Credibility of Clinical Trials

Most experts agree, '90% of all drugs trials are engineered for success, the drugs are then misrepresented to the licensing authorities and then miss-sold to the public'. Professor Joan Busfield, from Essex University said 'the industry was controlling science, with trials sponsored by drug companies likely to yield more favourable results'. In fact, most medical research is either wrong or fraudulent. John Ioannidis, a doctor and medical research analyst, has looked at hundreds of studies and discovered that 'two in every three conclusions published in medical journals are later found to be wrong or fraudulent' which has lead to a crackdown by the FDA on some drugs.

WHO Warning
The World Health Organization (WHO) issued a fact sheet [Dec 09 No:335] warning about the corruption and unethical practices that are endemic to every step of the pharmaceuticals business. The medicine chain refers to each step involved in getting drugs into the hands of patients, including drug creation, regulation, management and consumption. According to WHO data, unethical practices such as bribery, falsification of evidence, and mismanagement of conflicts of interest are "common throughout the medicine chain."

Senate Enquiry
For the past 4 years, the staff of the Senate Committee on Finance (Committee) has been examining allegations that pharmaceutical companies attempt to manipulate science to improve the marketability of drugs, potentially at the expense of public safety. These allegations include intimidating scientists, ghostwriting studies for academic researchers, suppressing studies that may show that a drug could be dangerous, and selecting data to publish results that favor one product over another.

The actions and deceptions of the pharmaceutical industry, their executives and scientists are considered the norm and constitute their 'industry standard'. This includes but is not limited to intimidation of unwilling scientists, deception of regulating bodies, falsification and suppression of evidence. Getting caught is a calculated risk. This is reflected in the fact that the pharmaceutical industry has paid fines and penalties of some $7billion between 2004 and 2009 in the U.S. alone.

It is not well known by the general public that the effectiveness of most drugs are exaggerated by the selective publication of favorable results. Terms such as 'clinically proven', 'scientifically proven' and 'evidence based' all sound impressive but they have little or no value and are used as smoke screen to imply most pharmaceutical drugs are much better than they actually are. One leading expert said ‘Clinical data, evidence based and scientifically proven all mean very little in reality, what really counts is how drugs perform in the real world and to establish that we have to listen to the people who use them'. Also, be very wary of clinicians who use these 'labels' to restrict the use of non pharmaceutical treatments claiming they are 'unproven'.

Some clinicians like to play both sides, they question the value of clinical trials as they know any unfavorable data is suppressed, destroyed or manipulated and only the favorable results from trials are presented and then published, they criticise the pharmaceutical industry for their deceptions and then attack the non-pharmaceutical industry for not having any 'clinical data' to support their treatment methods.

In order to gain medical acceptance for a non-pharmaceutical treatment, it needs NICE approval. But NICE demand ‘clinical data from controlled trials' which they call 'evidence based medicine (EBM)' however controlled trials cost many millions of pounds and EBM applies to 'populations and not individuals with real problems'. The industry has these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and most companies, only huge international pharmaceutical corporations can afford to run controlled trials now. By NICE demanding 'clinical data from controlled trials' they are in effect blocking non-pharmaceutical treatments from becoming a mainstream quickly, regardless of its effectiveness and patient benefits. Critics argue 'It is an organisation that has shown itself to be absurd and irrelevant at best, incompetent and deadly at worst. NICE are the biggest threat to patient health and should be scrapped'.

Starting from these basic facts: - that clinical trials are fraught with manipulation, corruption and suffer severe credibility issues: - most clinical studies are based upon asking the patient for feedback:- most drugs don't work for the majority of people who are taking them: - the participants in trials are paid for their co-operation: - the medical profession over prescibe drugs that they know don't work even though they have serious side effect and clinical trials can be bypassed when suited, critics argue 'clinical trials have no credibility should not be used as an excuse to block any established treatment method'.

“Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.” Sir Richard Sykes. House of Commons Health Committee -The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05.

Most clinical study data is simply complied by asking the participant for their feedback and comments about the effects of the trial/drug etc and then presenting this 'anecdotal evidence' as scientific fact/data.

Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody." This goes against a marketing culture within the industry that has relied on selling as many drugs as possible to the widest number of patients.

The so call volunteers are actually paid from £800 to £5,500 each to take part in trials and can be easily influenced to 'say/do the right thing' for further financial gain to obtain the most favorable feedback/results.

Doctors are not allowed to tell you about any "natural or alternative health therapies" and stay employed. Insurance regulations would preclude such suggestions. And they can get into serious trouble for recommending natural, non-drug treatments. Doctors are only allowed to prescribe drug based treatments for most conditions i.e. they prescribe anti-depressants for alcohol related problems which don't work or help the individual to stop drinking. The individual can then become dependent on these drugs which creates another set of problems and in most cases they are completely unnecessary, critics say 'a new study concludes these type of drugs simply put people into 'drug-induced states'.

The untested swine flu vacine had limited trials but the vaccine would be made available for use by the NHS in July 09 before the results came in. What the manufacturers submitted did not have any clinical trial data. The interim adult data would be available from September 09 and the first paediatric data from October 09 onwards. Crtics say 'with the creation of the innovation pass more untested drugs will be 'tested' directly on the patients. As a result over 50% of people developed side effects including gastrointestinal problems, such as vomiting and diarrhoea. But there were also cases of heart and eye problems - together with 46 cases of psychiatric disorders and 48 disorders of the nervous system. There has also been one unexplained death.

No Commercial Benefit or Profit
The only reason for the lack of research or no research in the field of any non-pharmaceutical medicine is because there is no incentive to invest in researching treatments or remedies which cannot be exclusively manufactured by a drugs company. You can't patent a herb or homeopathic remedies or a vitamin. The people who actually do the large-scale medical trials are the pharmaceutical companies, but if they can't get a product out of it, why would they bother?

This fact was highlighted in the media over the new polypill which could save thousands of lives yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies because its five constituent medicines are cheap, have been around for decades and their patents have expired, click here for details.

Any non-pharmaceutical treatments, which help with addiction for alcohol or drugs, are blocked from being used because of the argument they have not been clinically trialed or scientifically proven to delay medical acceptance of the treatment. However those in possession of the facts know this argument is unfounded due to the conflict of interest that exists between the drug companies and the medical profession, Labour MP Paul Flynn says 'the main concern is that the drugs companies have their tentacles in every area where decisions are taken - that includes the WHO, governments, civil service, and even charities'.

