Day 8: November 2, 2006

November 3rd, 2006

WOW! When I opened my mail box, there were 154 Citizens Petitions! Do the math: if we could do that many for a year, think of the size of the group taking exception to theillegal US Codex policy re: Vitamins and Minerals! Better yet, if you will email the link (http://www.healthfreedomusa.org/action/step3/petition-letter.shtml) to the Citizens Petition and ask every one you know to sgn it, We will have at least a hundred times that number every single day! And in this particular game, numbers most certainly do count.

Speaking of numbers, please help to add up our pennise. Search with the Yahool search engine, www:GoodSearch.com, (http://www.goodsearch.com/?charityid=817759) make it your home page and start searching. You search, we get a penny. You search again, we get another penny. Check it out. Using it funds the battle without taking anything away from your pocket. Good deal!
A lot of important events at a meeting like Codex do not take place in the meeting room. In fact, today’s important events took place on our “day off” while the Delegates went off to occupy themselves so the Secretariat, the administrative arm of the Committee on Nutrition and Foods for Special Dietary Uses, could get the report of the proceedings into shape for tomorrow’s discussion over what was, and what was not, said.

The plan for the day was that we would be able to spend several hours at the brand new Royal Horticultural Exhibit which opened yesterday and will run through January, 2007. It was built to honor the King’s dedication to agriculture and improving the well-being of the Thai people and is a lush, exhaustive (and exhausting) catalogue of the floral richness of this verdant land. It is huge and the sun was blistering. None the less, this floral pleasure garden was a delight.

On the bus on the way to the gardens, we happened to be seated in front of a member of an observer organization. Up to now there has been a lack of collegiality and productive contact but we have maintained, with them as with everyone else, an open hand and a welcoming attitude. After all, the healthfreedom sandbox is big enough for all of us and the more people there are who can whack at the giant, the better. Not everyone see things this way, though, and this organization has been pretty unfriendly.

We persist in our positive attitude, however, and had the pleasure of making real contact with a member of that delegation with whom we had the opportunity to discuss our two part strategy for solving the Codex problem. We presented the member of the organization a copy of our ebook.

Lo and behold, a reasonable, meaningful discussion ensued. Now we have a language of common focus and discussion. We were very pleased by that since dissent in our own ranks gets none of us anywhere.

In fact, that is a pretty good rule of thumb: if a person or organization is bad mouthing anyone else (by direct or indirect speech, writing, smear, etc.), there is no reason to suspect that person or group is either a useful advocate for health and health freedom or a trustworthy leader. Steer Clear!

So we had this meaningful discussion and suddenly our point was clear to the other person. That was worth the price of admission, I can tell you.

During the rest of the day’s activities (after we got home and showered — again!, we spent the day with known friendlies and discussed strategy during our visit to the silk factory and the famous “Night Market”.

I would mount the pictures but I cannot figure out how to do that. Besides, I am so tired I cannot see straight to type.

More tomorrow when I report on the Codex session devoted to preparing the report for this committee — that’s where the fist fights and hair pulling (so to speak) take place.

Day 7: November 1, 2006

November 1st, 2006

Before we get started, have you been using www.GoodSearch for your internet searches? Use this link and make this your home page. You’ll be using a great search engine (powered by Yahoo) and getting us a penny every time you search! Here’s the link: http://www.goodsearch.com/?charityid=817759

Dispatch from the trenches.

I am sitting in the Codex meeting right now. There is an oops: the other side is not giving up so easily (they never do). The fluoride battle for infant formula for ordinary use has been won BUT the war for safe and pure foods re: fluoride is not over yet.

Yesterday’s battle was won, with the help of the documentation we provided to South Africa (SA) in favor of infant formula but the fluoride standard for foods for special infant formulas and foods for young children was on the docket for today. These standards (which cover items which can be added to foods for sick infants, infants with special needs and young children) came up for discussion and South Africa almost managed, without opposition from anyone, to have both potassium fluoride and calcium fluoride deleted. Think again! Despite the fact that the discussion had been concluded, the EU came back to fluoride later. Ordinarily, Dr. Grossklaus does not allow anyone to revisit issues. His consistency is not in evidence, however, when the EU or US wants something. Right now the EU wants to keep fluoride in the list of permitted items (in this case, toxins) for kids that have special needs. In other words, the EU wants to leave these toxins in for especially vulnerable kids and so does the US. Australia joined in to support the US and EU.

