DC Medical Malpractice & Patient Safety Blog

It’s as if they’re playing hokey-pokey over at the FDA.

The Endocrinologic and Metabolic Drugs Advisory Committee recently gave a thumbs-up to Qnexa fewer than two years after recommending against it. It’s the first time since 1999 that an advisory panel for the federal agency has approved a weight-loss drug.

The FDA doesn’t have to accept the panel’s advice, but usually does.

The side effects that prompted the initial rejection of Qnexa are still of concern, but experts believe that if the drug is used only by a certain segment of the obese population and if trials study its performance after approval, the benefits for that population supersede the risks.

Like all the expansive media coverage of the Qnexa announcement, MedPage Today reported that concern centers around the increased risk of an elevated heart rate and of birth defects, specifically oral clefts.

Cardiovascular issues arise because Qnexa contains phentermine, the second member of Fen-Phen (fenfluramine/phentermine), an obesity drug yanked from the market six months after its introduction in 1997 because it increased the risk of valvular heart disease, posed a risk for birth defects and compromised mental acuity.

The drug combines phentermine, an appetite suppressant, with topiramate, an anti-seizure medication that increases the feeling of having eaten enough. Both drugs already are FDA-approved.

FDA panelists reviewed three studies that were conducted after the first advisory committee review of Qnexa and concluded that they did not show an association of topiramate exposure and risk of major congenital malformations. They warned, however, that topiramate exposure in pregnancy was likely to be associated with increased incidence of oral clefts.

Vivus, manufacturer of Qnexa, agreed to develop a risk-mitigation strategy that provides:

• labeling that states the drug should be discontinued if the patient becomes pregnant;


• distribution of Qnexa only through 10 certified mail-order pharmacies that agree to train pharmacists in use of the drug and submit to internal audits;


• targeted education programs aimed at providers and patients, including a brochure on contraception and recommendations for monthly pregnancy testing;


• development of a pregnancy registry to track pregnancy outcomes.

In addition, Qnexa is intended for use only by people with a body mass index (BMI) 30 or higher, or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes. A BMI of 25 to 29 signifies overweight, and 30 or greater is considered obese.

For a couple of years now, Southern California drivers have become used to seeing
billboards for a medical procedure that promises to turn overweight people into the thin creatures they want to be. By calling 1-800-GET-THIN, you could sign up for a gastric Lap-Band surgery at an outpatient facility and change your life. So they claimed.

Several people who took up the offer did change their life—they died.

Last week the FDA finally noticed. The agency issued a warning letter to eight of the surgical centers promoted on the oversized advertisements. The feds told GET-THIN to stop posting misleading advertisements. It’s a violation of federal law for advertising to minimize significant risks and complications of a procedure. It’s also illegal to fail to make clear that for Lap-Band to be truly effective, it must be accompanied by a significant change in the patient's eating habits and lifestyle.

Los Angeles Times columnist Michael Hiltzik said it was about time. “For nearly two years, my colleagues and I have been reporting on the 1-800-GET-THIN ad campaign,” he wrote. “In my very first column on the topic, in February 2010, I identified the people behind it as brothers Julian and Michael Omidi, and reported that Julian's medical license had been revoked by the Medical Board of California and Michael's medical license had been placed on probation. (Michael's probation has since expired.)”

The L.A. Times has reported the deaths of local patients after their surgeries were performed at advertised clinics, and on the lawsuits and coroners' reports that detailed them. “So far," Hiltzik wrote, “the known toll is four, with a coroner's ruling still pending on the death of a fifth patient, who expired after being rushed to a hospital in September from the surgery center where she had just undergone the procedure.

"We've reported on the shocking sanitary and safety conditions at one of the surgery centers affiliated with the ad campaign, and noted questions about whether the surgery centers' insurance billing has been proper.

"And we've reported that effective oversight of a potentially life-threatening procedure has been hampered by California's patchwork system of medical regulation, in which the medical board and the state Department of Public Health essentially pass the buck to each other over who should keep an eye on non-hospital surgery clinics like these.”

The Lap-Band is a cinch placed around the upper part of the stomach creating a smaller organ that minimizes the amount of food you can ingest. Although the procedure is approved by the FDA, and often is preferable to the more invasive and complicated weight-loss surgery that diverts food from being absorbed in the small intestines, it is not without risks that can be exacerbated if it’s performed in facilities whose personnel are less than vigilant or qualified.

Complications include the band moving out of position and eroding through the stomach wall. Nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD) and pain can result. One study said as many as 1 in 3 10 Lap-Band patients experience band erosion and almost half will have the band removed.

