AMcG wrote:Lack of double-blinding and placebo controls is one criticism that cannot be raised in this instance.
Yes it can, since the study was neither double-blinded nor placebo controlled.
AMcG wrote:Both blinding and placebo controls are ways of controlling the effect of the patient and doctors expectations. This effect is always to inflate the results, to make the drug seem more effective than it really is. No patient or doctor ever hopes the patient will get worse.
This is not
correct. Placebo controls, for example, are also used to try to reduce the impact of uncontrolled variables or side-effects between treated and untreated groups. For example, if you're measuring "quality of life", those getting the CRABs may score worse due to the injection reactions, but that doesn't mean their MS is getting worse. Furthermore, your assertions about biased results always being positive is also provably false. Don't forget that the Canadian control group also consisted of patients. Wouldn't their doctors be hoping just as hard for their own patients to get better?
AMcG wrote:If you applied some statistical technique to remove such effects from these results you would make the drugs appear even more ineffective.
There are no valid statistical techniques to reliably remove unknown biases or flaws in experiments. This is why it's so critical for experiments to be done properly if you want to reach a robust scientific conclusion.
Before this publication I would have been willing to believe that there was a real positive effect buried in the results but that it was very small and not noticed by the patients. Which I think is similar to dreddk’s POV.
It is inescapable that all previous smaller scale trials are now in doubt. I might say this is not a new POV. For an unbiased account I would recommend the summary of previous research by the Northern and Yorkshire Regional Drug and Therapeutics Centre here:http://www.nice.org.uk/nicemedia/pdf/Or ... il2000.pdf
Uh, did you actually read this summary? It clearly states in its conclusion:
NHS Health Technology wrote:
- Beta interferons and glatiramer reduce relapse frequency in a dose-related manner compared to placebo, the reduction being approximately 30% with the licensed doses. This effect is seen in relapsing remitting MS and secondary progressive MS.
- Interferon beta -1a and -1b and glatiramer produce modest reductions in progression of disability. The data suggest a dose-response relationship for interferon beta -1b and -1a. Studies in secondary progressive MS indicates that patients with a relapsing pattern of disease and/or EDSS scores ≤ 5.5 are more likely to benefit from treatment.
- Beta interferons produce reductions in MRI measures of burden of disease and disease activity and there is evidence of dose-response. Unpublished data also indicate a beneficial effect for glatiramer, although this may be less marked.
Where that summary is less positive is in the cost effectiveness
of MS treatment. They attempt to quantify how much quality-of-life improvement people get for the money being spent. Basically, it concludes that MS treatments are very expensive for their modest benefits, so maybe it's a better use of NHS money to let MS patients have their relapses and instead treat other illnesses. That's not saying they don't work, just that maybe they aren't worth the cost to the NHS. That's actually a rational argument, though it kind of sucks for pwMS.
AMcG wrote:The implications of this research cannot be overstated.
Sure they can. Here, let me try: this research will revolutionize the finance and hatmaking industries as we know them. Seriously, it can be overstated, and has been several times in this thread. These results are important and need more explanation and analysis, but they aren't proof that all prior studies are flawed.
AMcG wrote:It casts real doubt on the conduct of Drug Companies in reporting previous trials and destroys the basis for prescribing these drugs at all in the UK. And this is not just for one dmd but the four biggest!
Oh, please, it does no such thing. This study has numerous methodological weaknesses, including the fact that it's not
a randomized, double-blind, placebo controlled study, unlike many of the prior studies you believe it refutes. It does raise some interesting questions, and I'll be interested to see how this plays out, but it's not a smoking gun. The big failure here was the prior UK administration agreeing on an expensive gamble with the drug companies (using taxpayer money, I believe), and then the government apparently failing to collect on what was owed them under the terms of their agreement. One take-away is that when you have high-stakes financial negotiations between politicians on their way out, and a private company that's in it for the long haul, you can bet the taxpayers will lose.
And sadly, I think these kinds of shenanigans are bad for CCSVI, since they tend to make both the public and health care providers doubly-suspicious of treatments that lack extensive evidence of effectiveness.