Posts tagged FDA

OC OTC

Of course birth control should be available over-the-counter.

Shared Article from Change.org

Food and Drug Administration: Tell the FDA to Permit Over The Co…

The American College of Obstretics and Gynecology believes that birth control pills should be made available over-the-counter and many countries...

change.org


#ReproductiveRights #YourBodyYourChoice #NoVictimNoCrime

See also.

Dialogue ensues

Here are some comments I recently posted in reply to some of the commentary on yesterday’s Freeman column. I repost them here because they are long and detailed enough that they may be of some independent interest.

In an early comment, John Irby writes:

If it was so that medical care and mutual aid was so easy to come by, then why was their a perception that the poor and elderly were dying sick in the streets?

It depends on what period this “perception” is supposed to apply to.

  1. If you’re referring to the heyday of the mutual aid societies in the late 19th century through the 1910s, the answer is simply that this “perception” exists because statists often promote bogus perceptions of crisis without much supporting data, in order to put over the need for their desired programs with the politicized public. Some actual data on the circumstances faced by the poor and elderly, rather than impressionistic and sensationalistic “perceptions” would be useful here. I have some actual data on how available these arrangements were to ordinary workers, which I present briefly in the article — typically between 20% and 50% of workers in major urban areas in English-speaking countries were covered, and these numbers were rapidly rising in the 1900s, prior to the political campaigns to eradicate the associations and raise medical prices. If you want a fuller presentation of the data, I recommend David Beito’s excellent book, From Mutual Aid to the Welfare State, especially Ch. 6, “The ‘Lodge Practice Evil’ Reconsidered.” If you have actual countervailing data that tends to cut against the conclusion I draw, feel free to present it, but if what you’ve got is just ill-specified “perceptions,” well, so what?

  2. If, on the other hand, you’re referring to the decades leading up to the passage of major government entitlement programs for the “poor and elderly” — programs like Social Security (1935) or Medicare (1965), then you need to keep in mind that these programs were introduced and rolled out decades after the non-corporate, grassroots, free-market alternatives that I discuss in the article had been deliberately dismantled by politically-driven campaigns — coordinated mainly by establishment medical guilds, using their power over government licensure of practitioners as their primary means of enforcement — to drive them out. (The blackballing campaigns against lodge-practice doctors in the U.S. ramped up in the mid-1910s and succeeded in forcing dramatic declines in lodge practice starting in the 1920s. See Beito, p. 124 et seq.) So, to the extent that government could point to a crisis of health care accessibility or affordability for the poor and elderly, just before the New Deal and Great Society transfer programs were created, it’s because government was pointing to a situation where the kind of grassroots, consensual social organizations that had made health care accessible to the poor and elderly had already been rubbed out by government in the decades prior. Once again, an example of government breaking your legs, then handing you crutches, and telling you, “See, without me you couldn’t even walk!”

John:

However I am not ready to drink the cool-aid …

I don’t want to be a dick about this, but can you not use that phrase when what you mean is I don’t accept your delusional beliefs? It’s an offhand jokey reference where the punchline is the murder of 276 children, and the senseless deaths of almost 1,000 people, just 30 years ago. Jokes like that suck.

John:

… and say that we need to rid ourselves of the FDA or of medical accreditation. Kevin Trudeau is a salesmen of alternative cures for a variety of ailments [etc., etc.]

The existence of quacks and dangerous drugs today, in spite of already-existing heavy government regulation, seems like an odd argument for relying on government regulation as a means of getting rid of quacks and dangerous drugs.

In any case, the free-market position is not that we need to get rid of drug testing or medical accreditation. The free-market position is that the state should not force any particular scheme for drug safety or efficacy testing, or for medical licensure, on you or me without our consent.

The important thing, from the standpoint of individualist principle, is that, if you want to pay for snake oil without any consideration of demonstrated effects, you should be free to do so. And if I want to spend money only on drugs that scientific research has demonstrated to be safe and effective, or on doctors who have garnered the recognition of their peers as honorable and competent professionals, then I should be free to patronize only those that consensual consumer-protection outfits and professional medical institutions have approved.

In a freed market, there will certainly be both drug testing and medical accreditation; it will simply be drug testing and medical accreditation that relies on informed choice, or education and persuasion, rather than on the force of the law. How do I know that such institutions will exist? Well, of course, because they already exist, or have existed in the past. Before the modern prescriptions system was created in 1951, the role of objective watchdog for drug safety and efficacy in the U.S. was handled by the American Medical Association (which maintained a private drug-testing laboratory and published annual guidebooks of drugs that received their seal of approval). They provided a system of voluntary, independent oversight that worked — until government “fixed” it.

