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Made-to-order medicine

Rating

1 Star

Made-to-order medicine

Our Review Summary

This was a meandering story, wandering among wild claims for both bioidentical hormones and for “a personalized integrative regimen based on genetics.”  It allows claims to be made across a wide range of health concerns, yet offers no data, no evidence.  Three reviewers – two journalists and a physician with a research interest in the field of complementary therapies – felt this story committed disease-mongering.

We were surprised that the patients in the story and the physicians promoting their program were given such a large platform to espouse health claims for bioidentical hormones that have very little grounding in scientific evidence while dismissing (as “kerfuffle”) well established health risks associated with hormone therapy. There were was a little bit of skepticism provided by independent voices, but these voices were drowned out in the total package, bookended at the beginning and end by positive, yet uNPRoven, patient anecdotes.

We do appreciate, however, that this story is one of the few we have seen to spell out at least some of the costs of the therapies discussed.

 

Why This Matters

People who are, as this story describes, looking to “reduce stress, get a good night’s rest, eliminate the tire that circles their waist, or revitalize a sex life that has lost its sparkle,” are often the target of medical marketing promising miracle cures. This story could have taken the opportunity to examine some of the claims being made around bioidentical hormones. Instead, it helped promote another uNPRoven miracle cure by using boosterish language and presenting glowing anecdotes insead of hard evidence. There also is a larger issue. US expenditures on complementary and alternative therapies continue to rise. It is important that people seeking symptom relief from treatable medical conditions (depression, insomnia, hypertension) are provided with appropriate medical care first. Those who continue to have symptoms after receiving treatment consistent with best practice or those who suffer from stress-related symptoms may want to seek alternative therapies in addition to medical care. This story presented an imbalanced view of the mix.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We give the story high marks for beginning to discuss costs. It breaks out the costs of the two initial tracks of the Great Life Program. What it fails to do, though, is discuss the ongoing costs of bioidentical hormone therapy or the vitamin supplements described.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story never quantified any of the benefit claims made by the physicians pushing bioidentical hormones. Instead, anecdote is used instead of any hard data.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

It isn’t until the final third of the story that any risks associated with bioidentical hormones are mentioned, and here they are only mentioned in a he said/she said way that does not serve the reader. The story says, “Bazzan insists that bioidentical hormones, compounded by qualified pharmacists based on his customized prescription for each patient, are safer than the synthetic ones churned out by drug firms. But the American Medical Association and the U.S. Food and Drug Administration have said there is no evidence of the increased effectiveness or lower risk of bioidentical hormones.” The story has presented long anecdotes from patients claiming sweeping health improvements and two doctors claiming the same. Then, making matters worse, the story dismisses the best evidence we have on the safety of hormone therapy — the Women’s Health Initiative — by saying, “Despite the kerfuffle about the safety of hormone therapy, which Judith Volkar, a physician in the women’s health division at the Cleveland Clinic, feels has been overblown, both she and Schiff use it selectively, as does Bazzan, only with patients who show a deficiency, and always informing them about the risk/benefit ratio.” Kerfuffle? The Women’s Health Iniatitive has studied more than 160,000 women over 15 years in randomized, controlled clinical trials and observational studies. The entire basis for this story, by contrast, is the opinion of two doctors and the experience of two patients. In addition, the potential harm of testosterone was addressed only very briefly by noting the potential for rising PSA level. In fact, testosterone should be given only with clear indications and monitored carefully.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

There is no attempt to evaluate any of the evidence behind any of the dozens of health claims made in this story or what “extensive testing” means for patients at the Great Life center. In one sentence alone, the story makes seven different health claims: “Everyone on the program is asked to take supplements of Vitamin D, aiming for a 50 ng/ml blood level, which Bazzan believes protects against myriad conditions including diabetes, non-Hodgkin’s lymphoma, and breast, ovarian, and colon cancer; probiotics for a healthy immune system; and omega-3 fatty acids, which he calls ‘life-giving’ fat.” None of these or any of the other claims in the story are either backed up with data or with independent analysis. We have seen few stories of this length that spend so little time analyzing the evidence.

