Tag Archives: FDA

A Win For Big Tobacco

A federal judge has just handed the tobacco industry one of its more salient victories in recent years, having decided that the Food and Drug Administration’s plan to require graphic warnings on cigarette packs violated the manufacturers’ right to free speech.

Image of proposed warning courtesy the Food and Drug Adminstration

Richard J. Leon of the U.S. District Court for the District of Columbia issued an order that prohibits the FDA from moving ahead until at least 15 months after he has rendered a final decision.

It’s a firm rebuke to the agency, which had trumpeted the warnings as a crucial means of dissuading Americans from smoking.  In June, the FDA shared nine cigarette package prototypes and issued a final rule that ordered manufacturers to comply with the new packaging by Sept. 2012.

A few months later, R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands, Liggett Group, and Santa Fe Natural Tobacco Co. sued the agency. And it’s not just big tobacco that is fighting the regulation. Tobacco marketing is big business.

Not surprisingly, the Association of National Advertisers and the American Advertising Federation filed a friend of the court brief in September.  The brief excoriated the government for overreaching.  And, the advertising groups likened the effort to a thinly-veiled propaganda attempt.

“If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so,” said the brief.

Judge Leon was persuaded, at least in some way, to weigh these First Amendment arguments. According to the New York Times, in his 29-page opinion (which has not been made available online yet), he lambasted the government’s “obvious anti-smoking agenda!”

But activists and others who fought for many years to find a way to regulate tobacco expressed dismay over his stay.

Rep. Henry Waxman (D-Calif.) called the Judge’s ruling “extremely regrettable.” He says that Congress already worked out all the First Amendment issues “to ensure the FDA could act as it has proposed….”

Sen. Tom Harkin (D-Iowa), who in 1998 introduced the first bill to give FDA the power to regulate tobacco products, said that graphic warnings were necessary. “This decision must be appealed so that implementation of the warning label requirement can go forward without delay,” he said, in a statement.

In January, a U.S. District Court Judge in Kentucky upheld FDA’s authority to require warnings in a similar lawsuit. That case is now on appeal.

It may now be years before the legal wrangling is settled.

—Alicia Ault (on Twitter @aliciaault)

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Filed under Cardiovascular Medicine, Clinical Psychiatry News, Family Medicine, Health Policy, IMNG, Internal Medicine, Pediatrics, Pulmonary Diseases and Sleep Medicine

A Few Pills a Day to Keep Wrinkles Away?

Unilever, the international conglomerate that makes Dove soap, Axe body spray, Lipton tea and Ben & Jerry’s ice cream, is poised to bring the world a nutraceutical that it says can activate genes that will essentially repair the damage that leads to wrinkles.

Courtesy Wikimedia Commons user Bastet78/Creative Commons

According to an extensive article in the NewScientist, the nutraceutical will be launched in October in 44 spas that Unilever co-owns in the United Kingdom, Spain, and Canada.  Unilever is not seeking regulatory approval because the capsules contain ingredients already in use, and the company will not make any health claims, according to the article.

If Unilever is hoping to ever introduce the pill in the United States — which we can safely assume it will — it will likely take the same approach. Dietary supplements don’t require formal approval from the Food and Drug Administration, unless they claim to treat or cure a condition. (For more on how FDA regulates functional foods and supplements, see its web page here.)

The vast majority of supplements push as close to the legal requirements as they can, and some skirt past them, in the hopes that the FDA won’t notice. But the agency has been noticing more often and cracking down on products that make health claims.

The Unilever pill apparently has some scientific evidence to support its mechanism of action.

Again, according to the NewScientist, it will contain soy isoflavones, vitamin E, vitamin C, lycopene, and omega-3 polyunsaturated fatty acids extracted from fish oil. The omega-3s reportedly activate a PPAR gene (peroxisome proliferator-activated receptor). PPARs are involved in cellular differentiation, development, metabolism, and tumorigenesis.

