Undermining the USPSTF: The most important stakeholders are the patients

A strange “health care” drama plays out daily in our clinics and hospitals. A healthy person has a medical test done (even though he or she is healthy): a blood test, a chest x-ray or mammogram, maybe an ultrasound of some body part. The test comes back abnormal. The patient (for she has now gone from being a healthy person to being a patient) is struck with worry, and undergoes a further round of testing to determine whether the initial, “screening” test was accurate. This more invasive, risky definitive testing causes the patient pain, complications, infections, further procedures to fix the complications. But the testing shows that the original screening test was wrong, and the patient is relieved of their worry and overcome with a sense of gratitude: “Yes, the follow-up surgery was painful, but at least it’s not cancer.” However, notice what caused the worry in the first place: not some symptom that they were experiencing, but a test that was performed on a healthy person. What a marvelous bit of sorcery: we take a happy patient, create unnecessary worry, then win their undying gratitude by performing risk-laden procedures on them to remove their worry!

There is something very intuitive about the concept that detecting a disease (especially cancer) early leads to better outcomes, that screening tests are inherently good. Yet when one studies the actual outcomes of implementing mass screening programs in a population of people who have no signs or symptoms of a particular disease, one finds to one’s surprise that, not infrequently, more people are harmed by our screening test than are helped (See: PSA testing, carotid ultrasounds, annual stress tests, etc). This harm may take many forms: worry, invasive procedures with all the risk they bring, radiation exposure, disfiguring treatments, stroke, even death. Yet there is no shortage of promoters of various tests that capitalize on our intuition that “More testing is better.”

In steps the United States Preventive Services Task Force (or USPSTF), a group of experts in preventive medicine and primary care (since it is mostly primary care providers who order screening tests). Their task is to examine the scientific evidence of the potential risks and harms of preventive strategies like screening tests, and to make recommendations based solely on that evidence. They strive to use the best scientific data available to benefit the most people possible. Even when their recommendations are unpopular (because they go against our intuition that more screening is better), they have a large effect on what tests are performed — and what tests insurance will pay for.

This week the USPSTF recommended against screening for thyroid cancer in people without symptoms. The data show that screening has found lots of thyroid cancer that never would have been found otherwise. The data also show that screening has not produced a reduction in death from thyroid cancer or an increase in quality of life. What it has produced is an increase in harms, such as injuries to vital nerves from the increase in thyroid surgery. Who knew?

Now there is legislation pending in Congress proposing that “stakeholders” — that is, specialists and industry representatives — be included in the membership of the USPSTF. This is a very bad idea. Consider: What do specialists like thyroid surgeons (who are not experts in screening for thyroid cancer; rather, their livelihood is tied to operating for it) or drug and device manufacturers (who sell the tests and ultrasound machines used to screen for thyroid cancer) add to the USPSTF’s process?  The main thing “stakeholders” (that is, people with a financial interest in seeing the test done) add is a conflict of interest. Whatever difference such “stakeholders” make would be tilted to the advantage of the few who stand to profit from the screening, and to the detriment of the many in the population who would be harmed from the screening. The USPSTF’s work must not be transformed from a transparent procedure that seeks to minimize harm into a get-rich-quick scheme.

The surprisingly small benefit of some very (expensive) Big Ideas

Last week, JAMA published online a Viewpoint provocatively titled, “What Happens When Underperforming Big Ideas in Research Become Entrenched?” The overarching Big Idea to which the article refers is the “narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health.”

The article highlights three technologies that are integral to the Big Idea but that have not lived up to their promise. The first is genetics/genomics; as an example of unfulfilled promise, the authors trenchantly observe, “Sixty years after the discovery of the genetic defect, no targeted therapy has emerged for sickle cell anemia” — one of the simplest genetic diseases, caused by a single gene. The second is stem-cell therapies; the authors point out one analysis of studies of stem cell therapies, in which the supposed effectiveness of the therapy was directly proportional to the number of factual discrepancies in the published study. The third is electronic health records (EHRs), which have cost billions, but have not realized either the improved care and cost savings that were their major selling point.

