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Diabetes drug Avandia increases heart attacks 43%; Glaxo stole manuscript says Dr. Steve Nissen
Tuesday, February 23, 2010 10:15 am Email this article
The diabetes drug Avandia (Rosiglitazone Maleate) increases the risk of heart attack by 43% according to a study by Steven Nissen, MD, Chairman of the Department of Cardiovascular Medicine of the Cleveland Clinic in Cleveland, Ohio.
In an interview on CNBC's Squawk Box on Feb 22, 2010, Dr. Nissen noted that Glaxo, the maker of Avandia, stole a copy of his manuscript -- or as Mike Huckman of CNBC stated, they were given a copy of the manuscript by one of the peer reviewers for the New England Journal of Medicine, who later claimed he wasn't feeling well, and didn't know what he was doing.
Dr. Nissen said that after determining that the study was scientifically correct, Glaxo then planned a Public Relations campaign to discredit it. 75% of diabetics die from heart disease
A drug like Avandia that increases the risk is unacceptable
“75% of diabetics die of heart disease,” Dr. Nissen noted.
“A drug for diabetes [ like Avandia ] which increases risk of heart disease is unacceptable.”
The FDA should ban Avandia
Avandia should be pulled off the market
When asked if Avandia should be pulled from the market, Dr. Nissen said, “I think a time [to take it off the market].”
Avandia causes 500 heart attacks per month
500 heart attacks per month could be avoided by switching from Avandia to Actos
Avandia raises LDL
Avandia raises LDL levels, Actos does not
Dr. Nissen was asked why do you believe that Avandia does not protect the heart?
“Well, among other things, it raises cholesterol levels. It actually raises the bad cholesterol, or LDL. Actos, the other drug in the class, doesn’t do that. With aThis is been known now since 1999. The drug was actually approved despite the fact that it raises cholesterol levels. And it does other things.”
“These drugs turn on and off a large number of genes. The two drugs actually turn on and off different genes. We don’t understand what all of them do. But, clearly, Avandia is turning on some genes that is causing heart attacks.”
Glaxo tried to intimidate doctors
Glaxo tried to intimidate doctors who tried to sound the alarm about Avandia
One of the things that the Senate report concludes is that Glaxo bullied or intimidated doctors like yourself who tried to sound the alarm on Avandia’s risks. Were you one of them? And, if so,What did what did the company do to you?
“Well, I’m not easily intimidated,” Dr. Nissen replied.
Glaxo was given a stolen copy of Dr. Nissen’s manuscript
A peer reviewer for the New England Journal of Medicine gave Glaxo a copy of Dr. Nissen’s manuscript, then claimed he wasn’t feeling well and did not know what he was doing
“They did come to the Cleveland clinic after… without telling me that they had stolen a copy of our manuscript, and tried to convince me that I was wrong.”
“Wait a second,” Mike Huckman of CNBC said. “I don’t know if they stole a copy of your manuscript. According to the Senate investigation it was leaked to them by one of the peer reviewers for the New England Journal of Medicine, who later claimed he wasn’t feeling well, and didn’t know what he was doing.”
“Mike, by any stretch of the imagination, if you have stolen papers, it’s theft,” Dr. Nissen noted.
“They could have easily not accepted that material.”
Glaxo planned a PR campaign to discredit the study
Glaxo planned a PR campaign to discredit Dr. Nissen’s study
“Not only did they accept the material, but they disseminated throughout the company—50 executives saw it,” Dr. Nissen stated. “They analyze the manuscript, came to the conclusion that it was scientifically correct, and planned a PR [ Public Relations ] campaign to discredit it.”
Dr. Nissen was then asked, “Do you still have any of your patients on Avandia, and if not, what if you switch them on to at this point?”
“Well, I think most physicians around the world, were certainly many of them, have switched them from Avandia to Actos, two closely related drugs, one which increases the risk of heart disease, and the other one lowers it.”
The FDA has changed its standard for how diabetes drugs are approved
Diabetes drugs now must show cardiovascular safety
“As a result, in part of the Avandia problem, the FDA has changed its standards for how diabetes drugs are approved,” Dr. Nissen continued.
“They now have to demonstrate cardiovascular safety before approval, and also after approval.”
“So this is change public policy in a major way, but unfortunately, we still have a drug on the market that we really don’t need. We have great alternatives to Avandia. Most of us can’t figure out why it’s still on the market.”
Doctors unaware of the problem, are still prescribing Avandia
Doctors are still prescribing Avandia because they can’t read all the medical literature
Dr. Nissen was then asked, “Why, after hearing all this, are people still taking it, and why would any doctor, particularly in the US with all liabilities, be prescribing it?”
“Well, the problem is, the doctors don’t read every piece of the medical literature,” Dr. Nissen said.
“They have to prescribe so many hundreds, even thousands, of drugs. That’s why we have regulators [the FDA].”
The FDA must ban the drug
Doctors will continue prescribing Avandia until the FDA pulls it off the market
“The regulators are there to say whether a drug is safe or not.
“In the absence of regulators [the FDA] taking this drug off the market, it’s going to continue to be used.
“That’s why the time has come now to say we don’t need this drug. There are great alternatives. We have 12 classes of drugs to lower blood sugar. Why do we need a drug like this that has come under such a cloud?”