Clinical trials are merely the preliminary stage to establish if a product or treatment is efficacious and is safe, real world use establishes how safe and how effective it actually is. It is at this stage many drugs fail to deliver in real world use yet they were supposed to be quiet promising in controlled trials. Champix is a very clear example of how drugs are initially marketed to the public but deliver far less in reality and can be very dangerous.

The Champix Example:
Critics say 'champix is a clear example of how a useless drug is engineered for success, misrepresented to the licensing authorities and then miss-sold to the public'. Pfizer spared no expense in creating one of the most intense clinic quitting experiences in any smoking cessation study ever, creating highly artificial clinic study conditions. Real-world users, operating alone with their Champix pills, would be using the product under entirely different conditions but no mention of this was made in the marketing claims for champix, smokers expected to take the pill and stop smoking.

Champix study participants received a free 12-week supply of Champix, were reimbursed travel expenses associated with visiting their health provider to obtain it, attended 16 clinic visits involving one-on-one sessions lasting up to 10 minutes, with counselors trained in motivation and coping skills development, and received 8 follow-up telephone support calls from their provider and also used nicotine replacement therapy (NRT) following 12 weeks of Champix use, again none of which was mentioned to the public.

Launch Claims: 2007	An anti-smoking "wonder pill" that claims nearly half (44%) of patients who took Champix gave up in just three months, twice as successful as other methods, it's more effective than current alternatives and is a significant advance, clinical trials show the drug is effective after a 12-week course, with 44 per cent of smokers stopping.
Clinical trial side-effects	the most common side effect is nausea, which was generally mild and transient.

Reality success rate

Actual success rate less than 20%.

'Ancedotal evidence' of
side-effects

Llinked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders. The US Food and Drug Administration began investigating the drug, called Chantix in the US, in November after it reported 55 cases of suicide and 199 cases of suicidal thoughts in just one week.

Boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of Champix due to reports of behavioral changes, depressed mood , agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA's adverse event reporting system.

So far 24 people taking the nicotine-replacement have died, of whom ten took their own lives. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.

There are now 165 potential side-effects listed on Pfizer's "Full Prescribing Information"

It is not a 'wonder pill' and most smokers do not want to take it or stop taking it due to its unpleasant side effects.

The increase in side-effects from those disclosed during clinical trials means either the champix wasn't tested enough or the side-effects were not disclosed. Clinicians rely on client feedback 'anecdotal evidence' to assess the results and side effects of drugs once they are used by the general public.

Champix - an 8 in 10 failure rate or worse?
What we do not know is whether Champix's modest 1 in 5 success rate is attributable to the effects of Champix, to the 16 clinical counseling sessions participants received, to the use of nicotine replacement therapy (NRT) following 12 weeks of Champix use, or to the fact that more than 1,000 hard to treat smokers who would likely have generated substantially higher failure rates were denied participation. What we do know is that Pfizer's clinical Champix studies were not blind as claimed. Click here to read more.

Avandia - US Senate Investigation Medical Fraud
In another example [of which there are thousands] U.S. senators said the makers of Avandia, British firm GlaxoSmithKline, knew it carried a higher risk of heart attack than a rival medicine but had tried to keep evidence of the risk from the public. Senators Max Baucus and Charles Grassley said GSK executives 'attempted to intimidate independent physicians and focused on strategies to minimise or misrepresent findings that Avandia may increase cardiovascular risk'. Now the U.S. Food and Drug Administration, the medicines watchdog, has asked an advisory committee to look again at the drug.

Senators Max Baucus and Charles Grassley accused the FDA of not having banned the drug because it is too 'cozy' with drugs firms like Acandia maker GlaxoSmithKline. They quoted a memo written by two FDA reviewers which concluded: 'The risks of (Avandia) are serious and exceed those for' rival drug Actos. The reviewers said there was 'strong evidence that (Avandia) confers an increased risk of' heart attack and heart failure when compared to Actos.

For the past 4 years, the staff of the Senate Committee on Finance (Committee) has been examining allegations that pharmaceutical companies attempt to manipulate science to improve the marketability of drugs, potentially at the expense of public safety. These allegations include intimidating scientists, ghostwriting studies for academic researchers, suppressing studies that may show that a drug could be dangerous, and selecting data to publish results that favor one product over another.

The actions and deceptions of GlaxoSmithKline, their executives and scientists are considered the norm for the pharmaceutical industry and constitute their 'industry standard'. This includes but is not limited to intimidation of unwilling scientists, deception of regulating bodies, falsification and suppression of evidence. Getting caught is a calculated risk. This is reflected in the fact that the pharmaceutical industry has paid fines and penalties of some $7billion since 2004 in the U.S. alone. Click here to read the full 342 page report.

Reality
Most experts agree, '90% of all drug trials are engineered for success, misrepresented to the licensing authorities and then miss-sold to the public'.

Wonder Drugs That Can Kill
Recently a series of drug recalls have pulled back the curtain to show how the media, the public, and some doctors can misinterpret medical studies or take them out of context in ways that make medical treatments look safer and more effective than they actually are. Click here for further details.

Since Thalidomide in the 60's to Avanda in 2010, pharmaceutical history is swamped with allegations of fraud, corruption, non-disclosure and misrepresentation of its products with horrendous side-effects and the cause of thousands of deaths. Many people believe murder charges should be brought against some pharmaceutical executives for their role in marketing such dangerous drugs.

Double Standard: Evidence is 'evidence'
It's only when a drug is widely used that any problems come to light, patients report side effects under the 'yellow card' scheme and some can be serious enough and life threatening to have the drug withdrawn from the market, so clinicians rely on 'anecdotal evidence' to assess the effects of drugs. But when 'anecdotal evidence' is used to support a non-pharmaceutical treatment it's suddenly not good enough to support its use. But when the evidence is in the format of a signed declaration made by the client it goes beyond anecdotal and becomes a 'witness statement' as to the effectiveness of the procedure.

Obsolete Clinical Data
Clinicians like to go on about scientific data, clinical trials, evidence based medicine (EBM) however this 'evidence' can be as low as just 6% to claim the tag 'clinically proven' which in many cases, has no credibility. Some drugs look quite promising during trials however they turn out to be a flop when used in the real world. The dogmatic demand for scientific data is superseded by actual real world evidence and results. Critics argue 'some people within the scientific community are so blind they can not see the wood for the trees'. Any clinical scientist will tell you, laboratory results will only stand up when the treatment is used in the real world.

