DIABETES RESEARCH - are you being Serviered?

The big news in this last week has been the publication of a report in the New England Journal of Medicine (NEJM), and a paper presented at the American Diabetes Association’s conference in San Francisco, concerning ground breaking diabetes research conducted in Australia and overseas, branded as the ‘Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes’ study.

 

The study was conducted by clinicians from The George Institute for International (code word for trips) Health (code word for drugs), subtitled the ADVANCE Collaborative Group and masquerading as a branch office of Big Pharma and, in particular Les Laboratiores Servier.

 

This was a study that took donkey's ages to complete and involved over 1400 researchers and clinicians around the world (including Drs, Fu, Lu, Wu, Zu, Ding and Honka).

 

This was a study of earth shattering dimensions. After five years and 11,000 subjects, 1% less people will have a major kidney complication if they take a massive doses of Gliclazide and a swag of other diabetes drugs than if they take the normal doses (whatever that means) of diabetes drugs.

 

In round figures the health of a quarter of the subjects got worse. 10% of them died. 44% ended up in hospital. The study should have been aborted.

 

For lay readers who want to know more about the effect of Gliclazide, it has about the same effect on getting more insulin out of a worn out pancreas as squeezing has on getting blood out of a stone!

 

Instead of giving the suspects a scientific exercise program, that included intensive aerobic exercise and pumping iron, all the researchers could do was pump the suspects full of drugs: - 

 

-         Preterax -         Diamicron -         Perindopril -         Indapamide -         Gliclazide

-         Metformin -         Thiazolidinediones -         Acarbose -         Insulin in the form of            Glargine and Detemir

 

- not to mention the drugs used to lower cholesterol and blood pressure

  levels.

 

If you gave these people a good shake they'd rattle. For some it was the death rattle!

The 11,000 odd people were herded into two groups. The intensive group got more drugs than the standard group. Whilst it’s hard from the research report to determine exactly what went on, basically what it appears that what they did was double the dose of insulin for the intensive group, for short term gain, regardless of the effect it had on the long term metabolic health.

 

THE RESULTS

This was a monumentally successful study. The results were staggering – hence the appearance between the covers of the NEJM and on the platform of the American Diabetes Association.

 

‘At the end of the follow-up period, the mean systolic blood pressure was lower in the intensive-control group than in the standard-control group (135.5 vs. 137.9 mm Hg; average difference, 1.6 mm Hg.’ The difference is miniscule, about the effect of closing your eyes and taking a deep breath.

 

‘The mean body weight during the follow-up period was 0.7 kg greater in the intensive-control group than in the standard-control group.’ It is doubtful whether this weight gain was from an increase in lean muscles tissue. In the absence of more information we can only presume the subjects got fatter.

 

‘During the follow-up period, the use of most classes of oral hypoglycemic drug and of insulin had increased to a greater degree in the intensive-control group than in the standard-control group.’ If at first you don’t succeed, pump in more drugs.

 

‘A total of 2125 participants had a major macrovascular or microvascular event: 18.1% in the intensive-control group and 20.0% in the standard-control group.’ Nothing there to write home about!

 

‘A total of 1031 participants died: 8.9% in the intensive-control group and 9.6% in the standard-control group.’ Sounds like a very good treatment regime! Be interested to know what the ethics committee and the NH&MRC thought of that one.

 

‘More patients undergoing intensive control (44.9%) were hospitalized for any cause than those in the standard-control group (42.8%).’ A small difference, but a significant result. The drugs didn’t keep people out of hospital.

 

‘As compared with standard control, intensive control was associated with a significant reduction in renal events, including new or worsening nephropathy.’  I was about to give this on a big tick until I got out the calculator and found that it amounted to 1% less people in the intensive group having a major kidney complication than in the standard group. (The statistical; chart is attached at the bottom of the article.)

 

This is the result that the diabetes world is now goo gooing and gaa gaaing about.

 

150 patients (2.7%) undergoing intensive control had at least one severe hypoglycemic episode, as compared with 81 patients (1.5%) undergoing standard control.’ This is code for getting the dosage wrong. Subjects were over-dosed. Oops! Wrong result.

 

‘Minor hypoglycemia also occurred more frequently in patients undergoing intensive control.’ More over-dosing. Hello!

 

‘Intensive glucose control was associated with an increased risk of severe hypoglycemia and an increased rate of hospitalization, as compared with standard control.’ More overdosing. Hello again!

 

‘There were no significant differences between the two study groups in the rate of death from any cause of death from cardiovascular causes.’ Goodness me!

 

‘The explanation for the reduction in blood pressure in the intensive-control group is unclear.’ That’s because there was none, unless you count a difference of 1.6mm of Hg as being significant!

 

‘In the ADVANCE trial, an intensive glucose-control strategy involving gliclazide (modified release) and other glucose-lowering drugs as required reduced the glycated hemoglobin level to an average of 6.5%. There was no evidence that this treatment strategy increased mortality.’ Thank God for that.

 

‘There was no separately significant reduction in major macrovascular events, although a modest benefit could not be ruled out.’ Of course it can’t!

 

‘However, it is clear that the prevention of macrovascular complications of diabetes requires a multifactorial approach addressing all major modifiable risk factors, including blood pressure and blood lipids.’ No mention of including the exercise or diet prescriptions in the multifactorial approach.

 

And now let’s repeat the big news again.

 

In the intensive group the number with worsening kidney function was 4.1%. That’s a pretty low percentage. In the standard group the number of people with worsening kidney function was 5.2%. That’s pretty low too. To the untrained eye the difference doesn’t seem to be highly significant; it’s not. To the George Institute it’s a big difference, a 21% difference, enough to cause a run on Gliclazide stocks in pharmacies across the country.

 

If you missed it, here it is again in slow motion.

 

1.       Divide 4.1 by 5.2. You’ll come up with the answer of 78.846.

 

2.       Take 78.846 away from 100. You should get 21.154.

 

3.       Round it off and add a percent sign and you get 21%. I think I

          just felt the earth move over in Waltham Massachusetts!

 

Putting the results into perspective, what the 21% really means is that out of every 100 people, there is a probability that 1 less person from the ‘intensive’ group is likely to have some kind of kidney dysfunction compared with the ‘standard’ group.

 

Now here's how this cunning stunt is set up to make a trap for fools and medical journal editors. It's explained by Ray Moynihan and Alan Cassels in their book 'Selling Sickness', Allen and Unwin 2005.

 

'Now imagine you were told by your doctor that you had this risk factor for cardiovascular disease .... 'We have a drug that will treat this risk factor ... I am going to present you (with) the results of three different studies and I want to ask you if you would be willing to take this drug every day for the next five years based on the results.

 

Would you take a drug every day for five years if it ....

 

1.  Lowered your chance of having a heart attack by 33%

 

2.  Lowered your chance of having a heart attack from 3% down to 2%,

     a difference of 1%.

 

3.  Saved one person in a hundred from having a heart attack but there

     is no way to know in advance who that one person will be?'

 

Over 80% of people will vote for number 1. The trick is, they're all the same. It's the same study reported in three different ways.

 

In relative terms it's a 33% reduction. In absolute terms it's a 1% reduction.

