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 postmarketing 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.
Here’s a short post on how Congress leaves insured Americans at the mercy of the drug industry. Top 20-selling drugs in the U.S. are now three times more than the in the U.K. And, here are six tips for keeping your drug costs down, along with five programs that could lower your costs if you have Medicare. And, for other free and low-cost assistance programs, click here.
maybe you could provide a list of those drugs that don`t work so we can tell our doctors we don`t want it.
You wrote that Obama nominated Dr. Robert Califf to head the FDA. He has strong ties to the medical device and drug industries. He’s currently deputy commissioner of the FDA. Another Obama appointment at the FDA, Michael Taylor, is in charge of food safety. He was a Monsanto attorney before becoming Monsanto’s chief lobbyist.
No wonder that the FDA is so friendly to Big Pharma.
This has nothing to do President Obama. He has not ever receive 1 cent from any drug makers. Michael Taylor has not received one cent either.
This is about CANCER and how much money has been put into finding a cure for all of them. Look at the American Cancer Society. See when it started, now try to find out how much it has taken in. Now times that by 10. 10 being the others that have taken taken money for cancer. This all started in 1913. 102 years ago. 1913,1913. I remember my mother giving $100.00 to A.C.S. in 1952. Some say well we have come a long way. I say NO we have not. So at least $1,000,000,000,000 spent, I ask all of you ( Have we gotten our money’s worth ) for me I say NO. Somebody’s getting rich by keeping this going as long as possible. I think they know what is causing a lot of cancers. It is in the food we eat and water we drink. But seems nobody wants to step on the manufactures of these products or make them pull off the shelves. Yes we know family history is a factor. But after 103 years we can expect more for our money.
You have to realize, also, that cancer studies of ANY kind are notoriously difficult to do and to show efficacy, as the measures used are rather vague. This does NOT excuse the way that many drug companies handle their studies and their data, and it is certainly true that MANY kinds of ‘new’ drugs show appallingly minor differences from currently available medicines, yet are marketed as new and improved anyway, and many not-so-pleasant or actually dangerous side effects show up once the drug reaches a wider number of patients post approval. This is the system of clinical research that we have in this country, and until it changes, the unfortunate results will not change either. Perhaps our ire should be targeted to THAT, not to the limited efficacy of the drugs themselves. For a cancer patient, sometimes limited efficacy is literally ALL that they have available and they are grateful for it, which is something that only THAT patient can make a decision on. Provided that patient is given ALL the information by the physician and the drug company, that is. Those are the real issues, in my opinion.