The health of hundreds of UK patients is at risk because their GPs are secretly being paid to use them as guinea pigs in drug trials, an investigator has told the BBC.
GPs are paid up to £2,000 for each patient testing a medicine
Peter Jay of Medico Legal Investigations, the only British company specialising in medical research fraud, has tracked down 26 cases involving GPs and hospital doctors in recent years.
All but one of the doctors has been found guilty of serious professional misconduct by the General Medical Council.
Mr Jay, a former Detective Chief Inspector, said a small number of trusted family doctors were forging patient consent forms and fabricating data to earn extra cash.
"Several thousand patients are taking part in trials in the UK," he told BBC One's Real Story programme. "Those involved in fraudulent or dishonest ones will probably be in the hundreds."
Real Story looked at the case of Dr Robert Adams of Letchworth, Kent who was last year found guilty by the General Medical Council of putting patients on clinical trials without informed consent, forging data and pocketing himself over £100,000 in the process.
Trust me, I'm a Doctor
BBC One, 1930GMT
Tuesday, 9 November, 2004
According to Mr Jay, doctors are still exploiting their position of trust in this way.
Fraud 'costing millions'
"We've had cases where a patient thinks he or she is signing a receipt when in fact it's a consent form to take part in a study.
"It should be signed willingly and the patient must be told that he or she can withdraw at any time and be given as much information as possible."
Quite often, says Mr Jay, a doctor will be asked to recruit 20 patients but will recruit five or six and make up the rest.
Peter Jay began investigating research fraud after retiring from the CID
Pharmaceutical professionals are becoming aware of the way fabricated data impacts on their whole industry. A bad drug getting on the market can cost a company millions because they have to abandon a development process, which can take up to 12 years.
For a typical trial involving 20 patients over a two-year period, a pharmaceutical firm will pay a GP up to £2,000 per patient.
Mr Jay follows up tip-offs on a doctor's misconduct from drugs companies, health authorities or even from a GP's own partner.
He then approaches the GP's health authority for the initials and date of birth of each patient. Letters are then prepared and forwarded in bulk to a primary care trust which is asked to identify each person, address the envelopes and forward them on.
The investigation process then relies on the co-operation of the patient in filling in their details on a tear off slip and expressing a willingness to talk to Mr Jay.
The response rate is about 70%.
Once their notes state they are testing a particular drug, patients who have never developed the illness in question could have their future healthcare, job applications and insurance affected.
"The hypertension and depression studies seem to be the easiest to fabricate," said Mr Jay, "although we've had quite a few paediatric studies involving inhalers. Thankfully we've never had a problem in the oncology areas."
Should a patient in a fraudulent drug trial find themselves needing emergency treatment of any kind, a routine phone call from the hospital to their practice could, in the worst case scenario, prove fatal.
"It might be that the practice nurse there sees in the notes that the patient is on a study medication.
"The hospital could react to that by saying, 'Thank God we found out about that because now we know we can't use the first line treatment that we had in mind.'"
Sharing this concern is the group of GPs who have formed 'No Free Lunch', dissatisfied with the General Medical Council's ability to campaign against the offers of money, gifts or hospitality from the pharmaceutical industry.
Their spokesman Dr Des Spence told Real Story: "Recent research showed that twice as many people die from drug interactions and drug reactions than die on the roads. It's a very significant risk."
Just as worringly, the majority of patients whose trust is abused are elderly because, according to Mr Jay, "younger ones tend to question things more."
One doctor he investigated had tricked an elderly woman into giving large quantities of blood every month to satisfy the requirements of three different studies her GP was signed up to.
New legislation should see pharmaceutical companies dealing more aggressively with research misconduct. An EU directive came into force earlier this year introducing compulsory spot checks of drug trials by government-appointed inspectors.
And the government plans to set up an official body to investigate research fraud and misconduct, the National Panel For Research Integrity, by summer 2005.
But Mr Jay said that until then investigations such as his own, which were without any legal powers, would have to struggle along on good will.
Real Story: BBC One, Monday, 8 November 2004, 1930 GMT and streamed on the Real Story website.