Entries in Health care policy (50)

For Big Pharma, Desperate Times Require Desperate Measures: Now It’s Statins for Kids

It’s an article of faith among consumer goods companies that the best way to create long-term customers is to get them while they are children. Companies from McDonald’s to Apple Computer to Coca Cola have long followed this dictum, with great success.

The big pharmaceutical companies have begun to catch on, with significant success of their own, getting children onto drugs for attention deficit disorder and depression. Now, though, they are ramping up big time, as they encounter safety and government approval problems for their adult products.

Like a lot of people, I did a double-take as I half-listened to the national news last night. The big story was about a recommendation by the American Academy of Pediatrics (“Academy” sounds so official and scientific) that children as young as eight years old could be candidates to take statins for countering high cholesterol readings. These are the drugs that produce liver problems and muscle weakness in many adults.

I gave the program my full attention as anchor Charles Gibson quizzed Dr. Timothy Johnson, the Marcus-Welby-like guru doctor, and actually asked one penetrating question. “Will children who take statins have to take them for the rest of their lives?” Dr. Johnson seemed taken aback, stumbled a bit, since doctors tend not to think in such terms. After all, the Academy is the Academy.

“Well, yes,” he finally said.

(The segment I saw seems not to be available on the ABC News site, which has other items about this medical development.)

The other part of this story is that some kids as young as age one are being encouraged to consume low-fat milk. Seems even the pediatricians have long recommended whole milk for kids until at least age three.

How can physicians, who take an oath to “do no harm,” countenance such mass-scale drug taking for children using drugs that have been shown to have serious side effects for adults? They say that initially the statins will only be used on children with very high cholesterol readings, and a family history of heart problems. But we all know where this all ultimately leads—to wider and wider dissemination, as the “standards” are adjusted to encompass more and more children.

I had a physician explain how they rationalize it longer term. In their view, most people won’t take the life-style steps in terms of diet and exercise to improve their health (even allowing for the fact that there’s much disagreement on just what the diet steps should include). So doctors are simply responding to our instant-results, convenience-oriented society, and trying to alleviate a crisis situation.

The doctors seem to forget, in all their rationalizations, that they are simply the distribution network for the drug companies.

Posted on Tuesday, July 8, 2008 at 11:34AM by Registered CommenterThe Complete Patient in , , | Comments23 Comments | EmailEmail | PrintPrint

Dangers of Looking Anew At an Old Problem: Suddenly, We Have Poison in Our Mouths

bigstockphoto_about_to_have_filling_845674.jpgSo, the U.S. Food and Drug Administration’s tomato investigators are back to square one, it seems. Nearly 900 people have become ill, and the investigators are even suggesting the cause may not be tomatoes at all.

How about if the agency simply admitted, “We don’t know. We’re stumped. Maybe we just need to start over and look at the entire food supply with a fresh mind.”

Instead, as Henwhisperer points out following my previous post, there are complaints about how tough it is to trace products back to the farm, and there are frequent allusions to the need for bar codes for fruits and veggies—a real great way to help smaller farms remain competitive.

The danger of going back to square one and using it as an opportunity to change your perspective, of course, is that you may find you were going in the completely wrong direction to begin with. That seems to be what’s happening, very quietly, on the dental front, with the explosive issue of conventional dental fillings, or dental amalgams.

The FDA has had some study groups re-visiting the question of whether the mercury contained in amalgams that nearly all of us have in our mouths may be dangerous.

For years and years, patients who raised that possibility have been ridiculed. I know I have. I raised it with my long-time dentist several times in recent years, and each time he snickered as he told me, “There’s absolutely no scientific evidence that they are a problem.” The third or fourth time was the last time, as I moved my business to a dentist who refuses to use amalgams—not an easy person to find in the Boston area three years ago.

Just a few weeks ago, very quietly, the FDA posted on its web site a “Questions and Answers on Dental Amalgam,” and, lo and behold, the language has changed considerably from the line most dentists, dental associations, and the government long offered.

