The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7508.115 (Published 07 July 2005) Cite this as: BMJ 2005;331:115
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I live in the city where this took place and followed the Nancy
Olivieri story carefully at the time it was disclosed to the public. The
real issue is NOT that patients were denied access to a possible solution
to their health problems, but that the drug company deliberately
suppressed negative feedback and concerns of significant health risks
raised by a doctor involved in a funded study. That a commercial company
could go to such great lengths to suppress the physician's evidence and
concerns raises questions not only about the integrity of the drug company
involved, but it exposed the potential that exists for unsafe drugs to be
released and marketed because the process of testing and bringing a drug
to market may lack sufficient regulation and independent processes.
Competing interests:
None declared
Competing interests: No competing interests
It is difficult to ascertain from this review whether the reviewer
actually read this book. Rehashing what passes as the Oliveri story cannot
be considered a review, nor can the reviewer's wishes that Schuchman had
written a book about whistleblowers and ethics committees. But what is
most puzzling is the brushing off of the single most important issue in
this case, "she ventures no conclusion more dramatic than that Olivieri
still wants deferiprone banned, despite accumulating evidence that her
anxiety over its toxicity was an over-reaction." Deferiprone being banned
is the only issue that really matters in this case. And the thalassemia
patients who have been deprived of this drug have become the real victims
of this ongoing drama. This is what matters. We hear so much about the
ethics of this situation with drug companies financing the research into
their own products, and the ethics of the researchers working for them,
but why is it so silent about the ethics of allowing patients to die who
might have been saved by this drug? This is the real ethical question
here. While drug companies and the researchers jockey for the better image
and higher ground in the public eye, the patients are forgotten.
Deferiprone has been on the market in India for 10 years and several
patients I know there have told me it is the only reason they are alive,
as the alternative, desferal, is beyond their means (another ethical
problem? Ask the makers of desferal who are soon hoping to have their own
oral pill approved, but at a far higher monetary cost than desferal. I
guess the patients in India, Pakistan and throughout the poorer nations of
the world are still out of luck). While the approval of deferiprone in
North America has languished, with Oliveri being a key player, country
after country has approved its use and patients are surviving.
While you worry about the ethics of drug companies financing the
research into their own products, where is the concern for the patients
who have died because this drug has been withheld from the North American
public? What are the ethics here? Why are we worrying more about
perceptions than lives? It does seem as though the patients have been
forgotten amidst the pompous posturing of both sides.
Andy Battaglia
Thalassemia Patients and Friends
http://groups.msn.com/ThalassemiaPatientsandFriends
Competing interests:
None declared
Competing interests: No competing interests
Re: Thank you Andy !
As a thalassaemic from India, I totally agree with Andy about the
bigger picture being more important. The real issue always, is saving
lives first and that is the most ethical standpoint be it drug companies
or hospitals and the entire medical field/industry.
There are many unhealthy collusions that are taking place, in every
strata of life, in every field. While the point about having independent
studies and trials is also valid; at the end of it all, it is 'all' the
drug companies that are not living upto ethical standards. They are too
profit- oriented to really serve the medical needs of the world's poor and
meek. I do not see any effort made to make the drugs available cheaper or
free of cost to any of the Third world countries, and at such a time when
desferal was exhorbitantly outpriced for us ( like Exjade will now be !!)-
- deferiprone, the drug that was banned in the Western world, has saved
lives and I am one of them. All very well not to care about costs when
health care is covered but for those who have to pay through their noses
the deferiprone was a godsend.
How come many are doing well on this drug if it was so unsafe? How
come the drug by Apotex has been declared fit for the European countries
and even Australia? There are some possible sideffects which I can safely
say all/most drugs do have. Cannot a doctor make a mistake? I am not
getting into the ethics that information was suppressed by drug companies
( happens more often than we know), it is not the only REAL issue ... a
drug being withheld on any erroneous grounds seems to me far more
dangerous. It costs lives! Thank you Andy for being aware of the plight of
millions of thalassaemics who die unnoticed in the rest of the poorer
nations. Nobody ever mentions them but I see it all the time and it hurts!
This being from the horse's mouth, the drug seems better than
desferal, cheaper and painless and independent studies have proven it
removes the cardiac ironload.
Thank you and I hope I did not offend any sentiments, but as a
thalassaemic I think I have an insight to the very real, pressing issues
of life and death. Any delays can cost lives and I wish this would be the
focus of the day :)
Competing interests:
None declared
Competing interests: No competing interests