Unholy alliance? Impedimed and Stanford?

kira66715 · February 2012

I registered for the Stanford LE registry and got an email from the nurse that they want my medical records released. I didn't read the privacy information all that carefully, and then this pops up on my google alert: from Proactive Australian Investor and as impedimed is using the data, I'm not sure I want to share it:

http://www.proactiveinvestors.com.au/companies/news/25084/impedimed-l-dex-u400-device-receives-expanded-us-coverage--25084.html

ImpediMed L-Dex® U400 device receives expanded U.S. coverage
Thursday, February 09, 2012 by Angela Kean
ImpediMed's (ASX: IPD) L-Dex® U400 device will receive greater coverage in the U.S. as an aid in the clinical assessment of unilateral lymphoedema of the arm in females, following the passing of the Patient Protection and Affordable Care Act.

As a result of the passing of the Act, which makes certain indigenous tribes and organisations eligible to access the health plans for federal employees, ImpediMed expects an increase in covered lives for federal healthcare plans from 1 May 2012.

The estimated number of employees of indigenous tribes or organisations who are eligible to access federal health plans is about 350,000.

Direct family members of these employees are also eligible and include spouse and children up to the age of 26.

As a result, coverage under federal plans could be expected to increase by an estimated 700,000 covered lives.

Lymphoedema occurs when the lymphatic system does not work properly, resulting in the long-term swelling of parts of the body.

Stanford Breast Cancer Lymphedema Registry

Meanwhile, the first patient has been enrolled into the Stanford Breast Cancer Lymphedema Registry.

Stanford University Medical Center initiated the registry which will collect and analyse data from breast centres and physicians' offices across the U.S.

The registry collects clearly defined health and demographic information on patients with specific health characteristics, in this case, breast cancer.

The Stanford Breast Cancer Lymphedema Registry has been designed to investigate the impact of lymphoedema surveillance upon breast cancer survivors.

Within a year, researchers expect to have gained further substantial insights into the value of systematic early surveillance to prevent and minimise the lymphoedema risk in women treated for breast cancer.

Patient enrolment will increase in the coming months as the registry is rolled out to physician sites.

Data generated from ImpediMed's L-Dex® U400 device will make-up one arm of the registry.

The L-Dex® U400 device is the first medical device with a US Food and Drug Administration clearance to aid health care professionals, clinically assess secondary unilateral lymphoedema of the arm and leg in women and the leg in men.
Register here to be notified of future ImpediMed articles.

On further thought, I don't want my personal medical information to used as a marketing tool.

Kira

Binney4 · February 2012

Hmmm, sure looks like Impedimed intends to use our medical information to market their device. We need some real clarity on how this information is going to be used.

"Data generated from ImpediMed's L-Dex® U400 device will make-up one arm of the registry."

We need to know what the other "arms" of this registry involve. What exactly is Stanford examining? And how will the data be used? They've need to give us some answers here, and those registering need to understand what information Impedimed will have about us, and how they'll use it. We sure don't need to be party to them selling expensive devices with limited usefulness to our doctors and cancer centers based on our participation.

Grrrrrr! Yell
Binney

kira66715 · February 2012

I went back and read the study page, the registry page, and impedimed is never mentioned. And, I took the survey and found it virtually useless.

I am so sick of impedimed's influence on the LE researchers:

1) The Avon White Paper was a plea to get insurance coverage for their device and implied a cure for LE if caught early--they used major researchers to give this an appearance of a important concensus document. And got sponsorship from the LE foundations

2) Their fake patient website: they got caught in fraud and a lie--and posted private patient histories on facebook, pretending to be a patient community, while they were marketing their device

3) The Stanford Registry is sponsored by impedimed, yet this is not made clear, and their ability to access patient records is unclear as well.

I've asked all the LANA board if they find bioimpedance helpful--and they find it minimally useful, but it is relatively insensitve, needs proper use--prone patient, empty bladder, no caffeine or alcohol--and it is serial measurements that are helpful--if they are helpful--not one. And if there is fibrosis, the machine is not useful--admitted to Binney by the company, but their website says it can be used in all stages of LE.

We want objective measurements and early detection, but we/I don't want lies and deception and mining of my data to sell a device that may or may not be of any use in early detection, and could easily be misused--we had a woman with a visibly swollen arm be told she didn't have LE based on a single reading....

