Tuesday, September 13, 2011

The HPV vaccine, my bread and butter, and why Rick Perry should have known better

From the moment Rick Perry announced his 2012 Presidential candidacy, I knew there would be trouble. Michelle Bachmann's critique that Perry was in the pocket of big pharma (Merck), back in 2007, may or may not have legitimacy, but Perry's attempt to require the HPV vaccine in Texas played perfectly into Merck's marketing strategy for its new (and potentially controversial) vaccine.

In February 2007, Rick Perry, then governor of Texas, overrode the state legislature to require the human papillomavirus (HPV) vaccine for school entry. At the time, the HPV vaccine, Gardasil, was only available for girls, making it a touchy subject for parents who didn't like to think about their adolescent girls' risks for STIs. Concurrent with Perry's gubenatorial power grab, Merck was quietly lobbying state legislatures around the country, mostly through a questionable organization Women in Government, trying to get states to include the HPV vaccine as part of school entry vaccines.

On one hand, school entry vaccines have a long history in the U.S. Though there are increasing numbers of parents who opt out of the school requirements, this topic is more or less a non-issue for most parents when they enroll their kids in kindergarten. What makes the HPV vaccine different is its requirements were for sixth or seventh graders, and at the time only for girls, heightening the emphasis on its possible tacit acceptance of adolescent sexual activity. Interestingly, the parents who resisted the HPV vaccine requirements tended to emphasize not its association with sexual behavior, but rather these parents focused on a libertarian/Tea Party (though this was not yet a widespread movement in the States at the time) position: we don't want government deciding what's "right" for our children. No one seemed upset about other government public health measures, such as water fluoridation or even other school entry vaccines. Yet few of the opponents to an HPV vaccine requirement voiced explicit resistance to its association with the most common sexually transmitted infection (STI).

Rick Perry, at the time of his infamous mandate, framed his decision especially oddly. He argued that this measure was a pro-life one, stating:
Never before have we had an opportunity to prevent cancer with a simple vaccine. While I understand the concerns expressed by some, I stand firmly on the side of protecting life. The HPV vaccine does not promote sex, it protects women's health. In the past, young women who have abstained from sex until marriage have contracted HPV from their husbands and faced the difficult task of defeating cervical cancer. This vaccine prevents that from happening (emphasis mine, La Prensa, February 14, 2007).
The succession of events were fast and furious, with multiple parents suing Perry for overstepping his executive office and the state legislature promptly overturning his inititative. He had also been accused of accepting Merck campaign funds and that his former aide was now a lobbyist for Merck. Simultaneously with Perry's undone executive order, the New York Times published a couple of articles identifying Merck as the lobbying force around many of the state legislature initiatives. Almost all of the state laws failed.

Now that Perry is trying to win the Republican nomination, it's no surprise that he's being resoundedly attacked by his competitors. Though Bachmann's unrelenting insistence that the vaccine could have "very dangerous" side effects is unfounded (especially her endorsement that one girl suffered mental retardation as a result), I'm fascinated by the unfolding of this more than 4-year old discussion.

Bachmann's decision to attack Perry on the HPV vaccine does not seem to address his willingness to override the legislature's role nor his explicit indifference to the preferences of his constituents. Instead Bachmann wants to drag him down for his exposing girls to a purportedly harmful vaccine, which she herself admits she is not knowledgeable enough to determine whether its safety should in fact be called into question.

What's most interesting to me about the rehashing of the HPV vaccine debates (and I have to say, having written my dissertation on the topic, it's a little boring to me), is how perfectly it fits into the Tea Party agenda and how well it reveals the logical inconsistencies of this movement. Further, I have long argued that in order to avoid the conservative backlash against the HPV vaccine, Merck marketed the vaccine as a vaccine against cancer, not as an STI preventive. Even during the FDA hearing to approve the vaccine, the conservative organizations emphasized that they would never be against a vaccine that protected against cancer. All of Merck's ads for the vaccine have promoted it as a cervical cancer preventive, avoiding the controversy associated with sex in the U.S. It's ironic, then that the conservative movement, especially the Tea Party, has still been distrustful and critical of the vaccine and any of its proponents. Ultimately, this suggests that the debates are tacitly about sex, even as other cultural zeitgeist topics such as government regulation are invoked as the reasons for the groups' objections.

