SUPERmarket PHARMACIST

A pharmacist's look at the supermarket and beyond

Category: sexual health (page 1 of 2)

Metrics? We Don’t Need Stinking Metrics!

We all know that retail pharmacy or health care in general can be a difficult and often thankless job. I received this letter in the mail and it made me happy!
grateful letter
The gratitude was well received by myself and staff. Eventually I began to think about metrics. Pharmacists and techs spend hours every day dealing with undecipherable prescriptions, impossible billing, and a wide assortment of barriers to good pharmacy care. As pharmacists we dole out free advice on a regular basis to patients that are usually appreciative. Patients will talk to us about anything.
On the same day that I received this letter, I had a man in his 40’s wondering why his doctor ordered Prozac for him when he was not depressed, just dissatisfied with the quality, quantity, and duration of his erections. He broached the subject and responded to one of my counseling questions by saying, “I think I’d be OK with a group of half naked cheerleaders.” That’s when the conversation moved to a more discreet level.
Later, a student pharmacist asked for my assistance counseling a young woman who wanted help selecting a prenatal vitamin. Turns out she was trying to get pregnant, and after explaining the benefits of a prenatal product and other healthy options, she took the conversation to a deeper level. After discussing underwear choices for her husband, she volunteered information about her tipped uterus and asked, “are there any positions that might compensate for that?” I was tempted to tell her the joke about positional gender selection, but my professionalism vetoed that idea. In case you are wondering, missionary and girl on top are the top two recommendations.

All three of these interactions are wonderful and meaningful experiences for the people involved. They do not, however, have an effect on our metrics, which, increasingly, is how our job performance is measured. We are constantly bombarded with data that is presented as helpful information to make the job easier as we gain effectiveness. Yet our “Percent Effective” measure looks only at the labor hours (and minutes) gained for the tasks that are required to fill prescriptions. The bottom line is that the biggest chunk of data demands that we fill a prescription using about 8 minutes of labor. And, there is time built into that to allow for counseling, regulatory compliance, inventory control etc., but at the end of the day it’s how many Rxs were filled with the labor permitted.

You can easily see that the scenario that Jay describes in the letter would have taken much more than 8 minutes to complete. Multiple people were involved and it required several faxes and two phone calls to the prescriber, calls to the patient, and multiple attempts to successfully bill the claim for the product. The forty-something with problems “down there” and I had a ten minute conversation exploring possible causes and solutions for his dilemma, which included the recommendation that he should keep his lust for cheerleaders as a fantasy. The young mother-to-be was another lengthy discussion that started out looking at vitamins and evolved into a frank discussion of the physiology of fertility.

All three of these examples had great outcomes and yet only one prescription was picked up by the patient, the testing strips for Jay. The other guy did not get the Prozac prescription, effectively making all the labor to fill it wasted, and created more labor to return it to stock. The soon-to-be-mom bought a prenatal supplement and left with several helpful ideas for conception strategies. In my judgement, all three of these were big wins for myself, my staff that were involved, and the student pharmacist that gained perspective on the delivery of very personal, even intimate counseling.

If we are lucky the patients will do one of those ubiquitous satisfaction surveys and we will get a second of recognition that way. Our metrics will suffer though, and that is a price that I am willing to pay. My patients know that they are not numbers to me. My whole team works hard to establish a solid rapport with each patient and from that grows the trust and mutual respect that lets our pharmacy thrive despite intense competition.

Metrics are a tool, a limited tool that will never be able to measure the kind of outcomes that health care providers work for every day. Labor hours should be added to the metrics algorithm that would allow us the time to treat all of our patients the way they deserve. Wouldn’t the loyalty and improved health and happiness of our patients be worth a couple hours of labor per week? After all we give ’em $25 just to transfer a prescription to us from a competitor. We should be playing the long game.

A Prescription Gone Wrong

The national media and social media exploded a local story of a pharmacist refusing to fill an prescription for misoprostol for a woman carrying a dead fetus. It’s difficult to get the exact details of the whole process, which took place over several days, but I think some of the events are evident and worth discussion.

Let’s first be clear that we should not have this opportunity to discuss this specific situation. It should have been a private process involving prescriber, patient and pharmacist, as we expect for each prescription filled. This patient, however, chose to put her uncomfortable and personal experience on social media, Facebook, and from there it migrated to more traditional local and national media. OK, that is your choice. So now anybody who cares to voice an opinion is free to do so and I will take my turn.

The OB/GYN ordered an effective drug that would terminate this nonviable pregnancy. A miscarriage was inevitable and the drug would allow the patient’s medical team to control the process. The prescription was taken to a Walgreens where the pharmacist would not fill the prescription for reasons of strong personal beliefs. The patient attempted to explain the medical reason behind the prescription and the pharmacist was unyielding. Apparently there was significant back and forth discussion between the two with that patient’s 7-year-old child, other pharmacy staff, and other people standing in line listening.

This is where things go careening off the tracks. First, the pharmacist should have recognized the very personal nature of this exchange and taken the patient to a discrete location for a private consultation. Most pharmacies have a consultation room and if not can find a private space. Retail pharmacies prominently display a large HIPAA sign that explain patient privacy protections. The dilemma for retail pharmacies is that the area where patients pick up their prescriptions is not private. Oh, we may have a little plastic divider shield, but if you look at most retail pharmacies there is little barrier between the pharmacist and patient at the counter and the patients waiting in line to be next or even in the waiting area. Do patients in this situation implicitly give up their privacy rights simply by being there willingly? To me, this particular situation was handled poorly by the pharmacist and the patient, but the pharmacist, as the professional, failed to act professionally in respect to patient privacy. Yes, the patient chose to discuss the details in this setting and then further on social media. At the pharmacy counter, however, the pharmacy staff should realize the obligation for discretion and act upon it. I have asked hundreds of patients to join me in our consultation room or another private space to discuss sensitive issues. Most pharmacists I know would do the same.

