BMJ _ Drugs companies are defrauding healthcare systems, conference hears

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BMJ 2004;329:940 (23 October), doi:10.1136/bmj.329.7472.940-e

 

http://bmj.bmjjournals.com/cgi/content/full/329/7472/940-e

 

Drugs companies are defrauding healthcare systems, conference hears

 

London Lynn Eaton

 

Pharmaceutical companies are among those deliberately defrauding

healthcare systems throughout Europe, a conference in London heard

this week.

 

More than 150 delegates from 20 of the 25 European Union states

attended the two day event looking at fraud and corruption across the

European healthcare system. Although delegates considered everything

from health tourism (where individuals from one country go to another

to receive free or cheap health care) to how to identify fraud, a

recurring concern was the blatant fraud by some drug companies.

 

" In any country, pharmaceutical fraud is a big problem, " said Marieke

Koken-Vossestein, head of the department of claim control at the

Zorgverzekeraars Nederland (a Dutch department that develops antifraud

policies across all health insurance schemes in the Netherlands).

 

The fraud can range from doctors claiming for work they have not done

through to drug companies who bribe doctors by paying them for

switching patients to a new drug.

 

Professor Peter Schönhöfer of the Institute of Pharmacology, Bremen,

said the fraud included not being able to view data from clinical

trials submitted to the German regulatory body, the Federal Institute

of Drugs and Medicinal Products.

 

" If they have information they don't tell us it, " he told the BMJ. " We

don't have access to relevant data. "

 

That could mean therapeutic decisions were inappropriate-but because

the relevant data were covered by a commercial confidentiality clause,

those outside the institute could never know how appropriate the

treatment was.

 

He also cited what is euphemistically called a " drug use study, "

whereby a doctor is paid anything from ¤200 (£140; $250) to ¤500 for

transferring a patient from one drug to another and then filling in a

form to say what they have done.

 

" We know that the pharmaceutical industry in German has spent ¤1bn a

year for such drug use studies. And it is not just in Germany. In

Italy, GSK [GlaxoSmithKline] spent ¤28m over a 12 year period just for

doctors to provide a signature. "

 

State investigations of bribery by drug companies are becoming

increasingly common, with two cases in the last year alone (BMJ

2004;328:1333).

 

In the United Kingdom tighter antifraud measures have led to ongoing

legal action against the manufacturers of warfarin and penicillin.

 

Jim Gee, chief executive of the Department of Health's NHS Counter

Fraud and Security Management Service, said they had evidence to

suggest the existence of a price fixing cartel. Six pharmaceutical

companies are allegedly involved in fixing the price of warfarin,

costing the NHS £28m; seven are allegedly involved in keeping the

price of penicillin high, costing the NHS £30m.

 

The Serious Fraud Office has yet to decide whether criminal action

should be pursued on these cases, and the civil cases have yet to be

heard.

 

The NHS Counter Fraud Service is also pursuing a further £100m for

alleged price fixing of a generic version (ranitidine) of Zantac when

the patent for that drug expired.

 

" Clearly these companies operate in the other countries too, " Mr Gee

said, suggesting that other European countries might also have been

similarly defrauded.

 

Mr Gee said the NHS had done a great deal to try to tackle fraud and

that although other countries had health insurance based systems, from

what those delegates had told him, the level of fraud was as bad, if

not worse.

 

 

 

BMJ 2004;329:937 (23 October), doi:10.1136/bmj.329.7472.937

 

http://bmj.bmjjournals.com/cgi/content/full/329/7472/937

 

Consumer organisations criticise influence of drug companies

Zosia Kmietowicz

London

The pharmaceutical industry operates in a way that puts profits before

public health, members of parliament (MPs) heard last week. And the

regulatory authorities, which are meant to ensure the safety of drugs

and protect the public, collude with the industry, they were told.

Testimonies from five doctors and two consumer champions, who were

being questioned by the health select committee for its inquiry into

the influence of the pharmaceutical industry, built a picture of an

industry that creates health anxieties among the public to boost its

profits.

At the same time, withholding unfavourable trial results and

controlling what research gets published ensures that doctors get the

messages that companies want to promote, the committee heard at the

second public sitting of its inquiry.

Public awareness campaigns are part of a " multipronged marketing

approach " that are commonly employed by drug companies to " gain

further control over what medicines are being prescribed and to whom, "

said Graham Vidler, head of policy at the consumer organisation

Which?, formerly known as the Consumers' Association.

