JFS Exclusive: Show Biz medicine

Infommercials come in all types of formats, even talk shows. In fact, talk shows may be more influential, as we’ve come to trust their hosts and see them as friends we invite into our homes, as opposed to network newscasters reading prepared scripts bought by millions of advertising dollars. This past week, approximately ten million viewers watched a one-hour talk show promoting bariatric surgery for young teens, ages 13, 15 and 16. All of the children, still in the post-op honeymoon period, were portrayed as healthier, happier and doing great. Their surgeries were called “a success.”

It would have been a very different show had viewers been given the full story.

The Oprah Show*, which aired on February 4th, tore at viewers’ heartstrings from the very first minutes, talking of fat children teased about their weight since grade school, suffering depression and having low self-confidence because of their weight, and scared into believing they were going to die and that their only option to live is to have bariatric surgeries. Bariatric surgeon, Dr. Mary Brandt, repeated the common myth, telling viewers that an epidemic of childhood obesity has become so threatening that this may be the first generation to have a shorter life expectancy than their parents. She told how the Adolescent Bariatric Surgery Program at Texas Children’s now “is saving the lives of teens battling obesity.”

The mother of a 13-year old girl portrayed in the opening, said her daughter had been depressed about her weight and when she’d told her mother about being teased, her mother decided it was time to take action. Back then (2004), there was no bariatric program for kids her age, the mother said, and “no other options for these children [and] no doctor would touch her.” So, she took her daughter to Tijuana, Mexico, for surgery. According to the show, she’s now “happier and healthier.”

Dr. Brandt, the surgeon of one boy, told viewers his obesity was life-threatening and “will kill him eventually if he doesn’t have treatment.” His mother felt “he really had no choice but to get the weight off, and this was the last resort.” The consequences of his not having surgery weighed on her mind. “How long would it have been, you know, had he not had this surgery? How long would his life span be?,” she asked. “I would never want to bury my child before me....” So, his gastric bypass procedure was aired on the show and declared a success. Nine days later, he was reported as “doing great.”

A 16-year old girl on the show said that her gastric bypass surgery was “a matter of life and death,” but that she was thrilled with her weight loss. Although she struggles with not having to diet anymore, “it really gave me my life back.”

After these emotional and frightening claims about the seriousness of obesity, and the happy “after” stories, the only balance was provided in a brief caution inserted towards the end by a pediatric surgeon from the University of California, San Francisco Children’s Hospital, of the serious long-term implications. “How many children are dropping dead from obesity before the age of 18?” she asked. “The answer is none.” By then, this passing caveat had little impact. Claims about psychological issues of “food addiction” and overeating in fat kids, a recurrent theme on Oprah, were also mentioned as a drawback to coping with the surgeries.

The Oprah show provided only two resources for more information: the Texas Children’s adolescent bariatric surgery program, and UCSF Children’s Hospital, which has begun to evaluate bariatric surgeries for teens.

Press releases are marketing

Several press releases went out promoting this Oprah show — all from the centers doing bariatric surgeries on teens and part of the Teen-LABS (Teen-Longitudinal Assessment of Bariatric Surgery) consortium.

Baylor College of Medicine and Texas Children’s adolescent bariatric surgery program urged people to visit Oprah’s website to see photos and learn of their patient’s journey. According to these press releases, “one in five American children are [sic] overweight or obese...that if left untreated are potentially life threatening... Bariatric surgery may be required to reverse these life altering and life-threatening comorbidities and getting started on the path to lifelong health.” Since the diseases associated with obesity improve or disappear with surgery, they claim, “it is likely that teenagers who have these serious complications of obesity will most likely benefit from early intervention.”

A similar press release promoting the Oprah show came from Cincinnati Children’s Hospital, the coordinating center of the Teen-LABS consortium. The consortium is led by Dr. Thomas Inge, M.D., Ph.D., surgical director of the Comprehensive Weight Management Center at Cincinnati Children's, and the lead investigator for Teen-LABS, which is “the first-ever study examining [the] effects of adolescent bariatric surgery.” Dr. Brandt is one of its primary investigators.