Thursday, September 8, 2011

The virtue of the outsider

One of the reasons I think being an anthropologist in the tech world is essential is that it offers a critical eye that often gets lost in the tech world bubble. As a researcher at a health tech startup, I saw firsthand how easily the Bay Area and those within the tech sector presume a lot about the role of technology in everyday lives. For example, the iPad 2 had just been released, and the company's leaders were convinced that all the doctors were wondering what they were going to do with their new gadget. A day or two at a specialty conference made patently clear to me that most doctors in the U.S. were not fretting about the newest Apple gadget. Some Bay Area (and elsewhere) physicians were excited to be on the cutting-edge of mobile devices, but for most MDs, the iPad (1 or 2) was not a core element of their daily concerns. This doesn't mean that the technology won't become well-integrated into physicians' practices, and it is important to have an eye to future technology engagement when building a new product. But hyper-familiarity with certain practices and processes can lead to the inability to understand how and why users might engage with a new product. Some naysayers point to Steve Jobs' unwillingness to do user research, but I think this misses the point. It's not that we need more focus groups or direct market research to understand users' interpretation of technology or a new tool, but rather we need a more nuanced and complex understanding of users' behaviors to anticipate and to improve on existing tools.

Intel is a company that understands that broader research questions can be amazingly informative. Dr. Genevieve Bell, Intel's director of User Experience, is one of the lead anthropologists in the private sector. Her role at Intel and Intel's willingness to include an anthropologist as a key leader in their company demonstrate the company's foresight. Bell's work contributes to the very dynamic that I think is far too absent in the tech world. It's not that every company needs their staff anthropologists, but rather that the interdisciplinary nature of Intel's User Experience department is a sign of creative thinking and the willingness to imagine the world as radically different than just an American-centric world. It's easy to forget that mobile tools outside of the U.S. may have different meanings and utility for their users. The Intel approach has pushed its developers to think about technology in Western China or among the aging population, reminding the people who design and build the products that not everyone uses technology in the same ways. The first four minutes of this video-cast is worth skipping, but here's a chance to hear what Dr. Bell does at Intel and why it matters. If this episode has been updated (I can't find a direct link to the show), it's episode 41.

Thursday, August 4, 2011

MobiHealth's scathing, yet not inaccurate, critique of mHealth

MobiHealth News publishes on the ever-evolving and expanding health tech market. Last month, there was a fairly damning piece on why Silicon Valley often misses the point in its healthcare tech development. I'm less interested in the commentary about Google Health (now defunct), although I could go on for quite some time about the Google development methods, which I think often waste great opportunities.

Versel, the author of the piece, does a good job of highlighting the problems with Rock Health, a health incubator that has baffled me since its formal public appearance earlier this spring. Rock Health solicited innovators/developers to be part of the health tech incubator by announcing they didn't care if applicants had health experience. While outsiders do bring important innovative approaches to existing industries/practices, there was something arrogant about Rock Health's call for inventors. Though the MobiHealth article suggested there was only one health expert on Rock Health's team, that isn't actually true.

I would maintain that there needs to be more health savvy members in a health technology team than I've seen. My stint working in health technology has been brief so far, but I found there was a lot of redundancy. The tech world's approach to health education and behavior change has given short shrift to existing research that preceded contemporary digital technologies. Too often, these startups want to simply ignore the literature and research around these issues, as though approaching things from consumer + digital worlds will be the salve to the difficulties in implementing improvements in health (for both the individual and the population at large).

As always, I am a bit of a relativist on these issues. I think it's quite obvious that there's plenty of need for improvements to healthcare management (from any perspective, whether it's that of insurers, providers, or patients). I also realize that the startup world prioritizes the minimal viable product (MVP) as proof of concept. There's something incoherent, though, in melding those worlds. There must be a middle way, and it's something I'd like to be part of.

Wednesday, August 3, 2011

How effective are screening tools in reducing mortality from certain cancers?

As I work on an article from my dissertation, I've been thinking about one scholar's challenge to the pap smear. Ilana Lowy, a fantastic historian/social scientist of medicine, argues that the pap smear may not be the reason for the reduction in cervical cancer mortality. Now, the NYT also briefly mentions a BMJ article that suggests mammograms are not the cause for declining rates of breast cancer mortality.

