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Tuesday 30 July 2013

Darvon, Darvocet, Co-Proxamol: history of a banned painkiller

Pharmaceutical drugs come and go. They come initially heralded as wonder drugs, magic bullets. They go as unsafe, dangerous, or even lethal. It is a pattern that has been repeated decade after decade for the last 100 years. (See 'Banned, withdrawn, dangerous Big Pharma drugs').

Darvon, or Darvocet, or Co-Proxamol (Big Pharma drugs are called different names in different countries) is such a drug. The main ingredient of the drug is propoxyphene, and the drug may be masquerading under other names - it is the way the drugs industry obfuscates and misleads us so we never quite know what we are taking! The drug was introduced in the 1950's, and had a long history of safety fears. But obviously, it is in Big Pharma's best interests to keep drugs on the market for as long as possible, and this is what they have done.

The problem is that the drug caused heart problems. The public interest group, 'Public Citizen' called for the drug to be banned in 1978. It again called for a ban in 2006. It was eventually banned in the UK in 2006. But as dangerous as the drug might have been here, it continued to be sold elsewhere, throughout the world. The European Drugs Agency banned the drug in Europe in 2009. But it was still sold in the USA, and other parts of the world.

Eventually it was banned by the FDA in the USA on 19 November 2010. But even then, there was prevarication. Drugs are not banned without a fight! Following the Public Citizen petitioning to ban the drug in 2006, it took three years for an 'expert advisory committee' to vote, narrowly, to ban the drug. But that was not the end of the matter. The FDA overruled the committee's decision, and asked the drug company to investigate the affect of the drug on the heart. Only when this report was received was the drug banned!

When banning the drug the FDA said that it puts patients at risk of abnormal, and even fatal heart rhythm abnormalities. Yet the drug has been marketed as a painkiller for over 50 years before ANY action was taken, even though the evidence of its dangers had been known for most of that time. So, for over 50 years, patients were given a drug that could have given them serious heart disease.

It has been estimated that 10 million people in the US took the drug. But the advice from FDA had a further sting in the tale. Patients must not stop taking the drug - because there was a danger of 'serious withdrawal symptoms'. So they had to continue taking the drug, which caused heart disease; or they had to suffer severe withdrawal symptoms.

As usual, patients did not receive a good deal from the Big Pharma drugs industry!

And little timely, or effective protection from the statutory drug regulatory bodies!

Indeed, Public Citizen castigated the FDA for waiting for so long to protect the public. They said the because of FDA negligence at least 1,000 to 2,000 people in the USA died from using these drugs - just during the period between the ban in the UK and the ban in the USA.

Yet, in another sense, all this is routine stuff. The drugs industry introduces a drug, after testing and regulatory controls are undertaken. It is given to patients. Reports of 'side-effects' or 'adverse reactions' are received, and ignored by the regulators. Patients suffer by contracting new, usually more serious diseases. Many patients die. And only then, when faced with an untenable situation, do the drug regulators act.

There is no fail safe mechanism in the world of pharmaceutical drugs. Drugs are considered safe until such time that they prove, overwhelmingly, that they are not. It has been the same with drugs-past, drugs-now, and drugs-future. These drugs have little to do with health, and plenty to do with the drugs business, and making money.

