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NoahBriggs
12-11-2007, 11:00 PM
Yes, this is somewhat post-war, but applicable towards today - for many reasons.
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The 100th anniversary of the FDA marks a milestone in medicine before which cranks and charlatans ran amok

by Daniel Loxton
photo

Lydia Pinkham, as she appeared on an original antique advertising card, circa 1880.

This year has represented a little-remarked-upon major milestone in American medicine: the 100th anniversary of active Federal regulation of food and drugs. The Pure Food and Drug Act came into effect on January 1st, 1907 — the first step toward the creation of the modern Food and Drug Administration (FDA), and a step forward from the dangerous anarchy of the patent medicine era.

For the first time, drug manufacturers were required by law to disclose the dosage and purity of their products (including, for the first time, disclosing whether they contained poison, alcohol, or narcotics such as heroin or cocaine). They were also required to refrain from deliberately lying about their products, and from fraudulently substituting a claimed ingredient for some other ingredient.

Bizarrely, such laws were needed.

To celebrate this anniversary, and in time for the holidays, we’re pleased to share a brand new, free MP3 recording of a song with roots extending back to the bad old days of unrestrained snake oil: “Lily the Pink” (performed here by the Canadian bluegrass trio Dirty Dishes).

“Lily the Pink” (which evolved from “The Ballad of Lydia Pinkham”) is a comic send-up of the woman called “the queen of patent medicine.” Starting in 1875, Lydia Pinkham built a business empire on the hype-driven sales of a herbal concoction marketed to women for relief of “all those Painful Complaints and Weaknesses so common to our best female population.” In specific, it was intended to address menstrual cramps, and was also “particularly adapted to the Change of Life.”

True to the dizzy style of the unregulated patent medicine era, Lydia E. Pinkham’s Vegetable Compound was promoted with a blizzard of unlikely claims. (As the lyrics of “Lily the Pink” mockingly put it, “She invented a medicinal compound, efficacious in every case.”) Ad copy insisted that it cured everything from headaches to indigestion to farting, not to mention sleeplessness and depression. (Its primary ingredient was booze, so there was no doubt some evidence to support these latter claims.)

Less believably, Pinkham’s Compound was advertised to “dissolve and expel tumors from the uterus at an early stage of development. The tendency to cancerous humors there is checked very speedily by its use.” It was also, the ads said, remarkably effective: “98 out of every 100 women who take the medicine for the ailments for which it is recommended are benefited by it. This is a most remarkable record of efficiency. We doubt if any other medicine in the world equals it.”

Remarkable indeed.

It’s clear that most of these boasts were made up whole cloth, but was any of it true? I asked quack medicine expert Dr. Harriet Hall, “Was Pinkham’s herbal cocktail at all useful for treating anything?”

“The bottom line,” Hall told me, “is that we have no idea whether her product was effective or safe, since it has never been properly tested. We have no good evidence that any of the individual components are safe or effective, and we have no way of knowing what might happen when you mix them. Mixing remedies could do almost anything — they could cancel each other out, have additive effects, vastly increase the chance of side effects, who knows?”

Certainly the Lydia Pinkham Medicine Company had no idea whether its product was safe or effective. It was literally something Pinkham brewed up in her basement, without scientific testing of any kind.

On the other hand, we do now have firm evidence regarding the efficacy of black cohosh, the herb modern alternative medicine proponents most often cite as the effective active component to Pinkham’s Compound. Long considered promising as a treatment for the symptoms of menopause, black cohosh unfortunately bombed in a recent large trial designed by the National Institutes of Health to clarify the ambiguous existing literature and settle the question. The results of this randomized, double-blind, placebo-controlled trial were unequivocal: black cohosh is useless for the control of menopausal hot flashes and night sweats.

As far as science can tell, Lydia’s Compound was worthless in public health terms. By free market standards, however, it was a soaring success story. Pinkham’s booming 19th century enterprise raked in hundreds of thousands of dollars a year.

To be continued . . .

