WHAT DOCTORS DON'T TELL YOU READERS' BROADCAST

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- E-news broadcast. 240 - 17 March 2006

 

 

 

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News contents

 

 

 

DRUG TRIALS: It's not so unusual

 

BROCHURES AND LIES: How doctors stay informed

CANCER THERAPY: If all else fails, try thalidomide

 

CRESTOR: The 15 facts you really need to know

 

 

 

 

 

 

 

DRUG TRIALS: It's not so unusual

 

 

 

While our thoughts and best wishes go out to the six young men in

intensive care after participating in a clinical trial for a new

anti-inflammatory, it seems to have escaped everyone's attention

that two people died in the pre-licensing trials for Crestor, this

week's wonder drug.

 

In addition, a further 50 people suffered serious adverse effects

that can be life threatening, and there was a strong consumer

campaign to prevent its approval.

 

But that was all of three years ago, and today Crestor is hailed as

the great breakthrough drug for arterial health, something for which

it is not licensed to treat. Indeed, say the researchers, everyone

over a certain age should be taking Crestor at its upper `safe'

limit of 40mg a day.

 

Meanwhile, the damage limitation lobby has been getting in full

swing following the news that six young men, who participated in an

early-stage trial for the anti-inflammatory code-named TGN1412, are

still in intensive care. As we write, two remain on life-support

machines.

 

Drug company apologists are earning their `conference trips' to the

Caribbean, sponsored, of course, by a drug company, to state in no

particular order to any member of the media who will listen that: a)

this is incredibly rare, if not unprecedented; b) drugs are

remarkably safe; c) the industry is well regulated; d) and, because

of a, b and c, it will never happen again.

 

Each of these statements is false. What is unusual is that six

young men should collapse in agony just minutes after taking the

drug, and this is why the story has grabbed the headlines. Usually

it's something that happens gradually over a much longer period, by

which time most anything else can be blamed for the person's sudden

decline in health.

 

Drugs are not safe. They are as safe as we can make them, which is

not very safe at all. The fact remains that, in the USA alone,

deaths from drugs are similar to a jumbo jet crashing every three

days. Alarmist? Hardly. The figures came from the Journal of the

American Medical Association.

 

Finally, the industry is not well regulated. The regulators are

funded by the drugs industry, and invariably populated by experts

who are sponsored by drugs companies. Indeed, Britain's own drug

regulator has prided itself on being the fastest licensing agent in

the West, so a drug company that needs to get a drug onto the market

quickly knows just where to come.

 

Because of the above, people will continue to die in early, late and

post-licensing clinical trials. Indeed it happens every day, but not

in such a dramatic fashion. That's why you never read about it.

 

It would take a book to fully explain all of this. Fortunately

we've written one. It's called The Secrets of the Drugs Industry,

and it's available from our website today. Just click here to place

your order: http://www.wddty.co.uk/shop/detail.asp?id=4393 & did=537

 

* STOP PRESS: One of our drug industry contacts tells us that the

numbers of people volunteering for trials has actually risen since

the story broke. Apparently they've ignored the life-threatening

bits and concentrated on the £1200 fee they'll receive. That, plus

the promise of a lie down, free food and no washing up, as one drug

company promised. Nowt so strange as folk, as our Yorkshire

correspondent reminds us.

 

 

 

 

 

BROCHURES AND LIES: How doctors stay informed

 

 

 

So this is how it works. Doctor leaves medical school. Doctor

stops learning. Doctor becomes increasingly dependent on drug

company salesmen for updates in healthcare. Drug company lies.

 

A new study has discovered that three out of 20 brochures

distributed to family doctors by drug companies `exaggerated the

benefits of treatment'. When researchers compared the claims made

in the brochures against the findings of the research on which they

were based, they found a fair amount of artistic licence and

interpretation.

 

Three brochures in particular embellished the findings in order to

present the drug's benefits in a better light.

 

Quite how many doctors changed the prescription on the basis of the

brochures is not known. But lets' hope that hereon in, it's none.

 

(Source: BMC Family Practice 2006; 7:13).

 

 

 

 

 

 

 

CANCER THERAPY: If all else fails, try thalidomide

 

 

 

You can't keep a bad drug down. Thalidomide, the morning sickness

drug that spawned an industry of regulation and monitoring, has

continued to be widely used in the Indian sub-continent, and it

could soon become the treatment of choice for multiple myeloma.

 

High-dose chemotherapy is the standard treatment, but oncologists

have found that it is not so effective among the over-65s, but these

represent just a third of all cases. So, for most sufferers, there

is no effective treatment.

 

When researchers in Italy mixed thalidomide with standard

chemotherapy drugs, they found that it was twice as effective over

the immediate and medium terms.

 

With nothing better on the horizon, the researchers believe that

thalidomide with chemotherapy should become the standard treatment.

 

There's one problem with this picture. Those in the thalidomide

group were also twice as likely to suffer an adverse reaction to the

treatment, and problems ranged from sedation, fatigue and

constipation through to life-threatening deep vein thrombosis,

neurological toxic reactions, and infection.

 

Oh yes, and many more in the thalidomide group died in the first

nine months following treatment.

 

(Source: The Lancet, 2006; 367: 825-31).

 

 

 

 

 

 

 

CRESTOR: The 15 facts you really need to know

 

 

 

If you missed our E-news special on Tuesday about Crestor, hailed as

the great new heart wonder drug, here it is again, in an edited

form, as it's worth the repeat. The world's media has been buzzing

with the news that the statin drug, Crestor (rosuvastatin),

can `turn back the clock' and make furring and narrowing arteries

healthier. It's reckoned the discovery could prevent thousands of

heart attacks and strokes every year.

