Over the Counter Drugs: Good v. Evil

Yesterday morning @shelleypetersen tweeted an article in the WSJ about the FDA considering to make more drugs available over the counter (OTC) [If you're not following Shelley on Twitter,  you're missing some good stuff - head over and follow her].

After the initial tweet, Shelley and I went back in forth in 140 characters and had a mini-conversation about the impact. I had to leave the tweet-fest for a meeting but wanted to finish the conversation and thought I'd do so here (and break free of the 140-character bind).  There are many stakeholders in such an idea. To take a balanced look at the issue, I'll declare a winner and loser for each perspective. All of this my humble opinion, of course, and I welcome other points of view.

Also, keep in mind, the specific drugs the FDA decides to make available OTC will have significant impact on the outcomes of doing so. While I don't think Oxycontin would ever be on the OTC list it would most certainly result in a vast increase in sales. Winner? Pharma

Other Winners and Losers

1. Most prescription drug plans do not cover OTC medications unless they are deemed medically necessary by a physician (typically via a prescription). By increasing the kinds of drugs available OTC, fewer people would be likely to buy them because they would have to pay out-of-pocket. It may also increase the demand on our already overburdened primary care system as people seek prescriptions for these drugs so they are able to pay a co-pay vs. cash (see likely increase in demand #4). The total benefit dollars paid from prescriptions plans would decrease. Some patients simply wouldn't take the drugs any longer.

Winner: The people who pay for prescription drug plans (Medicare, some Medicaid, employers)
Loser: The consumer (particularly those with less discretionary income) and PCMs

2. The reduction in the total spent in prescription plans could make the overall healthcare system look less expensive (in the short term). The headline might read, "Health Reform Saves Billions in Prescription Drug Benefits." The article is not likely to go on to say how many people aren't taking the medication their doctors think they need. 

Winner: Budget people and the supporters of Health Reform

Loser: The consumer (particularly those without a "medical home" and an established relationship with a physician who they know and trust)

3. The costs of people skipping their medication won't hit the healthcare spend line (at least not enough to be noticeable) for a few years. When people stop taking their high blood pressure medicine because they can no longer afford it (or, possibly, they simply refuse to use their discretionary dollars on something that provides little instant gratification), they won't start dropping dead in the streets. It would take a few years before we'd see the likely increase in strokes and heart attacks. By then, revisionist history will take over and people won't relate A to B. 

Winner: Budget people and supporters of Health Reform

Loser: The consumer

4. When current prescription drugs become available OTC, sometimes, the manufacturer makes a less potent version available that is "safe" for unsupervised use. A patient taking a prescription at 150mg may only be able to get a 75mg OTC. This would have two results: More sales as patients would have to buy more pills and more sales as there would be more product on the market. And, of course the drug manufacturers would have to let Americans know about the health issues (some they don't know they have) while showing photos of people really, really happy because they are taking drug X or Y.

Winner: Pharma
Loser: Everyone who watches television -- can you imagine the volume of commercials? PCMs who will be flooded with patients requesting specific drugs because they have suddenly developed the latest Pharma-invented syndrome.

5. There are several Federal agencies with a role in the health of Americans. A quick overview: USDA deals with meat, dairy, agriculture and the food policy, FDA handles drugs and other foods, DHHS oversees health insurance programs, DoEd teaches our kids about health, DOI handles parks and outdoor space, DOT oversees transportation. The point being we don't have a way to budget for, or even understand, the true costs of health. If the FDA approves an increase in OTC drugs which negatively impact the cost of healthcare programs like Medicare and Medicaid, the FDA doesn't really need to worry about it. The FDA and DHHS don't share a budget, or accountability, for the health of Americans.

Winner: The agency accounting for "saving" money
Loser: The agency accounting for increased costs

6. One of the concepts behind additional OTC drugs is to increase access to the drugs which claim to combat epidemics like diabetes (first of all, one has to believe drugs are the best way to combat lifestyle diseases... I happen to think lifestyle changes are better and cheaper). The "improved access" could be done by kiosk-like devices to help patients self-diagnose to determine if they need a drug. What an opportunity here! I have many questions about the kiosk implementation: Who will write the questions? Will there be drug advertisements on the kiosk or as a commercial spot before the questionnaire? What reading level will written for? Are we going to track outcome (i.e., how many people who go through the kiosk would end up with a drug vs. those who visited their doctor)? Tricky policy and implementation here. And, forgive me, but too many interesting ideas get completely ruined in implementation. What is certain? More drug sales.

