Tag: FDA

Why Does The FDA Approve Cancer Drugs That Don’t Work

BRIAN KLEPPER

Posted 10/23/15 on The Health Care Blog

A new study in JAMA Internal Medicine finds that two-thirds of cancer drugs considered by the US Food and Drug Administration (FDA) over the past five years were approved without evidence that they improve health outcomes or length of life. (This study closely corroborates and acknowledges the findings published last year by John Fauber of The Milwaukee Journal Sentinel and Elbert Chu of MedPage Today.) Follow-up studies showed that 86 percent of the drugs approved with surrogate endpoints (or measures) and more than half (57%) of the cancer drugs approved by the FDA “have unknown effects on overall survival or fail to show gains in survival.” In other words, the authors write, “most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points.”

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Another Stent Device Biting The Dust

Tom Emerick

Posted 3/26/12 on Cracking Health Costs

We’re seeing a trend.  The FDA approves a stent without proper testing.  Death and complication rates with the new stent increase, the FDA is force to review it.

Remember the controversy over drug eluding stents?

According to an article in the WSJ by Thomas Burton, the so-called Stryker stent…aka the Wingspan device… is increasing rates of  death of patients who have received them.  Following protocol a panel has been convened.  According to the WSJ article, “The FDA had asked the outside panel to advise it on what to do in the wake of a large study last year showing more strokes and deaths in patients with the Wingspan device than among those whose condition was treated using drugs.”

Further, “Researchers in the study concluded the rate of stroke in the patients who got the Wingspan device was ‘substantially higher than the rates previously reported
with the use of the Wingspan stent.’ ”

This is yet another reason for patients to be cautious in agreeing to a stent, and another reason employers need to consider favoring clinics who practise strict evidence-based medicine constructs.

The Latest Advisory Committee at FDA

Merrill Goozner

Posted 12/7/11 on Gooz News

Is the Food and Drug Administration stacking the deck against a negative decision at tomorrow’s safety hearing for oral contraceptives that contain drospirenone, include Bayer’s Yasmin? Or is it laying the groundwork to combat lawsuits by Bayer should the agency decide to pull the drug, which the FDA has already warned increases the risk of blood clots?

The agency took two actions this week sure to anger safety advocates, especially in the women’s health community. First, it ruled that Public Citizen’s Sidney Wolfe could not take his usual post as consumer representative on the Drug Safety Advisory Committee because his widely read newsletter, “Best Pills, Worst Pills,” has already called for pulling Yasmin from the market. The agency accused Dr. Wolfe of an intellectual conflict-of-interest.

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On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication

Merrill Goozer

Posted 11/18/11 on Gooz News

They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

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Buck for the Bang: Premium Med-Tech Pricing

Adi Renbaum

Posted 10/31/11 on Medical Device Daily.

Cook Medical’s Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies.

I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had seen in some time. Cook presented a clear study that met all primary endpoints and showed improvement over percutaneous transluminal angioplasty, the current standard of care. To non-FDA experts like myself, it seemed as though Cook was recognized for setting a new bar for conducting clinical trials and collaborating with the FDA.

I imagine that Cook Medical’s leadership was able to make all the right clinical trial investments necessary for the long-term viability of the product’s market value, not just the ones that were on display at the advisory panel meeting.

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More On Supplements

Dov Michaeli

Posted 1o/16/11 on The Doctor Weighs In

I know when I tread on people’s cherished beliefs when I get pushback from readers, some of it ,let’s say, quite emotional. But that’s good.

It is important that we challenge our beliefs, and if the sacred cows don’t stand up to scrutiny, we should slaughter them (to our Hindu readers – I meant it as a metaphor, honestly).

The October 14 of MedPage Today had an interesting article on the issue of vitamins and other food supplements. Highly recommended. Here are a few choice quotes:

“As the dust begins to settle, physicians interviewed by MedPage Today and ABC News agreed on a bit of simple wisdom –a healthy diet is more important than a fistful of supplements”.

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A Victory for Coverage With Evidence-Development

Merrill Goozner

First posted 9/8/11 on GoozNews

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

The Gateway-Wingspan system, manufactured by Stryker, was approved by the Food and Drug Administration in 2005 based on “a small, less rigorous study,” according to this morning’s Washington Post. But use has been limited by a decision by the Centers for Medicare and Medicaid Services to deny reimbursement unless patients receiving the device were enrolled in a clinical trial. This “coverage with evidence development” policy began during former CMS director Mark McClellan’s tenure during the Bush administration.