Still, in some circumstances and for some people, it’s a suitable treatment for obesity.

But not the way GET-THIN promotes it. The billboards have included disclaimers that Lap-Band surgery has certain "risks, side effects, and contraindications," and that you should check with your own doctor before undergoing the procedure. That caution was too feeble for the FDA, especially because the disclaimers appear in such tiny type that they're "illegible."

The California insurance commissioner is investigating the Lap-Band industry for alleged fraudulent billings and misrepresented charges. Patient deaths and injuries have prompted a series of wrongful-death and personal injury lawsuits against GET-THIN, its affiliated surgery centers and doctors who performed the procedures. And a class-action lawsuit accuses GET-THIN of false advertising for failing to adequately disclose risks of the surgery and disciplinary problems of some of its doctors.

Hiltzik reported that the director of the L. A. County Department of Public Health complained about GET-THIN to the FDA, and the Omidis filed an administrative complaint against him, asserting that he was biased against them because he was a shareholder in Johnson & Johnson, which markets a competing weight-loss device they don't use. The director recused himself from matters involving weight-loss devices.

When the county coroner blamed the death of a Lap-Band patient at least partially on the "suboptimal" care she had received at a clinic affiliated with GET-THIN, the clinic accused the coroner's expert of a conflict of interest because she had once worked at UCLA, which they claimed was Lap-Band competitor.

As Hiltzik notes, the Omidis are less concerned about quality of care than they are in suing anybody who challenges their shaky performance. “[T] hey've sued me and my colleagues at The Times for reporting about them. So far, three of these lawsuits against us have been thrown out of court by state and federal judges. The plaintiffs have appealed the dismissals and filed more suits against us and commenters on our website.

"The public record is brimming with material — including complaints of wrongful death, negligence and irregularities in billing practices — that could fall well within the jurisdiction of several state regulatory agencies. It may be that the FDA has fired the first shot in what could be a barrage.”

Although this is a local issue, the fact that the Feds have finally taken notice is a cautionary lesson for anyone in search of an invasive weight-loss treatment. Often, these patients are desperate, depressed and vulnerable to claims that aren’t true, or only under certain conditions.

Always research the procedure to be informed about whom it suits, and what are the risks. Always investigate the background of the surgeon with your state medical board. Always investigate the facility at which it is to be performed with your state health department and insurance provider.

Blogger Jim Edwards has a list of "10 Weird Health Theories That Just Won't Go Away."

Many of them flower from the backlash to the medical industrial complex's desire to medicalize, and provide a pill for, all slightly different human behaviors. Others underscore how appropriate skepticism about modern medicine can lead to an over-correction and an endorsement of wrongheaded and dangerous ideas (autism being caused by vaccines as a prominent example).

Here's the list of myths:

• "The so-called obesity epidemic is just a scare tactic to make you feel bad"

• "Human growth hormone is the fountain of youth"

• "Women who don't like sex have female sexual dysfunction"

• "Low-dose naltrexone cures everything"

• "Multiple sclerosis is caused by blocked jugular veins"

• "Taking multivitamins can prevent prostate cancer"

• "High cholesterol is not a health risk" [Note from Malone: This one is complicated.]

• "The feds want to microchip you like a pet cat"

• "HIV is not the cause of AIDS"

• "Vaccines cause autism"

A pioneering new study of the popular liposuction surgery finds that the fat which a surgeon sucks out from one part of the body gets added back in elsewhere by Mother Nature.

The study published in the journal Obesity found that within a year, all the fat suctioned out in a liposuction was regained by the body -- not in the location of the liposuction but in other places such as the upper abdomen and shoulders.

Obesity researchers say that the body "defends" its fat, carefully regulating the total amount of fat in the body. So fat removed by surgery in this respect is no different from fat lost by dieting -- the body's natural mechanism tends toward putting that fact back on.

No one quite knows why liposuction fat doesn't come back in the same place, but researchers told the New York Times it may be due to the way that liposuction disrupts the fishnet structure under the skin where fat cells reside.

Since liposuction has been around since the 1970s, why hasn't a carefully controlled study like this been done before? It has a lot to do with surgeons who rely on anecdote to prove that their methods work, rather than careful statistical studies.

Some unethical doctors are charging patients big bucks for prescriptions of human chorionic gonadotropin (hCG) for weight loss. Supposedly you can lose fat in just the right places, the belly for one, if you take daily hCG injections in your abdomen. The claims are sheer quackery.

This use of hCG, a pregnancy hormone that is derived from the urine of pregnant women, is "off label," meaning the manufacturer is not allowed to promote its use for weight loss, since it's never been proven to work.

