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Dr. Gregory Pais, ND
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Home arrow Naturopathic News arrow Issue #23 - August 2004
Issue #23 - August 2004

Welcome to this issue of Naturopathic News, issue #23. It’s my goal to help you find natural solutions to health problems. This newsletter is one way to do that. The more educated you are about your health options the better able you will be to take control of your health.

YOU ACT WHAT YOU EAT

Parents and practitioners have long believed that artificial food colorings could cause hyperactive behavior in children. Now, at last, scientists seemed to have seen it as well.

Twelve months ago, at school and in his Glasgow home, seven-year-old Ryan Gallacher was all but uncontrollable. Then, in August last year, his father Alex changed Ryan's diet. Off the menu went anything with artificial food additives. Ryan's behavior dramatically improved. Around 20,000 children have been diagnosed as having what is variously known as "hyperkinetic disorder" or "attention deficit and hyperactivity disorder" (ADHD). But some commentators believe that the true number could be 10 times that.

To Alex Gallacher, the part that additives had played in causing Ryan's problem was blindingly obvious.

But many conventional clinicians and scientists who work on additives remained cautious if not downright dismissive about the alleged link. The preliminary findings of research at the University of Southampton suggest that, to some degree at least, parents may have been right all along. Ryan's problems began when he was just 18 months old. "He was excluded from his nursery for inappropriate behavior," Alex recalls. "He was very excitable, very jumpy. Not just raucous, it was completely beyond that." Nothing had improved by the time Ryan began school. Alex would be summoned by teachers as often as two or three times a week. "I'd get a call saying, 'Your son is running through the corridors screaming'. Or they'd say, 'You've got to come, he's hiding under a desk holding his head in his hands'."

Educational and family psychologists considered various explanations, from parental disharmony to sibling rivalry. But nothing added up. Ryan's older brother was fine. "I could let him play with the kids in the street," says Alex. "But not Ryan. I had to make excuses to him why he couldn't go out, because we knew that as soon as he did, there was going to be trouble."

Salvation came from a newspaper article on diet and behavior. Out went all foods containing additives - and Ryan's six-year nightmare drew rapidly to a close. The best-known conventional treatment for ADHD is a drug called Ritalin. A hint of psychiatry's caution in linking the disorder to diet can be gleaned from the brevity of the relevant section in a Psychiatrist’s fact sheet. "There is a small body of evidence about the effect of diet on some children," says the leaflet. "A few may be sensitive to certain foods. If parents notice that specific foods worsen hyperactivity, these may be avoided. It is best to discuss this with the specialist." That's it.

So, who is right: the doctors or the parents?

Enter Professor John Warner of Southampton General Hospital, a physician with a long-established interest in additives. His team's study of their effects, published recently in the authoritative journal entitled Archives of Disease in Childhood, used methods of a kind that are standard in all careful medical research. Among the 400 children who took part were some who showed signs of hyperactivity and some who didn't. Their parents were asked to keep them on a diet free of all additives and artificial preservatives for one month. In the second and fourth weeks, each child had to drink a daily bottle of fruit juice. During one week it was pure; during the other it was laced with a cocktail of additives. The drinks themselves were indistinguishable in taste and color, and parents weren't told which was which. The test drink contained four widely used food colorings: sunset yellow, tartrazine, carmoisine and ponceau 4R, and also the preservative sodium benzoate. The researchers conducting the study assessed each child at weekly intervals using tests that are routine in disorder-disorder clinics. Most importantly, parents, too, rated the everyday behavior of their children. They looked for signs such as switching from one activity to another, talking or interrupting a lot, fiddling with objects, and general restlessness. The results showed a clear distinction between the parents' assessments and those of the psychologists.

The latter found no significant difference between the effects of the two drinks; the parents did. So, what to make of the apparent contradiction? One of Warner's colleagues, the psychologist Professor James Stevenson, thinks that he can explain it. "Children were coming along to a clinic, meeting a bright young tester who was interested in them, and they were on their best behavior. It wasn't a context that would elicit inattention, distractibility and the rest. But parents see kids when they're tired, they see them in the evening, on the bus, in the supermarket." In short, in real life. This wouldn't be the first time that measurements made within the clinic have failed to detect what is more apparent outside it. The Southampton team's conclusions are unequivocal: "The observed effect of food additives and colorings in this community sample is substantial." For Stevenson in particular, the findings prompted a change of heart. "I'd worked in hyperactivity for a number of years, and originally thought that diet was probably important only in an exceptional, odd group of children. Having done this work, I've changed my mind." His guess is that within the general population there's a range of behavior that is affected by nurture as well as nature. "Additives seem to be shifting that distribution of behavior towards the more hyperactive end."