The company could spend the money and time to seek formal FDA approval for wrinkle improvement — following in the footsteps of say, a Quaker Oats getting a cholesterol-lowering claim for its oatmeal. Competitors have basically ridden on Quaker’s coattails — if one oatmeal lowers cholesterol, they probably all do.

But I can’t see Allergan (which makes Botox) or Medicis (which makes Restylane) sitting idly by while Unilever mass markets an over-the-counter dietary supplement with a claim to erase wrinkles. A pill could be seen as an attractive alternative to the currently available injections, fillers, and surgical options.

And everyone’s always looking for the next best anti-aging product.

The NewScientist story caused an eruption in the blogosphere, with citations appearing everywhere from the beauty site Jezebel to the Yahoo health and beauty page, Shine. A quick Google search shows that it even ran on the Ecuador Times, which bills itself as a bilingual site for all things Ecuadorian.

The world is waiting, Unilever.

—Alicia Ault (on Twitter @aliciaault)

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Is Your Phone Smart Enough to Cure Acne?

The Federal Trade Commission (FTC) says no, definitely not.  On Sept. 8, the agency announced that it had reached settlements with two companies that were claiming that their apps could cure acne. It is the first time the FTC has pursued any company making a health claim for an app.

“AcneApp” and “Acne Pwner” both claimed to be able to treat acne with colored lights that come out of the phone when the app is activated. Purchasers were told to hold the screen next to the affected area of skin for few minutes daily.

The agency was having none of it. “Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” said FTC Chairman Jon Leibowitz, in a statement.

Acne Clear app. Photo by Alicia Ault

According to the FTC, there were 3,300 downloads of AcnePwner, for sale in the Android Marketplace for 99 cents. AcneApp was downloaded 11,600 times from the iTunes store at a cost of $1.99 each. 

The AcneApp makers claimed that the app was developed by a dermatologist and that its technology was backed up by a study in the British Journal of Dermatology. Nope, not true, said the FTC.

The settlements bar the app makers from making acne-treatment claims and they were ordered to pay nominal fines. Koby Brown and Gregory W. Pearson, doing business as DermApps, have to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, was ordered to pay $1,700.

The trade journal mobihealthnews reported that both apps had been removed from retail earlier this year or late last year.  Mobihealthnews also noted that the New York Times gave the AcneApp some press in late 2009. Gregory Pearson is identified in that story as a Houston-area dermatologist.

Apps that claim to offer curative powers were the subject of a two-day workshop that the Food and Drug Administration just wrapped up.  The agency has been mulling over how and when to regulate mobile apps.  It looks like the FTC may have beaten it to the punch.

But there are likely to be plenty more apps to scrutinize in the future.

A quick check of the Android marketplace today from my smartphone found, “Acne Clear,” from United Holdings Group, being sold at 99 cents.  It supposedly “uses a specific sound frequency and a blue color wavelength from the Lapis Lazuli gemstone to help clear and detox the skin.”  United also markets a “Skin Cleanser” app that supposedly uses a sound frequency and “a yellow color wavelength from the Imperial Topaz gemstone to help clean the skin of dark spots, sun spots, and acne scars.”  It’s 99 cents.

There’s also “SkinApp” from M&R Selected, which is free. and advises that it allows you to do “color light therapy on the go.” It is listed as having 10,000 to 50,000 downloads. The reviews are full of testimonials that it works, but also that it is just plain “bad.”

What kind of review would you give these apps? Should patients download them, or are they better off keeping their 99 cents?

— Alicia Ault (on Twitter @aliciaault)

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Melanoma Heads Down the Genetic Pathway

The molecular profilization of melanoma is nigh. Assessment of advanced-stage, metastatic melanoma to determine whether it carries a mutation in the BRAF oncogene will turn routine soon, once physicians have the option to treat these patients with the new BRAF inhibitor drug, vemurafenib.

