tag:blogger.com,1999:blog-60795106702218998352008-07-18T09:38:00.181-04:00ReasonPharmStellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comBlogger40125tag:blogger.com,1999:blog-6079510670221899835.post-38010817139498117492008-07-16T10:17:00.003-04:002008-07-16T10:18:04.829-04:00I'm not dead......just a little distracted by my recent engagement!<br /><br />I promise to get my head out of the wedding-planning clouds and post something soon. :)Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-51526004970865016072008-06-10T23:15:00.003-04:002008-06-10T23:24:56.963-04:00I don't want to have to feel this way about cancer.Yahoo! News reports that <a href="http://news.yahoo.com/s/hsn/20080610/hl_hsn/medicarecostsforcancertreatmentsoar;_ylt=Atp3Bll6zdNnUycih0VlSgbVJRIF">the impact on Medicare of the cost of cancer care</a> is big -- and getting bigger.<br /><br />Cancer treatment has advanced quite a bit in the last twenty years. Now, it's not just about chemotherapy and radiation. There are biologic therapies that target individual molecules or structures within cells, aromatase inhibitors that block the formation of estrogen, not to mention what I call the "drugs for the drugs" -- that is, drugs like antiemetics that treat side effects caused by cancer drugs themselves, which tend to be harsher than medications for, say, a migraine. People with cancer are living longer and living better. That's a great thing, right?<br /><br />Well, that's how I want to feel about new developments in oncology. But when I hear that they're costing the government astronomical amounts of money -- and that those costs are only going to get bigger as even more therapies are developed and the population gets older (cancer is, after all, primarily a disease of the old) -- I cringe. That money is coming out of <span style="font-style: italic;">my</span> wallet, without my consent.<br /><br />In a free market, people with cancer would pay for their own treatment, perhaps saving for such an emergency (they don't have to, at the moment; Medicare will take care of it) or taking out a catastrophic insurance policy (again, they don't have to). Or they might rely on the<span style="font-style: italic;"> voluntary</span> charity of friends, family, or sympathetic strangers. Then cancer treatment could be paid for only by those who want to -- and we taxpayers wouldn't have to feel so ambivalent when great strides are made in conquering this very difficult disease.<span style="font-style: italic;"></span>Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-11507229132570621062008-05-28T16:49:00.003-04:002008-05-28T16:55:08.205-04:00Yay! (part 2)Yesterday I received my acceptance to the Objectivist Academic Center. Whee!<br /><br />As I wrote in my application materials, occasionally in writing posts for this blog and especially in writing my article for <em>The Objective Standard</em>, I've come up against difficulty in expressing what I want to say. It's not a defect in my vocabulary: I've always been a word nerd. I was nicknamed "Webster" as a kid in elementary school, and I'm now one of the fastest crossword puzzle solvers in the country. So when I have trouble saying what I mean, the problem is not a lack of words to express myself; the problem is an imperfect understanding on my part of the principle I'm trying to express. To paraphrase Ayn Rand, you don't truly <em>know</em> something if you can't express it in words. So I'm enrolling in the OAC to improve my understanding of Objectivism, the better to apply it to my writing and my life.<br /><br />Here's to better understanding!Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-56225559974697678732008-05-27T17:42:00.002-04:002008-05-27T18:06:31.585-04:00If there were no FDAA comment to an earlier entry challenged me to propose a solution for the problem of eliminating the FDA, rather than just grousing about the agency. You hear this type of challenge leveled when it's said that other government regulations or programs, like welfare, should be eliminated.<br /><br />The question presupposes that <span style="font-style: italic;">solving a problem</span> (poverty, snake-oil salesmen) is a primary goal. Actually, the primary goal should be to protect individual rights.<br /><br />This is not to say that no alternatives would arise in the absence of an FDA (or of welfare). In fact, getting safe, effective drugs on the market, and keeping unsafe, ineffective drugs from succeeding, <span style="font-style: italic;">is</span> a good thing -- which is why I believe private enterprise would come up with some great ways to make that happen without violating anyone's rights.<br /><br />Truth be told, I don't know exactly what solutions would arise. In a free market, businessmen who are smarter than I am would surely come up with ideas I can't even dream of at the moment. Would the average American in 1930 have been able to envision a computer, much less a laptop computer? Would a regular Joe in the 19th century have thought of movies or television? I think not. One cannot say that the FDA must stay simply because we don't know what would arise in its place. I can say this for sure: Free minds in a free market could not possibly come up with a <span style="font-style: italic;">worse</span> solution than tying the hands of drug manufacturers and patients for years while drugs wait for approval, and I am sure they would come up with better ones.<br /><br />Although I don't know exactly what solutions would arise, I am happy to speculate. Here are some private enterprises that I believe would arise, or assume more importance than they currently have, if the FDA did not exist:<br /><ul><li><span style="font-weight: bold;">Treatment guidelines from professional associations.</span> Medical associations, such as the National Comprehensive Cancer Network in cancer and the American Heart Association in cardiovascular health, already publish treatment guidelines that many doctors use in their practice today. Unbound by government regulation, these guidelines reflect far more recent data than the FDA's product labeling. Doctors who don't have time to read every journal article in their field could consult guidelines of organizations they trust to make recommendations for their patients.</li><li><span style="font-weight: bold;">"Seals of approval."</span> Know that "UL Listed" label that comes on just about every electrical appliance you buy? UL is short for Underwriters Laboratories -- a <span style="font-style: italic;">private</span> organization that tests appliances for safety. Its stamp of approval offers consumers reassurance that the model they are buying has been vetted by a trusted authority. Very likely, a similar private enterprise would arise to review pharmaceuticals. For a drug that does not obtain approval from such a company, either because it is too new to have the relevant data to submit or because the manufacturer simply chooses not to obtain it, the consumer would have the freedom to decide for himself whether he wanted to take the risk of taking the drug. No government agency would decide for him.</li><li><span style="font-weight: bold;">The media.</span> How do we decide which restaurants are worth our money, which movies we want to see, which shops to patronize? By reading newspaper reviews, checking sites like Yelp.com, asking friends, and evaluating their reviews according to how well we trust the source. Without an FDA, drugs would be no different: If you read an article in the <span style="font-style: italic;">New England Journal of Medicine</span> stating that a drug is effective against migraines, you might just take that drug. If, when you try to purchase a drug online, you read 50 negative reviews saying that it causes blurry vision, you might rethink your choice.</li><li><span style="font-weight: bold;">Fraud law.</span> Sans FDA, fraud would and should remain illegal. Actually lying to consumers about what your drug does is an indirect form of physical force (you are presenting them with lies that cause them to buy your product when they otherwise would not), and is properly a crime.</li><li><span style="font-weight: bold;">Tort law.</span> Again, sans FDA, if a company inadvertently produces a drug laced with toxic compounds, it is liable for the damage it causes. Drugs are a somewhat different animal than other products because even a pure compound usually causes some kind of side effects; thus, smart companies would declare side effects as soon as they are discovered (so as to avoid lawsuits for "sitting on" unfavorable information), and would probably sell compounds in their very early stages on an at-your-own-risk basis.<br /></li></ul>As I said, that's what I can come up with -- but the best minds in a free market will undoubtedly come up with better.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-20561577608651022942008-05-08T09:45:00.003-04:002008-05-08T10:47:27.021-04:00If you want more, you need less<em>The Financial Express </em>of India reports that <a href="http://www.financialexpress.com/news/PE-firms-shy-away-from-pharma-RampD/306778/">private equity firms are increasingly unwilling to invest in pharmaceutical research and development</a> because the risks of investing the large sums of money required are too high.