Thousands of Women in Lipitor diabetes Lawsuit - Liebhard

Thousands of Women in Lipitor Lawsuit Claims to Join South Carolina Litigation, Status Report Shows

Published on June 16, 2014 by Sandy Liebhard 

More than a hundred cases filed by some 3,000 female Lipitor lawsuit plaintiffs will soon join the federal diabetes drug litigation in the U.S. District Court, District of South Carolina, according to court documents.

A status report recently submitted by parties involved in the federal litigation indicates that 134 cases alleging new-onset Type 2 diabetes will be transferred to the multidistrict litigation in the coming weeks, on behalf of 3,000 plaintiffs.

According to Lipitor lawsuits included in the soon-to-be transferred claims, use of the cholesterol medication, may increase a woman’s likelihood of developing Type 2 diabetes, which its manufacturer allegedly knew about but concealed from the public. Lipitor diabetes lawsuits included in the federal proceeding, which was created by the U.S. Judicial Panel on Multidistrict Litigation (JPML) less than six months ago, include similar actions against Pfizer Inc. that accuse the company of marketing a product that was designed defectively.

A Case List updated June 16th by the JPML also shows a continued increase in the number of Lipitor lawsuits filed in South Carolina federal court. An update posted that day reflects 846 cases now pending in the federal litigation, which held its most recent status conference on June 13th. A month earlier, a total of 703 claims had been filed in South Carolina.

More than 840 Claims Now Filed in Lipitor Diabetes Litigation

Lipitor is a medication approved by the U.S. Food and Drug Administration (FDA) to help lower cholesterol levels in individuals who may be at an increased risk for strokes and heart attacks.
Since entering the market in 1996, the FDA issued a mandate in February 2012 that required Pfizer to adjust Lipitor’s labeling to include its possible association with Type 2 diabetes.  This action was prompted by research published a month earlier in JAMA: Internal Medicine that found post-menopausal women at an increased risk for developing the disease. In May 2013, results of a study published in the British Medical Journal showed a 22 percent increased risk for Type 2 diabetes in patients taking atorvastatin, the generic version of Lipitor.
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UPDATE:

Pfizer confronts surge of lawsuits over Lipitor

By Jessica Dye

Fri Aug 8, 2014 1:22am EDT

Lowering A1c below 6% will NOT give them heart attacks - Ruhl

 Lowering A1c below 6% will NOT give them heart attacks.

Over the past year I have heard from a horrifying number of people with diabetes whose doctors have reproached them for lowering their A1cs below 6% and warned them that lowering A1c to that level will give them heart attacks.

This is obscenely bad advice. But there is a reason why so many doctors are giving it. It goes back to a study called ACCORD, which was published in Februrary of 2008. You can read it here:

Effects of Intensive Glucose Lowering in Type 2 Diabetes The Action to Control Cardiovascular Risk in Diabetes Study Group.[ACCORD] NEJM Volume 358:2545-2559, June 12, 2008 Number 24.

What ACCORD Really Found

This study was designed to see if lowering A1c to 6.5%, instead of the ADA's recommended 7.0%, could prevent heart attacks. The study was stopped early when analysis of preliminary data showed a slight excess of heart attack deaths in the subjects in the group who were striving to lower their A1cs.

This is all most doctors ever heard about ACCORD--that lowering A1c led to an increased risk of heart attack. What they didn't hear about was the methodology used in the study. That methodology makes it very clear that it wasn't the lowering of blood sugars that caused the deaths, but the way the study attempted to lower A1c.

ACCORD studied only people with long-standing Type 2 diabetes who had been diagnosed with heart disease before the start of the study. These patients were put on a statin drug (which we now know can further raise blood sugar) and a fibrate drug.

Then the researchers set out to lower blood sugar by putting their subjects the discredited high carbohydrate, low fat diet--which a large body of research has shown not only raises blood sugar but worses triglycerides and LDL. To counteract the blood-sugar-raising effect of this diet, the ACCORD researchers put the study subjects trying to lower blood sugar on a cocktail of every diabetes drug available at the time, including Avandia and Actos.

