By Carl Labbe R. Ph.

“I can’t remember when I last had my prescription,” she said. That is not such an unusual statement in a busy pharmacy. But, imagine that the year is 2007, and watch what happens next. After obtaining the patient’s name, the pharmacist replies, “I’m showing last October, let’s take a look.” The attractive lady patient steps closer and opens her blouse slightly, revealing a faded tattoo just above the swell of her right breast. He sees a smiling cupid, just about the size of a quarter, barely visible. “Sure enough,” says the pharmacist, “those little guys just don’t last much more than eight months. Have a seat and the artist will be with you in a minute.”

In a matter of minutes a tattoo artist applies a new tattoo using a template containing a precise amount of micro-encapsulated hormones bound to the inks. She knows that she will not get pregnant in the next eight to ten months. If she forgets the date, she can look in the mirror and see if the bio-degradable inks have faded to obscurity, signaling expiration of her protection. The tattoo is effective almost anywhere on the body, so a cupid on a buttock or inner thigh could be selected as a more discrete location.

A little far-fetched perhaps, but contraceptive tattoos are only one of the conceivable new methods of reproductive health products that we may see in the future. As medical technologies advance, so too will the sophistication and effectiveness of both contraceptives and disease-preventing methodologies. Many of the new products will simply be refinements of currently available products, others will couple current therapies with new drug delivery vehicles, and, of course, there will be brand new ideas and discoveries that will make sex safer and more fun. Contraceptive methods will improve and the prevention of Sexually Transmitted Diseases (STDs) will be a major target of research and development.

One currently available contraceptive method that is not widely used is the post-coital contraceptive (PCC) or “morning after” pill. This is simply two double doses of a particular strength of birth control pill, usually Ovral(TM), taken 12 hours apart, within 72 hours of intercourse. Although not recommended for routine use because of side-effects, this is effective contraception. Currently, no pharmaceutical company lists this use in the prescribing literature for any product. Most women’s health practitioners are well aware of PCC and there is hope that some manufacturer will be brave enough to pursue a more specific drug product for this purpose. It would not be difficult to develop a single tablet that would deliver the correct amount of medication while avoiding the stomach upset that usually occurs with this regimen.

There is plenty of room for improvement in the area of implanted or injected contraceptives. It’s a safe bet that other pharmaceutical companies are trying to find better alternatives to Wyeth’s Norplant(TM) and Upjohn’s Depo-Provera(TM). We’ll most likely see an implant the size of a match head rather than Norplant’s match sticks. Five years is probably the longest time suitable for a contraceptive implant, so that probably won’t change. As doses and devices get smaller we’ll see fewer and fewer side-effects. The same should be true for “depot” medications, such as Depo-Provera. There have been some new progestational drugs developed recently, and either these or similar agents might be adapted to an injectable “depot” form. It is possible that we will see an injectable contraceptive that would last a full year. Potential patients would be first tested or “challenged” with a shorter acting dose of the medication to detect and minimize adverse reactions.

Now let’s suppose that our tattooed lady is concerned about HIV exposure. That’s certainly something that could take the fun out of a sexual encounter. She simply goes over to the feminine hygiene counter and purchases Lidakol(TM-LIDAK Pharmaceuticals) vaginal gel. Lidakol(n-Docosanol) is a real product, though not yet on the market, currently doing very well in studies on vaginal transmission of the Simian Immunodeficiency Virus (SIV). SIV is very similar to HIV and studies on humans are planned. Lidakol is also doing well in trials on herpes, and a cream for treatment of herpes will likely reach the market first. This exciting new anti-viral, in a good delivery vehicle, perhaps a bio-adhesive gel, will certainly result in well tolerated, easy to use products for personal use. Even the currently available spermicide, nonoxynol-9, has shown some anti-viral effectiveness. It is only a matter of time before a safe and effective product is brought to the marketplace. You can easily see that a product like this, when used with a condom, would provide excellent protection from both conception and disease.