<br /><br />The potential rewards for an investment into a new molecule are high -- but so are the risks. The vast majority of drugs studied in the laboratory never make it to market: They may not work as well in humans as they do in test tubes and animals, or they may have unforeseen side effects, or government bureaucrats might change the rules for what data must be collected when a company has already begun its clinical trials, forcing the company to abandon its earlier research.<br /><br />If the amount of money at stake is small, individuals and venture capital firms are more likely to consider a high-risk investment -- in fact, a firm could diversify its investment among several R&D targets, since if one or more of them paid off, those wins would cover the losses from drugs that failed. But the amount of money is <em>not</em> small. The price of bringing a drug to market has been estimated at $800 million to $1 billion -- thanks mostly to government regulations that dictate what and how many trials must be conducted, how many patients must be included, and how long the trials must run before the drug can be approved. All this costs beaucoup bucks, not to mention the time that is eaten away from the drug's patent life because patent life begins at the time of discovery, <em>not</em> at the time the drug is permitted to be sold. Is it any wonder investors prefer lower-risk, but non-innovative, areas like manufacturing?<br /><br />Venture capitalists do not invest in businesses out of charity. They do it because they want to make money -- and the greater their chance of losing money, the less money they will be willing to invest in any given venture. That's why government regulation of the pharmaceutical industry is so destructive -- because it raises the stakes so high that many investors are scared off. The result is less innovation and fewer lifesaving drugs that will be invented.<br /><br />If what we want is more innovation in medicine, we need less -- less government regulation.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-14988185505494561402008-05-06T09:58:00.003-04:002008-05-06T10:01:00.763-04:00Yay!I finished revising my article for <em>The Objective Standard</em> over the weekend, and I just sent it off for the editor to look at.<br /><br />Thanks very much to Paul Hsieh for reading an early draft and providing some excellent suggestions, and thanks to Craig Biddle for asking me to write the article. I've been thinking about writing such an article for quite a while, but didn't know where or how I would get it published. Then Craig asked, and I was motivated to carve out the time to do it. I'm proud of the article, and I can't wait to see it in print!Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-91318737869505944682008-05-05T14:57:00.002-04:002008-05-05T15:10:11.766-04:00A bleak futureAs the <em>New York Times</em> reports, <a href="http://www.nytimes.com/2008/05/01/technology/01proton.html?ref=health">state governments are barring hospitals from building expensive new treatment facilities</a>, citing the need for cost containment. The proposed facilities would provide a new form of radiation treatment for cancer that state officials say is not proven to justify its cost, which is far higher than the X-rays it is meant to replace.<br /><br />So, in the name of cost containment, both for the government (which, if the new treatment were included as a Medicare and/or Medicaid offering, would have to foot the bill for some treatments) and for employers and unions who don't want to pay the higher insurance premiums that would result from having a new treatment available, no one is to be allowed to have the treatment at all -- because the facilities to provide it are not to exist.<br /><br />This is a clear warning as to how socialized medicine works, and what we are all in for should universal health care be mandated.<br /><br />In a free market, hospitals would be able to build such facilities if they wanted to -- and treatment would be available to those who can afford it. Investors in hospitals would have to figure out whether new facilities would be able to generate enough income to justify their construction -- this, not bureaucrats, would decide whether new treatments are made available. Hospital administrators who chose wisely and offered new treatments that many people want and are willing to pay for, would be rewarded with profits; those who chose poorly and built expensive facilities that could not recoup their costs, would fail.<br /><br />Instead, treatment is to be denied to everyone, regardless of ability to pay, because government bureaucrats don't want to pay for those individuals who fall under their purview. Is it really better for everyone to have no treatment than for some people to be able to afford an available treatment while others cannot?<br /><br />The answer to the problem of rising costs of care is not to ban innovation. It's to get the government out of healthcare.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-16357800151164073802008-04-24T11:19:00.003-04:002008-04-24T11:53:05.979-04:00Whose right is it anyway?Yahoo! News reports that <a href="http://news.yahoo.com/s/ap/20080424/ap_on_he_me/genetic_discrimination;_ylt=AhJxHV57Tff7bYFNHww1aprVJRIF">the Senate is expected to pass a bill barring discrimination by insurers and employers on the basis of genetic testing results</a>. In the name of anti-discrimination "rights," Congress will violate the real rights of individuals to make hiring, firing, and insurance decisions based on their own judgment.<br /><br />Compare genetic-testing discrimination to racial discrimination: Unless one's job performance depends largely on one's appearance (such as acting or modeling), race is an irrelevant characteristic on which to base hiring decisions, and thus racial discrimination is irrational. Yet even though it is irrational, racial and other forms of discrimination ought to be legal. Why? Because no one suffers from discrimination on the basis of irrelevant characteristics except the person who exercises it -- the employer who only hires people of his own race so he can "feel comfortable" will lose out on being able to hire the most productive people available to him. What about those he discriminates against? No one has a right to a job, only the right to accept one if offered -- so the discriminated-against have lost nothing. The failure to gain a thing is not a loss; the discriminated-against are perfectly free to find more rational employers, and the discriminator must be left free to suffer the consequences of his own actions.<br /><br />The results of genetic testing, unlike race, are <em>not </em>irrelevant to employers in the current legal environment. Employers are required or strongly incentivized by the government to provide health insurance. Since the employer is forced to insure his employees as a group, neither raising the cost for employees at high risk of health problems nor lowering it for those at low risk, it is in the employer's best interest to hire healthy employees who are likely to stay that way. So it is that a job candidate with a positive test for a gene that causes, say, Parkinson's disease, is less desirable than another candidate with no such test results, all other things being equal. (And, obviously, the results of genetic testing are of interest to insurers in setting rates, whether or not employers are required to provide insurance.)<br /><br />Employers are already constrained from acting on their judgment by not being able to decide for themselves whether they would like to provide insurance to their employees (nor to which employees they'd like to offer it). The new law will constrain their judgment even more, by saying that employers cannot even use knowledge of an employee or potential employee's health risks to control costs.<br /><br />What this will mean is higher costs for everyone: more money paid by employers to insure a higher-risk pool, and lower salaries as employers need to find a way to save the money spent on insurance. What we really need is a fully free market in healthcare -- but in the meantime, the use of genetic testing results in employment and insurance decisions should be left out of the purview of the government. If an employer wants to know the results of genetic tests, he should be able to ask his employees to show them (the employee can always refuse, but he is not free to demand that his boss continue to employ him if he does). It's unfortunate that the results of such tests are in fact relevant considerations for employers, but even if they were not (ie, if a free market existed in healthcare), it would be a violation of individual rights not to allow them to be considered.<br /><br />The way to keep people from being discriminated against based on their health risks -- not always a relevant consideration for job performance -- is not to ban discrimination. It's to ban the government regulations that made such factors "relevant" to hiring decisions in the first place.