These women's health screenings have been considered essential, if sometimes problematic, methods of improving health outcomes. Adele Clarke and Monica Casper have written about the networks and many processes that go into cervical cancer pathology screening, noting all the actors, tools, and challenges for pathologists who read hundreds of cervical cell slides in a day. Public health has long considered the gynecological method of the pap smear to be a "gold standard" of screening, as it's a relatively cheap and effective way to purportedly reduce cervical cancer deaths. Indeed, since the institutionalization by gynecological associations of regular pap smears in the U.S., deaths due to cervical cancer have dropped radically. As a non-laboratory scientist, I've been persuaded that the pap smear, while imperfect, was really a meaningful intervention. Conversely, I've also been long concerned about the practices associated with gynecology. Terri Kapsalis has a fantastic set of essays in her book about some of the ongoing and historical problems with gynecological practice. At a recent conference, Lowy emphasized her skepticism about the efficacy of the pap smear. Based on epidemiological data from Brazil, she argued that the pap smear is not the reason for the reduction in cervical cancer mortality in that country.

With the mammogram data, it appears there's a real need to explore what might be changing in mortality related to breast cancer. One point that the authors of the recent study make is that healthcare in general may be improving significantly, such that overall improvements in mortality reflect this shift, independent of the use of mammography screening. Both cervical cancer and breast cancer mortality reductions raise radical paradigm shifts to public health assumptions about screening tools. Perhaps I'm redundant, but I also think this suggests the need for more qualitative data about these practices. Certain tenets are considered almost unassailable in the public health realm. Many subsequent interventions are based on the belief that the pap smear was the way to reduce cervical cancer deaths. When the foundational principles get disrupted, it forces us to examine other related ideas. I think it's a fantastic opportunity.

Sunday, July 17, 2011

Electronic medical records and the muddle of government initiatives

In a recent position, I worked in the health technology sector. A repeated challenge that I tried to impress on the team was that digitizing medical records, medical practices, and healthcare is not as simple as technologizing existing practices. One of the physicians with whom I spoke insisted to me that the best technology for her work was a pen and paper. Actually, I think she might have said a crayon and paper.

The U.S. government recently initiated a program to motivate physicians to start using electronic medical records (EMRs). The government is offering cash back incentives, up to many thousands of dollars, for MDs who meet certain basic criteria in their digitization. As is the wont of the U.S. marketplace, many many business have proliferated to "facilitate" the transition. Unfortunately, while the government provided a list of criteria that have to be met to receive the incentives, they did not really do a very good job at creating a standard format for EMRs. This means that doctors' offices need to evaluate competitors to determine which application will best work for their practice. The transition is daunting and overwhelming for many doctors' offices, which already perceive their workload to be more than they can handle (for the money that they believe they should receive).

This Sunday's Business Section of The New York Times has a cogent article about this problem. [Yes, I know I reference this periodical disproportionately.] I hadn't articulated this point as well as I'd like to have done, but I think the medical records dilemma is a great example of the limitations of innovation. We hurdle ahead to make things fancier, shinier, and purportedly more streamlined. But in the process critical details get lost.

During my last project, I repeatedly reiterated that we needed to really understand workflows and the processes in place. Digitizing practices is great for something that is repetitive and cumbersome, at least early on, as the technology becomes integrated into actors' needs. It also needs to capture tasks with a predictable workflow. This sounds like such a simplistic perspective on technology, missing all the amazing and fantastical things technological innovation might offer. But in industries in which data remain non-digital, you can't simply waltz in and show off the fancy things that might be possible. It's simply far too daunting and impractical.

Thus far, I have yet to see a platform or computerized set of practices that really address the needs of healthcare practices. These still remain too piecemeal and focused on the future to really meet the demands of the people who will use the tools. While one might be tempted to say that the healthcare industry is a particularly complex arena (and it is in some ways) because of the competing users' priorities (healthcare payers, for example, have a very different end goal than the users of the system [patients]), this is an overly simplistic explanation for why the tech industry hasn't gotten it quite right in the healthcare field. I would suggest that many of the people in the tech industry simply haven't done due diligence in understanding the problems.

Wednesday, July 13, 2011

On the "lure of innovation"

Innovation and technology are essential components of medicine and science. There is a constant drive to push our understanding of processes and improve upon existing knowledge further. It is a fairly central tenet of medical culture. Yet, as I've discussed here, it can be difficult to really balance the drive to move forward without trade-offs, sometimes losing the things that work well (though maybe not the most efficient).

This article appeared in The New York Times a couple of weeks ago, and I made a mental note to read it and comment on it. Meier looks at a new technology of hip implants, designed to allow patients to be more active, and the dangers posed by the implants' shedding of metal debris in the patients who received them. It's not just the hip implants, however, there have been an increase of medical technology developments that have posed very significant risks in the pursuit of the latest and greatest. The implants, Meier writes, "show[...] how innovation’s lure led almost everyone to seize on a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options."