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A High Price for Rare Cancer Drugs

Merrill Goozner

First posted 8/30/11 on Gooz News

Pfizer last week won Food and Drug Administration “accelerated approval” for Xalkori (crizotinib) for a rare form of metastatic lung cancer that strikes about 3 percent of people — almost always non-smokers — who come down with the disease. That’s about 10,000 patients per year in the U.S., and perhaps a similar number abroad. Multiply that times the $$115,200 a year the company plans to charge for Xalkori, and they’ve got themselves a billion dollar blockbuster.

What does it mean when a drug earns “accelerated approval”? Unfortunately, too many people think this means that it worked so well that the FDA rushed it to market. That’s not how it works. Accelerated approval, which really should be called interim approval, is reserved for drugs that show promise for treating life-threatening diseases like lung cancer, which is the best way to describe Xalkori.

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IOM Calls For Overhaul of Device Regulation

Merrill Goozner

First posted 7/29/11 on Gooz News

The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called this morning for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.

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Niseritide, the “Lost Decade”, and the Pinto

Patricia Salber

First posted 7/14/11 on The Doctor Weighs In

Eric Topol, MD wrote an interesting commentary in the July 7, 2011 issue of the New England Journal of Medicine, titled “The Lost Decade of Nesiritide.” Nesiritide is a drug for heart failure symptoms (e.g., shortness of breath) that was approved by the FDA in 2001. Since that time, according to Dr. Topol, “well more than $1 Billion was wasted on purchasing the drug.”

It turns out that the FDA approved the drug was based on a relatively small, not particularly well done clinical trial that showed improvement in self-reported symptoms of shortness of breath 3 hours after the drug was administered. Once the drug was approved, the drug was marketed like crazy. For profit outpatient heart failure “tune up” clinics opened so that heart failure patients could get weekly intravenous infusions of the drug.

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Healthcare Associated Infections: What Is The Message, and What Can We Do About Them?

David Harlow

First posted 7/8/11 on Health Blawg

The good people at GE and JESS3 have come up with an HAI infographic.  It’s pretty, and it conveys the horrible information that many of us already know — healthcare associated infections kill about 100,000 people a year, and add $35 billion a year to our collective health care bill (here in the US of A); 5% of hospital inpatients end up with an HAI.

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We Will Pay For Avastin

Merrill Goozner

First published 6/30/11 in The Fiscal Times:

How much should you, your insurer or the government pay for an extra month of life? How much is an extra month of hope worth, even if doesn’t extend life?

Those questions never came up during this week’s Food and Drug Administration appeal hearing on the agency’s decision to withdraw approval from the Roche-Genentech drug Avastin for advanced metastatic breast cancer. But they will be front and center in the years ahead as medical science and the drug industry continue to bring advanced cancer therapeutics to market that have only marginal effects on a devastating disease that takes half million lives a year, most of whom are elderly and receive treatment through Medicare.

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Lawyers and Medical Decision-Making

Merrill Goozner

First posted 6/28/11 on Gooz News

We’ve heard a lot over the years about the inappropriate role of lawyers in the medical system. The complaints usually center on trial lawyers who sue physicians for malpractice and drug companies for failure to warn consumers about unsafe drugs and devices. We’ve heard much less about lawyers who work for drug companies and try to game the regulatory system.

This latter problem was in full display this afternoon at the FDA hearing on Roche/Genentech’s appeal of the FDA’s decision to remove breast cancer from Avastin’s label.  Paul Schmidt, a Covington & Burling attorney representing Genentech, repeatedly tried to pin down FDA oncology drugs chief Richard Pazdur and his colleagues as to whether they had ever specified that replicating the progression free survival benefit seen in the first trial that led to accelerated approval would satisfy the FDA and therefore lead to permanent approval.

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GAO: FDA Can’t Monitor Device Recalls

Merrill Goozner

First posted 6/21/11 on Gooz News

The Government Accountability Office has weighed in on the failure of the Food and Drug Administration to properly monitor medical device recalls. Its review of the 3,510 recalls between 2005 and 2009 — 40 percent of which were cardiovascular radiological or orthopedic devices — found:

Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.

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Soaring Medical Costs Pinned on Medical Devices

Merrill Goozner

First published 6/07/11 in The Fiscal Times

While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions,  a fight is brewing that could have a major impact on efforts to control health-care spending.

The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.

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