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-89092948282388515912008-04-22T17:34:00.003-04:002008-04-22T17:43:40.497-04:00The real price of pillsA common criticism leveled at pharmaceutical companies is that they fleece consumers by marking up the price of their drugs far above what it costs to make them. Perhaps Pill X costs 25 cents to manufacture -- and the manufacturer wants $20.00 a dose. Sounds like highway robbery by Big Bad Pharma, huh?<br /><br />The problem with this point of view is that it blithely ignores what it cost to <em>get</em> to Pill X.<br /><br />The cost of manufacturing a drug that someone else has already discovered might, in fact, be 25 cents a pill. That's why generic manufacturers can sell their drugs so cheaply. Not so for the innovator, the manufacturer who seeks to create a therapy no one has ever used before. The cost of developing a drug, from the time the molecule is first discovered in a test tube to animal trials to clinical trials first in small and then in large numbers of people, has been estimated at $800 million. Eight hundred million dollars -- and that estimate is several years old! (That number would be <em>much </em>lower if not for excessive governmental regulation of the pharmaceutical industry, by the way.) The generic company doesn't have to pay this cost -- it only has to show the FDA that its product contains at least a certain percentage of the active ingredient originally developed by another company. But the innovator does.<br /><br />If the innovating company bases prices only what it costs to manufacture its drugs, and not what it cost to develop them, it will quickly go bankrupt. If, as many industry critics would like, manufacturers were forced to price drugs according to the manufacturing costs alone, then existing therapies might be cheap for a while -- but there surely wouldn't be any new ones.<br /><br />Remember, it's not just about the pill. It's about what it took to get to that pill.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-41648313127416172452008-04-09T11:57:00.002-04:002008-04-09T11:59:00.574-04:00Going quiet for a whileJust a note to say that I won't be posting much in April, if at all, because I'm focusing my writing energies (outside of work, anyway) on an article about the FDA for <em>The Objective Standard. </em>I'm thrilled to be writing for a journal I respect, and I can't wait to show off the results!Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-91340004259402626962008-03-24T10:51:00.004-04:002008-03-24T11:20:20.357-04:00A revealing attitude about the human conditionJanet Maslin's <a href="http://www.nytimes.com/2008/03/17/books/17masl.html?ref=health"><em>New York Times</em> review</a> of Melody Petersen's book <em>Our Daily Meds</em> is as full of vitriol for the pharmaceutical industry as Ms. Petersen's book appears to be, citing a number of "dirty tactics." I'll focus on one criticism that the book levels at the industry, and which Ms. Maslin happily parrots: that Big Pharma "medicalizes" normal conditions, causing people to take drugs for diseases that aren't really diseases, and that everyone should just live with. Says the review: "[T]here are the business strategies that have created illnesses out of what used to be facts of life, labeled them as syndromes, and have hooked customers into long-term use of medication to cure them."<br /><br />I used to carry this sort of cynicism around with me myself. Seeing drugs like Detrol (is having to go to the bathroom often really a <em>condition?</em>) and now Mirapex (for "restless legs syndrome") obtain approval and get advertised endlessly, I wondered if this was indeed an insidious tactic of Big Pharma to get us all to take drugs we don't need.<br /><br />Then I realized the attitude that underlies this criticism: that some amount of suffering is inherent to the human condition.<br /><br />Think about it: Maybe it's within the scope of normalcy to have to go to the bathroom once an hour, but is it desirable? What if I have an all-day meeting with a client? Is it any comfort as I constantly excuse myself that what I am doing is "normal"? Even if my condition is "normal," might I be willing to spend the money to make things better than normal? What's wrong with that? We might as well ban makeup because it's "normal" for women to look plain, or ban luxury foods because it's "normal" to scratch food from the ground like our ancestors did.<br /><br />In a free market, each of us would be free to decide whether the risks and price of a drug are worth the benefits, whether the drug treats overactive bladder or ovarian cancer. There is no need for the paternalistic implication that some drugs are not worth it to <em>anyone</em> and, worse, the implication that to be human is to put up with suffering.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-7651130047905449772008-03-20T14:19:00.003-04:002008-03-23T23:36:34.133-04:00An aphorism in practiceMy boss, who has been a great mentor and friend to me for nearly five years now, once gave me a rather pithy piece of advice that I have always followed: "Never be good at anything you don't want to do." Be good at something, and someone, whether it's your boss, your best friend who wants a favor, or even the U.S. government, is going to want you to do it.<br /><br />So, when being good at a particular skill requires years of intense training and thousands of dollars in student loans, and the reward is that one can expect nickel-and-diming from insurance companies at best, and outright slave labor at worst, is it any wonder that medical students, while they may not have heard my boss's advice word for word, are refusing to be good at what they don't want to do? The <a href="http://www.nytimes.com/2008/03/19/fashion/19beauty.html?ref=health"><em>New York Times</em> reports this week</a> that medical students are choosing in droves, not to pursue the "needed" areas of medicine like primary care, but the more lucrative (and, not coincidentally, less regulated) fields of dermatology and plastic surgery. With Medicare and private insurance companies demanding increasing amounts of paperwork for decreasing amounts of remuneration, medical students can see that being a primary care physician isn't the high-paying career it used to be -- and they may quite rightly decide that four years of medical school followed by additional years of working long hours for low pay in a residency, plus taking out hundreds of thousands of dollars in student loans, is too high a price to pay to pursue that field. Why not, instead, spend that time and money learning a different area of medicine -- one with which neither the government nor private insurance concerns itself, and thus one in which a doctor can make more money with fewer headaches?<br /><br />Worse still is the situation with emergency-room care, as anyone who reads <a href="http://docsontheweb.blogspot.com/">M.D.O.D.</a> will know. "Outright slave labor," as I described the situation for a newly minted doctor, is no exaggeration in the ER, thanks to the Emergency Medical Treatment and Labor Act (EMTALA). EMTALA requires that emergency rooms treat any patient who comes in, regardless of his or her ability to pay. What this means is that ERs are paid for about one-third of the services for which they bill. That means slave labor -- doctors performing services for which they will never be paid, often for bums who treat the ER like their primary care physician because they "can't afford" to see a regular doctor (yet somehow manage to scare up enough money to fuel their cigarette habits). Unsurprisingly, emergency room doctors are following my boss's advice and deciding they won't be good at what they don't want to do -- so they leave the ER, or even leave medicine altogether. Hospitals are doing the same -- they don't want to lose money to patients who won't pay, so they refuse to be good at it, meaning they stop offering emergency-room care.<br /><br />The result of combining heavy regulations with "never be good at anything you don't want to do" is that care cannot be had by anyone, while availability flourishes in freer markets like dermatology and cosmetic surgery. If Americans want more people who are good at what we need them to do, we must create a free market -- so that that will be what doctors <em>want</em> to do.<br /><br /><span style="font-weight: bold;">Update:</span> Check out <a href="http://docsontheweb.blogspot.com/2008/03/not-doing-primary-care-is-like-living.html">this post at M.D.O.D.</a> for a firsthand account from a doctor who knows what it's like to do primary care -- and has chosen to be good at something else because it not only pays better, but offers him an easier workday.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-49075951620872974842008-02-26T11:22:00.002-05:002008-02-26T11:43:01.528-05:00Want universal health care? Get ready to quit drinking.Picture a few liberals in a bar, railing about the need for universal health care over their gin and tonic. If such people get their way, eventually you can kiss the "gin and tonic" part of that scene goodbye.