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Fox story advertises unproven stem cell therapy for COPD

Rating

1 Star

How stem cell therapy may help treat COPD

Our Review Summary

iStock_000056688518_SmallWe were thrilled to see this story mention the costs of the treatment, its lack of FDA approval, and the fact that insurance won’t cover it. But that was just one sentence. The rest of the story is so heavily focused on the experiences of one patient who believes she was successfully treated through stem cells that readers would understandably be driven to dial up this doctor based on scant evidence, no real understanding of the potential benefits, no independent assessment of the treatment, no comparison to alternatives, and no mention of risks.

 

Why This Matters

Chronic obstructive pulmonary disease is very common. There are many out there who might be affected by this type of poor reporting.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

Costs are presented here as is the fact that the treatment Is not covered by insurance, and so we are marking this as a passing rating. But the cost information is framed as if it’s a bargain: “costs less than $8,000” and is “well worth the price.” That’s language that has no place in a story about an unproven treatment.

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

Not Satisfactory

There is no objective quantification of benefits here. Instead, the story allows the physician who is marketing this procedure to make unproven claims about the treatment, saying that “about two-thirds of his patients see COPD relief within several weeks to about five months, and that those results last for about a year.”

There are two big problems with a claim like this. First, the patient pool could be three patients, two of whom were treated successfully for a year. Second, the findings have no objective, independent measurement of improvement and no independent verification. No published studies. No peer review. Not even a group of collaborating physicians seeing the same results from different vantage points.

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

Not Satisfactory

There is no mention of risks in the story. Instead, the story repeats claims of amazing results in one patient.

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

Not Satisfactory

The story skirts any objective evidence – positive or negative – and opts instead to present unproven claims from the physician performing the treatments and the claims of one patient.

It says, helpfully, that stem cell treatment for COPD “isn’t approved by the Food and Drug Administration (FDA) or covered by health insurance,” but it should have explained why that is.

Does the story commit disease-mongering?

Not Satisfactory

The story presents a single patient with severe symptoms, making it sound like everyone with COPD could become incapacitated unless they resort to this extreme, untested treatment.  It also doesn’t mention that most COPD can be avoided by not smoking.

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

Not Satisfactory

There are no independent sources in this story, and it would have benefited from them.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is no real comparison of alternatives here. Stem cell therapy is the unproven treatment, and it is given all the air time. Traditional treatments for COPD are skipped or presented as failures in the case of one patient.

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

Not Satisfactory

The story has too many vague sentences that give the treatment the aura of efficacy. The one relating to the treatment’s availability may be the most dangerous:

As Calick ran out of options, she sought help from Dr. David Borenstein in New York City. Borenstein, an integrative medicine physician, is one of numerous doctors in the world who is using stem cell therapy to treat various diseases.

Understandably, readers with COPD might be calling their doctor the next minute to make an appointment. There are three main problems with the way the treatment is presented in this part of the story. First of all, integrative medicine is a controversial topic in and of itself, as explained by Dr. David Gorski on the Science-Based Medicine blog. Second, by saying that there are “numerous doctors in the world,” the story gives the impression that using stem cells to treat COPD is an established and now fully global practice, when, in fact, it may be three or it may be 3,000 doctors doing this. There’s very little evidence for the latter. Lastly, by saying “to treat various diseases,” the story misleads readers into believing that stem cells are a proven and established therapy for COPD and a range of diseases. In fact, as the FDA notes on its website:

FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system

There is no FDA-approved stem cell treatment for COPD or for nearly anything beyond the blood-related conditions that Hemacord is supposed to treat. And that’s because there is very little proof that stem cells are safe and effective treatments.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story makes claims that this is a silver bullet for COPD, but it does not establish those claims. The main novelty here is the incredible naivete of the coverage.

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

Satisfactory

We couldn’t find any specific news release that this story may have relied on, but since there are no independent sources, we can’t be sure that the story definitely wasn’t based on such a release. We’ll rule this Not Applicable. And we note that the story is clearly being used to promote the treatment center that is its focus.

Total Score: 2 of 10 Satisfactory

Comments (6)

We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.

We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.

