This is simply an area to post assorted articles of interest. There is no theme, and updates are random, so check back periodically!
More on laparoscopic prostatectomy
New Impotence Treatment on the Horizon?
Summary of Dr. Ablin's Syracuse Man to Man presentation, July 29th, 1999
Cryoimmunology/Cryoimmunotherapy: 30 Years
Eur Urol 2000 May;37(5):615-620
Monday April 10, 6:33 pm Eastern Time
SOURCE: Abbott Laboratories
LAKE FOREST, Ill., April 10 /PRNewswire/ -- TAP Pharmaceutical Products, Inc. announced today that the U.S. Food and Drug Administration's Urology Subcommittee of the Advisory Committee for Reproductive Health Drugs recommended approval for UPRIMA® (apomorphine HCl tablets) sublingual for the treatment of erectile dysfunction (ED). The committee's favorable recommendation will be considered by the FDA in its final review of the New Drug Application (NDA) for UPRIMA.
The committee suggested some cautionary recommendations for labeling. In addition, the committee advised that education materials be provided to patients at the point of care.
If approved, UPRIMA will be the first centrally acting oral ED treatment available to patients. ``UPRIMA could offer several benefits for patients suffering from ED,'' says John Mulhall, M.D., director of the Center for Male Sexual Health at Loyola University Chicago and an investigator in the UPRIMA clinical trials. ``In clinical trials, it worked quickly, in as fast as 10 minutes, with a median response time of 16-19 minutes. With its sublingual route of administration, it is not expected that UPRIMA will interact with food. Finally, data suggest that UPRIMA is safe and effective in men with varying severities of ED.''
TAP submitted an NDA for UPRIMA on July 1, 1999, for 2 mg, 3 mg and 4 mg doses. The NDA was based on data from 27 clinical studies in 3,035 men.
``We are extremely encouraged by the recommendation, as we feel that UPRIMA would greatly enhance the therapeutic options of millions of men with ED. Further, UPRIMA will be a significant addition to our product portfolio, allowing us to further build on our experience in urology and primary care,'' says Thomas Watkins, president of TAP Pharmaceutical Products, Inc.
Erectile dysfunction is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual intercourse. Approximately 30 million American men suffer from some form of erectile dysfunction.
In clinical studies, UPRIMA was administered to men with organic, psychogenic, or mixed etiology erectile dysfunction, and was evaluated for its ability to produce an erection firm enough for intercourse. Initial studies with UPRIMA included patients with controlled hypertension and diabetes (type I and type II). TAP has also evaluated UPRIMA in patients following nerve-sparing radical prostatectomy.
In addition, a unique aspect of TAP's clinical studies was the assessment of patients' partners for satisfaction. This assessment showed corroboration of findings from the patient.
The most commonly reported side effect was nausea. Of the nausea reported in the NDA clinical studies, most incidences were mild to moderate in severity.
Apomorphine HCl tablets sublingual for male erectile dysfunction was licensed from Pentech Pharmaceuticals, Inc. of Buffalo Grove, Illinois.
TAP Pharmaceutical Products Inc. is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd. of Osaka, Japan. Abbott and Takeda will jointly develop and co-market apomorphine in countries outside of the United States and Canada. TAP also markets Lupron Depot® (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer, management of endometriosis, anemia caused by uterine fibroids in combination with iron, and central precocious puberty, and PREVACID® (lansoprazole) for the treatment of various acid-related disorders including gastroesophageal reflux disease (GERD) and ulcers. TAP has also submitted a NDA to the FDA for the cephalosporin antibiotic SPECTRACEF(TM) (cefditoren pivoxil).
SOURCE: Abbott Laboratories
Yes, the Female Has a Prostate!
In collaboration with Doctor Milan Zaviacic (Head, Institute of Pathology, Comenius University School of Medicine, Bratislava, Slovakia), Doctor Richard J Ablin will present a paper at the International Prostatitis Collaborative Network Workshop, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, and the American Prostatitis Foundation, to be held 4/5 November in Bethesda, Maryland entitled: "The Female Prostate, Prostatitis and Recurrent Urinary Tract Infection".
Among his numerous contributions, notably in urology, Doctor Ablin, is noted for his pioneering immunological studies of the prostate, which included his identification of prostate-specific antigen (PSA), which led to the development of the PSA test.
In commening on his forthcoming presentation, Doctor Ablin emphasizes from a pragmatic point of view, that it is time to alert primary care physicians that women have a prostate and therefore, have diseases of the prostate as their male counterparts, i.e., prostatitis, cancer (although rare), which need to be treated appropriately, rather than as in the past by invasive urethral dilation and/or antidepressants (the latter implying that the occurrence of such diseases in the female is a state of mind rather than an actual disease).
The abstract of Doctor Ablin's presentation follows.