This is typical medical/pharma behavior, it just hasn't shown up in the LE world before. Because LE wasn't a money maker for anyone before.

Kira

carol57 · February 2012

Dr. Rockson seems like he's pretty dedicated to LE research. Is there a way to approach him about these issues and ask him to clarify the registry's relationship with Impedimed, and to ask him if he did any of his own review of Impedimed's effectiveness as a diagnostic device?

Carol

kira66715 · February 2012

Carol, I've emailed him, spoken to him, expressed my concerns as clearly as I can. His comment re: L-dex is that he "finds it useful in research" and he also told me that the two company executives--one is wildly wealthy and the other is more accessible, "really care about lymphedema".

Sorry, bs.

They care about profits.

They've been deceptive from the start--but not unusual for how pharma works, but don't being lied to repetatively makes me skeptical about the device--it's own site says it is not intended for diagnosis or prediction of LE (so what exactly is its utility here?) and why are they charging $40 for each set of electrodes, and I've checked insurance benefit guidelines and it's widely NOT covered as experimental.

When they created lymphconnnect and marketed it as a community of patients, that is really bottom feeding behavior. And many women were fooled and put their private information on line and on facebook--thinking they were joing a community of patients. But--on facebook--most people use their real names and their information is far from private.

Stanford is not creating a national registry of lymphedema--they don't want women with LE to sign up, they want women without LE, and then to get evidence that bioimpedance made a difference in their course.

I don't like being lied to, again and again.

Kira

Layla2525 · February 2012

Its like you said Kira..we just keep getting lied to by these corporations. they are steam rolling over the people...They are genetically modifying our food,tricking us into signing away our private information for their gain...(see Komen Pink Wash on vimeo.com) The state supreme court of Florida ruled that there is no state law which prevents corporations like Monsanto from lying and saying the stuff they put into the food doesnt cause cancer so the news story was deleted and the reporters were fired. I had to sign a stack of papers giving my employer rights to inspect my medical records in order to get 3 wks off to get surg on the 02/13/12. Is it their business? All they should need is a dr note saying shes got cancer and getting surg and needs to recover. But no! They get to know what implants I get and if I got an infection etc...Now the corp wanna use you and your illness to market their stuff and you dont even know for sure if their "stuff" is helpful or harmful. Where are our rights?

kira66715 · February 2012

I went and re-read the consent form and it's very vague and I can rescind it at any point--but only in writing to Stanley Rockson himself.

I feel so misled. And my privacy has been violated, and to have to write directly to Rockson to get released from his registry????? And yet I could opt in by internet.

I just heard from a great LE therapist and head of a LE school, and she saw a patient with symptoms and swelling in her hand, and bioimpedance score was normal--and she treated her, and she got reductiions in swelling up to her armpit! She uses the scores only in the context of a full evaluation.

Yet, the medical director of impedimed--Steven Schonholz, co-author of the Avon White paper, and breast surgeon--has his medical assistants take the measurements while he's doing something else and that's all he uses to assess a patient for lymphedema. How to misuse technology and deny your patients' reality and deliver substandard care. But, he stands to make a lot of money if biompedance screening is adopted at all post op visits as the standard....

Kira

lionessdoe · February 2012

Doctors Admit they Lie:

By Deborah Kotz, Globe Staff

Most physicians paint overly optimistic prognoses for their patients, and many have told lies or withheld information concerning their medical mistakes and financial relationships with drug companies and device manufacturers, according to a national survey conducted by Massachusetts General Hospital researchers.

The 2009 survey of nearly 1,900 doctors, published today in the journal Health Affairs, shows that many doctors don't adhere to the standards of medical societies and accreditation groups, which have long required doctors to be open and honest with their patients.

"There's an expectation that our doctors will be truthful, and most are but some are not," said study co-author Eric Campbell, director of research at the hospital's Mongan Institute for Health Policy. The researchers didn't determine whether any patients were harmed because of a physician's dishonesty.

The survey found that nearly one-fifth of doctors said they hadn't fully disclosed their mistakes over the past year in order to avoid a lawsuit.

"I was disappointed to see so many doctors not disclosing errors," said Arthur Caplan, a bioethicist at the University of Pennsylvania who wasn't involved in the study. "They may dodge a bullet, but if it's found out later, they can really get clobbered for not telling the truth -- to say nothing of the patient consequences."

