dras knowledge

Thursday, May 27, 2004

Bias in published studies

JAMA. 2004 May 26;291(20):2457-65.
CONCLUSIONS: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols.
Look forward to seeing this reference!!!
EBM and mainstream medicine antagonists will run with this report in order to belittle the credibility of the scientific method. It will be used to support the Death-by-Medicine like conspiracies, and to trump criticism of the positive, and support of the negative alt-med clinical trials. It will be used to favor current society's post-modernistic philosophy that everyone is equally right and wrong. Which is exactly what Alt-Med would have all believe.
Those who support EBM and who actually read the literature and follow the science understand scientific literary bias and apply this fact to the real world. The old med school adage: believe half of what you read (and none of what you hear.) For sure, the scientific community continues to try to get better at policing itself, as evidenced by this article and recent controversies over published trials. But, there are plenty of dollars available and other incentives to present and push the right data, so to speak.
No publication is without bias, either in content or existence. What is important to understand is that you can discover the different types and levels of bias and apply different degrees of credibility. The setting of these levels and degrees is often a matter of opinion (and bias); however, rational thought provides much common ground.
When I was little they said "If you believe you can achieve something, don't listen to anyone who says you can't." Now they say "If you believe something is correct, don't listen to anyone who says that it is not."

How to argue for your favorite Alternative health

Here's some practice arguments for you

It is Science. An argument used by business and manufacturer's, fringe practitioners, and others posing as, or seeking mainstream legitimacy.
"There are over 50 studies supporting ________ , which is more than the ones you say are against it."
"Of course it's based on science, __________ cites over 250 scientific references in his book."
"So what if the studies aren't published in NEJM, they are still scientific studies."
"You read Nature, an article about __________ was in there."
"________ is a Nobel prize laureate."
" __________ takes what is scientifically known and applies it in a revolutionary way."

Science doesn't matter. An argument used by spiritualits and others seeking converts to a product.
"If is works for me, that's all I care about."
"There's more to being healthy than scientific proof."
"Clinical trials won't disprove anything."
"Published health reports are wrought with bias and/or conspiracy and are not trustworthy."

It's a Choice: Uses an often emotional freedom-of-choice to substitute or supercede any other common sense, scientific or moral argument. Also used to discredit mainstream science as simply one alternative belief system.
"For health, you place importance on your Science, I place importance on harmony of the body mind and spirit."
"Do really think everyone should be denied their right to whatever health practice they choose?"
"___________ can be just as valid as any other idea about (health.)"

Wednesday, May 26, 2004

I asked thefollowing questions and the number of students who respondedaffirmatively is noted parenthetically behind the question. There were110 (chiropractic) students between the two classes.1. Do you believe that subluxation is the cause of all disease?(0)(LOTSof laughter from the group)2. Do you believe that subluxation is the cause of most diseases?(0)3. Do you believe that subluxation is the cause of many diseases?(2)4. Do you believe that subluxation is the cause of a few diseases? (10)4a. Do you believe that there is supporting scientific evidence for yoursubluxation causing a few diseases?(2)5. Do you believe that manipulation can cure heart disease?(0)6. Do you believe that manipulation can cure liver disease?(0)7. Do you believe that microorganisms cause human disease(the germtheory of disease)?(109)

My reply:

I submit that the way the survey was worded solicited answers that may have misrepresented to some the actual responder beliefs. Specifically, the use of the terms "all" and "cause" and "cure." I believe that had the words "some" and "contribute" and "treat" been substituted, there may have been very different responses.
For example:
Do you believe that subluxation contributes to most (or all) disease?
Do you believe that there is supporting scientific evidence that subluxation contributes to most diseases?
Do you believe that manipulation can be used to treat heart disease?
Do you believe that manipulation can be used to treat liver disease?
Do you believe that manipulation has a direct impact in allowing the body to recover from disease manifested by the presence of germs?