Similarly, nobody that I know of is proposing that existing methods of accrediting doctors or other medical practitioners be abolished. Where would you get such a ludicrous notion? There’s already plenty of non-governmental means of accrediting doctors — among them, well, the doctoral degree in medicine, which is issued by medical schools and still would be issued by medical schools in a freed market, based on standards of training and mastery. Similarly for nursing degrees, certification by professional associations like the AMA, etc. What radical individualists oppose is not accreditation, but state licensure laws, which add an unnecessary layer of politically-directed licensing restrictions on top of already-existing, voluntary professional standards and certifications within the medical profesion. The problem with this is, first, that they are coercive, and hence violate the rights of patients and practitioners; and, second, that the standards for governmental licensure are imposed through political decision-making and legislative fiat, rather than being determined through open debate and consensus over best practices within the health care market.

As a result, they often use the force of the state to shut down debate and impose requirements that have nothing to do with medical fact and everything to do with political pull — as when state licensure laws were used to attack feminist women’s health centers, midwives, or other alternative medicine providers, even without any evidence that any identifiable patients had been harmed or were even dissatisfied with the service. Or, to return to our original topic, when state licensure laws were used to blackball doctors who were providing perfectly adequate care, but who were seen as “underselling” (that is, providing competent care at costs that were affordable by ordinary working people) during the political campaign against lodge practice in th 1910s and 1920s.

John:

The truth is that of all the industrialized countries, America is the only one with a private for profit system, …

Didn’t you read the article? “America” doesn’t have a private health care system. It has a government-imposed health care system. The market is dominated first, by direct government control, and, second, by the operations of a handful of corporate privateers who depend entirely on a combination of government subsidy and government-imposed barriers to entry for their day-to-day operations and long-term strategy.

A freed market in health care would look completely different from the “system” that you and I face today.

In a later comment, a different John — John de Laubenfels — writes:

Would you give companies that research and produce new drugs NO protection from competition,

You are correct that I do not believe that protectionism for pharmaceutical corporations is an adequate argument for imposing government-granted monopolies.

If you want to “protect” pharmaceutical companies’ existing business models, do so on your own dime by boycotting competitors and directing your money to first movers. (Hey, it worked for Tolkien.) But I’m not nearly so invested in protecting current business practices in the pharmaceutical industry, and I’d rather that you don’t use government monopoly to force your protections on my pocketbook.

John de Laubenfels:

starting the moment someone gets ahold of the new drug, analyzes it, and creates a knockoff? Nothing for all the money the original company has spent doing trials? I don’t think that such a system would be either fair or likely to motivate companies to produce new, life-saving drugs.

On the cost of doing drug trials, of course, in the same sentence where I advocated the abolition of patents I also specifically stated that I supported the abolition of the FDA, which would dramatically reduce the compliance costs involved in developing new drugs and bringing them to market. So I don’t know what you’re referring to here. (Of course, if companies want to do internal testing they can do so, but in voluntary independent oversight systems, the costs of running trials are typically assumed by the independent watchdog organizations themselves, as part of their institutional charter.)

However, if it turns out that it’s no longer profitable for big, for-profit corporations to do medical research, then — horrors! — it may just turn out to be the case that medical research has to be carried on by non-corporate or not-for-profit institutions. But I hear we have some of those. And I’m not typically impressed by broken-window arguments that fail to take any account of the value of the unseen alternative uses to which money might be put, if not for the coercive government intervention.

How physicians learned to stop worrying and love Big Pharma

You could also call this How Government Solved the Health Care Crisis, Part II; Part I being Roderick’s excellent article from 1993, on the government’s deliberate obstruction of mutual aid societies (in order to raise medical costs), and the havoc that it’s wreaked on the medical insurance system ever since.

As a follow-up in a similar vein, here’s an interesting bit I stumbled across in Robert Whitaker’s Mad in America (2002); the topic came up in the course of explaining how neuroleptics, and thorazine in particular — first marketed as chemical lobotomies, later repackaged as antipsychotics — took American psychiatry by storm during the 1950s. An essential part of the process was the destruction of private, independent oversight over the therapeutic value of drugs — a medical watchdog system that worked, until government fixed it.

After World War II, global leadership in drug development began to shift from Germany to the United States, and it did so because the financial opportunities in the United States were so much greater. Drug manufacturers in the United States could get FDA approval for their new medications with relative ease, since at that time they did not have to prove that their drugs were effective, only that they weren’t too toxic. They could also charge much higher prices for their drugs in the United States than in other countries because of strong patent-protection laws that limited competition. Finally, they could count on the support of the influential American Medical Association, which, as a result of a new law, had begun cozying up to the pharmaceutical industry.

