The Burden Of Proof: The Lesson Of Airborne

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The Burden Of Proof: The Lesson Of Airborne

Postby JeffN » Fri Aug 15, 2008 4:20 pm

As I have said here many times...

"My position is that there should be some good evidence for anything we do, whether it is a food, a diet, a herb, a medicine, a supplement, a treatment, or anything. We should also be aware of the potential harm and/or side effects.

Good evidence, means peer reviewed published studies in mainstream scientific journals.

Anyone can came out and make virtually any claim they want. The burden of proof is not really on us to disprove everyone of them and all their claims but the real burden of proof is on them to substantiate their products, diets and their claims. And with more than short term unpublished data or anecdotal info. If they get shut down for one diet, they just rearrange a few things and come right back out with a new diet making the same extra-ordinary claims.

in addition, extra-ordinary claims require extra-ordinary proof.

The burden is on them, not me."


I am not sure which is worse, that a company like this can get away with the misleading advertising and promotion of their product for years with no proof of its effectiveness, or that consumers are willing to beleive it without any proof of its effectiveness, or that even after the fact that the truth comes out, that consumers continue to buy it and beleive in it.

In regard to the comment in the article about safety, there is still a safety issue as there is a potential to consume excess Vit A via Airborne.

You can read about this issue along with the rest of my comments on Airborne in a newsletter I wrote a while back..

http://tinyurl.com/5g8r3r

Caveat Emptor!

In Health
Jeff

Airborne Coughs Up Millions to Settle Suit
By Annys Shin
Washington Post Staff Writer
Friday, August 15, 2008; D01

Over the past decade, millions of consumers, including Oprah, have come to swear by Airborne -- fizzy orange tablets containing vitamins, herbs and minerals that its makers for years said keeps cold germs at bay.

Gena Crowe of Fairfax says she doesn't get on a plane without it. "If I feel like a sore throat is coming on," she said, "it seems to take it away."

Airborne, however, when used as directed does not prevent class-action lawsuits, charges of deceptive advertising -- or, according to the government, the common cold.

"There is no credible evidence that Airborne products . . . will reduce the severity or duration of colds, or provide any tangible benefit for people who are exposed to germs in crowded places," said Lydia Parnes, director of the Federal Trade Commission's Bureau of Consumer Protection, which filed a complaint against Airborne's makers.

The remedy prescribed by the FTC is for Airborne to pay consumers back for as many as six purchases, a nationwide total of as much as $30 million.

Under a settlement announced yesterday, the privately held Airborne Health, based in Bonita Springs, Fla., will add $6.5 million to funds it has already agreed to pay to settle a related class-action lawsuit. That suit, which alleged that Airborne falsely claimed its products could cure or prevent colds, was settled earlier this year for $23.5 million. Consumers who bought Airborne products between 2001 and 2008 have until Sept. 15 to apply for a refund for as many as six purchases, the FTC said. Claims will be paid by Oct. 15, 2008, the company said in a statement.

Airborne said it had already begun to change its packaging and marketing language. "It's important to note that this is a settlement over older advertising and labeling, and has nothing to do with public safety," said Airborne chief executive Elise Donahue. "We've offered a money-back guarantee for our products since 1997, and we have millions of satisfied customers. A class-action lawsuit sparked this matter. We're just one of many major consumer brands across America that are under assault by class-action lawyers."

Steven Gardner, director of litigation for the Center for Science in the Public Interest, a Washington advocacy group that was part of the class-action suit, vouched for the change but said it doesn't get Airborne off the hook.

"The fact they got away with it for years is not a reason they should not be held responsible for it," he said.

Three of the FTC's four commissioners voted to approve the deal. Commissioner Thomas Rosch dissented, saying the FTC should not have let Airborne use its existing inventory of paper cartons and display trays until Oct. 31, 2008, for fear of continuing to "perpetuate misperceptions" about the products.

The government's allegations of deceptive advertising have not hurt Airborne's standing with some local customers.

"Even if Airborne isn't doing anything for you, believing it helps," said microbiologist Stephanie Scovel-Toney, 28, of Fredericksburg.

"It may be mental, but it works for me," said Robin Roane, 46, manager of an Alexandria nonprofit. "I can't tell you the last time I had a cold."

Such responses don't surprise Gardner. "It is pretty much impossible to prove that it didn't prevent a cold if you don't get a cold," he said.

Airborne hit the market in the late 1990s with a bright yellow box and a testimonial that was hard to beat. Its creator was Victoria Knight-McDowell, a second-grade teacher near Carmel, Calif., who got tired of catching colds from her students.

