Avandia Kills Diabetics; FDA Strikes Again

Yet more news from the killing administration, aka FDA.  A New England Journal of Medicine, (known further as NEJM), report back in 2007 said there was a marked increase in death due to the use of Rosiglitazone, better known as Avandia by those with type 2 diabetes.  This prompted a Congressional investigation and those results are now in; Avandia kills.  The study done by Dr. Steven E. Nissen and Kathy Wolski, M.P.H., NEJM was blocked from getting all the data by GlaxoSmithKline and the FDA, (I’ll call it the fraud and death administration from here on out).  Here is a part of the report from the NEJM.

Steven E. Nissen, M.D., and Kathy Wolski, M.P.H.

Results Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06).

Conclusions Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.

This study was done from material found on the fraud and death administration’s web site as well as the studies from GlaxoSmithKline. Of 116 related studies, 42 trials met the inclusion criteria. All showed a marked increase in the risk of myocardial infarction and death from heart attacks.

The drugs are in a family of drugs called Thiazolidinedione and are widely used in the treatment of type 2 diabetes to lower glucose levels in the blood stream. One of these drugs, (troglitazone (Rezulin)), has already been removed from the market because it caused chemically induced liver damage. The drug known by different names; Rezulin, Resulin or Romozin,and was removed from U.S. markets in March of 2000. Yet, it is only now that another drug in this family is being looked at. Seems to me common sense would be to pull all the drugs in this family group until thorough studies are done to assure the safety of the drugs. Obviously it cannot be done by the companies that market them since they will lie, fudge data, or do anything they have to in order to get their drugs on the market.

The NEJM study shows that the data gathered on these drugs was inadequate to show the long term effects it would have on the human body and its microvascular, (smallest blood vessels in the heart), and the macrovascular, (largest blood vessels in the heart),   My personal belief is that the studies done excluded the data that showed this problem in order to fast-track the drug to the market.  More incompetence by the fraud and death administration.  And please, don’t tell me they are dependent on the manufacturer to determine the validity of their claims.  If that is the case the fraud and death administration doesn’t need to exist at all.  We can just take Big Pharma’s word for it, right?

In an all-out war against the information about the drugs killing effects, GlaxoSmithKline executives used intimidation,  misleading infomercials, emails, and phone calls to try to minimize the risks associated with the use of Avandia.  This is in the conclusion of the Senate report which was released over the weekend.   View the full congressional report HERE:

The Senate report was developed over the last 2 years by U.S. Senate Committee on Finance investigators who reviewed over 250,000 pages of documents provided by GlaxoSmithKline (GSK), the Fraud and Death Administration (FDA), the University of North Carolina, and others. Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA, and anonymous whistleblowers.

You will have to read the congressional report in order to see how often and how much of the data on Avandia was selectively hidden by the executives at GlaxoSmithKline and the doctors working for them such as Sir Colin Dollery, senior consultant for GlaxoSmithKline.  Once Dr. Nissen’s analysis was released by the NEJM, GlaxoSmithKline and cronnies set out to minimize the damage done to the drug and the company’s reputation:

Another Unwarranted Avandia Scare

February 22, 2010 – 10:27 am

Editors note: Dr. Mintz has received consulting and speaking fees from GlaxoSmithkline, the maker of Avandia.

Here we go again…… A piece recently published in the New York Times and cited by others has just kicked up the Avandia controversy again. As usual, this is both unnecessary, and will likely scare patients and cause more harm than it is trying to prevent. (In many ways like the current LABA scare).

The one thing NOT being discussed in all these reports is that the question of Avandia safety was answered this past July at the American Diabetes Association’s annual meeting when the RECORD trial was presented which definitively showed that Avandia did not cause heart hospitalizations, cardiac deaths, or any heart problems.

Apparently the Senate investigation didn’t agree with the good doctor… Couldn’t be his blog is biased by the contributions and consulting fees paid to him by GlaxoSmithKline? I have a hard time trusting someone whose interest is his own paycheck and not my health issues.  So many are being compromised by the money laid out by Big Pharma.    Nor does it take a rocket scientist to figure out which side of the bread this man butters…

Still, if you really want the findings and facts go to the Congressional report.  It is astounding how many emails were flying around and concerns being raised by those doing the studies for GSK.  They knew there was a problem and did everything in their power to make sure the data did NOT get out.  The fraud and drug administration was just as eager to to help them along…

The findings of the Senate investigation were as follows (page 9 of pdf file):

EXECUTIVE SUMMARY

This staff report was developed over the last 2 years by U.S. Senate Committee on Finance investigators who reviewed over 250,000 pages of documents provided by GlaxoSmithKline (GSK/the Company),
the Food and Drug Administration (FDA), the University of North Carolina, and others. Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA, and anonymous whistleblowers.