 

'It's a statistical gimmick that exaggerates benefits. Advertisements to doctors and patients will claim, for example that a drug offers a 33% reduction in risk of heart attack, without explaining the fact that you may have to take the medication for five years in order to lower your risk from 3% down to 2%.'

 

This a is exactly what the George Institute has done - and the NEJM has been sucked in, Norman Swan of the ABC Health program has been sucked in, media correspondents throughout Australia have been sucked in. As research goes, this is not a bang, it's not even a whimper.

 

Any one of the people could have lowered their risk of kidney dysfunction  by much more than 1% by adopting a lifestyle change. They weren't given the opportunity. This is junk pharmacy. It's an academic trick, a legerdemain that in this case got sprung.

 

It's bunkum.

 

THE DAMAGE

This was a study where the cardinal medical research sin was committed, that is, where one drug treatment was compared with other drug treatments without also comparing both treatments with other known successful non-drug treatments. That’s one of the sources of the bad smell.

 

For all intents and purposes The George Institute is being run as a branch office of the pharmaceutical industry. George V would be rolling over in his grave if he knew what he’d lent his name to!

 

In particular one could be forgiven for coming to the conclusion that The George was working hand in glove with Les Servier to find a point of commercial difference between the sponsor’s products and those manufactured by other drug companies. 

 

Certainly there's some monkey business going on here. Both the George Institute and Servier are reluctant to quantify the amount of money Servier spent on the project. It smells fishy.

 

The Head of the Centre for Research Management at The George is the former Clinical Research Director for Merck, Sharpe and Dohme’s Asia-Pacific Division.

 

Sixteen staff of The George involved in this project, including one of the Principal Directors, are hanging on to the drug company teat, acknowledging that they receive ‘lecture fees’ (nudge, nudge) from Servier. The full list of drug company financial involvement with researchers at the George Institute reads like a roll call from a Medicines Australia AGM.

 

One of the principal directors is a member of advisory boards for Servier, Pfizer and Novatis. In fact he’s not the only one on a drug company advisory board. What with time spent snagging grants, serving on drug company boards, driving down to Canberra, flying around lecturing goggle-eyed GP’s and presenting papers at overseas conferences you’d be forgiven for wondering how he has time to get any work done. This same director has also been in receipt of ‘grant support’ from Servier (wink, wink) and research grants from Servier, Pfizer and Novartis.

 

They know which side of their bread’s buttered up there in Camperdown.

 

This is an outfit that’s got Servier, Merck, Novatis, Pfizer, Sanofi-Aventis, Glaxosmithkline, AstraZeneca, Nono Nordisk, Boehringer Ingelheim, Eli Lilly, GW Pharmaceuticals, Bristol-Myers Squib, Neurochem, Prognomix, Medpharmgene, Bayer, Daiichi Sankyo and Mars written all over it. (I’m not sure how a confectionery company got involved, but it may have something to do with stimulating demand for pharmaceuticals further down the track!)

 

This is an organisation that’s out over its depth in a sea of drug company money.

 

What’s revealed here is the underbelly of Australian drug research.

 

There is no record of gratuities being received from Fitness First, Gold’s Gym or the Broccoli Council.

 

Down at The George Institute for International Health not many hands are getting dirty or palms sweaty in the quest to ‘improve the health of millions of people worldwide.’

 

In these studies one of the fundamental tenants is to ‘first do no harm.’ The second is to do something during the study that contributes to an improvement in the health, fitness and wellbeing of the subjects.

 

The George Institute failed on both accounts. What they did was a junk, reductionist, pharmaceutical survey.

 

40 years ago people were rolled into the Pritiken Centre in wheelchairs and after a couple of months strolled out in sandshoes as fit as trout and lean as greyhounds.

 

In the George Institute project, 44% of the subjects hobbled into hospitals. 1013 of them never returned home; just tragic, heart-rending, gut wrenching.

 

This was a survey that didn’t need to be done. A lot of theses surveys don’t need to be done. We know enough about diabetes to know that it is not prevented by pharmaceutical research and that it is not caused by a lack of Gliclazide.

 

The results of this survey are trivial when compared with putting people on a scientifically based, competently supervised exercise and diet program.

 

The NEJM through its editorialist (Dr. Cefalu) gave it a shellacking, even though they published it. A note from the NEJM editorial (writing about the Accord and the Advance trials) -    said that both studies ’ … do not provide a definitive answer to the problem of glycemic control and cardiovascular disease.’

 

ie, it was another, pharmaceutically driven waste of time.

 

If this research proves anything it’s that it’s time that the primary healthcare management of metabolic dysfunction, including diabetes, was handed over to the fitness profession.

 

 

EXUBERA

Diabetes: ‘Safe’ drug linked to lung cancer

 

Pfizer withdrew its diabetes drug Exubera last October because of lagging sales.  At the time the decision seemed strange.  The drug, an inhaled form of insulin, was reckoned to be Pfizer’s next blockbuster, and investors were anticipating annual sales of around $2bn.
 

Its sudden withdrawal cost the company £1.36bn ($2.8bn), made up of $661m of stock, $1.1bn of intangible assets, $454m of fixed assets and $584m of other costs.  The drug had cost $900m to research and develop.

At the time Pfizer’s chief medical officer Joseph Feczko said the withdrawal had nothing to do with safety issues – a surprising statement to make as, in April, the company revealed the drug dramatically increased the chances of lung cancer.
 

In clinical trials carried out by the company, six of the 4,740 patients taking Exubera developed lung cancer compared to just one out of 4,292 people who were not taking the drug.  After the trial finished, another Exubera patient also developed lung cancer.

(Source:  FDA website, May 2008)

 

THIAZOLIDINEDIONES

Diabetes Drug: New health warning over the most-prescribed oral medication

26 April 2007

 

There’s something very wrong about the world’s most heavily prescribed type II diabetes drugs.  They are a family of drugs with the very long name of thiazolidinediones, which is equalled only by the length of the list of adverse reactions they cause.

The thiazolidinediones are the world’s leading oral anti-diabetes drugs, and doctors regularly prescribe them as a ‘last resort’ drug when other medications have failed to reduce blood glucose levels.

Their heavy use is a puzzle, especially when you consider their safety record.  Back in 2000, Rezulin (troglitazone), a thiazolidinedione developed by Warner Lambert, was withdrawn from the American market because it was found to cause liver toxicity.  At the time, two of its rivals – Actos (pioglitazone) and Avandia (rosiglitazone) – were considered to be safer, and were allowed to stay on the market.

This may have been a mistake, judging by more recent safety reports.  Just last month Avandia was found to dramatically increase the risk of bone fractures in women, and now researchers have discovered that Actos has exactly the same effect.

Apart from increasing the risk of fractures and liver toxicity, thiazolidinediones also cause edema, a condition that causes a swelling or fluid retention in the lungs, and they increase the risk of heart failure.

Despite these concerns, most of which have been known about for some time, doctors’ prescribing of the drug family remains “robust”, as one researcher puts it, which is more than can be said for the patient.

(Source: Journal of the American Medical Association, 2007; 297: 1645).

 

AVANDIA:  So how exactly did it get approved in the first place?

 The New England Journal of Medicine has released the results from 42 studies involving 15,560 diabetes patients who were prescribed Avandia.