Simon Chapman, a professor of public health , writing in the journal PLoS Medicine in relation to NRT products said 'next time you hear the message that various drugs "double the quit rate", understand that these results come from clinical trials where participants get their drugs free, where they are often called up with reminders and questions, where they develop relationships with the researchers and often want to please them, and where we know that many using the active drug are able to correctly guess they are on it or on the dummy drug. 'Studies of the use of quit drugs in "real world" settings have not demonstrated that they have such success.

Clinical trials are not the definitive stage, they are just the beginning, what happens when the treatment is actually used, is the true 'evidence' of its value, at some stage the need to simply acquire 'scientific data' becomes obsolete if the treatment is already 'proven'.

Proven in Practice
Blocking non pharmaceutical treatments because they are not 'evidence based' is a double standard anyway as most (80% to 90%) medical procedures have not been clinically trialed and are not evidence based either, they are 'proven' by their use in the same way our treatments have been proven by its use over the last 5 years. If any clinicians doubt the intervention qualities of our treatments they are welcome to take part in the addiction challenge.

Controlled Data Excuse
Many medical professionals hide behind the 'clinical trials' excuse as a reason not to use our treatments, 'I want to see data from controlled trials', they say this as though clinical data is very easy to obtain and everyone should have it. The reality however is very different as they know, clinical trials are hugely expensive running into the millions of pounds and take years to complete so many critics argue 'demanding trial data for a non-pharmaceutical treatment is totally inappropriate'. Apart from that, controlled trials also have sever credibility issues and there is also no guarantee that once a treatment has been clinically trialed it would be used anyway. Critics argue 'medical professionals do not, as one would assume say 'that's promising, lets do an observation study and see if the treatment has any merit, they attack and undermine it, rather than exploring and supporting it'.

Libel
Most medical professionals are pre-programmed to dismiss any non-pharmaceutical treatment even before they know anything about it. Some even attack them with impunity however a recent liable action found that 'with rights comes responsibility, and scientists must realise they cannot simply publish with impunity what they know to be untrue and libelous'. The ruling came after Dr Singh wrote in the Guardian that the British Chiropractic Association was 'the respectable face of the chiropractic profession and yet it happily promotes bogus treatments'. The association sued for libel, demanding an apology and a retraction. In a preliminary ruling Mr Justice Eady said the use of the word 'bogus' meant Mr Singh 'had accused the association of dishonesty'.

However the BCA dropped their liable action two years later when the Court of Appeal held that what Dr Singh had written was a statement of opinion which was backed by reasons. It also made clear its view that the courts were not the forum for settling scientific disputes.

Lord Judge, the Lord Chief Justice, giving the judgment, said the court adopted the comment of Judge Easterbrook, now Chief Judge of the US Seventh Circuit Court of Appeals, who had said in Underwager v Salter, a libel action over a scientific controversy, that plaintiffs "cannot, by simply filing suit and crying 'character assassination!', silence those who hold divergent views, no matter how adverse those views may be to plaintiffs' interests. Scientific controversies must be settled by the methods of science rather than by the methods of litigation ... More papers, more discussion, better data, and more satisfactory models - not larger awards of damages - mark the path towards superior understanding of the world around us".

As those who have followed the publicity surrounding this case will know, Simon Singh has said publicly that he had never intended to suggest that the BCA had been dishonest. The BCA accepts this statement, which goes some way to vindicating its position.

We welcome sensible debate about our treatments bearing in mind 'scientific controversies must be settled by the methods of science rather than by the methods of litigation' [Lord Judge, the Lord Chief Justice] and encourage any clinician, medical professional etc to first take part in the addiction challenge before they feel free to criticise results, which they themselves are unable replicate.

Proof
Trials are only required for drugs to establish 'effectiveness and safety' however once a non-pharmaceutical treatment is used and it becomes established through its use, then its track record proves its effectiveness and safety, if it is unsuccessful, it will not become an established treatment. Also, clinical trials are not a reliable basis to judge any treatment method as 'outcomes' usually favour whoever is funding the trial, click here for further details.

The argument concerning clinical trials unfounded as 'efficiency and safety' have already been established through its use, in the same way that most medical procedures have not been clinically trialed either but are still used in common practice, critics argue this double standard is detrimental to patient care.

Comparison Trial
New drugs are often arrived at by extracting active ingredients from plants that have been traditionally used as remedies. So there is now a demand that clinical trials should also be tested against these natural remedy as well as a placebo, as testing against a placebo is merely establishing how much better the drug is, than no treatment at all.

In effect drug companies are testing their new drugs against 'doing nothing', which critics argue is not a significant benchmark for testing. In addition, most drugs also take advantage of the placebo effect. When they are launched, all the hype and the media attention builds up peoples expectation but years later they are discredited as not being as effective as first thought, it is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public. Glaxo Chief: Our drugs do not work on most patients. The Independent 2003.

Scientist have just discovered a drug made from the hydrangea roots could be used to treat a raft of common diseases and has the power to 'revolutionise' the treatment of multiple sclerosis, psoriasis, some forms of diabetes and arthritis but it is already one of the 50 staple herbs of Chinese medicine.

For example: Prozac should have been tested against a placebo and St John's Wort to establish if it better than 'no treatment at all' and a well known 'alternative remedy' used to treat depression. The drug made from the hydrangea root should also be tested against the root itself to establish if it is any better than the actual herb itself.

Resolved - The Ethical Dilemma
This 'comparison trial' as would also resolve the ethical dilemma the medical profession has been unable to resolve for over 60 years. The use of placebo-controlled trials began just before World War II, and the Declaration of Helsinki, which arose from the Nuremberg Code, was formulated after the war. Placebo-controlled studies soon became the gold standard of evidence, and the Declaration of Helsinki became the gold standard of research ethics. However, the practices of the first collided with the principles of the second, and researchers and ethicists have been trying to resolve this problem ever since. The debate over placebo-controlled trials is implicitly and inextricably linked to concern about withholding treatment — specifically, withholding proven or standard treatment, so providing treatment to both groups would resolve this long standing issue.

If a pharmaceutical company is successful in deriving a new drug that is more effective than, say, a tea made from the leaf or flower of the plant, then they can prove that point in the clinical trial. It will also show up natural or traditional remedies that don't work better than placebo, adversely affect the condition being treated, or produce significant side effects. 'Testing against a placebo establishes the lowest possible threshold needed to claim a successful result, the drug companies have managed to convince us all that this method is the best way to test the effectiveness of any new drug, which is ridiculous', claim leading patient groups.