The moral objection to filling a prescription is supported in most pharmacy organizations and each of them that I have seen advise the pharmacist to provide another means for the patient to acquire the medication. This did eventually happen and there is some disagreement as to why it took from Thursday to Saturday for the Rx to be filled and picked up. One side claims that there were other pharmacists in the pharmacy the day the Rx was first presented and they were not asked if they would fill the prescription, while others say that the pharmacist did transfer the Rx to another Walgreens that would fill the Rx and it was the patient that delayed picking it up. Some of the latter have claimed that on Friday the patient was too busy giving interviews to TV news outlets and playing the victim card. Perhaps there is some truth to both sides. I will let the Arizona State Board Of Pharmacy complete their investigation and trust they will come closer to the truth better than any individual possibly might.

Pharmacists are presented with medical dilemmas every day. I have refused to fill many prescriptions. Some of those have been fraudulent, some have been presented by obvious drug seekers using multiple doctors or other schemes, and others were instances where I considered the health and safety of the patient in jeopardy. I personally believe that is the scope of our practice. We should fill all legitimate prescriptions unless the physical or mental health or safety of the patient would be put at risk. I do not believe that we should be making religious or moral judgements when assessing the appropriateness of a particular drug for a particular patient.

This particular drug had been identified in the pharmacist’s mind as a drug used for inducing an abortion and therefore would not dispense it. Any other use of the drug was apparently disregarded. I believe we are scientists, not priests. There are plenty of opportunities for pharmacists to apply religious or moral judgment on patients based on the prescriptions that they ask us to fill. Is this birth control Rx for a 16-year-old appropriate? Is that too young for sex? Is it better to provide contraception rather than risk a future abortion if she is sexually active? Oh wait, those questions are moot because the patient is taking the medication to control disfiguring acne, or to lessen her disabling dysmenorrhea. Do you refuse to fill HIV drugs because you consider HIV the “gay plague” and God intends gay people to suffer the consequences of their “choice?” Is it right for a pharmacist to work in an establishment that sells tobacco, liquor and sex toys? Each of us must decide our own morality, and we are free to express our opinions, but we have no right to impose them on others.

Va Va Land

There are some pretty nifty developments in the realm of women’s health. We have come a long way from the days when I had the rather unique opportunity to learn how to install an IUD. Not too many pharmacists get an opportunity like that! Over a decade ago, as Pharmacy Director at ASU Campus Health, our wonderful Ortho rep set up a training class on-site and I was invited to attend along with several doctors and nurse practitioners. We sat in front of life-sized pelvic models similar to one seen here and did not have benefit of ultrasound or other technology, so using just sight and touch, used a small device to carefully place the Paragard IUD. On our models, there was a little trap door in place of pubic hair that we could lift open to see if we had properly placed the IUD. A training session that I will never forget! Yes, I got right the first time! I still have my stunningly stylish Paragard tie tack!

Speaking of vaginas, I came across a bit of trivia. The Walt Disney company is credited with releasing the first film to use the word vagina! Apparently working with funding from Kotex, the animators got to work on explaining menstruation. A ten minute restoration of this animated classic can be seen here on YouTube. I do find it hard to believe that the scary STD films they showed to our boys heading off for WWII didn’t mention vaginas, but maybe not.

Fast forward to modern times and we find that researchers at Northwestern Medicine have developed a miniature, functioning version of the female reproductive system. It is a small cube that can fit on the palm of you hand. This 3-D model is made with human tissue and uses artificial “blood” to allow transport of hormones and other secretions throughout the system. This technology, EVATAR, will enable the testing of new drugs without risk to patients. Imagine having a drug tested on this model, made from YOUR tissue! Ultimately the long term goal is a “body on a chip” which would use your stem cells to create tiny models for testing of various treatments for highly personalized therapies. You can take a few minutes to learn more about EVATAR here on YouTube. Someday, your doctor will harvest some of your stem cells, grow out a heart, a lung, liver, or an ovary and then test dozens of drugs and doses to see which best would treat whatever ails you. Creating a pancreas via this process may someday lead to a cure for diabetes! There is a male version on the way called ADATAR and another focused on the testicles and prostate with the working name Dude Kube.

In the meantime, as we see more and more young people opting for more natural food and drink, it is no surprise that modern women are looking for alternatives to the mass-produced, artificial menstruation products. Many women rightfully worry about exposure to bleaches and pesticides. Several new products are being marketed with moderate success, from natural sea sponges to reusable fiber products like “Glad Rags” or Thinx panties. There are also menstrual cups like the Soft Cup or the Diva cup (these cups may be referred to as catamenia cups in some literature – from the Greek, cat (pussy) -menia (blood) sorry, just kidding, although catamenia is a real word). From what I have read they require a short learning curve as well as the ability to become more intimate with your monthly visitor as well as your vag. If you want to read about one woman’s journey of discovery as she “test drives” these products visit Rachel Krantz. Considering that one woman can have about 450 periods in a lifetime and may use 16,000 tampons, pads, liners and such, its obvious that this is a big market not to mention more “stuff” in our landfills. Having reusable options seems like a good idea to me.

In world news, in Italy, the parliament is debating a measure that would have employers offer “menstrual leave” of up to 3 days per month for women with painful periods. Italy would follow in the footsteps of countries like Japan and Indonesia already offering some form of menstrual time off. It seems like a sticky wicket to me.