 

Patients getting Avandia were 43 percent more likely to have a heart attack. The study also suggested a trend toward higher death rates in the Avandia group.

 

Avandia (rosiglitazone) is manufactured by drug maker GlaxoSmithKline, and is one of the most popular pharmaceuticals for the treatment of Type 2 Diabetes.

 

The sudden safety alert from America’s drugs regulator, the Food and Drug Administration (FDA), about the diabetes drug Avandia leaves two vital questions unanswered.  The alert follows a study that has discovered that Avandia (rosiglitazone) increases the risk of heart attack by 45 per cent.

 

Why, in the first place, did the drug get approved?  It is part of a family of drugs known as thiazolidinediones, which were discredited in the earliest stages of their development. Another thiazolidinedione, muraglitazar, was withdrawn from the licensing process after early trials found it increased the chances of heart attack.  On hearing the news, other drug manufacturers abandoned the development of their own thiazolidinedione.

 

So how did GlaxoSmithKline’s Avandia slip through the net?

 

The second question concerns ongoing safety checking.  It’s well known that diabetics are much more prone to heart disease; it’s also known that the thiazolidinediones increase that risk further.  So why is it that in the eight years since approval, GSK has not undertaken a major study into Avandia’s safety?

 

In the event, it took two researchers from the Cleveland Clinic to review 42 small studies to come up with the alarming – but hardly surprising – conclusion about the drug’s dangers.

 

Avandia is one of the most popular of the drugs for treating type II diabetes.  It’s not known exactly how many prescriptions have been written for the drug, but GSK reveals that the drug’s quarterly sales stand at £414m, or £1.65bn a year, so it’s reasonable to assume that millions of tablets have been swallowed.

This beggars a third and final question: just how many people have died because of Avandia, and all the time the doctor was blaming the diabetes?

 

(Source: New England Journal of Medicine, May 21, 2007

 

AVANDIA LAWSUIT

Avandia lawsuits have resulted because of the serious Avandia side effects that have been reported. When Rezulin diabetes drug was recalled Avandia was intended to replace it as a safer alternative, however the consumer group Public Citizen never recognized Avandia to be a safe alternative. Avandia lawsuits have resulted because serious side effects as a result of using Avandia have surfaced, including congestive heart failure, hepatitis, and liver failure.

 

The FDA has sent letters to Avandia manufacturer regarding the promotional activities for Avandia. Avandia lawsuits have resulted, because of the serious Avandia side effects and because Avandia manufacturer minimized the risks associated with Avandia. In particular, the FDA warned Avandia manufacturer of the "oral representations denying the existence of serious new risks associated with Avandia at GSK's promotional exhibit booth" in September 2001. When Avandia was approved the FDA stated they were not confident of its safety regarding liver toxicity, just that Avandia appeared to be safer than Rezulin, a factor that Avandia lawsuits may point out.

 

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports.

 

FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

 

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

 

AVANDIA LINKED TO PULMONARY EDEMA AND HEART FAILURE

In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The FDA announced at the time of the Rezulin recall that Actos and Avandia were safer alternative in "this important class of diabetes drug," which Rezulin was the first FDA approved drug of the newest class. Public Citizen consumer group criticized the FDA for waiting too long to issue the Rezulin recall and remained skeptical that other drugs, such as Avandia, would not also cause problems.

Now, a new study published in the September 9 issue of the Mayo Clinic Proceedings has reported that congestive heart failure can occur in Avandia patients. Already known to cause fluid accumulation, Avandia is now being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency until further Avandia studies have been performed.

A new drug for diabetes, troglitazone (Romozin), has been declared unsafe and banned in Britain. The decision has come after six people died and numerous liver injury cases were reported worldwide.

 

Over 150 people have suffered reactions from troglitazone, out of the three hundred thousand patients worldwide who have been treated with the drug since its launch in October 1997. Reactions to the drug have ranged from severe liver damage to liver necrosis (cell death) and liver failure.

 

Glaxo Wellcome, the company which markets the drug in this country, and the Medicines Control Agency believe that since the harmful effects and the risks cannot be predicted accurately, the drug would not be safe for some patients, particularly those with the type of diabetes known as type 2.

 

Troglitazone is still available in the United States because the Food and Drug Administration (FDA) said that the benefits outweighed the risks - as long as patients receiving the drug are continuously monitored for signs of liver injury. The FDA has also suggested that a label should prominently display a warning of the drug's harmful side effects.

 

GlaxoWellcome has now withdrawn its application to market troglitazone across Europe (BMJ,1997; 315:1564 September 2003 ). 

 

AUSTRALIAN PRIMARY CARE COLLABORATIVES PROGRAM

The Australian Primary Care Collaboratives Program (the Collaboratives program) is a $17.3 million Commonwealth funded program designed to support Australian general practices deliver systematic and sustainable improvements to the quality of care they provide to their patients.

 

The Collaboratives program aims to improve clinical outcomes, reduce lifestyle risk factors, help maintain good health for those with chronic conditions and promote a culture of quality improvement in primary health care, focusing on three topic areas:

1. Secondary Prevention of Coronary Heart Disease (CHD)

2. Diabetes

3. Better Access for patients to primary care services

 

According to the official blurbs pumped out by the the Department of Health the Collaboratives program has led to improved health outcomes for patients with chronic disease by introducing better systems of care and enhancing overall business efficiency in general practice.

 

It's complete nonsense. All that happened was more people were put on drugs. There is no evidence that anyone became fitter or healthier.

 

RESULTS AND CLINICAL OUTCOMES

The following improvements in evidence based clinical measures have been recorded.

 

Here's what really went on.

 

Coronary Heart Disease (CHD)

 

27% improvement in the percentage of patients with CHD recorded as being on aspirin medication

 

25% improvement in the percentage of patients with CHD recorded as being on a statin medication

 

49% improvement in the percentage of patients who have had a myocardial infarction in the last 12 months who are on a beta blocker medication

 

48% improvement in the percentage of patients with CHD whose last recorded blood pressure was below 140/90mmHg

 

94% improvement in the percentage of patients with HbA1c levels equal to or below 7%

 

25% improvement in the percentage of patients with diabetes whose cholesterol was recorded below 4mmol/L

 

97% improvement in the percentage of patients with blood pressure equal to or below 130/80mmHg

 

All done with drugs; no smoke, no mirrors, not running round the block, just drugs.

John Miller June 2008

 

STENTS: 

25 years on and specialists learn that lifestyle changes are just as effective

 

The stent has become part of the standard toolkit for the heart specialist.  It’s a crude, but effective, device for ‘propping up’ arteries that may collapse after angioplasty, or which may get blocked by a build-up of plaque in a process known as restenosis.

 

This micro-engineering has been actively used for the past 25 years – and it’s only now just occurred to specialists that simple, and inexpensive, lifestyle changes work just as well.

 

A new trial, involving 2,297 heart patients with at least one blocked coronary artery, found that they fared just as well if they stopped smoking, exercised, and improved their diet.

 

They lived as long, if not longer, than the patients who were given a stent, but who otherwise carried on as before, and their quality of life was also far higher.

 

This is bad news for American heart specialists who routinely insert 1 million stents a year, funded by health insurance plans. 

 

The new study, known as Courage (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), may put an end to the “irrational exuberance that surrounds stenting”, says Steven Nissen, immediate past president of the American College of Cardiology.