She started selling in 1997, three after Congress voted to allow dietary supplement makers to claim their products have an effect on a body structure or function, such as the immune system. However, they can't claim to cure or treat illnesses without FDA approval.

The notion that a school teacher found a way to stave off germs from runny-nosed 7-year-olds proved to be advertising gold. Soon, Airborne-and-water cocktails became a favorite in-flight beverage for frequent fliers. Annual sales jumped from $21.4 million to more than $100 million in one year after Knight-McDowell appeared on "The Oprah Winfrey Show" in 2004.
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Re: The Burden Of Proof: The Lesson Of Airborne

Postby SactoBob » Fri Aug 15, 2008 9:24 pm

JeffN wrote:Good evidence, means peer reviewed published studies in mainstream scientific journals.


geoffreylevens wrote: The original works great though. But you have to take fairly large doses every 2 hours to get it to work and if you wait long enough to be coughing at all, it will do virtually nothing.


What a contrast! Science versus belief. Medicine versus quackery. The problem is that many people believe that anecdotal evidence stated by somebody with a firm conviction carries the same weight as a double blind peer reviewed well designed study that proves the opposite. No wonder so many people are confused.

Although I agree 100%, Jeff, as you see, others don't. That is why there is so much junk science and snake oil out there. With the millions at stake, don't you think that it would be easy to conduct a double blind legit study to prove the effectiveness of Airborne if it worked? Or that they would pay such a huge fine for deception?
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Good question, with obvious answer

Postby SactoBob » Sat Aug 16, 2008 1:08 am

and here is another one -
If Airborne were subjected to comprehensive testing and proven absolutely to be worthless, would it change your opinion or your advice to use it?

We don't have complete scientific knowledge about diet, and that is why it is so controversial. In another generation or so we may have better answers, and there is a question of what to do in the meantime. I know where I am putting my money and health at present.

My point, and I think Jeff's, is there should be some type of scientific evidence to support a health recommendation. Anecdotal evidence and custom are usually very weak evidence IMO. So is celebrity endorsement and raw authority.

We recently have revised our understanding of ulcers. We recently found in a very comprehensive study that ecanacia (sp?), an herbal remedy long used for colds, does not work, and that is conclusive. We recently found that very close control of blood sugar in diabetics leads to more rather than fewer deaths.

The real question is how do we know things, and that is a very difficult question. Science is not the only way to know, and I respect other methods. Other things elude controlled studies. I have my own biases and beliefs in things that can probably never be proven. I know that Myofascial Release, Accupressure, and yoga work, but it would be very hard to establish it scientifically. I recommend these to friends, but based on my own experience and belief and not scientific fact.

My objection is when things are represented as proven medical or scientific fact when they clearly are not. Even a great scientist like Linus Pauling fell into this trap with his advocacy of megadoses of vitamin C as a cold remedy. Dr. McDougall's knowledge started with observations that lead to educated guesses. Dr. Esselstyn recommended his program to colleagues before the final results were in because the trend looked obvious. Dr. Campell changed his ideas on account of the data he collected, which was not a controlled experiment.

But Airborne is a completely different story. If you read Jeff's article, you see that a sham study was done, and clearly known to be a sham. No attempt was made to do a legit study - their's made the drug companies look clean as snow. If Airborne wanted a good test, they would not have used such a sleazy "lab." Their story is very similar to a lot of other quack cures for cancer. Should we try them all because somebody says so and they might work?

As for those millions being pocket change, I wonder where you get such an idea. I know of no company that would consider that pocket change. With a fraction of that money, a legit study could have been conducted.

BTW, I agree with you on the drug companies to a point. Their problem IMO is not that they use science, but that they "rig" and spin the science and misrepresent the results. Dr. Campell does a good job of explaining the problem, as does Dr. McDougall. I think that this is an interesting topic, because we should sometimes step back and ask how it is that we "know" something, and what types of knowledge we trust.

Also BTW, my wife and I tried Airborne a few times at the recommendation of a friend who thought it worked great. It did not good at all that I could tell.
SactoBob
 

Postby TerriT » Sat Aug 16, 2008 2:35 am

geoffreylevens wrote:Quick riddle---if something is proven effective in a double blind, placebo controlled study w/ very large subject group and rigorous methodology, was that something effective before the study was done?