More world news. In a response to Donald Trump’s pussy grabbing quote, the Russian girl Punk Band, Pussy Riot, released the English language version of “Straight Outta Vagina,” which reminds us, “Don’t play stupid, don’t play dumb, vagina’s where you’re really from.” These ladies spent 16 months in a Russian jail so they definitely have street cred as fearless feminists.

And now: If your vag feels or looks a little worn out, and needs a little rejuvenation, and you can afford the procedure, and several days off work, you might consider an “Aussie makeover.” It’s suggested for a well-used or stretched out vag, or if it doesn’t match up to partner’s penis size. You can even have your labial lips sculpted! I would never have known about this, but I have the tendency to read anything I can get my hands on, especially in a waiting room.

That’s all for now, my final word is, support Planned Parenthood!

Oh Those Golden Grahams!

My supermarket had the Valentine’s Day candy out on the shelves before the Christmas clearance had been fully marked down. I always recall the son of one of my ASU technicians whom I met while he would visit us back in the time he was taking classes. He is now married with kids, but back then he was very single. I used to tease him that he always got confused this time of year because he couldn’t tell the difference between Valentine’s Day and Palm Sunday. Perhaps he should have been eating more graham crackers.

Minister Sylvester Graham, a married man and a member of the Pennsylvania Temperance Society in the early 1800s, who became a big believer in abstinence and vegetarianism, is usually credited with the invention of the graham cracker. He was ahead of his time in his recommendation for the use of whole wheat in bread-making and his disdain for branless, additive-laden white flour. He even published a Treatise on Bread and Bread-Making and during a cholera outbreak in the 1830 began lecturing on whole foods and healthy habits. These healthy habits most certainly did NOT include masturbation. In fact, his rigorous plan included cold baths, loose clothing (but not loose women), and a meatless diet in order to keep the libido in check. It’s not clear if he or one of his acolytes developed the Graham cracker which was touted as an essential part of the diet for those wishing to avoid masturbation or excess sexual activity.

His lectures targeted at young men spoke of the evils of spices and hot food. His ideas were not all crazy. He may have liked talking about sexuality, which was a part of his lectures. In my home state of Maine, one of his lectures was aborted by a mob of citizens too shocked to allow him to discuss sex in front of a mixed audience.

Remember, this was the early 19th century, when society was becoming more urban (and urbane?) and religions still tended toward severe chastity and restraint, proclaiming sex was only for procreation. I imagine many people found the crackers helpful if only as a placebo to curb their lustful urges and activities. Of course, combining graham crackers with chocolate and marshmallow and heating it up over a fire is far different than the pastor’s intention. Some might even say that s’mores are an aphrodisiac. Maybe Sylvester was on to something after all.

Almost a hundred years later, Nabisco, mass produced graham crackers with a different formula and even highlighted the “graham” taste with the addition of honey. You can see here that today’s honey grahams contain a mixed of enriched white flour and whole grain (graham) flour.
Sylvester Graham would not approve.

Today we have a multitude of graham crackers on our shelves and I don’t think any of them would meet Pastor Graham’s standards.

(Somehow I cut off the last couple paragraphs and pics in the first upload. Sorry)

Cholesterol: the Good, the Bad, and the Sexy

Billions are spent in this country to lower cholesterol blood levels. The two newest agents would cost $14,000 per year, FOR THE REST OF YOUR LIFE! Or at least until something better comes along. It’s a safe bet that the something new will NOT be cheap!

I have been thinking more about things that we have labeled as bad for us in such extreme ways that we may have overreacted and caused ourselves more harm than if we had just tried a little moderation and try to “act naturally,” meaning use our bodies as they are designed. As I discussed, some sunlight is essential for our bodies, particularly for synthesizing Vitamin D. It occurred to me that many of our issues regarding high cholesterol are a result of our modern lifestyle and nutrition. In order to see how we arrived at the point where over 70 million of us in the United States have high cholesterol (actually high LDL, AKA “bad cholesterol”), we must first have some idea what roles cholesterol has in the healthy body.

Cholesterol is an interesting molecule, on one end a -OH (hydroxyl), making it an alcohol and slightly water soluble, then four hydrocarbon rings, the hallmark of a steroid, and finally a hydrocarbon “tail” which is the oil soluble portion of the molecule. These characteristics give cholesterol its unique qualities. Cholesterol is transported around the body via the blood by lipoproteins. That is where the infamous LDLs and the happy HDLs come into the story. The cholesterol carried by these proteins is the same, only the proteins are different.

Cholesterol is a part of virtually every cell in your body, maintaining cell wall structure, integrity, and function. It is the key starting material for the sex hormones for both genders, for the corticosteroids, and bile salts, which are essential for digestion. Cholesterol is sexy beyond its conversion to testosterone, estrogen and progestins. Cholesterol and related sterols are part of sperm production, transport, and even seem to play a role in capacitation of the sperm after ejaculation. When sperm come in contact with various sterol-binding biochemicals produced by the uterus the sperm is “turned on” and now able to fertilize the egg. Changes in cholesterol levels have been linked to changes in vaginal lubrication, pH, and possibly other factors affecting female fertility. Every sexual act requires cholesterol, with climax and ejaculation consuming some cholesterol each time. To some degree, sex (yes, even by yourself) directly lowers cholesterol, not to mention the other healthful benefits for mind and body.

Cholesterol is converted to vitamin D as discussed previously in this blog. It is also critical for serotonin receptors and other neurotransmitter receptors. It protects our nerve fibers and plays many roles in the brain, many yet to be clearly defined.