NoahBriggs
12-11-2007, 11:02 PM
The secret, then as now, was marketing. Pinkham spread the message through national print ad campaigns, door-to-door sales, point of purchase postcard giveaways, and many books and pamphlets that alternated recipes or household tips with ads for her product. The company’s aggressive marketing pioneered a formula for selling quack medicine that is still common today:

1. Market directly to women: At the mercy of a male-dominated medical establishment, women were eager to seize control of their own health. Offering them a way to sidestep the then-primitive medical mainstream through the consumption and word-of-mouth promotion of a herbal “alternative” was (and still is) an effective hook for a sales pitch. With its “just us girls” attitude and its “Only a woman can understand a woman’s ills” tagline, the Lydia Pinkham Medicine Company turned shameful social inequality into a source of profit.
2. Sow fear of mainstream medicine: “ANY HOSPITAL EXPERIENCE is painful as well as costly and frequently dangerous,” warned Food and Health, a promotional book produced by Pinkham’s company. “Many women have avoided this experience by taking Lydia E. Pinkham’s Vegetable Compound in time…”
3. Present your big business as warm, folksy and personal: With Lydia Pinkham’s matronly portrait as its logo, the company was able to present itself as a homemade cottage enterprise. (Fans of the animated TV series Futurama may recognize “MomCorp” and its subsidiary “Mom’s Friendly Robot Company” as comic descendants of the Pinkham advertising model.) Customers who wrote for advice even received personal responses from Lydia herself — for years after she died. In fact, a large, dedicated department within the company churned out replies by the thousands.

Today, this time-tested advertising model — present your mainstream competitors as cold and mercenary, while presenting your own for-profit company’s herbal products as warm, homemade, and natural — is still in wide use in the alternative medicine industry. Indeed, it’s shocking how little has changed.

Today, herbal concoctions and other supplements are cooked up and marketed with wild abandon, with all the unrestrained, unverified boasting of the patent medicine era still on display. We are told (coyly, skirting the few rules for labeling) that herbs and proprietary blends can cure more-or-less anything — just as we were assured by Lydia Pinkham.

Have we really made so little progress against health fraud?

In fact, we’ve come a long way. Today, most medicines are carefully regulated, and consumers can be reasonably assured of the basics: that effectiveness, side effects and interactions are known to some degree; that the bottle contains what the label says; that we are not unknowingly buying bottles of heroin, and so on. We all know that regulation comes with its own cost (drugs take a long time to get to market, for example) but we’re much, much better off than drug consumers in Pinkham’s day.

Unfortunately, current regulations have a hole in them, a hole large enough to drive a truck through — or rather, truckload after truckload of untested, unregulated herbal “supplements.”

The fault for this lies with a piece of legislation called the Dietary Supplement Health and Education Act of 1994 (DSHEA), which seized back control of patent medicines from the FDA. Driven by strenuous lobbying from supplement manufacturers, this legislation removed all herbs, vitamins, and minerals from FDA oversight — despite the fact that herbs are drugs, exhibiting a full range of effectiveness (or ineffectiveness), dangerous side effects, and interactions with other drugs. Not only are the producers of herbal drugs and other supplements no longer required to prove that their products work — or whether they are safe — but the burden of proof regarding safety is explicitly shifted to the FDA.

That is, anyone can sell any old combination of herbs at any dosage, without any obligation to even try to find out if that product is safe or not.

Only if a supplement kills enough people to get the FDA’s attention, and if the staff of the FDA can find the time and budget, can the FDA then attempt to prove in court that the supplement is unsafe. This costly and lengthy close-the-barn-door-after-the-horses-have-escaped procedure is of course attempted only rarely, and in the most severe cases. The first such case was the banning of ephedra, a supplement suspected in hundreds of deaths. This ban was soon challenged in court (by a company which sells ephedra), and overturned — on the basis that the DSHEA forbids FDA action even in such an extreme case. Luckily, the ruling against the ephedra ban was itself overturned on appeal. After more than two years of legal battles, ephedra supplements are today illegal.

Despite this eventual victory on this one substance, the DSHEA renders the FDA almost powerless over herbal drugs, even if they are known to be dangerous. (Certainly the FDA has no power at all over herbal drugs whose dangers are simply unknown.) This industry-driven legislation inexplicably shifts the cost of safety testing from the companies that profit from the sales of supplements to the taxpayer. More to the point, the risk is shifted from the R&D budgets of companies to the personal health of individual consumers — exactly where we began, in Lydia Pinkham’s day.