90.2% of ACCORD Subjects Were Taking Heart-attack Raising Avandia

In fact, a subsequent analysis of ACCORD data found that 4,702 of the 5,128 people in the intensive treatment arm of ACCORD were taking a drug in the TZD class that includes Avandia and Actos--That's 91.7% of all of them. But here's the kicker: almost all of them--4,677 or 91.2%--were taking Avandia. And of course, we now know that taking Avandia raises the risk of cardiac death independent of how much it lowers blood sugar.

The researchers who came up with this finding concluded,

Although other differences in drug exposure warrant further analysis, we think that the authors[of the ACCORD publications] should consider (and address in a secondary analysis) the role of rosiglitazone in the excess deaths from cardiovascular causes, especially in the absence of biologic plausibility of a glucose-mediated effect. Given unbalanced exposure, we think that the ACCORD trial is inconclusive and that the recommendation to abandon lower glucose targets is not supported and has unknown consequences for the long-term management of diabetes. [Emphasis mine]

Intensive Glucose Lowering and Cardiovascular Outcomes N Engl J Med 2011; 364:2263-2264 June 9, 2011

Those Who Lowered A1c Were Not Those Who Had More Heart Attacks

However, another analysis of ACCORD data actually overturned the idea that it had been the people with lowered A1cs who experienced the excess heart attacks.

Diabetes in Control reported on a presentation given at the 2009 ADA Scientific Sessions which found that further analysis of ACCORD data "did not confirm the proposed theory that low A1c levels might be the cause" of the elevated risk of death in the ACCORD patients who attempted to achieve tighter control.
Matthew C. Riddle, MD, Professor of Medicine, Oregon Health Science University and a member of the Glycemia Management Group of ACCORD, who was a site principal investigator for the ACCORD study is quoted as saying,

An A1c below 7% alone does not appear to explain the excess deaths in the ACCORD trial and is not necessarily a predictor of mortality risk...Further, the rate of one-year change in A1c showed that a greater decline in A1c was associated with a lower risk of death.[emphasis mine]

Dr. Riddle and his peers subsequently published these results in this paper:
Epidemiologic Relationships Between A1C and All-Cause Mortality During a Median 3.4-Year Follow-up of Glycemic Treatment in the ACCORD Trial. Matthew C. Riddle et al. Diabetes CareMay 2010 vol. 33 no. 5 983-990. doi: 10.2337/dc09-1278
This study concludes,

...a higher average on-treatment A1C was a stronger predictor of mortality than the A1C for the last interval of follow-up or the decrease of A1C in the first year. Higher average A1C was associated with greater risk of death. [emphasis mine]

These analyses implicate factors associated with persisting higher A1C levels, rather than low A1C per se, as likely contributors to the increased mortality risk associated with the intensive glycemic treatment strategy in ACCORD.

So the bottom line is that ACCORD actually proved that not lowering A1c was more likely to cause a heart attack. But neither of these later findings made their way into the medical newsletters that are what most doctors rely on to keep up with medical research. So as a result, most doctors are still convinced that ACCORD "proved" that lowering blood sugar is dangerous for people with Type 2 diabetes.

The Veterans Study

A second study has been interpreted to mean that lowering blood sugar is useless for people with diabetes. It was conducted among a group of veterans with Type 2 diabetes, whose average average age was 60. This study concluded, "Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications, with the exception of progression of albuminuria [protein in the urine, a marker for kidney damage]"

It also found a higher rate of hypoglycemia in the intensive management group.

Dangerous Drugs Again

A look at the methodology of this study reveals why we can ignore its findings. The researchers explain, "In both study groups, patients with a BMI of 27 or more were started on two oral agents, metformin plus rosiglitazone [Avandia]; those with a BMI of less than 27 were started on glimepiride plus rosiglitazone [Avandia]. Patients in the intensive-therapy group were started on maximal doses, and those in the standard-therapy group were started on half the maximal doses."