Despite the lack of evidence of real benefit, these three technologies have received vast amounts of NIH and government monies. The article recommends changes such as the “NIH should fund many more high-risk, unconventional ideas instead of supporting the same familiar highly funded research fronts.” It also calls for accountability for funded studies to show real benefit.

The article’s title asks what happens when underperforming big ideas become entrenched — vast amounts of money and energy are wasted — and suggests solutions. But the article does not address why those Big Ideas have become entrenched in the face of all evidence, and this must be addressed before solutions can work. I do not pretend to have a definitive answer. But I think there is an even Bigger Idea that overlies all of these lesser ideas: the idea that more technology is inherently good, and in higher-tech medicine will be our salvation.

For example, look at those things that have been shown to make “transformative improvements” in mortality, morbidity, and life expectancy: Quitting smoking. Getting off the couch and doing a bit of exercise. Eating your fruits and veggies. Getting immunized.

Now, which sounds more exciting for research funding: stem cells that we confidently assert can cure Parkinson’s even though we can’t quite prove but it’s pretty obvious that they should, or finding ways to get more grocery stores into poor neighborhoods whose most affordable food source has golden arches in front of it?

If no travel restrictions, then….quarantine?

As the Ebola epidemic rages on, the debate about travel limitations has moved inevitably to the next stage: whether there ought to be a quarantine imposed on healthcare providers and others returning from service in endemic areas. We have been reading two opposing views, one emphasizing, as did Governor Christie of New Jersey, that “the obligation of elected officials is to protect the public health of all the people,” and the other warning of the “disincentive” and “stigma” that would affect those healthcare professionals who might volunteer in West Africa.

The fear of stigma remains a curious phenomenon. It is plainly obvious by now that healthcare workers caring for Ebola patients are the most likely Americans to catch the disease. I propose that their free and unquarantined movement through society would not make them suddenly immune to stigma. If science and its facts are to guide our decisions, we must not shirk from finding all facts that are relevant to the decision at hand. For example, key to such a decision would be to find out how likely it would be that healthcare workers would change their mind about serving in the Ebola epidemic if they knew that they’d face a 21-day quarantine afterwards. I won’t claim to know the answer, but nobody else knows it either. If “science” is to be our guide, then we ought to do the research and not speculate. One could easily posit that healthcare workers would be encouraged by having the confidence that they would return to accommodations that would ensure that the risk that they would transmit a deadly disease to loved ones was zero. As one Army physician told me, if he were exposed to a patient with suspected Ebola, he would not go home to his wife and children until the risk was nullified.

The Army’s self-imposed quarantine is enlightening. The Army knows full well how disruptive such a risk could be to a community, undermining its ability to function, both in how it supports itself and how it moves toward its goals (for the Army, of course, its mission). It knows the importance of establishing confidence and trust within its community, and with its neighbors. The Army also has vast experience in safety and risk assessments, and as anyone who has gone through the Army’s mandatory safety training knows, risk is determined by both the likelihood of occurrence and the severity of consequences. Admonitions from the director of the CDC that Ebola is not contagious like cold or flu viruses are willingly silent on the obvious fact that if a person catches Ebola, he or she is likely to die. My opinion is that Major General Darryl Williams is more circumspect about the totality of consequences than is Dr. Frieden.

Similarly, if our society is going to move forward on the admirable mission of assisting nations in West Africa, we need to have the confidence and trust in each other, and throughout our entire complex and interactive society, that can only be achieved by the discipline and assurances exemplified by the Army’s latest actions. I am sure there is a science for that.

Contain AND Extinguish

Dr. Tom Frieden, Director of the Centers for Disease Control, wrote an article published on October 9th entitled, “Why I don’t support a travel ban to combat Ebola outbreak.” In it he provides ten arguments against a travel ban; these arguments can be categorized as those claiming that such a ban would be ineffective, harmful, and unnecessary. Unfortunately for Dr. Frieden, they raise more questions than they answer, and do not convince that a travel ban is unhelpful.

He begins by claiming “It’s not feasible to build a wall,” and that a travel ban would be essentially a “quarantine” for Liberia, Sierra Leone, and Guinea. Frieden adds that “quarantining huge populations doesn’t work”. How a travel ban would not have prevented the US’s two cases to date—one patient a traveler, and the other a nurse who cared for him—is not apparent. It is also not apparent how travel restrictions (a ban being only one option) do not work in general, for Frieden merely makes an assertion. It is just as easy, and perhaps more appropriate, to note that fighting individual cases involves exactly that, and that successful work against Ebola within healthcare facilities and communities does as well.