 

But don’t bank on it.  As another specialist said: “Once Courage was released, I asked myself how this would change my practice, and I realized it wouldn’t.”

 

Carry on stenting.

(Source:  Journal of the American Medical Association, 2007; 297: 1967-8).

 

DOCTOR ERRORS:  Even the patient can’t spot them

Doctors have become so hopeless at spotting – and reporting – their own errors that they are asking their victims, the patients, to do it for them.

 

Unfortunately, a new report suggests that the patient is just as bad as the doctor – although the whole dubious system does presuppose that the victim knows when an error has happened.  And as 100,000 Americans die each year from medical error it also assumes that their survivors know about the error.

 

As it is, the patient – or his surviving family – often gets it wrong when identifying an error, according to a study from Harvard University.  After monitoring an oncology unit between February and September 2004, the researchers found that the patient was mistaking poor service for medical error.

 

You can’t rely on anyone these days.

(Source:  Journal on Quality and Patient Safety, 2007; 33: 83-9).

 

DRUG SAFETY

It’s not just chemotherapy that causes blood disorder

 

Agranulocytosis is a serious condition where the body produces insufficient white blood cells, making the sufferer much more prone to infection.

 

It’s a common side effect of chemotherapy drugs – but they are far from being the only culprits.  In a new study, researchers have pinpointed 125 other drugs that can also cause agranulocytosis.

 

They found 980 cases of agranulocytosis caused by drugs other than chemotherapy since 1966, including carbimazole, clozapine, dapsone, dipyrone, methimazole, penicillin, and rituzimab, a group that was responsible for more than half of all cases.

 

Of the cases reported, six per cent – or 58 – were fatal.

 

None of this is particularly new.  Doctors have known – or should have known – for quite some time that many anti-epilepsy, anti-thyroid, antibiotics, antipsychotics, and the NSAIDs can cause agranulocytosis. 

 

Doesn’t hurt reminding them, we suppose.

(Source:  Annals of Internal Medicine, 2007; 146: 657-65).

 

 ASPIRIN

It doesn’t stop cognitive decline after all

 

Aspirin has become the great just-in-case treatment for the West.  A little a day is supposed to ward off heart disease, high cholesterol, and mental decline.  Actually, strike off that last one.

 

A study that monitored 6,377 healthy women aged 65 or older, who took 100 mg aspirin every other day for nine years, found that they didn’t fare any better than women who were taking a sugar pill, or placebo.

 

There was virtually no difference between the two groups in terms of cognition and verbal memory – and each group had the same numbers who suffered substantial decline in their mental abilities.  In other words, aspirin didn’t have any protective effect.

(Source: British Medical Journal, 2007; 334: 987-90).

 

 ‘OFF-LABEL’

Doctors play fast and loose with drugs, and the patient suffers.

 

As if drugs weren’t dangerous enough already, doctors often use them as ‘off-label’ therapies as well.  It’s a medical euphemism for playing around with drugs in ways for which they’ve not been approved or tested for their safety.

 

‘Off-label’ prescribing is rampant, as researchers have discovered.  In one study of 7,752 heart patients, they found that drug-eluting stents – metal tubes that release a drug to help stop restenosis, where artery walls become blocked by plaque – were wrongly used in 47 per cent of all cases.

 

Worse, this inappropriate use endangered the lives of the patients, who were more than twice as likely to die or suffer a serious heart attack than someone whose stent was used properly.

 

The patient whose stent was used inappropriately faced this level of risk for up to a year following the procedure.

(Source: Journal of the American Medical Association, 2007; 297: 1992-2000).

 

ANTIPSYCHOTICS FOR CHILDREN

Psychiatrists who are paid the most prescribe the most

 

Why are so many young children given a powerful antipsychotic?  Because the psychiatrist is paid handsomely to write out the prescription.

 

Psychiatrists in America who are paid upwards of $5,000 from manufacturers of atypical antipsychotics on average write three times as many prescriptions for the drugs as those who don’t get such a good pay-off.

 

Between 2000 and 2005, antipsychotic use among American children increased nine-fold, while each psychiatrist received an average payment of $1,750 from a drug manufacturer during the same period.

The alarming practice of prescription pay-off has come to light only because just one state in the USA – Minnesota – requires full disclosure of industry payments to physicians. 

 

As one psychiatrist put it: “There’s an irony that psychiatrists ask patients to have insights into themselves, but we don’t connect the wires in our own lives about how money is affecting our profession and putting our patients at risk.”

 

Silly them.

(Source:  New York Times, 10 May, 2007).

 

 SLEEPING PILLS

Dozy drug regulator finally wakes up over drugs’ dangers

 

Every sleeping pill prescribed and sold in the USA is about to come with a far stiffer warning of its potential dangers.

 

Without exception, each brand must tell the patient that it may cause severe allergic reaction (anaphylaxis) and severe facial swelling (angioedema), even after just one pill.

 

It may also cause complex reactions, and the patient may continue to carry out normal daytime activities, such as driving a car or preparing and eating a meal, but while asleep.

 

America’s drug regulator, the Food and Drug Administration, has finally demanded the stronger warnings after months of consultations with the drugs’ manufacturers, and years of patient concerns and lobbying.

 

Drugs that will be coming with the stronger warning include Ambien, Butisol Sodium, Carbitral, Halcion, Placidyl, Restoril and Seconal.

 

(Source:  FDA website, March 2007).

 

SLEEPING PILLS

Dozy drug regulator finally wakes up over drugs’ dangers

 

Every sleeping pill prescribed and sold in the USA is about to come with a far stiffer warning of its potential dangers.

 

Without exception, each brand must tell the patient that it may cause severe allergic reaction (anaphylaxis) and severe facial swelling (angioedema), even after just one pill.

 

It may also cause complex reactions, and the patient may continue to carry out normal daytime activities, such as driving a car or preparing and eating a meal, but while asleep.

 

America’s drug regulator, the Food and Drug Administration, has finally demanded the stronger warnings after months of consultations with the drugs’ manufacturers, and years of patient concerns and lobbying.

 

Drugs that will be coming with the stronger warning include Ambien, Butisol Sodium, Carbitral, Halcion, Placidyl, Restoril and Seconal.

(Source:  FDA website).

 

MORE ON THE SLEEPING PILL DEBACLE

 

Question: What can you expect from a pharmacist responding to the adverse reaction of a junk pharmaceutical?

 

Answer: The prescription of another junk pharmaceutical.

 

Dr Geraldine Moses, Senior Pharmacist Adverse Medicine Event Line (funded by the Pharmacy Guild) based at Mater Health Services in Brisbane speaking on ABC Radio National's Life Matters program on Monday 19th of March 2007, expressed caution about certain types of sleeping tablets as per the advice from the dozy FDA.

 

But her advice at the end of the program was to go back to your doctor and get a prescription for an older-type sleeping medication - not go and find out the cause of your sleep dysfunction and then deal with it.

 

An inability to sleep well is just another of the many symptoms of general metabolic dysfunction - along with the usual suspects - diabetes, high blood pressure, high cholesterol, snoring, sleep apnoea, cardiac insufficiency, fatness, headaches, cardiac insufficiency ...