<br /><br />Don't believe me? Just take a look at <a href="http://news.yahoo.com/s/ap/20080221/ap_on_re_eu/britain_alcohol_abuse;_ylt=ArgfGRtl6zx1b0rxRwLpr3lZ24cA">what's happening in Britain</a>. Citing, among other reasons, the higher healthcare costs to which excessive drinking leads, the British Medical Association is asking for higher taxes on alcohol, restrictions on the hours alcohol-serving establishments can be open, and the prohibition of "happy hour" drink promotions.<br /><br />If the government pays for health care, the government will look for ways to reduce the cost of health care...and that means any activity that could lead to an increase in costs will be taxed, restricted, or even banned. Fish and chips? Uh-oh, that could lead to obesity and heart disease -- better tax that. Contact sports? Uh-oh, that could cause injuries -- better restrict people to low-impact aerobics. Unwinding with a drink at the bar after work? That might mean a trip in an ambulance later -- better slap that down. Never mind that plenty of people are able to enjoy fattening food, playing sports, and alcoholic drinks in moderation -- they'll pay the price for those who don't.<br /><br />In a free market, the overweight and the drunk would hurt no one but themselves. (Obviously, drunk people do stupid things, some of which can injure or even kill others; but they should properly be prosecuted for the action, such as driving a car, that hurt someone, not the mere fact of their drunkenness.) If a drunk passed out on the sidewalk and was rushed to the hospital, the bill would be sent to him -- not to taxpayers -- and the rest of us could enjoy a glass of wine with dinner in peace.<br /><br />So if you're wishing for universal health care, be aware of all you're <em>actually</em> wishing for, and know that that includes paying more for your beer -- if you can get it at all.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-69574511408365003162008-02-15T12:37:00.002-05:002008-02-15T13:04:23.195-05:00Finally, an op-ed that gets it rightWhen discussing the drug industry, it's rare to see a voice in a major media outlet that isn't crying out against the supposed evils of "Big Pharma." That's why it was so refreshing to read Paul H. Rubin's essay, <a href="http://www.forbes.com/columnists/forbes/2008/0225/026.html">"A Free Lunch,"</a> in the current issue of <em>Forbes</em> magazine.<br /><br />Mr. Rubin points out the flaws in the arguments of drug industry critics, who usually bemoan the fact that marketing dollars "could be spent on research." As Mr. Rubin points out, cutting marketing spending would not result in an increase in research spending -- because if nobody will know about or buy a drug, why spend the money to develop it?<br /><br />He also argues that the expectation of academics and politicians is that doctors should learn about new products from supposedly unbiased sources such as medical journals, and not from drug reps, is unrealistic. What doctor has the time to read through all the relevant journals? While each drug rep would be expected to present information most favorable to his brand, no doctor deals with only one rep -- he or she would have access to presentations from competing companies, and would be able to use his or her own judgment in evaluating them. I would add to this observation of Mr. Rubin's that the drug rep's presentation is actually <em>less</em> likely to contain a great deal of favorable information than a journal article! Why? Because the FDA doesn't regulate journal articles, but it puts a tight muzzle on what can be said in presentations by industry representatives. I'm often responsible for writing such presentations in my job in pharmaceutical advertising, and I cannot count the number of times I've seen a piece of data in a journal article that would support the use of the product I'm working on, but that we cannot put in print because the FDA won't allow it.<br /><br />In short, Mr. Rubin argues that drug companies should be allowed to market their drugs to doctors without being demonized. I agree, but would add that even marketing drugs to doctors is a result of improper government intervention in healthcare. As I argued last year in <a href="http://reasonpharm.blogspot.com/2007/07/rx-for-largesse.html">"Rx for largesse,"</a> the reason that pharmaceutical companies devote so much money to wining and dining doctors is that prescription drug law makes the doctor, rather than the patient (who, after all, is the one consuming the drug and who will benefit or be harmed by it in the end), the decision-maker in pharmaceutical questions. If prescription drug law (which violates the right of a patient to put whatever substance into his body he pleases) didn't exist, then the drug companies' marketing budgets would be used not to market to doctors, but to <em>patients</em>. Then, a greater share of that money would go, not to buying lavish dinners for doctors, but to rebate offers and other means of competing for the <em>consumer's</em> attention, not the prescriber's. One can already see this with existing over-the-counter drugs: for example, while Tylenol does advertise to doctors to persuade them to recommend it for the treatment of arthritis, a far greater share of Tylenol's budget goes to coupons and other offers targeted directly at the consumer.<br /><br />The point is, government intervention in pharmaceutical companies' marketing efforts is <em>not</em> a good thing. Kudos to Paul Rubin for recognizing that -- and having the courage to say it.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-17771520024352245902008-02-05T11:58:00.000-05:002008-02-05T12:18:16.616-05:00It would be cheaper if you were deadA study funded by the Dutch government is challenging the notion that obesity costs governments money in the form of increased health care requirements (paid for by socialist governments), <a href="http://news.yahoo.com/s/ap/20080205/ap_on_he_me/obesity_cost;_ylt=Aj.dY9c3EWbVvBqhxJFpigPVJRIF">as reported by Yahoo! News.</a> The study investigators were surprised to find that, according to their computer models, a fit, healthy nonsmoker would actually cost the government <em>more</em> than either an obese person or a smoker. Why? Because fit, healthy people live longer -- long enough to need expensive treatments for chronic illnesses later in life. As Pieter van Baal, the leader of the study, admitted, lung cancer is not an expensive illness (even though it may be treated with expensive chemotherapy drugs) because it doesn't last very long: The life expectancy of a typical patient with lung cancer from the time of diagnosis is months, not years. Alzheimer's disease, on the other hand, which a fit healthy person might live long enough to succumb to, lasts for years and requires chronic treatment -- very costly to a government that pays for its citizens' health care.<br /><br />Nobody, including Pieter van Baal (quoted in the article as saying "We are not recommending that governments stop trying to prevent obesity") wants to say it out loud, but these findings beg the question: Wouldn't it be cheaper if we all died young, before the expense of being old comes on? Wouldn't it be better for government bureaucrats if everyone lived long enough to pay plenty of income taxes, but not long enough to impose the costs of their age-related illnesses? Perhaps instead of banning trans fats and slapping warning labels on cigarettes, the government should be handing out free tobacco and chocolate cake.<br /><br />Under a proper system of government, in which health care is a free market and not a socialist entitlement, such macabre ideas would not need to arise. The cost of each individual's own health care would be his or her own concern, and not the concern of bureaucrats and taxpayers. Each of us would make the decision to smoke or not to smoke, to maintain a healthy weight or not to, based on individual context and values, and each of us would pay the price -- financial or otherwise -- for that decision ourselves.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-61836409888079526862008-01-30T11:27:00.000-05:002008-01-31T23:36:08.640-05:00Stuck on the concretesWould you agree that the following is a proper goal in medicine: Making sure that medicines are prescribed only to those who would benefit from them, so that money is not spent needlessly on drugs that, at best, do no good (and may in fact do harm) to the patients that take them?<br /><br />Would you also agree that the government has a role in making sure that that goal is met?<br /><br />I believe the answer to the first question is "yes" -- but evidence shows that the answer to the second must be "no."<br /><br />The FDA, in its approvals process, is trying ever harder to make sure that drugs are only sold to patients who need them, and for whom there is solid evidence that the drug will do what it is supposed to do. Sounds good, right? Unfortunately, allowing the government to meddle in the sale of drugs this way is stifling innovation in medicine.