Indeed, Houston, we may have a problem. It states, “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA’s rulemaking…will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.”

If you click on a link from a 2006 meeting of dental experts, you see that the panel wanted to “Consider informed consent for patients receiving amalgam” and “Consider labeling changes restricting its use in pregnant women and children.”

Bottom line, the FDA is now saying many of us are walking around with poison in our mouths.

Who knows what might happen if they allow honest re-examination of the problem of food-borne illness. (Thanks to Pete Gasper for forwarding me information on dental amalgams.)

Posted on Friday, July 4, 2008 at 05:22PM by Registered CommenterThe Complete Patient in , , | Comments24 Comments | EmailEmail | PrintPrint

Progress on the Raw Milk Front Is Encouraging, But What Forces Still Lurk in the Shadows?

Yesterday was a good day for proponents of food rights. The California Assembly’s Health Committee unanimously passed SB 201 and its provisions for pathogen testing and HACCP (hazard analysis and critical control point) programs instead of a coliform standard. Today, the legislation goes to the Assembly’s Agriculture Committee.

And in North Carolina, the House Health Committee approved legislation that has the effect of negating a state Board of Agriculture regulation requiring raw milk be dyed. The legislation substitutes new required warning labels for the dying requirement.

Even the Associated Press, responding to objections from Mark McAfee, came out with a correction on its original story about Organic Pastures Dairy Co., saying two families filed suit over the illnesses, not five as previously reported. No, it’s not a huge correction, but when you’re dealing with establishment media like the Associated Press, any correction is a big deal—they hate to admit fallibility.

The only one who didn’t have a good day yesterday was Mark Nolt, the Pennsylvania producer of raw milk, who was found guilty on three more counts of selling raw dairy products without a license. According to a press report, he didn’t offer any defense. That definitely doesn't work in the raw milk arena.

Which brings me back to the California situation. Mark McAfee is very upbeat, feeling that in yesterday committee vote, “The big hurdle has been overcome.”

He may be right, but I continue to worry about the California Department of Food and Agriculture. It has been silent on SB 201, supposedly because it’s not supposed to take a stand on legislation, but we know that its influence was key last January in preventing AB 1735 from being rescinded.

The fact is, the battle of SB 201 is just another chapter in a long bitterly fought battle that sometimes seems to be a personal battle of wills between the CDFA and Mark McAfee. Because Mark has decided to put himself out there, and sometimes seems to be changing his story, he takes a huge amount of heat, witness the first comment following my previous post.

Now, I presume curious is suggesting that Mark Calhoun’s response, because it sounds so lawyerly and dignified, is the accurate one. Yet we know from Mary McGonigle Martin’s frequent posts last year that no evidence of E.coli 0157:H7 was ever found in her son; thus, Calhoun’s statement about “6 children with identical, culture-confirmed cases of E-coli O157:H7,” is wrong.

It’s gotten so no one even knows any more if it was five children who had the identical E.coli 0157:H7 or six; three children who were hospitalized or two, a boy who drank milk at a friend’s or a girl, five children who consumed raw-milk products or six, two families who filed suit or five, and so on and so on.

Like many of the people here, Mark McAfee has told the story so many times, with a number of variations, that his version can’t be any more certain than Mark Calhoun’s. Mark McAfee, though, is one person who’s been under tremendous pressure--his complete livelihood is at stake--and hasn’t backed off any of the shots thrown at him. I’ve never met a business person, and I’ve met a lot, who’s been so unflinching and willing to answer questioners and critics, and I’m not sure this is totally a compliment.

But we should expect some consistency and forthrightness from the government regulators who are paid millions of dollars to protect us from real health problems, and here is where I have the biggest issue. Remember, CDFA declined two public requests from Sen. Dean Florez to testify at his hearing in April on SB 201, arousing his anger. It's made no effort to try to clarify the numerous examples of inconsistency in the state public health report on the illnesses, and later the Centers for Disease Control report that repeated the same data.

