Ethics of undisclosed payments to doctors recruiting patients in clinical trials

Dear Editor,

As busy hospital clinicians who regularly recruit patients into commercial
trials, we were alarmed to read the article by Rao and Cassia concerning
"undisclosed payments to doctors."1 Either they have got their facts wrong
or we have been hoodwinked by numerous companies, which owe us thousands
of pounds! We suspect the former is, sadly, the case.

The clear implication on reading the article is that companies pay
doctors for recruiting patients into trials "in addition to the doctor's
regular income." This is simply untrue. Over the past 13 years, during
participation in dozens of commercially funded trials, no doctor in this
department has received any remuneration for recruiting patients. Our
department receives income to compensate for the time medical and nursing
staff spend on this work and we employ two research nurses and two
clinical fellows who also do their own research leading to higher degrees.
The company pays for all consumables involved and the Trust charges a 30%
levy for overhead costs. We believe that patients would be disturbed to
think that NHS facilities were being used by pharmaceutical companies
without recompense. We have a symbiotic relationship with industry which
allows us to contribute to the development of new treatments for patients
and provides an income stream to underpin our personal research endeavours
assisted by financial support from major charities.

It is wrong to think that patients do not benefit from taking part in
commercially-sponsored clinical trials. They are more likely to receive
specialist care, closer follow up and appropriate evidence-based treatment
than non-trial patients.2 Participation has been associated with markedly
improved survival, not completely explained by the trial therapy, even
after adjusting for population differences.3 In addition, over 75% of
participants in trials for heart failure report subjective improvement,
irrespective of the outcome of the trial.4

So, should doctors disclose "pecuniary interests" to patients when
inviting them to participate in clinical trials? Yes, of course, but the
only disclosure to make is that the staff involved in the trial are
salaried, just like everyone else.

It may be different in general practice where doctors are self-
employed individuals, but to imply that doctors involved in research are
currently not disclosing financial incentives to their patients is
incorrect, even slanderous, and serves only to create distrust between
doctors and patients. Such trust is precious and highly valued on both
sides of the relationship. Care must be taken both by authors and by
editors of prominent journals like the BMJ not to erode it by publishing
misinformation in an unbalanced way.
Yours sincerely,

Dr Peter J Pugh, MRCP(UK)
Clinical Research Fellow

Dr Chris J Malkin, MRCP(UK)
Clinical Research Fellow

Dr Kevin S Channer, MD FRCP
Consultant Physician and Cardiologist
Corresponding author

References

1. Rao JN, Cassia LJ. Ethics of undisclosed payments to doctors
recruiting patients in clinical trials. Br Med J 2002;325:36-37.

2. Brown N, Melville M, Gray D, Young T, Skene AM, Wilcox RG, Hampton
JR. Relevance of clinical trial results in myocardial infarction to
medical practice: comparison of four year outcome in participants of a
thrombolytic trial, patients receiving routine thrombolysis, and those
deemed ineligible for thrombolysis. Heart 1999;81:598-602.

3. Jha P, Deboer D, Sykora K, Naylor CD. Characteristics and
mortality outcomes of thrombolysis trial participants and nonparticipants:
a population-based comparison. J Am Coll Cardiol 1996;27:1335-1342.

4. Yuval R, Uziel K, Gordon N, Merdler A, Khader N, Karkabi B,
Flugelman MY, Halon DA, Lewis BS. Perceived benefit after participating in
positive or negative / neutral heart failure trials: the patients'
perspective. European Journal of Heart Failure 2001;3:217-223.