Wednesday 24 July 2013

Health Charities and Patient Support Groups

There are many good causes that we can support. The number of Health Charities, or Patient Support Groups, has grown enormously – it is usually possible to find a charitable organisation that has been formed to support the sufferers, and the carers of sufferers, of most diseases these days. And many of them do a good job.
Yet what is becoming apparent in recent years is that a growing number of these ‘charities’ are receiving ‘support’ from Big Pharma companies, and clearly, when this happens, the impartiality of their health advice, and the stance they take on drugs, are brought into question. Indeed, some health charities are becoming too close to drug companies, some fear little more than an extension of their marketing policy
The practice is sometimes described as "astroturfing" – which involves funding patient groups in return for promoting pro-drug messages to members who assume they are getting ‘unbiased’ information on their condition. Dr Mercola referred to a report in the New Scientist (27th October 2006) described the practice in this way:
          “A marketing practice just as evil as exploiting sick patients with newer, better drugs far beyond their financial means: Bribing patient groups that monitor progress on specific diseases desperate for newer, better treatments with cash. The flow of cash between drug makers and patients is the theme behind this interesting and controversial report in today's New Scientist.
The magazine conducted a survey of US-based patient groups to learn what percentage of an organization's total budget was provided by drug companies. Of the 29 researched, the American Heart Association took the most funds - more than $23 million, even though that accounted only about 4% of their total budget. Those who took the biggest percentage of their income from Big Pharma were:
  •  C3: Colorectal Cancer Coalition: 81%.
  •  Depression and Bipolar Support Alliance: 50%.
  • Restless Legs Syndrome Foundation: 44%.
  • Narcolepsy Network: 35%.
Dr Mercola went on to report the other side of this picture, that is, organisations that refused to accept donations from drug or medical device companies, so it is important not to implicate every health charity in this practice
Sarah Boseley, health editor of the Guardian, expressed concern over a cancer group linked to a drug firm in an article published on 18 October 2006In an earlier Guardian article, 29 March 2006, looking at the campaign that heralded Herceptin as a ‘wonder drug’ for breast cancer, it looked at the charity CancerBackup. It found that their latest financial statement showed that 31% of its income from companies and charitable trusts that included Roche and around 14 other major drug companies.
It said that patient groups were “the most rewarding target” and that Big Pharma companies with turnovers as large as the GDP of small nations could obviously influence these groups. It reported that the industry journal ‘Pharmaceutical Marketing’ ran an article describing how "motivated patients can move mountains and boost your drug's fortunes".
The article also reported that Liberal Democrat MP Paul Flynn has done a survey to find out which patient groups accepted drug-company money. Of 24 major organisations, only six did not do so!
From April 2006, under new industry rules, the drug companies will have to declare on their websites what money they give to patient groups. As the Guardian article said - this should make interesting reading.
WDDTY reported that one company, Glaxo-Smith-Kline (GSK), had been caught out 'astroturfing' a patients group called Ekbom Support Group, which helps advise people with restless legs syndrome. GSK's advertising included a link through to the group's website, which described the company's drug ropinirole as an effective treatment for the problem. Yet this appeared eight months before the drug was approved, and the Prescription Medicines Code of Practice Authority, which oversees drug advertising in the UK, ruled that GSK "was, in effect, directing patients to a website that contained misleading messages about the safety of ropinirole, which might indirectly encourage patients to ask their doctors to prescribe it."
An article in the Sunday Times, 3rd December 2006, outlined how some health charities receive ‘covert’ aid from drug companies. Indeed, they were accused of doing so by Britain's chief drug regulator, Sir Michael Rawlins, chairman of NICE, who accused pharmaceutical companies of “covert and distasteful tactics in funding patient groups that campaign for wider use of the medicines they manufacture”.  NICE makes decisions about which drugs are provided by the NHS, and he warned that the industry’s sponsorship of health charities could lead to excessive pressure and unfair rulings about which medicines were made available. He is quoted as saying:
          “It is important everybody is aware that a particular patient organisation gets money from the pharmaceutical industry and that is not easy to find out at the moment. The patient group may not just receive money: the pharmaceutical company may be providing help and resources, such as the use of their PR manager. In the long term it will do the patient organisations an immense amount of damage and the confidence in their neutrality will dissipate. . . It certainly is distasteful.
The Times article stated that the Alzheimer’s Society led a patient campaign against a NICE ruling that the dementia drugs Aricept, Reminyl and Exelon were not cost-effective and should not be paid for from public funds. Yet during the previous financial year the Alzheimer’s Society received £31,000 from Pfizer and Eisai, which sell Aricept. In the last year the society also received £13,000 from Shire Pharmaceuticals, manufacturer of Reminyl, and £14,000 from Novartis, manufacturer of Exelon.
This article was first published within the E-Book, "The Failure of Conventional Medicine".

Monday 8 July 2013

Medical Mistakes? Or Dangerous Medicine?

