RESPONSE TO SEXOLOGY AND THE PHARMACEUTICAL INDUSTRY: THE THREAT OF CO-OPTATION.

In an excellent and timely paper in The Journal of Sex Research's special issue on Medical Advances and Human Sexuality (volume 37, number 3, August, 2000) Dr. Tiefer presents an overview of potential conflicts between sex researchers and the pharmaceutical industry (Tiefer, 2000). Sex researchers' objectives are to further develop the field, and the pharmaceutical industry's goals are to develop profitable drugs, and the two do not necessarily coincide. The fact that sex researchers are usually bound to confidentiality with regard to study outcome is, as Tiefer points out, an important threat to the development of science which can only benefit if scientific findings are public.

Tiefer's description of our presentation of data at the International Academy of Sex Research (Tiefer, 2000, p. 277; see also footnote 2) may have inadvertently given the impression that we are in a stranglehold with the pharmaceutical industry, which may discourage investigators seeking commercial financial support for their work. At that meeting we presented two studies. The first study had been conducted in 1997, the results of which were, indeed, embargoed until June 2000. Data collection for the second one, though, had ended only a few months prior to the meeting presentation. At the time of the meeting we were still blind to the experimental condition subjects had been in because the data file had not yet been closed due to unresolved queries unrelated to the data being presented. Obviously, we were not able to conduct these statistical analyses ourselves at this early stage. Therefore, we presented the results of the second study (which were, incidentally, unfavorable for the company) as being preliminary, and not because the company had kept us in the dark as to the study results for a period of three years! So, ironically, instead of being an example of a company delaying information, this actually is an example of a company cooperating with us to get the results out in the scientific community as quickly as possible.

It is not altogether impossible for a sex researcher to pursue his or her scientific curiosity without being compromised by the pharmaceutical industry. In our experience with several pharmaceutical companies over the past few years we have come across several pitfalls, which can be avoided. Companies' contracts typically contain a standard clause, which gives them the right to block or slow down publications. Recent legislation, however, helps investigators in resisting such blocking or delaying of publications. The most recent Declaration of Helsinki Guidelines (World Medical Association, October 2000) explicitly state that "Negative as well as positive results should be published or otherwise publicly available" (Section B, paragraph 27). The Dutch 1998 Medical Research Involving Human Subjects Act, enforced as of December 1, 1999, requires adherence to the Declaration of Helsinki Guidelines. We are sure that other countries have similar provisions.

Another pitfall is the timing of signing the contract. If the contract is signed before complete agreement on the study protocol is achieved, there is the risk of having to perform a study that does not meet one's standards. One reason to sign a contract at an early stage is to make sure the financial commitments an investigator might have made in the phase of protocol development are covered. One way around this is to ask the pharmaceutical company at a very early stage to sign a "Letter of Intent" stating that all expenses will be covered in the event one or both parties decide not to go ahead with the study.

A further important issue is who owns the data that are being produced. Although it is, in our opinion, quite obvious that the party who pays for the study owns the data, it does not mean that other scientific or technical inventions are, as a consequence, property of the company as well. In one of our studies, new equipment was being developed by us which would allow us to gather comparable data at more than one site. The contract specified that for those innovations, although paid for by the company, the intellectual ownership of the innovations was ours. In addition, ownership of data by pharmaceutical companies does not imply that investigators should not have access to the data. We have always made sure, and this was never opposed by the companies we worked with, that it is the investigator who conducts the analyses and writes the publications, as such insuring scientific integrity and independence.

Even though the points made by Tiefer are important and may serve as a guide for all sexologists and for investigators in particular, keeping one's scientific integrity while conducting studies funded by the pharmaceutical industry is not impossible. The sexology community is small and we have what pharmaceutical companies need. Good investigator sites for pharmaceutical companies to engage in studies with are limited. In our view, potential investigators should be aware that there is no need for compromises.