<br /><br />When the FDA approves a drug for sale, the approval is not granted unconditionally. A manufacturer of women's clothing does not have to place any restrictions on who can buy its wares; if that means a man buys the clothes for the purposes of cross-dressing or an overweight woman buys an outfit she doesn't really fit into, the government doesn't care. Not so for a drug. FDA approval is always granted for a particular "indication." What is an "indication" in this context? "Indication" used to mean "for a disease" -- that is, if a drug was shown to be effective against breast cancer, the FDA would approve it for the treatment of breast cancer. But these days, indications are far more specific than that. The FDA generally will only approve a drug in the exact subset of people that was studied in a clinical trial: If a birth control pill was tested in women between the ages of 18 and 34, the drug will be approved only for women in that age group. If a prostate cancer drug was tested in men who had already been treated with X, Y, and Z chemotherapy drugs, it will only be approved for men who have already gotten X, Y, and Z.<br /><br />The problem with such concrete-bound definitions of when a drug can be used is that there is often no <em>reason</em> to use those concretes in the definition. There may be no reason why that prostate cancer drug wouldn't work in men being treated for the disease for the first time. There may even be evidence, in the form of another clinical trial, that it does work in that setting. Too bad: Because the FDA bureaucrats have only reviewed the information from the "already got X, Y, and Z" trial, that is all they will consider. Thus, the judgment of bureaucrats considering a limited set of information is expected to supersede a patient's own judgment as well as the judgment of his or her doctor, who may know much more data than the bureaucrats about the drug in general and <em>certainly</em> knows more about the patient he or she is treating.<br /><br />Take the following examples:<br /><ul><li><strong>Gardasil.</strong> Gardasil is a vaccine against human papillomavirus (HPV), one of the most common sexually transmitted infections. Its effectiveness was tested in girls and young women aged 9 to 26. Consequently, the FDA approved it only for women in that age group. But women older than 26 were not excluded from Gardasil's clinical trial because the vaccine was less likely to work in them; they were only excluded because, if a woman is going to contract the virus, she is likely to do so before the age of 26. There is no reason to suspect that a 27-year-old -- or a 37-year-old -- who has not been infected would not benefit from receiving the vaccine. Yet the FDA insisted on the age restriction in Gardasil's indication.</li><li><strong>Ixempra.</strong> Ixempra is a chemotherapy drug recently approved to treat breast cancer -- but only breast cancer that has spread to other organs in the body, and only after patients have already had treatment with three other specific types of chemotherapy. Again, there is no reason to believe that Ixempra would not work for a woman whose cancer had spread but who had not yet received all three of those other types of chemotherapy.</li><li><strong>Lybrel.</strong> Last year, <a href="http://reasonpharm.blogspot.com/2007/08/lybrel-study-in-wasted-resources.html">I wrote about</a> how Lybrel, the only birth control pill approved to be taken 365 days a year, is no different from taking another brand of pill and simply skipping the placebo pills, thus sparing a woman from menstruation. No other birth control pill can advertise this -- although there is no reason why any other birth control pill should not work.</li><li><strong>Avastin. </strong>Avastin is a cancer drug used in combination with chemotherapy to treat several types of cancer -- but not only does the FDA recognize only two of those types (colorectal cancer and lung cancer, and only after those cancers have spread to other parts of the body), it also dictates what chemotherapy drugs are considered acceptable to use in combination with Avastin. Despite ample evidence that Avastin works in breast cancer, the FDA has yet to approve it for that use. Furthermore, when Avastin is used to treat lung cancer, the FDA specifies that it must be used in combination with two specific drugs, paclitaxel and carboplatin. If patients want to receive Avastin in combination with the two related (and very similar) drugs docetaxel and cisplatin, that's just too bad -- again, there is no reason it shouldn't work.</li></ul><p>Doctors and researchers come up with new ways to use drugs far faster than the FDA can possibly hope to approve such uses -- and that's if the pharmaceutical company chooses to go through the lengthy and costly bureaucratic process of getting a new indication approved at all. As a result, the FDA's recommendations for how to treat patients lag far behind actual, current medical practice. How could they not? A bureaucracy cannot possibly match the speed of individuals and their doctors making the decisions that are, <em>individually, </em>right for them.</p><p>Perhaps some patients might not be comfortable trying a drug in a setting in which it has not been previously tested, such as 30-year-olds getting vaccinated with Gardasil. But should <em>all</em> patients be denied the ability to do so? Certainly not: That is a violation of the patient's right to purchase whatever drugs he or she wishes, and of the drug manufacturer's right to sell the drug to whomever it can.</p><p>Fortunately, at the moment FDA approvals do not necessarily limit the treatment patients actually get: Once a drug has been approved for sale, a doctor can prescribe it for uses other than those for which it was approved (so-called "off-label" usage). But the company cannot promote the drug for such uses -- for example, an Avastin sales rep is currently not permitted to say one word about breast cancer, even if a doctor asks him or her about it. And, because some insurance companies use FDA approvals to determine what drugs they will cover, patients may have to pay for so-called "experimental" use out-of-pocket, even though they have already paid for prescription drug coverage.</p><p>How much money has been wasted on obtaining additional FDA approvals because the scope of a first approval was unnecessarily narrow? How many patients have suffered or died because they weren't allowed to try a therapy that had every reason to work, and no reason not to? The FDA's clinging to concretes, rather than allowing patients and physicians to exercise their own judgment, is expensive indeed.</p>Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-29175644565426461312008-01-29T10:19:00.000-05:002008-01-29T10:32:22.739-05:00The wrong questionPropose a free market in health care to most Americans, and you'll immediately draw the question: "But how can we make sure everyone has health care?" Unfortunately, explanations of how a free market would make health care less expensive and more accessible are usually lost on those who ask that question.<br /><br />The proper response is that <em>it is the wrong question to ask.</em><br /><em></em><br />The measure of a proper health care policy is not how many people it covers, but how much it protects individual rights. So the right question to ask is, "What policy will violate no one's rights?" where a "right" is properly defined, not as entitlement to the product of someone else's work, but as the freedom from interference in one's life by others.<br /><br />It is beside the point that poor Americans <em>would</em> have options in a free market -- they would be able to afford more drugs and physicians' services as the free market makes them cheaper, they could purchase insurance that covers only the services they are likely to need (saving money by not paying for services they won't need), they could turn to private charity if necessary. This is not what makes a free market in health care the only proper policy.<br /><br />What <em>does</em> make a free market the right choice is that it protects individual rights: the right of physicians to offer their services at whatever price the market will bear, the right of pharmaceutical companies to profit from the sale of lifesaving drugs, the right of patients to select only the services they want and can afford.<br /><br />Saying you support the defense of rights rather than the coverage of everyone may get you called "heartless." I submit that nothing is more cruel and heartless than slavery -- which is what government interference in health care produces. That's why it is so important to ask the right question.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-39260026696428024192008-01-10T10:41:00.000-05:002008-01-10T12:29:50.404-05:00Misguided generosityThis being an election year, HIV/AIDS activist groups are demanding that presidential candidates commit to ever-larger amounts of foreign aid for Africa's massive epidemic. An estimated 25 million of the 40 million HIV-positive individuals in the world live in sub-Saharan Africa, where HIV is still a virus that kills, not one that is managed like a chronic disease as it is in the United States. Sadder still, though the infection of children has been all but eliminated in the United States due to more vigilant testing and better methods of preventing mother-to-child transmission, more than 2 million children in sub-Saharan Africa have HIV. The cry is continually raised for more foreign aid to combat the problem.