| April
11, 2008
Cancer Drug Trials Often Halted Early
Without thorough review, Italian study says the trend poses risks to patients.
FRIDAY, April 11 (HealthDay News) -- An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.
The researchers looked at 25 randomized, controlled clinical trials that were stopped early because the treatments had started to show benefit to patients.
"When we analyzed 25 trials over a 10-year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials -- more than 50 percent were stopped within the last three years," study co-author Giovanni Apolone, said at a news conference Tuesday.
Of 14 trials halted early and published between 2005 and 2007, the researchers found that 11 (79 percent) of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S. Food and Drug Administration.
"This suggests a strong commercial component in stopping trials prematurely. In fact, this strategy could guarantee quicker access to the market for companies. On the other hand, a quicker clinical drug development may lead to an 'immature' benefit/risk balance of new drugs," Apolone said.
He and his colleagues "are aware that trials stopped early because they are showing benefit may result in identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation. We believe that only untruncated trials can provide the full level of evidence required to safely translate treatments into clinical practice. Without such evidence, unsafe and ineffective drugs could be marketed and prescribed, and patients' health could be jeopardized."
It can take several years for the long-term benefits or harmful side effects of a new treatment to become apparent, Apolone noted, but the average duration of the 25 studies he and his colleagues analyzed was 30 months, with a range from 12 to 64 months.
They also found that at the time five of the studies were stopped, they'd enrolled less than 40 percent of the total number of patients planned for final analysis.
The findings were published online April 9 in the Annals of Oncology.
"Clinical trails need to stop early for superior benefit whenever there's proof beyond reasonable doubt that the new treatment really is superior. That would be an ethical obligation," Stuart Pocock, a professor of medical statistics at the London School of Hygiene and Tropical Medicine in the United Kingdom, said at the news conference. "However, too many trials are stopped early claiming efficacy without strong evidence being available."
Pocock wasn't involved in the study.
Source: healthfinder.gov
Comments:
In the hopes to cash in on their product before patent expiration, drug companies are tempted to stop the clinical trials early, get expedited review from the FDA and start selling their product. They claim that they can always do the so-called “post marketing studies” to get a better picture on safety of the drugs. Of course until someone finds out real dangerous trends, profits continue to soar. Patent on a molecule starts when it is formed in the laboratory and the company has only limited years before they lose it to the generic version to complete phase I to phase III clinical trials, get it approved and make profit of the drug. No wonder there has been a consistent increase in such early discontinuation of trials and more than 50% were stopped within the last three years. It takes several years to find out about the long-term drug side effects, some of which are in fact taken for the rest of the life of a patient. Yet, the authors of this analysis found that an average duration of the 25 studies they analyzed was 30 months, with a range from 12 to 64 months. They also found that at the time five of the studies were stopped, they'd enrolled less than 40% of the total number of patients were planned for final analysis. No wonder that increasing number of medications is found to be more dangerous than what is found in their clinical trials, as the trials are not even completed as intended. The companies are in a rush to increase sales, not to find a cure.
Dr. Rath has been a crusader in unveiling such unethical practices by pharmaceutical companies. Dr. Rath's research team has also done outstanding research on more than 30 different types of cancers using novel synergistic combination of nutrients. Please read more about Dr. Rath’s outstanding research in cancer and pharmaceutical business with diseases on www.drrathresearch.org
|
|
