Junkfood Science: November 2008

November 30, 2008

Surgery is not for two

For women wanting to get pregnant, the soundest medical information is vitally important for their health and safety, and that of their babies. The riskiest thing a woman of childbearing age can do is to trust any medical information from reporters or a news story. No credible medical professionals would ever consider basing patient care decisions on news stories, either. Doctors know that the results could be devastating for the women and babies in their care.

Over recent years, fat women have been encouraged to have bariatric surgeries, with promises that it will help them get pregnant. Now, they’re hearing that bariatric surgery can help them have healthier babies.

The New York Times reported that a new study had shown that women who become pregnant after bariatric surgery have easier pregnancies with fewer complications and “their babies are also healthier and may be less likely to be born prematurely or to be very small.” This news story was taken verbatim from November 18th press releases issued simultaneously from the journal, the study’s sponsor and the academic center contracted to conduct the study.

Not only did the journal study find no credible support for these claims, but the actual data it reported bore little resemblance to the news or its own Abstract. By glancing at the news or the Abstract, both women and their doctors could come away with misunderstandings that could put mothers and babies at risk.

The news also failed to report the larger paper addressing pregnancy after bariatric surgeries also published last week. It suggested the risks to both mother and babies after bariatric surgery may be greater than realized.


The Rand Corporation Review

The study in the press releases and reported by the New York Times was published in the Journal of the American Medical Association. It was led by Dr. Melinda A. Maggard, M.D., at the University of California Los Angeles and colleagues with the Southern California Evidence-based Practice Center–RAND Corporation in Santa Monica.

This wasn’t actually a study providing new clinical research, but a thorough review of the literature. In this paper, the authors searched multiple electronic databases for articles published between 1985 and February 2008 to identify those about bariatric surgeries in women of childbearing age that also reported fertility, contraception use, and selected maternal and infant outcomes. They also searched the Nationwide Inpatient Sample (1998-2005) of ICD billing codes to calculate the total number of bariatric procedures done each year. The authors said that they identified 1,102 articles and went on to screen 260 before including 75 in this review.

No news reporter appears to have actually read the review and all failed to correctly depict the studies. Only 27 studies were described in the review, with 19 papers repeated two to three times, for each factor examined. Most disconcerting, not one of the studies was reported as a randomized clinical trial. They were all observation studies and even then, none were prospective (looking forward and following all of the women). The only studies included in this review were case studies or small (7-79 patients) retrospective cohort studies, many without controls and others with selectively matched controls, reporting correlations. Retrospective studies don't allow us to evaluate risks because they only give glimpses of those who survived the surgery and were healthy enough to get pregnant.

The studies universally suffered from weak methodology, the most problematic being selection bias (no randomization of the study populations, largely anecdotal and case reports, and selective control groups used for comparisons), copious missing data and small sample sizes.

Five of the 27 studies in the review were survey questionnaires, and one was nothing more than 17 anecdotal reports from a bariatric newsletter. One [Richards et al. 1987] had reported on only 162 of the responses from a survey of 580 bariatric patients done from 1979-1983; another [Marceau et al. 2004 ] had mailed out 918 questionnaires and of the 85% returned, 109 pregnancies were described; another [Tietelman et al. 2006] received only 51% of their mailed questionnaires back.

In other words, these are not the types of studies that a clinician would use as evidence for the effectiveness and safety of a medical intervention.

Nor is this the type of evidence that the FDA would accept as proof of the effectiveness or safety of a drug or medical device before permitting it to be marketed to the public.

The media has no such requirements in reporting health news.

The poor quality of the studies found by these reviewers made any conclusions impossible and any claims unsupportable. Maternal deaths weren’t reported at all. Cesarean deliveries were inconsistent, with some reporting more, less, or no difference after bariatric surgeries, or C-sections were not reported at all. Every woman is concerned about having a healthy baby, but almost none of the studies even reported neonatal outcomes: the number of low-birthweight babies, perinatal deaths and premature deliveries. Five of the six that did at least report premature deliveries found slightly more preemies after bariatric surgery than among controls.

There should at least be some evidence, after more than 40 years of these elective surgeries being performed, before they are marketed as offering a new benefit. Few doctors would publicize a risky surgical intervention for young women as being safe and effective for healthier pregnancies, with no clinical data at all — especially when best estimates have found bariatric surgeries increase overall mortality risks for patients 7-fold in the first year and by 363% to 250% the first four years post-op.

But, in the review’s Abstract, general lack of evidence was used as evidence:

“Neonatal outcomes were similar or better after surgery compared with obese women without laparoscopic adjustable gastric band surgery,” the Abstract stated. What wasn’t made clear in the Abstract was that this claim was supported by citing the results of a single observation study of 13 bariatric patient deliveries and ignoring the missing data in the second study.

“No differences in neonatal outcomes were found after gastric bypass compared with nonobese controls,” the Abstract reported. But, most of the studies in the review had missing data and hadn’t reported neonatal outcomes, and all three of the gastric bypass studies that had reported premature deliveries had found 17% to 71% more preemies born to the surgery patients than controls.

This is an example of why it is so important to critically examine the actual data revealed in a published study, because it can present a very different picture from the interpretations and claims in the news:


Bariatric surgery improves fertility?

Perhaps the cruelest false hope and potentially most dangerous claim in the news has played on women’s desires to get pregnant and encouraged fat women who want to have a baby to have bariatric surgery to increase their fertility.

The media hasn’t revealed that the review had only been able to find six papers that even addressed fertility outcomes among women after bariatric surgery, and two were survey questionnaires with low response rates, offering only anecdotal reports. The largest observational case series in the review was of 298 consecutive deliveries after bariatric surgery — which found that three times more bariatric patients had required fertility treatments to become pregnant compared to controls (6.7% versus 2.3%). Another small case report that compared pregnancies among women with gestational diabetes reported that the women who’d had bariatric surgery were 4 times as likely to have required fertility treatments to become pregnant compared to controls (21.4% versus 5.5%). Among the two questionnaires returned reporting pregnancies, one found no difference in fertility treatments and one said that 15 out of 32 women said they were able to get pregnant after bariatric surgery. Hardly evidence that bariatrics increased their fertility. The only two papers reporting improved fertility were 15- to 20-year old case reports on a total of 21 selected women who’d had vertical-banded gastroplasty (a procedure known as stomach stapling and rarely done today), and with sample sizes too small to have statistical power.

The review stated: “Most observations on fertility following bariatric surgery lack complete data on the total number of women attempting to get pregnant and pregnancy rate. Most studies present convenience samples of women who were able to get pregnant, in whom presurgery fertility histories were available.” The review found no clinical outcome data to support claims that bariatric surgeries improve a woman’s chances of having a baby.


When is it safe to get pregnant after bariatric surgery?

While the news media and press releases quoted Dr. Maggard as saying they recommend waiting about one year, that is not what the review’s data revealed, nor is it the consensus of the medical community.

Available research examining how soon after bariatric surgery women should become pregnant is limited, the review stated, and comes mostly from case reports or small cohort studies. The vast majority of studies the review identified had reported higher risks with pregnancies that occurred within the first two years of surgery, regardless of the procedure.

In studies of laparoscopic adjustable gastric banding (LAGB), biliopancreatic diversion/duodenal switch (BPD), and Roux-en-Y gastric bypass, the review found reports of:

● 31% spontaneous abortions following BPD compared to 18% in matched controls

● 29% spontaneous abortions following lap bands (no control group)

● more premature deliveries after bypass procedures — 50% among pregnancies within the first 12 months post-op; in 25% of pregnancies from 13-24 months post-op, and 20% for pregnancies 2 years or later after surgery.