For the doctors who prescribe hCG for weight loss, it's not illegal, just unethical. The use of hCG for weight loss has never been proven to work any better than injections of salt water (placebo).

The injections are prescribed along with an anorexic diet of 500 calories a day. So any claims about weight loss from the hCG are scientifically impossible to prove, since starvation is likely to cut weight anyway.

The hCG weight loss remedy has been exposed as quackery in articles in WebMD, Wikipedia, and other media.

Yet still the New York Times reports that women are lining up to pay up to $1,000 a month for hCG prescriptions and the syringes needed to stick themselves.

As the Times reports:

[t]he F.D.A. has also reiterated a warning, first issued in the mid-1970s, that is required on hCG packaging: It has not been shown to increase weight loss, to cause a more “attractive” distribution of fat or to “decrease hunger and discomfort” from low-calorie diets.

The F.D.A. recently received a report of a patient on the hCG diet who had a pulmonary embolism, said Christopher Kelly, a spokesman for the agency. He said the hormone carried risks of blood clots, depression, headaches and breast tenderness or enlargement.

Dr. Pieter Cohen, an assistant professor at Harvard medical school who researches weight-loss supplements, said that aside from the issue of side effects, the use of hCG as a diet tool was “manipulating people to give them the sense that they’re receiving something that’s powerful and potent and effective, and in fact they’re receiving something that’s nothing better than a placebo.”

But unlike other popular diet supplements, hCG, which is derived from the urine of pregnant women, has acquired an aura of respectability because the injections are available only by prescription.

The promoters of hCG for weight loss throw big dollops of paranoia and conspiracy theory into their pitches. Supposedly this is a "secret" that "they" don't want you to know about.

Well, here's a non-secret: The only way to safely keep a healthy weight has been known for a long time: A well-rounded, balanced diet plus regular exercise. But what could be more boring?

A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes.

“There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” said John Jenkins, MD, director of the office of new drugs at the FDA. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”

The move was described as “commendable but dangerously too late,” by Sidney Wolfe, MD, a member of the FDA’s Drug Safety and Risk Management Committee and director of the Health Research Group of Public Citizen, a consumer and health advocacy group.

The pressure from the FDA came after results of a clinical trial involving more than 10,000 patients showed that people who took Meridia had a 16% increase in relative risk of heart attacks. The trial also showed that individuals taking Meridia only lost approximately 2.5% more weight than those on placebo and that the weight loss didn't last very long.

Abbott maintained these results weren’t relevant because most of the individuals in the trial had cardiovascular disease and should not have taken the drug in the first place. The company continues to maintaion that for the right patients, the drug is safe.

European regulators took the drug off the market in January 2010. An FDA advisory committee was split on whether to remove the drug, but the ultimately decided to recommend doing so because “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” Jenkins said, adding that he did not believe Meridia users would have any residual increased risk once they stopped taking the drug.

Source: The New York Times

You can view an abstract of the clinical trial that led to the FDA recommendation here.

LipoDissolve is the brand name for an injectable drug that is supposed to melt fat. The patient gets a series of injections that supposedly dissolve the bonds between fat cells, and the body then flushes the fat away. Sounds great, doesn't it?

Patients who've had these injections have told the Food and Drug Administration that they've developed painful knots under their skin, scarring, deformities and other bad outcomes. What's worse, the drugs used -- chemicals caled phosphatidylcholine (PC) and deoxycholate (DC) -- have never been proven to be effective for these promoted purposes.

The FDA has tried to crack down on these treatments. Last spring, it sent warning letters to various "medspas" -- usually run by well credentialed dermatologists or plastic surgeons -- telling them that they were making false and misleading statements on their websites. For example, here's an excerpt of one letter sent to a dermatologist in the tony Washington suburb of Chevy Chase, Maryland:

Although intravenous phosphatidylcholine has been approved in some countries for the treatment of a variety of conditions, it has not been approved in the U.S. Currently there is no FDA approved injectable PC or DC, and therefore, your claim that PC and DC have been FDA approved individually for medical conditions is false or misleading. In addition, FDA is unaware of evidence to support the safety claims for your Lipodissolve products.

As explained above, the claims made for your Lipodissolve products are false or misleading in that they are not supported by substantial evidence or substantial clinical experience.

Read the full letter here.

Despite the FDA's efforts, LipoDissolve is still widely available. Lots of patients assume that someone in a white coat with an MD behind their name wouldn't offer to inject something into their body unless it was absolutely safe and legal. And the idea that you can lose weight effortlessly, and look better too, makes it all the more irresistable.

A good rule for patients to follow applies in other walks of life too: If it sounds too good to be true, it probably is.