Prior to 1951, the AMA had acted as a watchdog of the drug industry. In the absence of government regulations requiring pharmaceutical companies to prove that their medications had therepeutic merit, the AMA, for nearly fifty years, had assumed the responsibility of distinguishing good drugs from the bad. It had its own drug-testing laboratory, with drugs deemed worthwhile given the AMA seal of approval. Each year it published a book listing the medications it found useful. Drug companies were not even allowed to advertise in the Journal of the American Medical Association unless their products had been found worthy of the AMA seal. At that time, however, patients could obtain most drugs without a doctor’s prescription. Drug companies primarily sold their goods directly to the public or through pharmacists. Physicians were not, in essence, drug vendors. But in 1951, Minnesota senator Hubert Humphrey cosponsored a bill, which became the Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetics Act of 1938, that greatly expanded the list of medications that could be obtained only with a doctor’s prescription. While the amendment was designed to protect the public by allowing only the safest of drugs to be sold over the counter, it also provided doctors with a much more privileged status within society. The selling of nearly all potent medications now ran directly through them. As a result, drug companies began showering them, and their professional organizations, with their marketing dollars, and that flow of money changed the AMA almost overnight.

In 1950, the AMA received $5 million from member dues and journal subscriptions but only $2.6 million from drug-company advertisements in its journals. A decade later, its revenue from dues and subscriptions was still about the same ($6 million), but the money received from drug companies had leaped to $10 million—$8 million from journal advertisements and another $2 million from the sale of mailing lists. As this change occurred, the AMA dropped its critical stance toward the industry. It stopped publishing its book on useful drugs, abandoned its seal-of-approval program, and eliminated its requirement that pharmaceutical companies provide proof of their advertising claims. In 1961, the AMA even opposed a proposal by Tennessee senator Estes Kefauver to require drugmakers to prove to the Food and Drug Administration (FDA) that their new drugs were effective. As one frustrated physician told Kefauver, the AMA had become a sissy to the industry.

— Robert Whitaker, Mad in America (2002), pp.148–149

State Leftists who write on the medical industry routinely — rightly — talk up the corrupting effects that drug industry money and favors have had on the practice of medicine. But what they need to realize is that this is not some kind of disease endemic to a free market in medicine, or caused by the inevitable contamination from filthy lucre. Until 1951, there was no problem with drug companies bribing doctors to serve as drug-pushers; physicians’ organizations served as a system of voluntary, independent oversight on the claims of the drug industry — until, that is, the government shoved its way in to fix the problem of overhyped medication. What we found out is what we should have known all along: cartelization corrupts, and absolute cartelization corrupts absolutely.

EC OTC in OZ

Update: fixed typos and relocated the Extended Entry into the main text.

Here’s some more good news on the Emergency Contraception front: while the FDA process has advanced to the point where EC will probably be available over-the-counter sometime or another soon, Australia is quickly moving one step ahead of the United States: Emergency Contraception is set to become available over-the-counter in Australia tomorrow, January 1.

This isn’t to say that Australia’s EC situation is advanced over that of the United States in every respect. One major difference is that whereas the medical community in America largely supports the FDA’s move towards OTC availability, the medical community in Australia is at best nervous about the move, and in some cases directly opposed. The main issue for them, though, seems not to be the sort of religious Kulturkampf that flares around the American side of the debate. Rather, Australian doctors just seem to be more accustomed than American doctors to controlling the medical lives of their patients, and more jealous at giving up that power. For example, consider this Foucaultian bit of paternalism:

But Australian Medical Association president Bill Glasson said he was concerned that pharmacists were not legally required to record a woman’s visit.

I think that they really need to rediscuss how it is going to operate in the interest of good medical care, Dr Glasson said.

The pharmaceutical society’s national president, Jay Hooper, said many pharmacists would take it upon themselves to record each time a woman wanted the pill.

Not that American doctors don’t also sometimes engage in this tracking and scummy hectoring. At the Auburn University Student Health Center, for example, you could obtain EC—but they’d note when you got it, throw a bunch of red tape in your way, and if I recall correctly, they’d only let you have it once a semester. (The idea in both cases is for doctors to be able to lecture women that they decide are making unhealthy lifestyle choices. I am all for encouraging women to make healthy lifestyle choices, but I can’t imagine that an emergency situation to prevent a pregnancy is the appropriate time to do it, or that forcing women to listen by restricting access to EC until you’re done lecturing them is the appropriate way to go about it.) But the American medical community does not seem particularly squeamish about giving up that control if it means that women are more able to prevent unwanted pregnancies: the American Medical Association and the American College of Obstetricians and Gynecologists both lobbied for, and strongly supported, the FDA advisory panels’ decision. In Australia, however, the Australian Medical Association seems nervous and is ready to develop their own house guidelines to try to minimize the freedom it will offer women.