Dr. Inge is also the investigator of several other studies on bariatric surgery in teens, receiving $100,000 annually from Ethicon Endo-Surgery, Inc.; $200,000 to identify changes in diabetes precursors; $149,000 to describe the psychological functioning of teen patients; and more than $5 million on health benefits and risks. He is also a regular invited speaker on teen bariatric surgery for Ethicon Endo-Surgery’s Scientific Advisory Board for Bariatric Surgery (2003, 2004, 2005) and multiple other professional meetings.

Teen-LABS was awarded a $3.9 million NIH grant* in June 2006 to study bariatric surgery in teens. This project will, for the first time, “help to determine if it is an appropriate treatment option for extremely overweight teens... and help them remain at a healthy weight over the long-term.” This project, as registered on ClinicalTrials.gov, is an observational study that began enrolling teens in March 2007 and hopes to gather data on 200 teens by its completion date in July 2011.

There was no mention on Oprah that bariatric surgeries have never been studied in children and shown to be safe and effective for them or to improve their long-term outcomes compared to traditional medical management. Nor was there any mention that the bariatric surgeon featured on the show was one of the primary investigators of the first such study, that had just begun to enroll patients. If that information had been shared with the audience, they might have wondered why the “answers” to the research were already being publicized. Researchers who set out to objectively answer a scientific question do not use press releases or go on television shows to reveal the findings years before their study is even completed.

Teen-LABS

Teen-LABS’ goals, as stated on its trial registration, are “to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers. Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data-collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care.” They are building a database of teens who’ve had bariatric surgery.

Criteria. All teens (12-19 years of age) who’ve met the criteria for bariatric surgery and agree to participate meet the eligibility requirements for Teen-LABS. The government’s criteria for bariatric surgery in adolescents were released by the Agency for Healthcare Research and Quality in July 2004. The lead author of the Independent Expert Panel which wrote these criteria was Dr. Inge. Under “Financial disclosures/conflicts of interest,” none were stated. JFS readers will remember that the AHRQ is the health services arm of the U.S. Department of Health and Human Services and its role is to support government public health initiatives and “give information and technical assistance to State and local policymakers.” It partnered with Robert Wood Johnson Foundation in 2002 to create the largest and most comprehensive pay-for-performance projects in the country.

Objectives. Dr. Inge and colleagues described Teen-LABS in the November issue of the Journal of Pediatric Surgery as “the first prospective multicenter study of adolescent bariatric surgery.” They said that the goal of the study is to collect clinical, epidemiological (associations) and behavioral information on teen bariatric patients and compare them with their adult (LABS) database. Data will be collected on the teens at enrollment, 2, 12 and 24 months post-op. They said it will also examine the psychosocial status of these teens: “Psychosocial status will be examined in 3 domains: eating behaviors, depressive symptoms and health-related quality of life.” The study will also collect data on “family environment.”

In other words, Teens-LABS is assembling a database that can be used for future epidemiological studies to identify behaviors [no doubt ‘bad’] correlated with fat children who’ve been convinced to have bariatric surgery. Not unlike marketing research. It is also looking for correlations between obesity and health indices, to build support for the unhealthfulness of obesity. What medical questions will it answer? As readers know, the validity of any weight loss intervention cannot be demonstrated without follow-up for at least 5 years, so this short 24-month follow-up period will also be unable to make any clinical conclusions.

The secondary objectives, according to the authors, will be to document the behavioral aspects associated obesity in teens; assess health care utilization of patients undergoing bariatric surgery, school and job attendance and productivity; and gather and store biospecimens (serum, plasma, whole blood, urine) for future research into the pathophysiology of obesity and obesity-related complications. These ancillary studies derives their “financial support from sources other than the funds awarded for support of the Teen-LABS consortium.” Any and all communications, presentations or papers from ancillary studies using the study data have to come from the Teen-LABS Publications and Presentations Committee and must include at least one of its investigators. The mission statement of this committee is to put “limitations on the publication of results that could threaten the integrity of the collective data.”

As seen on TV

Oprah is not the first television show that’s promoted bariatric surgeries in teens and featured the Teen-LABS consortium. ABC News, for example, has had several specials, all of which followed a similar script of mothers and fat children terrified for their lives and feeling they had no other choice but to agree to the surgery, and focused on the rosy outcomes.

Last April 27th, a feature story on the Teen-LABS study depicted a 17-year old girl whose mother said they’d “exhausted all other options before resorting to surgery. “It breaks your heart to see your child struggling and becoming so depressed and to hear doctors say she won’t see 30 if she doesn’t lose weight,” said her mother. After her surgery, the girl was reported as gaining confidence and energy.

