British Medical Journal's statin articles to be investigated (about side effects)

[muriel_volestrangler]

The journal will set up an expert panel to decide if it should retract two articles saying the cholesterol-reducing drugs had harmful side-effects.

The papers were criticised when they were published in October.

Statins are offered to seven million people in the UK who have a 20% chance of heart disease in the next decade.

The BMJ said Dr John Abramson from Harvard Medical School and UK cardiologist Dr Aseem Malhotra had already withdrawn statements from the articles after some figures proved to be incorrect.

http://www.bbc.co.uk/news/health-27420100

[canoeist52]

1. These are financial decisions.

Pharmaceuticals Companies want more patient profits. They have nothing to do with actual health outcomes. They belong in the financial section of the news.

[Squinch]

2. The results of this will be interesting.

I'd say it's an even bet whether this is the result of bad statin studies or someone protecting their profit.

[tridim]

3. It's not about the side-effects, its about the primary effects of statins...

Effects which will destroy your body in order to reach an artificial number based on a test developed by the same people that make the drug, and worse it doesn't lower your risk of anything.

Or they're completely safe, like big pharma says.

[WCLinolVir]

4. It ought to scare people every time a doctor prescribes a drug.

The anecdotal evidence of the effects of statins has been known for a long time, regardless of who acknowledges them. And I do look to the side effects, but more importantly, I google for problems that patients say they have with any prescription drug. It seems we have a grossly inadequate standard of safety for prescription drugs. Doctors often look at your health piecemeal, and prescribe accordingly. We are nothing more than second tier lab rats.
When I was in nursing school, we weren't allowed to talk about anecdotal evidence regarding drugs during pharma classes.
Recently my partner, who is a vet,has been diagnosed with a murmur. The doctor was not going to test or treat it, but told him his episodes of faintness was associated with his HBP, even though he had episodes while sitting with no exertion. We clarified this for the doctor who then said, you have a heart murmur, and is ordering tests. But it wasn't going to happen without insistence. This weekend he had an episode of AFib and the drug he has him on is potentially not a good drug for patients with a murmur.

[grasswire]

8. yep, you're on your own these days.

I have come to have little faith in standard medicine. And the statin battles are partly responsible for that.

[hedgehog]

5. Isn't the point of publishing something in a journal rather than the Net that

the science is thoroughly checked by others before publication?

How in the world did the Lancet ever publish Wakefield's article connecting the MMR vaccine to autism?

http://www.bmj.com/content/342/bmj.c7452

[goldent]

6. The peer review process is hit or miss

and the science is NOT thoroughly checked, it is reviewed. The effectiveness all depends on how much time the reviewers take. The process is based on the assumption that the author follows established research methodology and is forthcoming on how the work was done.

Statins have been widely used for many years now with lots of data available, so I don't understand why the author would use data from an "uncontrolled observational study." This paper was going to make a big splash - you might wonder whether that influenced how forthcoming the authors were about the source of their data.

By the way, with the patent expiring on Lipitor, atorvastatin is now inexpensive.

[hedgehog]

7. The review can't determine if the results are honest or if they were tweaked,

but at minimum, journals should refuse any articles describing poorly designed experiments. Small sample groups, for example, should be a warning sign.

At least now, may journals require the authors to post any possible conflicts of interest.

[MickiSue]

9. Good Heavens

OF COURSE they have side effects, and some of them are dreadful. Liver enzymes skyrocketing, severe fatigue, muscle pain, on and on.

The reality is that statins are NOT benign, and saying so is a brave and honest thing to do. Big Pharma has very long tentacles. This "expert panel" sitting is just one of many too many examples.

[muriel_volestrangler]

10. RCTs comparing statins and placebos

What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice

Objective Discussions about statin efficacy in cardiovascular prevention are always based on data from blinded randomized controlled trials (RCTs) comparing statin to placebo; however, discussion of side effects is not. Clinicians often assume symptoms occurring with statins are caused by statins, encouraging discontinuation. We test this assumption and calculate an evidence-based estimate of the probability of a symptom being genuinely attributable to the statin itself.

Results Among 14 primary prevention trials (46,262 participants), statin therapy increased diabetes by absolute risk of 0.5% (95% CI 0.1–1%, p?=?0.012), meanwhile reducing death by a similar extent: ?0.5% (?0.9 to ?0.2%, p?=?0.003). In the 15 secondary prevention RCTs (37,618 participants), statins decreased death by 1.4% (?2.1 to ?0.7%, p?<?0.001). There were no other statin-attributable symptoms, although asymptomatic liver transaminase elevation was 0.4% more frequent with statins across all trials. Serious adverse events and withdrawals were similar in both arms.

Conclusions Only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo. Only development of new-onset diabetes mellitus was significantly higher on statins than placebo; nevertheless only 1 in 5 of new cases were actually caused by statins. Higher statin doses produce a detectable effect, but even still the proportion attributable to statins is variable: for asymptomatic liver enzyme elevation, the majority are attributable to the higher dose; in contrast for muscle aches, the majority are not.