So our victory is significant and, at the same time, marred by the need to continue the battle. Fluoride is still a toxin, even if the child has been weaned or has celiac disease or whatever. You can see from that how important eternal vigilance, the appropriate marshalling and deployment of our resources is to this battle. Here’s what’s going on in the Codex chamber right now:
SA is saying that fluoride is not essential for human nutrition. The US weighs in supporting the EU “based on the use of these compounds in special medical circumstances”. A health group supports SA and notes that water can be cleansed to remove fluoride. Australia supports EC also noting that Sodium fluoride is not up for debate and therefore potassium and calcium fluoride should be allowed. Dr. Grossklaus, the chairman, decides that they should be allowed but SA comes back and says that SA wants it noted in the final report that their objection to the use of fluoride continues. The Chairman declared the issue settled and quickly moved on.

The cool thing? More and more countries are getting the message: Codex texts are NOT mandatory. Countries which do not like what Codex has decided MAY, if they so uncomfortable with Codex policies (1. adopt a better guideline or standard based on better science and 2. then enact it as your country’s law) is becoming more and more relevant as countries realize that they have these options. The times really are a’changin’.

Antioxidants are now under consideration for addition to foods for children and infants, which would have been a new section in the standards. That is not a big deal. New sections are easily added. US and EU opposed adding either antioxidants or a new section. SA favored retaining the category for further discussion (“keep it in square brackets”). Dr. Grossklaus asked if any one supported South Africa or if it were a “personal opinion”. Since no one else spoke for it, the category disappeared. Are antioxidants useful for babies and children? Absolutely. Does Codex endorse their use? Not now: the US and EU ganged up on that option for our children’s well-being.

Remember: Codex serves the illness industry. We are fighting for Codex to act in the service of health or, if that cannot be achieved, for Codex to be left behind while countries create their own health standards and trade with others who value health as well.

Oh, yes, one other thing: on Sunday 29, 2006,October, before the actual beginning of the Codex meeting proper here in Thailand, there was a meeting that takes place on a regular basis at Codex meetings. The US, EU, Australia and Canada met to make sure that their positions were in line. It’s not too hard to draw the appropriate conclusions from that particular bit of information.

Next on the agenda (although there are quite a number of items before it, such as the amount of gum Arabic which can be added to food — should it be 100 mg/kg as previously allowed or 10 mg/kg as indicated through a typo in the standards document?) is the Global Strategy for Diet, Physical Activity and Health (GS).

You remember that SA has proposed 11 strongly pro-health principles which we support. You also remember the fight over them at the last Codex committee at which they were to be discussed.

We were loaded for bear. We had a coalition of 6 countries and 3 Observers (NGOs who can speak after all the countries have spoken) ready to raise a ruckus in support of SA’s 11 points. What happened next was fascinating, indeed.

Dr. Grossklaus, famous for his autocratic behavior, changed the tune. Explicitly ignoring any dissent whatsoever, he destroyed what might be said to be even a slightly democratic process when he defined the time allowed and the issues under consideration in such narrow terms that there was no possibility of dealing with health on any meaningful level.

First, time: Although my read of the procedural requirements is that the GS should have been considered as Agenda Item 2, Work Referred by Other Bodies, it was moved to the end of the proceedings. That should sound familiar since it is exactly what happened last year in this same committee when we had a total of about 6 minutes for discussion. This time it was almost the last item and Dr. G. used the time pressure which he had carefully engineered to race through the item so that there was no time for discussion of any meaningful nature. Lengthy reports were discussed in a minute or less with countries urged not to make comments in the interests of time! Countries which did make “interventions” (as comments are called) were scolded for taking the Committee’s valuable time.

Thailand introduced a paper urging the limitation of sugar in formula, cereal and drinks for children 2 and under to levels no greater than breast milk since the sweet taste preference is set in that period, chemo receptors are laid down, social meaning is acquired for food, etc. This is directly in accord with the GS’s recommendations.

