Thursday, September 27, 2007
Paying for product approvals
Nowadays, there are a lot of seals on products. Everyone from the American Academy of Dermatology to the American Cancer Society seems to offer some sort of seal for products you buy every day. Obviously, the manufacturers love it because they hope it leads to increased sales. Did you know, however, that many of the approving organizations are paid for their seals? In many cases, there are no independent tests performed and the consumers are sort of left wondering what it all means.

Today, we learned that Wrigley paid the American Dental Association to review some of the studies the company performed on its own products. After a review of that data and accepting $36,000, the ADA has offered its seal of approval on Wrigley sugar-free chewing gum products. That's right. These products now get the same seal of approval seen on some toothbrushes and on mouthwash. The ADA stands by its seal and told us any company can apply for the seal, as long as the company pays for it.

The ADA is not alone. The American Cancer Society has an ongoing relationship with Neutrogena. It offers the ACS seal, not as an endorsement, it says - but rather as recognition of Neutrogena's cancer-prevention programs. In case you're curious, Neutrogena pays $300,000 a year to get that seal of recognition.

Do you think that these organizations should be held to a higher standard when it comes to dispensing seals of recognition, approval or whatever? Or, is it acceptable for these seals to be purchased as long as the money is put to good use? And, should companies that make products be allowed to submit their own data, or should all data come from independent sources? What do you think?
You know, I never knew that these agencies were paid for their endorsements (seals of approval). Wow, it certainly changes the way I will think of those seals in the future. Thanks for point this out to us.
I had not paid much attention to ADA's seal of approval, but American Cancer Society raises money by other means, and is considered an authority. Their endorsement of a product will misguide the consumer to buy the product. It should be stopped. It is abusing the trust the consumer has endowed upon the respectable agency.
OK This is off topic, but health related. Check this out Sanjay

Eric Landford has posted a video called "zombie drug" on CNN.com.

http://www.cnn.com/video/#/video/bestoftv/2007/09/26/ntm.zombie.drug.cnn

The video makes the drug seem completely dangerous. In fact, it is used daily in the US as a safe pharmaceutical. The video is too sensational and is not balanced with standard medical knowledge. The piece should have been researched more before going on to CNN's website.
MD from Massashusetts
By no means am I surprised, for anyone that has lived in America for more than a few minutes quickly realizes how easily organizations are influenced by the sight of money. Maybe because they are underfunded, which encompasses mostly any non-commercial group, or a variety of other reasons.

However, it is NEVER acceptable to lie. That being said, should such associations accept payment and endorse products that don't live up to their claims and don't cause any harm in order to help others? I think I would have to answer a whole hearted 'YES!' Partially because people don't usually find it in their heart to donate their excess wealth to help others. People tend to be intrinsically greed, that's usually what helps them accumulate their wealth.

Beyond that I am absolutely against companies submitting their own data. It cannot be scientifically sound since they have a vested interest in their product. I mean any 5th grade kid in a science class can tell you that they will fudge numbers, since they believe that will result in a better grade. However, instead of from independent sources I think the companies should pay those groups, whose seal they want, to verify the companies claims through their own standards. We just have to hope those groups/associations are telling the truth.
If a non profit organization accepts money in exchange for seal recognition, then the non profit status of that organization should be revoked
We're on a slippery slope where the vast majority of money for anything comes from companies, who, by definition, have vested interests. Whether companies pay directly for things like seals of approval, or whether they make contributions that garner favor for them from organizations like the ADA (not to mention politicians), their money helps them achieve business goals. So, of course, many things would be judged differently by truly independent analysis, but then where would the money come from to run things like non-profit organizations, certifying organizations and political campaigns?
I think caveat emptor applies as much to product endorsements by any "medically-affiliated" organization as it applies to used car lots. All organizations are political animals that seek to gain and keep control and "turf." Money or market advantage is always the main factor used to establish and maintain control. By putting a seal on a product, a medically-affiliated organization is making that producer dependent on the seal, thus control is established. By having the seal in the consumer market, they estbalish themselves as a household name, and "clearly THE authorities."

In the same way, this applies to written statements by such organizations of acceptance or rejection of medical practices by various clincians and researchers. By publishing written statements of acceptance or rejection of medical practices, they attempt to establish themselves as the only authority.

Just because an medical organizations name begins with "The American" does not mean they represent all medical practitioners or all Americans.
Should these endorsing organizations be liable for defective products upon which their labels are affixed?