Critics also point out, that any health professionals who seek to undermine non-pharmaceutical treatments by stating 'there have been no clinical trials' are either unaware of this fact (but should be aware) or they have other 'undisclosed reasons' for seeking to undermine successful non-pharmaceutical treatments.

However the pharmaceutical industry is against comparison trials for two main reasons:

They have no desire to 'prove' some alternative remedies are better than pharmaceutical drugs
They would no longer be able to market 'useless' blockbuster drugs

Pesticides
The agriculture industry carries out 'comparison trials' on ALL new products which have to demonstrate a 'significant' improvement (not just 1% to 2%) on the comparison product. As a result of this procedure, the agricultural industry have not had a dangerous product for over 60 years, DDT being the last pesticide to cause any concerns, which were related to the food chain and not directly to the product itself. Compare this to the 1,000's of pharmaceutical drugs which have proven to be fatal and withdrawn from the market in the last 60 years.

Misconception
The general public assume that if a drug has been clinically trialed it's success rate must be very high, according to a consumer poll an individual would assume a clinically tested drug/product must be around 85% to 100% successful. However this is not the case and can be as low as just 6% as with nicotine patches but most drugs sold are around just 10 to 40 per cent successful. It is well known by the medical profession that the vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people who take them due their genes which interfere with the medication in some way. Drug companies never refer to a drugs' success rate, they simple rely on the public to assume it must be high and it must work in more than 85 to 100 per cent of the people who take it, which is clearly not the case.

"Just because a drug has been approved in clinically trials, doesn't mean it's any good". Anonymous 2007.

Keep Trying Until We Get What We Want
As early as 1993, a systematic review could find no evidence that the new antidepressant drugs were better than the old ones. Indeed, subsequent analyses have found that nearly all of the response to both the old and new antidepressants can be attributed to the placebo effect. So how did such drugs get licensed? This is because a drug company doesn't have to show that a drug is better than existing alternatives, but that it is safe and more effective than a placebo in two 'pivotal' trials. And what is 'pivotal' has never been defined, so the manufacturer can do as many studies as it wants until it gets two that meet the criteria.

The pharmaceutical industry's ruthless manipulation of data goes a long way to explain why some of the drugs in wide use today are not nearly as effective as is commonly supposed. And most importantly, only about 11 per cent of pharmaceutical industry revenues are spent on research, whereas a staggering 36 per cent is spent on marketing and hype.

Background
In 1976, the writer Ivan Illich warned in a book, Limits to Medicine, that 'the medical establishment has become a major threat to health'. At the time, he was dismissed as a maverick, but a quarter of a century later, even the medical establishment is prepared to admit that he may well be right.

From doctors and patients to drug companies and the media, there are relentless pressures to classify any condition as a disease. Richard Smith, the BMJ 's editor, wrote: 'Doctors, particularly some specialists, may welcome the boost to status, influence and income that comes when new territory is defined as medical. Global pharmaceutical companies have a clear interest in medicalising life's problems. Many journalists and editors still delight in mindless medical formulas, where fear-mongering about the latest killer disease is accompanied by news of the latest wonder drug.'

But drug companies have a vested interest in disease-mongering - because they profit by providing cures. Conditions are hyped as diseases, mild conditions as devastating, rare conditions as common. Whereas shy people used to just rely on a glass of wine, Roche developed the drug Manerix to treat 'social phobia'. It initially claimed that one million Australians suffered this 'soul-destroying' disorder, but then admitted it couldn't even find enough people for clinical trials.

In this world of cynicism, there is no sense of genuine proportion. Everything is geared towards the bottom line. Indeed Merck, which produces the anti-cervical cancer vaccine Gardasil, openly boasted in 2006 that its marketing campaign was 'proceeding flawlessly'. The company even won the industry award for 'the Pharmaceutical Brand of the Year' for creating 'a market out of thin air'.

Drug Push
The drugs companies target newspapers with stories designed to create fear about a condition, and then company-sponsored advisory boards supply 'independent experts' for the stories, while consumer groups supply 'victims'. The drug companies argue that there are clear benefits to this system. Their drugs are popular because they improve lives. Click here to see how this cycle works in practice.

Dr Iona Heath, head of ethics at the Royal College of General Practitioners, warns that there could also be clear downsides: 'Alternative approaches - emphasising the self-limiting or relatively benign natural history of a problem, or the importance of personal coping strategies - are played down or ignored. The disease-mongers gnaw away at our self-confidence. Inappropriate medicalisation carries the dangers of unnecessary labelling, poor treatment decisions, economic waste, as well as the costs that result when resources are diverted from treating or preventing more serious disease. At a deeper level, it may help to feed obsessions with health.'

Credibility of Clinical Trials
It is not well known by the general public but it is widely acknowledge and established through a House of Commons Health Committee Report, that clinical trials are fraught with problems and suffer severe credibility issues, “Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.” Sir Richard Sykes. 'House of Commons Health Committee -The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05'.

Pharmaceutical companies regularly carry out every aspect of a study on their products, then solicit academics to put their names on the final papers in order to disguise their involvement, according to an essay published in the journal PLoS Medicine. Author Sergio Sismondo calls this practice "ghost management," to distinguish it from mere ghost writing.

Buying the Right Scientific Results
On the research side of the issue, "Death by Medicine" cites an ABC report that says clinical trials funded by pharmaceutical companies show a 90 percent chance that a drug will be perceived as effective, whereas clinical trials not funded by drug companies show only a 50 percent chance that a drug will be perceived as effective. "It appears that money can't buy you love, but it can buy you any 'scientific' result you want," writes Dr Null and his team of researchers.

"In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals," Sismondo writes. "The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors."

In 1997, the US National Institutes of Health launched ClinicalTrials.gov, now the world's largest clinical trial registry. In 2004, then-New York attorney general Eliot Spitzer made headlines when he filed a lawsuit against GlaxoSmithKline, accusing the drug giant of hiding study data that indicated its best-selling antidepressant paroxetine (Paxil) might increase suicidal tendencies in children. A year later, the International Committee of Medical Journal Editors announced that many top medical journals would no longer publish unregistered studies. Within a month, the number of registrations in ClinicalTrials.gov jumped from 13,153 to 22,714.

PHASE I: Are not designed to see if the drug works, it is to establish how the body deals with it. Often the most dangerous part of the trial process as this is when a new drug comes into human contact for the first time. Only very small doses are give to volunteers. These first studies evaluate how a new drug or therapy should be given (by mouth, injection into the blood or injection into the muscle), how often, and what dose is safe. A phase I trial usually enrolls a small number of patients, sometimes as few as 6 to 10 people.

