FDA Approves Cancer Drugs With Out Proof They Even Work

For decades, researchers have focused on developing new cancer drugs that save lives or improve the quality of life. But when the U.S. Food and Drug Administration allowed #Inlyta a $10,000 a month drug, on the market in 2012, there was no proof that it did either.
A Milwaukee Journal Sentinel/MedPage Today analysis of 54 new cancer drugs found that over the last decade the FDA allowed 74% of them on the market without proof that they extended life. Seldom was there proof of improved quality of life, either. Nor has the FDA demanded companies provide such evidence.

Prompted by politicians, pharmaceutical companies and advocacy groups seeking to speed up drug approvals, the FDA has allowed shortcuts to make it easier for companies to get products on the market.

Heart drugs may be approved based on tests measuring various fats in the blood rather than fewer heart attacks, strokes or cardiovascular deaths. The whole paradigm is broken, and it is an unmitigated disaster. We’ve spent billions of dollars on trials that should have never been done in the first place.
Pharmaceutical companies now control the drug development agenda and, as a result, are able to price drugs at whatever they think the market will bear, said Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York. “We’re paying top dollar for drugs that do very little,” Saltz said. “If we continue to pay for drugs the way we have been, we’re actually stifling innovation.” The FDA’s approval of new cancer drugs has improved the financial health of drug companies. Once the #drugs are on the market, companies have charged an average of $10,000 a month for the 54 drugs examined, with four costing more than $20,000 a month and one priced at $40,000 a month. Spending on all oncology drugs hit $28 billion in 2013, an increase of 9.2% from 2012. Thats HUGE.

The FDA does not routinely push companies to do studies that prove a drug can extend or improve life as a condition of approval. When the agency does, drug companies sometimes ignore it. In 2013, the #FDA collected $490 million from drug companies to review their drug applications under the law.