I don’t think, incidentally, that the attitude is a matter of misogyny, exactly. But it is directly connected to patriarchy—it’s a matter of the authoritarian sense of entitlement that modern doctors have always felt and acted out vis-a-vis their patients. The condition exists in Australia and America both, but with regard to over-the-counter pills the Australian medical community seems to have divorced itself from it less than their American counterparts. Consider: at the same time as EC becomes available over the counter for the first time in Australia, so will ibuprofen. And this has caused no small degree of consternation for the Australian Medical Association:

Also from Thursday stronger pain relief medication will be available in supermarkets, a move that has angered and confused doctors and pharmacists. Dr Glasson said the pain killer ibuprofen, contained in products including Nurofen, should only be sold under the supervision of pharmacists. It’s a dangerous move and it’s a backward step.

Patients have to look at the medical aspects of these drugs and get good advice that only the friendly pharmacist can give. Paracetamol is much kinder on the stomach.

Ibuprofen, an anti-inflammatory drug, was only available in pharmacies until the Government ratified the new regulations in October.

Products containing ibuprofen have been available in supermarkets in the US since 1984 and in Britain since 1996.

The teeming masses of Ozzies will now be able to buy Advil without a doctor’s learned advice! O tempora! O mores!

But however the doctors and pharmacists may whine, the women of Australia have every reason to celebrate. A happy New Year’s to the reproductive rights community in Australia — good show!

Signs and Portents for EC OTC

Good news this month for women’s reproductive freedom! The widespread availability of emergency contraception (EC) is one of the main breakthroughs for women’s reproductive freedom in the past 10 years. So it’s even better to see that two advisory panels of the FDA recently voted to recommend that EC be made available over-the-counter without the need for a doctor’s prescription. You need to take EC within 72 hours of unprotected sex for it to prevent an unwanted pregnancy, and it gets less effective as time goes on; waiting around for a doctor and a pharmacy are not always a viable option. And there is no possible case to be made that it fails the FDA requirements for over the counter availability. Drugs are supposed to be made available OTC when (1) it is safe to use without a doctor’s supervision, and (2) the instructions are simple enough for self-medication based on the included instructions. That EC is safe, and doesn’t need close observation from a doctor, has been made obvious by all the scientific data and by the past 30 years of experience with both off-label uses of conventional oral contraceptives, and dedicated morning-after pills like Preven and Plan B. How about the simplicity of use? Well, here I’ll defer to Connie Schultz, who investigated the matter for the Cleveland Plain Dealer:

Still, … I thought it only fair that I try to decipher them for myself. The kind folks at Planned Parenthood of Greater Cleveland gave me a sample packet. To make it as difficult as possible, I imagined being a sexually active teenager who had abstinence-only sex education.

Would I, could I, understand what I was reading?

Instruction No. 1: Take the first tablet as soon as possible within 72 hours of unprotected sex.

Instruction No. 2: Take the second tablet 12 hours after you take the first tablet.

I think we women can handle it.

This is some great news. Unfortunately, it is only a promissory note for things to come: the FDA nearly always follows the recommendations of its advisory panels, but even if it is pretty sure that it will make EC over the counter, it is entirely unclear when it will do so. The Bush Administration’s FDA has a long record of foot-dragging on this issue, and it has taken two years of untiring activism to get to this point — quite in spite of the fact that the petition obviously meets all the relevant criteria. But the most recent events are a victory to be celebrated, and the light at the end of the tunnel is now in sight.

Now, here’s a question: chemically, Emergency Contraception is indistinguishable from a large dose of conventional oral contraceptives; dedicated EC drugs were developed based on a good 30 years’ worth of doctors’ off-label recommendations for using OCs. (If a patient needed emergency contraception, the doctor would offer a prescription for OCs and suggest that the patient take several at once.) So if safety and ease-of-use arguments show that EC meets the FDA’s requirement for over the counter drugs, then a fortiori they ought to show that the good old birth-control pill meets those requirements too. So while we work towards getting the government out of women’s medical decisions for the morning-after pill, why shouldn’t we also start thinking about a campaign to get the government out of women’s medical decisions for the conventional birth-control pill too?