Recently in FDA Category

Warm, touching, but inadequate story of a pro football player's daughter and her path to a heart transplant.

The story claims that a heart pump saved the girl's life - when that can't be proven. It also didn't discuss costs, didn't discuss evidence, didn't discuss some of the known problems with the heart pump - follow the link to see what it did and didn't do.


The Star Tribune, which has done a fine job reporting on University of Minnesota medical school conflict of interest issues, bombed on a story about problems with the FDA's medical device approval process - largely because it failed to counter the clear conflict of interest in the single source it used! Inexplicable.

Something doesn't feel right about FDA - WebMD partnership

In the circles I run in, there's been a buzz about an announcement first made last December about a "partnership" between the FDA and WebMD. Yesterday the two entities announced an expansion of that partnership "to provide increased access to FDA's consumer health information."

I can appreciate the FDA's interest in reaching the public more directly with its messages.

But WebMD has turned over its "channel" - some of it marked "news" - to a government agency. Should journalists "partner" with a government agency for news and information?

And they boast that "Since the launch, over 150,000 consumers have accessed the FDA destination on WebMD ... The FDA's consumer information is also available through WebMD the Magazine, distributed ten times a year and reaching an additional 11 million consumers with each issue."

And I would remind the FDA that, while there may not be any ads on the FDA pages of the WebMD site, users are just a link away from ads on WebMD material. I just visited and quickly found myself viewing ads for drugs for fibromyalgia, depression, coronary artery disease and others. Is that appropriate for the FDA?

Something doesn't feel right about this - for either party - or for the public.

Sandy Szwarc of the Junkfood Science blog looked at this in greater detail when the partnership was first announced in December.

What the FDA sees that doctors and patients may never know

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Steve Woloshin and Lisa Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice publish an important perpective piece, "Lost in Transmission -- FDA Drug Information That Never Reaches Clinicians," in this week's New England Journal of Medicine.

It's about how "critical information that the FDA has at the time of drug approval may fail to make its way into the drug label and relevant journal articles."

Examples they write about: sleeping pills Lunesta and Rozerem. Excerpts:

"Clinicians who are interested in (Lunesta's) efficacy cannot find efficacy information in the label: it states only that Lunesta is superior to placebo. The FDA's medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.


A sense of uncertainty about the net benefit of drugs is almost always lost. FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms. ...

Rozerem (ramelteon), for example, was approved in 2005 for chronic insomnia and was aggressively promoted to consumers. No efficacy data were provided in the label....The Rozerem review included a memo from the medical review team's leader, highlighting the team's struggle to determine whether this drug provided any clinically important benefit and whether that benefit outweighed the harms. ... The sense that the FDA's decision was a close call was not communicated in the label."

The authors have urged the FDA to consider a "drug fact box" featuring a data table of benefits and harms to be used in reviews, labels or both.

They conclude:

"We don't need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known."

Reforming FDA medical device approval

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I don't think the American public would be thrilled with the FDA's device approval system - if they knew more about it. But this week the issue is in the news.

Worse than oily stools

The FDA, in its ongoing safety review of weight-loss product orlistat (marketed as Alli and Xenical), now advises:

Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA's Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.


In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

John Mack tackles the question on his Pharma Marketing blog.

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Terrific WSJ story on FDA device approval

Front page. More than 2,000 words. The kind of story Americans need to understand. We're fortunate to have the WSJ on days like this with stories like this. - "FDA Backs Knee Device After Long Lobby Effort."


I think the American public would be shocked if they knew the guts of what was in the GAO report yesterday, "FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process."

The report suggests that FDA review and approval of new medical devices has been lax, allowing companies to get approval through an easier process whereby they only had to show their idea/product was "substantially equivalent" to an existing product on the market. But that loophole was only meant for the smaller toys of the medical arms race. It wasn't meant for metal hip joints, pacemaker electrodes and pedicle screws for spinal surgery - all of which slipped through the easier review process, according to the GAO.

And journalists and the public should take this into account when they hear or report news of FDA approval of some devices. It's NOT terribly big news, in my view, to trumpet FDA approval of something that's only judged substantially equivalent to something already on the market.

NBC, for one, gave a big chunk of precious airtime to FDA approval of a laser hair comb. Whoopee. Our review on HealthNewsReview.org showed that it was only judged to be substantially equivalent to 10 other products already on the market!!!

Breakthrough? Depends on how you spell hype.

Saga of the heart sock continues

I've been tracking news coverage of a Minnesota company's heart "sock" device for heart failure for four years. Four years ago, I questioned Star Tribune coverage.

Two years ago, questions of evidence started to surface.

Today the Star Tribune reports:

"The high-profile consumer advocacy group Public Citizen expressed "deep concern" this week about whether the company's experimental device has been sufficiently reviewed by federal regulators. ...

Two advisory panels for the FDA have recommended against approval of the Acorn device after reviewing the company's application and holding public hearings. The agency itself has rejected the company's application three times. Acorn has even taken its case to a dispute resolution panel, a highly unusual move in the device world, which also voted against approval of its device.

Normally, a company in this situation would have abandoned the rather-expensive effort, especially a start-up like Acorn, which has no other products on the market.

But Acorn has been encouraged along the way by Dr. Daniel Schultz, a surgeon who is head of the FDA's device division, and the company subsequently reached an agreement with the agency to conduct a second, albeit smaller, clinical trial involving 50 patients. If that study is successful, the device could be approved by the agency without being first reviewed by an advisory committee and without a public hearing, according to Public Citizen.

