Big Pharma... Or Should That Be Big Bully?

Big Pharma... Or Should That Be Big Bully?

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Over the last year, more and more reports have surfaced exposing the underhand tactics of drug manufacturers who publish ‘misleading’ results from drug trials in order to get their drugs on the market... or worse, some plainly withhold bad results from the public domain, putting patients’ health at risk.

Look closely and you’ll find that there are a few companies in the Big Pharma-gang that are repeat offenders...

Public 'misled' by drug trial claims

Previously I told you about Dr. Scott S Reuben, an ‘influential’ professor of anaesthesiology who received thousands of dollars in research grants from Pfizer to publish his ‘expert findings’ about their top-selling arthritis drug, Celebrex, in prestigious medical journals.

Turns out a routine audit, in 2008, uncovered the fact that Reuben was a fraud - his research on post-operative pain management had never actually been carried out... Furthermore, findings from an additional 21 published studies were later found to have been ‘misrepresented’, some of them dating back to 1996. These were retracted by the journals last year...

Now, researchers from The German Institute for Quality and Efficiency in Health Care say that unpublished trial data for Pfizer's antidepressant drug reboxetine (sold as Edronax in the UK) must be made public because it could change views about the drug.

Reboxetine is not sold in the US but is used throughout Europe as an antidepressant. The recent research, conducted by Dr. Beate Wieseler and fellow researchers, looked at the results of 13 trials, including eight previously unpublished trials.

Writing in the British Medical Journal (BMJ), the researchers said that previous trials overestimated the benefit of reboxetine and underestimated its potential harm. They added that reboxetine was no better than a placebo in terms of remission and response rates.

The study also revealed that a higher rate of patients had side effects with reboxetine than those taking a placebo. Get this... more patients stopped taking the drug as a result of the distressing side effects, compared with those taking a placebo or a different antidepressant...

Now if that doesn’t already ring alarm bells, I don’t know what will...

Pfizer maintains its drug is effective...

We’ve heard that old chestnut before! Remember GlaxoSmithKline tried to convince us their diabetes drug, Avandia, was safe right up until the time it was recently banned from the UK market.

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Pfizer – working for a healthier world

‘Working for a healthier world’ is Pfizer’s catch phrase, but when you look at reboxetine’s long list of harmful side effects, you can’t help but question just how true these words really are.

‘Mild’ side effects when taking reboxetine are blurred vision, vertigo, loss of appetite, palpitations, increased heart rate, postural hypotension, difficulty passing urine, urinary tract infection, impotence, pain on ejaculation, delayed ejaculation, or pain in the testicles (men), aggressive behaviour, anxiety, nausea and vomiting and hypertension.

Reading through that list, it’s no wonder so many people stopped taking this drug...

In response to the recent study, a spokeswoman for Pfizer said: "This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions [depressive illness/ major depression].”

She continued to say that Pfizer discloses the results of its clinical trials to regulatory authorities all around the world and the responsibility lies with the regulatory authorities to reflect all important safety and efficacy information in the approved product labelling.

In fact, Miss Pfizer, that is not entirely correct...

In the US, it is a regulatory requirement that all data - both positive and negative - is published. The UK, however, is still striving to achieve this.

According to the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) the European initiative to provide public access to all the results of clinical trials has a planned timeline for this information to become available in late 2011/early 2012.

If you ask me, it looks as if Pfizer saw a golden opportunity and made full use of it... Because, in the US, doubts were raised over reboxetine’s safety and effectiveness leading to its application for approval being refused in 2001... So if the US closes a door on the drug, let’s take it to Europe where the results of all the trials don’t yet need to be disclosed...

At least there is one man in the medical mainstream camp that’s talking some sense. Researcher Dr. Beate Wieseler said "It [reboxetine] is not a major drug in depression but every patient that is treated with an ineffective drug is one too many... if a patient is given an ineffective drug, that is unacceptable".

The same goes for every other ineffective high-risk pharmaceutical on the market. Scratch beneath the surface and you’ll find there’s a lot more at play when it comes to pharmaceuticals than you could ever have possibly imagined... unscrupulous marketing, misleading trial data, massive profits and turnovers, backroom deals and endorsements and perhaps at the bottom of the list, patient safety...

Forgive me if I’ve said this before, but when taking any kind of prescription drug always read the label, be aware of any interactions with food, supplements and other drugs and ask your doctor as many questions regarding potential side effects before you start taking your medication.

Depression Related Reading:

Natural Treatment Options For Depression

The Link Between Depression And Vitamin Or Mineral Deficiency

Depression: How saffron may help treat depression

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Sources:

Public 'misled' by drug trial claims, by Michelle Roberts, published online 13.10.10, bbc.co.uk

Pfizer Linked With Health Issues, by Rasik Sharma, published online 13.10.10, topnews.co.uk

Edronax, published online, netdoctor.co.uk

Pfizer Recall 2010: 191,000 bottles of 40-mg Lipitor affected due to uncharacteristic odour, published online 13.10.10, batangastoday.com