Obviously, dietary sources of saturated fats plays a role in the soaring incidence of high cholesterol. However, when seeing all the important functions of cholesterol in the body, I cannot help but wonder if our modern way of life, beyond nutrition, also plays a role in our dysfunctional lipid profiles. I already discussed how we have been taught to shun the sun. Could this avoidance of a normal biological process that uses cholesterol be a factor in higher cholesterol? I recently read that millennials are having less sex than previous generations (mine included!). Could this reduction in sexual frequency also contribute to higher cholesterol? There are some studies looking for a link between SSRIs and other psych drugs and high LDL cholesterol. Are we monkeying with normal biological pathways that require cholesterol for proper function and thus raising cholesterol levels? Are we denying our bodies the fun and frolic that keep us healthy?

Human physiology is amazing and its complexity continues to hold many secrets. Our biochemistry is a wonderful dance of chemical reactions, all trying to reach equilibrium and all part of a great feedback system that strives to keep us going. All those chemical reactions will only reach final equilibrium when we are dead. We have learned that when you tinker with one part of a biological process with drugs or other exogenous material that we can get unexpected results or “side effects” such as the dry cough from the buildup of bradykinins due to ACE inhibitor drugs.

It is clear that we function best when we eat mostly unprocessed foods low in saturated fats, and live an active lifestyle with regular exercise and sexual activity. Get outside, move around, make love, laugh, eat healthy, and you may find high cholesterol does not come knocking on your door. When I pay attention to what I eat, get outside and walk or ride my bicycle, and have some time to frolic, I not only feel better, my lab work shows numbers like this:
Cholesterol: 136
HDL: 48
LDL: 68
Those are my last lab results.
They took 3 blood pressure readings:
Blood Pressure Reading 1: 120/70
Blood Pressure Reading 2: 130/80
Blood Pressure Reading 3: 122/80

I report all this to show that even a man in his sixties can make lifestyle choices that lead to good health without pharmaceutical assistance. Somewhere around 25 million people take a statin drug to lower cholesterol. What if we didn’t just look for an easy answer like taking a pill and embraced cholesterol as a vital part of us that can be harnessed and utilized for good physical and mental health?

I believe that it is possible. Live and love!

Boob News

I’m in the middle of training for the Susan G. Komen 3-Day Walk for breast cancer. I’ll be joining my wife and her team to walk 60 miles in 3 days in the Twin Cities (August 19-21). I’ve helped out the team in the past 8 years by running errands, fetching jackets, taking jackets away, bringing ice cold Diet Cokes or G2 and ferrying the team from day’s end to the hotel and back again in the morning. In that role I’ve been called “team bitch,” “walker stalker,” and last year a lady gave me my personal favorite, “underwire.”
You have to realize that there are hundreds of teams and thousands of walkers for these events and their team names often eschew normal political correctness with team names proudly flaunted, using every variation of slang for breasts from ta-ta’s to tits (including itty bitty titties), boobs and boobies, of course, hooters, second base, cupcakes, and many more. So pardon any lack of decorum on my part.

It’s no wonder then, that I am attuned to breasts and stories about breasts when I see them. Who am I kidding? I’ve been tuned into breasts since my first ex utero meal. Here are couple developments that I recently noticed:

I caught this headline in USA Today: “Why Millennials are Going Braless” and I just had to see what was going on (or coming off!). It seems that this generation of young women are opting for lighter, wireless “bralettes” of simply doing without. As a teenager in the 60’s, I recall stories of women burning their bras as a statement of liberation for women. For young men like myself, our solidarity in that cause may have been somewhat tainted by the desire to see nearly naked boobies parading around our neighborhoods. Right on, sister!
This new phenomenon of minimal breast support is even having an impact of sales at places like Victoria’s Secret, where bra sales are are sagging and its stock price is down 30% this year. With about 1/3 of their revenue traditionally coming from bra sales, that is no surprise. The Wonder Bra is on the way out in favor of the more natural style preferred by Millennials. Victoria’s Secret now offers bralettes that are very light, offering little support or padding but are stylish and meant to be exposed. Maybe sales will bounce back. Celebrities are leading the way as they do in most areas of fashion. It looks like my underwire nickname may be in jeopardy. Also, according to Plastic Surgery News there were 279,000 breast augmentations in 2015 and that is down 2% from the previous. For the record, I like ’em natural.

About half of US states have breast density notification laws. Now before you guys start running around hefting the boobs in your lives, this is actually medically important because high breast density is a risk factor for developing breast cancer. The problem is that there is huge variation in how mammogram density results are interpreted and/or obtained. The human reading the results is the primary cause of variation as different providers must be subjective in their finding. There are no clearly measurable results that can be shared in a uniform manner. Even different brands of mammography equipment will show differing degrees of tissue density. Of course, BMI, race and ethnicity are also factors. Finally, the amount of compression used on the breast during the procedure can result in a different appearance. Talk about having your tit caught in a wringer! Roughly 2 out of 5 women have dense breasts and would be considered for additional tests such as MRI or ultrasound. There is hope that computer models will bring some objectivity to the measurement of breast density. Until that happens keep doing your self exams and always discuss your options with your trusted doctor.

Support a 3-Day walker!

A Hard Act to Follow

I was recently required to take a brief REMS (Risk Evaluation and Mitigation Strategies) course about the coming drug, Addyi, meaning that pharmacists will be asked to be the gatekeepers of any post marketing risks that arise. It asks pharmacists to have patients vow not to use alcohol while taking Addyi. At all. Ever. Good luck with that.

Quite a few things have come to light since my August 27 blog that criticized the approval of Addyi, the female sex pill.

