New Cancer Drugs Now Allowed to Skip Clinical Trials

October 15, 2013

(NATURAL NEWS) –  The regulatory framework that guides the approval process for new  pharmaceutical drugs is becoming increasingly compromised, as drug companies  continue to chip away at its core functions. And according to a new report by  Reuters, new cancer drugs are among the worst regulatory offenders these  days, with many of them now completely bypassing the normal clinical trial  process, as they are rushed to market as quickly as possible.

1326206_209Framed as a  positive development for the thousands of people suffering from cancers that do  not respond to traditional chemotherapy and radiation, the U.S. Food and Drug  Administration’s (FDA) relatively recent expedited review process for  immunotherapy cancer drugs is making experimental medications more widely  available to desperate patients. But is Big Pharma taking advantage of this  desperation by using it as an opportunity to skip the clinical trial  process?

Since the typical approval process for new drugs is both lengthy  and costly, sometimes lasting a decade or more and costing upwards of $1 billion  per drug, according to some reports, drug companies have long sought shortcuts  that might help bypass this laborious process. And now they have finally found a  way, convincing higher-ups at the FDA to shorten the approval process and get  new drugs to market more quickly.

Back in August, Natural News reported that the  FDA passed a new “Safety and Innovation Act” back in 2012 that allows untested,  but allegedly promising, drugs to be rushed to market under the designation of  “breakthrough therapy.” Such therapies do not have to undergo full-scale clinical trials and  can simply be approved based on preliminary clinical evidence that points to  “substantial improvements” over existing drugs.  But the process is  largely arbitrary and serves to benefit the drug industry far more than  suffering patients. According to Dr. Alexander Eggermont, chief executive of the  Institut Gustave-Roussy, France’s largest cancer center, the immunotherapy class  of drugs has the potential  to become a $35 billion a year market, which means rapid approvals will  translate into big bucks for Big Pharma.

We won’t have to do those  dinosaur trials,” Dr. Eggermont is quoted as saying by Reuters, noting  that immunotherapy drugs are the “biggest game changer” the industry has ever  seen. “It will change the whole attitude in drug development.”


In a further attempt to legitimize this obvious  sidestepping of regulatory standards, the drug industry has also posed the idea  that its drugs may become less expensive as a result of having to wade through  fewer regulatory hurdles. As anyone with a family member who has gone through  the traditional cancer treatment process can attest, the costs of chemotherapy drugs and radiation can  top hundreds of thousands of dollars annually, which makes lower costs  enticing.
But many experts are already saying that this is not actually  the case, and that drug prices have yet to drop in any substantial way. Even though the typical clinical  trial process for drug approvals is estimated to represent more than one-third  of the overall research and development (R&D) costs for drug companies, the  adoption of an expedited process for some drugs has not led to any significant  changes.

The costs should be coming down tremendously,” says Paul  Workman, head of drug discovery at the UK’s Institute of Cancer Research, as  quoted by Reuters. “What’s disappointing is that we haven’t seen it  happen yet.” 


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