  • It has been estimated that between 5-10% of patients admitted to hospital are infected with hospital-acquired diseases, such as MRSA (360 deaths in 2005 in England alone) and Clostridium Difficile (1,300 death in 2004). The problem, according to the NHS is that health professionals needed to do more to address hygiene to improve patient safety - thereby ignoring the troublesome fact that whilst these infections can be spread by bad hygiene their actual cause is the overuse of antibiotics – Conventional medicine’s most miraculous miracle drug!
  • It is the same throughout the world. On 25th October 2006 the BBC reported that in Italy it has been estimated that as many as 90 people die in hospital every day “due to medical malpractice and organisational errors”. Note again that the deaths are not caused by ‘medicine’ – but by malpractice, and error. The calculation of 33,000 annual deaths is more than the number of people killed on the roads in Italy, which means that there are an awful lot of ‘errors’ and ‘malpractice’ going on!
  • Celia Hall, Medical Editor, Daily Telegraph. "One NHS patient in 10 'is harmed in hospital'". 6 July 2006. This article said that nearly a million patient safety incidents or 'near misses' in a single year were recorded in NHS trusts, drawing attention to the effectiveness of the Patient Safety Agency. It estimated that in 2004-05 there were 974,000 patient safety incidents in England and Wales and MPs believe that 22% of mistakes go unreported.
  • In the same Daily Telegraph article the charity, Peter Walsh, the chief executive of 'Action against Medical Accidents' (AvMA) called for stronger sanctions. "We hope the report will give an injection of urgency into work to improve patient safety. Whilst there has been welcome progress we want to see more teeth given to existing guidelines and safety alerts. It should be compulsory for NHS providers to implement them".
  • Sarah Bosely, in the Guardian, 11th August 2006 stated that there were 40,000 NHS drug errors logged in a year, the figures having been collated by the National Patient Safety Agency. The article said that the statistics inevitably underestimated the problem 'since not all errors are reported'.
  • Jerome Burne. Daily Mail 12 September 2006. "In the UK, 10,000 people are killed every year by adverse drug reactions which happens when the prescription drug supposed to be curing you kills or harms you instead. That is more than the number who die from cervical cancer, taking illegal drugs, cancer of the mouth and passive smoking combined. It's actually more dangerous to visit your doctor than it is to drive your car - in 2004, traffic accidents were responsible for some 3,221 deaths. Yet a further 40,000 people each year are made sick enough by drugs they are taking to be admitted to hospital".
  • WDDTY e-news. Doctor Error: It’s rife, especially among the newborns. 07 February 2008. "It's an urban myth - and one that happens to be true - that the death rate plummets when doctors go on strike. Patients in hospital are especially vulnerable to the doctor's ministrations, and it's even worse for the newborn baby who hasn't yet made it home. A new study into newborns that needed 'hospital' care - usually because of low birth rate or premature birth - has revealed the extent of doctor error or doctor-induced (iatrogenic) problems. Researchers monitored the progress of 388 babies who had been admitted to a neo-natal unit in Southern France from January to September 2005; in that time, researchers witness 267 doctore errors, and nearly 30% of these were serious. Two babies died as a direct result of the errors". (Source: The Lancet, 2008; 371: 404-10).
  • WDDTY reported on research (published in the Archives of Internal Medicine, 2006; 166: 1410-6) that studied the progress of 7,054 patients admitted to a veterans' hospital between 2003 and 2004. Of these, 792 patients suffered a heart attack while in the hospital ( about 11%) and that they were twice as likely to die from the attack. As the article says, this means that up to 2,690,000 people could be harmed by medical ‘mishaps’ every year. This represents around 4.5% of the entire population. It goes on to say that in the USA, where twice as much is spent on ConMed drugs, the problem could be affecting up to 13,450,000 people every year. Government officials were said to be 'shocked' to hear that nobody knows how many of the reported 'blunders' ended in death. Apparently, only 1 in 4 hospitals 'own up' to the patient when something goes wrong; the rest presumably blame the patient illness on admission. Just 1 in 25 drug reactions is ever reported. Edward Leigh, chairman of the Commons Public Accounts committee said that 1 in 10 people admitted to a hospital in Britain every year will suffer a mishap or accident that will harm him, and that this is based on known, reported accidents. Apparently, the committee members discovered that the situation is not getting better, that doctors and hospital staff are not learning from mistakes, but repeating them every year, that guidelines are being consistently ignored, and safety recommendations are not being implemented.

How close are our GPs to the Pharmaceutical drug companies?