For example, historical records suggest that the use of fluoride in the treatment of teeth has never been proven to be effective in preventing tooth decay. On the contrary, communities with fluoridated water have been demonstrated to have greater occurences of fluorosis - mottled teeth indicative of fluoride poisoning. Fluoride has also been used in medications to treat hyperthyroidism. It has been demonstrated to cause hypothyroidism in children who have no thyroid problem. However, this kind of research and knowledge never gets into the mainstream medical community. Is this because organizations like the ADA (who have affixed their seal as an endorsement to fluoridated toothpaste and fluoride treatments in dental offices) could be held legally liable for endorsing hazardous products?

Even if there is no conspiracy by such an organization to squelch such research findings, by putting its seal of aproval on such products, the organization establishes a conflict of interest that will always cause others to question its motivations.
Dr. Gupta, this is an interesting question. Who else could or even would fund a study on a specific drug besides the manufacturer? Should the public be responsible for funding efficacy studies? I disagree. Instead, these "seals of approval" should be held to the high standards of the FDA, regardless of who funds the study
It does not surprise me one iota. Big business and big pharma have no feeling about our well being, it is just the bottom line, their pocketbook. What a shame in a country as great as ours, that we have the biggest crooks.
Yes, there should be a higher standard. Where is integrity hidding? If an organization gets paid to approve seals then they are only accepting bribes.
This situation is bad, but does anyone know that most of the medicines that Americans take are imported by bulk from CHINA? Then when the medicines get here various pharmeceutical companies put their names on the medicines, and sell them to the American public at a huge markup? I have proof of this. The company's name is HUBEI ZENITH PHARMECEUTICAL CO. LTD. They start by making the meds in CHINA, then send them to INDONESIA to be "finished", then on to the U.K. and then to the U.S. I have talked with everyone from the White House on down and they just give me the run-around, even the FDA just gives me excuses. I caled my Senators and Congressmen and they just ignore me.I am quite alrmed by this. It is bad enough that we have to buy clothes and other things that are made in CINA...but Medicine too???? My name is Joan Ladd from California ,Missouri.
@ Joan:

Thanks for the information. Has anyone been checking prepared food lately like cookies and mints, etc in gift baskets? Promo items with company names on them?

The food is made in China. Now if we can't get the lead paint right or the pet food right, how in God's name can we trust the human food?
I appeared on CNN's American Morning Show (Sept. 27) to talk about the American Dental Association (ADA) Seal of Acceptance program, but after reading this blog, I think it's important for me to explain how the American Dental Association (ADA) Seal of Acceptance differs from other "Seal" programs you may have heard about. I know this post is a bit long, but I hope you find this information illuminating.

The ADA Seal of Acceptance program has been around since 1930, and it was designed to help the public by independently evaluating scientific research on specific products and determining if the manufacturer claims match reality. When people see the ADA Seal of Acceptance on a product, they can rest assured it meets the ADA criteria for safety and effectiveness and provides an oral health benefit. The reason why a particular product earned the ADA Seal is explained on every package that carries the ADA Seal. So, look for the ADA symbol and read what's printed along with it.

Companies that submit products for evaluation under the ADA Seal of Acceptance program pay a modest fee to help defray the cost of evaluating the research and administering the program. The fee in no way guarantees that a product will receive the Seal of Acceptance. No matter what the product is...toothpaste, toothbrushes or in this particular case, sugarfree chewing gum...the submission fee is the same--$12,000 per product submitted. That's a far cry from the $300,000 example cited in this blog for another health association.

Also, it's important to note that almost 2/3 of the cost of running the ADA Seal of Acceptance program is paid for by ADA member dentists through a portion of their dues because they view the Seal program as a service to the public. Do other health associations allocate their member dues dollars for their "Seal" programs? It's one important way to put your money where your mouth is.

As Dr. Gupta explained during his American Morning segment, the cost of conducting clinical research on particular products, such as pharmaceuticals or in this case chewing gum, is very expensive; so yes, companies provide funding for research studies, but the important thing to bear in mind is that the researchers run the studies independently of the company that provides the funding. The researchers acknowledge the funding when a study is published, but the results of the study are independent of the company that funded it.

And, regardless of how the studies are funded, when the American Dental Association’s Council on Scientific Affairs reviews the research submitted for a particular product, our independent team of scientific experts and outside consultants rigorously review the studies to make sure they are well designed and that the results are valid. If the ADA believed the studies weren't adequately designed or the results did not support the product claims that the company wanted to make, it would not award the Seal of Acceptance.

The ADA Seal of Acceptance has helped consumers make informed choices about products for more than 75 years. If you see the ADA Seal of Acceptance on a product, you can be sure that the product “does what it says and says what it does.” For more information on the ADA Seal of Acceptance, visit the ADA’s Web site at www.ada.org/goto/seal

I'm proud to be the Director of the ADA Seal of Acceptance program, and even prouder of how our program helps the American public make informed decisions about products.

