The BlogHealth Post50cancer drugs fda

The Problem With Most Cancer Drugs Recently Approved By The FDA

According to a new study in JAMA, there is no evidence that the majority of the U.S. Food and Drug Administration-approved cancer drugs over the last five years work.
By 

Founder and CEO, JustCareUSA.org, a digital platform for boomers and carers

Founder and CEO, JustCareUSA.org, a digital platform for boomers and carers
|
This post was published on the now-closed HuffPost Contributor platform. Contributors control their own work and posted freely to our site. If you need to flag this entry as abusive, send us an email.

According to a new study in JAMA, there is no evidence that the majority of the U.S. Food and Drug Administration (FDA)-approved cancer drugs over the last five years work. The FDA used substitute measures, laboratory measures rather than clinical evidence, to approve two out of three cancer drugs, without any indication that the drugs either improve health or prolong life. Indeed, in follow-up studies, 86 percent of drugs approved through substitute measures showed no clinical benefits.

In the case of bevacizumab, a breast cancer drug treatment, the FDA allowed the drug to go to market based on substitute measures that showed "progression-free survival" or PFS. But, a later study showed substantial toxicity and no improvement in life expectancy. And, the FDA ended up removing authorization to market it.

In 2009, the U.S. Government Accountability Office took the FDA to task for failing to do post-marketing studies on all drugs that are approved using substitute measures. The GAO reported that the FDA had plans to improve oversight, but it was not prepared to say whether those initiatives would be effective. According to the GAO, there are no specific conditions that require the FDA to speed up the withdrawal of a drug from the market if a drug company does not conduct a follow-up study in a timely manner or if a drug is shown not to be beneficial in a follow-up study.

The drug companies prefer getting drug approvals using substitute measures that do not focus on efficacy or health outcomes. Substitute measures allow drug companies to bring drugs to market faster and at less cost. When the drug companies use clinical measures that look at health outcomes, they must spend more time and money on their trials.

The problem is that substitute measures may show good performance when in fact health outcomes are not any better. Health complications may also not be evident through the substitute measures. So, drugs approved using substitute measures may actually hurt patients.

The price of a new cancer drug can easily be $10,000 a month, regardless of either the drug's worth or its cost of development. The cost of cancer drugs can literally bankrupt a person with cancer. In 2014, the least expensive new cancer drug approved cost more than $120,000 a year.

Today, the drug industry helps cover the cost of the FDA's work. And, we are left to wonder whether the FDA's independence has been compromised at the expense of patient safety. At the same time, the public may wrongly assume that FDA approval means the drugs are safe.

Earlier on Huff/Post50:

The 5 Drugs Most Commonly Abused By Post-50s
#5 Stimulants(01 of05)
Open Image Modal
While stimulants such as Ritalin and Adderall are highly addictive, abuse among older people is not as widespread as it with young adults. However, illicit stimulants like cocaine are more common. In 2008, 63 percent of 118,495 emergency room visits made by those 50 and older involved cocaine. The number of older cocaine users likely increased in the past few years since more than 550,000 adults aged 50 and older reported cocaine use, according to a 2011 report.(Image via Flickr, Alex Dodd) (credit:Alex Dodd/Flickr)
#4 Antidepressants(02 of05)
Open Image Modal
While the names are varied -- Prozac, Zoloft and Lexapro, among others -- the effects are similar. Used primarily to treat depression and mood disorders, antidepressants have a slight potential for abuse and addiction. According to a 2010 report from The Drug Abuse Warning Network, antidepressants contributed to 8.6 percent of emergency room visits by adults 50 and older. (credit:Darren Staples / Reuters)
#3 Sedatives(03 of05)
Open Image Modal
Most often used to treat anxiety and insomnia, sedatives like Valium and Xanax may become addictive if taken incorrectly, or used too often. The Drug Abuse Warning Network identified sedatives, or depressants, as the pharmaceutical involved in 31.8 percent of emergency room visits by older adults. (Image via Flickr, Dean812) (credit:Dean812/Flickr)
#2 Pain Relievers(04 of05)
Open Image Modal
Painkillers like Oxycodone, Vicodin and Morphine have a high potential for abuse. According to a Drug Abuse Warning Network report, pain relievers were the type of pharmaceutical most often involved in emergency room visits for post-50s, encompassing 43.5 percent of senior ER visits. The vast majority of painkiller-related ER visits -- 33.9 percent -- involved high-level narcotics, rather than over-the-counter pain relievers. (credit:Hyungwon Kang / Reuters)
#1 Medical Marijuana(05 of05)
Open Image Modal
While many people have medical prescriptions for marijuana use, 3 million adults aged 50 and older have illegally used the drug within the past year, according to a 2011 report from The National Survey on Drug Use and Health, a branch of the U.S. Government's Department of Health and Human Services. Out of 4.8 million older adults who used illicit drugs, marijuana use was more common than non-medical use of prescription medicines among the 50 to 59 age range (though the opposite was true for those 60 and older). Marijuana is also far more popular among men than women aged 50 and older. (credit:Getty Images)
Suggest a correction
|
Submit a tip