A Triumph of Astroturf
posted by GJ on May 28, 2008 @ 7:32AM

A Triumph of Astroturf?

How a consumer protection law may be defeated
by a faux consumer watchdog campaign

by Daniel Loxton

Is it possible for a vested business interest to derail national legislation by posing as a consumer watchdog? We’ll soon learn whether a shadowy mail order drug company’s fierce, artificial grassroots campaign will rob the Canadian people of an important public safety law.

In April 2008, Canada’s federal Parliament began considering a proposed law¹ — Bill C-51 — that would revise the body of laws regulating food and drugs in Canada (the Food and Drugs Act). Of particular interest to skeptics, C-51 would finally allow Canadian federal health authorities (Health Canada) to enforce existing laws² that require substances sold under the multi-billion-dollar “natural health products” umbrella to be safe, unadulterated, honestly labeled, and marketed with supportable claims.

Although regulated in Canada since 2004, natural health products nevertheless enjoy a hothouse climate of easy licensing, minimal oversight, and toothless enforcement — which C-51 is designed to improve. “For instance,” Health Canada noted in a recent press release, “in dealing with cases of counterfeit [drugs], Health Canada has been limited to imposing a maximum fine of $5,000.”³

Think about that for a moment. The U.S. Federal Drug Administration estimates that “upwards of 10% of drugs worldwide are counterfeit, and in some countries more than 50% of the drug supply is made up of counterfeit drugs.”⁴ Counterfeits may contain any active ingredients in any amount, poison, or no active ingredient at all. Yet, if a Canadian company earns millions selling dime store candies in medicine bottles, Health Canada is powerless to fine them an amount they’d even notice. Bill C-51 would raise the maximum fine to a heftier deterrent of $5,000,000 (more if the offense is “reckless” or “willful”).⁵

Health Canada’s limited enforcement powers have created a wild west landscape in which the good, bad, and ugly parts of the supplement industry have all thrived. Not surprisingly, many — especially the shadiest operations — would like things to stay just as wild as they’ve been.

Amazingly, one supplement company’s sly manipulation of public opinion could accomplish just that.

The Anti-C51 Campaign

Like most Canadians, the first things I heard about C-51 were bad. I became aware of Bill C-51 when, largely in advance of mainstream media interest, dozens of “stop C-51” themed common interest group pages suddenly appeared on the social networking website Facebook. With alarming titles like “Stop bill C-51 from banning all natural health products!”⁶ these pages promote wildly unlikely claims about C-51, while urgently soliciting people to attend scheduled protest rallies and write letters to their Members of Parliament (MPs). “A new law being pushed in Canada by Big Pharma seeks to outlaw up to 60 percent of natural health products currently sold in Canada,” runs one often-repeated claim, “even while criminalizing parents who give herbs or supplements to their children.”⁷ Tens of thousands of people joined these groups within days.

Curious what the fuss was about, I took a look at C-51. It’s a complicated document (it amends the rules for matters ranging from drug manufacturing to fish inspection). However, its much-ballyhooed changes to the regulation of natural health products are actually quite modest.

Under C-51, the existing Natural Health Products Regulations (which came into effect in 2004 after extensive consultation with the natural health products industry) remain the law of the land. Even the standards for compliance action remain the same (a standing risk-based policy⁸ that explicitly deemphasizes vitamins, minerals, and homeopathic preparations). C-51 merely increases Health Canada’s ability to deter criminals from ignoring the existing laws.

Conspicuously absent from C-51 are provisions to “make garlic illegal” or “outlaw herbs, supplements, and vitamins” or the other dire consequences the internet furor kept warning me about. So where were these outlandish ideas coming from?