Avandia and glimipiride are both known to raise the risk of heart attack, so it is actually interesting that this study found no excess deaths, just no improvement in the incidence of cardiovascular deaths.

The excessive hypos are almost certainly due to the way that insulin was prescribed to the veterans. The "methods" section does not specify how insulin was prescribed, or even what kind of insulin was prescribed Were subjects put only on basal insulin, which only lowers fasting blood sugar, or were they given fast-acting insulins to cover their meals? Given how insulin was dosed in hospitals at the time this study was conducted, it is very likely that "insulin" was prescribed in the from of 70/30 mixtures which contain NPH, an insulin notorious for causing hypos, and that if fast acting insulin was prescribed at all, it was prescribed using the simple, but ineffectual "sliding scale dosing" technique which does not match the dose of fast-acting insulin to the amount of carbohydrate consumed.

Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes. William Duckworth, et al.

What The Studies Didn't Study

No patients in ACCORD attempted to lower blood sugar solely by using a strategy of lowering the intake of the carbohydrates that raise blood sugar.

No patients in any of these studies attempted to lower blood sugar without the dangerous drugs Avandia, Actos, or one of the sulfonylurea drugs now known to raise the risk of heart attack.

And it is very unlikely that any of the patients using what researchers only call "insulin" were using modern, effective basal/bolus insulin dosing schemes that match insulin to carbohydrate intake and prevent hypos.

Therefore, if you are controlling your blood sugar with any combination of carbohydrate restriction, metformin, or a modern insulin regimen that matches the dose to the amount of carbohydrates you consume on a meal-to-meal basis, these studies are completely irrelevant, and you'd do well to pay attention to the many other studies that have shown that lowering blood sugar will prevent and, at times, reverse all the classic diabetic complications.

Bottom Line: There is not a scintilla of evidence that lowering blood sugar using techniques that do not involve dangerous drugs is harmful.

There is a great deal of evidence, even from ACCORD and the Veteran's study, that lowering blood sugar even to the still-too-high level of 6.5% improves kidney function and reduces the risk of heart attack. Other studies cited elsewhere on this site confirm that lowering blood sugar also lowers the incidence of nerve damage and of the retinal damage that leads to diabetic blindness.
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Vascular Calcification Is Increased With Statin Use

Progression of Vascular Calcification Is Increased With Statin Use in the Veterans Affairs Diabetes Trial (VADT)

1. Aramesh Saremi, MD¹⇓,
2. Gideon Bahn, PHD²,
3. Peter D. Reaven, MD¹ and
4. for the VADT Investigators

+ Author Affiliations

1. ¹Phoenix VA Health Care System, Phoenix, Arizona
2. ²Cooperative Studies Program Coordinating Center, Hines, Illinois

1. Corresponding author: Aramesh Saremi, Aramesh.Saremi@va.gov.

Abstract

OBJECTIVE To determine the effect of statin use on progression of vascular calcification in type 2 diabetes (T2DM).

                   

RESEARCH DESIGN AND METHODS Progression of coronary artery calcification (CAC) and abdominal aortic artery calcification (AAC) was assessed according to the frequency of statin use in 197 participants with T2DM.

                   

RESULTS After adjustment for baseline CAC and other confounders, progression of CAC was significantly higher in more frequent statin users than in less frequent users (mean ± SE, 8.2 ± 0.5 mm³ vs. 4.2 ± 1.1 mm³; P < 0.01). AAC progression was in general not significantly increased with more frequent statin use; in a subgroup of participants initially not receiving statins, however, progression of both CAC and AAC was significantly increased in frequent statin users.

                   

CONCLUSION More frequent statin use is associated with accelerated coronary artery calcification in T2DM patients with advanced atherosclerosis.

