dras knowledge

Thursday, September 15, 2005

Pluralism of conventional medicine and alternative medicine

Commenting on the recent published Kaptchuk editorial http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrievedb=pubmeddopt=Abstractlist_uids=15734812query_hl=1

Kaptchuk has a long history of open and sincere efforts to achieve a standard of care in medicine that involves both EBM and treatment that is subjective and essentially unprovable.

According to the summary, "pluralism" versus opposition or integration of CAM recognizes "the value of freedom of choice in medical options" and supposedly sets the stage for the physician and patient to agree to disagree on the importance of a CAM treatment in the plan of care. In adopting pluralism, Kaptchuk doesn't advocate a relativistic stance toward CAM, but insists the practitioner not ignore the fact that their patients will continue to believe what they want to believe about a CAM treatment, regardless of what they are told.

First of all, pleasant or not, someone must be upfront with the patient that he/she may be being hoodwinked into adopting one form of CAM or another. To ignore the huge amount of blatant fraud associated with the marketing and advocacy of CAM is irresponsible practice of medicine. The predators in CAM are expert at playing off the emotions and psychological conditions of desperate and sick people and their families. Even the most pluralistic practitioner must make sure the patient understands the red flags and warning signs of charlatanism.

Second, pleasant or not, someone should help the patient understand the difference between physics and faith, science and pseudoscience, EBM and CAM. It is unethical to infer that that our empiric understanding of physiology and disease and the vitalistic approaches of CAM are each accepted if not equally valid approaches for practicing medicine. In the least, there must be understanding that both are not working off the same principles of action.

The dangerous social consequence of adopting pluralism is the same as for adopting integrative medicine: increased costs for healthcare. As individuals are willing, and as third-party payors are forced to pay for any (even whimsical) understanding and/or treatment of disease, more and more will apply for payment. As the market grows, so will the power to influence it. Worst case scenario: a totalitarian society with citizens solely dependent upon the State for every need, for every human need is ultimately associated with health, and the individual can't be expected to pay for all the (perceived) individual health needs.

dras

Thursday, September 08, 2005

Anitbody screening tests for cancer

"There is now. It's so new your doctor may not know about it yet. It's called the Anti-Malignan [sic] Antibody Screening (AMAS), and it tests for antibodies that indicate the presence of cancer."It appears to be the same as the "Anti-malignin antibody screening" promoted by one "Oncolab" (http://www.amascancertest.com/amas.html)

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There are lots of "screening tests for cancer." This report is deceptive. If anything, this is just one more proprietary mail-order test with, at best, very limited application for a very narrow population.

Two things can be considered when looking for legitimacy of any laboratory screening test.

First, is it a valid test? That is, has it been studied enough to determine the positive and negative predictive values in a target population, and are the risks of getting a false-positive, or false-negative test result minimal enough to generate confidence about the accuracy of the result?

According the website, low false-positive and false-negative rates of 1% on repeat determinations of 24-hour sera "have permitted successful screening in selected high-risk populations." I didn't verify this information in the references or other scientific resources. One thing for sure, "selected high-risk" means the test isn't indicated for large or general populations.

Second, is the test useful for making clinical decisions? "Useful" is a subjective term, and many new and existing cancer screening tests continue to be hotly contested in the medical community over their specific usefulness as determined by a potential cost or risk versus benefit ratio. In many cases, science isn't helpful in making this determination. For example, CEA and many tumor antigen tests can be widely accepted, but, per the science, are not very useful cancer screening tests for the vast majority of the population. Newer (and often proprietary) genetic (DNA) or stool antigen cancer screening tests really can't predict any degree of reduced morbidity associated with the cancer for which it is being used to screen. But, this doesn't mean these tests will never be useful for screening.

Experience has shown that, with a few exceptions, cancer screening tests for general populations are much more likely to lead to unnecessary follow-up procedures, that carry their own risks and costs to perform, than they are in identifying an unexpected, and immediately treatable condition.

dras

Friday, September 02, 2005

How do quack devices get FDA approval?

What is required for FDA approval, and how do quack devices like the sculptone http://www.vactherapy.com/ get it?

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I couldn't find anything on an FDA approval for the device using the search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

The FDA goes through the process of getting a device approval at their "Device Advice" site here: http://www.fda.gov/cdrh/devadvice/3122.html

Here is my basic understanding, that I'm sure may be lacking. FDA "approval" is required if you are marketing a device as something that diagnoses, treats, prevents or mitigates disease. Thus, your electrical units for "muscle conditioning" won't need an FDA approval, but the same device for "treatment of pain" does.

510(k) approvals are easiest to come by. Here, the device is merely riding the coat-tails of a device already having FDA approval, or being marketed since before a certain date. The only proof required is that the function and labeling (how you use it or the way it interacts with body tissue) be essentially the same as the predicate device.

Medical vacuum pumps have been around in medical care for eons, it probably wouldn't be too hard to get a 510(k). In fact, like a hospital bed, perhaps you can get one UL listed, be clever in the wording in your promotions, and suddenly you're selling them to unscrupulous medical practices! But, you are now in a gray area, and the vactherapy site is beyond gray, in my opinion. Also, in my opinion, a clinician is committing fraud by reporting and billing payors for use of this device.

On a huge side-bar, there's an intriguing story playing out concerning equipment for vacuum therapy for wounds. Seems one company developed, researched, submitted to the FDA, and marketed a system for vacuum wound therapy. Ultimately, they got their own AMA CPT codes and CMS RVU's for very lucrative reimbursement of their proprietary device. Now, it seems, some in medicine are figuring out this very expensive treatment is really no more than simple suction on the wound - something that could cost a mere fraction of what the proprietary device is currently getting.

dras