It seems that most of the blogosphere, much of the mainstream media, and perhaps even some Members of Parliament were drawing their arguments from a single source: an apparent consumer watchdog website, www.stopc51.com. The Stopc51.com website is slick, professional, and profoundly misleading. It presents screamingly hyperbolic misinformation under the guise of an urgent democratic appeal to Canadian citizens. “CALL TO ACTION” read the homepage headline over a lovely graphic of the Canadian flag. “YOUR FREEDOM AND HEALTH IS AT RISK!”⁹

What risk, exactly? The site urges us to “send our fact sheet to everyone you know.” According to the fact sheet, “Bill C-51 will … remove 70% of Natural Health Products from Canadians” and worse, “Punish Canadians with little or no opportunity for protection or recourse for simply speaking about or giving a natural product without the approval of government.” If you “give another person an ‘unapproved’ amount of garlic” this will “warrant action.” What sort of action? According to StopC51.com, “Inspectors will enter private property without a warrant … take your property at their discretion” and even “seize your bank accounts.”¹⁰

This is implausible on the face of it, of course. The idea that the Canadian federal government has the authority, inclination or even the manpower to storm the homes and seize the bank accounts of everyday folks for using garlic or vitamins is patently ridiculous. Federal authorities can’t even control the flow of marijuana, let alone police the herbs in your garden. (These claims distort C-51’s worst-case-scenario provisions for supplement manufacturers who flagrantly ignore the Food and Drugs Act: for example, Health Canada may impound drugs found to be counterfeit, adulterated, or poisonous.)

Nevertheless, many people who read these allegations were prompted into action. Which was the idea. Organizing protest rallies and urging Canadians to write and phone their MPs in complaint, the StopC51.com campaign spread the word through the web and through mass emails. The conspiratorial International Advocates for Health Freedom mailing list noted with approval that over 18 million emails had been sent to “dietary supplement consumers, supplement company CEOs, health food store owners, Naturopaths, Chiropractors, and other Alternative Practitioners triggering massive traffic to http://www.stopc51.org [sic]. So many people have been accessing the site that at times it won’t open and at other times the images on the site can’t be seen due to the effects of the traffic.”¹¹

The Company in the Shadows

But who was behind it all? Nothing at StopC51.com disclosed the authors of the site, nor did the site provide a contact address for the site’s administrators.¹² This coy façade was evidently good enough for many anti-C-51 activists, who promoted the url and the claims from the site without probing the heavily biased source.

But, it was a pretty thin facade: the 1-888 contact number for StopC51.com rally organizing¹³ is actually the phone number for a controversial online supplement company called Truehope Nutritional Support Ltd. (also called the Synergy Group of Canada Inc — both entities share the same directors and are involved in selling the same product¹⁴ ). In fact, the rally information number even spells “1-888-TRUEHOP.”

I sent formal requests to both Truehope and Truehope’s CEO asking for clarification of the relationship between Truehope and StopC51.com. I received no reply, but I was still able to further confirm the connection: the Stopc51.com domain was registered by one Ian Stewart, who remains the Administrative Contact for the site.^15,16 Mr. Stewart is the “the director of regulatory affairs for Truehope.”¹⁷ His mailing address, listed with the Stop.c51.com domain registration, is Truehope’s P.O. Box.^18,19

The primary organizer for the anti-C-51 campaign was revealed to be a vested commercial interest — a vested interest with a very shadowy history.²⁰

This is not the first time Synergy/Truehope has tangled with Canadian health authorities. Truehope has long been embroiled in a series of battles with Health Canada regarding their drug “Truehope EMPowerplus,” which is a $70 per bottle mail order multivitamin²¹ sold for the treatment of bipolar disorder and “multiple deficiencies in numerous areas of the body including the Central Nervous System.” (Users are instructed to consume between one and two bottles per month.²² )

Not surprisingly, Health Canada doubted the implausible marketing hype that an overpriced multivitamin was successful in “reducing/eliminating the symptoms of bipolar disorder and other mental illnesses in thousands of individuals.”²³ In any event, Health Canada advisories explained, “It is a drug … which has not been approved for sale in Canada.”²⁴

Health Canada had a tough time even finding this outfit; investigators were reduced to undercover phone calls and simply asking passersby on the street.²⁵ Nor was Truehope cooperative once located. After several years of wrangling, it was still the case that “Truehope Nutritional Support Limited and Synergy, despite repeated requests by Health Canada, is still refusing to comply with the Food and Drugs Act and Regulations, and continues to sell its unapproved drug, EMPowerplus, in Canada.”²⁶ A police raid and court battle followed.