Frieden spends much more time describing the harms from a travel ban. He reports that a ban would drive patients underground, and cause other countries (presumably those who learn they have Ebola cases and fear a travel ban) to “stop working with the international community.” This begs the question what “underground” means, and if whatever that is presents more of a risk for spread of the disease. Whether other countries would stop working with us depends largely on our threshold for instituting a ban, for it seems unreasonable to institute a ban for small numbers. Is anyone arguing that two cases in the US ought to result in a ban against Americans leaving the US?

He also describes how a travel ban would mean we could not get Americans out, nor medical aid in. These arguments are the most specious, for we can certainly get out any American through military or other arranged flights, and travel restrictions would not have to apply to the arrival of medical supplies and personnel to the affected West African nations.

Frieden closes by listing actions other than a travel ban that are being taken that will suffice to protect the American people, including the screening in the affected countries of people prior to departure, as well as upon arrival.  If these will prove to be sufficient it is too early to know for sure, but they are no guarantee of additional cases arriving—most, but not all, inbound travelers from affected countries are being screened. Unfortunately, confidence in their effectiveness is also not achieved by descriptions of the screening methodology, including Frieden’s less-than-reassuring comment that, “if there’s any concern about their health, they’ll be referred to the local public health authority for further evaluation or monitoring.”

What hurts Frieden’s argument the most is own glaringly faulty argument from the analogy that fighting Ebola is like fighting a wildfire: “When a wildfire breaks out we don’t fence it off. We go in to extinguish it before one of the random sparks sets off another outbreak somewhere else.” But only going in to extinguish a wildfire works only when it’s not “wild,” that is, spreading rapidly. Then the fire has to be contained as well as extinguished. Internet searches of the subject produce findings such as this: “The basic principle in fighting forest fires is to create a gap, or firebreak, across which the fire cannot move.” Frieden’s argument would work only if the effort to extinguish were so robust that containment is not necessary. Testimony from the ground states otherwise: http://www.doctorswithoutborders.org/news-stories/voice-field/ebola-fighting-forest-fire-spray-bottles

One lesson learned from reading Dr. Frieden’s article is that to include arguments so easily refuted only hurts one’s position. And what further hurts his argument is the news of the vast amount of resources consumed in our country from handling just two cases, as well as for suspected cases. These efforts only detract from our ability to send medical support such as scarce supplies to the nations in need…and to provide care to our own people. We now need all clinics, emergency departments, and hospitals to maintain robust procedures and supplies to handle suspected cases. Consider the enormous and ongoing costs to the Dallas community from just one imported case of Ebola. The arrival of even a suspected case of Ebola at a healthcare facility results in it being cordoned off, rendering it inaccessible to other patients, either by fiat or fear.

A robust response within the affected countries is needed, as Dr. Frieden indicates. But it does not preclude other measures necessary to prevent the spread of Ebola and diversion of desperately needed resources. If the cases in the US grow in number, the costs will grow exponentially, for even the current CDC case definition (reliant on known exposure or travel from endemic areas) could be threatened. As the flu season approaches, and more and more patients appear in healthcare facilities with fever and vomiting, anything other than high certainty that Ebola is nowhere around will lead to a startling disruption of healthcare in our own country.

(Gun) Violence as a Public Health Issue

In the Summer 2014 edition of Dignitas Greg Rutecki provides a thought-provoking article calling for reframing the gun control debate as a public health issue. He brings attention to the measures taken in Australia following a 1996 mass shooting (35 dead) in 1996, which subsequently appeared to produce a striking drop in homicides, as well as suicides by firearms.

Although we could have reasonable debate as to whether the specific actions taken in Australia would be appropriate here, it is appropriate to consider if current laws are adequate or need revision based on features of modernity such as increasing population and crowding, advances in technology, and so on. The need to balance public safety, or, as Rutecki puts it, public health, and individual freedoms, requires us to find an Aristotelian “golden mean” between unfettered and unregulated gun ownership and excessively strict control.