Never mine. No time, no time. Norway supported, as it has all along, this health measure which would save countless lives and untold numbers of diabetes, heart disease, cancer, obesity, stokes, etc. A simple measure, but a very expensive one. Sugar and sweeteners are a huge economic force. Here is a quote from Dr. G. when he rudely interrupted Thailand: “Thailand, we can’t discuss the whole strategy. Please give specific conclusions.”

Why “can’t we discuss the whole strategy?” That is, after all, the job of this Committee and the one on Food Labeling, mandated by the parent bodies, WHO and FAO.

On cue, the every industry-friendly EU said,

“The paper sets out the recommendations that are relating to this issue but I would like to know that the recommendations are relating to the overall diet and not to the individual products. The diversified diet of infants including cereal products are such that they consume several diets. Therefore we believe that applying the recommendations to a single product about sugar is going a little bit far. We notice the objectives but we believe that there are different means of achieving them, non regulatory and regulatory.”

Forget limiting sugar to breast milk levels. Ploy number 2 coming up: Dr. Grossklaus then confused the issue totally with the introduction of cereals:

We have general recommendations of pediatricians and it is hard to translate this diet guideline into the diet of individual persons. How does cereal based diet translate into dental caries, for example? It is very, very difficult.

I would like to discuss this item for another 5 minutes only. This is the maximum. [only another 5 minutes for countless millions of lives impacted by failure to enact achievable, but less profitable, disease control measures– comment added by Natural Solutions Foundation]

The question is whether the position of EU is also shared by other member state that it is difficult to revise the standard.”

South Africa, the breast feeding NGOs and (I think — it was hard to hear) Finland chastised the EU saying “We are deeply shocked by the unhelpful position of the EU. We would have expected them to support Thailand, Norway and SA”. But once the cereal issue got put on the floor, the discussion became chaotic. India said, quite rightly, that their problems were under nutrition in children, not over nutrition so cereals for their people should have more energy density, not less (e.g., calories per unit of food) and Dr. G. just stirred the pot.

So WHO weighed in. Here is a direct, verbatim quote of WHO’s intervention:

“We believe that the standards should be set having in mind healthy diet and healthy diet is for all. We are not looking at obesity without looking at under nutrition for all. The mentality is what leads to a healthy life for all children. The case is that for outside [these norms] will be dealt with by a number of different interventions. Last year we had already put the issue of the 10% level [energy from sugar] that was discussed; the translation of that figure is not a straight translation. In a general way we support very much the intent of Thailand wanting to reach a standard that is the best standard for all children, especially for infant feeding.”

At that point, NGO of European pediatricians with specialization in GI, liver and development volunteered to lead a Working Group to clarify these issues and report back to the Committee next year.

“We have been following this with great interest. It seems to us that different standards and issues have been raised by different delegations. We feel that these issues are complex and need to be examined in light of scientific data and we wonder if it might not be useful to bring together an ad hoc working group.”

WHO liked the idea: “I would like to support this because we need to take into account obese as well as malnourished children.

Ah! Not so fast there! Although Thailand agreed to the Working Group without really considering it,

“We appreciate this, but because of the shortness of time we don’t have time to discuss this in detail so we will support the proposal of ESPHAGAN [the NGO]”,

but as if on cue, the German Secretariat of this Committee, the Codex Committee on Nutrition and Special Dietary Uses (CCNFSDU), said that the Committee could not, for procedural reasons, accept a working group providing data if that group were led by an observer group.

The EU and then the US sucker punched the idea and the last word on the discussion of the Global Strategy this year came from Barbara Schneeman, US Delegate to CCNFSDU,

“It should be stated in the report that the committee cannot accept ESPHAGAN’s offer to have an ad hoc group.”

Creative chaos in the service of industry and illness. Thank you, FDA, EU and Codex.

We definitely did not win that round. The tune was changed and so we have to change our dance steps. Immediately after this disgusting session concluded (and, by the way, it was preceded with what appeared to me to be a completely unnecessary 30 minute break (although they may have been dealing with union rules — that I do not know) our team had a meeting which lasted for several hours to work out our forthcoming steps. They are good. Very good.