Committee staff began this investigation in May 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.

When an independent scientist sought to publish a study in 2007 pointing out the cardiovascular risk of Avandia, GSK acquired a leaked copy of that study from one of its consultants prior to the study being published. The company’s own experts analyzed the study, found it to be statistically reliable, and then attacked the soundness of that study in press releases and public comments. GSK also sought to counter the study’s findings by quickly releasing preliminary results from its own study on Avandia, even
though the company’s internal communications established that its study was not primarily designed to answer questions about cardiovascular risk.

As you can see, the Senate investigation looked deeply into the GSK emails and documentation to find the extent to which GSK was involved in the cover-up and misdirection of the data sets available.  The full report will show you the full effect of the disclosed evidence, but the summary is enough for most people to get a good idea of how far big pharma will go to put a drug on the market, even when they know the potential death risks to patients.  My guess is they figure the money earned selling a bad drug will more than make up for the lawsuits that follow.

According to an MSN article:

U.S.: Controversial diabetes drug harms heart

Internal F.D.A. reports are part of fierce debate over Avandia

By Gardiner Harris Feb. 19, 2010

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

See, it is all about the money.  And what did the NYTimes say?

Research Ties Diabetes Drug to Heart Woes

By GARDINER HARRIS
Published: February 19, 2010

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

An interesting article to read emphasizes the plight of patients vs. Big Pharma:

Is FDA approval for safety … or price gouging?

Colchicine is the latest drug targeted by an FDA plan to take unapproved drugs through its approval process. But does replacing a cheap, unapproved product with a similar, branded one help the public?

January 18, 2010|By Harris Meyer , Kaiser Health News

She pays only $12 at Wal-Mart for a 90-day supply, according to her daughter Tina Martin, who also takes colchicine for the condition. Colchicine has been prescribed for centuries, more commonly for gout. The form the two women use is cheap because, like thousands of prescription drugs on the U.S. market, it predates modern drug laws and has never been evaluated or approved by the U.S. Food and Drug Administration.

Now, Webb may have trouble getting the drug. In July, Philadelphia-based URL Pharma won FDA approval for a branded version called Colcrys, which sells for about $4.50 a tablet. This will dramatically boost costs for patients, like Webb, without drug coverage. The 66-year-old Morristown, Tenn., resident is on Medicare but can’t afford the Part D drug benefit, her daughter says. Even insured patients like Martin will feel the pinch; her co-payment will rise from $10 to $35 for a 90-day supply.

The FDA found that Colcrys’ drug-interaction labeling and recommended-dosing regimen make it safer and easier for patients to tolerate than the unapproved forms of colchicine. The agency said it had received reports of 120 patient deaths from unapproved colchicine’s interactions with other drugs. It granted URL Pharma and Colcrys three years’ exclusivity for treatment of gout — a recurrent arthritic inflammatory disease caused by uric acid buildup — and seven years for familial Mediterranean fever.

How does this benefit the Citizens of this country?  According to the home page of URL Pharma they are engaged in a commitment to DEVELOP NEW products.  So why would they be given permission by the fraud and death department to come up with a new drug when one already exists and which works well?  Money!

The fraud and death administration makes money from the drugs it allows on the market, not the ones that existed before the agency came to be.  The really interesting paragraph is here:

The FDA found that Colcrys’ drug-interaction labeling and recommended-dosing regimen make it safer and easier for patients to tolerate than the unapproved forms of colchicine. The agency said it had received reports of 120 patient deaths from unapproved colchicine’s interactions with other drugs.

So millions take this drug with little adverse reactions but because a minute few have died, (I’d like to see that report in writing), they are going to allow a Big Pharma company to make a high priced version few can afford while they allowed Avandia to continue on the market with substantially higher death rates and had no problems with it.  It is all about money to the fraud and death administration, not patient safety or concern.  You do the math.

I looked up the drug on the fraud and death website.  If you want to read something that will make you say BS 20-30 times, go read that. I can’t help it.  The fraud and death department hasn’t earned my respect for the past 10 years, if anything, pure contempt comes up each time I hear them mentioned.

One thing I have never been able to buy is the fact that all drugs manufactured have to have some side effects.  Mother nature works with out bodies so why does big pharma not have to?  Why are they given a pass when it comes to toxic substances?  Why is it they can’t manufacture a pill without consequences?  I don’t believe it.  I won’t buy it.  If that is the best they can do perhaps they shouldn’t be allowed to produce pills…

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~ by justmytruth on February 23, 2010.

One Response to “Avandia Kills Diabetics; FDA Strikes Again”

  1. After reading you site, Your site is very useful for me .I bookmarked your site!

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