 

The doctor and the chemist would be the last places you'd go to (not the first) in your quest for a good night's sleep.

 

(Of course, as avid reader, Veronica pointed out to me, there's always the risk that your headache, crook gut, tight chest ... might be the indication of a deadly serious complaint. She's right, that's a risk to living we all have to deal with and we all need to express you own caution on these matters.)

 

If this is the best we can expect from the Drug industry's Adverse Drug Reaction body then heaven help us. We're drowning in a sea of junk medicine.

 

The advice of the Senior Pharmacist is not to ask yourself 'Why am I not sleeping as well as I'd like to and what can I do about it?' On the contrary, the advice is to go to a doctor and get another prescription for another pill that will put you to sleep without dealing with the problems that are keeping you awake. Hello!

 

As Andrew Weil (MD) says, 'Don't go to doctors for things doctors can't sure.

 

Get yourself into exceptionally good shape and you'll sleep like a kitten.

 

MERCK

Merck, the drug company commissioned 1 million reprints of a favourable study of its COX-2 painkiller, Vioxx and distributed them, to doctors in order to drive up sales/ The study, funded by Merck, was later discredited and the drug withdrawn after it was found to increase the risk of heart disease. The company now faces 30,000 lawsuits from patients or their surviving families in what is the largest legal claim in history.

British Medical Journal, 2007; 334: 120-3 From WWDTY January 2007

 

HEART DRUG

After 13 years, they find it doubles the chances of killing the patient.

 

Aprotinin is a drug that’s routinely given to patients as they undergo coronary artery surgery.  It’s designed to reduce bleeding and it’s so effective that last year alone 246,000 Americans were given it during surgery.

 

Unfortunately it’s just been discovered – 13 years after it was first used – that the patient is almost twice as likely to die afterwards.  Everyone already knew that the drug had its problems.  It causes kidney poisoning, and can cause a whole new set of heart problems unrelated to the original condition.

 

But in a new study of 4,374 heart patients, researchers found that the drug almost doubles the chances of killing the patient within five years following surgery compared with patients who were not given the drug.  In all, it was associated with the deaths of 20 per cent of the 1,072 patients given aprotinon, a frightening statistic that suggests it may be responsible for the deaths of around 50,000 of the patients given the drug only last year.

 

In the under-stated fashion for which all researchers are beloved, the study group concludes that cardiologists might like to “think twice” before administering aprotinon again.

 (Source:  Journal of the American Medical Association, 2007; 297: 471-9).

 

HOW EASY'S THAT?

Want to know what junk medicine is?

 

Richard Kravitz, a professor of medicine at the University of California, recently led a team of researchers in an unusual study to evaluate the effects of direct to consumer (DTC) advertising on doctors.

The researchers recruited several actors to pay visits to more than 150 internists and family physicians. In nearly 300 visits, the patients described symptoms of major depression. When they mentioned an antidepressant drug by name (Paxil) more than half received a prescription. When they asked for a drug without stating a specific product, more than 75 percent received a prescription. When a patients didn't request or mention medication, prescriptions were written in more than 30 percent of the cases.

In half of the visits, patients described symptoms such as stress or fatigue that don't necessarily indicate depression. In these visits, when the patient mentioned Paxil more than half received a prescription for the drug.

These results are revealing, but not really surprising. All of the patients made an appointment to see the doctor but didn't let on that they were actors. In each case, the doctors were seeing a patient they'd never seen before, who simply asked for a prescription and, in the majority of cases, received it.

 

That's junk medicine. Don't you luv it?

HSI Alert May 2005
 

STATINS

Too many people are taking them (and they’re doing far less good than you think)

 

Cholesterol-lowering statins have become one of the most popular ‘just in case’ drugs on the market.  They’re handed out to anyone who may be at risk from developing heart disease – which, in the eyes of the doctor, will be pretty much everyone over the age of 50 or so. 

 

So it’s not surprising to learn that 36m Americans take a statin every day, generating annual sales of $15.5bn for the manufacturers, and making two statins - Lipitor and Zocor - the top two best-selling drugs in the USA. In Australia sales top $1b a year taking up about 15% of Government expenditure on the Pharmaceutical Benefits Scheme.

 

Statin use has been increasing by an average of 12 per cent a year, and it’s a trend that is likely to continue while medicine sees almost all of us as being at risk from raised cholesterol levels.

 

There’s evidence to suggest that those of us with a diagnosed heart condition may benefit from a statin, but this is a small fraction of those who take the drug. 

 

A new Harvard study has discovered that just 8 per cent of people taking a statin had a heart condition – the rest were merely considered to be at risk, a judgment that was entirely subjective, and based on very little evidence.

 

The Harvard researchers looked at the results of eight trials, and discovered that the statins didn’t reduce the number of deaths, even among those with a known heart condition. 

 

The drugs had a marginally positive effect on men, although it works out that 67 people would need to take the drug for five years in order to prevent one heart attack.  It had no benefit whatsoever among 10,990 women who took it.

 

All of this suggests that far too many people are taking a statin, and with no positive outcome.  Instead of being the universal ‘just-in-case’ drug, its use should be restricted to people who have been diagnosed with a heart condition, the researchers conclude.

 

Their findings follow on from last week’s discovery that statins may cause Parkinson’s (see WDDTY E-news No. 326), and from earlier studies that suggest the drugs may be causing the heart conditions they’re supposed to be preventing.

 

The Lancet, 2007; 369: 268-9 From WWDTY January 2007

 

PREGABALIN

The FDA Medical Officer who was the primary reviewer for the applications for approval of pregabalin for diabetic neuropathy and postherpetic neuralgia concluded that the drug should not be approved for a number of indications (peripheral neuropathy in people with diabetes, postherpetic neuralgia, a pain that lasts for three months after a rash due to herpes.)

Concerning the application for postherpetic neuralgia, he stated that "overall the risk of adverse effects of treatment approach or exceed the likelihood of treatment benefit." In similarly recommending against the approval for diabetic neuropathy, he stated that "it does not appear that the benefits of the drug in patients with diabetic neuropathy outweigh the risks. I therefore do not recommend approval of this application."

His concerns about risks involved statistically significant increases in visual abnormalities in patients using pregabalin as well as increased numbers of accidental injuries and edema. For blurred vision, there was a 4.3-fold increase in pregabalin users compared with those taking a placebo and for double vision, a 6.7 fold increase. Accidental injuries occurred nine times more frequently in pregabalin users. One possible explanation for the increased injuries is significant increases in dizziness and abnormal gait in people using pregabalin.
 
Despite the concerns of the FDA Medical Officer, he was overruled by his supervisors and the drug was approved for these two indications. After its approval, one review of the drug's performance rated the evidence for pregabalin for neuropathic pain as limited.
 

Pregabalin may control, but does not cure, these conditions, nor any off-label conditions for which it may be prescribed. It belongs to the same family as gabapentin (NEURONTIN), a drug that was illegally promoted for many off-label uses despite a lack of evidence of its effectiveness.

Worst Pills.com January 2007

 

JUNK POLITICS

The Canberra Minister for Health complained this week that there aren't enough doctors in Canberra - we have less than the national average number of doctors per 100,000 people.