This was, is, and continues to be, a winnable battle. Every time the other side behaves this obviously badly, more countries “get it” and the willingness to dance a different dance gets stronger. Last night there was a lot of willingness after this shameful performance by the forces arrayed.

Thursday, November 2, the delegates are being taken on an excursion to a horticultural exhibition created in honor of the King of Thailand. If I can figure out how to do it, I will mount some photos of that excursion. You may rest assured that there will be a good deal of talk about yesterday! It’s a working outing and the pictures should be terrific!


Day 6: October 31, 2006

October 31st, 2006

WE WON!

Today, we changed Codex from inside and protected every bottle-fed infant on the planet.  Today is a day for celebrating!

The bottle-fed infants of the world (and their loving, caring parents) owe the Government of South Africa a huge vote of thanks. Instead of being poisoned with baby formula containing added fluoride, instead of having their bones and teeth weakened, their joints stiffened, their thyroids and immune systems depressed, their lives shortened by leukemia, osteosarcoma and other cancers, instead of all these miseries, the babies of the world can drink their infant formula assured of baby formula to which fluoride cannot be added!

How did that happen? Once again the South African delegation to Codex was fearless about speaking truth to power and tireless in striving against the autocratic, hostile and insulting Chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) which is meeting right now, even as I write this in Chiang Mai, Thailand. Dr. Rolf Grossklaus uses derision, insults, twisting the Codex procedural manual, his apparent disfavor with South Africa with great vigor.  Yet South Africa persisted, despite being interrupted and treated very badly when it tried to make the case that a review of the US National Research Council’s position on Fluoride and other authoritative documents made it very clear indeed that fluoride is a poison and that it is absolutely contraindicated in infants and the serious disagreement of the US were nothing next to the bull-dog like determination of South Africa that this poison was NOT going to become part of the food system of the world.

In the end, South Africa prevailed. And, we are proud and happy to say, the documents that they used were the ones prepared by the Natural Solutions Foundation. Over 1100 media outlets have picked up our fluoride information, by the way, and more are publishing it every day. You can read it here for yourself and see how this deadly poison does its damage: http://emediawire.com/releases/2006/10/emw444513.htm.

You can also see in this document why babies should be protected from it with special care.

Science based?  You bet.

Even if nothing else positive happened at this Codex meeting, we would have reason to feel both proud and satisfied with the outcome of this meeting from our point of view.

However, there is a good chance to more good is yet to follow.

By the way, yesterday I mentioned that there was a real issue with the approval of additives which have not been evaluated for safety in people under 12 weeks old.  Well, it came up this afternoon when we heard the debate circle around: If we present a list of items which have no safety profile, the list cannot be approved.  If the list is not sent in, we will not be doing our job.

More than 10 1/2 years of wrangling over additives and it is not clear that the list CAN be approved.  Mmmmm.  This will be interesting.  We will wait to see what happens on this one and keep you posted. Stay tuned!

Health Freedom Trip: Days 1-5 (10/26-10/30/06)

October 30th, 2006

Day 1: October 26, 2006

This health freedom trip started before we even left the country. As many of you know, the American Academy of Medicine (www.AAEM.com) is an organization filled with doctors who think a whole lot like I do. Because of that, it is the professional organization with which I feel most allied and which is my professional organization. Imagine my delight, then, when I learned that General Stubblebine and I would be honored by this exceptional group with their coveted Carlton Lee Award for the person(s) who best exemplifies the principles of Environmental Medicine. And imagine my distress when I learned that the award ceremony was on October 26, 2006.

The delight is obvious. The distress only becomes obvious when you realize that this year’s Codex Committee on Nutrition and Food for Special Dietary Uses (CCNFSDU) started on October 30, 2006.

DAY 2: October 27, 2006

The fix?  Fly to Charleston SC (VERY early), drive 2.5 hours to receive the Carlton Lee Award on October 26, then drive back to Charleston after dinner, sleep at a motel for a few hours and then fly back (VERY early) on October 27.  Drop the old suitcase, pick up the new ones and fly to Frankfurt (6 hours) to Singapore (12 hours) to Bangkok (2 hours) to Chiang Mai (1 hour).

Day 3: October 23, 2006

Lost in the International Date Line.  Gone. Poof!

