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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

(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.

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.

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.

(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.

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.

But The Great Ship “Cholesterol-Lowering” Has Ripped Its Guts Out On The Harsh Rocks Of Evidence, But Still It Does Not Sink

Oh, the joy. Just how annoying can I be now? After the PROVE-IT and REVERSE trials comes the A to Z trial, looking at aggressive high-dose Simvastatin treatment vs. low-dose. And I have just been proved right.

There are those of us, poor misguided fools, who believe that the main point of taking drugs is to prevent an early death. We are clearly wrong. The important thing is that you must not die of heart disease. For dying of heart disease is clearly much worse than dying of something else.

I don’t know, for myself, I think a major unexpected heart attack is not a bad way to go. A sudden sharp crushing pain, then it all goes dark, then – well who knows actually. Not that pleasant, but this is a better way to go, surely, than a slow agonising death from cancer. Or maybe not, maybe we should all have a chance to prepare for death, get used to the idea….. discuss.

Imagine waking up and having no recollection of anything that happened the day before. All memory, wiped, gone. You find a letter written by yourself that you can’t remember writing. You go out to buy a present only to find, when you get home, that you had already bought it. Your next-door neighbour asks for his wheelbarrow back, the one he lent you yesterday, you look at him blankly and say you haven’t got it.

Every so often a story emerges that is just so exquisite that I have to rub my eyes and slap my cheeks to make sure I am awake, and I haven’t just dreamed it. One such story just emerged from the American Heart Association meeting in New Orleans.

Basically, what researchers have found is that if you take your drugs every day, rather than missing them from time to time, you will halve your chances of dying (A bit of a meaningless statistic, as we are all going to die. I think what they meant to say is that you will halve your chances of dying during some defined time period).

Some Thoughts After Discovering That Some Members Of A Panel Recommending New Statin Guidelines Had Big Pharma Ties

As P.G. Wodehouse once wrote (sic) ‘When an Englishman says ‘trust me’ it’s time to start counting the spoons.’ At what point does the same hold true for an international medical opinion leader?

A few years back the Attorney General in the United Kingdom, Lord Irvine, ( Britain’s highest ranking legal figure), was accused of acting in an improper fashion. He had asked various barristers for donations to the Labour Party – which was in power at the time – and Lord Irvine was both a member of the Labour party and personal friend of Tony Blair.

I was reading recently that the Intelligence community has come up with a phrase ‘groupthink’ to explain how groups of people can do really stupid or unpleasant things, whereas an individual would never go so far. When we are part of a group it seems that we can push the boundaries of far-out behaviour much, much, further.

I don’t like the word groupthink, it is functional and ugly. But it certainly is true. I have recently become fascinated by the conformity of many…most? people’s thinking, and I have been trying to work out why this happens. So I was open to the idea of groupthink before it came along.

One Contrary To The Same Company’s Aggressive Promotion Of Its Drugs To Treat High Blood Pressure And Lower Cholesterol

They say you should never explain a joke, because then it just isn’t funny any more. I quite agree, but something made me laugh over the weekend, and there is no way that I can get anyone to understand why without explaining it.

I shall attempt to set the scene.

1. Holoprosencephaly (defective septum separating lateral cerebral ventricles, with cerebral dysfunction), atrial septal defect, aortic hypoplasia, death at one month of age.
   
2. Aqueductal stenosis with hydrocephalus, concurrent limb deficiency
   
3. Cerivothoracic-to-lumbar neural-tube defect, myelocele, duplication of spinal cord, cerbellar hernation with hydrocephalus; apparent agenesis of palate
   
4. Spina bifida, right-arm abnormality
   
5. Left leg: femur 16% shorter than right side; foot: aplasia of metatarsals and phalanges 3,4 and 5; additional VACTERL (vertebral, anal, cardiac, tracheal, esophageal, renal and limb defects): left renal dysplasia, reversed laterality of aorta, disorganized lumbosacral vertebra, single umbilical artery; additional findings: clitoral hypertrophy, vaginal and uterine agenesis.

It always amazes me that some things seem to strike terror into the hearts of mankind whilst other, much more dangerous things, are accepted with a shrug of the shoulders. As my son has taken to saying ‘Yeh, whatever.’

When someone sent me a copy of an article in the Washington Post, stating that more and more doctors now think that children as young as four should be put on statins, my fingers started to itch.

Here’s the offending headline:

 ‘Despite Controversy, Pressure Grows to Treat High Cholesterol in Children After Studies Link Elevated Levels to Adult Heart Disease.’
By Elizabeth Agnvall
Special to The Washington Post
Tuesday, December 2, 2003

Forget about the alchemist’s magical "Elixir of Life" and Ponce De Leon’s "Fountain of Youth". These fantasies have recently been replaced by a combination pill concocted not by some "kook", but two distinguished scientists, Nicholas Wald, Professor and Head of the Wolfson Institute of Preventive Medicine in London and Malcolm Wald, a Professor at the University of London and University of Auckland in New Zealand. These researchers believe they can prevent almost nine out of ten heart attacks as well as four out of five strokes in anyone with cardiovascular disease and everyone age 55 and older. All you need to do is to take their powerful Polypill daily.

Theheart.org, a large cardiology site that receives sponsorship from the drug industry, is generally a well-regarded source of information for health-care professionals. The editorial board lists 85 doctors in 19 countries. Three of the eight editors, including the editor-in-chief, have declared they own stock options in the website’s parent company.

The British Medical Journal (BMJ) recently published a proposal calling for the development of a "polypill," a medication consisting of six different drugs, aimed at reducing the risk of cardiovascular disease by 80 per cent or more.

WHAT WE THINK WE KNOW ABOUT WOMEN’S HORMONES AND HEART DISEASE CAN HURT US ALL

"It’s not what we don’t know about nutrition that hurts us, it’s what we know for sure that turns out to be dead wrong." – Victor Herbert