Adverse Reactions : drugs

This pill makes you rich

Bryan Hubbard — Fri, 12 Sep 2008 20:20:00 GMT

Let's get down to the real nitty-gritty of what medicine is all about - money. As stock watchers amongst you may know, Big Pharma is being marked down by City (and Wall Street) slickers, who are putting up 'Sell' notes wherever they are seeing a pharmaceutical company.

Why? Haven't drug companies found a cure for cancer yet? Or perhaps they're not getting the rapid recovery rate for their patients?

Not a bit of it. Had that been the criteria for drug companies' share price, they would have been in the bargain basement long since. No, the reason for the panic sell is simply that many drugs are now passing out of the protection of patent, and so can be copied - with very minor modifications - by all and sundry.

In the past few days, both AstraZeneca and GlaxoSmithKline (GSK) have been downgraded because several of their key profit-making drugs are soon to pass out of patent. GSK, in particular, faces a turbulent 2009 as some of its hot-shot drugs suddenly face stiff competition from the 'me-too' boys who will be swamping the market with very similar concoctions.

It's sad that medicine is so judged. As I've often observed, what purports to be a benefactor of mankind is, in fact, purely an instrument of gain for shareholders.

And the sooner everyone wakes up to that reality, the sooner we may finally see a medical model that first serves mankind and its suffering.

Take a plane, not a drug

Bryan Hubbard — Fri, 04 Apr 2008 12:26:00 GMT

Do you think that the science that determines the safety of the drugs we take is the same as the science that determines the safety of aircraft technology?

It's a question that lies at the heart of a fascinating paper from Herman Jeggels, a medically-qualified doctor who now practises in his native South Africa. In it, he compares the science employed by NASA, the American Department of Defense and the UK's Ministry of Defence, with that of medicine.

Since the 1980s, NASA has used technology readiness levels (TRLs) to eliminate risk and determine the maturity and safety of their technologies, and which has been taken up by the two ministries of defence. NASA seeks a zero risk on all its technologies, and would consider as unacceptable even a 3% risk of an aircraft or satellite crashing in a residential area.

To achieve this level of safety, the technology must pass through nine stages, which embrace the science (TRL 1-2), experimentation (TRL 2-3), verification (TRL 4-7), and demonstration (TRL 8-9).

By comparison, medicine never gets beyond TRL 3 - the level of high-risk experimental technology - in asessing the safety of its drugs. At level 3, the technology - or pharmaceutical - would still have an immature, uncertain and high-risk status. A randomised controlled trial on a drug is an experiment, producing experimental evidence only.

"Therefore," writes Jeggels, "therapies marketed on the basis of randomised, controlled trials represent unverified, untested, immature, high-risk therapies, resulting either in the suffering or death of patients, and certainly do not reverse most disorders."

So now you have an intelligent answer ready the next time somebody tells you that medicine is 'scientific'.

Diabetes drug may soon be pulled

Bryan Hubbard — Tue, 22 May 2007 14:39:00 GMT

Avandia (rosiglitazone), the diabetes drug, may soon be pulled from markets around the world after a study discovered it increased the risk of heart attack by 45 per cent. America's drug regulator, the Food and Drug Administration ( FDA ), has issued...(read more)