The question about doctors being too close to drug companies is recognised as a serious problem. In a Daily Telegraph article on 9th July 2006, the GMC (General Medical Council) was said to be warning doctors about taking ‘freebies’ from pharmaceutical companies, and to ‘blow the whistle’ on colleagues who were ‘taking bribes’ from drug companies. They were revising their rules to enable such doctors to be removed from the register, and ‘struck off’.

          “The decision to toughen up the rules comes as evidence increases that, in return for promoting their products, some doctors are taking inappropriate gifts and hospitality from the pharmaceutical industry.
The article pointed to a report by the campaign group Consumers International that said doctors were continuing to accept kickbacks, gifts, free samples and consulting agreements in exchange for prescribing or promoting drugs. It said that such inducements accounted for a substantial part of the £33 billion spent on product promotion by the industry worldwide each year.
Despite this, concerns continue. WDDTY reported on 6th November 2007 that the drug giant Bristol-Myers Squibb (annual sales: $17.9bn) had been handed a $515m fine for mis-selling drugs, inducing doctors to prescribe drugs inappropriately, and setting fraudulent prices on some of its products. It said that the company had been caught making illegal payments to doctors as an inducement to get them to buy their drugs. Doctors had also received ‘consulting fees’ to sit on ‘advisory’ boards and programmes, some of which involved necessary trips to luxury locations. Meanwhile, the company was paying retail and wholesale pharmacies to buy its drugs. It was also encouraging doctors to prescribe its anti-psychotic drug Abilify (aripiprazole) to children when it had been licensed for use only with adults. (The source of this information was the British Medical Journal, 2007; 335: 742-3).
In another WDDTY article, “Bribery: Doctors gifted $100,000 a year to use hip replacement products”, dated 29th November 2007, Orthopedic surgeons in the US were reported to have received bribes of $100,000 and more every year to use special hip and knee replacement products on their patients. Apparently five manufacturers were fined $311m (£150m) by the US Department of Justice. The companies admitted paying 'many' orthopaedic surgeons 'consulting fees' that ranged from $10,000 to hundreds of thousands of dollars every year.  Investigators discovered that the payments had been common practice between 2002 and 2006, and that as well as receiving “consulting fees”, the surgeons were also treated to lavish trips and expensive gifts. (The source of this information was the British Medical Journal, 2007; 335: 1065).
The objectives of the ‘No free meals’ group of doctors is as follows:
     “We are health care providers who believe that pharmaceutical promotion should not guide clinical practice. Our mission is to encourage health care providers to practice medicine on the basis of scientific evidence rather than on the basis of pharmaceutical promotion. We discourage the acceptance of all gifts from industry by health care providers, trainees, and students. Our goal is improved patient care.

     "We aim to achieve our goal by informing health care providers as well as the general public about pharmaceutical industry efforts to promote their products and influence prescribing; provide evidence that promotion does in fact influence health care provider behaviour, often in ways that run counter to good patient care; and provide products that can replace pharmaceutical company paraphernalia and spread our message.

     "We believe that there is ample evidence in the literature-contrary to the beliefs of most heath care providers - that drug companies, by means of samples, gifts, and food, exert significant influence on provider behaviour. 
     "There is also ample evidence in the literature that promotional materials and presentations are often biased and non-informative. We believe that health care professionals, precisely because they are professionals, should not allow themselves to be bought by the pharmaceutical industry: It is time to Just say no to drug reps and their pens, pads, calendars, coffee mugs, and of course, lunch.
These are laudable objectives. However, there appears little evidence that their motives have been generally accepted by the conventional medical establishment.
This article was first published in my e-book, "The Failure of Conventional Medicine".

Tuesday 2 July 2013

Diabetes. Are patients better with, or without these conventional drugs?

Anyone suffering from Diabetes, and in Britain, about 2.5 million people do, must be wondering whether they are better off with, or without the drugs they are prescribed by their NHS doctor. 

A Channel 4 Dispatches programme, broadcast on 10th June 2013 set the scene. It linked certain diabetes drugs (it mentioned Januvia, Victoza and Byetta) with Pancreatitis and Pancreatic cancer. Despite these concerns, the programme said that the Big Pharma drug companies were

     (i) refusing to release data they had gathered on the drugs,
     (ii) but they were interested in using the drugs for the growing problem of Obesity.