Dr. Inge said on that special that “we know bariatric surgery is effective for weight loss...teenagers already can have a half dozen complications of obesity that the surgery within months if not weeks can remedy.” ABC reported: “The doctors expect their research will show that severe obesity in teens is associated with medical and psychosocial problems which may be more effectively treated during adolescence than waiting until adulthood.”

This ABC special was followed by another on April 30th, which featured a 16-year old girl who was teased for “wobbling” when she walked. She said: “Before I had the surgery, I was depressed. I didn't like going to school because the kids picked on me all the time. They constantly called me fat and that I was overweight and that I just didn't belong at school. But now, I don't care about what they say. I'm confident in myself. You can see me always with a smile on my face when I'm at school. I just think I'm the stuff now.” The head of the obesity clinic at Texas Children’s Hospital was featured as saying he worked to develop the bariatric surgery program because he “was seeing children literally dying from their co-morbidities from obesity.” He said that “in my estimation, obesity is the most serious public health problem we have in America today.” And the girl’s surgeon said he believed that if she didn’t lose a lot of weight soon, her life would be at risk.

Neither show balanced the claims or presented what is known about obesity and bariatric surgery in children, even that published by the study researchers.

Operate early to prevent problems later hypothesis

The key claim to support the urgency of bariatric surgery in growing teens, rather than wait until they are adults and the age of consent, is that long-term obesity-related health problems can be prevented. Dr. Inge and colleagues at the Comprehensive Weight Management Program at Cincinnati Children’s Hospital Medical Center, published a paper in the January 2007 issue of the International Journal of Obesity to support ‘early rather than later use of bariatric surgery in the treatment of obesity.’ Their review of the research to date (175 papers), however, is in sharp contrast to the optimistic statements heard in media (and even what appeared on its abstract). The public has never heard any of the concerns highlighted in this report.

A range of bariatric procedures have been tried on teens. They reported that 20 children had experimentally had jejuo-ileal bypass in the 1970s and 1980s and “the expected macronutrient malabsorption resulted in 34-36% weight reduction...[but] at the expense of fat-soluble vitamin loss, electrolyte abnormalities and diarrhea in some.” The malnutrition problems, liver and renal damage, and nutritional complications were so severe than “numerous patients required a reversal” of their bypass. A small number of teens have also had biliopancreatic diversion with bypass of the small bowel. This procedure proved to have “high risk for postoperative protein and micronutrient deficiency” and they listed the serious nutritional complications that had been seen in these children. They then described the malabsorption problems seen after another variation of bariatric surgeries, the duodenal switch, which were so severe it was made unadvisable for adolescents. Following these early experiences with malabsorption procedures (gastric bypasses), various restrictive procedures were tried in the early 1980s to mid-1990s. Weight losses were modest, they said, but complications from the surgery were profound, “limiting overall enthusiasm for this approach in the surgical community.”

The newest and current variations of gastric bypass surgeries, roux en Y gastric bypass (RYGB), has limited evidence in teens, they said. The largest retrospective study in teens with the longest follow-up to date, they wrote, was on 33 adolescents (average age 16) who had RYGB and variations. The surgeons reported that nine teens had major complications within 30 days of surgery, one died one year later and another at six years. All were still obese at every year measured after surgery. More importantly, they noted, all but six were lost in follow-up, with no data available on their status by 14 years.

Three other centers performing laparoscopic gastric bypass on a total of 41 teens since 2005 reported that 39% had complications, two of which had long-term consequences, including a death. Weight gain is not clear because of short, one-year follow-up, they said, but may be as high as 10-20%. International studies that have compared gastric bypass and gastric banding reported greater results with bypass in short-term follow-up, but by 5 years, weight loss efficacy was no different. While gastric banding “seems to be a technically safer operation with lower mortality risks than other procedures,” they said, “systematically collected information about both efficacy and potentially worrisome complications (5-10 years) later...for adolescents who have perhaps five or six decades to live with the device” make long-term information about efficacy needed. Despite claims that teens experience fewer post-op complications, recent analyses found they were similar to adults, they said.

Nutritional deficiencies are increased in both restrictive and malabsorption procedures (gastric bypass), they cautioned, and the resulting problems were not insignificant. A brief summary will give an indication of the severity of concerns raised and documented problems — all of which have been downplayed, if mentioned at all, in media.