 

On the one hand maybe this is good news. Maybe Canberra residents are healthier that residents in other states. They don't need to go to the doctor. Maybe other states should aim at having less doctors. Maybe the gold standard of health indices is how few medical practitioners there are in a state and how few people go to surgeries and hospitals.

 

Or maybe they're avoiding going to doctors. That could be a good thing. Very few people ever got fitter and healthier in a surgery!

 

Or maybe we have more fitness practitioners, though no-one in the medical statistic-collection business ever measures how many fitness practitioners there are. Recording anything other than doctors and nurses is below their dignity. They don't exist! Same with naturopaths, (heaven forbid that people would go to them, let alone measure how many there are.)

 

We wrote to Fitness ACT and there are 680 registered fitness practitioners on their books. All power to them.

 

On the other hand maybe Canberra people aren't healthier.

 

But going to the doctor is no guarantee that you're going to get healthier. Once you get into the junk medical loop that could be the end of you - just down the chute into the junk medical black hole.

 

You know the medical industry is doing a shithouse job when you see the record amounts of drugs being doled out for general metabolic dysfunctions like depression, cardiac insufficiency, sleep apnoea, sleep dysfunction, obesity, piles, crook guts, headaches, reflux, itchiness ...

 

But going to the doctor is no guarantee that you're going to get healthier. Once you get into the junk medical loop that could be the end of you - just down the chute into the junk medical black hole.

 

You know the medical industry is doing a shithouse job when you see the record amounts of drugs being doled out for general metabolic dysfunctions like depression, cardiac insufficiency, sleep apnoea, sleep dysfunction, obesity, piles, crook guts, headaches, reflux, itchiness ...

 

More doctors! Bah humbug.

 John Miller - January 2007

 

 COCHRANE COLLABORATION

If you want to find out what's wrong with you go to the Cochrane Collaboration, which describes itself as a reliable source of evidence in health care.

 

Click on your complaint and then dig down and find out what they advise you to what's caused it and what you need to do to fix it.

 

Chances are the advice will be about as useful as a hip pocket on a singlet. Just more selective-evidence-based bunkum that sustains serial paper writers, journal publishers and conference organisers in the hallowed walls of the sheltered workshops for the academically gifted.

 

I clicked on hypertension, diabetes and osteoarthritis; in the main, just useless medical and pharmaceutical guff. (I tried to establish hyperlinks to these pages but they got lost in the translation!!)

 

I'm yet to see any medical reference as to what type and how much exercise needs to be prescribed to have a beneficial impact on lowering blood pressure and blood glucose, or getting the body back into alignment and removing the stimulus to bone inflammation (arthro-itis).

 

Then I fed in 'arthritis cause'. The Cochrane Collaboration has nothing to offer on this account. There aren't any articles written by people who think they know what the cause is. If you don't know the cause it's highly unlikely you can prescribe a treatment which fix the problem.

 

In the main, and for the common body system dysfunctions, the Cochrane Collaboration is only useful for people who want to mask symptoms.

 

AUSDIAB STUDY into obesity and diabetes

The AUSDIAB study didn't measure how fit people were. You only have to look at the results of the Biggest Loser competition to see what happens when people dramatically increase their level of aerobic exercise. Glucose problems seem to miraculously be cured.

 

(It's not yet fashionable in medical circles to prescribe a vigorous physical activity program. About as far vas it gets it the amble around the block for ten minutes three times a day. If it were fashionable, there would be a prescription that involved time and effort. Click through to the Aerabyte site to get your prescription.)

 

The research team didn't measure aspects of blood chemistry that let you know whether a person is nutritionally deficient. They didn't even measure insulin levels, which apparently are elevated long before glucose levels become elevated.

 

The study could have been carried out for peanuts in every fitness centre and doctor's surgery.

 

The results

'The strong relationship we found between obesity and surrogate indices of energy expenditure needs to be confirmed in prospective studies, but suggests that reducing time spent in sedentary activities could be an important target for preventing and treating obesity.'

 

Code for: - more data hunting and collecting to prove what we already know.

 

Hidden meaning: - we think that if people exercise more they'd be immune from diabetic dysfunction, but we didn't measure how fit people were so we need more studies. Doh!

 

Sponsors of the study

Reads like a roll call of members at an AGM of Medicines Australia.

 

 'Eli Lilly (Aust) Pty Ltd, Janssen-Cilag (Aust) Pty Ltd, Abbott Australasia Pty Ltd, Merck-Lipha s.a., Alphapharm Pty Ltd, Merck Sharp & Dohme (Aust), Roche Diagnostics, Servier Laboratories (Aust) Pty Ltd, SmithKline Beecham International, Pharmacia and Upjohn Pty Ltd, BioRad Laboratories Pty Ltd, HITECH Pathology Pty Ltd ...'

 

Conflicts of interest listed

'None identified.' See directly above. Research heads turned by association with drug companies. Blinkers on. Didn't measure fitness.

 

Recommendations

'Our Stage 1 and Stage 2 findings provide compelling reasons why our research should be repeated every decade or so. We have therefore begun planning a Stage 3 study in 2009-2010, ie 10 years after Stage 1 and five years after Stage 2. Stage 3 would involve following up those who participated in Stages 1 and 2, and surveying a new representative sample of the Australian population.'

 

Code for: - keeping our jobs. We need to do more hunting and collecting. This work could be done on an ongoing basis in every surgery and fitness centre in the country.

 

'Armed with the results, we could then compare and quantify any improvement or decline in the nation’s health. This information would be vitally important to government, particularly in the areas of healthcare planning and formulating healthcare budgets. Such information would indicate how many new cases of diabetes will occur in any given period and how much care (doctors, hospitals, specialist clinics etc) will be required.'

 

Code for: - more ambulances at the bottom of the cliff. More doctors and nurses. Problem solved!

 

In fact there's no need for further quantification of the 'improvement or declining in the nation's health.' It's declining rapidly and there will be no improvement while the foxes are in charge of the hen house.

 

No reason for more information for 'health care planning' or 'formulating health care budgets' because it's not a government responsibility. Since when do governments have to shoulder the financial responsibility for personally-generated-lifestyle-neglect-body-system-dysfunctions?

 John Miller

 

JUNK WATCH - from worst pills.com

 

·  Misprescribing and over prescribing of drugs

·  Diseases caused by drugs

·  The public health crisis of adverse drug reactions

·  How to protect your family from adverse drug reactions

·  Cutting your prescription drug bill

·  Facts and myths about generic drugs

·  Ten rules for safer drug use

·  Drugs, Money and Politics

 

MORE FROM WORST PILLS, July 2006

New evidence of liver toxicity in healthy adults taking the maximum recommended dose of Acetaminophen (Tylenol)

 

Research published in the July 1 Journal of the American Medical Association found that healthy research subjects given the maximum daily dose of the popular pain and fever reducer acetaminophen (TYLENOL) of 4.0 grams (4,000 milligrams) per day developed a sign of early liver toxicity. This is equivalent to two extra-strength acetaminophen tablets per day. The people in the study were not using any alcoholic beverages, which would have further increased their liver toxicity.

 

The list of acetaminophen containing prescription and over-the-counter (OTC) drug products is long.  The list below gives the brand names and amount of acetaminophen contained in one dose of various painkillers and products widely promoted for colds and flu. 

