New cancer drugs now being allowed to skip clinical trials

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.

Framed 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, we 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."

Big Pharma sidestepping regulatory approval process with bogus claims of drug price decreases

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."