This is quite typical of what is happening in the Conventional Medical world. On the one hand, a complete lack of transparency when it comes to responding to concern about serious adverse reactions to drugs. But, on the other hand, a desire to use drugs in other, more lucrative areas of ill-health.

In both cases, the patient appears to be the last to be considered.

As always, when discussing the disease-inducing-effects (DIEs) of pharmaceutical drugs, a question is posed by the conventional medical establishment. Do the benefits of the drugs (in this case, for the treatment of Diabetes) outweigh the risk (in taking drugs that cause Pancreatitis and/or Pancreatic cancer).

One of the drugs concerned, Januvia, has apparently been found to double the risk of developing acute pancreatitis. This was the result of a study, published in the Journal of the American Medical Association (JAMA), in February 2013. The study found that in most cases, hospital admission for pancreatitis happened within the first 60 days of patients taking Januvia.

The makers of Januvia, Merck, have long rejected any link between Januvia and pancreatitis!

The link with pancreatic cancer is even more serious, as it is a disease that kills 80% of people within the first year of diagnosis. There is research, published in 2011, indicating that Januvia could increase the risk of of pancreatic cancer (by 172%) and thyroid cancer too (by 48%).

Equally, what cannot be denied is that Januvia is a money-spinner, one of Mercks best-selling drugs, earning an estimated $4.1 billion in 2012.

So what are the drug regulators doing? Not, it would seem, very much. The FDA announced in March 2013 that 'it will investigate' the risks associated with Januvia. Yet, in the meantime, there is little evidence that any move has been made to inform patients, or that there is much concern about those people who might contract pancreatitis, or pancreatic cancer, during the time it takes to investigate the drug. Not much urgency there, it would seem!

Yet this cannot be considered to be a new linkage. As Agora Health stated in their 'Daily Health eAlert  (June 2013), the FDA were aware of the dangers of Januvia as early as 2006, as between October 2006 and February 2009, the FDA received reports of 88 cases that linked this drug with pancreatitis.

It would seem that being diabetic, not an easy one at the best of times, is being made far worse by the drugs the Conventional Medical Establishment gets them to take.

Victoza, another diabetes drug, was introduce in 2012. Even at the testing stage, animal studies indicated that it cause thyroid tumours, and human studies indicated that it caused pancreatitis. So why was it approved? Only the drug regulators know. But despite the evidence, the drug was uncompromisingly heralded as a 'breakthrough' in the treatment of type-2 diabetes! Other drugs, of the same type, are called Byetta, Exenatide, Liraglutide - and of course, Januvia.

Dispatches reported that the British Medical Journal (BMJ) had looked at all the evidence concerning this drugs, and had concluded that the manufacturers (including Merck, Novo Nordisk and Amylin Pharmaceuticals) may have been trying to hide the potential harmful reactions the caused. Dr. Deborah Cohen, from BMJ, is reported saying that whilst the evidence of the trial "may seem inconclusive",

          "When considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug".

So, are diabetes patients better off with these drugs, or without them?

Remember the diabetes drug, Avandia? Some people dubbed it as 'the killer drug' - although it must be said that Avandia has many rivals to this claim! Recall that it was banned throughout Europe in September 2010, as it was found to significantly increase the risk of heart attacks? Yet Avandia was marketed from 2000, and for 10 years it was allowed to cause heart attacks and strokes - whilst it was being 'investigated' by the drug regulators.

Will it take as long for these 'new' drugs to be banned? Will the drug regulators allow pharmaceutical companies to profit from drugs that are causing death whilst they 'investigate' the problems? How long will it take before the needs of patients come before the profits of drug companies?

One thing that every diabetes sufferer can do is to challenge their doctor, challenge the NHS, challenge the Department of Health, challenge their MP - and demand safer medicine. We all need to ask the question. Is the need to treat diabetes worth risk of getting acute pancreatitis, and pancreatic cancer? Do the benefits of these drugs really outweigh the risks?

Monday 1 July 2013

Diclofenac. Too dangerous, causes patient harm, but still on sale

Diclofenac is a NSAID painkiller, launched in Britain in about 1993, that has been found to cause heart attacks, and banned by the MHRA in June 2013 - at least for patients with heart problems. As usual, this ban took a long time, even though all NSAID drugs have been linked with heart disease for many years. This has been one of the few such drugs that has faced even a partial banned. Vioxx is another. And, as far as I am aware, the drug is still available elsewhere in the world, and clearly, is still available in Britain for those patients who do not have heart problems!