<br /><br />Yesterday, I was speaking to a woman who frequently travels to Africa for her job, which is related to HIV/AIDS. She spoke of a problem of what she called "misplaced generosity" -- that philanthropic organizations, anxious to do good in Africa, send over sophisticated equipment for testing and treatment, but the equipment ends up unused in basements because clinics lack electricity or other resources required to use that equipment. What Africa really needs, she implied, is donations of more basic needs: water purification, food, anti-HIV medicines. I submit that even these gifts are misguided in their generosity.<br /><br />Pharmaceutical companies, charitable groups, and governments are already sending billions of dollars' worth of help to Africa in the form of free or at-cost drugs, simplified testing equipment, water-purification tablets, and the like. Yet the epidemic still rages. The solution, say many activists, is more of the same: more money, more free drugs, more donated condoms, more volunteer health care workers.<br /><br />Let us consider the environment to which such gifts would be sent. In many parts of Africa, tribes still believe that witches exist and that evil spirits cause disease. Understanding of how HIV is transmitted and treated is so limited that the belief still pervades that sex with a virgin can cure HIV. (Appallingly, this belief results in thousands of child and even infant rapes every year.) Untold numbers of young girls have their genitalia brutally mutilated in the name of myth and religion. Massive governmental corruption, fighting between rival groups, and even outright genocide, not freedom and individual rights, are the order of the day.<br /><br />Assuming one wants to help Africa (out of a sense of benevolence, not out of a sense of obligation or because one's help is being extorted through taxes), how can throwing more anti-HIV drugs, more equipment, and more doctors be the answer? Yes, the lives of some patients will be extended -- so that they can live in desolate poverty (or in fear that, having been saved from the human immunodeficiency virus, they will be killed by <em>humans</em>) because no rational, proper system of government exists to protect them and because they themselves likely hold irrational beliefs that make it impossible to live as a human being. In other words, not only is throwing more money at the problem not working, it merely allows those who do get treatment to continue living in a miserable situation.<br /><br />What Africa needs to combat the AIDS epidemic -- and myriad other problems as well -- is not money, drugs, and equipment, but <em>reason. </em>Only under a proper system of government, and with a populace that believes in the efficacy of reason, not destructive myths, can the HIV/AIDS epidemic be slowed or stopped. Only a rational understanding of the causes of HIV can slow the spread of transmission; only capitalism can provide the incentive for men of the mind to build the infrastructure Africa so desperately needs so that those who are already infected can get treatment. With good ideas, Africa would not need financial help to defeat the epidemic -- because with reason and capitalism, Africans could solve the problem on their own.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-72208776048221892162008-01-09T22:03:00.001-05:002008-01-09T22:09:14.646-05:00Two excellent reads on health careI'll be returning with more original posts soon, but in the meantime I wanted to point out two excellent articles illustrating the need for a free market in American health care:<br /><br /><a href="http://www.theobjectivestandard.com/issues/2007-winter/moral-vs-universal-health-care.asp">"Moral Health Care vs. 'Universal' Health Care,"</a> by Lin Zinser and Paul Hsieh. While <span style="font-style: italic;">The Objective Standard</span>'s articles are normally accessible only to subscribers, this important piece on the history of health care regulation in America and the reasons why medical care should be a free market, is free.<br /><br /><a href="http://www.forbes.com/business/2008/01/08/health-republican-plans-oped-cx_ybr_0108health.html">"The Right Vision of Health Care,"</a> by the <a href="http://aynrand.org/">Ayn Rand Institute</a>'s Yaron Brook. Along similar lines as the Zinser/Hsieh article, with the ominous note that Republicans are no better than Democrats at making health care the free market it ought to be.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-65129096037869114512007-12-12T14:39:00.001-05:002008-01-09T22:10:34.448-05:00The nanny state and your breastsBreast cancer patients have been dealt a setback: <a href="http://www.nytimes.com/2007/12/06/business/06avastin.html?ref=health">Last week, a federal advisory panel recommended to the FDA that it should not approve Avastin</a>, a cancer therapy first brought to market in 2004, for the treatment of breast cancer.<br /><br />The setback is not necessarily in terms of a lifesaving therapy being lost. Rather, it's the right of a patient to choose what therapy she gets.<br /><br />You see, while Avastin has already been approved for the treatment of advanced colorectal and lung cancers because the drug has been shown in clinical studies to extend the lives of patients (albeit by only a few months) when added to conventional chemotherapy, the data in breast cancer are more equivocal. In a large clinical trial, patients who received Taxol, a chemotherapy drug that has been available since the early 1990s, either with or without Avastin. The patients who got Avastin didn't necessarily live longer than those who didn't, although their tumors stopped growing for a longer period of time.<br /><br />On the surface, it looks like the advisory panel's decision is perfectly correct: if Avastin doesn't extend the life of a woman with breast cancer, why should it be sold for that purpose?<br /><br />The medical response to that question is: It's not as clear-cut as that. Many, many drugs are available to treat breast cancer, and women at the advanced stage of the disease (the type of women who were studied in the Avastin trial) are likely to get several of these drugs in succession. And, once the treatment given to a patient on a clinical trial stops working, she is not denied future treatment (indeed, it would be a violation of her rights to bar her from getting it). But, while treatment is tightly controlled while a patient is "on study," so to speak, the minute she stops taking study therapy, the course of her treatment is up to her and her doctor. That means we have no idea what treatment anybody on the Avastin study received after they stopped taking Taxol or Taxol and Avastin. Could some of the women who got Taxol have gotten treatments after the study that were better than the women who got Taxol and Avastin did? Yes -- in fact, it's even likely that some of them received Avastin itself, because the drug was already approved for sale at the time the study results (which many doctors considered positive) were first released in 2005. So it isn't clear at all that Avastin gave patients no survival benefit, because treatments given after the study could have extended patients' lives to the point that any benefit given by Avastin would have been obscured.<br /><br />But that's the medical answer. The <em>moral</em> answer is that pharmaceutical companies have a right to sell their product unhindered by the government, and if a breast cancer patient wants to buy Avastin, she should be allowed to do so without the nanny state's interference. What if the patient understands the fact that Avastin may not necessarily extend her life, but she would like to use it anyway because her tumors are making her physically uncomfortable and she'd like to keep them from growing as long as she can? What if she would rather have Taxol and Avastin for a year than have her course of treatment changed one or more times within that same year, as is likely if she were to stick with already approved drugs? Too bad; the nanny state has already made her decision.<br /><br />At least with Avastin, breast cancer patients can still get the drug; it has been approved for other uses, and the FDA has not yet gone so far as to forbid doctors from prescribing drugs for uses other than those approved. But it's a violation of both Genentech's and breast cancer patients' rights that such an end run has to happen in the first place.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-86269483779918493812007-11-26T17:00:00.000-05:002007-11-26T17:53:04.870-05:00In the battle for universal health care, there are no winnersAs the 2008 presidential election approaches, the Democratic hopefuls are arguing about health care. Each candidate claims that his or her plan will lower costs and provide coverage to more Americans. Nowhere is the question asked: should universal health care be a goal at all?