© 2012 by the American Diabetes Association.

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Vascular Calcification Is Increased With Statin - ADA

Progression of Vascular Calcification Is Increased With Statin Use in the Veterans Affairs Diabetes Trial (VADT)

Aramesh Saremi, MD¹,  Gideon Bahn, PHD²,  Peter D. Reaven, MD¹ and for the VADT Investigators

 

 Author Affiliations

1. ¹Phoenix VA Health Care System, Phoenix, Arizona
2. ²Cooperative Studies Program Coordinating Center, Hines, Illinois

Corresponding author: Aramesh Saremi, Aramesh.Saremi@va.gov.

Abstract

OBJECTIVE To determine the effect of statin use on progression of vascular calcification in type 2 diabetes (T2DM).

                   

RESEARCH DESIGN AND METHODS Progression of coronary artery calcification (CAC) and abdominal aortic artery calcification (AAC) was assessed according to the frequency of statin use in 197 participants with T2DM.

                   

RESULTS After adjustment for baseline CAC and other confounders, progression of CAC was significantly higher in more frequent statin users than in less frequent users (mean ± SE, 8.2 ± 0.5 mm³ vs. 4.2 ± 1.1 mm³; P < 0.01). AAC progression was in general not significantly increased with more frequent statin use; in a subgroup of participants initially not receiving statins, however, progression of both CAC and AAC was significantly increased in frequent statin users.

                   

CONCLUSION More frequent statin use is associated with accelerated coronary artery calcification in T2DM patients with advanced atherosclerosis.

 

© 2012 by the American Diabetes Association.
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Another industry funded statin study that smacks of bad science and bias - Briffa

Another industry funded statin study that smacks of bad science and bias

Aug, Wed 15th, 2012 By : Dr John Briffa

 

‘JUPITER’ is the name given to a study which tested the effectiveness of the statin drug rosuvastatin (Crestor). The effects of rosuvastatin were compared with placebo in a large group of individuals free from a history of cardiovascular disease (such as previous heart attack or stroke) [1]. Testing in this setting (what is known as ‘primary prevention’) generally yields less beneficial results than in individuals with known cardiovascular disease (‘secondary prevention’). Despite being deemed at relatively low risk, the individuals treated with rosuvastatin saw significant improvements in some outcomes (more on this later), and the study got a lot of positive media and medical attention as a result.

One slight fly in the ointment that emerged from this study was the fact that those treated with a statin had a significantly increased risk of developing type 2 diabetes. Other studies have also found statins can up the risk of this condition. So, last week a study was published [2] in the Lancet medical journal, in which the original JUPITER authors looked again at their data to, supposedly, assess whether or not the benefits of rosuvastatin outweighed any risk from diabetes.

The authors found that the enhance risk of diabetes was only seen in individuals with at least one major risk factor diabetes. They go on to tell us that in this group, treatment with statins led to 54 new cases of diabetes being diagnosed. However, all is well because the group treated with statins also had 134 fewer ‘vascular events’.

The term ‘vascular’ event, however, covers a multitude of ills, including unstable angina (heart pain that comes on in an unpredictable fashion), non-fatal heart attacks, non-fatal strokes, fatal heart attacks, fatal strokes, and ‘revascularisations’ (e.g. insertion of a stent or bypass surgery). An outcome that is made up of lots of different outcomes is sometimes referred to as a ‘composite endpoint’. There is at least some doubt about the appropriateness of using composite endpoints to judge the effectiveness of medical interventions.

To begin with, the wider the net is cast, the more likely benefit will be seen, and the more likely the benefits will be deemed to be ‘statistically significant’. Also, some of the outcomes that are of limited relevance clinically (e.g. unstable angina) can occur frequently. This can skew the statistics in favour of finding ‘significant’ results, even though the clinical significance is debatable. The risk of the most important outcomes (such as fatal heart attacks and overall risk of death) may be reduced only a small amount or not at all.

