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EDITOR'S CHOICE: Fiona Godlee Count the harms BMJ 2006; 332: 0-f [Full text]

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Screening Mammography: The Missing Link

Lynn Howard Ehrle   (26 March 2006)

Public enquiry needed for TGN1412 trial

Usha K. Sharma   (27 March 2006)

Count for the harms

David Isaacs   (27 March 2006)

Screening Mammography: The Missing Link 26 March 2006
Lynn Howard Ehrle, Senior Biomedical Policy Analyst Plymouth, Michigan USA 48170 Send response to journal: Re: Screening Mammography: The Missing Link	The Godlee editorial (March 25) and the Jorgensen-Gotzsche paper focus on the problem of over-diagnosis in screening mammography but there are three interrelated pieces of the puzzle that are never discussed or quantified in any of the relevant studies that have crossed this writer's desk. There seems to be no data on the number of screenings that require one or two retakes. Radiologists tell me that the procedure is necessary in many cases but no agency has seen fit to keep an accurate record of their frequency. A more serious issue arises as a result of the American Cancer Society's successful policy urging screening to begin at age 40, again with little follow-up data as to the total number of women who have yearly mammograms. When clinicians fail to inform patients as to the additional health risks from cumulative radiation doses due to multiple exposures, the admonition "to first, do no harm" is being compromised. Competing interests: None declared
Public enquiry needed for TGN1412 trial 27 March 2006
Usha K. Sharma, Pharmaceutical Physician Mumbai 400088, INDIA Send response to journal: Re: Public enquiry needed for TGN1412 trial	Approval to conduct Phase I clinical trials with a New Chemical Entity or drug, should be made extremely cautiously, keeping in mind the potential benefit of the new drug for the disease being targeted eventually, and the fact that in Phase I it is healthy, disease free and young subjects who take the medication, to help accumulate clinical evidence of safety for the ultimate benefit of the seriously ill. It is surprising that an extremely unusual biological, TGN1412, with an innovative mode of action was permitted to be given in its very first administration, simultaneously to 6 subjects. No clinical data were available to guide the investigators what to expect. The very uniqueness of the drug should have made the regulatory authorities AND the Institutional Review Board or Ethics Committee, extremely wary of possible consequences and it is THESE bodies which should have been the guardians of human safety. A clinical immunologist has commented in a letter to another publication, that had the authorities consulted any member of his specialty, they would easily have predicted the likely risks being undertaken. Ensuring the safety AND well being of the volunteer subjects is the VERY least that should be esnured by all parties involved in decision making in Phase I studies. I urge that the bodies responsible for this oversight should not be THEMSELVES permitted to review the fiasco. Rather, a committee of highly placed, socially responsible and medically learned experts should study how this came to pass, so that the errors be avoided in future. It is only through unbiased and detached expert peer review that the medical fraternity can itself learn from its mistakes, and avoid them in the future. Health regulatory authorities should learn from them, and not merely wield power through approvals of clinical trials. The wellbeing and safety of human subjects in clinical studies is of direct concern primarily to their physicians and this responsibility should be held sacrosanct by them, and not be abdicated to any other profession. I speak from my experience of being associated with, and actually conducting New Drug evaluations ranging from Phase I to Phase IV over 30 years, and the lessons I have drawn from the same. Dr. Mrs. U. K. Sharma, M.D.,D.Cl.Pharm.,Ph.D, PHARMACEUTICAL PHYSICIAN Competing interests: None declared
Count for the harms 27 March 2006
David Isaacs, Clinical Professor Children's Hospital Westmead, Westmead, Sydney, NSW, 2122, Australia Send response to journal: Re: Count for the harms	One aspect of the Northwick Park tragedy that has attracted scant attention is the issue of payments to volunteers. If the amount of money offered is more than just to cover expenses for travel and time off work, then it is an inducement. Financial inducements are ethically dubious, because they may cause people to take risks that they would not normally take. And of course, in such situations, it is the poor who are most likely to be disadvantaged. Competing interests: None declared