Simple questions deserve simple answers. So when Senator Grassley (R-IA) recently sent a letter to the Food and Drug Administration (FDA) asking them to review the safety of cholesterol-lowering drugs (statins). The response will be a straight forward statins are safe. But preparing that answer will probably cost the taxpayers thousands of dollars and lost staff time at the FDA.
Statins are drugs which reduce LDL Cholesterol (the Bad Cholesterol), they include branded and non branded products such as (pravastatin, atorvastatin, simvastatin, rosuvastatin, fluvastatin, lovastatin). These are amongst the most prescribed drugs in the world.
Perhaps no other drug class in history or even in the foreseeable future has been studied in more patients than statins. Each major clinical trial of statins included 10+ thousand patients, if there were real problems with the drugs it would have shown up during the trials. In 2004 Sidney Wolfe (of Public Citizen) called for withdrawal of a statin rosuvastatin (Crestor) on safety grounds and was summarily rejected by the agency.
Also, from an epidemiology stand point this class of drugs have been on the market since the early 90’s and given to millions of patients, if there was a strong safety signal it would have shown up in epidemilogy data. In addition, statins have been credited with a large portion of the remarkable decrease in cardiovascular disease we have seen over the past two decades.
According to an article published in Businessweek, cholesterol-lowering drugs last year racked up $33 billion in sales around the world, including Pfizer's (PFE) Lipitor, which earned $13.6 billion.” What concerns Mr. Grassley about such income is that the drugs seem to be having adverse side effects. (Just a note to the senators staff – all drugs have adverse side effects)
Some of the reports from Grassley's investigators include people who have suffered from “serious side effects and long-lasting injuries after taking the drugs, the most common of which is muscle pain.” In fact, Georgirene D. Vladutiu, PhD a pediatrics professor at the State University of New York at Buffalo, was quoted in Business week even went as far as saying that patients who stop taking the drug are actually still having such side effects.
What is interesting about this quote is that professor Vladuitiu is that according to pub med, he has two original papers (plus several letters to the editors) on statins, including a small research study, looking at incidence of rhabdomyolysis (muscle pain) and its relationship gene expression.
As a result, Mr. Grassley asked the agency how much it was seeing this kind of reporting for these side effects, and whether such problems are being adequately spotted and reported.
Consequently, the Senator went on to ask why there are side effects listed in other countries missing from U.S. labels, and whether there are problems with these drugs that aren't being addressed.
In response to the letter, FDA spokesperson Karen Riley noted that the agency will respond to all questions in a timely manner
The author of the Businessweek article John Carey has been writing about the potential problems with Statins for some time so it is not surprising that he would somehow end up being the only news outlet with a copy of the “letter”
The question posed by the Senator, is his prerogative to ask, but to share the letter to the press is inexcusable. The problem is that patients can be “scared off” of taking important potentially life saving medication when non medical experts on congressional staff’s publicize they are ‘investigating a class of drugs like statins.”
When we sent this over to several prominent cardiologist the word we got back was simple, we need congress focused on fixing the economy.
We have included links to several articles on Statin Safety from reliable sources for his staff to utilize so that they don’t have to embarrass their member in the future.
They also may consider getting on the phone with key doctors in a clinical area who know the history of the therapy and the clinical trials before firing off a letter and making their member look_____.
The Issue of Statin Safety: Where do we stand? Circulation. 2005;111:3016-3019, Scott M. Grundy, MD, PhD, University of Texas Southwest Medical Center Dallas Texas
Summary of The Report of the National Lipid Association: Statin Safety Task Force James McKenney, PharmD, Ed., Medical College of Virginia, Richmond — Am J Cardiol. 2006;97:Supplement
FDA:
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease" Agency recommends no change in prescribing and use of statins September 29, 2008
Just one note, there are good chances that trial attornies are giving this information to Grassley's office for this investigation as this is an "old news" inquiry. My bet is the attorney's clients are "suffering muscle pain". If the burdent of proof is muscle pain, then this may be the new "Yukon teritory" for trial attornies.