But we must ensure that our debate is sufficiently circumspect, otherwise we may find ourselves with unintended consequences that cannot be undone.

First, we ought to consider what is meant by “gun violence.” Descriptions and debates in the news of shootings frequently use this term, which seems to create a mental picture of guns wandering independently down streets and shooting innocent people. If “gun violence” is a public health issue, then so is violence in general. Therefore, interventions must include actions to address the social and moral breakdowns producing violence. When violence is an issue, the choice of instrument is but one aspect, and banning guns does not ban the problems that produce violence in the first place. In the absence of guns, there are plenty of other instruments at man’s disposal.

Second, Rutecki cites “dedication” and “commitments” to the Second Amendment. Critique of Second Amendment advocacy paints a picture of unquestioning devotion, as if the right to bear arms was considered, philosophically speaking, a “first truth.” This is too shallow a view, for the foundational principle was not gun ownership but self defense. It was, to the founding fathers, a commitment to individual freedom, a recognition that the tyrannical gather power when their force is unopposed. Gun ownership becomes both symbolic and an actual guarantor of freedom from tyranny.

There are many who consider such concern anachronistic, and are doubtful that 21st Century America needs such guarantees. Are modern dangers sufficient to justify gun ownership, as they were in 18th century America? If one were to say no, I would argue that he could not prove so unless gun ownership were eliminated and the subsequent net loss of life from violence turns out to be less than today’s. It is credible to argue that there are threats we are unaware of because of widespread gun ownership. If Rutecki’s public health analogy is valid, then one must note that this is the nature of the argument for immunization against rare diseases, when confronted by those who argue against immunizations due to vaccine safety concerns.

We must then decide if there is a more modern “disease” from which private gun ownership protects us. In a recent article in National Review   Charles C. W. Cooke brings attention to our own history, and the role of private gun ownership in defending Americans of African ancestry against racially-motivated violence:

In her harrowing 1892 treatise on the horrors of lynching in the post-bellum American South, the journalist, suffragist, and civil-rights champion Ida B. Wells established for her readers the value of bearing arms. “Of the many inhuman outrages of this present year,” Wells recorded, “the only case where the proposed lynching did not occur, was where the men armed themselves.”

That history may still be too remote to convince many of the threats diverted by gun ownership, but world events concurrent with Rutecki’s article provide sufficient evidence to me. To cite but one example—we have heard of an epidemic of the maladies of decapitation and mass execution raging through Iraq and Syria. We could argue whether a well-armed Yazidi populace may have saved many lives; the Kurds need no convincing.

This is not an impossibly remote or nebulous threat to America. It doesn’t take much imagination to figure out how a well-resourced group of people could find their way into the United States. And the question of whether ISIS desires to do so has already been clearly answered.

I would not deny the need to be expansive in one’s consideration of gun laws in the face of gun violence in the United States, whatever its root causes, and the need to seek solutions. But if the goal is to prevent violence, we must consider all sources, and ensure that we do not go so far as to remove a potential preventive measure. In the face of an advancing evil bent on shedding our blood, and considering our inability to protect our borders fully, a well-armed populace is our final defense against the current and advancing public health scourge of decapitation. If violence is a public health problem, then privately owned gun ownership amidst a determined citizenry facing an advancing and depraved evil is simply “preventive medicine.”

One Welfare

Among the hats I wear is my “participate in organized veterinary medicine” hat, which currently involves my role as Vice President of my state Veterinary Medical Association. In a recent board meeting, we identified and strategized goals for the year. With each passing year, I find my own ambitions for the association become somewhat less sweeping, tempered by realism and some battle-weariness. But veterinarians are generally an idealistic lot, and so we often dream big dreams. Our “breakout” sessions start to tackle these things, breaking our idealism into manageable heaps. One such group, in which I participated, was dedicated to issues of animal welfare. A member of our team was a public health veterinarian, which meant he was quite bright and terribly earnest, and was inclined to read the more cerebral, “big issues” sections of our journals, while we practitioners were skipping over those to read up on the best ways to treat chronic urinary tract infections or mast cell tumors. Based on his reading of a commentary published in the February 1, 2013 edition of the Journal of the American Veterinary Medical Association (JAVMA), he felt our best move was to advocate for a “one welfare” concept that was elaborated by the authors of that article, Tristan Colonius, DVM and Rosemary Earley, DVM. Even though I hadn’t read it, and therefore didn’t quite know what he meant, I intuitively and wholeheartedly supported that effort.