Why the fuss? “Our main concern,” Health Canada advisories warned, “deals with the unproven health claims being made about EMPowerplus, and the recommendation that patients decrease the dose of, or eliminate altogether, medications prescribed by their doctors. This can result in serious adverse health consequences. The drug is being promoted and sold to treat serious disorders, such as bipolar disorder, anxiety disorder, panic attacks, attention deficit disorder, schizophrenia, autism, Tourette’s syndrome, fibromyalgia and obsessive compulsive disorder. Serious central nervous system disorders such as these should not be self-medicated or self-diagnosed.”²⁷

Worse, Health Canada warned, there are reports of “serious adverse reactions associated with the use of EMPowerplus. Most of the adverse reactions relate to worsening of psychiatric symptoms in those patients with serious underlying mental health problems, such as bipolar disorder and depression. The worsening of these symptoms could be related to taking the product and discontinuing prescription medications or taking the product in conjunction with prescribed medications.”²⁸

What Went Wrong?

As Truehope’s StopC51.com conjures up protest rallies across Canada, I’m left asking, “Why has this worked so well?” Astroturf activism — the creation of a campaign that looks like grassroots activism, but isn’t — tends to be expensive. From the infamous Swift Boat campaign against John Kerry to the oil industry funding of climate change denial research, millions of dollars^29,30 are typically required to purchase TV spots, commission research, hire PR firms, and otherwise buy influence. Yet, while Truehope rakes in enough money to motivate the people involved, it’s no Exxon. The anti-C-51 campaign has little more going for it than a simple website, a little legwork, and gall.

One contributing factor is that C-51 and Health Canada are easy targets. Alternative medicine is popular. So is the notion of “health freedom.” Government bureaucracies aren’t. Many people are prepared to trust the manufacturers of natural health products, even as they glare in suspicion at anything “Big Pharma” touches (this is assumed to include federal regulators). This is a baffling double standard. Despite the warm, down-home marketing of the multi-billion-dollar alternative health industry, it is not a David to Big Pharma’s Goliath. The natural health products industry is a commercial juggernaut of entirely mainstream, big business proportions. Given the scale — by 1997, American out of pocket spending for alternative medicine almost matched that for hospitals and doctors combined³¹ — it seems bizarre to arbitrarily trust one marketing brand of multi-billion-dollar, for-profit drug manufacturers while simultaneously distrusting other drug manufacturers. Yet, this seems to cause little cognitive dissonance.

Another factor is simply this: Truehope had the incentive and sheer audacity to act when their profit margin was threatened.

“This alert just in from Tony Stephan of Truehope Inc. in Alberta Canada,” trumpeted a mass mailing that echoed around libertarian forums in April, 2008. “Tony has 8 employees hard at work in an emergency call center from which they’re contacting every health food store in Canada urging emergency assistance to kill the bill from hell: C-51 … if you are Canadian, please take action yourself, then download this info and bring it to every health food store within a 25 [kilometer] radius of your house and urge them to bag stuff the alert and to urge customers to call their MPs to strenuously oppose this. If you don’t you will lose your access to dietary supplements.”³²

Take Action!

Help fight bogus medicine and “astroturf activism” in Canada (especially if you are a Canadian):

• Assist local media — in advance! Tip off health reporters and health editors in your area that a controversial supplement company is behind StopC51.com’s media campaign. Share the url for this eSkeptic
• If your local media does buy the anti-C-51 hype, write a letter to the editor and post comments to the news story online. Politely point out that C-51 does not ban vitamins or natural remedies, which are already regulated (since 2004). Bill C-51 just raises the fines for crooks who disregard existing public safety laws.
• Write your Member of Parliament to voice support for Bill C-51’s firm enforcement of the existing regulations for natural health products. Find your MP (using your postal code)
• Learn about C-51 and Canada’s existing Natural Heath Products Regulations.
  • Read C-51 (or just the sections concerning therapeutic products, or enforcement, or penalties).
  • Read Health Canada’s simple guide:
    Bill C-51 and Natural Health Products — The Facts
  • Read the existing Natural Heath Products Regulations or the existing Compliance Policy for Natural Health Products
• Share accurate information on your blog or by emailing this eSkeptic to friends who might be concerned about C-51, or

SHARE this eSkeptic
on Facebook

The Bottom Line

Discussions of the high human cost of fraudulent or useless alternative medicine often seem to circle around a simple, hopeless question: “Why doesn’t someone do something?”

The anti-C-51 astroturf activism campaign provides important answers to that question. Few politicians or law enforcement bodies have the political will to go after people who claim they can cure terrible diseases — even if those claims are demonstrably false. It’s politically dangerous, easy to misrepresent, and unrewarding.