PHASE II: Are much larger and involve a group of a few hundred people suffering from the disease the drug is designed to treat. A phase II trial usually focuses on one type of illness, continuing to test the safety of treatment and beginning to evaluate how well it works. This is the essential intermediate step that will determine whether the drug will go into bigger and more costly phase III trials.

PHASE III: These studies test a new drug, a new combination of drugs or a new therapy in comparison to the current standard treatment. A participant will usually be assigned to the standard group or the new group at random (called randomization). Often it involves "double blind" trials, where neither the patient nor doctor knows who is being given the new drug.

Illusion - Clinically Proven
The imagery of the term 'clinical trial's, 'controlled trials' or 'evidence based' conjures up a large laboratory with men in white coats monitoring the effects of the patients who are taking the new drugs but the reality is phase III trials often enroll large numbers of people and claim to be controlled but they are conducted at doctors' offices, clinics and centers nationwide. Participants take the new drugs and report its effects anecdotally.

All the new drug has to show is, it is more effect than a placebo, for example: If they are trying to develop a new for say asthma and the placebo group report an 8% response rate and the new drug is just 9% it allows the manufacturer to claim the new asthma drug have been 'clinically trial, scientifically proven and it is evidence based' to help asthma suffers and publish the results in the medical journals, even though it is only 1% more effective.

i.e. any drugs tested against a placebo group should have their effectiveness recorded as the difference between the treatment group and the control group, therefore the drug is only 1% successful.

This was illustrated in the marketing of a vaccine supposedly to combact cocaine addiction, where 9 people in the vaccine group manage to cut their cocaine use compared to 7 people in the placebo group. These 2 people were enough to claim 'An experimental vaccine against cocaine addiction could be used to wean users off the drug, research has shown'.

Is the trial designed to Prove or Disprove?
Clinical trials can also be engineered to favour a particular outcome. As with the cocaine vaccine above, a difference of 2 people hailed the trial a success however a study into alternative pain control with copper or magnetic wrist straps was seen to prove these devices did not work although they did offer slight improvements. Participants reported lower sensory pain after wearing the standard magnetic wrist strap, than when wearing control devices. However, no adjustment was made for multiple testing. The resulting media stories were Copper bracelet arthritis cure is a myth, say scientists compared to the cocaine media story of Cocaine 'vaccine' could combat addiction.

No Published Success Rate
The medical profession are demanding homeopathic medicines are re-labeled as 'placebos' and taken off the shelf as they claim homeopathy has 'no provable clinical effect'. It is also worthy of note that no pharmaceutical medications publish their success rate on their labels as most are just 30% to 50%, however claiming a success result from clinical trials can be as low as just 6% (NRT). Would anyone really buy nicotine patches if they knew they were just 6% effective? No and that's why the pharmaceutical industry hide their results. Critics are now demanding that ALL pharmaceutical medication should display a success rate to allow the individual to assess any possible positive gains against any negative side effects.

Pharmaceutical medications should be priced according to their results as most drugs don't work for most people, this would stop the creation and marketing of useless block buster drugs which produce little clinical effect but cause serious side effects.

Media Campaign
It is here at stage III trials that 80% of drugs tested fail to establish their effectiveness and so it is becoming ever more popular for drug companies to halt stage III trials once they have 'some' favourable data to publish. They release a story to the press of usually just one or two people who have responded well to the medication to create public awareness and also demand for the partially tested and unproven drug, Herceptin & Sutent for kidney cancer were recent examples.

Drug trials are over too soon, warn doctors. The benefits of new cancer drugs are being "exaggerated" because trials are stopped too soon, research claims. It says growing numbers of pharmaceutical companies are halting trials, (as around 80% of drugs fail at stage III trials) including those for the breast cancer drugs Herceptin and Lapatinib - shortly after receiving good interim results. And it warns that patients could be at risk if drugs are licensed and rushed into clinics before possible side-effects are identified.

Without such evidence, unsafe and ineffective drugs are being marketed and prescribed, and patients' health could be jeopardised. Acomplia,a weight loss pill was withdrawn from sales 4 months after NICE approval for links to suicide and depression. New data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials.' The EMA said the drug had also proved less effective in 'real life' than in clinical trials, which is the case for most medication.

But three-quarters of the trials were halted after independent monitoring committees said the drugs were so successful, it would be "unethical" to deprive patients of them. Critics claim these committees are not independent and their decisions are hugely influenced by the drug companies.

Another practice is for failed drugs is to repackage for a different condition than the one for which the drugs had been tested in clinical trials, or to expand the market for drugs that don't bring in enough profits when marketed for a particular condition. Strattera and Cymbalta are antidepressants of the selective norepinephrine reuptake inhibitor (SNRI) class. In clinical trials Strattera had failed as an antidepressant, but is now a hot-selling drug euphemistically marketed as a "non-stimulant" treatment for ADHD.

Cymbalta (duloxetine), a potent dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine also failed in its original antidepressant trials. It is now being tested for incontinence at higher doses. The recycling of these failed antidepressants raises concerns because of evidence-from previously concealed clinical trial data and from a large number of case reports--all indicating that the newer generation of antidepressants can trigger serious adverse symptoms that can lead to life-threatening behavior in some patients. These unwanted effects include: movement disorders, withdrawal symptoms, mania, depression, hallucinations, agitation, aggressiveness, anxiety, psychosis, akathisia, and violent or suicidal behavior. The FDA had evidence of these drugs' adverse effects for years but failed to warn prescribing physicians and the public.