Winner: Pharma
Loser: Physicians (whose professional judgement will be replaced by a kiosk). Consumers (who will be even less likely to make lifestyle changes when all they have to do is go to the ADM (automatic drug machine)).

As I wrap this up, I have to admit feeling a bit discouraged. Is our system really as bad as this? I'll leave that up to you and would love your thoughts. In the meantime, I think I'll switch on the television to see what ails me and what magic cure might be available from my pharmacy.

Western Weight on the World

Today's Washington Post included an interactive graphic on the Body Mass Index across the world from 1980 to 2008. The data came from a study of cardiac risk factors and shows the growing prevelance of obesity, high cholesterol and high blood pressure across much of the world. Go to the article so you can truly understand the impact.

My commentary? We continue to export our Western ways of living (sedentary life consuming fast and processed foods), followed by our Western health issues (obesity, high blood pressure and diabetes) followed by our Western "solutions" (surgeries and pharmaceuticals). The only ones benefiting from the "Western-ways" epidemic are the shareholders of the companies that create the problem and then fix the problem.

Everyone else, and the environment, suffers. My advice can best be summed up with:

Shame on us.

Dietary Guidelines for Americans 2010

Today, the USDA and the DHHS released the Dietary Guidelines for Americans, 2010. The release was accompanied by an 112-page document outlining the new advice for what we should eat. This document was summarized by two over-arching concepts:

• Maintain a calorie balance over time to achieve and sustain a healthy weight
• Focus on consuming nutrient-dense foods and beverages

Relatively impressive, though benign, advice. Both of those statements are true and are good rules-of-thumb. I contend we have a significant information gap and many people need a great deal of (honest) education to understand what that means (which is what we at Cybercise work on each and every day). 

And, as with most things, the devil is in the details. At this writing, I haven't read all 112 pages though I promise I will. I did a quick skim though and here is my list of pros and cons from the recommendations in the report:

• Pros
• Increase physical activity and reduce sedentary behaviors
• Recognized calorie needs are different in different stages of life
• Reduce sodium intake
• Keep trans fatty acid consumption as low as possible
• Increase vegetable and fruit intake
• Increase whole grain intake
• Account for all foods and beverages consumed
• Cons
• Increased intake of fat-free or low-fat milk and milk products (These are highly processed foods and are suspect, at best, as your most healthful choice).
• Only reduced sodium intake to 2,300 mg/day and then goes on to say 1,500 mg/day recommendations apply to 50% of the population (Huh? Why even go there. Make it 1,500 a day and be done. Who is beholden to the salt lobby?).
• Suggests an increase in fiber, calcium and Vitamin D, which is good, though sets the stage for more "Now With Added (insert chemical food additive name here)" on package labels. 
• Suggests we reduce trans fatty acids though doesn't go so far as to eliminate the loophole in current labeling regulations that allow each and every product you consume to have less than .49 grams per serving. (Hello? If you want us to reduce our consumption, get it out of our food.)

Credit where credit is due, this is a pretty good report. While I don't really like the way we create policy in this country (little baby steps at a time so we don't alienate too many special interests), I understand that moving the behemoth of our Government sometimes takes time and always takes compromise. 

Stay tuned for more after I devote the time to read the entire report. Now, if we can implement The Real Food label and eliminate GMO/GE foods. "You may say I'm a dreamer..."

USDA (Unbelievable Series of Disappointing Actions)

If you're a reader of this blog, you've likely already heard that the USDA lifted all restrictions on the planting of genetically altered alfalfa. If you're not in the know, this means farmers will be able to freely plant "Roundup Ready" alfalfa and then freely poison the earth with the chemical pesticide Roundup.

Most alfalfa is used a feed for livestock so it is only a matter of time before we are consuming more and more genetically altered alfalfa and the chemicals used to keep the plants alive until harvest. Yes, I am disappointed. No, I do not have the science that says all of this is bad for us. Nor do I have the science that says all of this is harmless. What I do have is common sense and a general sense of foreboding about what this means for our organic farmers and natural food and our health of our planet. I refuse to believe dumping more chemicals on the earth is good for anyone (except, of course, the people who profit from said dumping).