Friday, May 21, 2004

FTC accusations against Pfizer

What disturbs me within the FTC allegations is the matter of those Physicians receiving "consulting fees," obvious totally recreational travel, and compensation from L-W to "speak on" the off-label indications. Most Physicians are a pretty bright bunch and I doubt that but few understood these as illegal altogether, loopholes in the intent of the law, or at least down-right unethical.

Tuesday, May 18, 2004

Jedi midi-chlorians and "quantam entanglement"

Another early thought on Science and Religion

You know, seems we could all relate to the religion of The Force by George Lucus as portrayed in the original Star Wars episodes. So much so that "Jedi" became an official religion in Australia -albeit haphazardly. Many perhaps became a little disillusioned with the theology when later Star Wars episodes converted faith in The Force to measurable "midi-chlorians." A direct parallel of making true faith equal to true science. The Church can no more convince us that the world is the center of the universe than science can convince us that faith-based religious concepts are right or wrong. It is a sad day, and a relapse to the dark ages when we begin to regard science, religion, and superstition as all the same thing.


Let's just suppose for a moment that "quantum entanglement" reaches the degree of scientific validity and understanding that we can justify it's association to Holistic Health belief or practices. Let's suppose for a moment that our scientific understanding enables us to quantify circumstances that cause identifiable "subluxations" that Chiropractors have preached of all along. Just because science can explain some concepts of a religion, does the religion become science? Do we then accept that Holistic practice and Chiropractic Adjustments likewise are validated by science? A Mormon prophet in the 1800's suggested tobacco, coffee and alcohol were not good for the body. This has turned out to be more correct than the popular belief of the time. Was Joseph Smith truly enlightened, or merely a good guesser? Science does not answer what faith can.

It is one thing to scientifically say that Chiropractic defined subluxations exist, it's quite another to likewise say adjustments correct energy-flow pathways to have a predictable, measurable impact on disease or health. Theories typically evolve and develop through the scientific process before they can be practically applied. I do not doubt that core beliefs of alternative medicine practice in regards to binding energies in the universe, life-force, or other innate energy could find association with what science discovers. Yet, any degree of discovery cannot validate practice without the associated subsequent study through the scientific process.
-dras
P.S. Rumor has it that Yoda always rejected the popular direct causation implied between one's midi-chlorian count and strength in The Force, choosing rather to believe that one's drive, based on heartfelt ideals stemming out of passion and choice, was a better identifier of one who is "strong in The Force."

Friday, May 14, 2004

When is something called a "disease"?

Us skeptics that need a precise clinical definition for CFS should note that it seems even traditionally objectively defined clinical diagnoses are leaning toward more open, arguably less clinically significant, and/or more subjective diagnostic criteria. Diagnostic criteria for obesity and hyptertension have recently been modified in relation to carrying out clinical pathways for treatment. The same goes for hyperglycemia, obstructive sleep apnea, certian mental illnesses, and probably hundreds of others over the past few years. Testament both to the scientific process and the powers driving health care.

As CFS struggles to be legitimate, seems other once formalized conditions are trending toward de-legitimacy by accepting a wider population. We then become skeptical of diagnoses of polycystic ovary, lupus, Raynaud's, lyme disease, etc. Others may not so quickly come to mind.

There is a recent BMJ article that addresses "The making of a disease" that uses an example of how common symptoms are formulated into a syndrome that then qualifies for a specific proprietary treatment. http://bmj.com/cgi/content/full/326/7379/45 Is it not sound marketing practice that if I have a drug with limited FDA approval to treat depression, that I pursue any means to expand my qualifying population base that has "depression?" If I'm not recruiting potential patients by reaching them with direct-to-consumer info about depression, I'm recruiting investors by protraying an epic need for the product.

Another reminder to us clinicians who have the patient's needs truly at heart that money often drives medicine, and to beware the health care fads, perhaps even in the guise of grass-roots efforts to "raise public awareness."