● 18% premature deliveries within first 2 years after gastric bypass in another case study

Of twenty published reports of surgical complications during pregnancy after bariatric surgery, 25% of the babies died and 15% of the mothers died. The most common (70%) complications in the literature were bowel obstructions and internal hernias, which are life-threatening. The August issue of the New England Journal of Medicine, for example, reported the tragic case of a pregnant woman who died after her intestines had herniated and become gangrenous. Her 31-week baby died, too. She had had bariatric surgery 18 months earlier.

Most doctors recommend women not become pregnant for at least two years after surgery and after her weight stabilizes, said Dr. Sattar Hadi, who runs the high-risk obesity clinic at Vanderbilt University’s Center for Human Nutrition. Dr. Mark Tucker, director of bariatric surgery at the University of Medicine and Dentistry of New Jersey, also told the press that hernias similar to the one experienced by this mother are common up to five years following gastric bypass.


Are nutritional complications the fault of the women or the surgeries?

According to the New York Times reporter, the nutritional problems seen among some women “appeared to be caused by their failure to take recommended supplements of multivitamins and iron.” But that wasn’t what the study data showed. The reviewers only reported 13 case studies (two of which were surveys and one was merely a report of 36 women who’d volunteered from an advertisement) and of those studies, in more than half, the researchers had failed to even follow vitamin supplement adherence. As the review noted, few of the available studies had been designed to follow nutritional outcomes; instead, for example, they were looking at contraceptive use. Even so, the nutritional information that emerged from these studies lends a note of caution for women.

Among the six studies of pregnancies after gastric bypass that were identified in this review:

● one reported 11.5% of the women had anemia that required parenteral (IV) iron, which was more than ten times the rate of pregnancy-related anemias found among control pregnancies;

● six cases of babies with neural tube defects were reported among women not taking supplements;

● another study reported 4.4% of women required IV iron for anemia.

Among the six BPD studies:

● 21% of women required parenteral nutrition for severe nutritional problems,

● four out of nine women in a small study required transfusions or supplements and one also required parenteral nutrition; unrelated to supplementation adherence;

● another small study reported one in four women had anemia despite iron supplementation;

● two other studies reported 20% and 32% of women required full parenteral nutrition to address severe nutritional problems.

The nutritional outcomes were only reported in one small LAGB study, which reported no nutritional events. But in four other studies of lap bands, according to the authors, nearly one in five women had required their bands removed or deflated because of severe vomiting and nausea.

Given the importance of good prenatal nutrition for the growth and development of a healthy baby, it would be expected that any procedure that reduces a woman’s caloric intake to about 1,000 kcal/day, not to mention impedes the absorption of essential nutrients, would increase risks for nutrition-related complications. With the nutritional complications that have been extensively reported in the medical literature among general bariatric patients and among young people, it is not surprising that the American College of Obstetricians and Gynecologists has cautioned that women getting pregnant after bariatric surgery “may see a host of complications such as gastrointestinal bleeding, anemia, intrauterine growth restriction, prematurity and neural tube defects. The surgery can also lead to deficiencies in iron, vitamin B12, folate and calcium,” it stated in its 2005 Guidance to obstetricians and gynecologists.

In the review’s concluding comments, the authors noted that “inherent limitations in the identified studies preclude us from drawing strong conclusions.” They called for randomized clinical trials or prospective cohort studies as needed to address this question.

Yet, despite the lack of credible evidence in the review article to support the use of bariatric surgery for enabling women have healthier babies, the Abstract concluded:

Rates of many adverse maternal and neonatal outcomes may be lower in women who become pregnant after having had bariatric surgery compared with rates in pregnant women who are obese; however, further data are needed from rigorously designed studies.


The sponsor

This is one study where the sponsor and its role in the review may be valuable for both healthcare professionals and consumers to pay close attention to.

Funding/Support: This project was funded under contract 290-02-0003 from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services to the Southern California Evidence Based Practice Center. Dr Maggard’s time was supported in part by a grant from the Robert Wood Johnson Physician Faculty Scholars program.

Role of the Sponsor: The Agency for Healthcare Research and Quality had input into the general design and conduct of evidence reviews conducted by the Evidence Based Practice Centers, but not this evidence review in specific. The sponsors were not involved in the collection, management, or analyses of the data, but did review and provide comments on the evidence report upon which this article is based.

As previously covered, the Agency for Healthcare Research and Quality (AHRQ) is the health services arm of the U.S. Department of Health and Human Services and its function is to support the government’s public health initiatives. As readers may remember, the role of the AHRQ was changed in 1998. It no longer just sponsors the development of clinical practice guidelines by independent professionals. This government agency was redirected by Congress to finance outside centers to conduct reviews of the evidence and compile technical reports. These reports are then used by stakeholders, such as third-party payers (employers, insurers and the federal government), to create guidelines for managed care. These also become the performance (“quality”) measures that providers must comply with in order to receive reimbursement. The AHRQ reports are also to be used by policy makers to shape public policies and for regulatory and public funding legislation. By its 2006 Congressional budget report, AHRQ said it had made “significant improvements in realigning the work we do with our strategic goals and those of the Department [of HHS].”

The AHRQ established a network of twelve practice centers at universities and private organizations to produce reviews and technical reports, which opened the doors to increasing influence of stakeholder interests, especially surrounding preventive health, with Robert Wood Johnson Foundation funding numerous AHRQ initiatives.* There are now “close relationships” between these academic centers, federal health agencies and professional organizations, which regularly attend U.S. Preventive Services Task Force meetings and provide draft review documents, explained doctors Steven H. Woolf, M.D., MPH., and David Atkins, M.D., MPH, in their historical review of clinical guidelines. From then on, achieving consensus among the private-public stakeholders took on a greater importance. This JAMA review of bariatric surgeries and pregnancy outcomes reveals that the AHRQ influences the reviews and technical reports themselves.

What all of this means, and the news hasn’t reported, is that this review paper in JAMA was an abbreviation of the larger Evidence Report/Technology Assessment titled Bariatric Surgery in Women of Reproductive Age: Special Concerns for Pregnancy that was published at the same time. It was written by the same authors at the UCLA practice center (the Southern California Evidence-base Practice Center-RAND Corporation), along with its invited Technical Expert Panel.

This Evidence Report/Technology Assessment had also been contracted by the AHRQ to the author’s practice center. As it states:

AHRQ encourages the EPCs [evidence-based practice centers] to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the nation. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers, as well as the health care system as a whole, by providing important information to help improve health care quality…

The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services… This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies.

We’ll look at the disclosure statement at the end and who those partner organizations might be. But first, let’s closely read this technical assessment because it offers additional information that may help women.

The most striking thing that stands out when one reads the actual Technical Assessment is how dramatically different the evidence is from the media statements and press releases issued by both the RAND Corporation and the UCLA practice center. As the RAND press release stated:

Obese women who have weight loss surgery before becoming pregnant have a lower risk of pregnancy-related health problems and their children are less likely to be born with complications, according to a new RAND Corporation study. Women who underwent bariatric surgery and lost weight before becoming pregnant had a significantly lower risk of gestational diabetes and high blood pressure than obese women who did not have surgery, according to the study published in the Nov. 19 edition of the Journal of the American Medical Association.

