Thursday, December 29, 2011

Billy Rubin Blog Hero & Villain Of The Year (and Year-End Book Review)

"It's an honor just to be nominated," crowed sex columnist Dan Savage in response to Andrew Sullivan's listing of Savage in his poll for the "Moore Award". Sullivan, in his Daily Beast blog "The Dish", has a variety of year-end awards, and his "Moore" award (named after the lefty agitpropster filmmaker Michael Moore) is for "divisive, bitter and intemperate left-wing rhetoric". Savage garnered a nomination this year, and has thus far worn that nomination like a badge. As of this writing, with just under 10,000 votes cast, Savage is comfortably in the lead with more than 58 percent of the vote in a field of ten candidates--a sum that Mitt Romney dreams about even more than Sugar Plum Fairies as we close in on the Iowa Caucuses. (What Simon Winchester, whose entire collected works I have nearly finished over the past few years, has said or written to be included in this group is unknown to me, but it must have been a doozy, since under normal circumstances one would not describe his utterances as remotely extreme.)

Savage's nomination came as a result of a dustup between him and soon-to-be-former-candidate-for-President Representative Michele Bachmann back in September during the Republican Presidential debates. At that time, Bachmann was indulging in one of her favorite political tactics in order to separate herself from her rivals and recover some of the mojo she had lost over the summer when she had been the darling of the party and led in the polls.

That tactic would involve departing entirely from reality and making up whatever stuff she deemed suitable to rile up sufficiently nitwitted partisans, as she did earlier in the campaign when she attacked Michelle Obama for advocating breastfeeding by supporting a tax break for breast pumps, turning the tax break into a right-wing fantasy that the government was "going out to buy my breast pump". In the September debate, Bachmann had decided to stake out the anti-vaccine territory to stick it to Texas Governor Rick Perry, who was then leading in the polls. In 2007, Perry had admirably issued an executive order mandating that Texas girls receive access to the HPV vaccine, a major cause of cervical cancer as well as other maladies. That order was later overturned by the Texas legislature, causing Perry to quip--correctly--that the bill's supporters were effectively killing women who would needlessly die from the cancer.

Not that he said it that bluntly, but he came close: "no lost lives will occupy the confines of their conscience, sacrificed on the altar of political expediency", was his rather eloquent retort at the time. Unfortunately, he may have wished he never uttered those words, as the HPV order came back to bite him rather fiercely as the primary season got more contentious and governmentophobic conservatives took a dim view of his actions. Bachmann, though, decided to go for the jugular, and took the almost-reasonable sounding "there are limits to government" argument and pushed much deeper into the Twilight Zone. At the debate, she merely parroted the usual lines about governments forcing people to do things against their will, but the following day, in an interview with the Today show's Matt Lauer, Bachmann noted that she had been approached by a mother who claimed that her daughter had "developed mental retardation" after receiving the vaccine, and asked the viewers to draw conclusions for themselves.

In response to this perceived bit of a politician's own mental retardation, advocacy groups rose up in unison to denounce Bachmann's position. "There is absolutely no scientific validity to this statement", wrote Dr. O. Marion Burton of the American Academy of Pediatrics. Doctors blogging on the subject blasted her, including one who chided Bachman for her "anti-vaccine porn". And a few bioethicists offered thousands of dollars to review the records searching for proof of the vaccine's harm. Bachmann, in the days to come, would disingenuously backtrack on the claim, noting that she herself never made a claim about the vaccine's harm, only that someone else had done so, in language and reasoning so slippery it invites comparison to any number of reptiles.

Enter Dan Savage.

Within two days of the blowup, Savage wrote a brief dispatch on the matter, noting that her "comments" on the HPV vaccine were much more accurately described as "lies". Then he let his savage pen loose, noting the following:

Bachmann and her ilk believe that woman [sic] who have sex—along with men who fail to purchase health insurance—deserve to die horrible deaths. That's why they hate the HPV vaccine, that's why they fought its introduction, that's why they tell lies about it now. Because they want women to die.

Presumably, Savage meant something more along the lines of "women who have premarital or extramarital sex". Regardless, Savage's characterization of Bachmann was unquestionably intemperate. It was obviously divisive. It was unambigously bitter. Thus, by Andrew Sullivan's criteria, an ideal nominee for his award!

Only one matter bears mention: Savage was almost certainly correct. And for that we name one of our favorite columnists, Dan Savage, for the Billy Rubin Blog Hero Of The Year, and his public foil, soon-to-be-just-Representative Michele Bachmann, for the Billy Rubin Blog Villain Of The Year. Happy 2011, y'all.

PS--In other news, we've been catching up on our reading around here and want to give a special shout-out to the following books, most of which came out in 2010, but we're almost never that up to date on our reading until someone actually pays us to write this blog. Besides, these books will have a shelf life to come, so please do consider them if you want to read excellent books on medicine:

The Emperor of All Maladies--Siddhartha Mukherjee's phenomenal "biography" of cancer. Though the subject matter may seem intimidating and depressing, Mukherjee takes the reader along on a ride that is suffused with the insight of a great clinician, the wonder of a thoughtful scientist, and the humanity of a fine writer. For his work he won the Pulitzer Prize for general nonfiction, and appropriately so. (Readers wanting to delve further into cancer literature might consider watching a Japanese film that received almost zero attention in the US, 1778 Stories of Me and My Wife, detailing the struggles of a writer and his cancer-stricken spouse. Be forewarned, however, that it makes the phrase "gut-wrenching" seem inadequate. I watched it on a flight from Europe to the US, and by they end the Dutch people around me practically had to carry my sobbing ass out on a litter.)