If obesity is a disease, what about sedentarianism and inactivity?

http://www.ajcn.org/cgi/content/full/69/3/373

Anecdotal experience of 3 years in a cardiac cath lab agrees with the study's observations. Many male patients were rather thin and lanky, but with a "cardiac gut" hanging over the belt. Conversely, all of us know "heavy-set" people who are in great cardiovascular shape.

People can get prescriptions and surgeries to loose weight; thus, being overweight is a legitimate medical condition. There is no good medical prescription to substitute for exercise. There's antidepressants to hopefully help us feel like doing it, but that's about it. Sedentarianism and inactivity, although apparently a huge risk to health, and suffered by millions of Americans, has no good commercial medical antidote. Don't bet on seeing it hyped up too much in the future.

-dras
Planning to take the credit (and royalties on sales of prescriptions) for Sedentarianism and Inactivity becoming more of a key diagnostic criterion for diagnosing depression.

Wednesday, May 12, 2004

Stevia - the anti-aspertame

A colleague today asked me about antimicrobial effects of Stevia, a sugar substitute. I'd never heard of Stevia, but apparently, the herbal nutritional supplement world has. Wow, and I thought the Aspartame controversy was wrought with conspiracy!

Anyway, I found about the best information and links at the CSPI website: http://www.cspinet.org/foodsafety/additives_stevia.htm

The only substantiation I found about antimicrobial effects was one rather obscure French laboratory study in 1997. The colleague wanted this information to help decide whether SPLENDA or STEVIA was the right sugar substitute for her. I don't really want to pursue that conversation.

Wednesday, May 05, 2004

Dentritic cells? What?

One Mexican clinic says this ---"The procedure involves drawing from the patient bloodcontaining mature and immature DC's and tumor cells. A bio-chemistinduces the maturation and activation of DC's in the presence ofproteins derived from the patient's tumor."( see http://www.citylightsnews.com/ce/ibc-vaccines-22dec03.htm )Now, knowing how extremely difficult it is to even detect circulatingcancer cells, and the extraordinary sophistication of the techniquesinvolved I am very doubtful that this quack clinic is producing anauthentic vaccine. Normally a biopsy sample of the patient's tumour isneeded.Any thoughts?

My reply:

This article seems to be several months (at least) old:

http://www.skincancer.org/melanoma/dentritic.php
"...Automated leukapheresis and countercurrent centrifugal elutriation can isolate a lymphocyte fraction and a comobined monocyte/iDC fraction, which represents nearly complete capture of these cells from the circulation. Because calcium mobilization induces both monocytes and iDC to acquire activated DC characteristics, the combined monocyte/iDC fraction requires only overnight CI treatment to convert its entire cellular contents to activated DC."


Tumor vaccines were all the rage in research several years ago, some subsequent research (clinical trials) were dissappointing, some remain uncompleted and/or unpublished. Still no vaccine has FDA approval. But there are open clinical trials (phase III) and some very optimistic proponents.

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what the devil is "elutriation"? Is it something like eluting?Can centrifuging a white cell fraction really separate out thelymphocytes from the monocytes? Must be a hell of a fine centrifuge.Biochemists please post

my reply:

My knowledge base here is limited to clinical outcomes of the human studies with tumor vaccines, I had not put much thought into how hard it may be to acquire or otherwise generate enough dendritic cells to even conduct a treatment. A reference in something I had on hand led me here:

Wong EC, Maher VE, Hines K, Lee J, Carter CS, Goletz T, Kopp W, Mackall CL, Berzofsky J, Read EJ. Development of a clinical-scale method for generation of dendritic cells from PBMC for use in cancer immunotherapy. Cytotherapy. 2001;3(1):19-29. MID: 12028840 (available on MEDLINE)

Since this didn't look like the exact same method as outlined in the article, I put my own search terms in MEDLINE using "dendritic" and "immunotherapy." There are well over 60 references to scientific publications just in 2004. (Maybe this is still hotter than I led myself on to think.) On casual perusal, I didn't get the impression that obtaining/generating at least suitable autologous dendritic cells involves any kind of onerous undertaking. It did, however, leave me even more skeptical of whatever real or pretended protocol they could be following at any cross-border cancer clinic.