More recently, an independent agency called the Project on Government Oversight (POGO) found that FDA has erred in approving the blood thinner, Pradaxa. Pradaxa was touted as an alternative to warfarin that does not require the close monitoring of clotting time. Although technically true, another critical difference between Pradaxa and warfarin is that if a patient is bleeding because of a too high warfarin level, vitamin K can reverse the problem quite quickly. Pradaxa has no such counter measure or antidote and patients have been bleeding to death as frustrated doctors could only try to pump new blood in fast enough to save the patient. Some of this was published in NEJM in 2011.

So what the heck is going on here? The list of drugs making it to market only to be discovered to be way more dangerous than originally thought continues to grow. Part of the reason may be the FDA Modernization Act of 1997. That was supposed to streamline the FDA and was easily passed despite an attempt to filibuster (by Edward Kennedy, no less) its failure. One thing that Act did was to reduce the number of clinical trials required to establish the safety and efficacy of a drug from two or more to one or more. Clinical trials have been the standard of proof for decades and should rely on sound scientific method to yield reproducible results. A single trial is an inadequate measure. I remind you of the Addyi study on alcohol use with the drug. A single study heavily weighted with men for a drug to be used exclusively by women, with worrisome results, did not prevent FDA approval. About a third of new drug approvals have been based on a single study, with an average of about 750 patients per study. Not exactly robust.

We now have before Congress, the 21st Century Cures Act. Boy doesn’t that sound impressive. Of course, so did modernizing the FDA back in 1997. Guess what. The “streamlining” continues. Have a look at some of the language found in the summary of H.R. 6 – 21st Century Cures Act found on congress.gov:

Section 1001 reauthorizes funding the NIH through fiscal year 2018 – that’s good, likely to be about 3% increase in NIH funding. Let’s read on though…

1023 “The NIH must reduce the administrative burdens of researchers funded by the NIH” – to me that sounds an awful lot like “the NIH will stop watching so closely and stop demanding all that pesky documentation.”

1081 “The Pediatric Research Initiative is revised to require establishment of a National Pediatric Research Network comprised of pediatric research consortia.” – Gee, I wonder who this consortia will be?

1141 “The Council for 21st Century Cures, a nonprofit corporation, is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.” – Shazam! A new nonprofit corporation! Pick me! Pick me!

2001 “This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the FDA to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.” Why bother with a clinical trial? Just ask Aunt Sally and brother Billy how they liked the drug. Are YOU experienced? This is a scary amendment folks.

2061 “The FDA must issue guidance that addresses using alternative statistical methods in clinical trials and in the development and review of drugs.” – Makes me think of Mark Twain’s 3 types of lies; lies, damn lies, and statistics. Now we can add alternative statistics because it is too easy to detect manipulation of current statistical analysis.

2263 “Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.” So, depending on who gets to define “minimal risk” and “safeguards,” we may be unknowingly subjected to clinical testing of drugs or devices. “Trust us, it’s better if you don’t know…”

4041 “The Cures Innovation Fund is established and funding is appropriated to carry out specified provisions of this Act.” – what the summary does not tell you is that this section requires the Secretary of Energy to draw down and sell oil from the strategic reserve. The money from those sales will flow into the General Fund though, so funding the Cures Act is not directly supported. Proponents of the Cures Act say that this Innovation Fund will be backed by $2 billion per year for 5 years. Show me the money.

There’s plenty more in there to worry about and I want to make sure you will stay awake for these observations:

Our wonderful democratic process that created watchful, protective entities like the FDA has been compromised to such an extent that we now need a watchdog agency like POGO to tell us that the government agency meant to protect us is really serving the desires of the companies that they should be regulating! Pharma is not alone in this assault on our democratic principles. Much of Congress answers to the plutocrats of the American oligarchy and the people are left unrepresented. What more could you expect when our Supreme Court has deemed corporations to be people and money to be free speech?

I love the POGO acronym mostly because I am old enough to recall the Pogo comic strip and the phrase it popularized; “We have met the enemy and he is us.”

The CEO of Valeant Pharmaceuticals, the company that bought the developer of Addyi, Sprout, two days after its approval has clearly stated that when “products are sort of mispriced and there’s an opportunity, we will act appropriately in terms of doing what I assume our shareholders would like us to do.” Just in case you had any doubt that Big Pharma is more about profit than medicine. Valeant has raised the prices on several drugs under current leadership, as much as 800%. Addyi will cost about $350 a month for questionable results accompanied by significant risks. Watch for the advertising, THAT should be fun.

The candidates are debating, the money is flowing, and we are heading into another year of muck and mire in our political cycle. It behooves you to pay attention. Our president cannot run again, but many of our Congressmen are up for reelection so be sure they have represented YOU before you vote blindly to keep them in office. Take the time to be informed.

Pharmacists. I talk to more and more colleagues on the front lines that are helping patients identify unnecessary drugs and suggesting lifestyle and dietary changes. If done properly, the patient can only benefit. We know drugs that are overused, barely therapeutic, or easily replaced by a low cost alternative. Don’t be afraid to intervene. You don’t need MTM appointments to make a difference in your patients’ lives. Use the mother test; “What would I do if this was my mother?”

The 21st Century Cures Act contains many wonderful ideas to modernize medical care and it may have started out as an altruistic attempt to improve health care. I fear, though, that like much of our legislation these days that it has been amended and tinkered with at the behest of industry lobbyists and other special interests to the point where many dangerous changes may be implemented if this thing passes the Senate and gets signed into law. If we the people let that happen then we are indeed our own worst enemy.

FDA Ends Summer!