Chris

January 10, 2016 at 1:18 pm

Dr. Borenstein is part of the Cell Surgical Network, a network of clinical practitioners using the same equipment, following the same protocols (recipe), and using the same GMP enzymes, all recapitulating the findings of the founders. The Cell Surgical Network has over 88 Stem Cell Treatment Centers around the world and 76 in 25 States here in the USA. The problem with these types of news stories is the lack of time provided to cover all the major aspects of the science. CSN has a world class database collecting the patient outcome scores of every CSN Affiliate, allowing the doctors to see how their own patients are responding to the SVF, and if their patient’s patterns follow those of the entire Network. For more information please check out Cell Surgical Network’s website: http://www.stemcellrevolution.com

Reply

    Kevin Lomangino

    January 10, 2016 at 6:31 pm

    Chris,

    Thanks for your comment. I think it’s all well and good for these centers to collect data as you state, but has that data been published and independently reviewed? That’s what patients need to make informed decisions about their care. And journalists need to help patients by presenting the data, or, if it doesn’t exist, pointing that out to readers and asking why that’s the case.

    Kevin Lomangino
    Managing Editor

    Reply

      Christopher Lindholm

      February 2, 2016 at 11:15 am

      Hello Kevin,
      You can find Cell Surgical Network on http://www.clinicaltrials.gov, and our Clinical Trial number is: CSN111
      CSN is finishing up a 1000 patient safety paper that will show safety and efficacy data spanning the spectrum of medical conditions, I just finished the stratification part of the one-year safety data points yesterday (woo hoo), our Ph.D. should finish and be ready for peer review in a months time. I believe the reason more companies like Cell Surgical Network do not post data is due to them being afraid of the FDA. We at CSN believe in working with State medical agencies and the FDA to ensure patient safety and provide better care than some traditional medicines allow. Cell Surgical Network would not have grown to over 80 Treatment Centers worldwide if our SVF procedure didn’t work; physicians wouldn’t stay with a Network if that Network were false hope. With the Cell Surgical Network, you have real science at work, every CSN affiliate around the world using the same equipment, same enzymes, and following the same protocols. Show me another clinical trial that can boast that? We are not a tiny group of scientist in one lab, doing one procedure 10,000 times then write a paper. Our physicians are providing better care to their patients now than they were not able to do a couple of years ago.

      Kevin Lomangino

      February 2, 2016 at 11:37 am

      Chris,

      I’m very glad to hear that you are planning to submit data on the safety and efficacy of this procedure. But this story is promoting the procedure NOW to desperate people who have no idea whether it works or not. Vague assurances that the network’s physicians wouldn’t offer the procedure if it didn’t work are no substitute for peer-reviewed data. Like the story we criticized, your comment is all promotional talk with no evidence to back it up. And that’s not helpful to anyone.

      Kevin Lomangino
      Managing Editor

Michele

January 10, 2016 at 2:34 pm

Fox is making the job of patient advocacy groups who try to protect vulnerable patients from these definitely costly and potentially dangerous procedures much harder. Because this type of autologous stem cell treatment is considered (proprietary) commercial intellectual property and there is no body of literature from research studies related to what specifically is included in the cocktail of each provider, it is impossible to know what is actually being injected into patients. Additionally, there is no requirement for informed consent and no IRB oversight because these are not research studies. As a consequence, patients are not told that taking these therapies may make them ineligible for future, legitimate studies of gene-based therapies and/or for lung transplant.

Several larger lung disease patient groups have weighed in on concerns with this therapy, including the COPD Foundation. These groups rely on medical and scientific advisers who are recognized experts in the conditions represented, who can be counted on to fully understand the state of the science in all areas related to these diseases. They would not take the word of a single physician of questionable expertise who has a clear financial interest in promoting a therapy. Nor would they rely on testimonial, which any journalist who wants to do quality medical journalism should know is not ‘evidence.’ Not only is this not good medical journalism, it actually does a huge disservice to sick and vulnerable people.

For individuals who want to know what actual lung disease experts say about these therapies, here are links to position statements from three major lung disease foundations. If you are interested in the bona fides of these positions, take a gander at the medical and scientific advisory boards of these groups:

http://www.copdfoundation.org/Take-Action/Patient-Access/COPD-Foundation-Position-on-Stem-Cell-Therapy.aspx

https://www.cff.org/News/News-Archive/2015/Stem-Cell-Therapies-and-Research-for-Cystic-Fibrosis/

http://www.alpha1.org/Newly-Diagnosed/More-Alpha-1-Resources/News/ArtMID/5952/ArticleID/6589/Buyer-beware-Alphas-urged-to-avoid-companies-advertising-unproven-stem-cell-treatments-that-can-cost-you-a-fortune

Reply

Wayne Bonner

June 26, 2016 at 1:45 pm

This is typical of the Fox sloppy journalism.
Still, it shouldn’t be a problem.
Who in God’s name would take medical advice from Fox TV?

Reply