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Doesn't imiquimod induce a Th1 response at the site of application? Which would raise the question of timing. And the nature of vaccine in general.

My reply:

I am far from an oncology researcher, but since I was familiar with some of the existing clinical outcomes research on tumor vaccines, I new I could quickly find a reputable reference to indicate that preparing dendritic cells for treatment is feasibly done, and could be a part of a cross-border cancer treatment. Skincancer.org is a #1 public info cite for skin cancer.
Anyway, confessing my ignorance, I did just a cordial search and can agree you may be right:

Movassagh M, Spatz A, Davoust J, Lebecque S, Romero P, Pittet M, Rimoldi D, Lienard D, Gugerli O, Ferradini L, Robert C, Avril MF, Zitvogel L, Angevin E. Selective accumulation of mature DC-Lamp+ dendritic cells in tumor sites is associated with efficient T-cell-mediated antitumor response and control of metastatic dissemination in melanoma. Cancer Res. 2004 Mar 15;64(6):2192-8. PMID: 15026362

I read a few more abstracts and found this fascinating. One study came up with a way to generate DC-tumor cell hybrids through electrofusion that may be better at generating a primary T-cell response. Of course, it seems since they use allo dendritic cells rather than auto, they can more easily create a market.

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My specific concern is that I was sure a sample of cancer tissue wasneeded to produce an authentic vaccine. Did you find anything aboutthis in your searches?

my reply:
That's the idea. You have to have a tumor antigen which, in almost all cases tried so far, comes from tumor tissue itself. Then, like a vaccine, you do something to it so it becomes ineffective except in provoking an autoimmune antibody response. Autologous dendritic cells are great because you can pulse them with peptides, RNA or DNA material, or other tumor tissue cell properties to provoke the autoimmune/antibody response rather than using chunks of the inactivated tumor cells themselves.

The impression I got was that using dendritic cells in formulating a tumor vaccine is something rather new and innovative. Research seems much more further along (Phase III, for the most part) using vaccines made from whole (allogeneic) dead or lysed tumor cells. There's at least one study using autologous tumor cells for a vaccine, and one using peptides or proteins from tumor cells.

I'm sure there's better, more accurate information available on-line than what I'm coming up with here. For now, I suggest that the theory is sound for dendritic cell derived tumor vaccines, but since May 2004 published research has barely arrived at a basis for the development of a protocol for application, anything a cross-border clinic has to offer on this would probably appear very dubious. Interferon is available for melanoma now, and there are other pretty predictable treatments, and treatment is NOT something you want to fool around with here.

Monday, May 03, 2004

Health Fraud is different when defined by science or payors

We can get bogged down in political or opinionated arguments about what's right or wrong. One example is the argument for or against a universal health care system. Or, whether or not doctors can bill concierge practice fees to medicare patients. Obviously, discussion into topics that evolve from too a subjective definition of Healthfraud will likely compromise the usefullness of the dialogue.
We agree that the science is the bane of so-called alternative medicine (sCAM.) Science says unsubstantiated treatment is associated with a direct or indirect health risk. Science will suggest we not spend money or resources when a predicted benefit cannot justify the cost. Politicking is sCAM's ally. Convincing the masses that they have a right to society-subsidized unscientific treatment, that government "protection" is wrought with conspiracy, that science should take a backseat to "choice" or that any treatment is equally based on science - any of these will win the day for sCAM.
Likewise, any aspect associated with a cut of the Healthcare dollar will have an ally busily politicking.
Thus, the common ground among the opinions is found in those aspects of healthcare where the biosciences can have influence. The only objective, unbiased approach.

Fraud is not black and white, even when science is the basis. There is an important distinction. Fraudulent billing is by the carrier, the payor. Science defines what is investigational or unnecessary. My idea would be to stick to fraud as defined by the science, because proper payment rules are a matter of opinion, perspective, payor and/or local or national legislation.
Our biggest problems are exactly those you define as cross-overs.