Labor Day is right around the corner and since I have not posted since the Fourth of July, I had better get in gear! I’ve had a very good summer, doing some teaching and traveling to Europe. I’m back in the groove now, though, and will take this opportunity to look at some of the things that the FDA has been up to. Some of these will relate to previous subjects on this blog and others are just kind of a “hey, look at this” tidbit.

The whole e-cigarette thing is becoming a fiasco in my mind. The FDA seems to be dragging its feet in regulating this new nicotine delivery strategy, while marketing continues to target our youth. All this as we continue to hear about devices exploding in peoples hands and in their faces. Emergency room visits continue as children and even adults misuse the liquid nicotine products that are out there. Warning letters are not enough. It is time to fully enforce tobacco-related regulations on electronic cigarettes.

There are still people pointing out the all too cozy relationship between Big Pharma and the FDA. One of them likes to point to this page on the FDA web site that 2 million adverse drug reactions and over 100, 000 deaths per year.The FDA apparently finds that perfectly acceptable and continues to approve marginal drugs or drugs of questionable value and safety. It’s not just Big Pharma, of course, many of the experts in other fields like food or cosmetics come from industry. It makes sense, where else are you going to become an expert in your field? What seems lacking, to me, is integrity.

It took three tries to get the new lady sex pill approved by the FDA, but, by golly, they got ‘er done! The studies supporting flibanserin were somewhat lackluster in demonstrating efficacy, with patients reporting 1/2 to 1 additional “satisfying sexual experiences” per month on the drug. It was unclear if that meant that orgasm was reached or that there was a sexual event with or without the big O. I assume the latter. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, so is does not affect blood flow (so not a “female Viagra”), nor is it hormonal. It works on brain neurotransmitters. And it purports to treat Hypoactive Sexual Desire Disorder (HSDD), or as I’ve been told a few times or more, “not interested!”
Anyway, there’s a significant fainting risk when used with alcohol, although how significant is yet to be accurately determined. The study on flibaserin’s interactions with alcohol performed by manufacturer Sprout included 23 men but only 2 women! WTF?
Two days after the FDA approved flibaserin (brand name Addyi) Sprout was bought by the larger Canadian company, Valeant Pharmaceuticals for $1 billion. The new owner has to honor the promise made to the FDA to do three more alcohol-flibaserin studies AFTER THE DRUG HITS THE MARKET!
By the way, FDA is on a roll lately, approving close to 90% of drugs submitted for approval this year.

New nutrition labels are on the way. The biggest change will be seen in serving size. FDA wants “more realistic” serving sizes. One example given is changing a serving of ice cream from 1/2 cup to 1 cup, saying that’s a more likely real-life scenario. Doubters are saying that it just encourages people to actually eat a full cup instead of limiting themselves to 1/2 cup. That’s a load of crap. Most folks are going to eat however much ice cream they want. For me, I just would like serving sizes to be easy to measure and make the math easy to do if I’m having a fraction of a serving or multiple servings.

Oh, FYI, a food labeled as having “zero grams of trans fat” may actually have 1/2 gram of trans fat per serving! I’m still waiting to see if FDA changes this clever ploy in the new labeling. One side effect of reducing trans fat in our foods has been the increase in demand for palm oil, further accelerating the loss of rain forest habitat as palm oil plantations spring up in places like Indonesia and Malaysia. On the plus side, last September big food companies like General Mills, Kellogg, Cargill and others pledged to use only palm oil from “sustainable sources.” I’m not sure how much of a plus that is though.

Apparently FDA believes it can regulate tweets. After Kim Kardashian boasted on Instagram (and so to Twitter) about how wonderful Diclegis can be to combat morning sickness, the FDA sent a warning letter to the manufacturer. The so-called twitterverse went crazy saying that FDA was over-reacting and Kim could say whatever she wants to on social media because she is a private citizen and has free speech, dammit! I was leaning in the same direction, until I discovered that Kim K was paid for that little bit of promotion. You can view the FDA warning letter here. It makes for an interesting debate, with several facets to consider. Kim Kardshian is said to have over 43 million followers, which although not up there with the 100 million plus that saw the Super Bowl, it’s a pretty big number and certainly worth monetizing. Diclegis is just two old products combined into one. Pyridoxine (vitamin B-6) and doxylamine are fairly benign and have been around for decades without many problems so why would the FDA be so concerned that a celebrity put in a good word for this stuff? Another thing to consider with a drug like this that takes older (inexpensive) drugs that are formulated into a new product is that the price tag to the patient is always incredibly high. I’ll let you hash all that out on your own.

Aspartame, not one of my favorite sweeteners, is being newly marketed with a cute new brand name: AminoSweet! Christ.
Originally studied for treatment of ulcers, aspartame is actually a result of mixing aspartic acid, phenylalanine and methanol. Granted that it does start with two amino acids, but the resulting aspartame molecule has been linked to adverse reactions from seizures to cancers. According to FDA, about 3/4 of complaints of adverse reactions to foods involve aspartame!
So watch for that new brand, AminoSweet, and stay the Hell away from it!

And that’s just for starters!

Heroic Pharmacy

I’m just back from attending the Annual Meeting of the Arizona Pharmacy Association and the last session that I attended is still rattling around in my head. Martha (Martie) Fankhauser is making good use of her so-called retirement by advocating for a more sane approach to health. She has devoted much study to the ecosystem of our bodies and brains and speaks eloquently of the need to keep some important realities in mind when treating our patients. Basically, she notes 1) the need to have a regular intake of protein (being sure to get all nine essential amino acids), fatty acids, complex carbohydrates, vitamins and minerals, and water. These nutrients provide the building blocks for our physical structures and our neurotransmitters, with the whole process being fueled by carbohydrates; 2) exercise improves the the release of neurotransmitters that contribute to our well-being; 3) during sleep we produce and store neurotransmitters for use during the next day; 4) a healthy endocrine system with the correct balance of hormones helps to properly control our physiology.