Fortunately (and, perhaps, uncharacteristically) I think my intuition was right. The authors derive their idea from the “one health” concept that has been used in epidemiology and public health circles. The latter they define as acknowledging “the interconnectedness of human, animal, and environmental health and the necessity for an interdisciplinary approach in these fields.” “One welfare,” by distinction, reflects a confluence of the otherwise distinct disciplines of animal, human and public welfare. At first glance, this would raise the eyebrows of those of us who wish to champion human dignity as a distinct reflection of the Divine Creator in embodied humanity. Do these welfare disciplines represent moral equivalencies? But I think in reality it addresses the inter-connectedness of life on Earth, and the consequences that arise when we seek to improve the welfare of one “group” while disregarding another. This reflection can occur while still defending human dignity.

To stress the impact of grouping human, social, and animal welfare under one umbrella, the authors cite the statistic that, “at the dawn of agriculture 10,000 years ago, humans and domesticated animals comprised approximately 0.1% of the vertebrate mass on land. Today, that figure is closer to 98%.” For better or worse, humans and domesticated animals run this place, and so we are inextricably linked with the ecological health of the planet we inhabit. Increased globalization means that the choices of one nation will impact multiple others. The authors further acknowledge that the “known and supposed tradeoffs in human and animal welfare create contentious problems.” Indeed.

The idea of animal welfare is not particularly controversial, with most veterinarians cheerily using the language of welfare and avoiding the more unpalatable notions of rights and liberation. Much surprised are we to discover that disciples of Peter Singer and Tom Regan have seemed to stealthily integrate themselves into the various animal welfare forums and literature while we weren’t looking. An idea of “one welfare,” frankly, helps ground the more radical elements within this group. In my own sphere, I deplore the numbers of animals that are surrendered to animal shelters when cute puppies grow up to be big dogs, or manageable behavioral issues cause pet owners to give up without a second thought. But I also realize that not every pet is adoptable and that public health is ill-served by packs of stray dogs roaming about, or that human and environmental well-being suffers when colonies of feral cats decimate songbird populations. It is humans that can impact animal welfare, and humans alone, so to ignore our own welfare while working to improve that of domesticated animals is foolhardy. It’s also impractical to animals. It might be wonderful to have all our meat originate from “free-range” sources, but there is nowhere close to the pasture land available on Earth to meet the needs of the increasingly meat-hungry population of the world. Horse-slaughter, whereby horse meat could be sold to receptive markets in France, is now gone from the United States, a victim of troubling aesthetics. A concomitant increase in the population of starving and abandoned horses has accompanied this ostensible act of kindness. A focus on animal welfare in a vacuum creates myriad consequences, some adverse to the very animals whose welfare we seek; a “one welfare” approach tempers this.

But human welfare may also be interpreted as complete satisfaction of human desire, however wrong that interpretation. Our desires to eat so much meat, well beyond what has ever been seen historically, has led to profound deforestation to create grazing space, and has increased levels of greenhouse gases. It is well-noted that flatulent cattle may have a more deleterious effect on our environment than American SUVs. Industrialized and suburbanized, prosperous nations are now so far removed from the sources of our food that we don’t give a second thought to how or where it was produced, or the welfare of the animals who give their lives as food for us. I have spoken before of the awesome powers and responsibilities God grants human beings in the “dominion” mandate over animals. Our welfare, personal and public, must not neglect the welfare of these animals, but must balance the consequences of our choices on the welfare of all.

So much of what we do with animals and our environment speak to us as human beings, and to the human condition. That, and some cautions associated with the “one welfare” concept, is something that I will explore, Lord-willing, in a next blog entry.

Stop those prying scientists!

After the events of recent months, one wonders whether anything can be done to reduce the likelihood of a Newton, Connecticut-type massacre recurring. This is not to shift the blame away from, or deny the ultimate responsibility of, the perpetrator of that incident; it is to ask whether there are steps that we as a society can take, within the limits of the Constitution that shapes our government, to reduce such occurrences.

