Sexual issues

It’s Big Business!

Posted on January 5, 2009. Filed under: medical ethics, Medical marketing, Sexual issues |

On his blog, Science-Based Medicine, Dr. David Gorski posted about the pharmaceutical marketing technique of “seeding trials”. I had participated in one such ruse, although I was unaware that it had its own official name. As I commented to Dr. Gorski:

Fascinating article. I had never heard the term, “seed trial”, but the one in which I participated was similar to Merck’s.

My practice was exclusively limited to male sexual dysfunction for over 20 years, so when Pfizer came to me to participate in the VIGOR pre-market “clinical research” on Viagra, I assumed it was related to my expertise. Their final application for FDA approval had already been submitted, but the release date was pending the FDA’s action. By regulation, they could not detail the drug to doctors, nor even discuss it, unless the doctor was conducting “clinical research” in a pre-market trial. I was assigned only 10 patients (”to eliminate biases”), paid $1000 each for my inconvenience and expertise, and assigned an “FDA compliance consultant” who flew to my office several times, supervising every word that my “study director” (my nurse wife) entered into the forms. Both being participants, my wife and I were sent to “The Dolphin” hotel at Disney World to discuss the “research” with the other “investigators”. Airport-to-hotel limo, etc., plus an honorarium for attending. I expected some sort of round-table arrangement for the discussion; in actuality, it was held in the completely-filled grand ballroom. Other “investigator meetings” were being held around the country, and there were many others both before and after the one I attended. The only thing the investigators had in common was an American license to practice medicine. Criteria for patient enrollment were: male under 65, no anti-hypertensives, no diabetes, no hx of CAD or PVD, no physically-detectable penile abnormalities, and no previous evaluation for ED (a more pleasant term the Pfizer CEO commissioned to replace “impotence”). In other words, it was designed for 100% positive response. Before the study actually ended, Viagra was released. I never heard anything further about the study, and I don’t find much when I Google “VIGOR Viagra”, except ads.

At the time (I was told), the marketing branch of Pfizer estimated that the first-year Viagra market was $3 billion (it wasn’t, but that was their best data). That’s $8.2 million per day (counting only work days, it’s $13.6 million). By having a fully-detailed prescription-writing corps of doctors on release day, they could readily afford the costs of the elaborate “pre-market trial”, versus the months of non-productive days by having reps come around and detail “cold” docs after the release. They couldn’t afford not to have the “trials”.

My ethics in the issue are suspect, to be sure. I justified it by saying that I already knew all about the drug, there were no competitors, it filled a necessary niche (previously unaddressed) for my patients, and I was going to prescribe it anyway. Mea culpa.

But I was misled, right? Do I have to give back the money?

This fits right in with economist David J. Balan’s recent post on Overcoming Bias entitled “It is Simply No Longer Possible to Believe”. The basis for his post was this article by Dr. Marcia Angell, fomer editor-in-chief of the New England Journal of Medicine. If you have bothered to read this far, you owe it to yourself to read Dr. Angell’s treatise. I did, and I am so embarrassed for my profession.

 

 

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Bigger is better

Posted on October 13, 2008. Filed under: Medico-legal issues, Sexual issues |

In the mid-1970’s, few doctors and almost none of the general public were aware of the existence of one of the 20th century’s most wonderful and most overlooked inventions: the inflatable penile prosthesis. Not so for the late Lafayette, Louisiana barrister J. Minos Simon (it’s a Cajun name, pronounced “minus see-maw”). His private medical library rivaled that of the local hospitals, and he often appeared in court seemingly better informed about the medical aspects of his clients’ cases than the health-care professionals he routinely grilled. A bulldog when convinced of the legitimacy of his position, Simon successfully sued Pope John Paul II in the early ’80’s as part of his ground-breaking attack on serial pedophile Father Gilbert Gauthe, a moral, ethical, and social vilification from which the Catholic church has never recovered.

Simon championed “lesser” causes as well, albeit for 40% of the action, but hey, that’s the American way. One such led to his involvement with the IPP. Lafayette is the “headquarters” for offshore oil and gas exploration and production in the Gulf of Mexico, as indicated by the presence, among other oil service companies, of the largest private helicopter company in the world. The offshore oil and gas industry is a magnet for personal injury attorneys because of the Jones Act, a federal statute that comes into effect beginning thirty miles offshore. Closer in, workers’ injuries are no-fault, covered under state Worker’s Compensation, and limited mainly to actual expenses and loss of income. Under the Jones Act, the sky is the limit, allowing huge punitive awards shared by the plaintiffs and those champions of the underdog who stand up to “the man” for millions of dollars in attorney fees. Simon had such a case in the person of Leroy Meaux (name changed to prevent a flood of calls from interested women). Leroy had been seriously injured while working about 100 miles offshore on a major-company oil rig. Among the consequences of his injuries was the inability to achieve penile erections. (more…)

