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    Can you trust statin drug studies?
    bobby75703 posted:
    Can you trust statin drug studies? A physician gives his opinion about scientific misconduct in medicine.
    iride6606 responded:
    Another doctor's opinion, gotcha. Maybe I'm a little slow on the uptake tonight but let me make sure I have this straight.

    A doctor who is trained, licensed and practicing in Iceland has a blog where he mentions a doctor trained, licensed and practicing in Japan who may have been involved in data manipulation on a trial concerning a hypertension drug. Is that really the point here? From that I'm not supposed to lose trust statin trials here, is that correct?

    The DO which is the regulatory agency in Japan is much like ours and the manipulation was caught, again the system worked. I don't see the problem and certainly don't see why this should cause anyone to doubt statin studies here.

    In reading the Iceland Doc's blog even he states this could be the tip of the iceberg or just a rare event. Why would that be convincing?

    I think it would be a better discussion if you would explain the mevalonate pathway you keep mentioning, what it is and how it works. Again, in your words, no links or cut and paste so we can understand it.
    LorettaLime replied to iride6606's response:
    You are very wrong if you think this is just about a doctor trained, licensed and practicing in Japan. The papers were published in international journals and the study results (Kyoto Heart Study) might have affected our understanding (I mean all over the world) on how certain drugs work among people with high blood pressure. An Icelandic cardiologist has every right to be concerned, and so has anyone interested in modern day healthcare.
    Of course this does not tell us anything about the statin trials, but you can?t help wondering how big the problem really is.
    iride6606 replied to LorettaLime's response:
    I'm sorry, you missed my point. First off, I am every aware of the consequences of falsifying data as I am a research analyst and contribute on papers such as this in the capacity of a statistician.

    My issue is simple, this is a cholesterol forum. Who knows how many thousands of people taking statins come here and they see the title of this thread. Only if they read the link will they see what this is really about, a doctor in Iceland is calling out a doctor In Japan about data on a small post market trial concerning a hypertension drug. It has absolutely nothing to do with statin trials, but it's a headline that some one read and had a "ah-ha" moment and tried to link it to statin trials. What do we get next? Another "drug company may have done bad" thread.

    Wouldn't it be nice to talk about cholesterol here? This is such a great site with great people. I visit a different cholesterol community and these kind of threads never come up, we talk cholesterol. Maybe these topics should be addressed in a discussion group instead of on a forum like this. WebMD makes those available as well.

    Make no mistake, what this doctor did is very, very wrong but to make the implication that it taints all statin trials is a reach at best. There are 8 million doctors out there, this guy is one. The number of corrupt doctors may be large and still be statistically insignificant. You can't throw the baby out with the bathwater.

    Someone here is on record saying;

    "I never have, nor will I ever accept drug company funded studies. They simply have to much financial interest in the outcome for me to accept it as valid medical science."

    Even after that statement, they will look at a study such as JUPITER and cherry pick a piece of data that supports their position, such as NNT. They point out that JUPITER showed an NNT of 1 which everyone acknowledges is incorrect due to early termination, but even though this individual does not trust any trial, they will still accept pieces of it that suits them. Ironically we then had a thread about how terrible cherry picking results is by the same person. I just want to discuss cholesterol.

    I read a post about the mevalonate pathway and how it is affected by statins, let's talk about that and stop with the studies & drug company talk. I am interested in that but can't get the poster to explain it to me. That would be a discussion to have here that would benefit many.

    Anyways, that was my meaning.
    iride6606 replied to iride6606's response:
    Sorry, that was an NNT of 100, my fingers got ahead of me:)
    bobby75703 responded:
    The integrity of drug companies that fund and conduct research on cholesterol lowering drugs is of vital relevance.

    Even if the misconduct was discovered on another type of drug, these are the same companies millions of people trust to their healthcare.

    Cholesterol lowering statins are the biggest selling drugs of all time, and they come from the same companies who have been charged with unethical practices.

    Heck yes the integrity of these companies matters to those who take statins.
    iride6606 replied to bobby75703's response:
    No Bobby, it's not important. First, this is nothing more than another red herring, a headline that someone read that caused an "ah-ha" moment. This is an absolute outlier, is statistically insignificant and should in no way be used to try to sway people to the thinking that the trials and studies that were done on the meds they have been prescribed are bad. That line of thinking is such a huge stretch and this is only being posted because it's an opportunity to bash the drug companies. It is meaningless but hey, if it casts the shadow of a doubt to the person using statins that's all that matters. Your next thread about China is the same thing, another red herring and "ah-ha" moment. The article is about the possibility that Chinese law may have been broken, may not they have not finished investigating. Even if it's found to be true, it does not prove that anyone did anything unethical in prescribing a drug.
    Also, the system in Japan worked, the possibly manipulated data was discovered and the papers were retracted. Where's the problem? You ask for accountability but when presented with an agency providing accountability it's still a problem.
    I expect that there was a headline out there at some point about the mevalonate pathway that caused an "ah-ha" moment as well as I still can't get an explanation. I guess we didn't get past the "ah-ha" moment and actually dig into the process. In any case, a headline is a headline and must be used to its full extent.
    You've heard the saying about researchers and doctors, if all you look for are zebras, you'll find zebras every time. This is no different, if all you look for are red herrings, you'll find red herrings every time. This thinking is no different.
    bobby75703 replied to iride6606's response:
    I respectfully disagree. I believe integrity in the pharmaceutical industry is vital to patient safety.
    iride6606 replied to bobby75703's response:
    And nothing about this article says it is flawed as an industry in entirety. Did you do anything other than read this article? Do you know what data was manipulated? Are you aware that this drug had already been through it's trial and was approved and on the market and this doctor was not involved? This was a small post market study (not a trial) used to follow up on the initial results. The irregularity was caught, the drug company was found not to be involved and the doctor and his two personal statisticians were dismissed. How much better could the safety features work? Yet still you want to use this as an indictment on the entire industry.