An FDA Advisory panel voted to keep Avandia on the market
A few years ago, an FDA Advisory panel voted 22-1 to keep Avandia on the market
Dr. Nissen was then asked, “Dr. Nissen, an FDA advisory panel voted 22-1 a couple of years ago that this drug [ Avandia ] should stay on the market. Now the FDA wants to convene another advisory committee to revisit this. Why do we need a do over?”
“I don’t think we do need to do over,” Dr. Nissen said.
The FDA Doesn’t like to admit they were wrong
The FDA Doesn’t like to admit they were wrong and that their decision cost people their lives
“I think the problem is that we’ve got a structural problem inside of the FDA.
“The very people who approved the drug in the first place are the ones who are being asked to pull it off the market.
“And the problem is that they are admitting to themselves that they made a terrible mistake that cost a lot of lives, and so they don’t go there.
“We need to strengthen the office of surveillance and epidemiology—the safety side of the FDA—and give them the authority to act decisively when these kinds of issues come up.
“Because we can expect the people who approved the drugs to be the ones who are going to pull it off the market,” Dr. Nissen concluded.
Comment About LDL
I do not believe LDL causes heart disease
I do not believe that LDL causes heart disease as Dr. Nissen implied.
The “current evidence supports ignoring LDL cholesterol altogether,” Dr. Rodney A. Hayward, professor of internal medicine at the University of Michigan Medical School, as quoted in a great article in BusinessWeek from Jan 17th, 2008 titled “
Do Cholesterol Drugs Do Any Good?.
Also read Dr. Malcolm Kendrick’s wonderful book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It .)
Comment About Blood Sugar Levels
Elevated blood sugar levels is NOT the problem
Some researchers have said that elevated blood sugar levels is NOT the problem in diabetes, and thus, simply giving drugs to lower blood sugar levels misses the point.
Comment About Looking At Cardiovascular Risk of Diabetes Drugs
They need to look at the TOTAL risk of death
Dr. Nissan notes that the FDA now looks at the cardiovascular risk associated with diabetes drugs before approving them.
I think this misses the point.
They should look at whether a drug lowers the TOTAL risk of death, and not just how it affects cardiovascular risk.
I am amazed that researchers and the FDA overlook this obvious fact.
Comment About Treating Diabetes
Dr. Julian Whitaker uses NO oral diabetes drugs
I also believe that there are natural ways to treat diabetes without drugs.
Read “Reversing Diabetes” by Julian Whitaker, MD.
Dr. Whitaker does not use ANY oral diabetes drugs.
Dr. Whitaker has noted that a study came out in 1972(?) when he was doing his medical residency at Emory University which showed that ALL oral diabetes drugs caused more problems than they solved.
Because of this study, the doctor, who he was studying under, stopped using all oral diabetes drugs.
Metformin May Be The Exception
Metformin is a life-extending drug according to Dr. Ward Dean
Metformin may be an exception, and have health benefits according to Dr. Ward Dean.
Ward Dean, MD has noted that Russian gerontologist, Vladimir Dilman, MD, said that he believed that phenformin, metformin’s stronger cousin, was the most potent life-extending drug available.
See the article titled “Metformin: An Effective and Underappreciated Life Extension Drug” by Ward Dean, MD here.
Increasing Potassium Lowered Blood Sugar from 400 to 100
Anecdote : Increasing potassium intake lowered blood sugar from 400 to 100 in biologist friend noted Professor Richard Moore
As well as lower blood pressure, increasing potassium intake may lower blood sugar levels and cholesterol levels as noted by Professor Richard Moore, MD, PhD, in his book “The High Blood Pressure Solution”.
He says that high blood pressure and Type 2 diabetes are two sides of the same coin.
He says both simply indicate an imbalance inside cells.
Professor Moore gives the following anecdote about how increasing potassium intake may successfully lower blood sugar levels. It is from the bottom of page xiv and the top of page xxv of the Preface.
“There’s a lot more to hypertension than just elevated blood pressure. The increased blood pressure is a marker, or a sign that something is out of balance. Just as a high temperature is a sign that something is wrong with the body, high blood pressure is a sure sign that there is a serious imbalance in cells throughout the whole body. This imbalance often involves increased blood cholesterol, increased levels of insulin caused by ‘insulin resistance,’ and a tendency to how high blood sugar levels. In the last analysis, these blood abnormalities are the result of imbalances within each living cell.”
“We’ve known that hypertension shares many things with adults diabetes.”
“Following this line of reasoning, there is a possibility that increasing dietary K factor [ that is, increasing potassium relative to sodium ] might be beneficial in treating type 2 diabetes. Thus far, I know of no clinical research groups that have tested this hypothesis, so don’t try this on your own.”
“A biologist friend of mine discovered that he was diabetic when his blood glucose came back at 400 milligrams per deciliter (normal range 70-100). He had heard he mentioned this idea and resisted the pressure to be placed on drugs until he tried increasing his dietary K factor [ increasing his intake of potassium relative to sodium ], which had been very low—he’d use large amounts of soy sauce [which contains lots of salt]. After he did that, his blood glucose decreased to normal—around 100 milligrams per deciliter. So some clinical research group should look into this lead.”
Copper Deficiency Elevates Blood Sugar
Copper deficiency is also associated with elevated blood sugar
A copper deficiency is also associated with elevated blood sugar levels.
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