In a Nov. 12 letter to Schultz, Public Citizen said the design of the new study "is so poor that it is unlikely to provide reliable data that would contradict the negative findings of the data so far submitted to the FDA." The number of patients enrolled in the study is too small, and they will not be followed for a sufficient amount of time, Lurie said."

I never would have picked up on the scent of this story had not the Star Tribune given such favorable coverage to the company and its product four years ago.

Patients v. Pharma

See Niko Karvounis's blog entry, "The Case of Patients v. Big Pharma." It starts:

On November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the “business case of the century�—and with good reason. In essence, Monday’s ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks.

Medical device ads more troublesome than drug ads?

The US Senate Aging Committee was looking at medical device ads yesterday.

The AP reports:

While spending by the device industry is minuscule by comparison (with drug ads), several of the biggest players are adapting similar high-profile tactics.

Johnson & Johnson currently promotes its orthopedic hips with a TV advertisement featuring Duke University basketball coach Mike Krzyzewski. Biomet has promoted its competing products with spokeswoman Mary Lou Retton, an Olympic gymnastics champion.

Unlike ads from pharmaceutical companies, medical device spots are not required to give equal balance to risks and benefits of their products. Because of that, they can "create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies," said Kevin Bozic, a board director of the American Association of Orthopedic Surgeons.

Consumers Union called for device ads to include information about infections and other complications. a CU news release stated:

A recent FDA report on data collected from fiscal year 2006 found a 25 percent increase in adverse events linked to medical devices over the previous fiscal year, including 2,830 deaths, 116,086 injuries, and 96,485 malfunctions. The CDC's National Nosocomial Infections Surveillance (NNIS) System Report shows knee and hip replacement surgery to be a serious source of infection. In some of the NNIS reporting hospitals, the risk of infection may run as high as five percent or more.
Warnings of side effects associated with implantable medical devices in direct consumer ads are generally non-existent or minimal. A review by Consumers Union found no advertisements that advised consumers of the very real possibility of deadly infections or of the need to seek out surgical centers with low infection rates.

The New York Times reported:

"...some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

'The results are irreversible because you are kind of stuck with a device,' said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco."

Should Pharma PR Pros Write the Government’s Advice to Consumers?

The FDA has launched a new website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers." masthead.jpg

But Merrill Goozner and the Integrity In Science Watch project of the Center for Science in the Public Interest distributed a news release with their concerns. Excerpts::

Drug ads can be confusing and often deceptive, so it makes sense that the Food and Drug Administration would develop a web site aimed at helping consumers separate fact from fiction. But to develop such a site the FDA turned to a nonprofit front group erected by Shaw Science Partners, a public relations firm that specializes in launching new drugs such as Viagra, Celebrex, Zoloft, Cymbalta and the now-withdrawn Rezulin.

CSPI today called on the FDA to scuttle the web site, to terminate its relationship with the drug companies’ PR. firm, and to seek out advice from leading physicians, pharmacists, or consumer groups before publishing a new site aimed at educating consumers. The connection between the FDA site and the Big Pharma PR. firm was reported this morning in Integrity in Science Watch, published by the Center for Science in the Public Interest. ...

“It’s not that any of the information presented on this web site is wrong, per se,� said Goozner. “But if the goal were to educate consumers about drug ads, the site is a dismal failure. Nowhere are consumers encouraged to view drug ads with any kind of skepticism. Nowhere are consumers urged how to evaluate messages about side effects. The agency basically invited an industry-funded front group to write the advice. Not surprisingly, they delivered a turkey.�

Big Pharma & Big Politics

The Wall Street Journal reports:

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. ...

FDA officials "are too cozy with the companies they regulate," Sen. Chuck Grassley (R., Iowa) said, adding that new leadership must "fix the culture." ...

"There's a total inability of the FDA to carry out" its mission," said Rep. John Dingell (D., Mich.)

Meantime, the folks at the Center for Media & Democracy on their PRWatch.org website caught a couple of things I had missed regarding Big Pharma and Big Politics.

Pushing Prescriptions

Source: Center for Public Integrity, June 24, 2008

"Washington's largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort," reports M. Asif Ismail. The spending, from companies and trade associations including Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, jumped 36 percent over the previous year. Much of the increase went to Democrats, after they became the majority party in Congress. "In the current election cycle so far, for the first time on record, the pharmaceutical and health products industry has given slightly more money to Democrats than Republicans," Ismail notes. Just two years earlier, "Democrats received only 31 percent of the contributions from the industry, while the Republicans received 67 percent." The industry's lobbying successes have included "thwarting congressional efforts to restrict media ads for prescription drugs," "blocking the importation of inexpensive drugs from other countries," and "ensuring greater market access for pharmaceutical companies in international free trade agreements."

If You Can't Beat 'em, Hire 'em

Source: Wall Street Journal (sub req'd) July 23, 2008

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices." He was also an active litigator who worked against consumer interests. "Representing the Washington Legal Foundation, an industry-supported business think tank, Mr. Troy argued for the protection of commercial speech. ... He was also part of the winning team representing Brown & Williamson in a suit against the FDA regarding tobacco advertising." At the FDA, he was known as a loyal friend of the very industries the regulatory agency is charged with monitoring. "Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical-device makers, saying that having met the FDA's approval and labeling standards, manufacturers should be protected from state-based suits for damages." His move to GSK is another example of the revolving door between government and industry. GSK said of Troy, "His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients."


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