In addition, nearly 40 percent of physicians said they didn't think it was necessary to tell patients if they had accepted speaking fees or a free vacation from the manufacturer of the drug they were prescribing or whether they owned the scanner for the imaging test they were ordering.

"If a reasonable person might think a financial relationship might affect what drug, procedure, or test they were prescribed, it's better to disclose," said Caplan. "A lot of time patients will say they don't care about the conflict," but they should be given the chance to ask further questions.

Efforts are underway to make potential financial conflicts more transparent: Partners HealthCare, the parent company of Brigham and Women's Hospital and Mass. General, may soon start requiring doctors to disclose to patients any substantial monetary ties they have to medical companies. And a new federal law requires pharmaceutical and medical device companies to publicly report any physician payments or gifts worth more than $10. Everything from stock options, meals, and consulting fees will pop up on a searchable physician database slated to appear online in September of next year.

For now, patients facing a choice between multiple procedures or medications might want to ask doctors about any financial interests that could bias them in favor of one treatment over another, said Dr. Michael Barry, president of the Foundation for Informed Medical Decision Making, a Boston-based patient advocacy group.

Barry added that he was "gratified" to see that nearly 90 percent of doctors reported that patients should be fully informed about the benefits and risks of a procedure or drug. He did, though, wonder whether they actually practiced what they preached. "It contrasts with what we found from patients who tell us their doctors tend to present more benefits than risks when it comes to treatments," he said.

While the survey was anonymous, doctors may have veered a bit toward reporting behaviors that they deemed to be acceptable to their colleagues rather than what they truthfully did in practice, said Campbell. "Only 11 percent of physicians reported saying something untrue to patients over the past year," he said, "which I suspect is much higher." The doctors were not asked what they lied about.

Some of the communication lapses reported in the survey may simply be signs that doctors are human. Nearly 45 percent of doctors said they've given patients prognoses that are rosier than reality in the past year, which Caplan said reveals their compassionate side. "It's a human impulse to fine tune how you present bad news or a grim prognosis," he said. "It's important to get to the truth, but it's a process to tell someone they will be dead in six months."

That's something doctors are loathe to do, especially when they have a strong relationship with a patient. A study published this week in the Annals of Internal Medicine found that most patients with incurable lung or colon cancer don't discuss their end-of-life care options with their doctors until a few weeks before they die. More than three-quarters had these discussions with physicians they didn't know during an emergency hospital visit, rather than with their regular oncologist.

"I understand why this happens. I have this instinct, too, to not want to cause harm and pain to people by bringing up topics" such as death and how it should be managed, said study author Dr. Jennifer Mack, a pediatric oncologist at Dana-Farber Cancer Institute. "But I also feel obligated to do it." And patients may be grateful for doctors who convey that last bit of hope.

While medical association guidelines recommend that doctors discuss end of life care with all cancer patients who have a life expectancy of less than one year, the timing of those discussions are left to the doctor and patient. "We're still learning about the right time to have these conversations," said Mack. "What's right for one family may not be right for another, and I ask what's important for you to know right now? Would it be helpful to talk about your prognosis?"

Anonymous · February 2012

Dammit, data correction again? Time to fix the dough-nuts!! Seriously this is not a proper way to conduct a study. Patients should not be duped into giving out personal info without knowing what they are agreeing to.

It angers/worries me this device could be identified as the "one way" to measure LE. Cornering the market and selling to providers, Impedimed could make a ton of money and insurance companies would use to "legitimately" limit payments for LE therapy and garments.

After just winning a second-level appeal for medical necessity for a Solaris compression vest where the insurance co needed to be educated on truncal LE and was asking for clinical studies and peer-reviewed articles for the garment, I find this frightening. We need research, but not faulty research that will make it even harder to have our LE validated and treated.

kira66715 · February 2012

And I got three adamant emails from Stanford that their research is ethical and impedimed will not see patient data.

Really, then why did they put out the press release implying that they're involved with this registry?

No medical test is 100% sensitive and 100% specific--so why are they marketing biompedance, which isn't even approved to diagnose LE, as a possible cure for LE--because it will diagnose it (but it's not approved for that purpose) at such an early stage.