As a result, many people question the 'credibility & the findings' of clinical trials & 'scientific data' and consider they should not be regarded as the 'gold standard' as they are fraught with problems, manipulation, engineered for success and in many cases are meaningless. In fact the Government has recommend that a clinical trials register be set up and maintained by an independent body and the results of all clinical trials data, containing full trials information, be put on the register at launch as a condition of the marketing licence, in a hope it will help overcome some of the following common practices:

Manufacturers are known to have suppressed certain trials & suppression of trial results
Haulting trials when favourable data is available to avoid later stage III failure
Repackaging of failed drugs to new markets
Manipulated figures to show better results
PR & hype used to sell products with little benefit
trials not adequately designed
that they could be designed to show the new drug in the best light
sometimes fail to indicate the true effects of a medicine on health outcomes relevant to the patient
selective publication strategies and ghost-writing
suppression of negative clinical trial findings
all the evidence is not published
negative findings are hidden
allegations clinical trials are engineered for victory
company-sponsored information from medical journals
excessive promotion of the drugs to doctors
fragmented and customer un-friendly nature of academic units and clinical services
confusing ethics approval procedures
few adequately trained medical researchers or specialist research facilities
too few individuals who can organise clinical trials or take part in a reviewing or implementation capacity
NHS does not have a coherent approach to industry sponsored clinical trials

Other practical problems exist and are widely acknowledged:

Investigators are often happy amateurs; being a good basic scientists is not enough to make you a good investigator
The investigator is always biased
Bias should be accepted and eliminated through randomisation, controls and, whenever possible, blinding
Clinical trials are expensive
Lack of non-commercial support is a major problem
Drugs go to market without being fully optimized at the clinical trial level
No reason for industry to support trials of drugs which cannot lead to a patented claim
No interest in non pharmaceutical based medicine

No Full Disclosure - No Credibility
The fundamental problem with all clinical trials is only the favourable data is published any adverse data is never published. As the data is 'cherry picked' the value of such trials is therefore meaningless. The standard question about any data published from clinical trials should be, 'what data has not been disclosed?

A senior executive with Britain's biggest drugs company has admitted that most prescription medicines do not work on most people who take them. Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody." This goes against a marketing culture within the industry that has relied on selling as many drugs as possible to the widest number of patients.

GlaxoSmithKline were also criticised, but not prosecuted, over claims that it withheld information about the increased risk of suicide for children taking Seroxat, the bestselling antidepressant drug. Ministers have promised to tighten laws that require pharmaceutical companies to disclose data from clinical trials after a report suggested that GlaxoSmithKline (GSK) knew about safety risks but failed to report them to the medicines safety watchdog for five years.

In the legal system, witness evidence (anecdotal) is considered the best form of evidence, now imagine a document that everyone knew had been specially doctored with only the favourable points and any unfavourable evidence had been deleted, how much weight would the Court allow this document? None as it is meaningless. In the scientific community this is how 'clinical evidence' is prepared, in the legal system it would not even be allowed as ‘evidence'.

'Cherry Picked' Clinical Data Vs Client Comments
If pharmacology history teaches any lesson it is that clinical studies have no credibility and are engineered for victory, and unless real-world users can find a way to duplicate study engineering they should expect to experience dramatically lower success rates. Many people actually consider what happens in the 'real world' (anecdotal evidence) to be far more important than in the engineered laboratory under clinical conditions, as this is a true reflection of the drug or treatment.

But the industry however relies on anecdotal evidence to identify adverse side-effects with drugs which in most case are quite severe as in the case of more than 1,300 schoolgirls have experienced adverse reactions to the controversial cervical cancer jab. Doctors have reported that girls aged just 12 and 13 have suffered paralysis, convulsions and sight problems after being given the vaccine. Dozens were described as having pain 'in extremity' while others suffered from nausea, muscle weakness, fever, dizziness and numbness. So anecdotal evidence is welcomed in one respect but ignored in others with regard to successful results from non-pharmaceutical treatments.

Media Hype
Clinical trials are cut short or stopped as soon as there is sufficient evidence to support a favourable outcome with a success story released to the press of usually just 1 patient who has responded well to the treatment. One good result is often all it takes to launch a media campaign to raise public awareness and demand for the latest 'wonder drug' however numerous successful cases for a particular complementary therapy are ignored by medical professionals who demand clinical trials to validate their claims. One very clear example of this practice involves cancer treatment, Sutent for kidney cancer was the subject of much media attention although it was only 20 to 40% effective in limited trials whereas the news from U.S government scientists that vitamin C injections stop cancer cells was greeted by the medical profession and Cancer Research with scorn both stating 'there is currently no evidence from clinical trials in humans that injecting vitamin C is an effective way to treat cancer'. The simple reason for this is because no trials have been done but more concerning is the fact Cancer Research who have an annual income of £468 million and spend £315 million on 'research' have no plans to conduct such trials in the future.

Monopoly
It costs £500m to bring a drug to market. Much of that is spent on randomised trials. The industry has these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and even small companies: only huge international pharmaceutical corporations can afford to run drugs trials now, and so corporations are in complete control of the information. This is bad, as the problems with Vioxx, SSRI's, and other 'killer' drugs have shown.

Often clinical 'results' often have little value, as it all depends on: who is doing the counting, how they are counting, what they are counting or measuring and what they have excluded. Click here for further details.

Even blockbuster drugs are not efficacious all the time and adverse drug reactions (ADRs) cause many untimely deaths. "Right now, even the best of medicines work in only 50% to 70% of the patients who get them," reported The Wall Street Journal in its April 16, 1999 issue. In addition, adverse drug reactions in U.S. hospitals may be responsible for more than 100,000 deaths nationwide each year, making it one of the leading causes of death, according to an article in the April 14, 1998 issue of The Journal of American Medical Association .

Exploiting GP Ignorance
Drugs need to be tested to qualify their claims and establish any harmful side-effects especially as many GP's know next to nothing about the powerful drugs they prescribe, leading medical experts admit, doctors know so little about the drugs that they are prescribing that their ignorance is harming – and sometimes killing – their patients, leading pharmacologists have said. GP's rely on what they are told about the drug by the pharmaceutical companies, which highlight the benefit and play down the risks.

Improper Use of Clinical Trials
Due to the public perception that clinical trials are in some way ‘beyond reproach' this trust has been abused in many cases as critics point out that clinical trials are often used to validate poor results in an attempt to market drugs which have little or no merit.

Many drugs have little to no benefit but are hyped or sold as an effective treatment. Anti-depressant tablets taken by millions of Britons may be a waste of time and money, research shows. An analysis of dozens of studies involving thousands of patients revealed that some of the most widely-prescribed anti-depressants work little better than dummy pills. The drugs studied - including Prozac, Seroxat and Efexor - were little more effective than placebos in improving the mental health in the majority of cases, the University of Hull research showed. Only in the most extreme depression did the tablets, which are taken by around two million Britons and have been linked to a host of side-effects including suicide, prove substantially superior in improving mental health.

Dr Tim Kendall, of the Royal College of Psychiatrists, described the results as "fantastically important". He added that one of the study's strengths lay in the inclusion of data which drug companies had chosen not to publicise - perhaps because it was less favourable than they would like. The study, published in the respected journal PLoS Medicine, suggests hundreds of thousands of Britons are needlessly taking powerful - and potentially dangerous - drugs.

