Red Flags - Drugs

Conflicting Advice On Blood Pressure Pills

Wed, 07 Jun 2006 20:48:54 -0400

Last fall, a Food and Drug Administration (FDA) advisory panel gave its overwhelming endorsement to a diabetes drug made by Bristol-Myers Squibb. The FDA sent a letter calling muraglitazar “approvable” after some additional safety tests. A few weeks later, three prominent Cleveland Clinic cardiologists writing in the Journal of the American Medical Association used the same data to show the drug increased patients’ risk of heart attacks and strokes. The company soon withdrew its new drug application.

Coenzyme Q10 And Statins: A Tale Of Two Bestsellers

Wed, 17 May 2006 20:53:50 -0400

In the world of dietary supplements, CoQ10 is a best seller. Every year, its popularity grows. So the apparent struggle between this vitamin-like substance and the widely prescribed statin drugs reminds me of a wrestling match — a young, muscled fighter grappling with a powerful giant.

Statins And Cancer

Wed, 11 Jan 2006 04:00:00 -0500

For a few years now, studies have been concluding that statins not only protect against heart disease, they also protect against a whole host of other diseases, including — naturally — cancer.

So, I Was Wrong About Vioxx

Wed, 14 Dec 2005 04:00:00 -0500

U.S. judge declares a mistrial in first federal trial
over Merck & Co.’s Vioxx

The judge overseeing the first federal Vioxx liability suit declared a mistrial after the jury failed to reach a unanimous verdict due to a single juror’s refusal to vote in the drug maker’s favor. Merck & Co.’s general counsel Kenneth Frazier commented that the mistrial ruling "is in no way, shape or form a loss for the company."

And to think that I thought a federal court would find Vioxx not guilty. I even wrote that it would be thus. Yet, it is not quite thus. Although I gather that only one juror voted against Merck, the rest were going for a not guilty verdict. So we had a mistrial. Nearly, but not quite, the result that I predicted.

The New Scientific Ducking Stool

Fri, 25 Nov 2005 04:00:00 -0500

I shall probably be told that I am wrong, but I understand that the ducking stool was used to determine whether or not someone (usually a female someone) was a witch. The defendants were placed in the stool and lowered onto the surface of a pond. If they sank, they drowned, but were pronounced innocent. If they floated, they were witches; so they were then drowned anyway.

Other ways of determining witchery included grasping a red-hot poker. If it burned you, you were innocent; if it didn’t burn you, you were a witch. To be frank, once the powers that be had decided you were a witch, you were going to be found guilty — then killed. Or found innocent — but killed in the process. Take your pick.

Vioxx And The Tricky Concept Of Proof

Wed, 23 Nov 2005 04:00:00 -0500

How do you prove something? How can you prove that Slobodan Milosevic or Saddam Hussein are guilty of war crimes? How do you prove that smoking causes lung cancer? Proof is damned tricky to achieve, even when the evidence appears overwhelming.

More than a century ago, German physician Robert Koch was struggling to decide how you could absolutely, definitely, prove that factor X caused disease Y. The disease in this case was tuberculosis. In an attempt to define proof of causation, Koch formulated his famous postulates, which now bear his name.

ASCOT–BPLA (Another Stupid Commercially Overhyped Trial – Before Prescribing Look Again)

Wed, 19 Oct 2005 04:00:00 -0400

I have been aware of the ASCOT study for some time. In fact, it seems to have been spewing out results for the past 500 years or so. Maybe not quite that long but, boy, it sometimes seems like it.

First we had ASCOT–LLA (Anglo Scandinavian Cardiac Outcomes Trial – Lipid Lowering Arm). This was stopped early because of the fantastic benefits of giving people a statin. So great were the benefits that it was considered unethical for the trial to continue. The difference in overall mortality between the two arms of the study was a majestic, gigantic … zero.