In addition, these women's babies were less likely to be born prematurely, be born underweight or be born overweight than children born to obese women, according to the study. "Obese women who undergo bariatric surgery and lose weight prior to becoming pregnant may improve their own health, as well as their children's health," said lead author Dr. Melinda A. Maggard, a UCLA surgeon and a researcher at RAND, a nonprofit research organization. "Further research is needed, but the results seen thus far are positive."

In comparison...


The Technology Assessment

The technology assessment followed the same methodology and reviewed the same body of evidence as in the paper published in JAMA, but it provided more detailed information on the 57 studies included in its review. In describing the studies its literature search found, the technology assessment was extremely reticent, stating:

Our findings are based on observational studies, which have a potential for greater bias. Furthermore, many of the studies lacked the necessary design to allow for definite conclusions (i.e., patient selection not defined, no presurgery pregnancy information). Our overall findings are therefore tempered by the limitations in the available data, and are cautious.

These moderated statements are considerably different from the press releases and the news headlines which assuredly reported that research had found bariatric surgery helps fat women have healthier babies.

Similarly, medical professionals who read only the Abstract, rather than the full report or the original studies it referenced, might also come away with an impression that the evidence is stronger than it is. The Abstract had concluded: “The data suggest that fertility improves after bariatric surgical procedures, nutritional deficiencies for mother and child are minimal, and maternal and neonatal outcomes are acceptable with laparoscopic adjustable band and gastric bypass as long as adequate maternal nutrition and vitamin supplementation are maintained. There is no evidence that delivery complications are higher in post-surgery pregnancies.”

It is doubtful that anyone reading the full 77-page report and appendix would reach those conclusions.

Bariatric patients. In reading the technology assessment, what first jumps out is that bariatric surgeries are primarily done on women of childbearing age (18-45 years) and they represent the greatest growth in people having these procedures — yet young women are the demographic group with the lowest risks for premature death and morbidity, and the most “morbidly obese” women still have longer life expectancies than even normal-weight men.

To attempt to learn how many bariatric surgeries were being performed in women of reproductive age, the authors analyzed data from AHRQ’s Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample for the years 1998-2005. These use ICD-9 procedure codes with diagnosis criteria from hospital billing claims. Since they don’t include outpatient procedures, they noted that outpatient laparoscopic band and bypass procedures wouldn’t be captured, so its figures will underestimate the actual number of bariatric procedures. Never the less, they found a dramatic increase in the number of procedures performed each year — about a 600 to 800 percent increase since 1998. In just the past three years, about 50,000 women of childbearing age have had inpatient bariatric surgery. But no one knows how many of them have gone on to become pregnant, the report stated.

Of special note were the lengthy discussions of the nutritional effects of bariatric procedures. The authors found scarce published research examining the nutritional supplement needs, such as vitamins and iron, for women after bariatric surgeries, or their most effective forms. They were unable to make nutritional recommendations for pregnancy.


Lap band. According to the reviewers, no studies have examined pregnancy-related nutritional outcomes among lap band patients or described the vitamin supplementation regimens, although one observational study of 79 women reported no nutrition problems. The reviewers identified only three case series of pregnant women who had had gastric banding. In the two that had reported pregnancy outcomes, 72-78% of the women had carried their babies to term. And among all three studies, 18% of the women had had to have their bands removed or deflated for severe vomiting, dehydration and electrolyte abnormalities. Some women had difficulty complying with vitamin supplementation because of chronic vomiting. They also found a case report of a pregnant woman with a lap band who developed severe vomiting and weight loss that led to severe fetal growth retardation and the mother required enteral nutrition via a feeding tube to normalize the fetus’ weight gain. Overall, the reviewers said that the evidence was insufficient for them to reach conclusions and make recommendations on band management in pregnant patients.

Studies on bariatric procedures that result in degrees of malabsorption are more available and suggest more significant nutritional-related adverse events.

BPD. BPD is associated with more severe nutritional deficiencies and adverse neonatal outcomes than any other type of bariatric procedure, the authors stated. Beyond those already described above, the review found that parenteral nutritional support had been required in 21% of post-BPD pregnant women, with about one-third of these women needing hospitalization. In another small case series, “all four patients tested suffered from nutritional deficiencies, requiring blood transfusions, parenteral nutrition, or parenteral iron supplementation.” Case reports were suggesting the risks may be greater than realized:

In one case, dehydration and malnutrition as a result of vomiting and diarrhea led to an emergent caesarian section despite vitamin supplementation and multiple hospitalizations to administer intravenous fluids. Another case report demonstrated vitamin A deficiency in pregnancy following BPD; late in the pregnancy, the patient was hospitalized 5 days weekly for parenteral nutrition. The baby was still found to have symptoms of vitamin A deficiency, such as micropthalmia, at birth. As the risk of nutritional adverse events in pregnancy following BPD is appreciable, even with good compliance with supplementation, it is logical that there are [also] reports of adverse events following noncompliance with supplementation. For example, there is a case report demonstrating neonatal vitamin A deficiency with maternal night blindness during the third trimester associated with refusal of nutritional treatment during pregnancy following BPD.

Gastric bypass. Among the limited data on gastric bypass patients, in addition to the reports already mentioned, this review discussed two case reports of failure to thrive in babies which was thought to be due to low-fat content in the mother’s milk, and another documented vitamin B12 deficiency in the babies. While most reports attempt to attribute problems to a woman’s noncompliance with supplements, this review found that wasn’t always the case:

There are also case reports of maternal and neonatal nutritional deficiencies during pregnancy in patients following gastric bypass despite compliance with supplementation. One case study reported on neonatal B12 deficiency despite the use of prenatal vitamins during pregnancy and lactation. Another case report documented iron and vitamin B12 deficiencies starting at six weeks gestation; the patient required parenteral B12 and blood transfusion due to the anemia being refractory to parenteral iron…

Among the case series studies on pregnancies after gastric bypass, they said that the most notable finding was the higher than expected number of babies with neural tube defects. “One report was about three women who had four pregnancies, all of which had neural tube defects, and the other report was a case series of 110 pregnancies in 87 women who had received gastric bypass; three babies had neural tube defects.”

An important caveat,” the authors highlighted, is that published reports of pregnant women after bariatric surgeries have not monitored the vitamin, mineral and trace element levels in mother or baby, “and if clinical manifestations of these deficiencies are subtle and thus difficult to detect, they may be higher than reported.”


Pregnancy complications. While two small studies had reported rates of gestational diabetes, preeclampsia and hypertension after gastric banding were reduced to rates similar to those in the community, the authors said the small sample sizes made it impossible to determine if these complications are actually still elevated after bariatric surgery. Examining absolute values they said:

The rate of gestational diabetes in post surgery pregnancies could conceivably still be twice as high as community rates. Therefore it is premature to conclude that bariatric surgery reduces the rates of these complications to those of the average women. One stillbirth and one case of duodenal atresia occurred in pregnancies following bariatric surgery; sample sizes were too small to draw conclusions. The five case series articles included 141 pregnancies in total.

They reached the same conclusion about studies suggesting that gastric bypass might reduce rates of gestational diabetes, preeclampsia and hypertension, finding the sample sizes too small to make any credible conclusions, regardless of the procedure.

It’s important to note that they repeatedly caution that the data is insufficient and studies are too small to reach valid conclusions about purported benefits for reducing pregnancy-related complications.