Day 4: October 29, 2006

When we arrived in Chiang Mai and got to our hotel room at about 6:00 PM we met someone we knew who asked us if we would like to come to the famous Chiang Mai Night Market or the special Sunday Market.  We looked at each other, said, “No, but thanks for asking” and collapsed onto the bed.  We slept 13.5 hours. No dinner, just bed.  Ahhhh!

Day 5: October 30, 2006

Today was the opening day of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). The big surprise was that the rumors were true: Dr. Grossklaus did not allow anyone else to chair this meeting.  It may have been in Chiang Mai, Thailand and the Vice Chair of CCNGSDU may have been right here, but there was NO WAY Dr. G. was about to let a strand, not a single strand, of the reigns of power out of his hands.  And he did not.

The session was opened by the usual remarks of introduction and then the new Codex film played (for the first time in public as far as I know).  In it, Dr. Grossklaus talked about how difficult consensus is (although watching him and other chairmen at Codex it would appear to the eyes of an observer that consensus is remarkably easy to achieve: you simply ignore, override, dismiss or misinterpret anything that gets in the way of what you have already decided will happen and then you declare that decision “achieved by consensus” regardless of the sense of the body on that issue.  Perhaps it is not really so easy.  Perhaps ruthless autocracy takes its toll.  Because today, when Dr. Grossklaus made his obligatory opening remarks he, quite astonishingly, said that Codex had to pay more attention to the health of consumers than to trade and that it was the responsibility of Codex to show responsibility for the most vulnerable, i.e., infants and those who were sick, particularly those who were sick with food-caused diseases!

Although the content of the meeting so far has been no different, it is very important to note that our work is causing changes at the “show and tell” level because, we believe, our input is causing friendly nations to ask questions inside and outside of Codex about what IS the purpose of Codex?  Why ARE they taking decisions based on trade at the expense of health, etc.?

Consider the posture struck by Dr. G. just one year ago in the CCNFSDU ’05 meeting (Bonn, Germany) when he cut South Africa off at the knees when she stated that since the goal of Codex was optimal health and…. She never got further than that.  Dr. G. roared at her “Health!  It would be very nice if Codex were about health!  But it isn’t!  It’s about TRADE”.  Well, this year, at least in the first few moments of the meeting, it’s about health.  Well, well, well.

Next, another surprise.  During last year’s CCNFSDU meeting in Bonn I was approached by a film maker to be interviewed.  He said that he had been following the work of the Natural Solutions Foundation, that he was a big supporter, and that he had been commissioned to make a film about Codex BY Codex.  I said that I did not think he wanted me in his film since I did not imagine Codex really wanted to hear what I had to say about it.

“On the contrary”, he said, “it is precisely because you will say what you believe that I do want you in the film.  I only took this commission”‘ he said,” on the condition that I could make a film that honestly expressed people’s perceptions and believes about Codex and that the Directors of Codex would watch it.”  “OK”, I said, let ‘er rip”

And rip she did. I talked openly and at great length about the flaws, dangers and missed opportunities of Codex from a structural, administrative, scientific and psychological perspective.  During the time that I was being interviewed on a balcony overlooking the meeting room (as the last interviewee at about 4 PM after the end of the CCNFSDU meeting), I had my back to the balcony railing so I did not see who walked in as I started to talk, stopped, cocked his head skyward and stood listening to my interview.  But General Stubblebine and the film maker did: it was Dr. Rolf Grossklaus.  You can imagine, of course, that much of my discussion of the dangers and shortcomings of the system and of CCNFSDU centered on a very unfavorable analysis of the gentleman listening in silence.

Well, when the film went on this morning I realized it was THAT film and that it was being shown in THIS committee!  Let ‘er rip once more, I said to myself and General Stubblebine. And rip she did, to some extent.  My contribution was edited to make a single, but very important, point: “The Codex process stifles the voice of dissident scientists”.  That is, those scientists whose work does not serve corporate ends are not quoted or cited for supposedly “science based” decisions.  This is a very serious flaw indeed.

Then we took a coffee break.