REFERENCES

Ministry of Health, Welfare, and Sports (1998). Medical Research Involving Human Subjects Act, Staatsblad 1998 [Bulletin of Acts, Orders and Decrees 1998], 161. Available: http://www.minvws.nl/tc.

Tiefer, L. (2000). Sexology and the pharmaceutical industry: The threat of co-optation. The Journal of Sex Research, 37, 273-283.

World Medical Association (October 2000). Ethical Principles for Medical Research Involving Human Subjects [On-line]. Available: http://www. wma.net/e/policy/17-c_e.html

RESPONSE TO LAAN, BEEKMAN, AND EVERAERD

I welcome the opportunity to continue the dialog about the role of the pharmaceutical industry in sex research. I appreciate my Dutch colleagues' letter and acknowledge the greatest respect for their work. Indeed, I regard Ellen Laan as a close personal friend. I obviously misheard Laan's presentation in Paris in 2000 and thus misrepresented it in my footnote. I can only surmise that I was so shocked to hear that data from one study had been embargoed by a company in 1997 and kept secret for three years that I didn't attend properly to the fact that the data being presented came from a subsequent study.

Let me reply to four points raised in their letter.

First, they write that "sex researchers' objectives are to further develop the field, and the pharmaceutical industry's goals are to develop profitable drugs, and the two do not necessarily coincide." This frank statement is hugely important. Our goals not only don't necessarily coincide, they rarely coincide. They may overlap, as when sex researchers and drug companies are both interested in knowing more about human genital physiology, in developing treatments for sexual dissatisfaction, or in measuring sexual experiences. But, the overlap is always partial, particularly in the case of industry giants with the resources and determination to create multi-billion dollar blockbuster drugs. I believe we must always keep in mind that the ultimate ends of our work are vastly different: human welfare versus corporate profit.

Second, Laan and colleagues indicate that new professional rules reduce a company's right to delay or prevent publication of data, and they cite recent guidelines from the World Medical Association. Indeed, there is a backlash building within the scientific community against restrictive clauses in drug company contracts. However, a recent review in the New England Journal of Medicine (Bodenheimer, 2000) estimates that "30-50 per cent of contracts submitted by companies have unacceptable publication clauses that must be negotiated" (p. 1541). Each scientist must be prepared and supported to enforce such negotiation. Only organized and ongoing pressure will maintain scientists' rights to freely present and publish their data. We cannot tolerate data embargoes.

Third, Laan and colleagues write that "it is, in our opinion, quite obvious that the party who pays for the study owns the data." I believe this is a complex and controversial conclusion which should be widely debated. What does "owns" mean, and what are "the data" in question? "Intellectual property" is a new area of commerce, and it is not clear where scientific data will fall. Obviously, it is in the interest of drug companies to make the issue of ownership seem transparent, but Bodenheimer (2000) cites examples where such control led to limits on data analysis, publicity of selected sections of studies, and other kinds of anti-scientific "spin control." Let's undertake a sophisticated discussion of the question of "ownership."

Fourth, Laan and colleagues emphasize that "it is the investigator who conducts the analyses and writes the publications." This is crucial, because journalists have uncovered how drug company employees are analyzing data and writing up studies that are published with scientists' names tacked on for window dressing. This has even happened in our field, I am told, and it is important that we have researchers like Laan, Beekman, and Everaerd taking a public position against such practices.

These are rapidly changing times for sex research. Commercial opportunities for sex-enhancing drugs have exploded, and sex researchers are eagerly sought for help in commercial ventures. Our dance cards are no longer empty. Professional sexological organizations must develop ethical guidelines to advise individual scientists attempting to navigate these new waters. Laan and her colleagues point out what they have learned from their experience. Will each of us have to reinvent the wheel alone?

REFERENCE

Bodenheimer, T. (2000). Uneasy alliance--clinical investigators and the pharmaceutical industry. New England Journal of Medicine, 342, 1540-1544.