Peripheral neuropathy is one of the most common vitamin deficiency manifestations, occurring in up to 16% of patients. They described their own 2004 study, as reviewed here, when Dr. Inge and colleagues reported on three teen girls who experienced neurological complications from thiamine deficiency. The girls, 14 to 17 years of age, developed a range of neurological symptoms, including hearing loss, dizziness, numbness and pain in extremities; vomiting; weakness and loss of strength, and inability to walk, just 4 to 6 months after their surgeries. In fact, researchers at Wake Forest University School of Medicine found that lasting brain damage and neurological damage is considerably more prevalent after all types of bariatric procedures than previously estimated, occurring as early as six weeks after surgery and despite oral vitamin supplementation.

Dr. Inge and colleagues went on to caution about increased risks for iron deficiency anemia seen after gastric bypass, especially in menstruating young women, despite oral iron supplementation. They expressed concerns about osteoporosis and osteopenia surfacing among patients a decade out from surgery; although they reported that decreased bone mineral density is evident at 9 months, despite normal parathyroid hormone, calcium and vitamin D levels. “Long term data on these adolescents are not yet available.”

Not only are the supplementation needs for adolescents after bariatric procedures unknown, but only 14% of teens have been shown to take recommended supplements, highlighting the added dangers for them.

Young women should also not become pregnant after bariatric procedures, they noted, especially during the period of rapid weight loss because higher incidences of prematurity and low birth weight babies have been reported. The nutritional deficiencies seen after bariatric surgery can place the mother and infant at greater risk and can result in poor fetal growth or even malformations and result in suboptimal breastmilk quality, they said.

Whether ‘normalizing’ cardiovascular risk factors in adolescents will ultimately reduce the incidence of cardiovascular disease after they become adults — the main selling point for surgeries in this population — is unknown, they reported. Although significant improvements in carbohydrate metabolism have been reported after bariatric surgery, they said, “studies also demonstrate that in response to a glucose challenge there is only incomplete normalization of parameters of insulin secretion and insulin resistance.” [Given teens normally have temporary insulin resistance with growth, whether its resolution can be attributed to the surgery is unknown.] It is also not known if obese teens will see long-term benefits for nonalcoholic fatty liver disease or potentially progressive fibrosis and cirrhosis; studies are currently lacking, they stated.

One of the most disturbing findings was that children seeking treatment for obesity are those who’ve been most victimized throughout their lives. “Our initial data suggest that adolescents who are at extreme levels of obesity and choosing an aggressive surgical intervention have accumulated greater distress as their obesity has progressed.” Many of these young people (“two-thirds in our data”) present with depressive symptoms. Because of its affect on impairing their quality of life, they wrote, “one could reasonably hypothesize that these psychosocial ‘comorbiditites’ may well be irreversible if adolescent extreme obesity is not effectively treated during formative adolescent years.” In other words, rather than address issues of discrimination against fat children and correct misinformation and fears about obesity and health, and help them with self-esteem issues, a life-threatening surgery to physically change their appearance is recommended.

Given the numerous reports of positive outcomes of bariatric surgery for teens in the literature and media, they concluded, it’s likely that demand will increase. “Thus, there is good reason to believe that many of the hypotheses outlined above will be testable and in the future and more evidence will be available on which to base treatment decisions for youth and adults worldwide who suffer with extreme obesity and health consequences.”

Missing ingredients

Neither Oprah or the ABC television specials made much note of the nutritional consequences of bariatric surgeries. While the children’s new stomachs were described on Oprah as only holding about six grapes (and one girl said that she could only eat half a hamburger and a couple of fries or she throws up), the small portions were described as a benefit. Dr. Brandt said bariatric surgery is “an enforced behavioral modification...You can’t cheat.” No one presented research questioning the healthfulness of long-term dieting or of vomiting, which is why bariatric surgeries, especially lap bands, have been called surgically-induced bulimia by so many medical professionals.