It seems that the more we learn of the role that nutritional and lifestyle choices make in disease and drug therapy effectiveness, the more we can glimpse a better pathway to health. It’s really quite amazing that deficiencies of vitamin B-12, folate,iron, or vitamin D may manifest in a variety of negative effects beyond the familiar anemias or bone density issues. Martie showed how many of the enzymes that are needed to synthesize neurotransmitters require these vitamins to function. She also reminded us that despite its name, vitamin D, is actually a hormone. Ergocalciferol, or D2 is less effective than cholecalciferol, D3. Martie is not a fan of the 50,000 unit per capsule that many of us dispense, more often D2 than D3. She prefers a more modest daily intake of about 400 units of D3.* Kind of tucked away in all this is one of the reasons that not all cholesterol is bad. Our bodies convert 7-dehydrocholesterol to cholecalciferol when our skin is exposed to UVB light. That’s D3, humans don’t make D2, so if you are buying a supplement, look for D3 or cholecalciferol.

She pointed to a whole host of issues with nutrients, vitamins and minerals that cry out for pharmacist to learn more about and become better able to help patients take better care of their bodies. I was struck by the courage of her convictions and her heroic stance to educate the health care community and our patients. This is a huge paradigm change for most of us practitioners. Our focus is too often to take a pill, and when we don’t get the desired response, take a different pill or even worse, another pill. Before you know it, we have a patient taking handfuls of drugs every day, some of them working against others. That’s polypharmacy at its worst. There is little in our system of care to help to undo this approach. The economy of health care is dependent on the prescribing of treatments and in modern medicine those treatments are drugs and all too seldom corrective measures in diet and exercise. This is of particular note in the area of behavioral health.

Martie mentioned the example of serotonin, the neurotransmitter considered to be critical to a good mood and sense of happiness. Our body requires the essential amino acid tryptophan in order to produce serotonin. The entire class of antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors) work by preventing serotonin being reused by our nerve cells. The theory is that by blocking the reuptake, there will be a higher concentration of serotonin to act upon the nerve receptor that improves our mood. As we learn more and more of the physiology involved, it become apparent that this approach is not without its flaws. So having more serotonin in the synapse sounds great but, the longer it stays in that space and not reuptaken into the storage vesicle, the more apt it is to diffuse away from the area of activity or be dismantled into inert by-products that are eliminated (some serotonin may be converted to melatonin to help regulate or sleep cycle). It’s easy to see that if the patient does not have a source of tryptophan, then no new serotonin will be produced. All the SSRIs in the world will not work if there is no serotonin in the neuron! Some sources of tryptophan are red and white meats (beef, pork, chicken), fish and other sea creatures, eggs, and dairy products. Yes! It’s OK to eat eggs again! Other neurotransmitters like dopamine and norepinephrine have analogous biochemical properties and pathways that we are discovering.

Martie has her work cut out for her but her passion for this subject is winning people over every day. It’s a tough challenge. It is difficult to undo the status quo. Patients, caregivers, and providers are too ready to seek an easy answer in a capsule or tablet. Half the commercials on the evening news are for prescription drugs. Expensive prescription drugs. I’ve said many time that I strive mightily to have my pharmacy students think things through before “going to the literature.” They have been taught the pathophysiology of the body and the pharmacokinetics of drugs, but little time is spent on presenting a complete picture of healthy physiology and the pharmacodynamics of the drugs we supply. I just love that Martie pointed out that these are often pharmacodynamic problems. In other words, it’s not what the body does to the drug (pharmacokinetics), its how the drug affects our entire physiology (pharmacodynamics), our bodies and our brains.

This is a huge mountain to not only climb, but to completely relocate! The healthcare industry will need to be overhauled with a new focus on prevention and healthful behaviors, including a fair payment model for those of us that may guide patients to better health (and so less cost in treatments and other interventions), while medical and pharmacy schools must be willing to rely less on the “literature,” where studies are mostly funded by pharmaceutical manufacturers, and more on basic research into physiology and pharmacodynamics. We must find unique ways of disseminating the information that scares the beejeezus out of Big Pharma and Big Med. It seems all our information sources are bought and paid for by the entities that are making billions from the status quo. Pharmacists must be willing to demonstrate that their value is in creating healthier, happier patients, not shoveling more drugs into these patients. We must have the courage to speak up just as Martha Fankhauser is doing. I’ll repeat what she quoted at the start of this talk, “knowledge is power.” Grab that knowledge and use that power. Your patients will love you for it.

There was so much information crammed into her presentation that I am still processing it all. I appreciate all that Martha Fankhauser has done for the profession of pharmacy and I am thankful that we have such a dedicated believer who has the strength of her convictions to be a change advocate for all of us. Such is the practice of heroic pharmacy and Martie is truly one of our heroes.

I do have a few key points left to make, some that are new and some that you may have seen here before…

Remember the three main components of health: Nutrition, Exercise, and Sleep. Patients, ask your pharmacist for any nutritional advice based on the drugs that you are taking.
But, don’t forget the importance of touch and movement. Touching, hugging and yes, sex, are all important to a healthy human being. As far as movement goes, I am reminded to tell all you youngsters that I had to walk across four yards of shag carpet just to change the channel. Do you even know how to change the channel without using the remote? Get up off your ass and move! If it helps, you don’t have to call it exercise. Maybe you’ll sleep better!

