Officials at Vancouver’s Inex Pharmaceuticals Corp. had encouraging news last week: researchers reported that tumors shrank significantly in close to half the patients given a new Inex cancer drug. It was a heartening development for the firm that has already spent more than $5 million developing the drug to treat victims of non-Hodgkin's lymphoma, a form of blood cancer. But it could cost Inex another $15 million to
find out whether it can bring the drug, Onco TCS, to market. The reason: Onco TCS is only in the second of three expensive clinical trials required by Health Canada before a drug can be approved—or rejected —by the federal regulators. “This drug is doing what it is supposed to do,” said Inex president Jim Miller. “But there is a long and tortuous process we have to go through before it can start helping patients.”
As complicated and costly as the process is, clinical drug trials have undergone explosive growth in the past decade, as drug companies use sophisticated technology to bring new products to an increasingly health-conscious North American public. According to the Wash-
ington-based industry organization, the Pharmaceutical Research and Manufacturers of America, about 1,000 new drugs are currently undergoing clinical trials in North America, compared with half that number at any one time a decade ago. With regulatory agencies demanding more rigorous tests, the cost of clinical testing has soared. U.S. drug industry officials say it now costs between $139 million and $231 million to take a new drug through clinical trials, up from the equivalent of $57 million in 1998 dollars two decades ago. And they point out that for every five drugs that enter the clinical trials process, only one is ever approved for sale.
Under regulations laid down by Washington’s Food and Drug Administration and Canada’s Health Protection Branch, a new drug can enter clinical trials only after laboratory studies have shown it is likely to be safe and beneficial to patients. Phase I clinical testing involves a small number of patients who act as guinea pigs to uncover any harmful side effects. In Phase II, doctors give the drug to a larger number of patients to see whether it acts therapeutically. They repeat the process in Phase III when thousands of patients may be involved in testing a drug to verify its safety and effectiveness.
As the furor over alleged drug company interference in research demonstrates, concern over the potential for abusing the process is rising. But for all the looming issues that beset new drug development, clinical testing remains the public's best protection against medications that can harm instead of heal.
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