Otis W. Brawley M.D. in the year 2000 was Director of the Office of Special Populations Research and Assistant Director, Office of Science Policy at the National Cancer Institute. When he worked at the Division of Cancer Prevention and Control (DCPC) at the National Cancer Institute, he was part of a team that developed and launched the Prostate Cancer Prevention Trial, an 18,000 man trial looking at screening and epidemiology of prostate cancer and at prevention of benign prostatic hyperplasia and prostate cancer. He also served as chief of the NCI intramural prostate cancer clinic.
This interview, conducted by E-mail January 29 and February 1, 2000, was arranged in Q & A format and edited for length.

PSA Rising: Dr. Brawley, do you know what your own PSA is? If so, at what age did you start taking PSA tests? If you have ever had PSA drawn, how much information were you given before doing so about risks and benefits, and did you feel you needed more?

Otis Brawley: I have never had a PSA and do not desire one. I have had relatives with the disease. I just do not believe it saves that many lives. SEER data show that a large proportion of so called early detected patients with pathologically localized disease (the best prognosis one can have) ultimately relapse by PSA. This means they really had distant disease at diagnosis.

PSA Rising: In view of Dr. Gabriel Feldman’s resignation from his post looking after colon and prostate cancer at ACS, your name has come up in several places as candidate for that job. Is this true? Has ACS approached you and are you interested?

Otis Brawley: I cannot imagine that the American Cancer Society would consider me for the job you are referring to. As things go, most would consider my current job a bit better than any job the ACS could offer.

PSA Rising: We don’t know where this rumor arose, we figured we needed to get the facts straight. Can you in any event please give a brief outline of your views on priorities for prostate cancer research and services for patients?

Otis Brawley: My views on prostate cancer research are in http://www.nci.nih.gov/prostateplan4.html#1-3-3 and http://wwwosp.nci.nih.gov/planning/prg/toc.htm.
These are NCI documents that I helped prepare.

PSA Rising: One specific question has bothered us for some time. In December 1997 or maybe Jan 1998, the American Cancer Society (ACS) made a press release on what they characterized as the “disgraceful tragedy” of prostate cancer especially in African American men. At the time, we put a report based closely on that release on line; we have maintained the page (“African American Prostate Cancer Crisis – Disgraceful Tragedy“) ever since, tying our coverage of African American prostate cancer research news to it.

That press release quotes Charles J. MacDonald, MD, head of ACS, and John R. Kelly, an ACS board member. They urged grassroots action, more research and early detection from age 40 up. How did that press release, that policy, get made? What was the process by which, under Dr. Feldman, it was so drastically revised as to be rescinded? The public needs to know this after having been told at the time what Dr. MacDonald and Mr. Kelly said.

Otis Brawley: I can make no statements about the ACS and their inner workings. I can only vouch for the fact I did attend a series of meetings in 1997 when the ACS gathered fifty leading cancer specialists (epidemiologists and treaters) to re-evaluate their screening recommendation. This meeting led to the ACS repealing their recommendation that all men over fifty get screened and instituting a recommendation that men be offered the test and informed of potential risks and benefits. This latter recommendation was adopted in June 1997.

PSA-Rising: From your article in JAMA and elsewhere it’s evident that you oppose screening. What are your current views on early detection of prostate cancer?

Otis Brawley: It is unfortunate that you have interpreted my writings as against screening. Indeed if you carefully review them, I am against misleading people by saying it clearly saves lives and there are minimal downsides. I have been fortunate in that I have had the opportunity to publicly express my views on many occasions and have published it in several articles. For example, in the journal CANCER in 1997. There I call for informed consent of the risks and benefits and say no one should criticize a man who decides to get screened.

I reiterated this stand in: Brawley O: Prostate Cancer and Black Men. Seminars in Urologic Oncology. 16:184-186, 1998.

If a man is truly informed and chooses to be screened I have no difficulty with it. I am against those who oppose informed education about the screening issue.

Many of my views about ethics and misleading people about what is scientifically known and what is not known and distinguishing it from what is believed come from my experiences in working in the aftermath of the Tuskegee Syphilis Study. The tragedy was initiated and prolonged because well meaning folks who did not understand, supported the trial and actually conveyed untruths to men participating in the trial often in an effort not to worry them with something too complicated. I wrote about this in:

Brawley OW: The study of untreated syphilis in the Negro male: Modern lessons of the Tuskegee Syphilis Study. International Journal of Radiation Oncology, Biology and Physics, 40:5-8, 1998.