No mention was made of another review of the evidence published by Drs. Inge and Xanthakos of Cincinnati Children’s in July 2006, which concluded that “bariatric surgery can carry significant risks of nutritional complications.” According to these authors, research suggests that the prevalence of micronutrient deficiencies generally increases over time. Worse, “adolescent patients may be at greater risk due to poor [supplement] compliance and longer life span.” Among some of the concerns mentioned in this paper were:

· Protein- calorie malnutrition

· Impaired fat absorption resulting in deficiencies of fat-soluble vitamins and essential fatty acids

· Iron deficiency seen in 47% of patients after just 4 years, with supplementation not preventive

· Vitamin B12 deficiencies (because this vitamin requires gastric acid and pepsin for release from foods, while binding to intrinsic factor is required for intestinal absorption, both of which are produced minimally by a reduced functional-size stomach)

· Reduced bioavailability of natural micronutrients in foods that require gastric acid for release — plus, the lack of gastric phase digestion means that time-release and enteric-coated vitamin and mineral supplements largely pass into the colon unabsorbed

· Calcium deficiency as mentioned above, yet it’s unknown if even 1200 mg of daily calcium is enough to prevent deficiency long-term

· Vitamin D deficiency, as this vitamin isn’t just for normal calcium homeostasis, they said, but may also have important secondary effects on multiple metabolic processes. “Deficiency of vitamin D has recently been linked to cancer, hypertension, rheumatoid arthritis, diabetes and peripheral vascular disease.”

· Thiamine deficiency, with beriberi symptoms appearing as soon as 6 week post-op and Wernicke encephalopathy presenting with opthalmoplegia, nystagmus, ataxia, and encephalopathy and rapidly progressive visual loss secondary to optic neuropathy

Can you imagine the research that could be being funded to learn how to best help bariatric patients regain their health, rather than facilitating its use in greater numbers of young people? Can you imagine what a different show Oprah might have had, had she reversed the balance of information and presented the known and unknown medical issues people rarely hear, showed how children are being victimized by fat prejudice and terrified into believing they were going die (when none are), how the bariatric industry is targeting the most depressed and vicitimized children and leading them to believe that their only chance in life is to lose weight and have major surgeries on healthy organs, and if she'd portrayed the young people living with the long-term complications? A brief mention of the short-term weight loss seen during the honeymoon phase might then have had a much different impact.

Oprah would have found no dearth of tragic reality stories to choose from, such as the hundreds upon hundreds, all seeking help for similar problems year after year at OSSG-gone-wrong, having learned too late what the research was actually showing. A cursory search of bloggers who’ve gone beyond the honeymoon phase and are experiencing the long-term aftermath would also paint a very different picture, such one who wrote in her online journal last week “WLS Life Sucks” and “Follow-up WLS Life Sucks.”

The power of media

Just as the special effectiveness of talk show hosts to influence people is not lost on advertisers, shows produced to appear as documentaries are also effective marketing. Discovery Health, for example, aired an 8-part special on bariatric surgery, featuring the bariatric surgeon lobbying organization, Obesity Action Coalition. Physicians could also get free continuing education credits by watching Discovery Health’s documentary on bariatric surgery sponsored by Ethicon-Endo-Surgery, Inc. It also produced the documentary for healthcare professionals on childhood obesity and its treatment, with free continuing education credit, created by Kaiser Permanente’s weight management initiative.

Discovery Health’s Media Enterprises are vast, as described here. It was the first television network to bring a national weight loss challenge. Its experts include Discovery Health’s chief medical correspondent, Dr. Mehmet Oz, author of the anti-aging diet book, You: On a Diet; as well as an organic living expert; and diet cooks.

Oprah has teamed up with Discovery Health to create OWN: The Oprah Winfrey Network. According to the press release issued just weeks ago, this “multi-platform media venture will be designed to entertain, inform and inspire people to live their best lives” and will air in more than 70 millions homes on what is currently the Discovery Health Channel. “Both organizations will contribute advertising sales services to the venture,” according to the press release. Oprah’s new branded cable channel is scheduled to go live in 2009.

Basing a personal medical or health decision on something seen on TV is not in the best interests of our health or that of our children. Television is entertainment. Or, more accurately, a 24/7 infommercial. Remember, even reality TV isn’t real.

© 2008 Sandy Szwarc

* Email contact for the show is here. Oprah may be emailed online here.

** This extraordinarily large amount of government funding is not to cover the costs of the surgeries and medical care, but only for creating and managing this database. According to the NIH, Teen-LABS will not pay for the costs of bariatric surgery or patient care. Study participants must be able to support the cost of their surgery and related patient care through medical insurance or other means.