Natural Society – by Julie Fidler
Congress will vote today on a nearly 1,000-page bill that holds drastic changes for the U.S. Food and Drug Administration (FDA). If the bill is approved, it would speed up the approval of new drugs and medical devices. The House has been heavily criticized for allegedly rushing piece of legislation through without sufficient scrutiny. [1]
The legislation, dubbed the 21st Century Cures Act, sets aside $6.3 billion for biomedical research, opioid abuse prevention, and support for the FDA, which oversees the safety of drugs. Multiple provisions are contained in the bill that are designed to loosen the requirements for drugmakers seeking approval from the agency to market their products.
Lawmakers on both sides of the aisle largely support the bill, but consumer advocates say major trade-offs in the legislation could actually strip the FDA of some of its regulatory power. Sen. Elizabeth Warren (D-Mass.) and other lawmakers argue the bill contains giveaways for the pharmaceutical industry.
In a tweet dated November 28, Sen. Warren said:
“Congress has been working on medical innovation legislation for yrs. But in the final days of 2016, Big Pharma hijacked 21st Century Cures.”
Drug and medical device companies are thrilled with the legislation, which lobbyists have been working overtime to try and get passed. According to the Center for Responsive Politics, more than 1,400 lobbyists have pushed for the bill’s passage, including drug companies and universities, which would all benefit from an increase in biomedical research funding.
A version of the bill that passed easily in Congress ended up dying in the Senate. The updated version, unveiled by House and Senate leaders over Thanksgiving weekend, has been altered to speed its passage through both houses.
Are Drugs Being Approved Fast Enough Now?
Dr. Michael Carome, director of Public Citizen Health Research Group, is concerned that, under the bill, drugs would be approved by the FDA even faster than they are today. And make no mistake about it, the agency already rushes medications to the market. [2]
There are 4 possible channels for the FDA to expedite approval for promising new drugs for the treatment of serious or life-threatening medical conditions. These programs were intended to be an exception to the rule; however, a 2015 study in the BMJ showed that the programs have become the rule themselves, with a statistically significant increase of 2.6% per year over the last 20 years in the number of drugs qualifying for the FDA’s expedited drug development and approval programs. [3]
The FDA can approve drugs based on the presumption that they work, but without proof of a long-term benefit. Researchers use a “surrogate endpoint,” such as a tumor’s response to a drug, even though that response might not translate into a longer or healthier life.
Most of these early approvals and developments rely on information gathered from early-stage trials that are generally small in size. The authors of the report wrote that “this trend is being driven by drugs that are not first in class and thus potentially less innovative.” In fact, according to Diana Zuckerman, head of the National Center for Health Research, 1 study revealed that 18 of the 36 the cancer drugs recently approved on the basis of surrogate endpoints failed to help people live longer. She says:
“What’s happening is we are flooding the market with medical products that don’t work very well, or we don’t know whether they work.” [2]
Zuckerman has a new study that is slated to be published in JAMA Internal Medicine which shows that often new cancer drugs fail to even improve patients’ quality of life, despite the drugs’ weighty price tags.
The authors of the BMJ study reached a similar conclusion, writing:
“Effectively, the FDA has been granting most supplemental approvals without evidence of meaningful clinical benefit.” [3]
Patients would like to see drugs approved faster, for obvious reasons, but doing so may jeopardize their health even more. Can the FDA assure patients that the new therapy they’ve just been prescribed is safe?
Even former FDA Commissioner Mark McClellan admits the FDA hasn’t done a very good job of following up on provisionally-approved drugs. McClellan said:
“A lot of follow-up studies have not been performed or have not been performed well because we don’t have good systems in place to learn about drugs once they are on the market.”
Despite the controversy, some advocates of the bill say the legislation is still a step in the right direction, including Fran Sasinowski, an attorney who notes that the FDA didn’t even mention patients until 2008, more than 100 years after the agency was founded. He said:
“This bill, if it were to become law, would even give more prominence to the role of the patient in this process.”
Fast-Tracking Can Be A Problem
But fast-tracking drugs has cost people their lives in the past. The best example of this is Vioxx, a non-steroidal anti-inflammatory drug (NSAID). During the review process for the pain reliever, an FDA medical officer looking at clinical trials noted a threefold increase in cardiovascular problemsby people taking it, but could not definitively say Vioxx was the cause. [4]
At the time, Celebrex, a similar drug, was already on the market. Yet, the FDA fast-tracked Vioxx with the goal of making a decision within 6 months.
Within 6 months, another Vioxx clinical trial showed that people taking the drug had double the number of heart attacks and strokes. Merck, the maker of Vioxx, took the medication off the market. A standard review of Vioxx – and the FDA’s insistence on better studies, earlier in the process – could have led the agency to restrict who used the drug or delay its arrival on the market.
By the time Merck pulled Vioxx in 2004, more than 38,000 deaths related to its use had been reported, and as many as 25 million Americans had taken the drug. [5]
Sources:
[1] The Washington Post [2] NPR [3] Specialty Pharmacy Times [4] Boston.com [5] DrugWatchNational Center for Health Research