That might happen any day now. Reuters said on August 9  that the FDA’s approval of vemurafenib could get announced soon. Roche/Genentech submitted their NDA for vemurafenib to the FDA in May, and in June came impressive efficacy results in a phase III study that got reported at both ASCO and in a New England Journal of Medicine article.

malignant melanoma; courtesy Nephron/Wikimedia Commons

Last week, I covered the American Academy of Dermatology’s summer meeting in New York, and melanoma specialist Dr. Richard D. Carvajal from Memorial Sloan-Kettering, New York, told me that once vemurafenib was on the market, genetic analysis of advanced melanomas to find BRAF mutations would suddenly become standard of care. Once testing for one mutation starts, several more genes can easily piggyback onto the assay, which will help to further flesh out the range of genetic mutations that can exist in metastatic melanoma and provide potential targets for new drugs.

It’s becoming a well-trodden path that’s rapidly driving the treatment of advanced cancers of all kinds into the molecular-profiling era. Just a couple of weeks ago, I blogged here on how it had already transformed advanced lung cancer management. Breast cancer and colorectal cancer have an even longer history of genetic assessment, and more cancers will likely follow this route soon.

When I wrote my blog post about lung cancer in late July, I focused on the challenge to successfully treating late-stage cancer, and I said that better alternatives were lung cancer prevention, by not smoking, and earlier diagnosis, with CT screening.

Melanoma does not pose the same screening issues as lung cancer. It’s much easier to survey the skin than to peer into a person’s lungs. And the idea of melanoma prevention by sunlight avoidance and protection has transformed the way many Americans approach outdoor activity. Over the last generation or so, SPF has become a cultural touchstone.

Despite that,  cases of advanced melanoma are inevitable. Last week at the AAD meeting, Dr. Darrell S. Rigel from New York University showed evidence of a troubling, new wrinkle in melanoma epidemiology: an appreciable blip in cases that first appeared about 10 years ago in American women aged  30-34 years, a shift that Dr. Rigel attributed to an increased use of tanning salons among teenage girls that started in the 1980s.

Even if advanced-stage tumors, melanoma, or lung cancers are unstable and unlikely to respond to even the best targeted of drugs for more than a few years, those extra years of cancer control with good quality of life can make a big difference to each patient who responds to a genetically targeted treatment, Dr. Carvajal told me.

—Mitchel Zoler (on Twitter @mitchelzoler)

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FDA Misses Lessons of Device Recalls

A new report from the U.S. Government Accountability Office (GAO), the auditing arm of Congress, found that the Food and Drug Administration isn’t doing everything it can to learn from medical device recalls. That’s despite the fact that on average more than 700 medical devices are recalled each year. The report was requested by Sen. Chuck Grassley (R-Iowa), the chairman of the Finance Committee and Sen. Herb Kohl (D-Wisc.), the chairman of the Committee on Aging.

The GAO investigators didn’t take issue with what the FDA does in initiating and classifying the mostly voluntary recalls of medical devices. Instead, they wrote that the agency took a haphazard approach to assessing the effectiveness of recalls and analyzing information after a recall. Those gaps represent a missed opportunity to learn went wrong and keep it from happening again, the GAO warned.

An open and charged AED. Image via Wikimedia Commons user Owain.davies.

Specifically, because of the FDA’s lack of analysis on medical device recalls, they couldn’t give definitive answers to questions from the GAO about the common causes of recalls, the trends in the number of recalls over time, the variation in recalls by risk level, the types of devices and medical specialties that account for the most recalls, and the length of time it takes for companies and the FDA to complete recall activities.

But the FDA told the GAO investigators that it does use recall information help target their inspections. And the GAO gave FDA a gold star from use of recall information to detect and address safety issues with automated external defibrillators. Late last year, the FDA held a conference on AEDs where in presented historical recall data to make the case for safety improvements in the device, the GAO wrote.