Thanks to the DSHEA, the supplement industry has exploded (by several hundred percent or more). It now rakes in tens of billions of dollars a year. Requiring no expensive safety testing or FDA approval, these products are produced with an enviable profit margin, which has of course drawn large pharmaceutical corporations enthusiastically into the supplement industry. (People buying “alternative” herbal products rarely appreciate the likelihood that they are feeding their dollars into the exact same Big Pharma system they are attempting to circumvent, with the only difference being that corporation has been excused from the responsibility or cost of ensuring the safety or effectiveness of one of its lines of drugs.)

We’ve come a long way — but we’ve also, in some ways, come full circle.

This is a shame, because the room for mischief we’ve granted to modern alternative medicine manufacturers is the exact same ground we won at such great cost and effort from the early 20th century patent medicine industry. Like today’s Natural Cures infomercial star (and convicted con-man) Kevin Trudeau, the Pinkham company engaged in a series of running battles with Federal regulators regarding the dishonesty of its labeling and advertising. As is still the case, vagueness and coy insinuation became the best friends of quack medicine manufacturers. (Noting yet another label change in 1939, Time magazine quoted the American Medical Association’s exasperated patent medicine czar: “Lydia E. Pinkham’s Vegetable Compound is ‘Recommended as a Vegetable Tonic in Conditions for which this Preparation is Adapted.’ This statement is about as informative as it would be to say that ‘For Those Who Like This Sort of Thing, This is the Sort of Thing That Those People Like.’”)

It’s clear that we still have much work to do in this important public health arena:

In 1875, one business empire was founded on the sale of Lydia Pinkham’s Vegetable Compound, an untested medical potion for “those painful Complaints and Weaknesses so common to our best female population.”

Today, after a century of wrestling with the patent medicine industry, another company markets an alternative medicine concoction promoted as “beneficial in menstrual and menopausal distress.”

It is called Lydia Pinkham Herbal Compound.

Rob
12-12-2007, 06:14 AM
http://www.codehot.co.uk/lyrics/qrst/scaffold_lily.htm

sbl
12-13-2007, 05:55 AM
Noah,

I've been by there a few times.


"TDF is located in the historic Lydia Pinkham Building in Lynn, MA."

http://www.tdfmetalfinishing.com/history.asp

rpd_girl
12-29-2007, 03:36 PM
very cool.

amity
12-30-2007, 03:18 AM
My issue with the article is that it picks one alternative treatment to discredit alternative medicine generally. The fact is, much of alternative medicine is proving to be quite safe and effective under scientific trial. Much of traditional alternative medicine proved to be so effective in fact that it has now been coopted by allopathic medicine (i.e. digitalis). Like anything else, it needs to be administered through a competent practitioner. Casual dabblers do not have the knowledge needed to make good use of it.

hanktrent
12-30-2007, 06:54 AM
Much of traditional alternative medicine proved to be so effective in fact that it has now been coopted by allopathic medicine (i.e. digitalis).

In the case of digitalis, though, that happened in the 1700s, right? By the Civil War, it was recognized by the US and London pharmacopoeias and was a solid part of mainstream allopathy.

What are some examples of 19th century alternative medicine that wasn't accepted by allopaths then, but is now?

Most of the examples I can think of are negative, rather than positive. For example, the Thomsonians who said that calomel was bad. Yes, they were right, and allopaths now agree that calomel is bad. But they haven't co-opted Thomsonian lobelia either, in preference to more appropriate medicines.

Aspirin/willow bark? Already in the U.S. secondary pharmacopoeia as Salix at the time of the war. "The bark of the willow is tonic and astringent, and has been employed as a substitute for Peruvian bark, particularly in intermittent fever. It has attracted much attention from the asserted efficacy of salicin in the cure of this complaint."

What's an example of an alternative medicine from the 1860s, that was rejected by allopaths then, but has been proven effective and become a treatment of choice today? I'm sure there were some, but I just can't think of any.