Does the story commit disease-mongering?

Not Satisfactory

Clear examples of disease mongering. The story conflates serious, life threatening conditions, such as diabetes, non-Hodgkin’s lymphoma and various cancers with lesser health issues, such as insomnia and low libido. All of them are mentioned in this story as reasons to start this bioidentical hormone program, and all of them are presented as problems that can be overcome with the program. The lead anecdote about a patient says that a woman who has had bioidentical hormones injected into her buttocks for four years “feels energized and less stressed, and experiences none of the agonizing symptoms of menopause that troubled her in the pre-pellet days.” That patient’s husband claims that bioidentical hormones rescued him from “debilitating fatigue following critical spinal surgery and grueling rehabilitation.” Note how everything these patients were experiencing before is “agonizing,” “debilitating” or “grueling,” while the hormones give them “a dramatically enhanced quality and quantity of life.”

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

This story is chock full of people opining about the supposedly miraculous benefits and allegedly negligible risks of this program’s “personalized integrative regimen based on genetics.”  But fewer than 10 percent of the word count is devoted to any independent perspectives offering healthy skepticism. The imbalance in the sourcing leads us to grade this unsatisfactory.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is no comparison in this story to alternatives to bioidentical hormone therapy. Instead, through the anecdotes, other modes of therapy are dismissed. For example, one patient says he started the biodentical hormone regimen described in the story because he wanted to “to get off my blood-pressure and cholesterol medicines and get in better shape.” We are never told, though, whether bioidentical hormones or the diet described can successful replace cholesterol lowering drugs. As research has shown, dieting and exercise alone are not adequate to reduce cholesterol levels in some people with heart disease and a predisposition to high cholesterol. This is just one area in a story full of broad statements like this that could be misleading and, frankly, dangerous for patients currently following established, effective treatment plans who choose to abandon them for uNPRoven therapies. Programs aimed at exercise and appropriate diet may yield similar benefits in terms of reducing obesity related illnesses.

Again, Arnold Relman’s skepticism was appreciated – “Relman insists integrative medicine is “all nonsense.” “I believe it’s a whole collection of things said to be effective that have never been proven or tested. When patients who are tired or depressed or have no energy say they feel better” after trying integrated medicine, “it is only a placebo effect. They’d be better off going to church or joining an exercise program. Medicine is for people who are sick, not for people who are unhappy. This is just a waste of money.” – But it’s overwhelmed by the unverified, non-evidence-based claims for the Great Life Program.

Does the story establish the availability of the treatment/test/product/procedure?

Not Applicable

We’ll give the story the benefit of the doubt on this criterion, since, to address availability of this approach, the story at least stated:

“Integrative programs can be found in academic centers and hospitals throughout the country, although the flavor of each can differ. The Integrative Medicine and Digestive Center at the Johns Hopkins School of Medicine, headed by Linda Lee, focuses on integrative strategies particularly for women with gastrointestinal disorders. Memorial Sloan-Kettering in New York targets cancer patients. “There is a lot of flexibility,” Lee says. “Some centers bring in massage therapists or specialists in Chinese medicine or homeopathic consultants. But one thing is similar: Patients are usually highly motivated.”  “With so many baby boomers turning 65 this year, the timing is perfect,” says Gerald Katz, who has been a health-care consultant to hospitals and physicians groups for 30 years. “Integrative medicine is definitely a trend.”

Does the story establish the true novelty of the approach?

Not Satisfactory

The story never establishes the novelty of bioidentical hormones but, instead, presents anecdotal evidence as proof of their superiority. It’s not hard to find practitioners who offer the same type of “extensive testing” highlighted in this story. For example, patients may be asked for urine, hair, nail clippings and the like. They may be given, as this story describes, “tailored dietary supplements and advice.” What makes this Great Life program different?

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not rely on a news release. We have no doubt, though, that it will be used in the marketing materials for this center and for other bioidentical hormone promoters.

Total Score: 2 of 9 Satisfactory

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