    Your intent was to cast a doubt on statins by throwing an unrelated article out there and giving it a statin slanted title, we have all seen it time after time. That's fine, some won't look further, some will and see through the red herrings.

    I guess we're not going to get to hear about the mevalonate pathway either.
    bobby75703 replied to iride6606's response:
    I never made the claim the industry was flawed in its entirety.

    But in the wake of big busts by the Justice Department there are major problems that need to be addressed and major changes are needed.

    One beneficial thing about the happen is the sunshine act with physicians reporting gifts over $10 from Pharma.

    These new laws are the result of past problems. They wouldn't have been written if it was a minor isolated problem. These laws were written because it was a huge problem.

    We still don't know what all the unreported trial data says from the last two decades. I think both physicians and patients have a right to that data. All of it. Not just part of it.

    Too many skeletons have been falling from big pharma's closets. So many you have to wear a helmet every time you open the medicine closet.

    It causes public distrust. But I think over the course of time there will be industry improvements as time changes things for the better. Its just going to take time.
    iride6606 replied to bobby75703's response:
    Can't believe you're satisfied with the Sunshine Act, LOL. Have you read it? Yes, providers are required to report gifts or transferred value of $10 or more, but you know what does not have to be reported? Discounts and rebates, exactly what you complain about i.e. kickbacks. This is what those that oppose the Sunshine Act have been fighting since it's introduction. Again, look past the talking points.

    What causes distrust with the public is threads and statements like these, half truths and glorified headlines, innuendo and conjecture, saying anything to get a rise out of the public.

    Someone here has said many times that degrees have no value, this thread is a perfect example why it matters. I have a BS, Masters and PhD and this person has told me it means nothing. Let me tell you why it matters. Continued education is more than learning facts. Anyone can get on the Internet and get facts. The difference is educations teaches us how to learn, how to question and how to breakdown any issue to it's root cause. Where some people read a headline and go "ah-ha" I see a problem, I see another question that needs to be asked. You learn not to over react to glorified titles and headlines and to look beyond. It teaches us how to see a red herring and look past it like the one in your post concerning unreleased data. What, where and how, please show me. Does unreleased data include data on the mevalonate pathway?

    You made my evening...................... The Sunshine Act
    bobby75703 replied to iride6606's response:
    I never said I was satisfied with the sunshine act. But I think its step in the right direction despite the holes in it.

    Higher education is good, but academic achievement and integrity are two different things. We have plenty of educated people in the world. But we have a severe shortage of people with high ethical standards. Most give in to greed. That's the real world.

    Most people can be bought.
    iride6606 replied to bobby75703's response:
    Wait, you brought up the positive changes that resulted in the Sunshine Act not me. Maybe I just assumed that you understand how drugs get from drug company to patient, but perhaps not so let me explain. The drug company sells the drugs to a large traditional 3 step distribution system. So a distributor like Cardinal Health or AmeriSource buys the drugs and sells them to a drug store chain like CVS. CVS sells to a patient via a doctor. The drug company can legally give a discount or rebate to the distributor who uses the funds to attract drug store chains and ultimately customers. How do you do that? You flow the money back from drug company to distributor to drug store to doctor in the form of a rebate. That is the major loophole in the Sunshine Act that has made it unacceptable for those that demand that rebates are reported. Now not all of us think this is a common practice, but if you're going to get corruption, that's where it will come from. So yes Bobby, you are correct, the pens and note pads are reported, but the avenue to flow real money is still wide open, it's the basic issue of discussion with those of us who have looked at the Sunshine Act, again reading beyond the talking points but rest assured, every pen with Lipitor on it is being reported. It doesn't sound like you've had a chance to read it fully before commenting, you should it is very interesting and really does not speak to your point. We're you aware of the exclusions before you posted?

    I never have and never will buy into the flawed vision of human nature you have so no I don't think most people can be bought. And remember, there are far more people without higher degrees and I'm pretty sure there is less dishonesty among the highly educated than those without higher degrees. We worked for many years and a whole bunch of money to get what we have and you will find very few willing to risk it all, that's the reality. Those with less to lose have a higher propensity to mislead or be less honest. For all I know you've got degrees coming out of your ears and your just disenchanted with the education system.

    Again, thanks for the post.
    bobby75703 replied to iride6606's response:
    I fully understand the role of a distributor in commerce. That is not what this thread is referring to.

    My thread is titled "Can you trust statin drug studies?" and the question is based upon the scientific misconduct already discovered within the industry.

    I have your opinion iride. If anyone else is watching this thread it would be interesting to hear from them. Public, do you believe drug company sponsored statin studies are pure? Do you trust stain drug studies?

    Iride, I understand you don't buy into the idea of flawed human nature like I do, but let me tell you about a guy named Adolf Hitler...
    iride6606 replied to bobby75703's response:
    I'm sorry, based on the way you responded to the Sunshine Act it looked obvious that you were not familiar with how drugs got to market or the Sunshine act itself or both, just trying to help. I would have thought you would respond differently if you knew.

    Also, it is VERY pc incorrect to make any public comparison to Hitler. It is an outrageous stretch trying to compare what one misguided doctor did to Hitler who is responsible for 69 million deaths. Both my parents lost siblings while living through WWII in Rotterdam, I'm sure many others here have similar stories.

    Back to you premise, the NIH states that up to 17,000 trials are done in the US alone every year. Some put the annual number world wide at 80,000 so no a handful of outliers does not alarm me. I don't get worked up by red herrings.

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