I should note that I am aware of twenty three different organizations of experts in screening around the world who have considered the question and all have chosen not to make the blanket statement that screening saves lives and men should be screened. Most actually recommend men not get the test because it is not proven effective.

PSA-Rising: I think we do understand about Tuskegee. Some degree of that same risk applies today to recruitment of minorities into clinical trials at a time when several major trials, badly run, have been halted for their disarray. And men going into clinical trials often include men who were not diagnosed early enough to have currently curable disease.

Otis Brawley: The Tuskegee issue goes far beyond clinical trials and misleading people in clinical trials. My point is that when twenty-three organizations of experts from the Canadian Urology Association to the American College of Physicians to the U.S. Preventive Services Task Force recommend against screening and men are encouraged to get and not told that the predominance of professional expert opinion is that it is unproven and should not be done then they are being misled and misinformed just as the men in the Tuskegee trial were lied to.

This again is not to say that a man cannot still legitimately decide to get screened. The prostate cancer screening question is far more complex than just doing the test and diagnosing cancer. There are a number of issues such as diagnosis of lesions of no clinical significance and the resultant unnecessary treatment. Indeed there are now several studies that suggest that perhaps a third of all men diagnosed by PSA and quote “cured” would never have been bothered by their disease without our current screening technologies. They would have lived long not knowing they had prostate cancer and ultimately died of something unrelated.

There is also the issue that nearly 40% of men diagnosed and “cured” with radical prostatectomy ultimately relapse with metastatic prostate cancer. For most of these men early detection (no matter how early) would not save their lives.

Now the above are the known proven facts. There is reason to believe and I do believe that some men’s lives are saved by screening but I must stress no one knows for sure.

I far rather tell men that the test exists and it may save lives, it may not, than twenty years from now find out that it is like lung cancer screening and the misleading of men has caused more harm than good.

I have also been very outspoken about the ethics of private industry which stands to gain from prostate cancer screening advocating it so heavily. In reality I know private industry benefits from prostate cancer screening, I do not know that the men who are screened benefit.

I have also been critical of physicians who get into the business of giving screening advice but cannot define for me the basic principles of screening such as defining length bias or lead time bias. You see many physicians who advise prostate cancer screening [who are] ignorant of the discipline of screening.

By the way the money to be made is not through selling drugs or through treatment of cancer. If you like money you want a piece of PSA reagent sales.

PSA Rising: Do you oppose the Prostate Cancer Awareness stamp?

Otis Brawley: Given these facts I believe any awareness campaign for prostate cancer screening must stress what is known, and what is not known and what is believed. Given this, my personal belief is the U.S. Postal Service should stick to trying to deliver mail rather than publishing stamps that give misleading advice. They should not have a stamp advocating early detection and suggesting that it saves lives when this is a significant area of debate among experts.

I am committed to continue unearthing all the data for or against prostate cancer screening so that we can finally have an answer to this very important question.

PSA Rising: A lot to follow up here. We will continue to do our best to give coverage to the issue. With that in mind, I would like to check in with you from time to time to bounce some opinions and ideas and get facts straight.

Otis Brawley: An NCI screening statement on PDQ really sums up my position better than I ever could put it in words:

No trial of prostate cancer screening where the intervention arms were analyzed as randomized (analogous to an “intention to treat” analysis in a treatment trial) has been reported. There is, therefore, insufficient evidence on which to decide the efficacy of transrectal ultrasound and serum tumor markers (including PSA) for routine screening in asymptomatic men. While awaiting results of these studies, physicians and men (and their partners) are faced with the dilemma of whether or not to recommend or request a screening test. A qualitative study undertaken on focus groups of men, physician experts, and couples with screened and unscreened men has explored what information may help to inform a man undertaking a decision regarding PSA screening. At a minimum, men should be informed about the possibility that false positive or false negative test results can occur, that it is not known whether regular screening will reduce deaths from prostate cancer, and, among experts, the recommendation to screen is controversial.