After Avandia: Does the FDA Have a Drug Problem?
by ilene - August 14th, 2010 2:47 pm
This could have been titled, "Does America Have an FDA Problem?" My yellow highlighting and red comments. – Ilene
After Avandia: Does the FDA Have a Drug Problem?
By Massimo Calabresi with Alice Park, courtesy of TIME
Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug’s maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company’s $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.
What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies "strengthens the [cardiac-risk] signal observed in the [previous] analysis." Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an "increased risk of ischemic event ranging from 30% to 43%!" Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.
But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.
Such examples of the drug industry’s outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is…
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Might I Also Suggest Subsidized Crack For Crackheads Perhaps?
by ilene - August 14th, 2010 5:24 am
Might I Also Suggest Subsidized Crack For Crackheads Perhaps?
Courtesy of Jr. Deputy Accountant
Oh Big Pharma, your marketing talents never cease to amaze me. As if Crestor and the like haven’t gotten enough of a push lately with drug companies now able to market statins to those with lifestyles that might lead to higher cholesterol, British researchers have actually suggested that statins should be offered as condiments to balance the unhealthy effects of fast food.
You have got to be kidding me. Why not try keeping the Big Mac out of your mouth, fat a*s?
Patrons of fast-food restaurants may see packets containing statins next to the ketchup and salt at the self-serve counter if the suggestion of British researchers becomes reality.
Emily Ferenczi, BMBCh, of Imperial College London, and colleagues calculated that most daily statin regimens would be enough to neutralize the increased cardiovascular risk associated with eating a quarter-pounder with cheese and small milkshake every day.
Because statins are cheap, relatively safe even at high doses, and effective for reducing cardiovascular risk across patient subgroups, offering them to individuals who choose to eat an unhealthy diet against best medical advice might make sense, they argued in an editorial in the American Journal of Cardiology.
"It cannot … be reasonably argued on safety grounds that individuals should be free to choose to eat lipid-rich food but not be free to supplement it with a statin," they wrote.
A recent LA Times article wonders just how effective statins can be - it appears to me they are quite effective… at making money, that is.
As the world’s most-prescribed class of medications, statins indisputably qualify for the commercial distinction of "blockbuster." About 24 million Americans take the drugs — marketed under such commercial names as Pravachol, Mevacor, Lipitor, Zocor and Crestor — largely to stave off heart attacks and strokes.
At the zenith of their profitability, these medications raked in $26.2 billion a year for their manufacturers. The introduction in recent years of cheaper generic versions may have begun to cut into sales revenues for the brand-name drugs that came first to the market, but better prices have only fueled the medications’ use: In 2009, U.S. patients filled 201.4 million prescriptions for statins, according to IMS Health, which tracks prescription drug trends. That’s nearly double the number of prescriptions written for
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Treat the Risk, Not the Cholesterol: Study Challenges Current Cholesterol Recommendations
by ilene - January 23rd, 2010 2:57 pm
Here’s a very important – maybe paradigm shifting - press release on a study that challenges the current, broad-based recommendations for people to lower their cholesterol. My highlights. – Ilene
Pharmboy had this comment:
Good article, and I agree with most of what’s in it, from scientific standpoint. I am not a Doc, but I have worked on this area of research. There are a few things in the pipelines of several companies that may help the inflammation of the arteries when someone is on a statin, and [the biotech] VIAP is spearheading the trials for this exact study. Unfortunately, their drug is for a shorter term treatment, and the real trials will have to be a bodybag trial….either they preserve life, or don’t. Diet and exercise are the two biggest things we can do to stay healthy.
Treat the Risk, Not the Cholesterol: Study Challenges Current Cholesterol Recommendations
ANN ARBOR, Mich., Jan. 22 /PRNewswire-USNewswire/ — A new study by the University of Michigan Medical School and VA Ann Arbor Health System challenges the medical thinking that the lower the cholesterol, the better.
Tailoring treatment to a patient’s overall heart attack risk, by considering all their risk factors, such as age, family history, and smoking status, was more effective, and used fewer high-dose statins, than current strategies to drive down cholesterol to a certain target, according to the U-M study.
While study authors support the use of cholesterol-lowering statins, they conclude that patients and their doctors should consider all the factors that put them at risk for heart attack and strokes.
The findings will be released online Monday ahead of print in the Annals of Internal Medicine.
"We’ve been worrying too much about people’s cholesterol level and not enough about their overall risk of heart disease," says Rodney A. Hayward, M.D., director of the Veterans Affairs Center for Health Services Research and Development and a professor of internal medicine at the University of Michigan Medical School.
The National Cholesterol Education Program recommends harmful LDL cholesterol levels should be less than 130 for most people. High risk patients should be pushed even lower — to less than 70.
The U-M study took a different approach, called tailored treatment, which uses a person’s risk factors and mathematical models to calculate the expected benefit of treatment, by considering:
-- A person’s risk of a heart attack or…
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Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...
Ilene is editor and affiliate program
coordinator for PSW. She manages the site