Dr. Cliff Whall
American Dental Association
Chicago
Consumerlab.com reviews your product for price. Whether that review is meaningful or not that is a another thing. If you test a tree for diabetes,of course it would not manifest the disease. Our world is becoming more complicated. Not only do we have to scrutinize producers but the agencies and bodies that look over them. Hopefully we get some meaningful legislation that really protect us. Declaration of ingredients on the front of products is a start. Universal insurance would be nice with some accoutability on the part of the users. Getting credits in an insurance for doing the right thing would certainly promote prevention over cure.Those credits may then be use for more prevention and early detection screening programs. Stay healthy.
in your special on diet i saw no focus on where the responsibility lies within the family. fast food is a quick and easy fix to busy adult lifestyles. a quick and easy fix. kids eat and parents obligations are fufilled. there is no sitting at the dinner table for a little human family contact. and thats what this boils down to. simple contact and communication between family over a simple homemade meal. comfort food to remember. not a big idea. quit complecating and easy does it. basic.
Below is a comment by an anonymous, I would like to add:
And held accountable for failure of the products to perform as advertised.
This is what Anon said:
If a non profit organization accepts money in exchange for seal recognition, then the non profit status of that organization should be revoked
This is interesting. Thanks for bringing this to light, Dr. Gupta. I recently attended an NIH conference where the idea of creating a national "Prevention" brand was brought up - basically where national researchers, health stakeholders, etc. would get together and decide what to brand as an official disease prevention tool (e.g., certain food, exercise program, etc). The "Prevention" brand would then be used in marketing of public health initiatives and products, to get people on-board in the same way they get on-board with any new product by a company they are familiar with and like.

Some people in the audience were critical of this idea, seemingly because it wants public health organizations to run too much like businesses, businesses that put profit first and public good second. At first I didn't think there was much to worry about, but now I see that public health orgs are already accepting money for their seal of approval and the concerns of audience members were very valid.
@ Dr. Whall:

Thanks for your post. I guess I am a bit confused. Do you do anything to protect the consumer ongoing once the product gets the seal? Once the seal is given, is it ever revoked?

ie: checking the toothpaste for lead or any other bad source.

ie: the product recall of Listerine Agent Cool Blue

Thank You.
@ Dr. Whall,

You might have scientific studies that show fluoride is helathy for teeth. But do you have studies that show that oral fluoride is not detrimental to a normally healthy body? You do not, because it isn't. Any endocrinologist would be able to tell you that. I doubt that you even have any scientific studies that show fluroide is healthy for teeth. The use of fluoride for the tretament of teeth is "grandfathered" by the FDA as "generally accepted treatment." There are no scientific studies. But there are many scientific observations (remember the first step of the scientific method) that suggest that fluoride has no consistent effect, and that it can cause health problems.
@ Dr. Whall,

There is one logical mistake and one "gloss-over" that you make in your post.

1) Logical Mistake: Any time the money from a product manufacture is directly connected to the researcher studying its efficacy or safty, there is no full independence. How much more business of this type do you think a researcher would continue to get if he/she published "rejection" studies. This source of income (upon which the researcher might come to depend) would quickly dry up.

2) Gloss-Over: Does the ADA seal of approval mean that the product has been proven through testing to contain the amount of active constituent that it claims, or does the seal of approval mean that the product contains a constituent that has been scientifically proven to be safe and effective for the indicated use. There are many "medical" products that have no scientific studies that suppoet them, but that are allowed by the FDA, because they have been used by the public long before the FDA started regulating such substances.
I believe that if these companies pay for approval from any of these societies, these societies should inform the consumers about what this approval entails.
The fact that societies don't run independent studies before approving a product concerns me. It is misleading on their part. I believe most people assume that behind their stamp of approval, is thorough unbiased research. These Societies are leading consumers to the highest bidder and I think that it is highly unethical.
ABOUT THE BLOG
Get a behind-the-scenes look at the latest stories from CNN's chief medical correspondent, Dr. Sanjay Gupta, and the CNN Medical Unit producers. They'll share news and views on health and medical trends -- info that will help you take better care of yourself and the people you love.
SUBSCRIBE
CNN Comment Policy: CNN encourages you to add a comment to this discussion. You may not post any unlawful, threatening, libelous, defamatory, obscene, pornographic or other material that would violate the law. Please note that CNN makes reasonable efforts to review all comments prior to posting and CNN may edit comments for clarity or to keep out questionable or off-topic material. All comments should be relevant to the post and remain respectful of other authors and commenters. By submitting your comment, you hereby give CNN the right, but not the obligation, to post, air, edit, exhibit, telecast, cablecast, webcast, re-use, publish, reproduce, use, license, print, distribute or otherwise use your comment(s) and accompanying personal identifying information via all forms of media now known or hereafter devised, worldwide, in perpetuity. CNN Privacy Statement.