After the coffee break we got down to business.  One of the orders of business was requesting changes in the order of agenda items.  The very important Global Strategy for Diet, Physical Activity and Health (which Codex was told to implement by its parent organizations, WHO and FAO at the Codex Commission meeting (Rome, 2005) was, once again, late on the agenda.  Last year at this same committee that meant that the item was, in effect, not discussed at all.  Several countries were not about to see that happen again so a request was made by them to put the item on the docket earlier to allow adequate discussion.  We shall see what happens.

Another important bit of business pertains to baby food additives: but CCNFSDU appears to have made a rather large oops, at least according to the Codex contact point of a major European nation and about a half a dozen other seasoned Codex hands.  You see, the recommendations for additives made by CCNFSDU must be approved by the joint commission of food additives run by WHO and FAO (JCFA) and by the Codex Committee on Food Additives and Contaminants (CCFAC).

Back in 1985, JCFA made it clear that it had no data on additives on people younger than 12 weeks of age.  As far as most of us are aware, infants are born younger than that.  Therefore, there is no process currently available for determining which additives can be approved in such babies.  Clearly, a way out of this morass will have to be found but, again according to this expert, this will likely be a major black eye for CCNFSDU.  We will let you know as things unfold.

During the last coffee break of the day I spoke with a representative from WHO who was very distressed that only a few countries were actively participating: the US, Australia, Japan, New Zealand, occasionally Indonesia and Malaysia on one side an, always, on the side of nutrition and consumer protection, South Africa.

Then the WHO representative Codex is not making food safe.  Farmers know how to make food safe.  Cultures that deal with food in various climates and conditions have learned how to make it safe.  Codex is not helping.  It is serving industry.  Why do the countries let it?  Codex, he said, does not mean anything if…. and then he proceeded to explain to me the same strategy which the Natural Solutions Foundation has been taking to countries in Africa and Asia.  He articulated the same two step process which you can see applied to the Vitamin and Mineral Guideline in the Codex eBook !

Some say this strategy will not protect countries.  They are, according to the representative from WHO, simply wrong.  I must admit, it was very pleasant to hear this additional, and unsolicited confirmation of our policy advice from WHO!

This evening, after the session was over, we were taken to a folkloric presentation with Thai food and dance.  I am very, very glad that this gala was not held last night!

Sessions are on again tomorrow.  Rest assured I will let you know what happens.

Yours in health and freedom,

Rima E. Laibow, MD

Medical Director

Let the House Cleaning Begin, and Let the Lethal Games End!

October 25th, 2006

The FDA is one of the most highly corrupted and corrupting organizations on the planet. Charged with food, drug and cosmetic safety, what has been protected is the financial safety of corporate profits with the tickle-down effect firmly in place: regulators and panel members get rich quick through lucrative, unethical and often illegal stock deals, stock options, family financial hanky panky and a host of variations on the theme.

Perhaps you remember the advisory panel of experts that put Vioxx back on the market despite at LEAST 55 thousand deaths in the US alone (perhaps as many as 188 thousand, according to some). The members of that panel had a majority of experts on it who owned stock and had other financial interests in Merck and related corporations. They overruled previously presented advice by people who did NOT have financial interests to allow Vioxx back on the market. Shortly thereafter they approved Vioxx for children!

But perhaps things are getting better. Lester Crawford, who served as the acting Commissioner of the FDA for over a year before his confirmation in 2005 suddenly left his post — suddenly, as in during the course of a single day. His reason? Spending time with the family, of course. The real reason? Illegal stock dealings. Could this be the beginning of a house cleaning? Let’s hope so. The Institute of Medicine says that the FDA is broken. It certainly is. What broke it is the corruption of too much money buying too much influence.

The Institute of Medicine released a study on the safety of pharmaceuticals which was a damning condemnation of the FDA.  Coming from the same organization which supports the status quo in a report that says there is no link between autism and mercury (http://www.fda.gov/fdac/features/2004/504_iom.html) this is a stinging criticism, indeed.  The IOM says the FDA cannot be trusted and is, frankly, broken. In placid, cool bureaucratic tones, here is the scathing abstract of that report in the IOM’s words:

In response to growing public concern with health risks posed by approved drugs, U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services announced a series of steps to address drug safety, including asking the IOM to convene a committee to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs.In its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, the committee considered the drug safety system as the sum of all activities conducted by FDA and other stakeholders to monitor, evaluate, improve, and ensure drug safety.

