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I refer to your article in the 10th March edition of the British
Medical Journal (1) concerning a recent Dutch radio broadcast on the issue
of deep venous thrombosis and third generation oral contraceptives.
There is no truth to the allegation made in the Dutch radio broadcast
that Wyeth suppressed the results of a research study. The study report
was provided to the European Agency for the Evaluation of Medicinal
Products (EMEA) in April 2000 and appropriate other regulatory
authorities. To repeat this allegation at all, much less by giving it
prominence in the title to your article is, at the very least,
irresponsible in the context of what is a serious and unresolved
scientific debate.
It is clear that there is a need to understand why there are reported
differences between various studies carried out on the UK General Practice
Research Database (GPRD). As we have made clear in past correspondence
with the BMJ (2) Wyeth, to help resolve this issue, has repeatedly
requested independent scientific review of studies of combined oral
contraceptives using the GPRD. We must reject absolutely the reported
assertion by Dr Walker that the differences in results are due to the
source of funding. In our opinion it is the quality of the study, not
whether it is industry sponsored or “independent”, which should be the
most important criterion for reviewers.
Many research studies are not submitted for publication. The study
in question added nothing to the scientific knowledge on the subject, and
the decision was taken quite properly not to submit it for publication.
The study was not designed to look at deep venous thrombosis as a primary
endpoint. In addition, the study had major design and implementation
errors some of which include; the definition of current users in the study
allowed for the possibility that women could have discontinued therapy and
still be considered an oral contraceptive user; cases/controls were not
matched by practice, which increases the possibility of prescriber bias;
patients with arterial events (e.g., arterial retinal events) were
included in the group with DVT as well as patients who had recently
delivered a baby or had surgery -- both known predisposing factors for
venous thrombosis.
Wyeth hopes that the BMJ will, even at this late stage, deal with
this issue objectively and not react to inaccurate and unsubstantiated
reports in the press. For its part, Wyeth remains committed to the
resolution of this important public health issue through rigorous
scientific evaluation.
P. Brock, Medical Director Europe, Radnor P.A., USA.
Response from Wyeth
Dear Sir,
I refer to your article in the 10th March edition of the British
Medical Journal (1) concerning a recent Dutch radio broadcast on the issue
of deep venous thrombosis and third generation oral contraceptives.
There is no truth to the allegation made in the Dutch radio broadcast
that Wyeth suppressed the results of a research study. The study report
was provided to the European Agency for the Evaluation of Medicinal
Products (EMEA) in April 2000 and appropriate other regulatory
authorities. To repeat this allegation at all, much less by giving it
prominence in the title to your article is, at the very least,
irresponsible in the context of what is a serious and unresolved
scientific debate.
It is clear that there is a need to understand why there are reported
differences between various studies carried out on the UK General Practice
Research Database (GPRD). As we have made clear in past correspondence
with the BMJ (2) Wyeth, to help resolve this issue, has repeatedly
requested independent scientific review of studies of combined oral
contraceptives using the GPRD. We must reject absolutely the reported
assertion by Dr Walker that the differences in results are due to the
source of funding. In our opinion it is the quality of the study, not
whether it is industry sponsored or “independent”, which should be the
most important criterion for reviewers.
Many research studies are not submitted for publication. The study
in question added nothing to the scientific knowledge on the subject, and
the decision was taken quite properly not to submit it for publication.
The study was not designed to look at deep venous thrombosis as a primary
endpoint. In addition, the study had major design and implementation
errors some of which include; the definition of current users in the study
allowed for the possibility that women could have discontinued therapy and
still be considered an oral contraceptive user; cases/controls were not
matched by practice, which increases the possibility of prescriber bias;
patients with arterial events (e.g., arterial retinal events) were
included in the group with DVT as well as patients who had recently
delivered a baby or had surgery -- both known predisposing factors for
venous thrombosis.
Wyeth hopes that the BMJ will, even at this late stage, deal with
this issue objectively and not react to inaccurate and unsubstantiated
reports in the press. For its part, Wyeth remains committed to the
resolution of this important public health issue through rigorous
scientific evaluation.
P. Brock, Medical Director Europe, Radnor P.A., USA.
Correspondence author: e-mail: brockpg@wai.wyeth.com
References
1. van Heteren G. Wyeth suppresses research on the pill, programme
claims. British Medical Journal; 2001;322:571
2. de Laat W, Raff R, Brock P. OCs and pharmaceutical industry
sponsored research. BMJ Letter;
http://www.bmj.com/cgi/eletters/321/7270/1171#EL3
Competing interests: No competing interests