An interesting commentary FYI:
By: tdiamonds
15 Jan 2007, 04:28 PM EST
Msg. 363251 of 363254
(This msg. is a reply to 362821 by samlion.)
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Dnag’s PR numbers and Myopathy . . .
First, I found the following information on myopathy and ZOCOR:
“In HPS involving 20,536 patients treated with ZOCOR 40 mg/day (n=10,269) or placebo (n=10,267), the safety profiles were comparable between patients treated with ZOCOR and patients treated with placebo over the mean 5 years of the study. In this large trial, only serious adverse events and discontinuations due to any adverse events were recorded. Discontinuation rates due to adverse experiences were comparable (4.8% in patients treated with ZOCOR compared with 5.1% in patients treated with placebo). The incidence of myopathy/rhabdomyolysis was less than 0.1% in patients treated with ZOCOR.”
That’s right, out of 10,269 patients treated with ZOCOR ten people might feel some weakness and/or pain and have to discontinue taking the drug as a result.
Second, according to DNAG’s PR, they have finally validated a marker:
“DNAPrint's study of 750 patients who had taken either atorvastatin (Lipitor®) or simvastatin (Zocor®) showed that patients carrying one specific genetic marker were approximately 2.5 times more likely to experience mild to severe muscle pain (myalgia).”
So, to use easier numbers, let’s say there were 7 people of the 10,269 patients taking ZOCOR who discontinued taking the drug due to myopathy/rhabdomyolysis. According to DNAG’s PR (if they are making the correct comparison – which is always doubtful with a company that names an eyecolor classifier after the retina instead of the iris), of those 7 people, 5 would have the marker and 2 would not have the marker.
Unfortunately, according to DNAG’s PR the incidence of the marker in the general population is about 20%. If the marker is not correlated with high cholesterol, then it would appear that 2,053 people treated with ZOCOR in the above-mentioned study will carry the marker. If the marker is correlated with cholesterol, that number could rise significantly. Even at 20%, is it not the case that only 5 patients out of 2,053 that carry the marker actually report “mild to severe muscle pain?”
Would you pay for that kind of information?
It also seems that most or many patients who complain of myalgia resolve the problem when taken off the medication.
Now, let’s look at the so-called science itself:
It is important to keep in mind the fact that reporting symptoms is a very subjective phenomenon (the side effect may or may not exist even in those who report it). That is one reason why the placebo group often reports side effects at the same rate or greater than the drug group in these controlled studies. Another reason is that there is simply a base rate of incidence for any given side effect. For example, with or without ZOCOR, many people experience headaches. That is why controlled studies report statistically significant differences between the drug group and the placebo group, as opposed to the difference between drug group incidence and no incidence.
Further, these are correlation studies and as such offer little/no evidence of cause and effect relationships. For example, on average, who do you think would be more willing to report muscle pain or weakness – Men or Women? I think men would be more likely to complain, but you might think just the opposite or that there is no difference. The point is that if there is a difference between gender rates for reporting myopathy, the marker could simply be associated with gender. That is, of the very small percentage of patients reporting myopathy, men might be 2.5 times more likely to do so and the marker is simply associated with being male. On the other hand, some ethnicities might be more stoic or more open to complaining and that, too, might be mediated by gender differences. For example, Hispanic women might be more prone to complaints than Hispanic men or vice versa.
Additionally, the marker may simply be associated with people who have a tendency towards hypochondria. When told they might experience muscle pain or weakness, these people may have a tendency to exaggerate the severity of any of the minor aches and pains for which millions of people take an occasional aspirin or other OTC analgesic.
Of equal significance, (the examples are almost infinite) it could be that the samples used to find and validate the marker were composed of similar numbers of patients who also had diabetes. Rhabdomyolysis, for example, is associated with statin taking patients who are co-morbid for diabetes (a known risk factor). If the marker is also associated with diabetes, it adds nothing to the predictive model and is virtually worthless, though equally predictive – the problem being patients already know they have diabetes.
The point here is that when the company claims they have “validated” their findings, they are simply claiming they have “validated” their findings with respect to frequency of occurrence in two samples (I think) – certainly not that they have validated any cause effect relationship or that they have any “validated” insight into any causal factors. Importantly, if the samples are identical in make-up, then there is little reason to generalize beyond the samples themselves.
To be fair, the predictive relationship is important at some level. That is, it does not necessarily matter that there is no cause effect relationship, if one variable predicts another variable. On the other hand, having a marker that is really only associated with being a Hispanic female, elderly Caucasian male, or diabetic of any gender/ethnicity (though predictive) is still probably not worth much in the grand scheme of things.
So, what have we got?
1. a side effect with very low incidence (maybe 7 to 10 out of 10,000)?
2. a side effect that appears to be transient in most cases, when treatment is stopped.
3. a marker that is carried by 20% of the general population (or 2,000 out of 10,000).
4. a marker that suggests for every 7 patients out of 10,000 who complain of “mild to severe” myalgia, 5 will have the maker and 2 will not have the marker.
5. evidence from correlation that may have absolutely nothing to do with myopathy.
6. self reported symptoms that may or may not be real.
Of course, we need to see the actual paper; however, it would appear the company has precious little worth paying for with this marker, which of course begs the question:
Why would the company put out a PR heralding a finding that may be next to worthless in the marketplace?
We all know the company has been in the business of “printing shares” for the past three years and the resultant MASSIVE DILUTION has virtually destroyed the value of the investments of early-stage buy-and-hold shareholders. To continue to make their shares look valuable to naïve investors, it would seem reasonable to expect just such a PR from a company that is constantly engaged in the process of diluting every shareholder’s percent of ownership in the company. When a company destroys virtually the entire value of the investments of their shareholder base, it seems only reasonable that they go after unsuspecting investors to get them to invest in the same losing proposition – PR’s seem to be the preferred method of most PUMP and DUMPs, along with paid-for analyst reports.
Is this a PUMP and DUMP?
You be the judge!
As always, I am not a lawyer, accountant, stock broker or (doctor or analyst), so please do your own DD and invest your family's money responsibly. PLEASE consult a professional before buying or continuing to hold any risky investment.
My opinions are just that. Even though I put a lot of thought into them, you should always consult a professional before making any investment decision. That is especially true of the high risk OTCBB market (IMO).
The truth is out there,
td
AI