Brand name = amount of acetaminophen per dose
Drixoral Plus - 500 milligrams
Excedrin Migraine - 250 milligrams
Extra Strength Tylenol - 500 milligrams
Fioricet - 325 milligrams
Lortab - 500 milligrams
Percocet - 325 milligrams
Regular Strength Tylenol - 325 milligrams
Tavist Allergy/Sinus/Headache - 500 milligrams
Tylenol Caplets - 650 milligrams
Tylenol Geltabs - 650 milligrams
Tylox - 500 milligrams
Vicks DayQuil Multisymptom Cold/Flu Relief - 325 milligrams
Vicks NyQuil - 500 milligrams
Vicodin - 500 milligrams

The amount of acetaminophen contained in OTC drugs is clearly listed on the label.  Always read these labels before taking any OTC drug to make sure you are not taking the same drug such as acetaminophen in two or more products.  Many prescription painkillers contain a combination of a narcotic drug and acetaminophen.  Examples of these drugs from the list above are Lortab, Percocet, and Tylox.  If you are prescribed a painkiller, ask your pharmacist if it also contains acetaminophen.  Mixing various OTC drugs and prescription painkillers may result in taking too much acetaminophen.   

Alcohol in combination with acetaminophen can increase the risk of liver toxicity.  OTC acetaminophen products now have the following warning on their labels:

Warnings
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

There are two important points that you should always consider.  One, just because a drug is sold OTC does not mean that it is totally safe.  Acetaminophen is a prime example.  Two, when using any OTC product, always use the lowest dose that helps your symptoms.  See your physician if symptoms persist.*

What You Can Do?
You should carefully read the labels on OTC drug products.  If you are prescribed a painkiller, ask your pharmacist if it contains acetaminophen. There is new reason for concern in using 4 grams a day of acetaminophen for more than 4 days that should preclude such usage. If you consume alcoholic beverages (see above), even this amount may be dangerous.

If you or a family member develop any of the symptoms of potential liver toxicity, stop taking all acetaminophen-containing products and call your physician immediately. These symptoms are:

-Pruritus (itchy skin)
-Jaundice (yellowing of the skin or whites of the eyes)
-Dark urine
-Upper right-sided abdominal tenderness (location of the liver)
-Unexplained "flu-like" symptoms

 

* Could be either a dangerous move or a waste of time. Chances are they'll give you another drug to mask the symptoms of acetaminophen toxicity, etc, etc, etc, etc, etc until you kark it

 

RESMED

A company dedicated to treating the particular symptoms of general metabolic dysfunction, namely sleep apnoea, with a gas mask, instead of treating the cause - people being in dreadful physical condition.

 

How fit are you? If you want to know whether you're at risk of sleep apnoea, see how many 20m laps you can run in 5 minutes. If you can't get 40 you're at risk.

 

Have you got a fat guts? If it's more than 102 cm around the circumference, you're at risk.

 

How many kilos are you over your ideal weight? If you're more than 10 Kg's over you're a prime candidate; 20 Kg and you could be lining up for a $2000 gas mask sooner than you anticipated.

 

How big's your neck? If it's over 45cm in circumference you're a prime candidate.

 

Do you smoke? More risk.

 

Do you drink? More risk.

 

Are you stressed out of your brain? More risk.

 

Do you now sleep in the back room because your wife can't put up with your snoring? A grave risk, not only to your health but your marriage.

 

If you're still sleeping with your wife, does she lie awake at night ready to give you an elbow in the ribs every time you stop breathing? Congratulations, you've got sleep apnoea.

 

Here's what to do

Get 1000 aerabytes a week and eat from the top of the Hourglass. The weight will peel off you. Get back to within 5 Kg of your ideal weight (for men a percent body fat score of less than 20, and for women less than 30), lay off the grog, and stop smoking,

 

No need go in to hospital for the night and wire yourself up. No need to pay a couple of grand for the pump and the gas mask. When you're in good shape you'll sleep like a kitten; you won't snore and you won't stop breathing when you're asleep. Your wife might even let you sleep in the same bed.

 

AUSTRALIAN DIETICIANS ASSOCIATION

An organisation dedicated to promoting healthy eating which nestles up to the junk food industry.

 

Food and Nutrition Organisations - Food Industry links

 

Note: DAA advises that the information obtained from the Internet should not be substituted for professional care. DAA does not endorse any links on this website. Please consult your health care provider if you have, or suspect you have, a health problem.

 

Kelloggs and Nestles are the two companies rate at the top of the confectionery industry ladder.

 

If you want to know more about eating wisely click here.

 

 ARTHRITIS

Arthritis sufferers were traditionally prescribed an NSAID (non-steroidal anti-inflammatory drug) to help relieve the pain.  But eventually researchers realized that NSAIDs such as Advil and Aleve caused gastrointestinal (GI) bleeding, and also increased the risk of heart problems.

 

So the drug manufacturers went back to the shareholders, sorry, drawing board, and came up with a new family of painkillers known as the COX-2s.  But researchers eventually realized that COX-2s such as Bextra and Celebrex increased the risk of heart problems - just as much as an NSAID.

 

And now researchers have discovered that the COX-2s also cause gastrointestinal bleeding - just as much as an NSAID.

 

This latest discovery comes after monitoring the progress of 34,701 arthritis sufferers who were given either an NSAID or a COX-2 for 18 months.

 

The researchers hope their discoveries will help doctors develop better treatment guidelines for arthritis.  Such as not giving the patient an NSAID or a COX-2?

(Source: The Lancet, published online 13 November 2006).

 

DON'T DESPAIR if you have arthritis.  There's so much more you can do without resorting to an NSAID or a COX-2, and all is revealed in the Arthritis Manual.  This ring-bound volume is a comprehensive overview of arthritis, and lists every therapy and treatment that has been proven to work.  To order your copy of this must-read volume, click here.

www.wddty.com November 2006

 

 

BIG PHARMA

Is UK Prime Minister Tony Blair still US President Bush's poodle?  We'll soon find out following intensive lobbying by the White House to grant the American pharmaceutical giants unrestricted access to the UK market.

 

That means every new, approved drug would become immediately available on the UK's National Health Service as part of a free market initiative.

 

And the American system of advertising drugs directly to the patient would also be introduced, US deputy health secretary Alex Azar has mooted.

 

These radical suggestions are an attempt to circumvent Nice (National Institute for Clinical Excellence), the gatekeeper of the NHS that determines which drug should be prescribed on the NHS, based on an evaluation of efficacy and cost.

 

Nice has been upsetting quite a few drug companies of late, and has blocked many an 'innovative' drug, either because it doesn't work or because it costs too much.

 

Things reached a head recently when drug company representatives met with UK government officials to complain about Nice.

 

Pfizer said it might withdraw its investment in the UK if Nice continued to block its Alzheimer's drug, and Bristol-Myers Squibb said it wanted to invest in countries that had a "favourable environment".

 

Now, we know medicine tries to maintain the pretence that it is a science, but we suppose it has finally abandoned that charade when it threatens to send the boys round.

(Source:  The Guardian, 14 November 2006, and 28 September 2006).

 

 DRUG COMPANY BOYCOTT

That's not the only 'we’ll take our toys home' tantrum from the drug companies reported this week.  A young medical researcher almost stopped the show after her talk about drug company influence on medical education at a conference in New Mexico.

