Why is There Still a Controversy Over Chronic Lyme Disease With So Much Scientific Evidence?

Why is There Still a Controversy Over Chronic Lyme Disease With So Much Scientific Evidence?

I continue to encourage suffering victims of chronic Lyme disease that researchers will vanquish the politically corrupt medical doctors through scientific studies.  Yet as the evidence continues to mount in support of chronic Lyme disease, the following comment was caught in an email by Yale Professor Durland Fish who is an author of the IDSA Lyme Guidelines:

“This battle cannot be won on a scientific front. We need to mount a socio-political offensive; but we are outnumbered and outgunned.  We need reinforcements from outside our field.”

What ever happened to doctors wanting to help patients get better?

 Read the following from Poughkeepsie Journal

Granted, these emails are old, and newer emails would probably be even more alarming when you consider that certain research re chronic Lyme disease has been suppressed and misrepresented for over a decade.

Lorraine Johnson from LymeDisease,org writes in her blog about the disastrous misrepresentation of the Klepner Study, the research used in the creation of the IDSA guidelines.

Ms. Johnson generously allows for human error or incompetence, but I can’t believe that a group of highly intelligent doctors could all make the same mistake when so much has been at stake.

It seems far more likely that the vital information was purposefully misinterpreted to fit the goals and predisposed mind set of the doctors in power.

A sample from referenced post (read entire post here.):

So what was the fatal error in the Klempner study?

Researchers who design clinical trials define when a treatment is considered a success. Does the treatment work or not?  How much does a patient have to improve before you can say the treatment helped? Do they have to return to perfect health?  Clinical trials usually require that patients improve, but not that they return to perfect health.  DeLong found that the Klempner trial set the level for determining treatment success excessively high. For instance, in the seronegative arm of the trial, treatment success required that patients not simply return to the norm for the general population, but instead surpass the norm by essentially one full standard deviation.  That type of success is unheard of in clinical trials.

More specifically, the Klempner study used too high a level to determine success on something called the SF-36 scale. It used a measure that was not clinically meaningful.  Let’s look at this in context.  While other chronic diseases set the bar for improvement on the SF-36 between 2 to 5, the Klempner trial set the bar at roughly 7 and 9 in the seropositive arm and between 9 and 13 in the seronegative arm. This amount of improvement is far higher than the amount of improvement that could reasonably be expected among the chronically ill.

If the Klempner trial had used a clinically meaningful measure of success, say between 2 and 5, it would have had to have used much, much larger sample sizes, which it did not have.  For instance setting the clinically meaningful measure of success at 2 would have required a sample of 400 or more per treatment arm. The sample sizes in Klempner were only 78 (seropositive) and 51 (seronegative)—a sample size which would not yield statistically significant results. When researchers select an excessively large treatment effect required for success, as was done here, the size of the sample required is reduced.  The trade-off, however, is that the results are not clinically meaningful.

Many researchers say that small sample size trials are unethical because they can literally steer scientists down the wrong path.  That’s what the Klempner study did.  It was a waste of money, a waste of time, and it has led research down the wrong path for the last 10 years.

Was it a matter of researcher incompetence?  DeLong and colleagues point out that studies on the level of improvement that is clinically meaningful for other chronic diseases had not been done at the time the Klempner trial was conducted. So the Klempner researchers did not know that they were using an excessively large treatment effect at the time they conducted the study.  Does that take the researchers off the hook?  Not really.  First of all, once the studies on the way to measure success in chronic disease had been conducted, the Klempner team could have acknowledged a possible error.

Second, the Klempner team could have avoided “overstating” its findings and highlighted the potential for error.  The ethical implications of exaggeration in science are understood by other scientific societies.  For example, the code of conduct for the American Chemical Society states: “Public comments on scientific matters should be made with care and accuracy, without unsubstantiated, exaggerated, or premature statements.”

Instead, the Klempner study concluded flatly that retreatment was ineffective.

Continue to read post here.

I am almost finished with my new ebook “Proof of Chronic Lyme Disease”.   If you are interested in reading for free, please email me at jenna@LymeDiseaseResource.com.  I will be giving out free copies in exchange for reviews on Kindle for the first few months.

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