I am a worrier by nature, but when I worry about what tricks the CDFA may have up its sleeve to spread disinformation and otherwise try to derail SB 201, I’m not so sure I’m off base.

Posted on Wednesday, June 25, 2008 at 10:19AM by Registered CommenterThe Complete Patient in , , | Comments11 Comments | EmailEmail | PrintPrint

Why Is It So Much More Difficult to Deal with Ambiguity on Food-Borne Illness?

bigstockphoto_Business_Man_Shrug_213339.jpgWe’ve been very fortunate on this blog to have had a number of people willing to share their experiences and knowledge around food-borne illness.

First, there’s Mark McAfee of Organic Pastures Dairy Co. Mark is open almost to a fault. He can’t resist commenting, and in so doing, turns himself into a lightning rod. He discussed his views of what happened regarding the illnesses of the six children, ad nauseum.

Then there’s Mary McGonigle-Martin, mother of Chris Martin, followed by Melissa Herzog, mother of Lauren Herzog. They both discussed the situations from their perspectives, to the point of exhaustion for many readers.

And finally, we’ve had any number of extremely well informed participants in these debates—Miguel, Dave Milano, Steve Bemis, Sylvia, C2, Kirsten, milkfarmer, and many others too numerous to mention.

Now, we can dispute these individuals—especially Mark, Mary, Melissa—in terms of what they said, how they said it, when they said what, and so forth, but the simple fact that the discussion took place is highly unusual.

The reason it’s so unusual is that, despite the fact that millions of people (the CDC says 77 million) are victims of food-borne illness each year, there are three huge obstacles that prevent the kind of discussion that took place here.

The first obstacle is the legal/public relations obstacle. There are very very few business executives who, when their companies are identified as possible sources of foodborne illness, are willing to candidly talk about it. Most fear the Bill Marlers of the world, and are advised by their attorneys not to say anything because it could be held against them in a court suit. Mark is very much the exception, for any number of reasons.

The second obstacle is the privacy obstacle. Patient privacy is protected, as well it should be, and so it’s difficult for the media to locate victims of food-borne illness. Many of these victims don’t want to get in the middle of media debates about the topic. In the September 2006 California case, only two of the six have come forward—Mary, to the extent she shared many personal and painful details of her family’s ordeal.

The third obstacle is that our government officials and their scientific advisers refuse to be candid about the subject. So we are left with documents like those produced by California public health department and the CDC that raise more questions than they answer.

Now, why do the government officials and advisers—these lions of our scientific, public health, and medical establishment—resist being candid? As much as we want to blame conspiracies, I think the real reason is very simple: they don’t fully understand the problem of food-borne illness.

In fact, none of us fully understand it. If we did, we wouldn’t be having the debates we have here. Some of us think we understand it—I agree with those who see our obsession with pathogens and food sterilization as having created the unintended effect of weakening people’s immune systems. But I can’t prove it conclusively. The establishment view that we just need to tighten cleanliness up some more to completely rid ourselves of the pathogens holds sway. But they can’t prove their case conclusively either.

The government’s problem is that the officials are unwilling to admit they don’t have all the answers. There was an interesting exchange in Congress yesterday to this point, in hearings about the salmonella outbreak affecting tomatoes, reported by The Wall Street Journal. “Some lawmakers expressed exasperation with the (FDA). ‘The longer you sit on this committee, the more depressed you get, because the issues never get resolved and crop up again and again,’ said Rep. Diana DeGette (D., Colo.), who for years has urged the agency to develop a program to track food from the farm.”

We can argue about this legislator’s perspective all we want [just over the fact she wants a tracking system for all food], but the reality is she is frustrated because the scientists at the FDA won’t tell her/us they don’t fully understand the food-borne illness phenomenon.