As I sit here hoping someone will stand up and stop this from actually happening (Michelle Obama, are you reading?), I'm left to accept the current reality and do something proactive. I have added another row to the Real Food label so, at the very least, we'd be able to see if the foods we are buying include genetically modified ingredients. And while I was at it, I included some of the other things people look for while shopping.

Now we have a label that identifies, with simple red and green, if a food is:

• Organic
• Vegetarian
• Vegan
• Kosher
• Gluten-free
• Genetically modified
• Irradiated

In my black-and-white thinking, zero is zero and any amount counts. In other words, the ingredients must all be organic to qualify for a green tab "O" and if there is any trace of an ingredient genetically modified the GMO tab is red. I greatly dislike that products with less than .49 grams of trans fat are allowed to say the product is trans fat free so I don't want to leave any wiggle room with the Read Food label. 

It does occur to me we could continue to add things to this label so it is no longer useful (or perhaps as useful as the nutrition information now on the back of packages). I also recognize that if we keep growing this front-of-package label there may not be room for cartoon characters and flashy colors designed to lure people to the box. Hmmmm... something to think about there. Nonetheless, I would appreciate this kind of tool when I go to the grocery store. At this rate, if I'm buying anything other than whole, real, natural food I spend quite a bit more time shopping because I'm  reading through ingredients until I find a "lesser evil" package. 

Any thoughts out there? Are these additions to the label too much or too little? Did I choose the wrong categories for the second row? Shall I simply give up and buy stock in Monsanto? 

I'm going to sit by the phone and wait for The White House to call. I am a neighbor, after all, and would be happy to pop down and give the Real Food label to Mrs. Obama and be ready to answer her questions as she calls the agency responsible for the Unbelievable Series of Disappointing Actions (aka USDA). 

The Real Food Label
v4

The Real Food Label Explained

As the debate on GMA and FMI's nutrition keys label continues, we're going to devote today's article to exploration of our Real Food label. If you'd like, you're welcome to go to the backstory.

The objective of a package label is to:

• Clearly communicate
• Be consistent across all products
• Require little to no "training"of the end-user

The Real Food label meets these objectives and is designed to give inform consumers with a simple red-yellow-green system. The benefits of the Real Food label are:

• People of all ages inherently understand green is good and red is not so good so little training would be required. 
• Language and cultural barriers are minimized.
• In a sea of packaged foods lining store shelves, the healthier options would be very easy to spot.
• It provides subtle education which, over time, could help consumers become more aware.
• It introduces "real food" and "miles traveled" to labels to further the underlying concepts and health benefits of whole and local foods.
• The points system could be used for personal rewards, societal rewards (walking paths, new parks) or group rewards (schools, churches).
• The QR code gives the consumer an opportunity to get more information and could lead to a "Yelp" type site for crowd sourcing and reviews of products.
• Non-packaged foods could easily use the same labeling system attached to store shelves and displays vs. the package. There would be huge benefit of 100% consistent labeling across ALL foods. 
• This label could also be required in all eating establishments (restaurants, carry-out, cafes, etc.) so consumers would have the same information about the choices they make while dining out. 

I'm not naive enough to think implementing this label design would be easy. The challenges:

• Big ag, the fake-food industry and the restaurant associations would amass their lobbying power to keep this from happening. 
• We have to establish the thresholds for red, yellow, green. Possible certainly, but it would require some wrangling because nutrition science is hotly debated.
• Innovators would need to build the point system and the QR code system (I trust there are plenty of entrepreneurs out there to take this on).

All of that being said, we could easily implement the Real Food label in 9 months like so:

• Month 1: Congress passes the Read Food Label Act. The President signs and while doing so names the Real Food Panel members. 
• Month 2-4: The Real Food Panel members, comprised of nutrition and food experts, meets to establish thresholds (to be clear independent would mean no employer, consultant, investor or fiscal relationship to food or the Government)
• Month 5-6: The thresholds are published for public opinion while the innovators develop and test the points and QR code systems. 
• Month 7: Final rules published. Implementation begins. 
• Months 8-9: Implementation period 

The moral of this story? If some enterprising leaders in our Government take this on, we could have the Real Food label system everywhere by October 2011. Now that is progress. 

Front of the Box

Inspired by Michael Jacobson's blog in the Huffington Post yesterday, I decided to do some more research into food labels and "front of the box" activities. This summer, inspired by my niece, I offered the idea that we only eat things less than five degrees from nature. That work inspired further research into processed food and I then thought it would be a good idea if the processed food box was required to list what had to happen to get the food in the box. 