The answer to this question is probably not simple (unless the answer is simply “No, there is nothing to be done.”). After a tragedy like Newton, the tendency is to just do something, and do it quickly. But to rush blindly  into a legislative attempt at a solution would undoubtedly be ineffective and entail lots of bad, unintended outcomes. No, it will probably take years of research (= lots o’ money) to even begin to come to any conclusions about effective steps that will do more than make us feel good about having done something.

Such research has been attempted in the past. Between 1985 and 1997, medical and public health researchers at the National Center for Injury Prevention and Control at the CDC were researching firearm safety; however, certain members of Congress attempted to eliminate the Center. They failed, but they did manage to get the following language into the appropriations bill: “none of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control.” Justifiably worried about what might be construed as “advocating or promoting gun control,” researchers stopped looking into firearm safety. And after publication of research in 2009 examining whether carrying a gun increases or decreases the risk of firearm assault, funded by the National Institute on Alcohol Abuse and Alcoholism, Congress applied the same restrictive language to all Department of Health and Human Services agencies, including the NIH, which funds a lot of the research in this country.

Now, maybe the gun lobby is right. Maybe the government shouldn’t be involved in trying to find an answer to this problem. Maybe government answers will be ineffective. (I personally think this is another place where the untapped potential of the Church’s transformative influence would do far more than legislation ever could.) But whatever actions are taken, they must be ethical actions. As I have written several times before in this space, “Good ethics begins with good facts.” But in this instance, we might have to move ahead without knowing what we’re doing, because some are so afraid of knowledge that they have blocked any attempts to discover it.

I have written before of agenda-driven, unwarranted interference in the physician-patient relationship. It seems to me this is a case of agenda-driven, unwarranted interference in public health research. Coincidentally, both involve the pro-gun lobby. I am not advocating for or against any type of gun control; I am advocating against blatant interference in much-needed research, driven apparently by a fear of what that research might show.

 

 

(See here for the original article in JAMA on which this post is based.)

Making us be healthy

New York City’s mayor has proposed a drastic public health measure: banning sales of sugary drinks that are greater than 16 ounces in size, in an attempt to curb obesity.

Two questions: First, will banning a certain size of soft drink really make a difference in obesity? I guess we don’t know until someone tries it and measures the effects, but I’m a little skeptical that addressing a single caloric source in such a limited way will make a significant difference. (And what’s to stop someone from buying multiple smaller-sized drinks in order to achieve the same effect as a super-size sugary drink?)

Second, and more important, even if for the sake of argument we grant that the answer to the first question is yes, how far should the law go to try to coerce people to make healthier choices? If we accept the apparent logic behind this proposed law, then it seems we must accept that government should limit how many pieces of pizza one can buy, how many greasy-double-cheezies one can order at the burger palace, how many packs of cigarettes one can purchase, how many bags of candy one can acquire, and how many bottles of beer one can obtain. And as long as we’re talking about unhealthy behaviors, should the law proscribe the number of sexual partners one has, limit the number of hours of television broadcast each day, and regulate the number of hours we spend in direct sunlight without sunscreen? Most of us would agree that such measures would be onerous and intrusive, although they arguably might marginally increase the health of a population. But is that benefit enough to justify criminalizing certain actions? Should it be an illegal act to do things that might be bad for your health?

Government is good for a lot of things: keeping order, administering justice, defense, overseeing big public-good projects like roads and clean water, and, well governing. I think it’s OK for government to protect our health by doing things like making sure the eggs I’m sold aren’t loaded with salmonella or other toxic substances: there is a direct, preventable, cause-and-effect relationship between my eating infected eggs and developing salmonellosis. But protecting my health from someone else’s actions in this way is quite different from trying to enforce my health by micromanaging my dietary actions. Government is good for a lot of things; but it is not within government’s purview to make me be healthy.

 

How private enhancement decisions led to a public health crisis

 

The proponents of using medical techniques not just for treating disease and dysfunction, but also for enhancing normal form or function, often appeal to privacy. Since most public and private insurance schemes do not pay for enhancement technologies, people who desire such “treatments” pay out of their own pockets; so, the argument goes, if they’re not hurting anybody, and they’re paying for it themselves, what’s the problem?