Hank Trent
hanktrent@voyager.net

amity
12-30-2007, 10:05 AM
I wasn't speaking with specific reference to the civil war, Hank, but to last Wedensday! Many of the herbal treatments are now shown to act on neurotransmitters, a new field of research and previously unable to be demonstrated practically. Chelation looks very likely to be proven to reduce atherosclerosis, although the study is still ongoing. Chriopractic has been shown to affect blood flow, and therefore enervation, to organs. Vitamin C and other substances like ozone and hydrogen peroxide are increasingly viewed as an effective adjunct to conventional cancer treatment. Visualization techniques and biofeedback are looking pretty good, too. If you look back over the last few years of articles in the New England Journal of Medicine, JAMA, and other professional publications you can find quite a few articles that address different aspects of "alternative medicine." One of the M.D.s I type for is quite into it and cites the journal articles fairly frequently, and often prescribes "alternative therapies" for his patients. I believe he would be what is called a complementary or integrative practitioner himself, with one foot in each camp, as am I. I have only read a couple of those articles myself, once my curiosity was aroused. I only hope the day isn't coming where it is all subsumed under allopathic medicine, because those of us who do not have health insurance will no longer be able to afford it.

At any rate, coming from a background in allopathic medicine, I would say that many aspects of other medical philosophies, pharmacopoeia, practicum, are also right on, black cohosh to the contrary notwithstanding. The main problem I see with much of alternative and complementary medicine is that consumers tend to look at it in reductionist terms, i.e. "my eyes look a little yellow, it must be my liver, so I am going to try some milk thistlle. Milk thistle is good for the liver." It does not work that way. Alternative therapies are every bit as subtle and profound in their actions, AND every bit as dangerous, as modern chemical drugs are. They need someone who knows what they are doing to be truly effective, and research, though promising, is really just beginning.

Look at how osteopaths were frequently viewed in the 19th cent. Now they have every bit as much professional credibility and respect as M.D.s and are addressed accordingly as "Doctor" by everyone.

hanktrent
12-30-2007, 03:25 PM
If you look back over the last few years of articles in the New England Journal of Medicine, JAMA, and other professional publications you can find quite a few articles that address different aspects of "alternative medicine."

Ah, I see! Yep, seems like there's always been a constant stream of treatments which begin as unproven, alternative, or "word-of-mouth" remedies, for lack of a better term, that get noticed, get tested, and finally become incorporated into mainstream medicine.

There's also a steady stream of treatments in both alternative medicine and allopathy that are widely accepted, then shown to be ineffective and are abandoned.

Seems like it's always two steps forward and one step back, but at least the general trend is forward!

Hank Trent
hanktrent@voyager.net

Longbranch 1
12-31-2007, 02:59 AM
Sirs,

Curious as to your feelings about historical, documented , and safe, home remedies. *Not for sale, mind you.

Here in WNC those remedies abound. Passed down through the generations from the "Old Country", but most have Native American origins.

I have used some of these since childhood without ill effect. I am gathering as much info as I can from some of the old-timers in order to write some of these down.

A lot of these are seasonally and part particular to each plant. ( Only the root, After the berry, etc..)

* Slight skewer on this topic.
I'll bet that at least 90% here have consumed a product with ginseng.
Gum, tea, heck , even Coke with ginseng.
The last I dug this season sold for $980 a dried pound.
Not too bad for a day's walk in the fall mountain woods.

Thanks,
Kevin Ellis,
26th NCT

NoahBriggs
12-31-2007, 03:59 AM
If you are referring to remedies from specific parts of specific plants, then I'd classify that as herbology, which does march hand-in-hand with a lot of regular medicine, because a lot of the remedies and pharmaceuticals of the period were in fact plant- as well as mineral-based.

My educated guess would be that you could - in theory - document the remedies back to the Native Americans. The obvious logic is that as people living off the land they would be familiar via oral recitation and memory which plants did what, and their doctors or spiritual leaders knew they'd get the results they needed.

The problem with the folklore is that it can be changed and/or embellished as it's passed down from one person to another, especialy if it's transmitted orally and the original person who discovered its use may not have written down where he got his information. (And that doesn't imply dishonesty, either. Maybe the person could not write and trusted his/her memory.)

Hank pointed out in an earlier post on another topic that the idea the remedy can be traced back to the Indians may have been added to increase the medicine's legitimacy (and retail appeal for patent medicines), somewhat the same way we kick around the term "organic" for foods and other items, foods and so on. I think a couple of weeks back we critiqued a home remedy list. Most of the remedies seemed to work on the post hoc and placebo effects.

