Impedimed/deceptive marketing

kira66715

I know I've been on a tear about this, but this lymphconnect.com site http://lymphconnect.com/ has really gotten to me: and on further review, the Avon White Paper had as one of the authors, Steven Schonholz, medical director of impedimed, who has only one publication to his name on LE--a letter to the editor of Cancer on how he uses bioimpedance--which was shot down by Nicole Stout.

So, they write this Avon White paper, and promote bioimpedance as a way to catch LE early, when the symptoms could possibly be reversed. That's awfully close to acting like they could "cure" LE.

Then, they start this site, with some decent information, but it all comes back to bioimpedance, and promoting the L-dex: which states "is not intended to diagnose LE" and they solicit personal stories of LE from patients to post on their site and facebook.

Here is Dr. Schonholz's one publication--other than the Avon White Paper, which was also written by Stanley Rockson of Stanford and Nancy Hutchinson of Minnesota:

http://www.ncbi.nlm.nih.gov/pubmed/19152432 

 In Cancer, Stout Gergich et al1 demonstrated the successful treatment of lymphedema in breast cancer patients who were presurgically base-lined and postoperatively monitored for subclinical lymphedema. The data support prospective assessment and periodic surveillance. There were 2 limitations. First, the lack of a randomized-control design allowing some patients to have lymphedema progression. Second, the optoelectrical device is not Food and Drug Administration (FDA) cleared and may not be practical.

A randomized control study is ethically difficult. It would have allowed extracellular fluid to accumulate and put these patients at risk of permanent damage to their lymphatic systems. In 2007, the FDA cleared a device for clinical assessment and monitoring of lymphedema. The technology uses a low-frequency bioelectrical current that passes through the extracellular space of the patient's limb. The device compares the patient's at-risk limb and her contralateral uninvolved limb. The result of that ratio is the Lymphedema Index score. An abnormal score can identify subclinical lymphedema up to 10 months before clinical presentation.

At the Breast Care Center at Mercy Medical Center in Springfield, Massachusetts, all breast cancer patients are evaluated preoperatively using the Lymphedema Index. Repeat measurements are obtained on the first visit postoperatively, before initiation of radiation, and with completion. They have repeat evaluation every 3 months for 2 years and then every 6 months thereafter. If chemotherapy is involved, measurements are obtained before, monthly throughout the course, and when completed. The patients having mastectomy also have a physical therapy consult for teaching and postoperative management for the first 1-2 weeks.

With this new technology not only will we be able to identify subclinical lymphedema, but we will be able to prevent the chronic sequelae of the disease process, and may be able to identify the risk factors associated with lymphedema.

Reference
1
Stout Gergich NL,Pfalzer LA,McGarvey C,Springer B,Gerber LH,Soballe P. Preoperative assessment enables the early detection and successful treatment of lymphedema. Cancer. 2008; 112: 2809-2819.
Steven M. Schonholz MD*, * Mercy Medical Center, 271 Carew Street, Springfield, MA 01102.
 

And Nicole Stout replies:

Our study "Preoperative Assessment Enables the Early Detection and Successful Treatment of Lymphedema" used infrared technology to measure limb volume for screening and diagnosis of lymphedema.1 The Perometer device is used routinely in research related to lymphedema diagnosis and management. Limb volume change over time can be tracked with a high degree of accuracy using the Perometer. Many trials have been conducted to qualify it as a sensitive, reliable tool.2 Our study was the first to use this measurement tool in a prospective manner to diagnose subclinical swelling. We defined subclinical lymphedema as >3% change in limb volume as compared to the baseline, preoperative limb volume with consideration for the contralateral limb. The Perometer device is sensitive enough to capture this slight change in limb volume, although it occurs before clinical signs of swelling are apparent. Because the Perometer is not an invasive device, there is no requirement for the FDA to approve it.

The multifrequency bioimpedance unit is a new measurement technology that is valid to measure clinically apparent lymphedema and to quantify change over time.3, 4 Prospective studies using the bioimpedance unit, however, have not been conducted to demonstrate its efficacy in detecting limb volume changes consistent with subclinical lymphedema at the threshold that we have demonstrated can be captured with the Perometer (3%). Box et al conducted a prospective surveillance program and found that the multifrequency bioimpedance unit was not sensitive enough to capture 50% of the patients in her cohort who developed lymphedema.5 They concluded that the device was not sensitive enough to detect the earliest clinical changes in the limb. This could be associated with several limitations of the device, including; the loss of sensitivity the device has when the patient is in an altered state of hydration, has not voided their bladder before measurement, or has not lain supine for 10 minutes before measurement. Each of these confounding factors may have precluded the device from being able to capture limb volume change at such a sensitive threshold of 3%.