" These can often be for quite trivial conditions, such as toenail

infections, and they encourage patients to go and see their general

practitioner, often in quite strong terms, " said Mr Vidler. " At the

same time the industry will be advertising drugs to these GPs, and our

research shows that GPs often take the path of least resistance and

say yes to patients and prescribe the drug even though they feel it

may not be the most appropriate thing to do. "

GPs can see pharmaceutical representatives on a daily basis, and their

influence can lead to changes in prescribing habits, said Des Spence,

a GP in Glasgow and spokesman for the No Free Lunch campaign, a group

of UK healthcare professionals concerned at the undue influence of the

pharmaceutical industry on doctors in promoting drug products.

 

" Within three or four years [of it being launched] Vioxx [rofecoxib]

became 40% of the medicines we were using in my area, " said Dr Spence.

" The industry has a major influence on healthcare policy. The

influence is across the field and affects doctors, nurses, patient

organisations, and government agencies. The industry is active in all

these fields and has a very clear agenda-that of profit-and that is in

direct conflict with the responsibilities of the NHS. "

 

Des Spence: Industry has a clear agenda-namely, profit-which is in

conflict with the NHS

Part of the problem is that the industry is charged with policing

itself through the Association of the British Pharmaceutical Industry,

which is funded by drug companies, said Ike Iheanacho, editor of the

Drug and Therapeutics Bulletin.

" A regulatory body needs to punish companies that are responsible for

misleading activities and tell people they have been misled. If these

are the standards that we would like to see then they are largely

absent from the present regulatory system, " he said.

David Healy, head of psychological medicine at the University of

Cardiff, believes that research articles have a greater influence on

doctors' prescribing habits than promotional activities. But again the

process of publishing research is rife with pharmaceutical industry

influence, he said.

Professor Healy claimed that at least half of articles on drug

efficacy that appear in the BMJ, the Lancet, and the New England

Journal of Medicine are ghost-written by pharmaceutical companies and

that " the most distinguished authors from the most prestigious

universities " put their names to them without ever seeing the raw data.

Peter Wilmshurst, a consultant cardiologist at Royal Shrewsbury

Hospital, said that in the past he has been offered bribes by a

pharmaceutical company not to publish unfavourable research results.

Dr Wilmshurst also claims that he knew of three professors of

cardiology who were told their results were aberrant and were

persuaded by the pharmaceutical company who had sponsored the study

not to publish.

" I suspect this is as common now as it ever was, " said Dr Wilmshurst.

He also told the committee that key opinion leaders can be paid in the

region of £5000 ($9000;euro 1.gif 7000) for an hour's talk about a

drug they have no experience of using, and their influence can have a

big impact on practice.

 

Richard Brook resigned from an expert group over delays in warning the

public about SSRIs

Dr Spence added, " The amount of hospitality received by doctors

compared with other public services is a disgrace. If policemen,

teachers, or MPs received this level of hospitality there would be a

public outcry. "

Also giving evidence to the committee, Richard Brook, chief executive

of the charity Mind, called for greater transparency in how the

Medicines and Healthcare Products Regulatory Agency operates and for

disclosure of any links between people working in the agency and

people in the drug industry.

Mr Brook resigned from the agency's expert group investigating the

safety of selective serotonin reuptake inhibitors (SSRIs) after he

discovered that the agency waited many years before disclosing the

evidence about withdrawal effects of these drugs and their potential

to pre-dispose children to suicide.

Many of the agency's key personnel have longstanding links with the

pharmaceutical industry and own shares in companies, said Mr Brook.

" For a number of reasons I was very concerned that there was no

robustness [at the agency]. We want to see a better way to do health

research and people with consumer and legal interest serving on the

agency, " he said.

Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, Oxford,

called the relationship between the industry and the agency " a closed,

inbred community where the industry is the client and the client must

be looked after " and where a " culture of secrecy " permeates.

 

 

Andrew Herxheimer: The regulatory agency feels it must " look after "

the drug industry

He called for the reporting of adverse drug reactions to be separated

from the business of licensing drugs.

Witnesses also called for stronger enforcement of formularies in

general practices, declaration by pharmaceutical companies of their

contact with and payments to doctors, and regulation of the industry's

influence on consumers.

Commenting on Professor Healy's comments after the hearing, Dr Kamran

Abbasi, acting editor of the BMJ, said: " The BMJ takes the issues of

transparency and accountability very seriously. We believe that

authors must accept full responsibility for the integrity of their

research-including having the idea, collecting and analysing the data,

interpreting the results, and writing the paper-and we have several

policies in place to ensure this. "

 

 

 

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