There is, in fact, a bio-adhesive gel containing nonoxynol-9, now on the market. Lake Pharmaceutical’s Advantage-24(TM) comes in boxes of 3 or 6 pre-filled vaginal applicators. The gel, developed by Columbia Labs, offers an exciting new vehicle for the application of medications to mucus membranes. The gel seems to form an effective barrier, which, when containing the proper active ingredients may inactive sperm, virii, and even bacteria.

New antibacterials and antivirals may be discovered as a result of research on biologically active agents found in saliva. These substances, present in minute amounts in saliva, seem to protect people from transmission of disease. This mechanism helps to explain why several infecticious diseases are not easily transmitted by kissing. If these substances can be isolated and then synthesized, we will have some new weapons in the fight against disease.

While all of these innovations are happening, the Pill will continue to be widely used as a preferred method of contraception. Here again, technology is aiding in the development of agents that are more specific and more potent. The newer synthetic hormones require doses measured in micrograms, rather than milligrams, and are therefore better tolerated. We’ll continue to see the one-a-day dosing but the new oral contraceptives will be superior in safety and effectiveness.

Diaphragms and cervical caps are near the pinnacle of their design now. Simple and effective, they would be hard to improve upon. It is recommended that diaphragms be used with a spermicidal gel and there may be some changes in the type of spermicide used. This barrier method would be greatly enhanced by some mechanism that would prevent the transmission of STDs, such as a bio-adhesive containing bactericides and viricides.

With only minor modification of existing estrogen patches necessary, the contraceptive patch is probably only a few years away. The estrogen patch now in use delivers a therapeutic amount of estrogen in a controlled manner. It is only a short pharmaceutical leap to design a patch to deliver both an estrogen and/or a progesterone in proper amounts to provide effective contraception. Initially, patch technology required applying an estrogen patch twice a week, but with science improving the design, a once weekly patch recently became available. This would be a convenient method of birth control for many women, particularly those who do not like shots, implants, diaphragms, IUDs, or are not good at remembering their daily pill.

It is also possible that a contraceptive “vaccine” can be developed that when given to women would cause the production of sperm antibodies. These antibodies would prevent the sperm from fertilizing the egg. One hurdle to overcome in this scenario is how to limit the length of time that this “immunity” would last. Of course, this would again put the burden of contraception on the woman.

Whoa! Wait a minute! What about MEN? When are men going to have to remember to take a pill, or put on a patch, or do anything besides carry a condom in their wallet? The answer is soon, at least by the next millennium, which, thankfully, is not too far away. The search for a male contraceptive pill has not been going very well but there is renewed hope. Gossypol, the cottonseed pigment that some thought might be the answer, has proven to be too toxic, causing long lasting sterility and loss of libido in some patients. Scientists are now looking for compounds that will either affect the maturation of sperm cells or somehow hamper their ability to fertilize the egg. These methods are being approached in a variety of ways. One hurdle to overcome is designing agents that will target only the testes or epididymis so that unwanted effects can be minimized.

Here’s an interesting fact: Sperm need cholesterol to function! Yes, that clogger of arteries is essential to sperm function. In fact, a fairly specific amount of cholesterol must be present for sperm to function effectively. There are other physiological factors such as enzymes and membrane receptors that are also necessary for sperm function. All of these are being studied as possible of sites of action for male contraceptives. Considering that many of these biological processes have counterparts in other organs it is most likely that a localized application of the contraceptive would work best. So, the most likely male contraceptive to be first on the market will be something like SpermBan Scrotal Ointment, or PregNO Scrotal Gel. One application, as little as ten minutes before intercourse, will render sperm, dare I say, impotent. This will most likely be more fun than putting on a condom. This method is also desirable since it would not demand that the female partner trust that the male had remembered to take his pill.

One new drug delivery system recently disclosed by Vivus Inc., a Menlo Park company is MUSE, Medicated Urethral System for Erection. In a study on 234 impotent men, drugs that relax smooth muscle and dilate blood vessels were delivered into the penis via the urethral opening. A tiny plunger device is used to deliver a minuscule pellet of medication which is then absorbed through the mucus lining of the urethra. Over 70% of the men in the study succeeded in having intercourse as a result of this treatment. Perhaps this delivery system could be adapted to deliver spermicidal agents that act only locally.