Drug companies have to submit all their clinical evidence to drugs watchdogs in order to gain a licence but they do not have to publish negative results to the wider medical community. Researchers at the University of Hull used the Freedom of Information Act to obtain all clinical trial results submitted to the Food and Drug Administration including trials that had not been published.

Seroxat is the most frequently prescribed antidepressant in Britain and among the selective serotonin reuptake inhibitors ( SSRI ) group of drugs that account for 16 million prescriptions a year. It was subsequently banned for use in under18s.

Another well established unethical practice is the use of NRT. 'Manufacturers say NRT is 'clinically proven' to double a smoker's chances of giving up. - But critics point out that this is still only an improvement from 3% with no assistance at all, to 6% with NRT'. The use of the words 'clinically proven' is to imply that NRT actual works.

Critics also point to Champix tablets another aid to smoking cessation as an example of misleading data used to sell a product which during trials had to be supported by counselling sessions and the use of NRT to achieve an average 22% success rate over 12 weeks. The use of counselling and NRT was not disclosed to the public. In addition it was claimed during NICE approval that the drug was effective after a 12-week course, with 44 per cent of smokers managing to stop, which was clearly not the case.

Evidence Based Medicine - An Averaged Result
Evidence based medicine is the new buzz word for the medical community, however the quality of the 'evidence' can be highly questionable. Treatment effectiveness reported from clinical studies may be higher than that achieved in later routine clinical practice due to the closer patient monitoring during trials that leads to much higher compliance rates and so what happens in the 'real world' proves in many cases to be far more significant than under clinical conditions. The most common criticism is that EBM applies to populations, not to individuals and is based on an average percentage result, which is often quiet low. EBM is a generalised result and therefore not a 'gold standard'. Click here to read more about EBM.

Blocking Non- Pharmaceutical Addiction Treatments
Clinical trials are merely used as a smoke screen to block any non-pharmaceutical addiction treatments from being widely available even though trials are fraught with problems and manipulation and can not always be relied on as 'credible'. And hiding behind the excuse 'that no system is perfect' is simply not good enough, especially when these treatments are blocked from being widely used by using the argument, 'but it has not been clinically trialed'.

Detractors are very quick to point out there is ‘no scientific basis' for alternative addiction treatments and they are usually right as independent practitioners can not afford to carry out scientific research, a simple fact which continually escapes the vision of any detractor, in addition no journal wants to run their studies, dominated as they are by Big Pharma, and that most of their patients have already tried conventional allopathic medicine, with no improvement in their condition.

Double Standards
When a therapy is widely accepted by the medical profession, no scientific proof of effectiveness is required, and anecdotal evidence is accepted as valid. If an alternative therapy is contested by those physicians, however, they attack by demanding that the therapy in question be subjected to very expensive and time-consuming double-blind, placebo controlled trials. Medicare regulations also exclude the need for scientific proof for treatments that are utilized by a majority of physicians.

The most frequent criticism leveled by critics of non-traditional and alternative medical therapies is that new treatments are "unproven" because randomized, double-blind, controlled studies have not yet been done to prove effectiveness. Those criticisms ignore the fact that most medical procedures routinely performed in the practice of medicine are also unproven using those same criteria.

The Office of Technology Assessment, a branch of the United States Congress, with the help of an advisory board of eminent university faculty, has published a report with the conclusion that, " . . . only 10 to 20 percent of all procedures currently used in medical practice have been shown to be efficacious by controlled trial." Therefore, 80% to 90% of medical procedures routinely performed are unproven. That report further points out that the research which purports to prove effectiveness of the remaining 10% to 20% of medical procedures is largely flawed, and "many of the other procedures may not be efficacious."

But despite the lack of any scientific evidence whatsoever, millions of people around the world continue to use alternative medicine therefore the evidence must be of a personal nature and by recommendation to others. If people did not get a result from such treatments they would not use them or recommend them. But a leaked memo reveals that there is 'a co-ordinated campaign' to derail alternative therapies on the NHS and more recently funding is been withdrawal from NHS homeopathic hospitals.

The standard technique used to block any non-pharmaceutical addiction treatment from being tried (let alone widely used) is 'clinical trials' as to most the proposition seems insurmountable, however those in possession of that facts know firstly, that clinical trials are not all they claim to be, secondly there are enormous costs involved and thirdly the lack of a coherent infrastructure to conduct such trials makes the statement and argument almost inane.

Those who immediately state 'there is no scientific proof' do not understanding the complexities of obtaining scientific proof and their ignorance is often detrimental to the advancement of patient care. However there is a mountain of evidence for those who can be bothered to look. The newly published encyclopedia gathers a lot evidence on complementary medicine based on double-blind, placebo-controlled studies, regarded as the best assessment of whether a treatment is effective.

Efficacious
Clinical trials are required for high risk pharmaceutical medications to establish if they are efficacious and to determine their side-effects, low risk non-pharmaceutical therapies can be assessed in practice, by their use and results. A clinical study of our treatment methods would only consist of treating patients and then recording their 'anecdotal evidence' regarding their consumption of nicotine, alcohol or drugs post treatment [backed up with the appropriate substance testing to confirm the anecdotal evidence] and then presenting this data as 'evidence base' or 'scientific fact'. We collect this 'anecdotal evidence' as unsolicited client testimonials which are submitted weeks, months and even years post treatment. Although we lack the resources required to conduct an in depth clinical study [which are generally acknowledged to be unfit anyway], substantial client testimonials prove 'beyond reasonable doubt', the treatment is 'efficacious'. [efficacious - capable of or successful in producing an intended result; effective as a means, remedy].

Public Interest
Once a non-pharmaceutical treatment is used and becomes established through its use, then its track record proves its effectiveness and safety, if it was unsuccessful, it would not become an established treatment. Our treatments for addiction should become a mainstream treatment as it is in the public interest and established by independent monitoring committees that it would be "unethical" to deprive patients of successful treatment.

Summery
Clinical trials and supposed ‘evidence based medicine' has been exposed for what it is, they are not the gold standard or without reproach , they have no credibility, are fraught with corruption, misrepresentation, medical fraud, include intimidating scientists, ghostwriting studies for academic researchers, suppressing studies that may show that a drug could be dangerous, selecting data to publish results that favor one product over another, intimidation of unwilling scientists, deception of regulating bodies, falsification and suppression of evidence. Critics say 'the next time you hear some clinician, doctor or medical professional say in relation to a non-pharmaceutical treatment process 'there is no scientific evidence', 'it's not evidence base medicine', 'there is no clinical trial data' or 'it's not clinically proven' as an excuse not to use it, by very wary of them as they either 'incompetent or corrupt'.