If a patient believes something is effective, they're often more likely to benefit from taking it, even if it's a placebo -- and strangely enough, even if they know it's a placebo. A study done in 1965 demonstrated this.

http://www.leecrandallparkmd.net/researchpages/placebo1.html
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Postby JeffN » Sat Aug 16, 2008 4:11 am

TerriT wrote:
geoffreylevens wrote:Quick riddle---if something is proven effective in a double blind, placebo controlled study w/ very large subject group and rigorous methodology, was that something effective before the study was done?


If a patient believes something is effective, they're often more likely to benefit from taking it, even if it's a placebo -- and strangely enough, even if they know it's a placebo. A study done in 1965 demonstrated this.

http://www.leecrandallparkmd.net/researchpages/placebo1.html


The placebo effect is well known & documented & is why the best type of studies are the ones called randomized controlled trials which have a control group which accounts for this effect. The experimental groups(s) have to significantly outperform the control group.

However, this effect does not rationalize the known misleading advertising & scam promotion of a product as being clinically proven as effective.

If you have not seen it, you may want to search this forum for the post on Moisturol

http://www.drmcdougall.com/forums/viewtopic.php?t=6614


In Health,
Jeff
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Postby JeffN » Sat Aug 16, 2008 4:58 am

geoffreylevens wrote:The Chinese until recently did not do double blind studies, did not even use a control group as they believed it was unethical to withhold a treatment you feel likely to work from those who need it. I very much appreciate the scientific method. But I am not willing to wait and have upper respiratory infections until someone decides to pony up the millions of $ necessary and take several years to do a study. I used to get one or two per year, often turning into bronchitis then a sinus infection lasting months When I found out about Yin Chiao in acupuncture school I tried it next time I started to get a sore throat. Hmmm it vanished! Likely a coincidence. Then it happened the next time and the next. And the next. 800 years of successful clinical use is not "belief". The Chinese system of herbal medicine was developed over probably a couple thousand years of home cooking trial and error as they developed and refined a non-technological system to explain what they were finding out and sure enough, that system turned out to have strong predictive value.

In the "modern" world the scientific method is worshipped and misused. You have only to look at the research on diet where 30% fat is "low fat" and a couple pounds weight loss over a year is called "success" to see it. The whole process is corrupted by politics and big money so that true science is all but buried. That does not invalidate science! Likewise, NewAge airheads, charlatans etc often believe that if I think it so then it is true. That has absolutely nothing to do with non-technological sciences developed over many generations of hard work in other cultures. Ours is not the only way that "works" and from all the signs it does not seem to be working all that well. Should we thank the scientific method for global warming, the devastation of the rainforests, the sterilization and strip mining of the oceans, the denuding of topsoil, the soaring cancer rate (plus heart disease, diabetes, etc)?

If someone did a study on Airborne, it would be interesting to know who paid for and designed it. The ingredients are all non-patentable and easy to get. Tthe formula would be a no brainer for any herbalist to imitate but slightly different enough to get around any patent anyway so who would want to spend the money. I'm sure the fine is pocket change compared to the profits already made. Cost of doing business. The cumulative science shows that a great many pharmaceutical drugs either don't work at all or have such common and horrendous side effects that no one who took the time to know about them would want to take them and some are downright criminal in my opinion yet they continue to be used often based on either faulty science or deliberately concealed data. Where is the real scientific method when we need it?


Your points are well taken. However not only is the scientific method sometimes misused, so are the criticisms of it

Having something around and used for centuries, does not justify its use or act as any proof at all of its safety or effectiveness. We all know of many substances out there that have been used for centuries by indigenous people that are now known to be harmful and toxic.

In addition, finding flaws in the modern scientific system does not negate the entire system. Besides, anyone truly involved in the system, understands its flaws and shortcomings. Part of the requirement in getting a study published is to discuss the studies own weaknesses and shortcomings.

As I pointed out in previous discussions on this topic, there are literally millions of dollars being spent and thousands of studies being done on many of these "alternative" remedies, and most all of them are failing any attempt at a well done study. Not all of them, but most all of them are. These studies are being done by a national program set up (with your money) to study (and hopefully prove) the effectiveness of these substances and finally help settle the argument that there just isn't enough money available to study them. This is not a conspiracy against these substances but an honest attempt at trying to prove they are effective.

Also, you can be sure, that if anything (like airborne) has the potential to work and be effective, the pharmaceutical companies will put their money into studying it. Another example is hoodia. What is not commonly known is Pfizer owned the original rights to hoodia and did lots of research on it. One of the chemicals they isolated was called P-52. They eventually released and sold the rights to an herbal company after realizing it was not effective . Now it is being sold as a herb/supplement saying it contains H 52, an effective chemical.