My time as a consultant in oncology biotech/pharma certainly bore this out, as well. The current debates around Avastin for breast cancer struggle with whether incremental benefits (to some) are worth the risks to many. Often new drugs will have a couple of months' improvement over an existing drug, but this potential may be touted as a critical need, even when the trade-offs in quality of life may not be considered by the scientific criteria of risks and benefits.

I would suggest that this is a very American conception of innovation. As one of the physicians interviewed in the article, Dr. Henrik Malchau, notes, "As a non-American, I don’t completely understand it, but there is a phenomenon in the U.S., the latest and the greatest." One of the arguments for the U.S. structure of healthcare and privatization of health (including pharma companies, etc.) has been that the capitalist model generates innovation in a way that government run health simply does not. This position takes American individualism and competition as critical drivers for improvements and innovation in health (and elsewhere). But it's also clear that this model has serious consequences. Even the way in which medical science is funded and regulated reflects this prioritization of privatization as the way to better medicine and knowledge.

What I'm calling for is not a complete abandonment of existing models, but I believe we need to actually take these instances (of which there are many) of failure/serious tradeoffs to be more methodical in how we approach innovation. I realize this is probably highly impractical. People drive technology forward fairly heedless of the individual effects, with the hope that the population-level overall benefit will be worth the costs to the individuals affected. I do believe that one should be circumspect about embracing new products/technologies. And I think that the government could actually make some in-roads into demanding higher standards of proof before approving health-related technologies. Meier writes, at the end of his article, that it is not just a problem with regulation, but also with the attitudes of physicians and patients. This is a cultural problem as much as a structural one.

Friday, June 24, 2011

The somewhat arbitrary condemnation of profit-seeking in healthcare

This morning's California Report covered the illegal exportation of marijuana from CA to other states. I really recommend listening to the story linked above. California is the largest medical marijuana industry in the country, after Prop 215 made medical marijuana legal fifteen years ago. What I found most fascinating was the condemnation of "unscrupulous" physicians who were "misusing" their access and prescribing power of medical marijuana to improperly profit from the bounty of California pot. Multiple commentators in the news piece maligned these doctors for their activities. One physician emphasized that doctors should only prescribe marijuana for the "right reasons," and that doctors need to "police" themselves. One commentator notes that "somebody got rich" from the ability to sell the marijuana at about $3000-$4000/lb.

The story prompted me to think about the health insurance industry, which is explicitly designed to maximize profits. Or the pharmaceutical industry, which also turns sometimes naturally-occurring compounds into profitable pills. These legal practices that seek out profit do not receive the same vilification from mainstream media. I realize that the physicians' participation in the export of the marijuana is illegal, but this is one of those moments in which the illegality seems completely arbitrary. This also reflects a by-product of the medical marijuana movement, that in order to garner support and emphasize the innocuousness of using marijuana medicinally, it also needs to be portrayed as an organic, non-capitalistic product. At some point, when/if marijuana is legalized, it will surely be converted into all sorts of packaged and processed products. THC, one of the main compounds in marijuana that helps stimulate appetite, is already purchasable (and reimbursable by health insurance) under the name Marinol. Reading the National Institute of Health's recommendations on the use and dosage of Marinol is unsettling and a great example of the transformation of health and wellness into a highly medicalized practice.
"Dronabinol comes as a capsule to take by mouth. When dronabinol is used to treat nausea and vomiting caused by chemotherapy, it is usually taken 1 to 3 hours before chemotherapy and then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses a day. When dronabinol is used to increase appetite, it is usually taken 2 times a day, before lunch and supper, or once a day in the evening or at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dronabinol exactly as directed."
The transformation from a self-medicating product that the marijuana dispensaries allow to an FDA-regulated and medically managed pill is transparent in the package instructions that the NIH has put on its website.

Not once in the story, which links the physicians to underground drug gangs, is there an exploration of the consequence of making the plant illegal. While they discuss the value of a statewide registry to help crack down on moving marijuana into illegal markets, they fail to really consider the challenges of making health part of the capitalist system. I'm not interested in ranting on and on about capitalism, but I do think we need to inject more of the economics of health into the discussions of issues like this one. The story emphasizes how people take advantage of the medical marijuana system, yet not once is there a consideration of how pharma and health insurance companies are also taking advantage of a very badly structured "system." The medical marijuana conundrum is about more than legal and illegal use of a plant, but rather reflects the slipperiness between medicine and profit.