Unfortunately, skeptics do little to improve the rewards of evidence-based policy decisions. We do not rush out into the streets to defend new laws against health fraud. Nor, when responsible measures are proposed, do we flood the offices of our elected officials with letters of support.

But the bad guys do. They do whatever it takes. As in so many things, it all comes down to an ancient problem, a problem with us: “The best lack all conviction, while the worst are full of passionate intensity.”

Bibliography

1. BILL C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3398126 Retrieved May 18, 2008.
2. Natural Health Products Regulations http://canadagazette.gc.ca/partII/2003/20030618/html/sor196-e.html Retrieved May 23, 2008.
3. Bill C-51 and Natural Health Products — The Facts. Health Canada. www.healthycanadians.ca/pr-rp/billC-51_e.html Retrieved May 18, 2008.
4. Counterfeit Drugs Questions and Answers. US Food and Drug Administration. www.fda.gov/oc/initiatives/counterfeit/qa.html Retrieved May 18, 2008.
5. BILL C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. 31.(1)(a) Government of Canada. www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3398126 Retrieved May 18, 2008.
6. Stop bill C-51 from banning all natural health products. www.facebook.com/group.php?gid=11529874237 (requires Facebook account) Retrieved on May 23, 2008.
7. ibid.
8. Compliance Policy for Natural Health Products. Health Canada.
   www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/ complian-conform_pol_e.html Retrieved on May 23, 2008.
9. StopC51. www.stopc51.com Retrieved May 14, 2008.
10. Canadian Rights and Freedoms Are At Risk: An Important Notice Regarding Bill C-51. www.healthcanadaexposed.com/c51backups/Canadian%20Rights%20Facts.htm Retrieved May 17, 2008.
11. zoey_01. “http://www.stopc51.org” Online posting. May 9, 2008. www.restoretherepublic.com/component/option,com_fireboard/ func,view/catid,31/id,5848/limit,6/limitstart,0/ Retrieved May 17, 2008
12. Scouring StopC51.com, I failed to locate any “about us” disclosure statement, nor any “contact us” information for the site, nor any direct links to the company Truehope — except as part of a signature buried within some pdfs the site hosts. The pdfs suggestively feature information about Truehope, but do not clarify whether there is any relationship with StopC51.com. (Truehope is much admired in “Health Freedom” circles, so it’s not unusual to see information about their fight with Health Canada at many sites in which they have no direct involvement). To try to lock down the link, I wrote directly to Truehope and to Anthony Stephan, Truehope’s CEO to request clarification of the relationship between Truehope and StopC51.com. I received no reply. (A Canadian national newspaper, the Globe and Mail, followed roughly the same trail for their May 13, 2008 C-51 article by Gloria Galloway — see endnote 17)
13. Canadian Rights and Freedoms Are At Risk: An Important Notice Regarding Bill C-51. www.healthcanadaexposed.com/c51backups/Canadian Rights%20Facts.htm Retrieved May 17, 2008.
14. Brosseau, Miles. A Meeting with Truehope/Synergy Directors @HPFBI — WOC Burnaby, B.C. — January 14, 2003. Government of Canada Memorandum. Jan 16, 2003. www.circare.org/FOIA/hcls_176_179.pdf Retrieved May 23, 2008.
15. Network Solutions. www.networksolutions.com/whois/results.jsp?domain=stopc51.com Retrieved May 14, 2008.
16. Go Daddy. http://who.godaddy.com/WhoIsVerify.aspx?domain=stopc51.com& prog_id=godaddy Retrieved May 23, 2008.
17. Galloway, Gloria. “Minister defends crackdown on safety of natural health products.” Globe and Mail. May 13, 2008 www.theglobeandmail.com/servlet/story/LAC. 20080513.NATURAL13/TPStory/TPNational/Politics/
18. http://who.godaddy.com/WhoIsVerify.aspx?domain=stopc51.com& prog_id=godaddy Retrieved May 23, 2008.
19. Truehope. www.truehope.com/SEF/depression.asp Retrieved May 23, 2008.
20. Polevoy, Terry and Ron Reinhold, Marvin Ross. Pig Pills, Inc. — The Anatomy of an Academic and Alternative Health Fraud. 2003. A choppy but fascinating eBook digging deep into the Truehope back-story, available at www.pigpills.com
21. Truehope. www.truehope.com/_empowerplus/empIngredients.asp Retrieved May 23, 2008.
22. Truehope. www.truehope.com/_faqs/faqs.asp#15 Retrieved May 23, 2008.
23. Truehope. www.truehope.com/_research/research.asp Retrieved May 23, 2008.
24. Health Canada is advising Canadians not to use Empowerplus. Health Canada Advisory. June 6, 2003 www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2003/2003_41_e.html Retrieved May 23, 2008.
25. Brosseau, Miles. Investigation: RE: The Synergy Group of Canada, Inc. Government of Canada Memorandum. Oct 12, 2000. www.circare.org/FOIA/hcati1_050056.pdf Retrieved May 23, 2008.
26. Health Canada executes search warrant related to Empowerplus. Health Canada Advisory. July 15, 2003. www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2003/2003-07-15_e.html Retrieved May 23, 2008.
27. ibid.
28. Reports of adverse reactions in patients with serious mental health conditions suspected in association with use of prescription medications and EMPowerPlus. Health Canada Advisory. February 28, 2007. www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2007/2007_17_e.html
29. Frank, John. “2 Texans dig deep for boat vet ads.” Houston Chronicle. 10/05/2004 www.chron.com/CDA/archives/archive.mpl?id=2004_3806652 Retrieved May 18, 2008.
30. Exxon is Pumping Out Lies. Greenpeace. May 18, 2007. www.greenpeace.org/usa/news/exxonsecrets-2007 Retrieved May 20, 2008.
31. Eisenberg, David M., and Roger B. Davis, Susan L. Ettner, et al. “Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a Follow-up National Survey.” Journal of the American Medical Association 1998; 280:1569–1575.
32. Equus Os. “Kill the bill from hell: C-51.” Online post. April 28, 2008. www.freedominion.com.pa/phpBB2/viewtopic.php?t=98813&sid =2832dc5a9dc620f423307ea78de0b4fa Retrieved May 23, 2008.

