I have been to medical studies in the past..Biokenetics, and I know for a fact they fudge results to favor the drugs they are testing. So I feel these major drug companies that are out there are NOT in it to help others, just in it to make a profit and make ppl addicted to there products, or suffer from side effects to take another product ( more money for them) so ppl put more money into there pockets. Its immoral. In a hundred years there probably wont be enough of us left to buy meds and support the industry. Think about it...EVERYTHING we take has some possiblity of an ever worse side effect. Take something for the runs, you could end up with some syndrome youve never had before. Point?...Human misery and suffering is a business that pays for drug companies and they will say and do what ever it takes, even lie and bribe, at the expense of our lives to make that profit.
'Very Serious' Allegations
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That's an important distinction.
Even that [October] is almost 18 months after the study ended.
It appears that Merck and Schering-Plough not only postponed the release of the data but considered changing the study's endpoints, which could effectively change the study's results. What changes did they make?
We don't know that and that's why we're still asking for more information. When the results weren't what they thought they would be, they asked an internal advisory panel--these so-called "independent" people--to look at it. And they said, here are the results. How do we put lipstick on this pig? [Irvine says the end points did not change and, even if they had, the end results would not have differed.]
Do we have more information on who was on that panel? I understand some of the members were doctors who were on the companies' payroll.
We know the names and our preliminary understanding is that three of five had some sort of financial interest with these companies. Dr. [John J.P.] Kastelein [of the University of the Netherlands], the principal investigator, was not included in the independent panel. If he is their expert, don't you think the person who designed the trial should be involved in any decision to change the endpoints of the trial? … We're still trying to understand what the communications were between the doctor and Merck and Schering-Plough and the doctors on this panel. [Irvine says that Kastelein "chose to decline to participate in that meeting so that his attendance would not bias the results."]
If it's determined that the companies intentionally withheld the unfavorable study results from the public for nearly two years, could that be punishable under current law?
At the time that this particular study was completed in April of 2006, there was no requirement and there would be no punishment for not putting it online. [A law passed last year now requires the registration and publication of such trial results online.] There is a problem with the delay, though, and it can be punished administratively and maybe elsewhere in the FDA rules and regulations.
What role could the FDA have in this?
Well, we don't know if they contacted the FDA. It's not clear what role the FDA had, or if they were even aware of [the trial data].
Do you think that Schering-Plough and Merck intentionally sought to delay the release of this data?
Do I think they knew about it and attempted to put lipstick on the pig, so to speak? Yes. They knew about it. This was their blockbuster drug. Take away $5 billion or more from these companies, and man … These allegations are very serious though. We've been on this since October, and we have enough information to go for a hearing now. But we've asked for more information. [The company has denied intentionally delaying the release because of the unfavorable results. "Obviously a positive result would have been more favorable," says Irvine. "(But) this was a very challenging study, given the high hurdle set by the study."]
Discuss