 

The statin drug family was developed to help lower cholesterol

levels, but researchers have discovered that it can also reduce the

effects of atherosclerosis, where fatty deposits build up in the

arteries, by up to 9 per cent. It can make a narrowing artery three

or four years `younger', and some estimate on that basis that the

drug could reduce the age of the artery by up to 15 years if taken

for 10 years.

 

The good effects were seen only at the maximum licensed dose of 40

mg, and lead researcher Dr Neal Uren, a cardiologist at Edinburgh's

Royal Infirmary, admitted that doctors would need some convincing to

prescribe such an aggressive dose for long periods.

 

So should you, and here are 15 reasons why.

 

1. Crestor has been associated with myopathy and rhabdomyolysis, a

muscle-wasting disease that can lead to kidney failure. This was

especially apparent at doses of 40 mg.

2. In the USA, the 40 mg dose has a restricted use, and is

available only to people below the age of 65, and who have no health

problems.

3. Another statin, Baycol, was taken off the market in 2001

following reports of 31 deaths from rhabdomyolysis.

4. Crestor's manufacturer delayed the launch of the drug after

early clinical trials reported kidney damage and muscle weakness,

the early stages of rhabdomyolysis.

5. Even before it was granted a licence in the USA, lobby groups

were fighting to keep Crestor off the market. They pointed to

evidence that suggested that it was especially toxic to the

kidneys. Aside from rhabdomyolysis, a number of patients given the

40 mg dose suffered from persistent protein in their urine

(proteinuria) and blood in the urine (hematuria). Lobby groups such

as Public Citizen's Health Research Group said that in the pre-

licensing trials alone, two people had died and another 50 suffered

serious adverse reactions.

6. A special committee of America's drug regulator, the FDA, urged

that every patient on a 40 mg dose of Crestor have regular

monitoring of their kidneys. This recommendation was never taken

up.

7. The FDA is very aware of the dangers of Crestor at the 40 mg

dose. In an attempt at `risk management', as it calls it, 40

milligram Crestor tablets cannot be stocked at retail pharmacies.

Instead the pharmacist must order them especially from a wholesaler,

which takes an extra day before they are in the hands of the

patient. It's hoped that this extra day may encourage the

pharmacist and patient to opt for a lesser dose.

8. Crestor can create a potent, and potentially deadly, chemical

cocktail if it's taken with other prescription drugs. People

already taking gemfibrozil or niacin, cholesterol-lowering drugs, or

warfarin, the blood thinning agent, or cyclosporine, should not also

take Crestor.

9. General symptoms of adverse reactions while on Crestor include

muscle pain, weakness, tenderness, fever, dark urine, nausea and

vomiting.

10. The FDA is not the only drug regulator that's worried about

Crestor. The Canadian authority has advised patients to take only

the lowest dose of the drug.

11. In 2004, the FDA ordered Crestor's manufacturer to tell

patients in Europe about the dangers of myopathy, serious muscle

toxicity, especially at the high dose of 40 mg. This effect became

very apparent only after the drug was granted a licence in the USA

in 2003, even though it was part of the initial warning when the

drug was released in the States.

12. Crestor is a statin, a group of drugs that may harm as many

people as it helps, according to scientists at the University of

British Columbia. They analysed the findings of five major trials,

and discovered that statins reduced the risk of heart attack and

stroke by 1.4 per cent – but increased the risk of serious side

effects by 1.8 per cent.

13. All drugs have to measure up to the risk-to-reward ratio. As

every drug comes with a potential side effect, doctors have to be

sure it will probably do more good than harm. But when scientists

at the University of Sheffield investigated the statins, they found

that they were associated with a 1 per cent increase in mortality

every 10 years of use.

14. Some researchers go further, and reckon that statins actually

cause heart disease. Leading this controversial research is

cardiologist Dr Peter Langsjoen, who has coined the term `statin

cardiomyopathy' to explain the very high number of cases of heart

failure he's witnessed in his 17 years of practice among patients

who were taking statins.

15. His heretical thinking is supported by science. Researchers at

the University of Texas gave us our first clues in 1985 when they

found that those suffering from heart failure had a deficiency of

the enzyme ubiquinone in their heart tissue. The less ubiquinone,

the worse the heart failure.

 

 

The whole ethos of What Doctors Don't Tell You is that there are

many simple and inexpensive ways of treating – even reversing –

chronic conditions without having to use powerful drugs. Why take

the risk when there's so much more you can do, and which can be just

as effective, if not more so? You can only find out by trying, and

you can start today with our special heart health pack that we've

put together as our welcome to all new rs.

 

Many simple and inexpensive ways of improving heart and artery

health are outlined in the welcome pack. The pack includes our best-

selling book My Healthy Heart, the insightful report Secrets of

Longevity, and two special reports on Antihypertensives and Heart

Failure. In all, these free reports and books are worth more than

£36. And we'll start your subscription with our special issue on

the hidden reasons for heart problems, which can be reversed with a

simple vitamin. To place your order,

http://www.wddty.co.uk/shop/detail.asp?id=4665 & did= & Curr=GBP

 

 

 

 

 

 

 

 

 

Listen to Lynne

 

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Digital Radio Station focusing on your health and your environment -

http://www.wddty.co.uk/passion_main.asp

 

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on Passion, there's a new one each week -

http://www.wddty.co.uk/passion_archive.asp

 

 

 

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