GJ's note:  This was taken from this week's e-Skeptic, published by Michael Shermer's Skeptic's Society newsletter.  All rights reserved (and none are mine!).  I hope you find these interesting and thought-provoking, at a minimum.

No comments | Tags: medicine, skepticism

Ultrasound Screening -- Not Such a Good Idea
posted by GJ on February 20, 2008 @ 10:10AM

First off, if you missed it, look below this long post for the update post from Kristen.

Now, I get a e-zine from Skeptic Magazine weekly, which usually has a nice column that I enjoy reading, but usually it's very skeptic-centric and would either be totally uninteresting to the rest of you, or fan the flames of, well, you know.  It's not like we haven't played out that game often enough here.

Anyhow, I'm including this latest one because it's really not about woo, pseudoscience, religion, or any of that.  Note the lack of a "woo" tag this time.  It's simply an interesting point of view about a procedure that is done all over the country that in all likelyhood, is really just a waste of money.  Read on for the details:

Ultrasound Screening: Sometimes Ignorance is Bliss
by Harriet Hall, M.D. 

I never thought I’d be promoting ignorance! I’ve always thought the more information, the better; but there are exceptions. I’m going to explain something that is very counterintuitive and grates against every fiber of our truth-seeking skeptical brains.

The ad shouts, “Tests That Can Save Your Life … Stroke is America’s third leading killer … Half of all stroke victims have no warning signs before a stroke occurs.” Life Line Screening comes to your community, sets up their ultrasound machines in a church or community center, and offers screening for stroke (carotid artery), abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), and osteoporosis for $129. The Healthscreens company adds gallbladder, kidney, liver, thyroid, and heart screens for a total of nine screenings for $215. They say “Don’t Wait … Until it’s too late!”

A skeptic asks: if these tests save lives, why doesn’t my doctor order them, and why doesn’t my insurance company pay for them? The ultrasound peddlers answer that doctors don’t care about prevention and insurance companies are stingy. That’s nonsense. Doctors do care very much about prevention, and insurance companies would save money in the long run by diagnosing things early. Doctors do use these tests to screen patients at high risk and to aid in diagnosis (and when used that way, they are covered by insurance). They just don’t use them to screen the entire population of mostly healthy people.