Strike My Comments From the Record

Mon, 03 Oct 2005 04:00:00 -0400

When Merck first pulled Vioxx from the market, I commented that Merck seemed to have acted in a reasonably ethical fashion. I thought, at the time, that Merck officials knew nothing of the increased heart attack risk from Vioxx. As soon as they knew, they withdrew the product.

Even if Vioxx had caused a whole load of heart attacks, my view was that you couldn’t blame Merck, if it didn’t know. After all, side effects can emerge many years after drugs are launched. If the drug trials are relatively short, you will probably miss a side effect that may only appear after several months, or years. We all know that smoking causes lung cancer, but a five-year study on new smokers would — in all probability — show no effect.

What Tangled Webs We Weave

Fri, 09 Sep 2005 04:00:00 -0400

Refreshed from a holiday in France, I returned to work to find an e-mail informing me that a German study has concluded that Lipitor (atorvastatin) might not be as effective as the other statins, and might also have more side-effects.

Well, it must be true because it was a study done by the Institut fuer Qualitaet und Wirtschaftslichkeit im Gesundheitswesen. And there is no way on Earth you could argue with an institute as formidable sounding as that. An institute, I picture, entirely populated by white-haired professors all looking like a cross between Albert Einstein and Socrates.

Statins And Dementia

Thu, 14 Jul 2005 04:00:00 -0400

The great thing about statins is that, in study after study, they have been shown to have remarkable, life-enhancing effects on all sorts of diseases — other than heart disease. I have kept a rough checklist: statins have beenfound to protect against breast cancer, colorectal cancer, Alzheimer’s, rheumatoid arthritis, diabetes, multiple sclerosis, liver damage and macular degeneration.

Tony Bliar On Statins

Tue, 05 Jul 2005 04:00:00 -0400

(No, Not A Misspelling)

There is a quaint custom in the House of Commons in the UK, whereby once a week the Prime Minister takes questions from the House. It’s all somewhat formal and weird, with questions put to the Speaker of the House, who will then choose which ones can be asked.

You will always get one or two questions from a sycophantic member of his own party that go something like. ‘I think we can all agree that Tony Blair has shown great vision and leadership over the past eight years. Can he tell us how he sustains his energy, and brilliance and… damned good looks.’ You think I exaggerate, but only by a very small amount.

Spotting The Sleight Of Hand

Tue, 28 Jun 2005 04:00:00 -0400

A redflags reader wrote me a quick e-mail, with a plea ‘Please tell me this study is biased in some way!’ He enclosed a link to an article that had appeared, on-line, in Medical News Today (never ‘eard of it).

The article headline was ‘Lipitor reduces heart attack and stroke risk for diabetes patients.’ And it referred to a sub-group analysis from the TNT (Treating to New Targets) trial. In this trial people were given either 10mg, or 80mg Lipitor to see what would happen.

A Marketing Tale

Tue, 07 Jun 2005 04:00:00 -0400

Once upon a time, in a land far, far away, wise medicine men decreed that cholesterol should be lowered to prevent heart disease. So the alchemists retreated to their dark laboratories, and developed magic potions such as fibrates and cholestyramine. And yeah verily, cholesterol was lowered, but the people taking these potions tended to die in higher numbers than those not taking the potions. So it was decreed that these potions should be swept under the carpet whilst no-one was looking.

Statins And Cancer

Tue, 24 May 2005 04:00:00 -0400

(Now It Is Getting Silly)

I was not sure whether to even bother responding to the latest news that statins prevent breast cancer. But I think I must, as I believe we are now entering very dangerous ground with statins. We are moving beyond accentuating the positive towards a total distortion of the facts. Over the last year or so, I have seen articles stating that statins prevent Alzheimer’s, prostate cancer, heart failure and now breast cancer. I have seen, and groaned.

Stopping Statins Is Bad For Your Health!

Tue, 17 May 2005 04:00:00 -0400

A kind reader just sent me a link to an article in Geriatrics

It was entitled, ‘stopping statins is bad for your health.’ I’m afraid to say that it isn’t new news, as it came out in October last year, but it is news to me. And it is such a mind-bogglingly stupid article that it demands some comment.