The dangers of Diclofenac have been known about for many years. In June 2005 a BBC article outlined ‘Safety doubts for more painkillers’. This referred to all NSAID painkillers, and within the article there is a comment that “enough concern exists to warrant a consideration of the cardiovascular safety of all NSAIDs”. However, it took the drug regulatory system a further 8 years to act on Diclofenac, whilst other NSAID painkillers are still being given to patients. After the ban was announced (June 2013) I checked the Wikipedia website, and it still  had this to say about Diclofenac.

          “Diclofenac is among the better-tolerated NSAIDs. Though 20% of patients on long-term treatment experience side effects, only 2% have to discontinue the drug, mostly due to gastrointestinal complaints

Other internet websites that described the ‘side-effects’ of Diclofenac also failed to give clear warnings that the drug caused heart attacks, and were content to repeat this bland ‘well-tolerated’ assurance.

This is quite typical. Most drugs are known to be dangerous for many years before they are banned, and prior to the ban patients are told little about the dangers, but plenty of re-assurances about their safety! 

The Daily Mail reported the problems in September 2011, but even then added “Don’t stop taking the pills, but do talk to your doctor”.

An Asian vulture seemed to have been treated better than human patients! Diclofenac is used for veterinary purposes, and in India its manufacture was banned for cattle as it was killing a rare species of Asian vulture! Even this did not appear to suggest to the Conventional Medical Establishment that Diclofenac might be a dangerous drug! The withdrawal of the drug in India did, however, lead to the recovery of the vulture. This was happening in 2009 - 4 years prior to the current ban.

The ban on Diclofenac was announced by the BBC, a media organisation which has a long history of relaying news of conventional ‘medical breakthroughs’, but rarely about medical catastrophies like this. So I searched on the internet to see what they had been telling us about this drug. 

* May 2013. BBC article refers to ‘common painkiller’ that ‘poses heart risks’ on the basis of an article published in the Lancet.

So, like most of the mainstream media, they have been well aware of the problems associated with Diclofenac, but rather than warning us, they have relied almost entirely on what they are told by the conventional medical establishment. Our Media appears to have little stomach for investigative journalism when it comes to exposing dangerous drugs!

This puts us all at risk. Known drug dangers are kept secret by the conventional medical establishment. And the Media is not prepared to ask serious questions about the dangers caused by pharmaceutical drugs or vaccines.

What this means is that no patient, at any time, can be satisfied that any current drug or vaccine (Diclofenac was a ‘current drug’ even for people with heart conditions until the MHRA announcement) is safe.

Thanks to Vijay Vaishnav for this additional information on Diclofenac - sent to me via Facebook. Clearly the dangers of Big Pharma drugs go further than the damage caused to human populations.

          "Doclofenac can also indirectly affect human health because of the ecological disturbance it causes. For example, use of diclofenac in animals has been reported to have led to a sharp decline in the vulture population in the Indian Subcontinent, a 95% decline in 2003, 99.9% decline as of 2008. The mechanism is, it is presumed, renal failure, a known side effect of diclofenac. Vultures eat the carcasses of livestock that have been administered veterinary diclofenac, and are poisoned by the accumulated chemical, as vultures do not have a particular enzyme to break down diclofenac. 

          "The loss of tens of millions of vultures over the last decade has had major ecological consequences across the Indian Subcontinent that pose a potential threat to human health. In many places, populations of feral dogs (Canis familiaris) have increased sharply from the disappearance of Gyps vultures as the main scavenger of wild and domestic ungulate carcasses. Associated with the rise in dog numbers is an increased risk of rabies and casualties of almost 50,000 people. A major shift in transfer of corpse pathogens from vultures to feral dogs and rats can lead to a disease pandemic causing millions of deaths in a crowded country like India; whereas vultures' digestive systems safely destroy many species of such pathogens. 

          "Diclofenac has been shown also to harm freshwater fish species such as rainbow trout. (Wikipedia)

P.S.  Diclofenac might have been banned by the MHRA, but it is still sold as Voltarol, and still advertised on television (January 2014). And on Voltarol's website you can search in vain for any mention of the known dangers.