When a good agent is found that effectively and reversibly blocks sperm function it is also possible that this drug could be incorporated into other drug delivery systems. Alza Corp. already has a scrotal testosterone patch on the market. Testoderm(TM) is indicated for testosterone deficiencies and is applied to dry-shaved scrotal skin and changed every 24 hours. It sounds uncomfortable, but is a valid vehicle for delivery of hormonal agents. If the new “sperm-inactivators” can be made to be site-specific, then men would also be able to wear a contraceptive patch or even a tattoo on a more comfortable area. Of course, if site-specific drugs can be developed, then a birth control pill for men would become a reality.

Condoms will continue to be the most effective barrier to conception and disease, and continuing research will result in improved efficacy. Recently, the non-profit Mariposa Foundation, in conjunction with UCLA and USC, studied over 30 specific condom brands for HIV leakage. The brands that scored well include Schmid’s Ramses Non-Lube(TM), Ramses Sensitol(TM), Sheik Elite (now renamed Sheik Classic(TM)), and Circle’s Gold Circle Coin(TM), Gold Circle(TM), and Pleaser(TM). More recently, Ramses and Sheik brands scored well in air-burst tests conducted by Consumer’s Reports. These tests are an indication of the condom’s potential for breakage. It’s obvious that we have the technology to manufacture HIV-proof condoms now that are sturdy yet comfortable. We can be sure that production techniques will improve. Schmid recently introduced a polyurethane condom under the name Avanti(TM). Clinical studies are lacking but this new product provides an alternative for people that are allergic to latex, the most common condom material. The future will certainly see the introduction of other synthetic films that can be fashioned into condoms.

There is also a female condom now available which is made from polyurethane. This device fits inside the vagina rather than over the penis. The Reality(TM) female condom appears ungainly and peculiar. But, in an informal survey taken at the Student Health Pharmacy at Arizona State University, 7 out of 10 women who tried it at least once had favorable comments and would use one again. This is a market niche that will likely see other companies develop their version of this innovative product. Negative comments mostly referred to the condom moving or sliding excessively, while some felt discomfort from the flexible rings built into the product. Healthy competition will lead to new ideas and better, more desirable, products.

There are a variety of other drug delivery systems that might be used for contraceptives, but these seem the most likely to be a part of safe sexual practices in the future. There are already plenty of methods to prevent pregnancy and the future will see a fine-tuning of those presently available. An insulin nasal spray is currently being studied and although it might be possible to deliver contraceptive hormones by this method, it is unlikely that this would be a popular method of birth control. Contraception does not require require daily injections so a nasal spray would be a tremendous advance for diabetics but only a curiosity for family planning.

Better barriers to prevent transmission of STDs will result from today’s research. New, user friendly, bactericides and viricides will find their way to the market-place eliminating, or at least reducing, the worry of contracting an STD, including HIV. Millions and millions of dollars are being invested in the search for these new agents. It’s a big market, with about 12 million Americans contracting some type of STD each year. There have been and will be disappointments along the way, but eventually science and technology will prevail and safe sex will not be an oxymoron.

One key issue in all of this will be educating the patients/customers in the proper use of all of these new and wonderful tools. The same thing holds true today. This is an excellent practical care opportunity for pharmacists. As patient educators we must be well aware of all of the choices available, their proper use, and, importantly, be available to discuss these products in a professional manner. When not properly used, the pregnancy rates for contraceptives rises in proportion to the level of misuse. That will be one area of importance when marketing these new agents, as well. They must be as easy to use as possible (with clear, easy to understand instructions), have minimal side-effects, and be readily available. Pharmacists can be key players in increasing the level of patient compliance and enhancing the health of their patients. With a high degree of customer awareness future pharmaceutical technology will make sex more enjoyable and eliminate some of the fear and guilt that has become associated with what was once simply an act of love.

Carl Labbe R. Ph. July 1995

“Safe Sex In The Future,” appeared in the October, 1995 issue of Pharmacy Times, a national
professional magazine published by Romaine-Pierson.