The same frustration is spilling over onto this blog. There’s this feeling, I know I get it sometimes—why the hell don’t Marler and C2 and CP see the big picture? And they get frustrated with being labeled and mocked, and the beat goes on.

I’m not sure exactly why the scientific establishment can't bring itself to admit it doesn't fully understand what's happening. Maybe because Congress appropriates money and drug companies come up with highly profitable products and so on and so forth based on the conventional wisdom. To say you don’t know—as admirable a human trait as that might be--well, it doesn’t inspire the confidence that legislators and investors like.

In terms of this blog's etiquette, I urge people to be more respectful. In that vein, I strongly suggest avoiding identity switches. The most disrespectful individuals seem to be those hiding behind ad hoc signatures. Don't write stuff here you wouldn't say directly to another individual in conversation. The way most blogs counter such problems is to require signup info. Let’s see if we can avoid that.
Posted on Saturday, June 14, 2008 at 12:22PM by Registered CommenterThe Complete Patient in , , , | Comments42 Comments | EmailEmail | PrintPrint

Talking Past Each Other Is One Thing--Interfering With Our Rights Is Another

I was listening to a segment on NPR yesterday afternoon about preparations already well under way for next winter’s flu vaccine. (Unfortunately, I can’t find the link on the NPR site.) A scientist from Princeton, I believe, was explaining how the flu virus mutates slightly each year into several variations, and how scientists have developed advanced models to anticipate the changes so they can come up with a flu vaccine that is likely to be effective against next year’s crop of strains.

Of course, there was no mention in the discussion about the role of our immune systems in reducing the odds of being hit by the flu bug. No consideration of the role of nutrition in helping strengthen the immune system.

Both the interviewer and the interviewee were totally consumed by the wonders—no, the miracle--of medical technology in protecting us.

What Miguel, Gary Cox, and others are saying in the lengthy dialogue following my May 17 post, it seems to me, is that the problem of pathogens and food safety need to be viewed holistically.

But our medical and public health systems are based on specialization, which is at the other end of the analytic and diagnostic spectrum from any kind of holistic approach. We have professionals who specialize in controlling the flu bug, just like we have professionals who each specialize in controlling parasites and E.coli and asthma, and so on down the line.

Among public health and agriculture professionals, there are those who deal with E.coli 0157:H7 in vegetables and those who deal with it in farm animals, and those who deal with it in processing plants and others in restaurants.

It’s very difficult to have any kind of discussion about holistic systems with these people, because they have been taught to think about problems within their area of specialization. I think that’s why it’s so difficult for individuals like cp2 and concerned to really relate to the arguments being offered, even as they attempt to demonstrate sensitivity. Miguel’s wonderful illustration about flies and garbage doesn’t make any sense if you’ve been conditioned through umpteen years of schooling and professional work to obsess about the germs the flies might carry around.

To these people, raw milk is like the flies—it is a carrier of pathogens, and thus must be eliminated. They can’t take seriously an approach that views raw milk as part of a larger holistic system that helps build immunity and reduces the risks associated with pathogens and viruses, not to mention the risks of various chronic diseases. There can be no question of “choice” because enforced “protection” from any and all pathogens takes precedence.

NAIS raises the same issues. The animals must be tagged and followed because if there’s disease, we need to be able to track down the source of the pathogens, the flies, as it were, that started the whole thing. The idea that animals left to graze on healthy pasture fed by nutrient-rich soil are much less susceptible to disease in the first place sounds to them like gibberish.

What’s most bothersome, though, isn’t the difference of opinion. There’s always been room in this country for people with divergent opinions on issues large and small. What’s bothersome is that the germ/safety-obsessed want to impose their obsession on everyone. They can’t stand it that some of us aren’t terrified because a few people became ill from Dee Creek raw milk or someone in Missouri may have become ill from raw milk, or wherever. It’s very difficult with such mindsets to see the forest for the trees.
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