Who are you going to beleive?

Makes you wonder, doesn't it?

The thought that they don't study herbs because you can't patent a herb is not entirely correct either. As we know, many drugs today, were originally herbs and were made into patentable medicines.

For instance, the alt health community used that excuse for years that because stevia was a natural plant leaf as to why it was not "approved" and could only be sold as a supplement and not as a food or food ingredient. Reality is, there were some health concerns, and 4 international health organizations and several countries had banned its use. However, more recent (and better done) studies and reviews by the WHO in 2006 have shown that the concerns may not be valid . Now, Coca Cola has recently submitted for a patent on it and will start using it on their soft drinks in 2009 under the name Rebiana. So much for that conspiracy theory. :)

http://www.thecoca-colacompany.com/pres ... biana.html


The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for scientific research on complementary and alternative medicine (CAM). We are 1 of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services.

http://nccam.nih.gov/research/results/

Our Mission

The mission of NCCAM is to:

* Explore complementary and alternative healing practices in the context of rigorous science.

* Train complementary and alternative medicine researchers.

* Disseminate authoritative information to the public and professionals.

What We Do

NCCAM sponsors and conducts research using scientific methods and advanced technologies to study CAM. CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.

NCCAM has four primary areas of focus:

1. Advancing scientific research
We have funded more than 1,200 research projects at scientific institutions across the United States and around the world.

2. Training CAM researchers
We support training for new researchers as well as encourage experienced researchers to study CAM.

3. Sharing news and information
We provide timely and accurate information about CAM research in many ways, such as through our Web site, our information clearinghouse, fact sheets, Distinguished Lecture Series, continuing medical education programs, and publication databases.

4. Supporting integration of proven CAM therapies
Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.

http://www.theannals.com/cgi/content/citation/41/7/1256

The Historyof Complementary and Alternative Medicine in the US. The Annals of Pharmacotherapy. 2007 July/August, Volume 41

Research and Reimbursement

More than 462000 citations have appeared in the CAM section of PubMed from 1966 to today and the NIH is spending $300 million per year on CAM research

In Health
Jeff
Last edited by JeffN on Sat Aug 16, 2008 8:14 am, edited 1 time in total.
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Re: The Burden Of Proof: The Lesson Of Airborne

Postby JeffN » Sat Aug 16, 2008 7:00 am

SactoBob wrote:With the millions at stake, don't you think that it would be easy to conduct a double blind legit study to prove the effectiveness of Airborne if it worked? Or that they would pay such a huge fine for deception?


Right. It always amazes me that these companies say they can't afford to do the proper studies but yet they spend millions in advertising (of which one well done study would be worth way more) and also spend millions defending themselves in legal battles.

Its like the fast food companies that say it is to expensive to update their product packaging to add calorie information on their packaging but will spend millions updating their packaging to feature the latest star and/or trend everytime a new hit movie or TV show comes out.

Somehow they can all afford to put the Dark Knight on all the packaging ASAP, but to make the one time change to add the calorie value to their packaging is to expensive.

SactoBob wrote:The problem is that many people believe that anecdotal evidence stated by somebody with a firm conviction carries the same weight as a double blind peer reviewed well designed study that proves the opposite. No wonder so many people are confused.


Unfortunately, it appears that the real problem is that many people actually give "more" weight to anecdotal evidence then to double blind peer reviewed studies.

I agree with the criticisms of the scientific method. But, the solution is to come up with a "better" system and not to rely on a less effective system, and to give the less effective system equal or more weight.

In Health
Jeff
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At the core of the matter

Postby SactoBob » Sat Aug 16, 2008 10:54 am

geoffreylevens wrote: There is a formula that Airborne was stolen from that really does work for early stage, upper resp. viruses. Usually.


This is the real issue. When you declare that this formula works, what evidence do you have? If you could administer this formula to 1000 random people during cold season, and compare to a good control sample, and the formula takers got only half the colds and half the severity, then I would be using it.

If Geoffrey says it works and others say it doesn't, and the argument is that it has been used for many years, I probably wouldn't use it. In the first case there is solid evidence to use it, and in the second no scientific evidence at all.

And when it doesn't work, people always say that you took it too early or late, or too much or too little, or you are the wrong blood type, or some other bogus reason made up after the fact. This is old hat.

I can't even count the number of bogus cancer treatments, bogus supplements, bogus trendy diagnoses, etc. that I have come across which have been used by many but later proven scientifically false and perhaps even damaging.
SactoBob
 


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