Neither Stevenson nor Warner suggests that additives are the only factor; but their effects are large enough to take seriously. Not least, adds Stevenson, because most of them are there only for marketing purposes. Heartened by these findings, Warner is planning a further study.

As for young Ryan up in Glasgow, he rebelled at first over the loss of sweets. But his parents' will prevailed, and the change in his behavior has now persisted for a year. "Far from me being called up to the school," says his father, "he has even won a 'pupil of the week' award. That in itself is just mind-blowing. When people see Ryan now, they ask if it's the same boy." Small wonder that Alex Gallacher talks about the effects of additives with a crusading zeal.

 

SOME COLORS TO WATCH

  • Sunset yellow (E110) is a dye used in, among other foods, orange jellies and squashes, apricot jam and packet soups.
  • Tartrazine (E102), one of the more controversial coloring additives, is another yellow dye used in fizzy drinks, ice cream, sweets and jams.
  • Carmoisine (E122), a red dye, is used in jellies, sweets, and cheesecake mixes.
  • Ponceau 4R (E124), also red, is used in canned fruit and jellies.

Arch Dis Child. 2004 Jun;89(6):506-11.

GP: It’s important that further work is being done along these lines. This approach to hyperactivity was first researched by Benjamin Feingold, MD (http://www.feingold.org/home.html) Now it appears as if some of the discrepancy between parent’s knowledge and research has been addressed by these current findings. It’s a much better option to make lifestyle changes first, before resorting to drugs like Ritalin.

 

LEGAL DRUG PEDDLERS

Faced with exorbitant prescription drug prices and contemptible marketing tactics, the American public seems to be swinging back against major drug companies. Marcia Angell, for two decades the Editor-in-Chief of The New England Journal of Medicine, is contributing to that fight with an expose of Big Pharma's excesses and neglects. In a disturbing new book, Angell, now a Senior Lecturer in Social Medicine at Harvard Medical School, spotlights the dubious tactics that garnered big drug companies an estimated $400 billion in worldwide sales in 2002.

Angell uses her new book, “The Truth About the Drug Companies: How They Deceive Us and What To Do About It”, to propose reforms that could bring the industry under control. Here are some of the topics she covers:

Me Too Drugs
A "me too" drug is a drug that's a minor variation of a drug already on the market. Most of what big drug companies turn out are "me too" drugs. There are, for example, six statin drugs on the market. These are cholesterol-lowering drugs of the Lipitor type. Lipitor wasn't the first statin. The first statin to come on the market was called Mevacor. It had such a large potential market that other companies realized that reconfiguring the molecule a bit would allow them to have a share of this very large market. Lipitor is now the best-selling drug in the world. But it is a "me too" drug.


Research and Development (R&D) Costs

The pharmaceutical industry talks a lot about how much R&D costs. But the R&D is consistently less than big companies make in profits and far less than what they spend on something they usually call "marketing and administration." Companies vary a little in the name for this but it's a big category that includes all kinds of promotional activities plus administrative costs like executive salaries, legal fees and so forth. This is by far the largest part of their budgets, usually somewhere from two to two-and-a-half times what they spend on R&D.


Medicare Reform

The Medicare drug benefit that was just passed in late 2003 will do very little to help senior citizens because it specifically prohibits Medicare from bargaining with drug companies for lower prices. All large private insurers already do this. So do some government programs such as the Veterans Affairs (VA) system. Medicare would be the biggest purchaser of all. It would have enormous bargaining power. The pharmaceutical industry did not want that to happen and they made sure it would be explicitly prohibited. And it was. What we are left with is a drug benefit that is inadequate to begin with. It has this huge donut hole for example. As prices increase at the rate they are now, and they'll probably increase at least that fast, [the benefit] will quickly be washed out by rising prices.


Potential Reforms
The most important reform in my view would be for the Food and Drug Administration (FDA) to require that new drugs be tested - not against placebos, but against older treatments already on the market for the same condition. If that were required, most new drugs, which are "me too" drugs, wouldn't be approved. That's because there's no reason to think they are better. By default, that would force the industry to put some real R&D efforts into genuinely important novel drugs. They wouldn't get away with this gigantic "me-too" industry.


Drug Trials
It's not so much the fact that the drug companies are sponsoring clinical trials, as it is the terms of sponsorship. Drug companies have always sponsored trials of their own drugs. But they used to give a grant to an academic medical center and the center would get a faculty investigator to do the trial. The company would stand back and wait for the results. Now they don't do that. They are intimately involved in all aspects of the trial. They design the trial. They analyze the data. They write the paper. They even decide whether the paper will be published. So now they do have real control over the evaluation of their own products. That's a terrible conflict of interest.

