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FDA Sends Warning Letters To California Surgical Centers For Misleading Advertising Of The Lap-Band

The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.

Source: fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm283455.htm#.TueG3YY1aZY.facebook

We have blogged on 1-800-Get-Thin and Lap-band surgery in general before. Read more »

*This blog post was originally published at Truth in Cosmetic Surgery*

MSNBC Promotes Treatment For Condition Plastic Surgeon Named

MSNBC commits an egregious example of disease-mongering in a piece they headlined:

Plastic surgeon wants to fix your ‘runner’s face’.

What is so egregious? Let us count the ways:

• They pass along a plastic surgeon’s news release about his treatment for a condition he calls “runner’s face”.
• So it is a promotion for his treatment for a condition he has named. This is what is called “advertising” – not “journalism.”
• They provide no data.
• They describe Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Solving The Health Care Crisis By Understanding The Uncertainty And Variability Of Health Care

Every day in the U.S. countless experts discuss plans and policies to contain the cost of health care using words and concepts that run counter to our (the public’s) experiences with finding and using care. Most of us ignore the steady stream of proposals until one political party or the other crafts an inflammatory meme that resonates with our fears of not getting what we need. At which point, we leap into action online, in town meetings and in the voting booth. As Uwe Reinhardt noted in his Kimball Lecture at the recent 2011 ABIM Foundation Forum, researchers and policy makers “cannot even discuss the cost-effectiveness of health care without being called Nazi(s).”

Our discomfort with the array of private and public sector proposals to improve health care quality while holding down costs should not be surprising. Most of us hold long-standing, well-documented beliefs about health care that powerfully influence our responses to such plans. For example, many of us believe that:

… if the doctor ordered it or wants to do it, we must need it.

… talking about less expensive treatments makes us feel that others are trying to bargain-shop our care and that scares us.

… clinical care does not vary much among our own doctors and hospitals.

… when we talk about the “quality” of health care we are referring to Read more »

*This blog post was originally published at Prepared Patient Forum: What It Takes Blog*

Why Pharma Advertising Often Misses The Mark

The Pharmaceutical industry has effectively made a mockery of itself with television advertising (harsh assessment, I know, but bear with me). In the late 1980s – 30 years after television advertising was figured out – Pharma finally jumped into the game after regulatory constraints were lifted. Some of it worked – but mostly, the efforts just amplified the industry’s public relations comorbidities.

I actually believe that the industry could learn a few things in this video I came across. It’s a road safety advertisement and it brilliantly weaves together a simple idea with visual and emotional vigor. Read more »

*This blog post was originally published at Phil Baumann*

Online Advertising 3.0: Harnessing Social Media Users For Precision Targeting Of Friends

Do you advertise on your social networks? You might not think that you do, but every time you tweet or update your status on Facebook or post a picture to Flickr, you’re advertising – perhaps not with commercial or self-promotional intent, but you are advertising something: an item of news, a humorous post or a moment from your vacation. I don’t believe that Advertising is bad; but there is bad advertising, the kind that pointlessly interrupts and annoys and leads to no action.

As the Web expands and evolves from a tangle of static web pages towards social and real time streams, Advertising will need to evolve into a suppler and friendlier animal. Google may have perfected Advertising on the traditional web platform, but the door is open to new players who can socialize advertising. It’s not an easy task: the bull’s eye of targeting customers is getting tinier everyday. Enter MyLikes, a start up which has taken on the task of helping advertisers reach their base. Read more »

*This blog post was originally published at Phil Baumann*

Latest Interviews

How To Make Inpatient Medical Practice Fun Again: Try Locum Tenens Work

It s no secret that most physicians are unhappy with the way things are going in healthcare. Surveys report high levels of job dissatisfaction burn out and even suicide. In fact some believe that up to a third of the US physician work force is planning to leave the profession…

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Caring For Winter Olympians In Sochi: An Interview With Team USA’s Chief Medical Officer Dr. Gloria Beim

I am a huge fan of the winter Olympics partly because I grew up in Canada where most kids can ski and skate before they can run and partly because I used to participate in Downhill ski racing. Now that I m a rehab physician with a reconstructed knee I…

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Latest Cartoon

Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

***

Click here for a musical take on over-testing.

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Latest Book Reviews

The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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Unaccountable: A Book About The Underbelly Of Hospital Care

I met Dr. Marty Makary over lunch at Founding Farmers restaurant in DC about three years ago. We had an animated conversation about hospital safety the potential contribution of checklists to reducing medical errors and his upcoming book about the need for more transparency in the healthcare system. Marty was…

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