Although much of the committee’s work was focused around the drug review, safety surveillance, and related activities of the Center for Drug Evaluation and Research (CDER), the committee also reviewed some key aspects of the roles and considered the potential contributions of the pharmaceutical industry, the academic research enterprise, Congress, the health care delivery system, patients and the public.

During its research, the committee found that

  1. There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
  2. Most stakeholders–the agency, the industry, consumer organizations, Congress, professional societies, health care entities–appear to agree on the need for certain improvements in the system.
  3. The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
  4. FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.

Noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

Recommendations include:

  • Labeling requirements and advertising limits for new medications
  • Clarified authority and additional enforcement tools for the agency
  • Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
  • Mandatory registration of clinical trial results to facilitate public access to drug safety information
  • An increased role for FDA’s drug safety staff
  • A large boost in funding and staffing for the agency


Part of that failure, of course, is a failure of leadership.  Lester Crawford is not unique in his corruption.  He is unique in that his corruption (or a small piece of it?) has been publicly exposed.  Here is Pete Yost’s story on Crawford’s corruption:

Ex-FDA Chief to Plead Guilty
By PETE YOST
The Associated Press
Monday, October 16, 2006; 6:44 PM
WASHINGTON — Former FDA chief Lester Crawford has agreed to plead guilty to charges of failing to disclose a financial interest in PepsiCo Inc. and other firms regulated by his agency, his lawyer said Monday.
The Justice Department accused the former head of the Food and Drug Administration in court papers of falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.
Court papers say Crawford chaired the Food and Drug Administration’s Obesity Working Group while he and his wife owned shares worth at least $62,000 in soft drink and snack food manufacturer Pepsico Inc., based in Purchase, N.Y. In addition, the documents say, he held stock worth at least $78,000 in food product manufacturer Sysco Corp., based in Houston.
While he and his wife owned the stock, the panel Crawford chaired met with representatives from the packaged food industry and gave congressional testimony encouraging manufacturers to relabel serving sizes to give calorie counts greater prominence.
Crawford “is going to plead guilty to two misdemeanors tomorrow afternoon and he is going to admit his financial disclosures had errors and omissions, mostly with his wife’s continued ownership of stocks,” said Crawford’s lawyer, Barbara Van Gelder.
“At the end of the day, he owned these stocks and he will admit he owned them while he was at the FDA and he will take responsibility for that,” said Van Gelder. She said Crawford was not disputing the government’s claims in what she called a plea agreement.
Accused of making a false writing and conflict of interest, Crawford was scheduled to appear before a federal magistrate Tuesday afternoon. Each charge carries a maximum penalty of one year in prison.
The papers say Crawford failed to disclose his income from exercising stock options in Embrex Inc. of Research Triangle Park, N.C., an agriculture biotechnology company that has been regulated by FDA. Crawford had been a member of Embrex’s board of directors, according to federal filings.
Crawford, a veterinarian, abruptly resigned from the FDA in September 2005 but gave no reason for his departure. He had held the top position for just two months but had been acting head of the agency for more than a year.
According to the Justice Department’s court papers:
_A government ethics official inquired about Crawford’s ownership of stock in several companies FDA regulates and Crawford replied in a Dec. 28, 2004, e-mail that “Sysco and Kimberly-Clark have in fact been sold.” Actually, the court papers state, Crawford knew that he or his wife still held shares in both.
_Even though financial reporting requirements for federal officials say all income must be disclosed, Crawford failed to reveal $8,000 in income from the exercise of Embrex stock options in 2003, and failed to report $20,000 from the sale of Embrex stock options in 2004.
Crawford’s ownership of shares in Pepsico, Sysco, Embrex and the other companies was prohibited under federal regulations, since the companies are considered to be “significantly regulated” by the FDA.
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AP reporter Andrew Bridges contributed to this story.
© 2006 The Associated Press
Of course, the current “leadership” of the FDA, in positions 1 and 2 are industry men, through and through.  Will the outrages, deaths and betrayals of the American people have to get worse before the house is really cleaned by an outraged Congress acting on the outrage of its citizens?  Let’s hope not.