One of the more popular enhancement technologies worldwide is the cosmetic surgical procedure of breast augmentation. In the last few weeks a crisis of sorts has erupted around a particular brand of silicone breast implant, manufactured by the now-defunct French company Poly Implant Prothese (PIP) and exported all over Europe and South America. It turns out that the silicone used in PIP’s implants was not medical-grade, but industrial-grade, made to be used in mattresses; this may make the implants more prone to rupture. Rupture can lead to increases in inflammation and scar tissue formation.

About 300,000 of PIP breast implants are thought to have been used worldwide. This week, France and Venezuela took the step of offering to pay for the removal (but not the replacement) of all PIP implants. “We have to remove all these implants,” said Dr Laurent Lantieri, a French plastic surgeon “We’re facing a health crisis …” France will pay for ultrasounds every six months for those women who opt not to have the surgery.

Two things to note: first, removal of an implant is not like taking out a splinter. It is a major surgery, under general anesthesia, with all of the attendant risks — and expenses — of surgery. Second, other than those women who had implants inserted after breast cancer surgery, all of the women involved paid for their augmentation themselves. But now the state — that is, the citizens of France and Venezuela — will be paying for the corrective surgeries.

All techniques and technologies carry unintended and unforeseeable consequences. Even with the best planning and forecasting, all techniques will surprise us in some way. Medical techniques, because they work directly on the human body, have the potential and power to do very great unintended harm. The silicone breast implant crisis is an example of how choices made in private can have significant unforeseen consequences and costs for the public. The argument that using medicine for enhancement is merely an individual and private decision is simply not valid. How many more individuals will be hurt, and how much more will society pay, as enhancement techniques — and their unforeseen consequences — proliferate?

Stop those prying doctors!

 

Florida residents have their saviors in the Florida legislature to thank for shielding them from the insidious “prying into personal lives” that doctors have shamelessly been inflicting upon patients.

Apparently, doctors have been asking their patients questions about whether they own guns, and – prepare yourself for a shock – if the patient answers in the affirmative, some doctors have actually been counseling patients on how to store the guns safely and protect any other people in the home, particularly children, from accidental harm.

Fortunately, some attentive citizens were alerted to this disgusting practice and enlisted the NRA in helping them to get the Florida legislature to pass, and the Florida governor to sign on June 2nd, HB 155, which prohibits physicians from making written or oral inquiries regarding firearms ownership or recording such information in a patient’s chart (unless the doc believes “that this information is relevant to the patient’s medical care or safety, or the safety of others”).

It is a great relief to see that the physician-patient relationship — too long the purview of a suspiciously-dressed clique of highly-trained, dedicated professionals and their trusting patients, too long full of “prying into personal lives” as exemplified by questions like, “How do you feel?” “Does that hurt?”  “What do you use for contraception?” and “Did anybody in your family ever have cancer?” — is at last being exposed and regulated by those people we all trust way more than we do our doctors, the elected representatives in our legislatures.  My only regret is that some of the original provisions of the bill, such as the stipulation that a violation would amount to a third-degree felony punishable by up to five years in prison and a fine as high as $5 million, did not make it into the final legislation.

Encouraged by the NRA’s success, other bodies are stepping up to protect the unsuspecting public from some of the horrifying practices that routinely take place behind the closed doors of the consulting room.  The Tobacco Growers Coalition is promoting legislation to ban doctors from making inquiries about smoking, the GFFFA (Greasy Fried Fast Food Alliance) is working to make it illegal for doctors to counsel their patients about healthy diets, the NARL is drafting laws to ensure that doctors don’t counsel pregnant patients against abortion, and the Colombian drug cartels are looking for ways to prevent doctors from advising patients against using their special brand of products.

Sound too ridiculous to be true?  OK, I made that last paragraph up.  But read this.

Lest anyone misunderstand, this post is not about gun ownership, nor do I have anything against the NRA.  This post is about unwarranted encroachment upon the sanctity of the central economy of the medical profession, the physician-patient relationship;  and about what sort of Rubicon has been crossed when the paranoid intrusion and constraint represented by this bill is placed upon the good will and judgment of a doctor — and enshrined in the law of the land.