<br /><br />Apparently, American politicians have learned nothing from the examples of Canada, the UK, and the like. Canada and the UK provide health care to all citizens -- or do they? In fact, while the national health services of both countries technically guarantee care to citizens, the reality is long waits for even the most basic services, a chronic shortage of healthcare providers, and technology that lags behind that of the US. This is no accident -- not that American politicians have figured that out.<br /><br />Instead of asking how we can provide health insurance to each and every American -- since providing it to each and every Canadian and Briton clearly has not worked -- why not ask instead whether health insurance as we know it makes any sense at all?<br /><br />Compare health insurance to other types of insurance with which you are familiar: fire, car, homeowner's, etc. What does insurance typically cover? When you buy car insurance, for example, you buy coverage for the catastrophic costs of highly unusual situations: the cost of replacing your car and paying medical bills should you be involved in a serious accident, for example. What you don't buy is "insurance" to pay for gasoline, oil changes, or even a part that won't wear out until the car has been driven for ten years. It wouldn't make sense to do so -- in order for the insurance company to remain in business, it would have to charge you the cost of those routine supplies and repairs, plus a premium for the salaries of its workers, the rent for its office building, and other costs, not to mention profit. So if car insurance covered gas and routine maintenance, its cost would go up astronomically. It would no longer be "insurance" for an unpredictable catastrophe, but a regular maintenance fee -- and it would cost more than covering regular, <em>predictable</em> expenses yourself.<br /><br />Health care is no different. Health "insurance" as we know it covers not only truly catastrophic, rare events (such as a cancer diagnosis or a heart attack), but also a vast array of predictable, regular expenses like birth control pills, annual checkups, and psychological therapy sessions. Americans could save money by planning and paying for these expenses out of pocket, and saving health insurance only for the rare healthcare crisis.<br /><br />I'll use myself as an example. I've been in the work force for seven years now. Throughout those seven years, my employer and I have paid, in total, about $400 per month, or $4,800 per year, for my health insurance. So, that's a total of $33,600 paid for my health insurance.<br /><br />How much health care have I gotten for that amount? I'm a very healthy 29-year-old who doesn't engage in risky behavior: I'm in a monogamous relationship, I drink perhaps once a month, I don't smoke, and although heart disease runs in my family, I do my best to lower my risk by exercising five or six days a week. I see my gynecologist once a year (and I'd probably see him less often if prescription drug law didn't require me to come back every year to get my birth control pill prescription). Including the Pap smear he performs every year, that's about an estimated $300 per visit, or $2,100 in the last seven years. My birth control pills are partially covered under my insurance; that's another $500 per year, or $3,500 total. I visited the emergency room for a fainting spell that turned out to be dehydration earlier this year; the bills from that visit added up to about $5,000. I see a doctor at most once a year if I should happen to get a cold I can't shake. Let's call that $150 per visit, or $1,050 total. I'm usually prescribed penicillin at these visits, which my insurance does not cover because it costs less than my co-pay.<br /><br />Add all of those medical bills up, and you get $11,650...which isn't even close to the $33,600 that my employers and I have put into the system. The rest is used by my insurance company to pay for other people's care -- other people who are probably engaged in more high-risk behaviors than I am. Why should I pay for that? And it is I who am paying, even though my employer shoulders most of the cost on paper -- that $4,800 per year could have gone to my salary. Given my druthers, I'd drop the plan I have in favor of catastrophic coverage to take over at, say, the $25,000 mark, the point at which my savings would be strained by a medical emergency. Such coverage would run me less than $100 per month -- so the total bill for all the care I've received to date, plus the cost of catastrophic coverage, would still fall short of what I've actually paid.<br /><br />The obvious liberal response to my example is: But you're low risk. What about people who aren't so lucky?<br /><br />First of all, it isn't entirely luck; a great deal of my good health is due to my good choices. If Americans weren't insulated from the cost of their lifestyle choices -- if smokers had to pay more for health insurance because of their higher risk for lung cancer and other health problems, if the obese had to pay more because they're more likely to require treatment for apnea or request a gastric bypass, if IV drug users had to pay more because they're at higher risk of infectious diseases -- then perhaps they would choose to modify their lifestyle to save some money. Furthermore, even for the high-risk individual, <em>insuring for regular expenses still doesn't make sense.</em> The insurance company has to stay in business; how will it do so if not by adding a premium to what those regular expenses normally cost? And, most importantly, a person's high risk for health problems does not constitute a claim on anybody else's time or money. Healthcare is a good, not a right; it has to be traded for like any other good, not extorted from the pockets of others. For those who cannot pay their own expenses, family, friends, and private charity may be inclined to benevolently help out; but even if they don't, the sick and indigent do not have a claim on the well and the wealthy.<br /><br /><em>This</em> is why socialized medicine -- even socialized medicine dressed up in the guise of "private insurance" where the insurers have no right to select who gets covered or how much they pay -- can never work. It has not worked in Canada or the UK, and it will not work in America. Would that there were a presidential candidate who understood that.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-47365164925114756222007-11-14T15:02:00.000-05:002007-11-14T15:25:24.392-05:00Black box tautologyIn FDA parlance, the "black box warning" is the most severe with which a product can be tagged. The information contained in the black box warning is considered so important by the FDA that the manufacturer of a drug must place it at the top of the prescribing information included with the drug, contained in the eponymous black box for prominence. Furthermore, any drug with a black box warning is considered a sufficient safety threat that no advertising for that product may be made without prominently featuring the warning on the advertising. Drugs without black box warnings can advertise without devoting column space or TV time to "fair balance" (read: bashing their own product) as long as they make no claims about their product -- that's why you'll often see an ad with nothing more than a drug's logo, or perhaps an "Ask your doctor about Drug X," without any text saying that Drug X works, or even what it's used for. But even this type of advertising is forbidden to a drug with a black box warning. Merely using the colors in the drug's logo is enough to force the manufacturer to include the content of the warning in the advertisement.<br /><br />What triggers a black box warning? Usually, the FDA requires one when a product has been linked to an increased risk of death or life-threatening or debilitating side effects, even when the increase in risk is small.<br /><br />In the case of the diabetes drug Avandia, however, the FDA has slapped down a black box warning because, as <a href="http://news.yahoo.com/s/ap/20071114/ap_on_he_me/diabetes_drug;_ylt=ArGGI6lLn8XdRiaPEQNviTfVJRIF">this Associated Press article</a> puts it, "it may, or may not, increase the risk of heart attacks."<br /><br />Wait. Because it "may or may not"? Isn't that a tautology? Isn't that true of <em>any substance whatsoever?</em><br /><br />According to the FDA, currently available study results are contradictory as to whether Avandia indeed increases the risk of heart problems. Which means: there isn't enough evidence to convict Avandia, but there's enough to convince some power-hungry bureaucrats to handcuff GlaxoSmithKline, maker of Avandia, as they see fit.<br /><br />Of course, even though the evidence is inconclusive enough that FDA panel members voted 22 to 1 to keep Avandia on the market for the time being, the black box warning language itself hardly conveys that to patients. Here is what doctors and patients interested in Avandia will read when they open the product package: "A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive." Notice that the scary words "showed Avandia to be assocaited with an increased risk..." come well before "the available data on the risk of myocardial ischemia are inconclusive," not to mention the total lack of mention of the <em>magnitude </em>of increase in risk. (See Monday's post, <a href="http://reasonpharm.blogspot.com/2007/11/statistics-in-context.html">"Statistics in context,"</a> for a fuller explanation of why this is misleading.)