical trials required to get a drug approved, forcing some researchers to reduce the scope of their studies. It ultimately threatens to throttle new-drug development.
Close to 80% of clinical trials fail to enroll the required number of patients in the time promised by the investigators, says CenterWatch, a Boston-based publisher of newsletters and books on clinical trials. The scarcity could get even worse.
Look at the math. Researchers have 1,900 drugs in human trials worldwide, says IMS Health. Of the total, 330 drugs are in Phase III, the final and longest phase that often requires many thousands of patients. Some 400 new drugs will advance to Phase III in the next few years, requiring a million warm bodies.
The patient shortage is particularly severe in cancer research. Scientists are testing drugs that, for the first time, target the flawed genes that promote cancer growth. Exciting stuff, but only 3% of cancer patients take part in trials—and investigators need three times as many.
"It's really a tragedy," says Dr. Eric Rowinsky, director of clinical research at the Institute for Drug Development at the San Antonio (Tex.) Cancer Institute, where dozens of experimental cancer drugs are in early-stage trials. "As all these drugs move into Phase III trials, they're going to need thousands of people. But people aren't participating."
At the National Cancer Institute, it takes four years on average to fill up big Phase III trials, which can include 10,000 patients or more. Trials can last seven years. "We want to bring it down by at least two years," says Jeffrey Abrams, who oversees the institute's effort to speed up the process.
Delay can make the difference between life and death. In early 1995 Genentech set up Phase III trials for Herceptin, a promising breast cancer drug that blocked tumor growth linked to an overabundance of the Her-2/neu gene. Some 150 investigators prepared to recruit 450 patients for a key study. By year-end they had signed up only 25.
The company redesigned the trial to quell some doctors' concerns and expanded its recruitment efforts. Herceptin hit the market last fall, offering real hope for the 30% of breast cancer patients with high quantities of the Her-2 gene. Still the drug might have started saving lives a year earlier had test patients been in abundant supply.
Aviron, a small developer in Mountain View, Calif., is in late-stage trials of a nasal spray vaccine against influenza. Last year it set a new study in Temple, Tex., hoping to sign up 15,000 children—but landed only 4,300. The effort continues. "If I can get 10,000 children, I'll be happy," says Dr. Manju Gaglani, an investigator for the study.
The patient problem is made worse by marketing needs. Drugmakers run extra tests of already-approved remedies to extend their use to additional illnesses. They also extend trials over many years to land a better advertising claim, such as the power to prevent a first heart attack.
In the early 1980s a new drug typically underwent 30 trials with 1,300 volunteers. By the mid-1990s the average was 68 trials and 4,200 patients, says the industry's trade group. Eli Lilly & Co. tested Evista, its osteoporosis prevention drug, on 10,000 women.
Money is an issue. Sometimes patients are told that the trial sponsor will not be picking up the cost of medical care like X-ray exams and blood tests—and that their insurance company or HMO won't pay either, since experimental treatments aren't covered. The American Association of Health Plans recently endorsed reimbursements for people in federally funded trials. Maryland and Virginia have passed laws mandating insurance coverage for routine care in certain trials; similar proposals are pending in Congress. But Lee Newcomer, chief medical officer at United Health Group, a big HMO in Minnetonka, Minn., doubts such measures will help. After United told its 14 million members it would cover routine care in any of a thousand government-funded cancer trials, only half a dozen members took up the offer. "I think the academic community is going to be surprised at how few people do this," Newcomer says.
What to do? While drugmakers have plowed billions of dollars into the tools and techniques for creating new chemical compounds, they still use methods from decades past to recruit test patients. They leave it up to the trial investigators, who rely mainly on ads in newspapers. Doctors often aren't eager to have their patients participate, particularly when they might just end up on a placebo.
Almost half of clinical trials now are conducted overseas, where patients are easier to find and costs are lower. Middleman businesses have emerged to speed up recruitment. Site management organizations, which own or run networks of investigator sites, now account for 7% of testing.
Contract research organizations—which drugmakers hire to run trials from start to finish—also work the problem. Drugmakers spend a fourth of their $21 billion annual R&D budget on contract researchers.
Covance Inc., based in Princeton, N.J., says it can recruit thousands of people in only months. Speed means money. "For a billion-dollar blockbuster, one day late is $3 million," says Harris Koffer, a vice president charged with accelerating the process. Even then, he says, drugmakers lack the resources and patients to pursue all prospects. "They're going to have to pick and choose."
Science created this crunch, and one day will help ease it. Researchers are racing to decode the human genome, the map of the 100,000 or so genes that inhabit every human cell and dictate molecular function and dysfunction.
Once they do, new drugs may target particular genes and get tested only on the patients who carry them. With a higher hit rate, the drug researcher can prove a statistically valid conclusion using a smaller number of patients.
The genome fix, however, could take many years to arrive. Until then drug companies will be competing for a scarce resource—willing volunteers. They may have to scale back their plans. |