Based on our study, the Perometer was effectively able to detect a minimum 3% limb volume change when a preoperative measurement was taken and patients were monitored at regular intervals overtime. This enabled early diagnosis and treatment of lymphedema. Further research should be conducted using the Perometer and the multi-frequency bioimpedance unit not only for concurrent validity in monitoring volume change over time, but to study the sensitivity of the measurement device for early detection.

References
1
Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early detection and successful treatment of lymphedema. Cancer. 2008; 112: 2809-2819.
2
Warren AG, Brorson H, Borud LJ, Slavin SA. Lymphedema: a comprehensive review. Ann Plast Surg. 2007; 59: 464-472. Comment in:
Ann Plast Surg. 2008; 60: 228.
3
Cornish BH, Chapman M, Hirst C. Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology. 2001; 34: 2-11.
4
Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol. 2005; 3: 208-217.
5
Box RC, Reul-Hirche HM, Bullock-Saxton JE, Furnival CM. Physiotherapy after breast cancer surgery: results of a randomized study to minimise lymphoedema. Breast Cancer Res Treat. 2002; 75: 51-64.
Nicole L. Stout Gergich PT, MPT, CLT-LANA*, * National Naval Medical Center, Breast Care Center, 8901 Wisconsin Avenue, Building 10, 4th Floor West, Bethesda, MD 20814.

I actually spoke to Steven Schonholz and he told me that he thought they no longer made perometers.....

I very much want lymphedema to have a valid, objective, reproducible method of diagnosis, and I firmly believe that early diagnosis is important.

But, I also feel we deserve to know when our personal, private medical histories are being used to market a device that essentially has not been proven to be sensitive or accurate and is expensive ($40 a measurement, currently)

And I resent when a position paper that is co-written by leading researchers in lymphedema is also essentially promoting a device.

If the Avon White Paper had been in a peer reviewed journal, the writers would have had to reveal financial conflicts of interest. As an independent position paper, they didn't, and yet--to my reading--there are conflicts of interest present here.

I really, really resent a website that appears to promote LE information and solidarity and solicits private information from us, and it's really a marketing device.

We deserve better, IMO 

Binney4

Hear, hear!

We're vulnerable, we want to tell our stories, we want the world to know what we're dealing with. But for Impedimed to set out to deceive us with a promotional site designed to look like a patient site and then invite us to share our stories on it is not only unethical, it's an insult to our intelligence.

Here's the Impedimed "contact us" page from their company site -- yesterday I sent them off an objection and a request that they clarify their LymphConnect site as being company-generated. Haven't heard back yet, but I'll let you know if I hear.

If you share this concern, please do let them know about it:

http://www.impedimed.com/about-us/contact-us/

Together we can make a difference! Be well,
Binney

kira66715

The conclusion of the Avon White paper, which was endorsed by the NLN and the Lymphatic Research Foundation is:

10
Routine use of perometry or the validated and more economical alternative of
bioimpedance spectroscopy (BIS) holds great promise as an aid to clinicians in the early
detection of LE and identifying who needs physiotherapy.
Early detection and intervention methods for BC patients at risk for lymphedema should
be developed analogous to the model used in screening mammography. Similar to the
rationale for mammography, a surveillance model of early detection and early
intervention (at early stages) in BCRL can prevent progression. Currently there are no
clinical guidelines for early intervention of LE and these procedures are often not
reimbursed by managed care providers. However, the Avon Foundation for Women
Breast Cancer Crusade and other nonprofit foundations make funds available to hospitals
to enable at-risk BCRL patients to access these new technologies with the anticipation
that managed care providers will soon provide coverage.

Is that marketing? Are the researchers who are accepting funds from impedimed truly impartial?

Unfortunately, the new Stanford LE registry contains identical language.

These are the national LE experts and the national LE advocacy groups.

I sent emails to the authors of the White Paper expressing my concerns about this, and especially the fake patient lymphconnect.com website, and heard from the Lymphatic Research Foundation that they are passing along my concerns.

I don't know why I'm so shocked at this behavior: I've witnessed medical researchers receiving large sums of money from drug companies, while releasing dubious data, it's just that I care so much about LE treatment and research, I can't stand to see it sullied, and to feel misled.

I have a dog in this hunt.

Kira

Binney4

Bumping for Purple. Hope everybody's having a happy Friday (or Saturday, if you're on the other side of the planet from me!)

Binney