<br /><br />That the FDA is unafraid to shackle pharmaceutical companies inside black boxes full of maybes and perhapses is disgraceful. The FDA ought to be given its own black box warning: "'Innocent until proven guilty' doesn't apply to us."Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-73167345988322990562007-11-12T16:54:00.000-05:002007-11-12T17:15:43.658-05:00Statistics in contextIf a news article reported that Drug X doubles your risk of cancer, what would you say? "I better throw out my prescription now"?<br /><br />Nope. The correct response is, "I need more information."<br /><br />A perfect example is <a href="http://blogs.orlandosentinel.com/features_healthblog/2007/11/pill-raises-cer.html">this quickie blog post</a> on the Pill and the risk of cervical cancer, added to the <em>Orlando Sentinel</em>'s news blog. The post warns that "New research suggests that women who take the pill for at least five years have nearly double the risk of developing cervical cancer." Ouch! I'd better quit the Pill, huh? Yet, just half a sentence later, the post admits, "The increased chance is small, according to the researchers. In developed countries, there are 8.3 cervical cancer cases among every 1,000 women who take the pill. The non-pill takers have a slightly lower rate of 7.3 per 1,000." (Note that this is an incorrect citation of <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140673607616845/abstract">the original <em>Lancet</em> paper</a>, which states that these incidence rates are for <em>less</em> developed countries.)<br /><br />How come "nearly double the risk" sounds so terrible, and "8.3 per 1,000" versus "7.3 versus 1,000" doesn't sound so bad at all? The answer is that risk in medical studies is calculated as a relative number. The "nearly double" pronouncement was made based on the <em>relative risk ratio</em>, a number statisticians calculate meaning that, based on the data collected in their study, a woman on the Pill at any given time would have about twice as much chance of developing cervical cancer as she would if she were not taking the Pill. What this number doesn't tell you, however, is the <em>absolute </em>change in her level of risk. Does the Pill mean she goes from a 50% chance of having cervical cancer to a 100% chance? Or does she go from a 1% chance to a 2% chance -- or even from an 0.1% chance to 0.2%? The statistic doesn't tell us that -- but as a woman taking the Pill, <em>that </em>is the information I most want to know. As it turns out, for women in developed countries, 3.8 out of every 1,000 women who do not take the Pill are expected to develop cervical cancer by the age of 50; the number rises ever so slightly to 4.3 of every 1,000 in women who do take the Pill.<br /><br />Armed with the <em>absolute,</em> and not just the relative, differences in risk, I can make a decision based on my own personal context. Is this increase in risk large? No. Are the benefits I get from taking the Pill large? Yes, definitely: I have an easy, affordable, effective method of making sure I don't get pregnant. In my personal context, are the benefits worth this and other risks I'm aware of? Without a doubt.<br /><br />Next time you're reading about risk, don't forget that while statistics are valuable, they shouldn't be used as scare tactics. Get the numbers in full context -- both the context in which they were gathered, and the context of your own life. Only then is an informed decision possible.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-88439758998491707252007-11-07T13:06:00.000-05:002007-11-07T13:24:56.779-05:00From goddess to girlThese days, it's rare to see a healthcare story that inspires me to write in praise of men, rather than to write about their irrational policies. So it was a breath of fresh air to read about the <a href="http://news.yahoo.com/s/ap/20071107/ap_on_re_as/india_eight_limbs;_ylt=AqBrTZGR58SkUzaMK52AATLVJRIF">southern Indian toddler with 8 limbs</a> having a successful removal of the extra arms and legs. For those who haven't followed this story in the news, a two-year-old girl, Lakshmi, was born with eight limbs due to a parasitic twin, somewhat like a Siamese twin that stopped developing while still in the womb. Unable to walk, she was nonetheless revered as a reincarnated goddess by others in the village in which she lives; her eight limbs gave her a resemblance to her namesake Hindu goddess. Today, Lakshmi has just four limbs thanks to the work of doctors at a hospital in Bangalore, and while she still has more surgeries ahead of her, she now has a chance of living a normal life.<br /><br />The things to love about this story:<br /><br /><strong>Reason triumphs over mysticism.</strong> The girl's parents could have decided that their daughter was indeed Lakshmi reincarnated, and that they shouldn't tamper with the body of a goddess. Instead, they realized that their daughter is a human being who could not have lived a normal life in the body she was born with. Says the AP article: <em>"It will be great to see our daughter have a normal body," her father Shambhu, who only goes by one name, told reporters. "We were worried for her future."</em><br /><br /><strong>Voluntary charity.</strong> Lakshmi's family could not afford the estimated $625,000 cost of her surgery; the doctors of Sparsh Hospital performed it for free. No government coercion was involved, only the kindness of skilled medical personnel to a child.<br /><br /><strong>Medical skill.</strong> Lakshmi's surgery involved not only the removal of limbs, but also of the parasitic twin's organs; furthermore, Lakshmi's spine had to be separated from her twin's spine, to which it was fused. And since parasitic twinning is a very rare occurrence, this cannot have been a procedure to which any of the physicians involved were accustomed. More than 30 surgeons and 24 hours were required to complete the operation. They are heroes.<br /><br />There's much to admire in young Lakshmi's story. I wish her a happy and healthy life in her new body, and I salute the doctors who gave it to her.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.comtag:blogger.com,1999:blog-6079510670221899835.post-66417847286557951372007-11-03T19:36:00.000-04:002007-11-06T15:13:06.002-05:00Survey says: Unreason!<a href="http://news.yahoo.com/s/afp/20071101/hl_afp/ushealthobesitytobaccorights;_ylt=Ao1lmNLoJot_kKFMN.edhcKISbYF">Yahoo! News reports</a> that a Harris poll indicates Americans believe employers who fire employees for smoking or being overweight should not do so.<br /><br />One can, in a way, understand the frustration of those polled. Unless a job is physically demanding (such as police work) or requires a certain appearance in order to be performed well (such as modeling), one's obesity or smoking has no direct effect on the ability to perform work -- so why should it be a consideration in hiring or firing? In a free market, rational employers would realize this and not base employment decisions on an employee's health habits. (Irrational employers would have the perfect moral right to use lifestyle as a criterion in choosing employees -- and they alone would pay the price by limiting the size of their applicant pool to exclude many qualified applicants.)<br /><br />The problem is that we <span style="FONT-STYLE: italic">don't</span> live in free-market conditions. Under the current legal system, employers are obligated to provide health insurance for full-time (and many part-time) employees. They aren't allowed to ask those with unhealthy lifestyles to bear a greater share of the cost of their insurance. This drives the cost of health insurance up -- and because insurers are increasingly not allowed to discriminate between those with poor health habits and those with good ones, that means that <span style="FONT-STYLE: italic">everybody's</span> rates go up. So, all of a sudden, that highly qualified candidate who also happens to be a chain smoker doesn't look so attractive any more. Maybe he'll be passed over for the job in favor of a less qualified, but healthier, candidate. Not the optimal decision when it comes to getting the job done, but when the full price of hiring -- benefits and all -- is taken into account, it's often the better business decision.<br /><br />The solution to the problem, many feel, is to put laws on the books forbidding employers from firing employees based on health status. But shackling employers to expensive employees only drags down productivity and violates the employer's moral right to hire and fire for any reason -- or no reason. The answer is fewer requirements for employers, not more -- employers should not be forced to provide health benefits, which some employees may not even want or need.<br /><br />So, to those who answered the Harris poll saying that no one should be fired for his or her health habits, you can have what you ask: Just advocate for a free market, in which such a policy would make perfect sense.Stellahttp://www.blogger.com/profile/07219727425604646356noreply@blogger.com