Some researchers have raised the idea that drug companies and researchers may ‘game’ (deliberately manipulate) the design of studies by using composite endpoints in a way which inflates the apparent benefits of a drug [3].

In this latest regarding the impact of rosuvastatin on diabetes risk seen in the JUPITER study, the authors seem keen to remind us of the benefits of statins using a composite endpoint. However, analysis of adverse effects are limited to one outcome (diabetes). This basic technique really does much to stack the odds in favour of ending up a favourable end result.

I have seen many, many statin studies which use composite end points for benefits. Never, though, have I seen one which uses composite endpoints for adverse effects. In addition to increasing diabetes risk, statins have the potential to precipitate a range of other adverse effects including muscle pain, muscle damage, liver damage and kidney damage. How about lumping all those and other effects together to see how that ‘benefits’ and ‘risks’ stack up then?

There’s more than a whiff of bias here. Is there any other evidence that the authors of the study were biased and committed, perhaps, to finding positive results for rosuvastatin? I believe so.

In the abstract (summary) of the study, the authors are keen to point out that in individuals statins reduced the risk of venous thromboembolism (e.g. clots in the veins of the legs known as deep vein thrombosis) by about half. They also tell us that in people with or without risk factors for diabetes statins reduced overall risk of death by 17 and 22 per cent respectively. These are impressive statistics perhaps. But what the authors neglect to tell us, though, is that none of these outcomes was ‘statistically significant’, which means the ‘benefits’ the authors laud were much more likely to be due to chance than any genuine effect from taking statins.

It’s unlikely that any of us will be too surprised to learn that the original JUPITER study and this latest poor excuse of a paper were funded by the company that makes rosuvastatin (AstraZeneca).

References:
1. Ridker PM, et al. JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359(21):2195-2207
2. Ridker PM, et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. The Lancet 2012;380(9841):565-571
3. Kip KE, et al. The Problem With Composite End Points in Cardiovascular Studies – The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2008;51(7):701-707
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AHA Scientific Statement

Triglycerides and Cardiovascular Disease

A Scientific Statement From the American Heart Association

1. Introduction

A long-standing association exists between elevated triglyceride levels and cardiovascular disease* (CVD).^1,2 However, the extent to which triglycerides directly promote CVD or represent a biomarker of risk has been debated for 3 decades.³ To this end, 2 National Institutes of Health consensus conferences evaluated the evidentiary role of triglycerides in cardiovascular risk assessment and provided therapeutic recommendations for hypertriglyceridemic states.^4,5 Since 1993, additional insights have been made vis-à-vis the atherogenicity of triglyceride-rich lipoproteins (TRLs; ie, chylomicrons and very low-density lipoproteins), genetic and metabolic regulators of triglyceride metabolism, and classification and treatment of hypertriglyceridemia. It is especially disconcerting that in the United States, mean triglyceride levels have risen since 1976, in concert with the growing epidemic of obesity, insulin resistance (IR), and type 2 diabetes mellitus (T2DM).^6,7 In contrast, mean low-density lipoprotein cholesterol (LDL-C) levels have receded.⁷ Therefore, the purpose of this scientific statement is to update clinicians on the increasingly crucial role of triglycerides in the evaluation and management of CVD risk and highlight approaches aimed at minimizing the adverse public health–related consequences associated with hypertriglyceridemic states. This statement will complement recent American Heart Association scientific statements on childhood and adolescent obesity⁸ and dietary sugar intake⁹ by emphasizing effective lifestyle strategies designed to lower triglyceride levels and improve overall cardiometabolic health. It is not intended to serve as a specific guideline but will be of value to the Adult Treatment Panel IV (ATP IV) of the National Cholesterol Education Program, from which evidence-based guidelines will ensue. Topics to be addressed include epidemiology and CVD risk, ethnic and racial differences, metabolic determinants, genetic and family determinants, risk factor correlates, and effects related to nutrition, physical activity, and lipid medications.

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