Also many of the researchers have other financial ties with the same companies whose drugs they are studying. They sometimes have equity interest in the company. They get consulting fees. They are on speaker's bureaus and so forth. So they are biased from the get-go. I think the public ought to be very concerned about this.

GP: It’s great to see someone so intimately connected with the conventional medical establishment come out with criticism and reform proposals.

 

ANTIDEPRESSANT INCREASE SUICIDE RISKS

A top government scientist who concluded last year that most antidepressants are too dangerous for children because of a suicide risk wrote in a memo this week that a new study confirms his findings.

The official, Dr. Andrew D. Mosholder, a senior epidemiologist at the Food and Drug Administration who assesses the safety of medicines, found last year that 22 studies showed that children given antidepressants were nearly twice as likely to become suicidal as those given placebos.

His bosses, however, strongly disagreed with his findings, kept his recommendations secret and initiated a new analysis.

In his memo, dated 8/23/04, Dr. Mosholder said that the results of the new analysis, undertaken in part at Columbia University, matched his own. Though the two studies used different methods and different numbers, they came to similar conclusions, Dr. Mosholder wrote in the internal memo.

In the new analysis, Paxil, which is manufactured by GlaxoSmithKline, and Effexor, made by Wyeth, have been found to be even more likely to lead children to become suicidal than Dr. Mosholder's original analysis found, his memo says.

The findings add to the debate over whether the government should ban prescribing the pills to children. Dr. Graham Emslie, a researcher whose studies of the drugs in depressed children have been paid for by both drug makers and the National Institutes of Health, said he still thinks the benefits of the medicines outweigh any risks.

"Limiting doctors' choices in treating depressed kids is not a good thing," Dr. Emslie said.

Officials at the Food and Drug Administration have struggled to explain why it has acted so differently from British health authorities, who last year banned the use of all antidepressants.

The F.D.A. is scheduled to hold an advisory committee hearing on the issue next month. According to people inside and outside the agency, the F.D.A. may next week make public the results of the Columbia study.

The controversy had its start two years ago when Dr. Mosholder was reviewing data submitted by GlaxoSmithKline regarding studies of Paxil in children. Dr. Mosholder noticed that children given the pill suffered more emotional "lability" or vulnerability, than those given placebos. He asked the company for more specifics about what it meant by "lability."

In May 2003, the company submitted a new report showing that children given Paxil were more likely to become suicidal than those given placebos. Also, the drug did not improve their depression any better than the placebo.

Dr. Mosholder asked for similar data from other drug companies. By last fall, he was looking at the results of 22 studies involving 4,250 children. His analysis of the combined results suggested that children given the drugs were 1.89 times more likely to become suicidal than those given placebos. He recommended that the agency ban doctors from prescribing the drugs to children.

His bosses, however, suppressed his report and hired researchers at Columbia to re-analyze the underlying data that Dr. Mosholder had used, saying that some events labeled by drug-company researchers as suicidal did not seem worrisome.

Though the original studies had identified just 108 suicidal-related adverse events, the Columbia researchers expanded their inquiry to include about 400 adverse events, many of which had been originally labeled as "accidental."

The risk of a suicidal event among those given antidepressants in the trials was 1.78, only slightly less than the risk Dr. Mosholder found.

A spokesman for the F.D.A. did not return phone messages. A spokesman for Wyeth said that Effexor is not approved for use in children. A spokeswoman for GlaxoSmithKline declined to comment.

Senator Charles E. Grassley of Iowa, who has been pushing an investigation into the F.D.A.'s handling of the controversy, said through a spokeswoman that the new memo from Dr. Mosholder "underscores what my committee investigation is finding as far as the strength of Dr. Mosholder's original analysis about antidepressants and kids."

GP: This is the latest round in a controversy that I have been relaying in this newsletter for the past several months. Emotional ‘lability’, drug speak for suicidal risk—Big Brother would be proud. There are homeopathic and nutritional tools that address depression. None of them increase the risk for suicide. The next time you hear of a young adult being treated with these drugs, speak up.

 

EMERSON ECOLOGICS

If any of you would like to check out Emerson Ecologics online here is the address of their home page. http://www.emersonecologics.com/Main.asp Here you will find information on herbal products and nutritional supplements as well as product specials. If you have any questions about these items feel free to email me.

 

That’s it for this issue of Naturopathic News. If you’ve thought a bit extra or learned something new, then I achieved my goal. As usual, if you have questions or concerns brought up by these subjects, let me know.

Gregory Pais, ND, DHANP