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No good deed goes unpunished

Posted on October 10, 2008. Filed under: Everything you wanted to know about doctors, Medico-legal issues, Sexual issues |

“Doc, I just cain’t get a hard-on by no-ways, and it’s torturin’ my wife and a-killin’ me.” The man was from the “redneck” area of Louisiana, a society very different from the Cajun-influenced culture of “Acadiana”, the site of my practice. He was an evangelical born-again-Christian 54-year-old hypertensive diabetic who had not been able to have sex with his wife for over two years. He had been referred by his family-practice doctor, who managed his diabetes and hypertension, after failing to respond to the pills. Short of traumatic nerve damage, such as is seen in spinal cord injuries, impotent men usually retain the ability to have orgasms. Many are incredulous when they first find that they can ejaculate without ever achieving an erection, but in reality, the two functions are completely separate. Consequently, if erections can be restored, they’re back in business.

There are very few physical causes of erectile dysfunction for which treating the underlying cause improves the erections. For example, normalizing the blood pressure or gaining better control of the blood glucose will not help the problem at all (in fact, getting the BP back to a normal level actually makes atherosclerotic ED worse, since there is less pressure to drive the blood through the narrowed penile arteries). To see where we stood, I tested the man by injecting alprostadil into the muscle of his penis (described here). He developed about 50% rigidity, a level which buckles easily when pressed (such as in the attempt at intromission). As often happened, he was thrilled at what seemed to me to be a terrible result, since he had not been seeing any response at all. He felt certain that self-administered injections were the answer. As another similarly encouraged patient told me, when I opined that the injection-produced rigidity was inadequate: “Doc, I’ve been screwin’ with a limp dick for so long that I’m sure I could shoot pool with a wet rope.” (more…)

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The sooner the better?

Posted on September 16, 2008. Filed under: Sexual issues |

When does a normal function become a medical disorder? When it’s premature ejaculation. There are a myriad of things one could discuss about this phenomenon, most of them controversial, and frequently gender-biased. Just the definition is confusing. Premature? For who? 

The mammalian activity of relatively rapid ejaculation (within one to several thrusts) when mating had been selected for its advantage long before Homo sapiens arrived on the scene. There are a number of imaginable reasons that success went to the quick; among them: not getting killed while having sex. While it is said that all men pay for it one way or another, that price is too high. To my mind, I see no reason to imagine that early hunter-gatherer humans had long bouts of lovemaking, just as modern non-human primates do not, as a rule. I have commented earlier about the lack of evidence for a reproductive role of the female orgasm, and I doubt that Alley Oop brought flowers and practiced foreplay. Actually, I doubt he asked permission. I feel certain that the desire of males to increase ejaculatory latency voluntarily is a relatively recent development, and a social one, that goes against genetic tendencies. In other words, the condition we now call “premature ejaculation” is biologically normal. But this is one area in which almost every man I know prefers to be “abnormal”. At least since Casanova, men have recognized that this is a race in which they are better off not to finish first.

I have some thoughts about this, as you may have anticipated. Consider this: (more…)

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Penile undermarketing

Posted on September 6, 2008. Filed under: Everything you wanted to know about doctors, Medical marketing, Sexual issues |

Alert blog-reader Moshe has asked the question: “If these penile implants you’ve talked about are so wonderful, how come I haven’t heard much about them?” You know, Moshe, I’ve been asking that same question since 1975, when I scrubbed in for my first inflatable penile prosthesis (IPP) operation. The result was so impressive that the female scrub nurse (unmarried) remarked, “Can you get me a list of men who have these things?” She wasn’t referring to size; the finished product was no bigger than the original. What she saw was control: comes up when you want it to (no matter how drunk the guy, nor how ugly the girl), stays up ’til everybody’s happy (or at least finished). The most urgently anxious patient I ever had was a widower in his 70’s who had just married a similar-aged widow. “Doc,” he begged, “I just got to get me one of those transplants (sic) right away: I just found out her late husband had one!” Ah yes, tough competition there. (more…)

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Rise and shine!

Posted on September 5, 2008. Filed under: Medical marketing, Sexual issues |

MIT computer scientist Dr. Scott Aaronson, in a post at Overcoming Bias, asked: Why do we, as a society, provide food stamps for the hungry but not sex stamps for the celibate?

Exhibiting a version of Godwin’s Law, the reader comments eventually deteriorated into a discussion of rape. Two anonymous commenters, the first an (I would guess) outraged feminist calling herself “Noir”, and the second a male chauvinist pig (as they were called in my day) using the clever nom de plume of “Anon”, argued over the plausibility of female-on-male rape. Anon’s eloquent pronouncement was: A woman forcing a man into sex is nigh-on physically impossible. She could of course violate him in various ways, but these mostly don’t even resemble sex. Retired urologist happened to be passing, and his shock at such ignorant effrontery caused him to wade in with the last comment in the thread. Alas, he was casting pearls before swine, as the readers showed no interest in his erudite remarks. Hence, the necessity for this fascinating post.   (more…)

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You’re going to stick what into my what?!!