The Female Prostate, Prostatitis and Recurrent Urinary Tract Infection
M. Zaviacic. R. J. Ablin
Institute of Pathology, Comenius University School of Medicine, Bratislava, Slovakia (MZ), Innapharma, Inc., Suffem, NY (RJA)
In contrast to the almost 2 million office visits annually in the USA for male prostatitis. in excess of 5 million office visits by women for the urethral syndrome, the commonest urologic complaint among female patients, attributed to infection in the distal paraurethral glands ('the female prostate'), have been noted. Given the general misconception that the prostate gland is exclusively a male organ, the failure to recognize the existence of the female prostate and to investigate its pathology have resulted in the misdiagnosis and inappropriate treatment of female prostatitis. In consonance with earlier anatomical and embryological data, our extensive anatomical, light and electron microscopic, biochemical and immunohistochemical studies of the normal and pathologic adult human female prostate substantiate the unambiguous existence of the female prostate. The female homologue of the male prostate is susceptible to the same diseases, including prostatitis. Within this framework, it appears rational, in the interim of further studies, to apply knowledge gained from immunobiological studies of the male prostate suggesting the existence of what has been termed the 'prostatolymphoreticular system,' to the female prostate. If the female prostate exhibits the similar immunopermissiveness of its male counterpart, it may also serve as a nidus for various infectious agents, inclusive of HIV. Of particular significance in this regard, as elucidated from our studies, are the substantially increased number of mutually communicating ducts and intraepithelial glands with the urethra and anterior wall of the vagina in the female vs. male prostate. Providing an environment exceptionally favorable for the long-term survival of uropathogens, it is suggested that this may not only explain relapses of female prostatitis, but also the recurtent episodes of urinary tract infections diagnosed as acute cystitis.
R. J, Ablin
(published in the July 29th meeting summary of the Syracuse Man to Man organization, an affiliate of the American Cancer Society)
Dr. Ablin is deeply concerned about the quality of care given to the prostate cancer patient.
He is concerned that the four fold increase in the use of the radical prostatectomy since the advent of the PSA test has not been accompanied by increased patient education so that an informed decision could be made by the individual involved. The profession is short on giving the patient the various alternatives in treating him and his cancer and describing the possible morbidities involved in alternative procedures. Nor is the probability of successful treatment discussed.
Dr. Ablin cites the media for misleading the public and simplifying the prostate cancer problem with celebrity testimonials of successful outcomes. It is known that some 40% of the radical prostatectomies leave positive prostate capsule margins and 80% of external beam radiation patients suffer recurrence within 7 years- You wouldn't know it from the media.
The problem with the PSA test is that it is not specific to prostate cancer. Dr. Ablin states that 80% of men who have elevated PSA don't have cancer; 40% of men with cancer have normal PSA; and 23 to 35% who have a positive digital rectal exam have normal PSA. He says you should have a PSA done but you should also understand its limitations.
One result of a biopsy of the prostate is a Gleason score. A lower score describes the more differentiated and less aggressive tumor- A higher score describes the less differentiated and more aggressive tumor. Dr. Ablin states that the biopsy Gleason score correlates to a post-operative pathological score only between 35 and 48% of the time; about 60% of the time the biopsy understaged the tumor and about 30% of the time overstaged it. He warns that the Gleason score is only an indicator and must be put together with other factors to determine the procedure you should undergo. Remember, only a cancer totally confined to the prostate can possibly be cured and an understaged tumor can lead to an unsuccessful prostatectomy with its side effects.
He also states that an MRI, a CAT scan and a bone scan can detect a tumor when it gets to a certain size. So the fact that these are negative does not mean that you don't have metastases. Micrometastases that these procedures cannot detect may exist.
Dr. Ablin says the use of combined hormonal therapy in conjunction with a prostatectomy or radiation (adjuvant therapy) can reduce the tumor burden to significantly increase the probability of a successful outcome.
There are many ongoing investigations involving such things as the immune system, angiogenesis inhibitors, antibodies with a cytotoxic lymphocyte that attack a tumor.
In summary, Dr. Ablin encourages men to understand the risks and benefits of each option, be informed of all your treatment options, know your rights, and don't be intimidated.
Proceedings 10th World Congress of
Cryosurgery
Cryoimmunology/Cryoimmunotherapy: 30 Years
November, 1998
Richard J. Ablin.
Innapharma, Inc., Upper Saddle River, New Jersey 07458-1935, USA.
The principal objective of cryosurgery is the localized destruction of the target tissue. However, in the course of destruction thereof, attention has been drawn to the contributory role of an immunologic response. Directed toward proteins (antigens) of the frozen tissue, the immune response following cryosurgery, ergo, cryostimulation, and the cryoimmune response, occurs locally and systemically, and is expressed by humoral- and cell-mediated immunity and associated cytokines. When considered in concert with its capability to elicit an immune response, cryosurgery provides a "double-edged sword" to our therapeutic armamentariurn and, thereby, a way to treat localized and metastatic cancer. One of several concerns toward achieving the successful cryoimmunologic augmentation of tumour destruction has been suggested to be related to the "cryosensitivity" of the subject. Cryosensitivity is currently defined by the immunogenicity of the target tissue (organ) and the immunecompetency of the subject. Continued developments in genetic engineering, which permit increased immunogenicity of tumours and enhancement and modulation of the immune response, provide unique opportunities to enhance the cryosensitivity of the subject and, thereby, the local and systemic cryodestruction of tumours. As we prepare to enter the next millennium, let us recognize that cryosurgery, in concert with its immunologic effects, is comparable and, in the case of metastatic disease, selectively advantageous to other modes of cancer therapy. Equally so, maximization of the synergist effect of cryosurgery and selective cytotoxic agents, i.e., cryochemotherapy, may prove useful.