What could be wrong with checking all these areas of your body for potential problems? Wouldn’t you like to know if your neck arteries are clogged? Wouldn’t you like to know you had an aneurysm that was about to explode? Wouldn’t you like to know if there was a lump lurking somewhere in your anatomy? Like everyone else, I would like to know those things, but my critical thinking skills have overcome that desire. I wouldn’t take those ultrasound tests even if they were free.

Obviously we’re not going to do every possible test on every possible person. You could test all 5-year olds for gonorrhea, but you probably wouldn’t. What makes a good screening test? The answer depends on the four possible outcomes of any test:

1. True positive (the test is positive and you have the disease)
2. False positive (the test is positive but you don’t have the disease)
3. True negative (the test is negative and you don’t have the disease)
4. False negative (the test is negative but you really do have the disease)

A good screening test has a low rate of false positives and negatives.

It makes a big difference how common the disease is in the population being screened. The rarer the disease, the more likely a positive test will be a false alarm. Only 10% of positive mammograms actually turn out to be cancer. Assuming you find a true positive result, you want it to make a difference. Does early diagnosis prolong your life span, or does it just prolong the time you carry the “sick” label? Is there an effective treatment that will prevent death or improve well-being? Are there risks to the treatment that must be weighed against the benefits?

We no longer do routine screening urinalysis. It wasn’t productive. If patients had no symptoms, a urinalysis rarely found anything that mattered, and we wasted a lot of time and effort trying to explain minor transient findings.

We no longer do annual chest x-rays. Why? Because they did more harm than good. There was a small risk from the radiation itself. When a lung cancer was big enough to see on x-ray, it was usually too late for treatment to prolong survival; and we found too many questionable shadows that required further investigation. My father-in-law was a case in point. A routine chest x-ray showed a mass. They operated and found something benign and insignificant, but he had complications from the surgery and died. His screening test killed him.

The U.S. Preventive Services Task Force wrestles with these issues, studies risk/benefit ratios, examines the latest and best research, and makes recommendations for screening the general asymptomatic population. They recommend one-time ultrasound screening for AAA in men between the ages of 65 and 75 who have ever smoked; they recommend against screening in women. They recommend against screening for PAD, because if we find PAD the recommendations are the same ones we make for everyone: smoking cessation and exercise. They recommend osteoporosis screening for women over age 65 (or 60 if they have risk factors). When ultrasound is used for osteoporosis screening, about a third of patients have a positive result that must then be confirmed by a DEXA test; it makes more sense to use DEXA in the first place. When tests fall under the USPSTF recommendations, Medicare and insurance companies usually pay.

Carotid artery testing can lead to life-saving treatment for patients who have symptoms, but if you have no symptoms, you may not need treatment. Even if the artery is 60–99% blocked, surgery may only reduce risk of stroke by 1% per year, and the surgical risks may outweigh the benefits.

Indiscriminate ultrasound screening is a blunt instrument: it sees a lot of suspicious findings that are due to benign conditions that don’t require treatment. Diagnosing the benign conditions requires more tests, which may be expensive, invasive, and possibly even lead to complications and death. When ultrasound finds something important, it is often something that would have been found later when symptoms developed, and usually finding it sooner makes no difference in survival. And think of all the needless worry!

These direct-to-consumer peddlers of ultrasound fail to divulge crucial information; so their customers can’t really give informed consent to a procedure that, while harmless in itself, can lead to various kinds of indirect harm. They play on people’s fears and their desire to take control of their own medical care. They imply a promise of far more than they can deliver. They may not do as much harm as the peddlers of whole body screening CT scans (which involve substantial radiation exposure), but in my opinion, they are just as wrong-headed.

8 comments | Tags: medicine, science

The Immortal Lily The Pink
posted by GJ on December 12, 2007 @ 11:11AM

The Immortal Lily The Pink
The 100th anniversary of the FDA marks a milestone in medicine before which cranks and charlatans ran amok
by Daniel Loxton

 
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.

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:

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.
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…”
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.

17 comments | Tags: woo, medicine, science

Interesting study about doctors and religion
posted by GJ on July 31, 2007 @ 4:52PM

I'm not drawing any conclusions here, but it is interesting.

10 comments | Tags: religion, medicine