
Beware of Clinical Trial Studies
Posted Mar 2, 2011 by anonymous | 135 views | 0 comments
I recently had a very bad experience at a clinical trial unit in Neptune, New Jersey at MDS Pharma Services. This unit tests healthy subjects for pharmaceutical companies. I've participated in two studies over the past 14 months and I have screened nearly a dozen times there. At no time did I feel uncomfortable with my exams. But this screening involved a breast exam. First, I was never told over the phone in the initial consultation that a breast exam was required. Secondly, once I arrived the breast exam was never explained. The only mention was that it was routine when an oral contraceptive was given in a trial. I asked who would be performing the exams. The nurse stated she didn't know. I knew if it was the male doctor, that he would be curt, quick and very clinical, never smiles, yadda, like he always is. This doesn't bother me, as I like doctors to keep a professional distance. But he was a completely different person for the breast exam. He was smiling and laughing and being too personable. Before I had my exam, he examined about 7 women. He was alone in the room with each woman. I was shocked. I went to the nurse and her response was, 'most girls don't mind'. I had to demand a female be present during my exam. Before the doctor examined me, I told him I had lumpy breasts and they were diagnosed normal by my family dr. He had me go into detail about where they were and how long I had them, if they changed in size, yadda. In the past, this doctor never had any questions about my health. He then examined my breasts very, very slowly. I've never had a breast exam done at that speed. Then he asked me if I knew how to examine my own breasts. I said yes. He asked me to point to where I would start. When I did not point to the correct position, he took my hand and pressed it with his own onto my breast. I have never had a doctor do that to me. When he finished the exam, I asked him if lumps in the breast were an exclusion from the study. All of a sudden he became curt and stated he did not know, that only the drug sponsor could decide that. I felt very uneasy about his touching me. I felt something was wrong. Because of this I called management and demanded to know if I was pre-excluded from the study because of my lumps. I was told yes. I was told that I should have been informed about the breast exam and that I would be instantly excluded for breast nodules. I told the doctor before he touched me that I had 'nodules'. Right away he should have told me I was excluded from the study and given me the option of walking. He instead decided to give me an unneccesary breast exam. What he did to me sickened me. I felt dirty and violated. I believe he 'got off' on touching me. Got off on the power and the thrill. I filed complaints with the FDA but they referred me to the drug sponsor, the internal review board and the attorney general. I have filed with all except the atty general. Currently the clinic has suspended the doctor from screening patients. When I screened there this Monday I noticed that 2 female techs are present during ecg exams and now a female chaperon is present during the dr.'s exam. I just read today at the Medical Examiner's site, that by law, a patient must be given notice that he/she can request a chaperon during an intimate exam. I was never given notice. I contacted an attorney and he said I have an impossible case because the doctor could always say that he wanted to make sure I had lumps. Or he could say that my inclusion in the study depended on the size or amount of lumps. So I'm SOL. I know in my heart he sexually assaulted me. If he had been his typical distant self, I never would have thought twice about his examination of my breasts. But he became a different person when he touched my breasts. I know people will ask, 'well why go back to that clinic if you believe you were assaulted?' Because when someone has wronged me, I confront them to their face. Why should I be made to feel ashamed when I did nothing wrong. If I don't speak out, then this behavior will be allowed to continue. The first rule in the medical profession is to do no harm. It's amazing how many so called professionals forget this oath. What I want to bring home is that sexual assault, even in it's most subtle form can be very harmful and damaging to the unsuspecting patient. Patients must be made aware of their rights to object. Communication works both ways. Doctors must fully disclose what they are doing and why and patients must voice their concerns. Two weeks after that incident (and after I filed an official complaint with the clinic), MDS called me and told me I could not come to the clinic again unless I had a mammogram. I was livid. I told them that I thought their actions were retalitory. But I went to my private physician. And guess what? My breasts are 100% normal and healthy. The N.P. found no lumps or nodules. What she found was extremely dense tissue, typical in athletic, small breasted women. It is a very common condition called cystic breast changes which most women have. If the doctor at MDS had examined my breasts instead of fondle them, he would have made the correct diagnosis. I have done hours of research online and have discovered that about 10-12% of doctors admit to sexual misconduct. It is not rare. What is rare is that it is reported. Women know your Rights!!! Don't go to any clinical trial unit without first asking if a breast or pelvic exam is required. If it is, you have the right to go to your own private doctor and give the clinic your doctor's note. If they don't accept it, then WALK!! Also report anything you see as a violation to the IRB, Instituional Review Board and Medical Examiners Board. Protect your body because no one else will.
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