Health of drugs industry still in question

Medicine is big business. The British pharmaceutical industry alone is worth around £8 billion per year. 

But with this massive profit-driven industry comes the question: is all this money ultimately a force for good, or ill? How do you regulate an industry that carries so much financial clout? 

Drug companies’ interests have come to surpass those of patients, said a report in 2005 by the House of Commons Health Committee. The report criticised regulatory bodies and medicine prescribers for being too closely linked to and swayed by incentives from the pharmaceutical industry.

The committee recommended greater transparency in the various ways industry aggressively markets new drugs. At the same time it was critical of healthcare professionals who were “sometimes too willing to accept hospitality from the industry and act uncritically on the information supplied by the drug companies”.

Six years on, and experts from the medical community consulted by the committee have mixed views as to the progress that has been made. 

Some say there is now greater transparency and a greater awareness about how industry operates, with doctors less influenced by drug companies in what medicines they prescribe. Others say more needs to be done. Still others think that things have got worse. 

 

Funding from the pharmaceutical industry accounts for more than 90 per cent of drug research and development in the UK, with only 8 per cent funded by the government and British businesses

the Association of the British Pharmaceutical Industry (ABPI)

A Department of Health (DH) spokesperson said that “a great deal has been achieved” since the committee report back in 2005. The DH also believes that the processes of the drugs licensing body “are now transparent and it has strengthened its internal processes in relation to managing potential conflicts of interest”.

Funding from the pharmaceutical industry accounts for more than 90 per cent of drug research and development in the UK, with only 8 per cent funded by the government and British businesses, according to the Association of the British Pharmaceutical Industry (ABPI).

The government is reluctant to regulate too heavily because some companies have threatened to pull their research and development out of the country.

The National Institute for Health and Clinical Excellence (NICE) is the independent body that reviews clinical evidence of drug efficacy and recommends cost-effective medicines to the NHS.

NICE chair Sir Michael Rawlins says, “The industry has a lot of work to do to regain the respect of many physicians, patients, and the public.”

“This is partly due to the ways that companies promote – directly and indirectly – their products as well as the persistent failure to place results of clinical studies in the public domain,” he says.

Any new drug needs a licence from the Medicine and Healthcare products Agency (MHRA). Then the drug company patents it under a branded name for 10 to 12 years and exclusively markets it here. After the patent expires, other companies can produce generic versions of the same drug, at a cheaper cost. Where a generic medicine is available, GPs will generally prescribe them.

So to increase profits, drugs companies must constantly manufacture more new, branded drugs that they can market as more effective alternatives to pre-existing drugs. Many new drugs are never approved for sale. Some experts say the problem is that new drugs may not be as good as the old ones, with little known about harmful side-effects, and that these new products are more expensive then generics.

Central to many grievances with the industry is the lack of transparency of research data. 
Clinicians and researchers are calling for the raw data – negative and positive results – from clinical trials to be openly published so that they can be independently analysed. Whether the data belongs to the drug company or the volunteers who took part in the studies is under discussion.

Dr Andrew Herxheimer, emeritus fellow of the UK Cochrane Centre and former editor of the Drug and Therapeutics Bulletin, says drug companies want “to portray the drug in as rosy a way as possible and not do research on harms, but only on the benefits”. 

Herxheimer also argues that all the results of trials, the methods used to measure effects, and how the harms were looked for and assessed should be published. 

The industry uses “tricks” to make the data from trials look better: using statistics to hide negative results and burying data are commonly used approaches, said Dr David Christmas, consultant psychiatrist at Ninewells Hospital in Dundee, speaking at an annual meeting of the Scottish Mental Health Research Network in December.

Read on        Another practice under fire

Another practice under fire from some quarters is the use of professional “ghost-writers” who produce scientific papers, which are then published in medical journals under the name of a respected physician, a so-called key opinion leader (KOL). 

The practice has in the past resulted in KOLs giving the green light to harmful drugs without scrutinising raw data. KOLs have also been exposed in the United States for having received considerable fees from drug companies, which they failed to disclose.

The concern is that ghost-writing allows drug companies to manage the scientific literature to the point that they are effectively writing the papers on their own drugs.

Ghost writing is routine, says professor Edwin Gale of the School of Clinical Sciences, University of Bristol. “I have spoken to several ghost writers who have produced articles which were then signed by someone else.

“The pharmaceutical companies analyse their big trials themselves from data no one else can view, have a team of medical writers who draft the trial reports, and then ask the ‘authors’ to revise and comment. They also draft reviews of their own products for apparently independent authority figures to sign.” 

But the use of medical writers is not illegal, Gale points out, although it is sometimes apparent. 

“As an experienced editor, I could usually spot their footprints, mainly because the articles were too well written, and the marketing message too stereotyped,” he says. 

Dr David Healy, professor of psychological medicine at Cardiff University, known for being outspoken on the industry, said six years ago that half of scientific research literature on drugs was ghost-written. 

Now he thinks that the situation is worse. “I don’t think anything has been put in place to improve things. What you had was an incoming tide back then that we haven’t stemmed.

“Ten years ago was a culture which thought that these things was not acceptable, but even that culture has got eroded. We are in a world where the pharmaceutical industry has more control over things than they did before,” says Healy. 

In the next 10 years the problems around the promotion of medications and unnecessary treatment will begin to become much more apparent, we’re just on the cusp of that

Dr Des Spence, Glasgow GP and spokesperson for No Free Lunch, a group campaigning for more transparency from doctors

ABPI declined to respond specifically on the issue of ghost-writing, but defended more generally the close connections between the medical community and pharmaceutical industry in a statement: 

“Collaboration between industry and the medical community is not only essential to developing new medicines but also benefits patients, clinicians, and the NHS. ABPI is working with the medical Royal Colleges and other medical bodies to continue to ensure that the relationship meets stakeholder expectations and benefit patients.”

Disease-mongering by the pharmaceutical industry is endemic, some claim. Herxheimer accuses the drug companies of inventing new illnesses and marketing them. 

The number of drugs prescribed has been rising over the years. More than 886 million prescriptions were written by GPs in England in 2009, an increase of more than 200 million per annum since 2003, according to the UK National Statistics website.

“Medicine which once regarded drugs as poisons to be used with care has been transformed into a discipline where they are much more likely to be regarded as fertilisers to be sprinkled as liberally as you can sprinkle them,” says Healy.

In particular, he says that the overprescribing of antidepressants is “a big problem”. 

“The licence indication is for severe depressive illness, but they’ve been very widely used for mild and moderate depression. It’s a big mess,” says Healy.

Others also blame the medical community itself for overdiagnosing and overmedicating patients and not questioning the practices of drug companies.

Dr Des Spence, GP in Glasgow and spokesperson for a group campaigning for more transparency from doctors, No Free Lunch, says, “There are dire warnings about cholesterol and hypertension that have never really materialised. We’ve seen the massive explosions of statins which have doubled in the UK in the last five years.

“In the next 10 years the problems around the promotion of medications and unnecessary treatment will begin to become much more apparent, we’re just on the cusp of that.”

In the United States over the last decade various lawsuits and fines, some reaching over $1 billion, have exposed some of the problems within the pharmaceutical industry.

But in the UK, no lawsuits against drug companies have ever had successful outcomes. 

Some doctors who do question and make allegations of malpractice of pharmaceutical companies say they have paid a hefty price. Healy said he had a job contract with Toronto University withdrawn and invitations to speak at conferences dried up. Dr Doug Bremner, author of The Goose That Laid the Golden Egg, alleges that a drug company set about a relentless campaign to destroy his career after he exposed its drug’s deadly side-effects.