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Thursday, 2 April 2015

BMJ accuses Novartis of misconduct. RNIB implicated in supporting Novartis, who fund them!

What is the motivation of drug companies? 
Are they motivated by assisting public health? 
Or are they more interested in selling drugs, regardless of patient safety?

Another case of misconduct, probably fraud, has been reported (2nd March 2015) by the British Medical Journal (BMJ). Unusually, it has been picked up by the mainstream media, including BBC News. But typically, they discuss the issue only in the most superficial and unsatisfactory way - they fail to engage in the 'real health debate' that this blog has been demanding, for so long.

The situation, as reported, can be simply stated:
  • The British Medical Journal has accused the drug company, Novartis of trying to block access, and undermine research, into a cheaper drug for treating the condition wet, age-related macular degeneration.
  • The Novartis drug, Lucentis, licensed to treat the condition, costs around £740 per dose! The alternative drug, Avastin, costs about £60 per dose, but is not licensed for treatment the condition.
  • Drug trials are said to show the Avastin is also an effective treatment.
  • The BMJ claims it has evidence that clinicians with ties to Novartis urged some primary care trusts to pull out of one trial, and tried to derail a second trial.
  • Continuing to use Lucentis rather than Avastin costs the NHS several £100 millions every year.
  • Novartis are said to have denied the allegations, as, of course, they would be expected to do!
The BBC article outlines the battle that has been going on between the two drug companies involved in the scandal.

          "In November 2014, the Royal College of Ophthalmologists called for Avastin to be made available for treating the condition on the NHS, arguing that switching to the drug could save the NHS £100m. And in February clinical leaders from 120 clinical commissioning groups called on ministers and NHS England to clarify regulations that make it hard for physicians to prescribe Avastin for wet AMD".

On the BBC Radio 4 'Today' programme, the Health Charity, the Royal National Institute for the Blind (RNIB) were implicated in the scandal, supporting Novartis in trying to end one of the trials, whilst at the same time, admitting that Novartis provide about £150,000 to their coffers!

So what has our mainstream media been looking into? Not some of the major issues that might suggest to people and patients that their interests are not best served by the financial interests of the conventional medical establishment.

What, for example, are conventional doctors doing, prescribing a drug for which there is no licence, no clear evidence that it works, and no permission to use it? How often does this situation happen with other drugs, and other conditions?

What are the wider implications that can be learnt about the integrity of the entire drug testing and regulation system that is supposed to protect patients? How often, and to what extent, to drug companies pressurise researches to produce the result their business interests crave? How much do drug politics and vested interests play in determining the drugs that patients receive?

What is the motivation of drug companies? Are they more interested in profit than the health of the patients treated with their drugs?

What is the motivation of Health Charities like the RNIB, a "charity providing a range of information for blind or partially sighted people", including "fund raising details and events". Why do they accept money from for-profit pharmaceutical companies? Do they declare their vested interests when providing advice to blind and partially sighted people? Are other Health Charities, who most people will believe to be above this kind of scandal, compromised bb Big Pharma money in the same way?

And what about some information about the two drugs.

We were told that Lucentis is exorbitently expensive. Have the media ever invested why? Have they ever asked what the profit margin is that they are making on this drug?

And has anyone bother to tell us the long list of 'side effects' that patients receiving this expensive drug may suffer?
  • Blindness (Yes, really, described as 'common'!!)
  • bloody eye
  • blurred vision or loss of vision
  • decreased vision or other changes in vision
  • disturbed color perception
  • dizziness
  • double vision
  • dry eye
  • eye pain
  • fainting
  • feeling of having something in the eye
  • halos around light
  • headache
  • night blindness
  • overbright appearance of lights
  • pain or tenderness around the eyes and cheekbones
  • red, sore eyes
  • redness of the white part of the eyes or inside of the eyelids
  • redness, swelling, or itching of the eyelid
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
  • sensitivity of the eye to light
  • tearing of the eyes
  • tunnel vision
  • watering of the eyes
  • Body aches or pain
  • chest pain
  • chills
  • cough
  • difficulty with breathing
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • general feeling of discomfort or illness
  • head congestion
  • hoarseness, loss of voice, or other voice changes
  • loss of consciousness
  • muscle aches and pains
  • nasal congestion
  • pain in the chest, groin, or legs, especially the calves
  • painful blisters on the trunk of the body
  • pale skin
  • runny nose
  • severe, sudden headache
  • shivering
  • shortness of breath
  • slurred speech
  • sneezing
  • sore throat
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • sweating
  • tightness in the chest
  • trouble sleeping
  • troubled breathing
  • unexplained weight lossunusual tiredness or weakness
  • Back pain
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • muscle stiffness
  • swelling or redness in the joints
All these side effects for just £700 per shot!

So what about the cheaper alternative drug, Avantis? Is this perhaps also safer? Well, not really.

Avantis is a cancer drug. I was introduced in February 2004, and was being hailed as the great new breakthrough in the treatment of cancer. However, in just 9 months, by November 2004, the Magazine 'What Doctors Don't Tell You' were reporting that it could cause stroke, heart attacks, angina, and doubled the risk of a fatal blood clot. Even when it was approved in was known to cause fatal stomach perforations and congestive heart failure! WDDTY commented:


These new concerns must make Avastin one of the untouchables, but the new discoveries raise concerns about the efficacy and reliability of the pre-licensing clinical trials that too often miss adverse reactions that could even kill the patient. 

It's not for the first time, when faced with these deadly therapies, that we've said we'd rather take our chances with the cancer."

Eleven years later it is still available to us!

In 2008, the Independent reported on 27th June that the National Institute for Clinical Excellence (NICE) had, for the first time, terminated an assessment of a powerful new cancer medicine "because of a row about its price with the manufacturer". Not, you notice for unacceptable side effects, but on the grounds of cost! Nice is reported as saying that Roche had supplied "insufficient evidence" about the product, which costs £3,600 a month for a typical patient!

Also in 2011, and most pertinent to the treatment of macular degeneration, Avantis was found, in 5 separate reports, to cause blindness. This was reported in the New York Times, on 1st September. This article rehearses the same argument, 3.5 years ago, that we are now going over again.

So what are our free media in Britain, including the BBC, telling us about the side effects of these two drugs? Side effects that patients might want to know about in order to make an informed choice?

Absolutely nothing!