Sex is, of course, a touchy subject. I expected to get some letters written and I was right! In later issues of Pharmacy Times, these letters were published:

From pharmacist Scott Snively of Beverly, New Jersey:

“In October’s issue, the article entitled “A Pharmacist Looks at Safe Sex in the Future” once again shows that the profession of pharmacy is not immune from the ignorance of pop-culture buzz phrases. For us to use the phrase safe sex implies we accept the media’s idea that the wearing of a condom and/or other similar methods make the act of sex safe. Nothing is farther from the truth. We know the only safe methods are a monogamous, heterosexual relationship or abstinence. For us to believe otherwise is to put our patients in unhealthy and life-threatening situations. This article boldly promote the advances of medical tehnology while ignoring the moral implications of the need for such drugs and devices.

I absolutely agree we must be compassionate and that we must help to heal and comfort those in need. We are committed to healing the sick regardless of the acquisition of their illness. A cure, however, is no excuse for lack of moral guidance. We must treat the entire person: body, mind, and soul. The author ends by stating, “With a high degree of customer awareness, future pharmaceutical technology will make sex more enjoyable and eliminate the sense (mis-quote) of the fear and guilt that has become associated with what was once simply an act of love.” How can sex be any more enjoyable than being in a married monogamous relationship with the one you love – a relationship in which there is no fear or guilt. Guilt and fear are a result of ignoring God’s moral laws. Let our profession not promote immorality, but help our patients to understand that an immoral lifestyle leads to emptiness and disease.”

Then, pharmacist Bonnie Brown of Springfield, IL wrote…

“This is in regard to the article in the October 1995 issue “A Pharmacist Looks at Safe Sex in the Future.” The morning-after pill referred to in the article is an abortion mechanism.

Those of us who are Christian do not accept abortion, just as we do not accept the taking of any innocent life. Mr. Labbe makes the comment that there is hope that some manufacturer will be “brave enough” to pursue this pill. In my opinion, the bravery lies in protecting the innocent.

People need to take responsibility for their actions, and if they participate in sex, killing an inncent person (the fetus, which is a living person at the time of conception) is not the answer. Why is it so few people think of abstinence as a method of birth control?

It is important to remember that the mother of each and every person reading this article chose life. Our profession calls us to preserve life, not to end it.”

My response to pharmacist Snively was printed in a later issue. It read:

“Regarding Pharmacist Scott Snively’s letter in the January issue commenting on “A Pharmacist Looks at Safe Sex in the Future;” I think, perhaps, that you are wearing the wrong jacket. You should trade in your white jacket for a black one with a high white collar beneath. Although I appreciate your concern for your patients’ souls, I do not believe that as pharmacists we can consider the patient’s immorality when seeking preventive and curative measures.

People do have sex outside of marriage. Even people within a happy marriage may wish to avail themselves of some of the protective and contraceptive methods mentioned in the article, for a variety of personal reasons. Do not be so hasty to judge others.

Your letter made me wonder what kind of pharmacy you practiced. I can almost envision a short “morality questionnaire” for patients seeking contraceptives, certain antibiotics, and treatments for AIDS. Treat the patient, care for his soul, but please don’t deny good health to him based on your personal moral standards.

The article intended to inform pharmacists and stimulate imaginations, it did not “promote immorality” as you asserted. In fact, it presented hopeful ways to maintain and regain one’s health. I encouraged pharmacists to communicate openly with their patients, certainly there are times when a word about the dangers of promiscuity are appropriate, but these patients come to you for your pharmaceutical expertise, not a morality sermon.

Keep your patients healthy, care for their “body, mind, and soul,” but let their souls be saved by those committed and trained to do so.

This response was written before pharmacist Brown’s letter appeared, but I believe that my general attitude would remain the same and apply to her more specific and somewhat stronger complaint. However, I should point out that Post Coital Contraception, when initiated very soon after intercourse may, in fact, preclude the very fact of conception. With that said, I would like to return to exploring the science of contraception and disease prevention and let the philosophers and theologians debate the morality of sex.