Longbranch 1
12-31-2007, 04:32 AM
Noah,

Another problem I've encountered in research is the variety of different names for the same plants.

One man's "Bloodroot" is another's "Indian Root".
One man's "Old Man" is another's " Goat's Beard".

The same specimen, but it can sure add to the confusion.

Thanks'
Kevin Ellis

hanktrent
12-31-2007, 04:44 AM
Curious as to your feelings about historical, documented , and safe, home remedies. *Not for sale, mind you.

Well, I'll chime. I'm sure others will have different opinions.

In modern life, I'm more skeptical than most, when it comes to medicine. I rarely take any, and ironically, I rarely need any.

The fact that I'm over-sensitive to most medicines and need smaller-than-normal doses probably made me skeptical as a child, because I saw parents and doctors as people who forced me to take stuff that made me sicker, when I was already feeling miserable.

It was only when I grew up and could explain I was having negative side effects and needed the dose adjusted, that I realized medicine could actually make you feel better!

So I try never to mix my modern opinions about real-life medicine, with historic research. Otherwise, it's like the neo-Confederates who take personal offense at criticism of the south and therefore need to spin the past to show their side was "right."

And really, I don't think there's as wide a gap between folk medicine and allopathy as most people think. All medicine is a mixture of the placebo effect, unrecognized or tolerated negative side effects, and actual benefits. So it's not that I'm pro-allopathy and against folk medicine. In modern life, if I needed a remedy, I'd research both equally.

There's no overall type of medicine from the 1860s that I can think of, that didn't enthusiastically include things we know are wrong today, mixed in with useful medicine, and when interpreting 19th medicine, all of it needs interpreted together. So whether a remedy really works, from our modern viewpoint, is irrelevant to me.

And, also, folk medicine has changed over time just like modern medicine. I remember visiting a modern herbalist interpreting at an early 19th century historic village, with bags of real herbal medicine really for sale. I asked if she had any lobelia--not that I wanted it; I was there for the history. No; she'd barely heard of it. That would be as silly as an early 19th century allopath barely having heard of calomel. Some folk remedies are still common, some go in and out of fashion, and only historic research can pinpoint which is which.

As far as getting rich in the modern world with period remedies: I'd go for homeopathy! No active ingredients necessary at all, and people still buy it and swear by it today!

Hank Trent
hanktrent@voyager.net

amity
12-31-2007, 10:51 AM
Hank pointed out in an earlier post on another topic that the idea the remedy can be traced back to the Indians may have been added to increase the medicine's legitimacy (and retail appeal for patent medicines), somewhat the same way we kick around the term "organic" for foods and other items, foods and so on. I think a couple of weeks back we critiqued a home remedy list. Most of the remedies seemed to work on the post hoc and placebo effects.

Actually the term "organic" has a very specific technical meaning, and is regulated for various products in the U.S. It is not a kick around term.

Leaving herbalism to one side, because I think that is pretty technical too, one old remedy I remember from my youth was massaging temples for a headache. This works very well, depending on the source of the headache. Another was hot poultices for localized infections. Another was tying a red cloth around one's forehead for a headache, and still another was putting a raw egg in a bowl under the bed for a cold or flu. Not sure of the rationale of these last two at all. They go back aways, but not sure how far, or in what region of the U.S., among what socioeconomic class or ethnic group, etc. The Foxfire books have a bit about home remedies, but I would look for a period source before I portrayed them. Also many of the cookbooks and household management books for women seem to have had sections on home remedies.

NoahBriggs
12-31-2007, 12:20 PM
Actually the term "organic" has a very specific technical meaning, and is regulated for various products in the U.S. It is not a kick around term.

Indeed it does. However, not everyone knows the specific definition and never bothered to learn, so they have their own definition of "organic". Or there are other people who have created their own definition of organic, to satisfy their own social agendas.

Point being, "based on an old Indian receipt" was often applied by the medicine manufacturers in an effort to lend legitimacy to their products.

amity
12-31-2007, 12:25 PM
Indeed it does. However, not everyone knows the specific definition and never bothered to learn, so they have their own definition of "organic". Or there are other people who have created their own definition of organic, to satisfy their own social agendas.

Hopefully they know better than to put it on their labelling, or the relevant federal authorities will get 'em! That area of agriculture is especially heavily policed.