The reviewers also said that because of the limited data, it’s not known if pregnancy increases the risks for surgical complications associated with bariatric procedures. “We identified over a dozen reports of complications requiring surgical intervention during pregnancy following bariatric surgery, many with deleterious effects for the neonate and mother,” they said. The complications included bowel obstructions, hernias, mid-gut volvulus, band erosion and bleeding, perforated gastric ulcer and strictures. Most complications required surgery and “the maternal and fetal mortality and morbidity rates associated with these types of complications are high,” they stated. As they described:

An emergent cesarean section or premature rupture of membranes occurred in six of 13 cases (46%). Overall five of 13 (38.5 percent) neonates died (one natal outcome was not reported). Five were delivered at full-term. There were three maternal deaths (21.4 %).

Several patients were in florid septic shock by the time the problem was identified. They cautioned that any pregnant women presenting with gastrointestinal symptoms should be worked-up without delay for bariatric surgical complications.

This review also stated: “We conclude there is scant evidence of pregnancy outcomes upon which to make recommendations about how long to delay pregnancy following surgery.” The review closed with an additional note calling for more research, saying: “Much more research is needed to answer almost every key question in this report.”


The actual report provides a considerably different perspective of the evidence than consumers, public officials and healthcare professionals have heard from the media and press releases.

Television newswire services are now broadcasting stories of “surgery for two.” Ivanhoe Broadcast News, which distributes medical news to more than 250 television networks, is telling women that bariatric surgery “may be the healthiest decision for both mother and baby.”

“Surgery for two” may make a catchy news headline or sales pitch, but it does not make sound medical information women should use to make any healthcare decision. Please, ladies, keep safe and protect yourselves and your babies. Don’t make a life-altering or life-threatening decision based on anything you hear from media. Media is only entertainment and advertising.


© 2008 Sandy Szwarc



Disclosures

According to the article published in JAMA: “Financial Disclosures: None reported.”

Consumers and healthcare professionals were left to believe there were no potential sources of bias. Yet, the interpretations presented to media and in the press releases deviate so dramatically from the actual data, a closer look might help us understand.

Lead author, Dr. Maggard founded and is the Deputy Director for the Center for Surgical Outcomes and Quality at UCLA and has an adjunct appointment at RAND, working on several projects with the UCLA practice center, commissioned by AHRQ. Remember the role of the AHRQ in contracting with practice centers to create data for clinical guidelines and quality (performance) measures. Co-authors Sydne Newberry, Margaret Maglione, Paul Shekelle and Lara Hilton are also affiliated with the RAND Corporation.

Dr. Maggard led another meta-analysis in 2005, also authored by the UCLA practice center and RAND, reporting that bariatric surgery is more effective than nonsurgical methods for weight loss and comorbid conditions. These same authors also wrote the Clinical Guidelines on the Surgical Treatment of Obesity for the American College of Physicians, published in the April issue of Annals of Internal Medicine, based on that meta-analysis.

Dr. Maggard is also a Robert Wood Johnson Clinical Scholar, a fellowship program which funds graduate degrees and research to foster physicians who will lead the transformation of public health and go on to have other leadership roles. RWJF has awarded her a $300,000 grant to develop multidisciplinary approaches to improve bariatric surgery outcomes.

RWJF, as readers know, is the foundation of Johnson & Johnson, Inc., which has $53.324 billion in annual sales and is the world’s largest supplier for bariatric surgical devices and lap bands (Ethicon Endo-Surgery, Inc.). It’s also an international giant in weight loss and healthy eating products, selling nutritional supplements (McNeil Nutritionals, LLC), artificial sweeteners (Splenda), diet pills, and employer wellness programs (J&J Consumer Companies, Inc. Vida Nuestra).

RWJF partly sponsored this review article. RWJF has sponsored numerous projects at RAND, such as convening an Expert Panel, in which five member were from RWJF, to make recommendations on the management of chronic diseases for the U.S. HHS Centers for Medicare and Medicaid, contracted from 1998 to 2003.

Paul G. Shekelle, M.D., M.P.H., Ph.D., is not only the director of the UCLA practice center for the RAND Corporation, he is the co-chair of the Editorial Board for the National Guideline Clearinghouse/National Quality Measures Clearinghouse at the AHRQ. He is also the Associate Director of the Robert Wood Johnson Clinical Scholar Program at UCLA.

Another author of this review, Dr. Heena P. Santry, M.D., is also a Robert Wood Johnson Clinical Scholar and has led other studies supported by RWJF, including one in the 2007 issue of Annals of Surgery called “Predictors of Patient Selection in Bariatric Surgery,” a 2005 study in JAMA on “Trends in Bariatric Surgical Procedures,” and another in a 2006 issue of Social Science & Medicine called “Internet marketing of bariatric surgery: Contemporary trends in the medicalization of obesity.”

Another author of this review, John M. Morton, M.D., is a bariatric surgeon and a Robert Wood Johnson Clinical Scholar. He is the Director of Bariatric Surgery at Stanford Medical Center, was on the RAND Expert Panel on Bariatric Surgery, and on the Research Committee for the American Society of Bariatric Surgeons. He co-authored an article in the February special supplement on the rising epidemic of obesity in Diabetes Care titled “Bariatric Surgery in Patients With Morbid Obesity and Type 2 Diabetes.” According to RAND, he is also the President-elect of the California Chapter of the American Society of Bariatric and Metabolic Surgeons, and was Associate Editor of the ASBS journal Surgery for Obesity and Related Diseases, and on the Editorial Board for Obesity Surgery.

Dr. Edward H Livingston, M.D., is a well known bariatric surgeon and wrote the book on Bariatric Surgery. Dr. Zhaoping Li , M.D., Ph.D., webpage at UCLA states she has conducted three industry-sponsored obesity studies.

The point being, that seeing “no financial disclosures” at the end of a study does not mean that the authors have no career interests in an issue. Disclosure statements aren’t required to reveal funding or appointments that come through foundations or academic positions.


* There is no evidence that government-funded healthcare will divest itself from political-commercial interests, given how the establishment of performance guidelines, especially preventive health guidelines, have been set up. As Drs. Woolf and Atkins explained, along with the changes in the AHRQ’s role in supporting the government’s health objectives, changes were put into place to strengthen the role of stakeholders and the compulsory nature of preventive health guidelines.

“The Partnership for Prevention convened a panel to develop methods for prioritizing services,” explained Drs. Woolf and Atkins. The priorities it outlined provide the basis for future priority-setting among policy makers to improve the execution of preventive guidelines. These priorities were written with Robert Wood Johnson Foundation, Merck & Co., the AHRQ, Health Partners Research Foundation, American College of Preventive Medicine, CDC, and others. As readers may remember, Partnership for Prevention is a nonprofit dedicated to increasing the adoption of preventive health practices and public policies and legislation. The Partnership is funded by RWJF and GlaxoSmithKline. Its initiatives include promoting the government’s Healthy People goals and workplace wellness programs. Its member organizations include stakeholders in screenings and preventive health, from Abbott Laboratories to Wyeth Pharmaceuticals.


Click here for complete article (and single page version).
Bookmark and Share

November 28, 2008

Who needs science and facts when you can just hire a public relations firm?

A new computer game for children, ages 10 to 14, is already being called the autopsy game. Its goal is to scare children about their food and health, and teach them that if they eat bad foods — ‘red light’ foods with fats, sugar and salt — they could die before their parents and get fatal diseases like heart disease and diabetes.

The goal of the game, called Yoobot, is said to be to get kids to realize that their food and lifestyle choices can have dire consequences and that they are “playing with their futures.”