Here are the essential amino acids:
histidine
isoleucine
leucine
lysine
methionine
phenylalanine
threonine
tryptophan
valine

The ONLY way to get these protein building blocks is from what you eat. You’ll recall that tryptophan, for instance, is best obtained from animal sources. If you are a vegetarian, please consider adding whey to your diet, it will add the essential amino acids, including tryptophan, that you may not be getting in sufficient amounts. I know it is dairy-sourced, but it can contain up to 10 times the amount of biologically available (you can absorb it) tryptophan when compared gram for gram with even the best plant protein sources. Whey provides all nine essential amino acids. I have no interest in any company selling whey, I do occasionally recommend it to patients that are vegetarian or perhaps lacking sufficient dietary protein.

Avoid nicotine, alcohol, caffeine. I suggest complete avoidance of nicotine (yes, even e-cigs), and drastically limiting your intake of caffeine (check your beverages, it could be hiding in there), and restricting your use of alcohol to a glass of wine less than once a day.

If you think you are a victim of polypharmacy, ask your pharmacist to do a comprehensive review of all of your current meds and supply him or her with a list of non-prescription products and supplements that you use. Allow time for the response to be prepared for you. If you are both pharmacist and patient and are taking a multitude of drugs, ask a trusted colleague to do the med review. You can even make it anonymous.

Changing your evil ways does not have to be a huge undertaking, it can begin with baby steps and be a wonderful journey towards health and happiness.

Always remember that knowledge is power, but not as powerful of love. Love somebody, love yourself.

Thanks for sharing, Martie! I’m waiting for your book!

* My recall of this talk wasn’t quite as good as it may seem. Martie contacted me to say, “I would recommend a higher daily dose of vitamin D3 based on a blood level and most adults need a total daily dose of 5000-6000 IU D3 if they can’t synthesize it via the skin. Some may need higher doses based on risk factors.”

Where my pill at?

Are we on the verge of a new male contraceptive?

The demand is there, coming from both men and women, although there is still that concern that men could not be trusted to take a pill every day. Research in the area of male contraceptives is underfunded compared to the more attractive and lucrative areas related to form and function. Enhancing libido and genitalia attract many more dollars than looking for a male contraceptive. Besides, don’t women already have that taken care of?

I first wrote about non-barrier male contraceptives in a Pharmacy Times article in October of 1995, predicting that a male contraceptive pill was coming soon, or, “at least by the next millennium.” The new millennium is here and there may be some new options beyond the condom for men willing to take the responsibility of baby prevention into their own hands, as it were. That reminds me of the poor guy whose only date was with his right hand… he always got Valentine’s Day confused with Palm Sunday.

You can read the original article and other predictions on this page.

The Chinese and the Brazilians have considered gossypol, a cottonseed component, as a male contraceptive. At first things looked pretty successful as the gossypol pill provided a very high degree of contraception, reportedly by blocking enzymes necessary for sperm to mature. Problems arose when frequent hypokalemia and rates of permanent infertility proved unacceptably high. Brazil almost got the gossypol pill, Nofertil (subtle Brazilians!) on the market at about the same time my PT article appeared. The FDA considers it a toxic substance and spends some time and money making sure it does not turn up in animal feed. It’s still being looked at as a kind of chemical vasectomy for its ability to cause permanent infertility.

In India, they have been working on a reversible contraceptive for men that involves a direct injection into the scrotum. Vasalgel (TM), a polymer, is injected into the vas deferens, preventing sperm from traveling beyond the epididymis. A product called RISUG (TM), Reversible Inhibition of Sperm Under Guidance, has been used by Indian men for over 15 years. Although the R stands for reversible, the reversing process has only been tried on animals, not “officially” on humans. The hope is that the newer polymer Vasalgel is more easily reversed and has been licensed for study in the US. Other polymers have been used in China and elsewhere to plug the vas deferens.

The search for a male hormonal birth control pill is ongoing but may have been abandoned. Most hormonal choices that may limit or stop the production of viable sperm are not good candidates for oral use, either being quickly destroyed by stomach acid and digestive enzymes or simply not being absorbed into the bloodstream. That means the needle is most likely guys, although their may be something in a couple non-hormonal drugs that seem to reduce male fertility.

Dibenzyline (phenoxybenzamine), for pheochromocytoma and Mellaril (thioridazine), a behavioral drug both seem to have a peculiar effect on male orgasm. Relax guys, you’ll still have an orgasm, but it will be a cum-free cum. Here’s the rub: Many drugs, notably α-adrenergic antagonists, have effects on contractility of the vas muscles and thus normal ejaculation. It’s a common side effect of these drugs. Normally, sperm and seminal fluid are propelled through the vas by the orchestrated contraction of both longitudinal and circular muscles. It’s quite a trip, starting in your balls and passing up and behind your bladder, right through your prostate, up the shaft of your penis and into the loving environment provided by your partner. Anyway, phenoxybenzamine and thioridazine are particularly good at blocking the contraction of the longitudinal muscles and allowing the circular muscles to contract. The net effect is to close down the highway. We’re trying to take advantage of a side effect here, so much research still needs to be done. Yet studies are ongoing to find more specific agents that will have targeted effect with few side effects. This is also an area being examined to find a drug for premature ejaculation. The calcium channel blocker, nifedipine. is also being looked at because it was observed that men taking it had altered sperm that have a diminished capacity to latch onto the egg.

It’s illuminating to see that there are a huge number of articles (mine included) in the past few decades promising a male contraceptive pill and still nothing has reached the market. Perhaps we are chasing unicorns.

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