Combine all of those thoughts with some of the ways the U.K. uses labels to help consumers and....  I have designed a "front of the box" label for all food sold in the U.S. Yes, you are welcome. We can now avoid and eliminate months of wrangling and politics and simply implement my idea. I'll even give it away!

My front of the box label looks like this ------->


As you can see, it is very clear from the beginning the food is processed. The label then lists each ingredient (with synonyms) and describes the process used to create the ingredient. 


Doing this research was frightening. I have no clue what "epimerized" means and I'm too afraid to look. To make matters worse, in the attempt to find this information I came across a catalogue of food additive manufacturers based in China.



Are the majority of our food additives made in China? Given some of the concerns with pet food and baby formula recently, this is really scary. Not to mention the fact many of these additives say "safe for infant food" on them. Safe? Who made that decision? The FDA and the GRAS list? Am I the only one who is a bit skeptical here? Apologies for the rant. Back to the label...


The bottom of the front of the box food label lists Fat, Sugar and Salt with easily understood, colored stickers. This particular product (a real product and a relatively "healthy" one which I omitted the name from to protect the innocent) scored all green. The protocol for the labels would also allow for yellow and red stickers. It would be relatively easy to educate the public on how to use this system: Choose products with mostly green stickers. Yellow stickers are to be used in moderation. Avoid things with red stickers. 


Of course, there are some details to work out and maybe we add another category or two into the sticker system. This box label gives consumers the information they need to make better choices about the food they buy and consume. Shoppers would be able to quickly see information and would not be distracted by cartoon characters and health claims. Plus, it would help to educate people on what the "processed" in processed food actually means. I don't know about you, but this information would certainly impact my eating decisions. And I think, over time, it would improve the way food is made for Americans. 

Follow-Up on Manwich

Up early, good exercise and some time this morning reading comments on yesterday's redux blog on Manwich led me to see if there were any updates on the ConAgra website since they didn't have nutritional information when last I checked. Goodness... are we going to have fun with this for a few days!

Yes, ConAgra has updated and launched a new site for Product Nutrition information. Excellent, I thought. I will go and search for Manwich and see what I can find. Should be easy, right? ConAgra would want their consumers to quickly find the information they are seeking, right? Ha!

I would consider myself a pretty savvy web user and... this is one of the most confusing, difficult-to-use search features I've ever encountered. For the record, the idea of the web is to make it easy for people to find what they are looking for. Can I just have a search box to type in Manwich and get the nutritional information? No! 

When I tried the search box and entered Manwich, I did get a nifty news release on the Investor Relations page that talks about the release of the "full serving of vegetables" campaign and says: 

• "new television advertising campaign promoting the full serving of vegetables found in each serving of Manwich"
• "mark Manwich’s first new creative campaign in three years"
• "new strategic message requires a deeper communication with the target consumer"
• "promoting the full serving of vegetables strategic messaging and encouraging moms to feel good about serving Manwich to their families more frequently"
• "lighthearted spots feature a young girl who is dressed as a Manwich for a school play while her classmates are dressed as vegetables. She touts the wholesomeness of Manwich to her classmates and family."

Excuse me? This a strategic message to encourage Moms to feel good about serving Manwich? How about a strategic message to help Moms understand what is healthy and good for their family? How about a commercial with only the vegetables on stage? 

There are so many things wrong with this, I don't even know where to begin. Discuss and share. Until we get together and point out the absurdity of such things the people who need good and honest advice the most will continue to be subjected to "strategic messages."

Tomorrow? An experiment in actually using ConAgra's Product Nutrition Search. Stay tuned!!!

Step Really Far Away From the Box

Today's Washington Post included a follow-up article on the Kellogg cereal recall. If you missed the recall this summer, Kellogg recalled 28 million boxes of cereal due to elevated levels of the chemical 2-methylnaphthalene in the packaging.

According to the article, both the FDA and the EPA don't have data on the health impact and safety of 2-methylnaphthalene. In fact, our Government lacks data on over 80,000 chemicals in the U.S. marketplace today. Somehow, and for reasons I cannot fathom, these chemicals are still permitted in consumer products. Basically, everything around us is toxic. And, we wonder why there is an increasing incidence of cancer and childhood diseases like autism? 