To play, children create an online avatar that looks like themselves and then see their bodies decay as a result of their food and exercise choices. Kids must give their email addresses because the game isn’t just active while they’re online — Yoobot emails and text messages them throughout the day wanting to be fed or telling them its sick. The game uses a “time warp” accelerated ageing process, with one human day equivalent to three Yoobot years, and a decay curve feature to show kids what they'll look like in old age. Left to its own devices, the Yoobot will eat ‘junkfood’ all day. When the Yoobot dies, kids perform an autopsy to find out how junkfood and sedentary behavior supposedly killed it [and them].


Scaring children called educational

Yoobot was released yesterday by the British Heart Foundation, along with results of a survey that ostensibly supported the need for its new Food4Thought healthy lifestyle campaign directed towards children — or more accurately, its traffic light food labeling legislative lobbying. Both the game and campaign were created for BHF by the PR firm Grey London.

Jon Williams, chief creative officer of Grey London said: “The medium of gaming is the perfect way to show kids who think they're immortal, that the choices they make now will catch up with them eventually.”

Mike Knapton, BHF director of prevention and care, told BBC news:

Today's junk food generation can't see beyond the burger box. They are missing the fact that eating unhealthily can have dire consequences on their long-term health. The Yoobot is an innovative way for children to explore the effects of eating a diet of junk food. The clock is ticking on the obesity time bomb and it is now more important than ever for children to be educated enough to take control of their diets.

According to the game’s welcome page, children “should” become familiar with the nutritional content of foods and the “implications of each choice” they make. By “allowing children to watch the future unfold before their eyes,” the game says, “it is hoped the game will show them the relevance of the food and lifestyle choices they make now and encourage them to make healthier choices from an early age.” Yoobot admits it exaggerates its dire claims to heighten the impact on kids:

[I]n order to clearly link certain actions with health implications we have exaggerated reality in order to emphasise the key points we would like users to understand. We have also had to simplify risk factors for heart disease, and to some extent alter the progression of the process of heart disease in order to not dilute the message of healthy eating and physical activity.

One sentence later it says: “Overall, the British Heart Foundation has endeavoured to make Yoobot an engaging and scientifically based educational tool.”

It turns out, the source of the claims used by BHF is the Foresight Report. This Orwellian report had even acknowledged that there is no sound medical or nutritional evidence for any of its claims or that any of its proposed tactics are healthful, effective or safe for growing children. Never the less, this game is being marketed as an educational tool. New Media Age reports that the game will be “supported by advertising across kids sites such as CITV, Bebo, Disney and Cartoon Network, a TV ad campaign co-created with Nickelodeon, and a leaflet campaign to 4,000 schools.”

For the game’s launch, BHF issued a press release with the results of a marketing survey its PR firm conducted. The press release has been picked up verbatim by media across UK. News stories have been reporting that most children are unaware that junkfood is dangerous and has devastating health effects. The BHF online poll of 1,100 UK children, 8- to 15-years old, reportedly found that more than seven out of ten children don’t “know” that eating bad foods can shorten their lives.

More accurately, 76% of kids had the right answer, which is now the wrong answer. There is absolutely no credible science that children’s diets are shortening their lives or causing them to develop adult diseases. There is no credible scientific support for traffic light claims that low-fat, low-sugar, low-salt foods define healthier foods for youngsters, prevent heart disease or obesity, or lead to longer lives. [Background on traffic lights: here, here, here, here, here and here.]

No credible research supports any beneficial effects for negative food and health messages for children, or that threatening and scaring them, especially with unfounded scares about perfectly safe food, is good for them and doesn’t put their welfare at greater risk.

And the results of a poll certainly aren’t credible scientific evidence to support any health intervention.

In fact, the BHF poll suggests that food scares are already having detrimental effects on young children and leading to disordered relationships with food. A quarter of the youngsters believed “bad” foods will shorten their lives. And nearly half of the kids polled said they believed that if they ate ‘junkfood,’ it would make them fat and unpopular, cause their teeth to decay and their skin to break out.


“For the children”

In any other situation, preying on children using threats of death, and trying to scare them about some unsubstantiated fear would be seen as wrong. Children are protected and their welfare is safeguarded. Few parents want their children to be used to advance political ideologies or commercial agendas, either. Yet this specious public health campaign targeting children is going to be marketed on children’s television and in public schools.

Not only that, the Food4Thought campaign is backed by the Northern Ireland Commissioner for Children and Young People (NICCY), Patricia Lewsley. NICCY is the agency tasked to protect children’s rights there. It receives complaints and concerns from children, parents or carers on any issue. “So far, we have had cases dealing with education, health, adoption, fostering, youth justice, road safety and bullying,” its literature says. “NICCY can also examine services if we think they are not good enough for children or that they harm children.”

The best interests of children are abandoned when it comes to the current obsession among public health officials over children’s diets and the readiness of special interests to capitalize on a sham health crisis. Who needs science or evidence, when you can popularize beliefs by hiring an advertising agency and issuing a press release?


© 2008 Sandy Szwarc


Click here for complete article (and single page version).
Bookmark and Share

November 27, 2008

Remembering those less fortunate

Thanksgiving is a day to give thanks for our blessings. It’s also a good time to remember those whose tummies aren’t full of turkey and all the fixins, who find themselves alone and who don’t have enough to eat.

The latest Household Food Security in the U.S. 2007 report from the U.S. Economic Research Service revealed that the percentage of food insecure households in the United States have remained stable over the past decade, but those with hunger (now called “very low food security”) have steadily crept up — rising by one-third since 1999. Just over 4% of households experienced hunger in our country in 2007.

[The food insecurity data collection methods and survey periods were standardized since 1998, so early data is unable to be compared.]

According to the report, hunger and food insecurity is intermittent for only 25% of these households, experienced for one to two months of the year. For most, hunger is recurring and experienced for three or more months of the year, and for one-third it is chronic and suffered nearly every month.

How has hunger been defined for decades? According to the Government’s 2002 Food Assistance and Nutrition Research Report, Economic Research Reducing Food Insecurity in the United States: Assessing Progress Toward a National Objective:

Hunger, as measured in food security assessments, refers to “involuntary hunger that results from not being able to afford enough food.”

Hunger and food insecurity mean people are suffering and it has far reaching health consequences. The health; mental, physical growth and emotional development; and futures of children are jeopardized. There are also severe health implications for the elderly. The medically-documented consequences for all ages include fatigue, functional decline and diminished mental acuity, delayed wound healing, impaired immune system and increased risks of infection, exacerbated chronic and acute illnesses, depression, loss of muscle strength, falls and increased fractures, longer hospital stays, higher rates of complications and rehospitalization, significantly higher healthcare costs and higher mortality rates.

According to Healthy People 2010 objectives, food security means adequate nourishment and is defined as assured access by all people at all times to enough food for active healthy lives.”

This latest Food Security report described those who are hungry in our country. Once again, the single biggest reason for hunger and food insecurity was poverty, and was most prevalent among single-parent households, elderly living alone, and among Hispanic and Black minorities. The more that households are able to spend on food, the more food secure they are. Rising food prices mean more households are unable to purchase enough food and food insecurity increases. The greatest reductions in food insecurity and hunger happen as a result of economic growth, with its concurrent improvements in employment and incomes, according to the Food Assistance and Nutrition Research Report.

The relationship between food security and various food assistance programs is complicated, since it is hoped these programs reduce hunger. As a result of government assistance programs, “just over half of food stamp households, 47% of households that received free or reduced-cost school lunches, and 42% of those that received WIC were food insecure,” said the report.