Posted on September 3, 2008. Filed under: Sexual issues |

In this post, I promised to give it to you “straight” about some treatment options for ED, and the inside (a little more ED humor there) info that goes along. Yesterday, we talked about the pills your ol’ pappy wished he’d had when his “best friend, Mr. Happy” died before he did. Today, we’ll feature the self-administration of  intra-penile injections for the purpose of showing “condition wood”. The operative word is “showing”, as this account of the legendary first public demonstration of the ability of injected vasoactive drugs to produce erections recalls: “The introduction of the penile prosthesis paled in comparison to British physiologist Giles Brindley’s dramatic demonstration at the 1983 Annual Meeting of the AUA. Brindley closed his lecture by dropping his pants to reveal a perfectly erect phenoxybenzamine-induced erection.”   Now that’s science! Medical conventions are just not what they used to be (nor is ol’ Giles).  (more…)

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“How ya like me now?” he asked stiffly …

Posted on August 26, 2008. Filed under: Medical marketing, Sexual issues |

Since the “little blue pill”, the question that seems to be on everyone’s lips is, “What about these phosphodiesterase-5 inhibitors?” Right? Here’s someone inquiring, even as we speak. PDE-5’s inactivate one of the chemicals that makes erections go away (yeah, I know it seems that the verb should be “make” instead of “makes”, but that’s because the subject “one” is hidden by the prepositional clause “of the chemicals”; trust me: I went to school on an English scholarship). Male sexual arousal produces a chemical to initiate erection, and unless opposed, erection is maintained. Eventually, the almost non-flowing blood in the erect penis would clot (priapism), and without rapid treatment, probably no other erections would ever occur. Clearly, animals whose penises worked in this fashion were eliminated by natural selection. In those of us who have evolved long enough to be reading this blog, male arousal produces, along with the “get it up” chemical, a “get it down” chemical. When arousal is adequate, the former exceeds the latter. Eventually, e.g., after ejaculation, or when boredom replaces curiosity, or when the kid says, “What are you doing to Mommy?”, or when the prolonged friction has produced near-toxic levels of latex vapor emanating from the girlfriend’s woo-woo, or the Super Bowl is starting, the production of the “up” chemical slows, and the “down” chemical takes over. In the case of ejaculation, epinephrine production hastens the decline. If you want to know the exact technical aspects, check this summary.

But that’s not what I’m here to talk about. I want to explore the marketing of these miracle pills (more…)

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How old is too old to … well, you know …

Posted on August 23, 2008. Filed under: Sexual issues |

How old is an old person? I’m not sure (although Ohio State University seems to have a strong opinion). It’s got some range to it, certainly. For instance, at the upper end, “old” is at least somewhat younger than “dead”, yet at the lower end, “dead” might be younger than “old”. What to do? Well, if you really want to generate some strong opinions, modify the question and ask, “When is a man too old for sex?” Here are categories of people with whom I’ve discussed the subject, and who have widely varied opinions (guess what they are):**

  1. the man himself
  2. the man himself, if he is a Cajun musician
  3. the man’s wife, if she’s never had orgasms
  4. the man’s wife, if she’s always had orgasms
  5. the man’s fiancee, if he’s wealthy and she’s younger, with a boyfriend
  6. the man’s fiancee if he’s a pauper, their age is similar, and they’re in love
  7. the daughters of a widower whose marriage lasted 40 years
  8. the sons of a widower whose marriage lasted 40 years
  9. a feminist of any age, once she discovers the feds will pay to make it possible for every man on Medicare, but won’t pay for her mother’s eyeglasses
  10. fanatically religious men
  11. fanatically religious wives
  12. some others I’ll probably think of as this goes along

** Hint: all the opinions given by the men are the same; the ones given by the women vary (more…)

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Not tonight, dear; I have a headache.

Posted on August 17, 2008. Filed under: Sexual issues |

In a post on the Future of Humanity Institute’s “Overcoming Bias” blog, Dr. Robin Hanson discussed the “inexplicable shortage of sex” and the neglect of sex as a research topic. He asks the question: since sex is the greatest gift, what can we do to inspire more precious gift-giving? The question addressed is “why we have too little sex”. An implied question is “why have men evolved to desire sex more than women?” (more…)

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    The director of the Sexual Medicine Center leaves penile implants behind, and launches a quest for knowledge about Artificial Intelligence, extended life, and the issues inside the health-care industry.

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