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Source: House of Commons Health Committee -The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05.

About 650 million prescriptions are written each year by GPs alone. Medicines cost the NHS in England over £7 billion every year [£11bn by 2009], 80%of which is spent on branded (patented) products. However, there are disadvantages in the increasing use of and reliance on medicines. The inappropriate or excessive use of medicines can cause distress, ill-health, hospitalisation and even death. Adverse drug reactions are responsible for about 5% of all admissions to hospitals in the UK.

Professor Pirohamed from the University of Liverpool, England, conducted a study into ADRs at the Liverpool Royal and Arrowe Park hospitals in 2001 - 02 and found that they cause 18,000 deaths and 600,000 hospital admissions in the UK every year, costing the NHS £466m per year. (British Medical Journal 3.7.04)

Allegations that clinical trials were not adequately designed – that they could be designed to show the new drug in the best light – and sometimes fail to indicate the true effects of a medicine on health outcomes relevant to the patient. We were informed of several high-profile cases of suppression of trial results.

We also heard of selective publication strategies and ghost-writing. The suppression of negative clinical trial findings leads to a body of evidence that does not reflect the true risk:benefit profile of the medicine in question. Guidance produced by NICE and others relies on the published evidence. If all the evidence is not published, or if negative findings are hidden, accurate guidance cannot be issued and prescribers cannot make truly evidence-based decisions.

As medicine progresses ‘from bench to bedside' over a period of many years — from initial development in the laboratory, through clinical testing, licensing, promotion to doctor and patient, and final prescription. The rationale for the very existence of major pharmaceutical companies is their ability to bring new and useful drugs to market. According to the ABPI, it takes an average of 12 years and over £500 million investment to
bring one new drug to patients.

Following initial drug discovery, NMEs undergo several phases of development involving all levels of research from molecules, cells and tissues, animal models, whole organs and systems to individuals and populations, as shown below:

Candidate/target selection – selection of a promising compound for development
Pre-clinical and non-clinical – necessary animal and bench testing before administration to humans plus start of tests which run concurrently with exposure to humans
Phase I – First Time In Man (FTIM); the first study of a new compound in humans, usually healthy volunteers
Phase II – Proof of concept (PoC); evidence of efficacy and safety in patients
Phase III – studies in a large population to generate safety and efficacy data for licence application
Licence Application (in UK) – filing all data to regulatory bodies (known as Marketing
Authorisation Application in Europe, New Drug Application – NDA – in US)
Phase IV – post-marketing studies.

Once licensed, medicines are intensely promoted to prescribers. The very high costs of developing a new drug make it vital that a company recoups its costs as quickly as possibly after licensing. Coupled with company-sponsored information from medical journals and supplements, ‘medical education’ materials, advertisements and sponsorship to attend conferences, workshops and other events, it is little wonder that prescribing practices are affected.

GPs are particular targets; they have more prescribing freedom than hospital specialists and their prescribing practices are not limited to hospital formularies. Promotion of medicines to patients and links between drug companies and patient organisations may add to this problem, leading patients to demand new drugs from their doctors. The problem is far less to do with any particular activity; rather the volume may distort prescribing practice. At the heart of the problem may be the trend for the industry to become ever more driven by its marketing force.

The most immediately worrying consequence of the problems described above is the unsafe use of drugs. Over-prescription of the COX-2 inhibitors, Vioxx and Celebrex, has been linked to thousands of deaths and many more cases of heart failure. These case illustrate a series of failures. Manufacturers are known to have suppressed certain trials for these drugs in the US and may have done the same in the UK. In addition, there were inadequacies in the licensing and post-marketing surveillance procedures and excessive promotion of the drugs to doctors.

What has been described as the ‘medicalisation’ of society – the belief that every problem requires medical treatment – may also be attributed in part to the activities of the pharmaceutical industry. While the pharmaceutical industry cannot be blamed for creating unhealthy reliance on, and over-use of, medicines, it has certainly exacerbated it. There has been a trend towards categorising more and more individuals as ‘abnormal’ or in need of drug treatment.

Government has rightly sought to assist industry, but it needs to do more to help pharmaceutical companies conduct research. They have to cope with confusing ethics approval procedures as well as relatively few adequately trained medical researchers or specialist research facilities.

The “fragmented and customer un-friendly nature of academic units and clinical services” was highlighted by the Royal College of General Practitioners (RCGP). The College also mentioned the “multiple layers of Research Ethics approval” that may be required and a “disparate, and sometimes competing, collection of clinical and academic teams” that may need to be brought together to achieve sufficient mass for large-scale
research.

Many large-scale Phase II and III trials are currently being carried out in Eastern Europe and elsewhere as a result of high costs imposed here.36 Dr Malcolm Boyce, who runs a London-based Contract Research Organisation (CRO), stressed: A strong pound sterling makes matters worse for overseas companies. For those reasons, companies are increasingly placing their Phase II and III trials outside the UK, in low cost areas such as Eastern Europe, Russia and India.

There are not enough trained medical researchers in the UK. This means there are too few individuals who can organise clinical trials or take part in a reviewing or implementation capacity. Prof Patrick Vallance, from University College London (UCL), told us "There is a shortage of appropriately trained clinical investigators in the UK, and this reflects lack of investment in clinical research and problems with clinical training
pathways".

Specialist facilities are also lacking. There are very few centres in which paediatric clinical trials may be effectively conducted, for example. This will become more relevant following the introduction of a new European Regulation on Paediatric Medicines in 2006, which will require more medicines to be licensed for use in children.

Witnesses pointed out that the NHS does not have a coherent approach to industry sponsored clinical trials and lacks the staff and specialist facilities in which to conduct them. This partly explains why a very low percentage of patients are enrolled in clinical trials in the UK; experience shows that recruitment can be increased substantially provided suitable policies and other measures are in place. For example, the National Cancer Research Network (NCRN) provides the NHS with the ‘infrastructure’ to support cancer clinical trials in England. It was established by the Department of Health in April 2001.

Since that date the number of patients taking part in cancer clinical trials in the UK has doubled. All results from NCRN trials are scrutinised by an Independent Data Monitoring Committee, which is the only body to see unblinded data. All results emerging from trials approved by the Clinical Trials Awards and Advisory Committee are published.