 

One drug company representative said her company would immediately withdraw its sponsorship, while every drug company exhibitor, save one, dismantled its stand and left.  The one who stayed hadn't heard the speech.

 

As the speaker, Prof Adriane Fugh-Berman from Georgetown University, told the audience: "Drug representatives are paid to be nice to us, as long as we cooperate, sustaining our market share of targeted drugs and limiting our continuing medical education lectures to messages that increase drug sales."

 

Brave words, and ones you won't hear around New Mexico again in the very near future.

(Source:  British Medical Journal, 2006; 333: 1027).

 

 OLDTIMERS

A decision on the fate of three existing Alzheimer's drugs is imminent. The drugs, donepezil, rivastigmine and galantamine, are due to be removed from the list of drugs that are available under the UK's National Health Service.  The National Institute for Clinical Evidence (NICE), the group that reviews drug efficacy against cost, has recommended that the drugs be removed from NHS lists.  Each drug costs £2.50 per day per patient, and none provide a worthwhile benefit.

Of course, it could be that the problem is better tackled by an approach that doesn't involve expensive drugs, but where's the bottom line in that?

(Source:  Archives of Neurology, 2005; 62: 1047-51).

 

PULP FICTION - PROZAC

You've got to love the pulp fiction sound of this: The British Medical Journal (BMJ) recently received some "missing" drug company documents. They were sent from an anonymous source. And no doubt they arrived on a dark and stormy night.

According to reports from the BMJ, the documents indicate that more than 15 years ago, executives of Eli Lilly were fully aware that Prozac use increased the risk of suicide and violence. The fact that the information in these documents was not reported is bad enough. But that's only part of a larger story that includes a secret deal and some convenient rubber-stamping from an FDA panel.

Probably none of this would have come to light if it weren't for a 1989 tragedy in which a young American man named Joseph Wesbecker killed eight of his co-workers, wounded a dozen, and then turned his gun on himself. He had been taking Prozac for a month prior to the shooting.

The victims of the incident eventually brought a lawsuit against Eli Lilly, charging that the company had withheld clinical trial data from the FDA that found nearly 40 percent of patients who used Prozac reported new "activating" symptoms that include agitation, mania and hostility.

Lilly actually won that case. Executives later crowed that Prozac had been proven to be safe and effective "in a court of law." Case closed? Not quite.

According to the BMJ, the judge who presided over the case smelled a rat. Years later, in 1997, he got Lilly execs to admit that they brokered a secret settlement with the plaintiffs. The judge changed the verdict to read "settled with prejudice," and stated that Lilly had "sought to buy not just the verdict but the court's judgment as well."

And if you're thinking, "Gosh, how low can this go?" here's the answer: even lower.

Whoever sent those internal Lilly documents - "missing" from the Wesbecker case - to the BMJ was apparently aware that sending them to the FDA would be like sending them from one oblivion to another. But wait - the FDA is supposed to be the US drug safety watchdog, right? Yeah, right.

The FDA granted the approval for Prozac in 1987, just two years after Germany refused to license the drug because of "suicidal risk." Feeling some pressure a few years later, in 1991 the FDA appointed a scientific advisory panel to study the suicide risk of Prozac. The panel's verdict: No link to suicide. But some FDA insiders didn't agree with the results. And guess what? Several of the experts who served on the panel had financial ties to - yes you guessed it - Eli Lilly!

So here we are, 20 years after German scientists found a Prozac/suicide link, 16 years after young Wesbecker went on a killing rampage, eight years after a judge took away Lilly's claim about Prozac being found safe in a court of law, and NOW here's what an FDA spokesperson has to say to US newspaper USA Today about that 1991 verdict from the advisory panel: "To date we have not seen anything that would lead us to question the conclusions."

FDA officials are still reviewing the documents that were supplied to the BMJ. To say the least, it will be very interesting to see how they react to this damaging information that's still a smoking gun, nearly two decades old. And in spite of sticking to their 1991 advisory panel conclusion, they can't really be too shocked. The agency has received many thousands of adverse reaction reports concerning Prozac; more than any other drug in the agency's history.

Where there's a smoking gun, there's fire.

HSI January 2005

 

FLU JAB SEASON 

They don't work, of course, researchers discover

The over 65s among us will soon be exhorted to visit their local doctor for their seasonal flu jab.  And if they're as well read as our readers, they'll have ringing in their ears the World Health Organization (WHO) proclamation that flu vaccinations "reduce the risk of serious complications or of death by 70 to 85 per cent" in the elderly.

This very impressive statistic has doubtlessly informed public health strategy in the care of the elderly since it was highlighted by WHO in 2002.

The claim is based on one, dubious, study - and it turns out to be not true. In fact, the flu vaccine is ineffective, as a review of all of the studies has discovered.

In one major study, 95 per cent of elderly people who were vaccinated developed pneumonia that year, and nearly one per cent died from the infection.  In a study of healthcare workers, another target group for annual vaccination, 39 per cent died from pneumonia, despite having the flu jab.

The vaccination's poor protection extends to younger people in the community.  In a study of adults below the age of 65, 67 per cent of those vaccinated still had influenza later in the season, and a similar total was registered in a group of children aged above six years.

So why do our health services spend millions in advertising and administering a vaccination that doesn't work?  Nobody is sure, but we guess everyone stopped reading once they had seen the WHO statement.

(Source: British Medical Journal, 2006; 333: 912-5) WDDTY December 2006

 

BACK-HANDERS!

Have the US and UK health authorities been conned yet again by the promise of a ‘new generation’ of better and more effective drugs? 

 

Atypical anti-psychotics – designed to treat schizophrenia and bipolar disorder – were introduced in 1990, and were heralded by the drug companies as being more effective and safer than the standard antipsychotics. 

 

As a result, drugs such as Seroquel, Zyprexa, Risperdal and Geodon have become the first-line treatment for many psychotic disorders, generating around $10.5 billion a year in sales for the manufacturers.

 

But a major study – the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) – has discovered that the atypicals are no more effective than the older antipsychotics, and they cost around 30 per cent more.

 

And they are certainly not safer drugs.  So far Eli Lilly, the maker of Zyprexa, has signed a settlement of $690 million that is being paid to 8,000 plaintiffs who have claimed the drug has caused their diabetes.

 

So how did they get approval in the first place?  There are stories swirling around that government officials in the USA received a pay-off from the manufacturers, and that safety records were suppressed.

 

What we do know for sure is that the drug companies have been the only winners in a gambit that has brought in more than $100bn in sales of the atypicals. 

 

(Source:  American Journal of Psychiatry, 2006; 163: 2080-9). WDDTY December 2006

 

HORSE URINE THERAPY

Want to know one of the major causes of breast cancer? It's your local GP who for years has been encouraging menopausal women to swallow derivatives of horse urine every day for years and years.

 

When women stopped taking the horse hormones, the incidence of breast cancer dropped, considerably.

 

The word is out that mammograms, flattening and x-raying women's breasts isn't all that good for them either.

 

So who do you believe?

 

Certainly not the members of the industry who's first response to any health problem is to reach for the pad.

 

Keep yourself fit and healthy. Eat wisely and stimulate the body's various exhaust mechanisms with regular, vigorous physical activity.