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This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell
Yeah ... "for" not "by" … but that's as least as concerning. Thank you for this, pkjody. This is something should be dragged out into the light of day. I'll get round to the author there - Ankur Pandya - but first ...
Me? I'm "going to down to Rosedale" again - more after the video:
So here's what Dr. Rosedale, God bless him for his honesty and compassion, says:
Ron: I am just dying inside hearing this story! It’s such—I don’t know even how to describe it. There’s no science to back up anything they say about statins. In fact, the science will almost absolutely refute what they say.
Sam: But the statin does lower the—
Ron: Yes, it lowers the cholesterol number. It does. Does it lower mortality rate? Will it reduce your risk of dying?
Sam: I don’t know.
Ron: It won’t. In fact, it’ll increase it. You said your muscles ached. You called it a cramp. Did they tell you why statins do that?
Sam: They may have, but I don’t remember.
Ron: They probably didn’t. I will tell you. It’s not a side effect, it’s a secondary effect—actually, it’s a primary effect of statin drugs, not even a secondary, not even a side effect. The primary effect of statin drugs like Lipitor is to reduce an enzyme called HMG coenzyme A reductase. That’s what it does. They’re known as HMG coenzyme A reductase inhibitors. When statins were first developed, that’s what they were developed for. They were specific developed in a laboratory to inhibit that enzyme. That is what they do. It’s important to recognize that. They were not developed as antioxidants, for instance, or anything like that. They were specifically developed to inhibit HMG coenzyme A reductase, which is an enzyme that manufactures cholesterol in the liver. It’s one of the steps. When you inhibit the enzyme, you reduce the manufacture of cholesterol in the liver.
Ron: That same enzyme, as is very typical in biology, is not used for just one purpose, however. It’s used for multiple process. One of the other purposes of HMG coenzyme A reductase is to manufacture something called coenzyme Q10, which is involved in the so-called mitochondrial respiratory chain. Co-Q10 is very critical in transferring energy from food into usable little batteries within the mitochondria of our cells – batteries that all of life uses called ATP. When you diminish coenzyme Q10, you diminish the ability of all your cells to produce energy. That’s really, really important, because without energy, you have no life. The reason you were developing muscle cramps is because your muscles use energy. You called it cramps. It was really aching. That’s because whenever you use a muscle, it has to rebuild itself. It can’t rebuild itself fast enough if it doesn’t have enough energy to do so.
Ron: It’s interesting that “experts” that recommend statins don’t connect the fact that your heart is a muscle. You were not, unbeknownst to you, just having a problem with your skeletal muscles. You were having a problem with your heart, too, when you took statin drugs. It wasn’t able to pump as hard, to constrict as hard. In other words, it was weaker because you took statin drugs than if you didn’t. The purpose of your heart is to pump blood. Under the misguided—if you want to call it that, and I’m being polite in saying that—attempt to reduce risk of future coronary heart disease, people who prescribe statins give you heart disease. It is an effect of statin drugs to reduce energy production, especially in muscle tissues, in other words, the tissues that use a lot of energy will be the ones most adversely affected by the inability to produce enough energy. And the heart is one of the major tissues, heart muscle, one of the major organs that requires lots of energy. It is adversely affected.
Ron: Not only that, but because, perhaps, and this is somewhat speculation, it is known that when you reduce cholesterol, you increase risk of death. Not necessarily cardiovascular death, and that’s the kicker. What they try to tell you is that taking cholesterol-lowering medications reduces risk of cardiovascular disease. That may or may not be true. There’s a lot of twisting of data to come up with that. But what they fail to tell you is that despite—perhaps—reducing cardiovascular deaths, taking statins increases total mortality. Perhaps you won’t die of heart disease, but you’ll die of something else.
Sam: Is there research?
Ron: There’s been research since the 1970s that has shown, over and over and over again. It’s not news.
If I could speak to Vinnie Tortorich I'd like to ask him why he had a drug-company woman on his show - and one who did, among other things, take a little time to oh so casually and gently whitewash the statin affair - rather than getting Dr. Rosedale on. But then I heard Vinnie promise Dr. Kendrick on air that he would read his book, and clearly he hasn't.
So … Mr. Pandya. Here he is:
Ankur Pandya, PhD, is an Assistant Professor of Health Decision Science in the Department of Health Policy and Management. Dr. Pandya’s research focuses on developing and evaluating simulation models that have the potential to improve cardiovascular disease policies in developed and developing countries. One specific initiative funded by the American Heart Association aims to optimize the use of medical imaging in the prevention and treatment of ischemic stroke in the United States. He has also evaluated the role of cholesterol in primary cardiovascular disease screening for the United States and South Africa. In addition to this applied work, he is exploring broader methodological and policy aspects of health decision science.
Dr. Pandya most recently served as Assistant Professor of Healthcare Policy and Research with a secondary appointment in the Department of Radiology at Weill Cornell Medical College. He graduated from the Harvard PhD Program in Health Policy in 2012, and holds a BS from Cornell University in Nutritional Sciences, and an MPH from Yale University in Health Policy and Administration. Prior to entering the PhD program, he worked for two years at a health economics/outcomes research consulting firm. He is an active member of the Society for Medical Decision Making.
Kind of cosy the way he's popping into the world of business and then back into academia, isn't it?
I wonder about the optimisation of the "the use of medical imaging". Sounds like that could be a pretty expensive programme with substantial profits for some in there Wonder if it would be likely to do any good I also wonder if a paleo/primal diet would be more effective than such a scheme.
I liked "active member of the Society for Medical Decision Making". I felt I had to look them up. I didn't find it easy to find who might be financing them, but this seems quite significant:
Interesting to find that "our Institutional Membership" includes some of the following:
Amgen Inc., Archimedes, AstraZeneca R&D Lund, Biogen Idec, Bristol Myers Squibb, Center for Disease Analysis, Eli Lilly and Company, Express Scripts, Inc., F. Hoffman-La Roche, GE Healthcare, IMS Health Care, Merck & Co., Novartis Pharmaceuticals Corporation, Pfizer, Schering- Plough Corporation, Treeage Software, University of Toronto THETA Collaborative, VA Technology Assessment Program (VATAP).
I think I'll leave Dr. Rosedale with the last word:
Ron: Most of the data indicating dangers from statins is not done on statins particularly, because the people who are doing research on statins are the drug companies. You’re not going to find an independent person spending upwards of $50 million or $100 to do a big study on a statin drug to show a negative effect. That’s a major problem in medicine. You don’t spend money to show a negative effect. You spend money to make money. Pharmaceutical companies will spend a lot of money to do a study, not to find an ultimate truth that would better your health or even care about your health, but to look after their financial interests and the financial interests of their stakeholders, to which they are beholden.
Good link to Dr Rosedale. He sums up virtually all the statins are bad positions.
I really like his statement on cholesterol and think the analogy used is on target:
Correlation does not imply cause. Firemen are correlated with house fires. Rarely is it the firemen who cause it. Occasionally, maybe, but I would certainly not want to kill the firemen as a means to put out the fire. And that’s what they’re doing with cholesterol.
The Buck stops here. I am responsible for my past and my future. So for today: I choose to be happy. I will seek wisdom. I will be a servant to others. I will greet this day with a forgiving spirit.