Considerably higher numbers of people living in households with food insecurity and hunger, however, turn to private charitable services than utilize government programs (53.4% are on food stamps, 46.7% of children are getting reduced school lunches, 41.5% of pregnant women and children are on WIC). More go to food pantries (69.2%) and emergency kitchens (70.1%). These figures for those turning to food pantries and soup kitchens don’t include the homeless, which raise the importance of charities. The disabled make up the largest segment of the homeless and the greatest numbers of homeless are in urban areas.

Food insecurity and hunger vary considerably from state to state, but the report highlighted: “No state registered a statistically significant decline in very low food security [hunger].” The states with the highest rates of food insecurity and hunger were Mississippi (17.4%), New Mexico (15%), Texas (14.8%) and Arkansas (14.4%) .

While in most food insecure homes, the children are protected as much as possible, about 323,000 households (0.8%) have had to reduce the food for one or more children. The older children in a household are affected to the severest effects of food insecurity as adults try to protect the youngest.

The highest percentage of food insecure and hungry households in our country were reported to be in principle cities. To complement this information, we turn to the latest U.S. Conference of Mayors report, A Status Report on Hunger and Homelessness in America’s Cities: A 23-City Survey, which had assessed hunger and homelessness in America’s cities during 2007. None of the cities were in states with the highest rates of food insecurity and hunger, but were those of the 1983 mayoral Task Force on Hunger and Homelessness. They also found that the major causes of hunger in cities was poverty, along with unemployment and high housing costs.

A full 90% of hunger was attributed to poverty.

Eight out of ten cities reported that requests for emergency food assistance had increased, an average of 10% just in the past year. Requests for emergency food assistance had increased the most among households with children (79%). Elderly were next with a 62% increase in need. These figures are precisely what were described several years ago when Melody Wattenbarger, Executive Director of Roadrunner Food Bank in New Mexico said that “over one-half of the increase we see are the most vulnerable of our community – children and seniors.”

Most of the mayors reported that demand for emergency food assistance increases during the winter months or during the summer when children were out of school and access to school-based meal programs is more limited.

More than two-thirds of the cities reported that they were unable to meet the demands for emergency food assistance last year. An average of 17% of people who needed emergency food assistance did not receive it; 15% of households with children who needed help didn’t receive it. In Los Angeles, alone, more than two out of ten people coming to food banks had to be turned away.

All responding cities reported that they expected requests for emergency food assistance to continue to increase in 2008.

To find your local food bank for assistance or to make a much needed donation over the holidays and throughout the coming year, see the Food Bank Locator or Food Bank Directory.



© 2008 Sandy Szwarc


Click here for complete article (and single page version).
Bookmark and Share

Happy Thanksgiving!

Bookmark and Share

November 26, 2008

FDA alert: All-natural weight loss supplements found tainted

The FDA has issued an alert to consumers and healthcare professionals about two dietary supplements sold for weight loss. Both have been found to be adulterated with prescription drugs and could endanger consumers.

According to the FDA’s Safety Information and Adverse Event Reporting Program, these products sold as natural diet aids have been recalled by the manufacturers. Consumers should discontinue taking them and return the products to the manufacturers.


STARCAPS

Balanced Health Products, Inc. has finally recalled STARCAPS due to the presence of the prescription drug, Bumetanide. This medication is a potent diuretic used in the treatment of edema associated with congestive heart failure, and liver and kidney disease, including nephrotic syndrome. It can cause serious fluid and electrolyte loss and elevations of uric acid. Bumetanide increases the risk of low blood pressure and fainting with resultant injuries, especially among those with normal blood pressure or who are already taking a high blood pressure medication. This drug is contraindicated for people allergic to sulfonamides. Those taking certain other medications are at risk for significant drug interactions with Bumetanide that can lead to toxicity, such as people taking digoxin and lithium.

The company’s recall notice, including specific lot number information, is available here.

StarCaps had been marketed over the internet as an all-natural product from Peru that combines papaya enzyme and garlic that’s been used since the time of ancient Greeks and Incas. A bottle of 30 tablets cost about $100 and it was billed as the diet supplement of the stars. The StarCaps website is frozen and currently says it has received notice of a problem in an NFL player and has ceased all product shipments until it can ensure StarCaps is safe and effective.

Bumetanide is a drug banned by the NFL, and Saints players Deuce McAllister, Will Smith and Charles Grant had reportedly tested positive for this substance. According to Pro Football Talk, Saints guard, Jamar Nesbitt, has been suspended four games for violation of drug policies and has filed suit against the manufacturer of “StarCaps,” for containing bumetanide unbeknownst to Nesbitt.

Why it took the company so long to issue a recall is unclear. Last year, in the November-December, 2007 issue of the Journal of Analytical Toxicology, researchers at the University of Utah reported that bumetanide can be used by athletes as a masking agent to increase urine production and reduce urinary concentrations of performance-enhancing drugs such as anabolic steroids, and to drop weight. The investigators had tested StarCaps and found that when administered to human volunteers, all of their urine samples tested positive for bumetanide. “Bumetanide was also detected in the StarCaps capsules at concentrations approaching therapeutic doses,” the researchers found. They concluded: “The results showed that unregulated dietary supplements may put consumers at risk for unwitting consumption of prescription medications, and that it is possible for athletes to inadvertently test positive for bumetanide and face disciplinary actions.”


Zhen De Shou Fat Loss Capsules

The second recall notice reported by FDA’s latest MedWatch safety report was issued by Fashion Sanctuary for its Zhen De Shou Fat Loss Capsules. This was in response to FDA analysis which found the product contained undeclared sibutramine, the prescription appetite suppressant. “This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” the FDA reported.

The company’s recall notice includes ALL lot number codes and use-by dates and is available here.

Just because a product is used by stars and promises to be all natural and used since ancient times, does not make it true, safe or effective. No weight loss drug has ever been shown to be safe or effective for long-term weight loss. Not one.


Click here for complete article (and single page version).
Bookmark and Share

Political correctness teaching prejudice

University students voted to discontinue its fundraiser for a genetic disease that cuts short the lives of young people. The reason they gave is what has caught attention: the victims of the disease aren’t the right color or gender. The Carlatan University Students' Association said the disease is not “inclusive” enough.

The student newspaper, The Charlatan reported, that the student council voted on Monday — with a vote of 17 to 2 — to abandon its 25-year Shinerama fundraising tradition, which has raised nearly $1 million for the Canadian Cystic Fibrosis Foundation since the mid-1990s. More than 60 Canadian universities and colleges have participated in Shinerama since its inception in 1964, raising about $19 million for CCFF, which has become one of the leading, non-governmental granting agencies for cystic fibrosis research and medical care. When CCFF was founded in 1960, CF victims died in infancy with no treatments available. Today, and the average survival has risen to just over 35 years.

This student council motion was proposed by Donnie Northrup, a fourth-year “integrated science” student representative from the Faculty of Science at Carleton University in Ottawa, claiming cystic fibrosis is a white man’s disease:

Motion to Drop Shinerama Fundraising Campaign from Orientation Week

Whereas Orientation week strives to be [as] inclusive as possible;

Whereas all orientees and volunteers should feel like their fundraising efforts will serve the their diverse communities;

And Whereas Cystic fibrosis has been recently revealed to only affect white people, and primarily men

Be it resolved that: CUSA discontinue its support of this campaign

Be it Further Resolved that the CUSA representatives on the incoming Orientation Supervisory Board work to select a new broad reaching charity for orientation week.