This is the most impactful paragraph in the article, "The information gap is hardly new. When the Toxic Substances Control Act was passed in 1976, it exempted from regulation about 62,000 chemicals that were in commercial use -- including 2-methylnaphthalene. In addition, chemicals developed since the law's passage do not have to be tested for safety. Instead, companies are asked to volunteer information on the health effects of their compounds, and the government can decide whether additional tests are needed."


So until Congress catches up with what is in the people's best interests and creates rational legislation, each of us should do two things:

1. Write your elected officials and tell them how important this issue is to you, and
2. Avoid as many chemicals as possible

Number one requires a small bit of effort. To find your elected officials in Washington, DC search here. Number two can be an epic undertaking. It would be virtually impossible to eliminate 80,000 chemicals from your environment. However, don't get discouraged and do whatever you can. Some ideas: 

• don't buy bottled water (filter your tap water instead), 
• buy organic food, choose whole foods that come in as little packaging as possible, 
• shop at a local farmers market and avoid all packaging, and 
• clean your house with natural products. 

Start with these ideas and keep working at reducing the amount of chemicals in your life, as much as possible. Small efforts can build up and deliver big results. 

A Slippery Slope We Want

A Slippery Slope We Need
The Huffington Post published a top 10 list of why we want to require labels on products that  include the presence of GEF, or Genetically Engineered Food.  The reasons why to do so are compelling and it's scary to think there is even a possibility that such labeling would not be required. And the possibility is very real. Lobbyists for big agriculture and food manufacturers are working hard to prevent required labels. Why? Three reasons I can think of:
1.  It could add cost to the production process
2. Some consumers may then choose not to buy products with GEF
3. The honesty in labeling could the extend to other things

Number 3 is really what they are worried about. There are very questionable ingredients in many processed foods that we buy, eat and feed to our loved ones. There are huge, gaping loopholes in what is required on labels. For example, most people would avoid something with monosodium glutamate (MSG) if the package had it on the ingredient list. Unfortunately, manufacturers are permitted to use the generic term "spices" on a label when in fact they are referring to MSG.

So, if we actually implement true, honest and accurate labeling for GEF, we are only a few short steps away (or at least the kind of short steps that exist in our policy process), from extending that policy to all of the things that end up in the boxes of processed food we buy. Such a policy would be a huge benefit for the public and a really big pain for the people that put things in our food that probably shouldn't be there in the first place. 

We are a Government of the people. Wouldn't it be nice if the policies they create are also for the people?         

2010 Dietary Guidelines

Stay tuned! The US Government, via the USDA and HHS, is working on the 2010 dietary guidelines. The new guidelines are scheduled to be published this fall. In the meantime, if you'd like to keep up with the progress click here for the website.

On the website, there is a link to the comments submitted by individuals and industry. Suspecting some of the comments would be interesting, I scrolled through the list and downloaded the comments submitted by the Corn Refiners Association (who knew such an association existed?). You might be surprised to learn the Corn Refiners Association submitted a great deal of research in support of High Fructose Corn Syrup (HFCS). Much of the information they submitted was Government and association research reports which suggests HFCS is not harmful and should remain Generally Regarded as Safe (GRAS). The FDA created the GRAS list in 1958 as a tool to help consumers and manufacturers determine what additives can be used in food. We could spend a very long time examining the process and the validity of the GRAS list. Here is a small peek...

The list of things on the GRAS list is frightening. One example: Propylene Gycol (PG). On the Dow Chemical webpage describing PG, they say it is "not acutely toxic" and is "essentially non-irritating to the skin." Excuse me? And this means it can be added to my food, cosmetics and pharmaceuticals? Yes, quite so. If you'd like to know what else can be added to your food, here you go, but be prepared. Things removed from the GRAS list: saccharin (though Congress granted a special exception and it is still being used), cyclamates (now completely banned) and Red Dye No. 2 (also banned).

Are we supposed to feel good that our dietary guidelines include things on the GRAS list? Given all of this, I am a bit skeptical the 2010 Dietary Guidelines will be good for us.

Foxes at the Government Guarding Your Henhouse?

Kudos to Jonathan Safran Foer for his opinion piece on the CNN website this week. He carefully describes the environment between the FDA, charged with regulating our food stuffs, and the food manufacturer's and special interest groups.

Basically, the Government agencies responsible for creating policy and guidelines about what we eat have a very cozy relationship with the very organizations working very hard to protect their own interests.

We need a truly independent organization without the pressures of special interests, profitability and status quo. The question is how do we get there?