The Panic Virus--Seth Mnookin's book about the vaccine-causes-autism movement. An excellent primer on vaccine hysteria, narrower in scope than Arthur Allen's Vaccine but no less important or readable.

Anatomy of an Epidemic--Robert Whittaker's compelling analysis of modern psychiatry, which I've written about before here.

Thursday, December 1, 2011

Lipitor Goes Generic, and Everyone Wins...Theoretically

I like to play a game with my med students, residents, and fellows--although really the game can only be played with residents and fellows as the students don't have enough medical mileage under their belts to fare well. I ask them this question: what do they think are the five greatest drugs of all time? After all, people routinely debate the greatest baseball player--I'm partial to Willie Mays--the greatest writer in the English language, the greatest movie, and the list goes on. Why not have a discussion about what makes a drug great?

So we talk about how drugs are used and what makes them good or not. I do this exercise to get them thinking about qualities that define particular drugs or entire classes of them, and why some may be preferable to others. Such qualities include "applicability" (i.e. how many people would benefit from its use, as Tysabri is an incredible drug that preserves quality of life, but only does so for people with advanced multiple sclerosis, a very small group), the magnitude of benefit (a drug that saves a life is more important than one that eases wrinkles, such as Botox™), ease of use, minimal side effects, and a proven track record (drugs that are new to the market often appear miraculous; most don't last, as the brief life of Xigris shows) among other things.

Lively debates ensue, but what I find most interesting is that the drugs that most housestaff end up agreeing on are ones that have been around a very long time and weren't developed by recent pharmaceutical company R&D programs. And by "recent" I mean the past 30 to 40 years. Aspirin may be the greatest drug of all, and has been around in its current form since the mid-19th century (and the active ingredient was found in folk remedies long before that); morphine and its narcotic siblings are likewise more than a century old; penicillin-class and sulfa antibiotics were developed before World War II; insulin was first used in the 1920's after decades of research; and beta-blockers were first developed in the 1960's.

That said, one class--relative teenagers compared to these elders--stands out, and one drug from that class stands out in particular.

The class of drugs are known as "statins", and the drug is Lipitor, the signature product of Pfizer. Since its introduction in 1996, Lipitor has not only gone on to become a blockbuster drug--its total estimated gross is $100 billion--but has by any measure been proven to meet the definition of a wonder drug. It is reasonably safe, most people tolerate it, lots of people require it, and it saves lives. Lots of lives. It's usefulness has been proven over and over again in well-designed trials. Unlike so many other drugs, its initial promise has not begun to fade.

The biochemical pathway in which Lipitor and its fellow statins work disrupts cholesterol synthesis, but we're still learning about how it works its magic: other medications that lower cholesterol in different ways, such as ezetimibe (trade name of Zetia™), seem not to have the same benefit in terms of preventing heart attacks and death that the statins do. Moreover, while Lipitor wasn't the first statin to market, and there are six other members of the statin class, Lipitor has reigned supreme. This is due in part to a more profound reduction in "bad cholesterol" LDL and an elevation in "good cholesterol" HDL than others in the class, but also its "gentleness", as for instance rosuvastatin, whose trade name is Crestor™, lowers the LDL the most of any in the class, but does at the cost of more serious and more frequent side effects. (A useful consumer review on statins from Consumer Reports can be found here.)

Pfizer has seen an enormous windfall from Lipitor, and they have deserved every penny. It is, in other words, an "honest" drug: no ridiculous shenanigans, such as those seen in the marketing of the generally unimpressive drug Neurontin by the very same Pfizer corporation, or the introduction of the current #1 drug by sale, Nexium, which is nothing more than a clever repackaging of Prilosec, whose patent was due to expire and would have deprived its maker Aztra Zeneca of billions of dollars. But today Lipitor is now open to the competition, as its patent expired on Wednesday, so generic atorvastatin can be made and marketed in the US, which should drop the price of atorvastatin considerably. Thus, although I make no claims to be an economist or an intellectual property law expert, it looks like the expiration on the patent of the greatest modern medical drug was a win-win for both consumers and the shareholders who brought the drug to market.

I say "looks like" only because Pfizer, as this article explains, still intends to protect Lipitor's brand name in some ways that defeat the entire purpose of the spirit of patent law. Some of their efforts, like direct mailings of "coupons" for lower copays for Lipitor, seem free-market legit. Others, however, have that unpleasant odor so frequently associated with Big Pharma these days. In particular, Pfizer appears to be cutting deals with so-called "Prescription Benefit Managers" to elbow out the competition. PBMs serve as third-party payers for insurance companies and administer drug formularies. Pfizer's goal in negotiating with the PBMs is to give Lipitor at a discounted price in exchange for the PBM not carrying other companies' generic atorvastatin, effectively cutting them out of large markets.

It is not an illegal practice, although I fail to understand how this benefits consumers tremendously. Nor does the CEO of Watson Pharmaceuticals, Paul Bisaro, who complained about Pfizer's tactics on CNBC's "Squawkbox"--not exactly the kind of haven for socialist ideologues. But the story is still in motion, the deals are taking place in the backrooms and boardrooms away from journalists, so time will have to tell about atorvastatin's future. Today, however, was a good day for medicine, for business, and ultimately, for patients.

PS--we also note with great enthusiasm that Gary Schweitzer's Health News Review blog has adopted a new look. Go check out the makeover! It is among the most valuable resources on medicine, and comes awfully cheap.