Moved: Donnie Northrup

The public comments from the leadership of the student council supported the move: “We have a diverse community,” the vice president of the Charlatan University Students Association told the student newspaper. “We need something that is more representative of the greater student [body] than just one small group… we need to appeal to a larger demographic.”

Like all prejudices, racism is based on ignorance and this incident is no different. The students had failed to research cystic fibrosis [which is pretty amazing given how much information is readily available online*] or understand what is meant by the fact that this inherited disease afflicts a higher proportion of “Caucasians.” That term in population research refers to people from widely varied race/ethnicities and is not a measure of skin color. As Cathleen Morrison, head of the Canadian Cystic Fibrosis Foundation, said on a CTV television report, the term “Caucasian” includes people from South Asia, North Africa, the Persian Gulf, and Israel. [CF also afflicts significant numbers of Latinos and Native American peoples.]

“It includes people with a whole rainbow of skins,” Ms Morrison said. She added that cystic fibrosis is the most common fatal genetic disease among young people in Canada, and that it affects just as many girls as boys. In fact, women with the disease have shorter life spans.

Cystic fibrosis is an inherited disease of the mucus and sweat glands and affects the lungs, pancreas, liver and intestines, causing mucus to be thick and sticky. It makes breathing terribly difficult, requiring intense respiratory therapy, causes repeated respiratory infections and leads to lung damage. Digestive functions are increasingly impaired. There is no cure yet and just a few decades ago, most victims didn’t survive childhood. Treatments have improved over recent years and now people with CF live, on average, to more than 35 years of age, according to the National Institutes of Health.

The true picture of CF bears no resemblance to the students' misconceptions. The photo archives of Cystic-L, an online information and support group for CF patients and families, poignantly illustrates that CF is a disease of babies, children and young adults:

Nick Bergamini, a third-year journalism student on the student council, was the only elected councilor present to vote against the motion. The decision is an example of campus political correctness gone too far, he told the Canadian news. He was the only one at the council meeting who appears to have understood the political divisiveness behind the students’ motion. “They're not doctors. They're playing politics with this,” he said. “I think they see this, in their own twisted way, as a win for diversity. I see it as a loss for people with cystic fibrosis.”

The Chronicle for Higher Education said this action has drawn widespread criticism, from Facebook to national newspapers. Andrew Steele wrote a sad article in the Globe and Mail about his deceased college friend with CF who had grown up in a household of adopted special needs kids. Jonathan Kay wrote in the National Post that CF is a horrible disease and most victims die in their 30s. “All of which would seem to make cystic fibrosis research a worthy cause, right?” He pointed out a picture of a little black girl with CF undergoing a respiratory treatment [side photo] and chastised the students for failing to do their homework. He then called them on their reverse racism:

But even if it were true that only white males got CF, what of it? We raise money for breast cancer even though it is primarily a female disease. We raise money for Tay-Sachs, even thought it strikes almost exclusively Jews. We raise money for AIDS, even though it disproportionately affects gays and blacks. That’s because we raise money to save people — not tribes…

Update: Donnie Northrup isn't backing down! He reportedly is telling Facebook pals that sticking with the CF funding would reflect "the same mentality that kept slavery legal, and prevented the women's vote."

Sadly, the racism card is increasingly being pulled out — often by privileged white healthy young people — without understanding, and often revealing their own prejudices. Political correctness has become its own form of prejudice, even towards elderly, poor, fat, minority, sick or disabled fellow citizens. But some students haven’t succumbed to popular political correctness. A small group of students has begun a campaign in support of Shinerama and confirmed that the Canadian Cystic Fibrosis Foundation will be devastated by losing Carleton’s support. Their slogan is: “Diseases don’t discriminate.”

Today, the student newspaper published a much less favorable article of the student council’s actions, writing it “is far more than disappointing — it is outrageously politically incorrect, never mind the fact that it's based on false information…. it will go down in history that CUSA and Carleton students are racist, sexist, uninformed and very narrow-minded.” The motion claiming the disease discriminates “just makes CUSA discriminatory.”



* Information on Cystic Fibrosis is just a mouse click away:
Azer’s Cystic Fibrosis Website [source of opening photo]
Cystic Fibrosis Foundation
National Institutes of Health

From the CF Research, Inc.:
Foundations and Other Organizations about CF
United States Adult Cystic Fibrosis Association
The Milan Foundation
The Reach for the Stars Foundation
Heroes of Hope Living with CF
Second Wind Transplant Association of St. Louis
My Cystic Fibrosis dot com
Medrise's page
National Cystic Fibrosis Awareness Committee
International Association of Cystic Fibrosis Adults
The Cystic Fibrosis Center at Stanford
The Boomer Esiason Foundation
Cystic Fibrosis Mutation Database
Cystic Fibrosis Genetic Analysis Consortium
Aetna InteliHealth's Cystic Fibrosis Genetic Testing Guide

Individuals and Groups
Ask James About CF
Dreamsurfer Network
65 Roses
Melinda Sue Kerns' site
CF message board
Risa Gans' site
Sandy Cochran's CF information site
Jeff Wine's page of CF links
CYSTIC-L internet
Norma Kennedy's page of CF Links Cystic Fibrosis Pharmacy
Hardin Meta Directory

Sites by people with CF
Michelle Compton's website
The Breathing Room

International
Cystic Fibrosis Prescriber (UK)
Cystic Fibrosis Resource Centre (UK)
Jose Pulido (en español)
The European Cystic Fibrosis Society
Canadian Cystic Fibrosis Foundation
Cystic Fibrosis Victoria (Australia)

Newsletters
Newsletter list www.cysticfibrosis.com

NETWORK A national (USA), quarterly newsletter for adults with CF.
You may subscribe by contacting NETWORK at the address below. If you or your child(ren) have CF, please provide date of birth. Thank you. CF Network, Inc, P.O. Box 3459 Littleton, CO 80161-3459

Informer Produced by the CF Pharmacy in Florida (see above link). 16 pages, bi-monthly. Nicely home-spun. Informational but also informal. Pictures, mail-buddies, birthdays, etc. Bev Donelson at: bevd at hhcs dot com

CF Roundtable A newsletter put out by USACFA (US Adult CF Association). To subscribe email CFRoundtable@cysticfibrosis.com or call (503) 669-3561.


Click here for complete article (and single page version).
Bookmark and Share

November 25, 2008

Do you know where your health news and information comes from?

If a commercial entity provides $3-4 million to finance a news service to produce in-depth coverage of policy issues that make a case for its services — including paying journalists to write columns, and create video interviews, multimedia and free content for syndication to news outlets around the world — would most readers consider the news to be unbiased journalism or paid marketing?

If a stakeholder pays a medical journal and a health policy journal $1.4 million for editorial activities to publish special editions that raise awareness of the need for its services — including paying experts to author articles and hosting media policy briefings — would most medical professionals feel the journals’ content would be more or less likely to be objective?

The integrity of medical education and health information free from industry influence have been turned topsy turvy this past month. Yet, not one medical professional appears to have noticed that it might warrant thoughtful consideration about disclosures with health information intended for both professionals and consumers.

To better grasp the issue requires us to recall recent events…


Remember when?

Just six months ago, the Journal of the American Medical Association produced a history-making issue when its editors impugned the integrity of medical reporting, education and research for being inundated with industry influence. “It is time to stop,” wrote editors Dr. Catherine D. DeAngelis, M.D., MPH; and Dr. Phil B. Fontanarosa, M.D., MBA. They called for the medical profession to clean up its act in regards to conflicts of interest and proposed sweeping changes.