And, I am so uncomfortable having my personal records released anywhere, I just withdrew from it.

I've seen the article that Doe posted, and it's just so true.

It's not hard for impedimed do a study at one breast cancer where they have access to patient information and use perometry and well trained therapists and look at long term outcomes. Just do it.

I've been in three clinical trials for bc so far: I gave NYU a saliva sample to look for genes other than BRCA, I filled out an on line survey for UCLA on my experience with tamoxifen, I even wore a pedometer for U of Illinois for two weeks--and NO ONE asked for my patient records.

I'll look at the literature--but I'm avoiding Stanford.

Impedimed already fooled women into sharing their personal stories on Facebook, they have no concept of patient privacy.

Kira

carol57 · February 2012

Kira, in addition to having no concept of patient privacy, it seems they have no concept of ethics. Thanks for bringing the whole debacle of Impedimed to our attention, and for staying on top of its spider web of extended miss-truths and misrepresentations.

Carol

kira66715 · February 2012

So, I've been searching for instructions on the proper use of the L-dex, as it requires a lengthy period of rest, an empty bladder, no caffeine or alcohol--but that's never mentioned on the site, and I found Blue Cross of Delaware's reasons for not covering it:

As a diagnostic test, the technology must demonstrate accurate and reliable technical performance, diagnostic performance (sensitivity, specificity, and positive and negative predictive values) and clinical utility, defined as demonstration that use of the technology can improve patient outcomes. The evidence published in the peer-reviewed literature to date consists mainly of studies evaluating the technical and diagnostic performance of bioimpedance measurement devices as compared with other established methods of assessment for lymphedema. The oldest study by Cornish et al (2001) enrolled 102 women, and measured bioimpedance and circumferential measurements at 2-month intervals for 24 months. The authors reported that bioimpedance detected 22 patients with lymphedema, 20 of which were confirmed. In contrast, only one case of lymphedema was detected using circumferential measurement. The authors reported 100% sensitivity and 98% specificity for bioimpedance in this study. Box and colleagues (2002) compared bioimpedance with water displacement and circumferential measurement in 65 women, with assessments performed preoperatively and at 1, 3, 6, 12 and 24 months postoperatively. Lymphedema was confirmed in 12 of 57 women at 24 months, all of them correctly identified by water displacement. Bioimpedance detected only 8 cases, and circumferential measurement 7. The authors did not state whether these numbers were significant, possibly because of the lack of statistical reliability due to the small size of the study. The largest comparative study (n=287) was that of Hayes et al (2008). This comparative study among bioimpedance, circumferential measurement and patient self-assessment compiled measurements at 3 month intervals for one year, beginning six months after surgery. Circumferential measurements showed 42% sensitivity and 88% specificity. For self-assessment, sensitivity and specificity were 61% and 59% respectively. Bioimpedance in this study was assumed to be the most accurate method yet there was no evaluation of false negative or false positive results that were correctly addressed by the other techniques. Ward and colleagues (2009) compared bioimpedance with perometry in a study group of 45 women who were known to have lymphedema following breast surgery. Although there was correlation between bioimpedance and perometry results, bioimpedance gave false negative readings in 27%. When this figure was tested in a group of healthy women (n=21) who had had no surgery, similar results were reported. No studies were found that focused on the clinical utility of bioimpedance. The evidence therefore does not permit conclusions as to whether bioimpedance assessment of lymphedema improves health outcomes.

3. The technology must improve the net health outcome:

Results of the available studies do not provide clear evidence that bioimpedance improves net health outcomes. Possible harms could possibly result from the false negative readings, leading to failure to intervene against developing lymphedema, so further studies are needed to determine whether bioimpedance is a reliable assessment tool. Promoters of bioimpedance maintain that it is able to detect lymphedema earlier, leading to improved outcomes through earlier intervention, but studies could not be found to confirm this assumption.

http://www.bcbsde.com/ProviderPolicies/public_site/2.01.62_Bioimpedance_for_Assessment_of_Lymphedema.htm

carol57 · February 2012

That Blue Cross explanation is certainly clear and well documented. Sensitivity = picks up a measured volume; specificity = correctly assigns the cause to LE? I'm not sure I understand the terms here.

Unholy alliance? Impedimed and Stanford?

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