For its part, the FDA says it’s getting better. In statement in response to the GAO report, FDA officials said that last year launched the Recall Process Improvement Project, which is aimed at better educating the industry about the recall process. And about a year ago, the FDA began using recall data to aid in the review of devices. The agency has also developed initiatives that use recall data to help improve the safety of infusion pumps, external defibrillators, and radiation from medical procedures.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

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Filed under Cardiovascular Medicine, Drug And Device Safety, Emergency Medicine, Family Medicine, Health Policy, Hospital and Critical Care Medicine, IMNG, Internal Medicine, Nuclear Medicine, Practice Trends, Primary care, Radiology

Emil Corwin, Longest-Serving Federal Spokesman -30-

In the good old days of public relations and journalism, the symbol -30- was often used to signal the end of a press release or news story.  Today I use the symbol in my headline to pay tribute to Emil Corwin, who died on March 15 at his home in Chevy Chase, Md., according to the Washington Post.

Via Flickr Creative Commons user derekGavey

Apparently, Mr. Corwin was one of the longer-serving spokesmen for the Food and Drug Administration, but, as of now, he was also the oldest public affairs officer to ever have been employed by the federal government. Mr. Corwin retired at age 96, in 1999.  He was 107 when he died.

The Post said that he joined the FDA in 1974 at age 70 — generally a time when most people are starting to enjoy retirement, not start a new career.

I have covered the FDA since the late 1980s, but, much to my chagrin now, never interacted with Mr. Corwin that I remember.  It may be because he largely handled food and dietary supplement issues.  Oh, the things Mr. Corwin must have witnessed in his long career.

These days, when public servants are under attack across America, how about a tip of the hat to someone who gave so much of his life to the taxpayers?

— Alicia Ault (on Twitter @aliciaault)

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Quality vs. Quantity: Who’s to Say?

Is quantity of life more valuable than quality of life, and who should be the judge? That seems to be the crux of the dissension between the Food and Drug Administration and the breast cancer guideline panel of the National Comprehensive Cancer Network (NCCN) regarding the use of bevacizumab (Avastin, Genentech) for the treatment of HER2-negative metastatic breast cancer.

In December of last year, the FDA announced that it would be removing the breast cancer indication for the drug, which was initially approved under the agency’s accelerated approval program in 2008 based on promising findings of its use in combination with paclitaxel (Taxol) in the E2100 clinical trial. Following a subsequent review of the trial data and information from additional clinical trials provided by Genentech, the FDA deemed the small increase in progression-free survival in the absence of an overall survival benefit to be outweighed by the risks associated with the drug, and has begun the process of removing the indication.

Although the FDA action would not preclude off-label use of the drug in breast cancer patients, it would effectively prevent it by giving payers a reason not to finance it. As such, Genentech is appealing the decision and appears to have the support of the NCCN, which is retaining bevacizumab in the updated treatment recommendations announced over the weekend at the organization’s annual conference in Hollywood, Florida.

Dr. Robert W. Carlson. Image courtesy of Stanford University.

After multiple “marathon” meetings to discuss the FDA action, the 26-member NCCN breast cancer guideline panel decided unanimously to reaffirm its existing recommendation for bevacizumab in combination with paclitaxel as a therapeutic option for metastatic breast cancer, panel chair Dr. Robert W. Carlson announced at the conference. “The data observed in the [E2100 clinical trial] really had not changed from its approval previously, and we thought, if the data were compelling 2 years ago, why isn’t it compelling enough today?”

A revised footnote accompanies the panel’s recommendation: “Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time-to-progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.”

Dr. Carlson, of Stanford University (Palo Alto, CA) was not dismissive of the toxicities associated with bevacizumab, but reiterated the panel sentiment that the progression-free survival benefit is a quality of life measure that should not be overlooked. “Progression-free survival is an important end point in the adjuvant setting. If it means the difference between 5 months with the disease under control vs. 5 months of disease progression, there is value in that.”

Dr. Carlson disclosed receiving grant and research support from AstraZeneca Pharmaceuticals LP, Genentech, Inc., Pfizer Inc., and Sanofi-aventis US.

—Diana Mahoney

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