As covered here, the editors had written:

[M]anipulation of studies and misrepresentation of study results could not occur without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewers and… public trust for clinical research is in great jeopardy especially when the extent of how widespread such practices have become is unknown… [I]n addition to clinical research, clinical practice and medical education also are greatly influenced by for-profit companies. Drastic action is essential, and cooperation of everyone involved in medical research, medical editing, medical education and clinical practice is required for meaningful change to occur.

The journal editors had gone on to make eleven proposals to preserve and strengthen the integrity of medical science, which had included:

“All journals must disclose all pertinent relationships of all authors with any for-profitcompanies, and must publish all funding sources for each article.” Funding sources and author disclosures should included in journal editors’ decisions of accepting a paper for publication.

For-profit companies… should not be solely or primarily involved in… preparing the manuscript reporting study results. These responsibilities should primarily or solely be performed by academic investigators who are not employed by the company sponsoring the research.”

“To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs.”

“Any editor who knowingly allows (or is party to allowing) for-profit companies to manipulate his or her journal must be relieved of the editorship.”

At that time, JFS had highlighted a major oversight in these proposals: for-profit pharmaceutical and medical device companies are not the only sources of conflicts of interest. Nonprofit organizations and foundations are also important sources of conflicts, as exampled. While the source for any information is never a measure of its soundness or completeness, in reality, it can be difficult for many people to recognize sound science and information from spin and marketing, and disclosures can help understand the perspectives of a source and alert us to potential bias. That might, perhaps, encourage us to think more critically about what we hear.

Currently, so much of our health information is funded by stakeholders, with most consumers unaware of those entanglements. The lines between education, entertainment and marketing have become blurred, perhaps irreparably. We’ve seen it in canned health news segments; television specials, documentaries and paid public television specials; press events; and journalists wooed by trips and writing awards and even unconsciously motivated to write copy favorable to sponsors. It’s not just a concern in mainstream media, as the internet has become a ready venue for marketing through patient advocacy groups, social media marketing and bloggers, and even scientists and doctors writing for PR firms while their industry backers are undisclosed to readers.


A new health nonprofit

SCAN Healthplan is one of California’s fastest-growing Medicare Advantage plan providers, with more than 100,000 members, and is a provider of long-term care management for individuals enrolled in Arizona’s state long-term care system. Earlier this year, on April 11th, it announced it had funded its own new nonprofit foundation with $205 million. Their new SCAN Foundation will be one of the country’s largest foundations focused on senior care, according to the press release. “Because SCAN Health Plan is itself a not-for-profit organization, there were no shareholders or stock conversions involved in the creation of this Foundation.”

Health Affairs reported last month on the new foundation and its $205 million endowment. The SCAN Foundation will be headed by Bruce Chernof who told Health Affairs that its public awareness and public policy work will have a state and national focus. “Given that federal policy and funding drive so much of long-term care through the Medicare and Medicaid programs, an active national presence is critical.”

Last week, on November 20th, the SCAN Foundation issued a press release saying it was awarding “nearly $1.4 million in grants aimed at recasting the dialogue between health professionals, policymakers, and the public about how to provide long-term healthcare.” According to the media release:

A $450,000 two-year grant to [University of California, San Francisco] will support the organization and writing of a special patient and caregiver-focused section on aging and independence to be submitted for peer review and possible publication in JAMA. For this special section, Dr. Seth Landefeld and colleagues at the UCSF will organize the section, interview patients, and work with experts in the field who will author articles on issues in aging important to maintaining independence and reducing morbidity. The grant will fund these editorial activities at UCSF.

“JAMA is pleased to work with The SCAN Foundation and the University of California, San Francisco. America's demographic changes are presenting a challenge to the medical profession to develop and disseminate new techniques and protocols that respond to the growing demand for long-term healthcare,” said Dr. Catherine DeAngelis, editor-in-chief of JAMA.

Two grants totaling $947,389 will be given to Health Affairs: $197,389 to fund a half-day policy briefing in Washington, DC, in mid-2009, aimed at making the case for why long-term care must be on the nation's broader health reform agenda; and $750,000 to support a special issue of Health Affairs journal on such themes… and issues surrounding financing long-term care and long-term care insurance.

Susan Dentzer, editor-in-chief of Health Affairs, said: “Along with changes in how medical care is provided, we must raise the awareness of policymakers and the public about long-term senior care and the prominent role it must have in any discussion about the nation's health priorities.”

On October 29th, Kaiser Family Foundation announced it was launching Kaiser Health News, a new news service to provide in-depth coverage on political and policy debates surrounding the healthcare system. “Supplementing the stories will be columns, video interviews, graphics, and multimedia features, as well as a daily synthesis of news stories from around the country,” it stated. Kaiser Family Foundation’s own Kaisernetwork.org, established in 2000, will be merged into Kaiser Health News, creating a comprehensive news service.

Journalists who work for KHN will have resources for research and travel to get out and cover stories… KHN will also enter into partnerships with news organizations to jointly produce and publish articles, and will provide content for syndication to news organizations in the U.S. and around the world, free of charge. Over the next several months, a team of full-time of journalists will be hired and top freelance journalists will be recruited to write stories and series for distribution through KHN.

Yesterday, the New York Times and International Herald Tribune reported that Kaiser Health News will be “the largest and best-financed project of its kind,” with funding expected to reach $3 million to $4 million in its first two years. The new news service will not accept advertising. Instead, it is being financed by the SCAN Foundation.

Reporter, Kevin Sack, noted that this is not the only health foundation funding health news. The California HealthCare Foundation, with an initial budget of $239,000, is launching a pilot project to report on health issues in California. If the pilot succeeds, the foundation may fund it with multi-millions, he said. Seven health foundations provided the seed money for Florida Health News. And Kansas Health Institutes’ own news service is also founded by a foundation.

Healthcare is big business. The money, and more importantly, the potential influence, is too great to believe that the most successful news and information sources will be immune. Accurate health information is important for everyone, though. Do you feel you deserve to know where your information is coming from? When stakeholders form their own nonprofit foundations, should that release them from disclosing those interests to you?

If health information was labeled as paid advertising, would that change the way you look at it and make you apt to think more critically about it?

Medicare Advantage is an example of just one issue easy to underestimate its significance. Bloomberg reported Monday that three companies — Humana, WellCare Health Plan, HealthSpring Inc. — depend on Medicare Advantage for more than 80 percent of their earnings before interest, taxes, depreciation and amortization, according to Carl McDonald, an analyst with Oppenheimer & Co. in New York. Medicare Advantage is so lucrative for insurers, said Kaiser Family Foundation, it estimated that 70% of the entire $46 million advertising budgets of insurers was spent to advertise Medicare Advantage plans.

With $100 billion in government payments to Medicare Advantage plans this year alone, and four times that possible, it’s understandable the companies would be committed to shaping the public policy debate. Similarly, those opposing them have their own even larger financial and political interests, yet we almost never hear about those, either.

With issues as important as our health, ideally media would objectively report the facts, use knowledgeable professionals and dig deep with investigations of original sources, while keeping staunch separations of editorial and advertisers, to enable us to make more informed choices for ourselves. There is no evidence that we’re heading in that direction. Health information is one area where that old adage caveat emptor can stand us in very good stead.


© 2008 Sandy Szwarc


Click here for complete article (and single page version).
Bookmark and Share