Monday, October 22, 2007

Recognition of deficient evidence when it suits

It is certainly deplorable that these things have not been tested properly but a few apparent adverse reactions out of billions of doses are unlikely to mean anything. This sounds more like an attack on the drug industry than any reasonable caution

Over-the-counter cough and cold medicines have not been proved to work, are potentially dangerous and should not be used in children ages 6 and younger, an advisory panel to the Food and Drug Administration decided Friday. The expert panel also voted to urge the FDA to require companies that make the popular products to conduct thorough research to finally determine whether they are effective in any group of children. "This one is really important because so many people are using it, there is so much money spent on it, there is no evidence that it works, and there is evidence of harm," said Dr. Jesse Joad, a UC Davis professor of pediatrics and pediatric lung specialist who served as a consultant on the committee. "Something really needs to be done about it."

The advisory panel's recommendations are not binding but, if adopted by the FDA, could lead to a major shift in the way these medicines are labeled, sold and used by parents. "We need to go back and review all these recommendations that we heard today and decide what the path forward might be," Dr. John Jenkins, director of the FDA's office of new drugs, said after the meeting. If the agency does adopt the committee's recommendations, it must undertake a rule-making process that can "take anywhere from one to many years," Jenkins said.

Manufacturers, who last week withdrew more than a dozen cold products labeled for use in infants and toddlers, said they would fight the new recommendations. "We believe these products will remain on the market," said Linda Suydam, president of the Consumer Healthcare Products Association, an industry trade group.

There are about 800 pediatric cold products sold in the United States that use one or more of 39 drugs. Parents spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine, according to Suydam. The products under review include common brand names including PediaCare, Robitussin and Triaminic, many of which are marketed for toddlers and other children younger than 6.

The FDA review was prompted by a petition from Baltimore's commissioner of health after the deaths of four children. Earlier this year, the FDA completed a review that found that between 1969 and 2006, there were 54 reported child deaths from decongestants and 69 from antihistamines. Most of the deaths occurred in children younger than 2. Joad said the 22-member committee looked at several types of cold medicine ingredients including pseudoephedrine, a decongestant, and antihistamines to combat runny noses and sneezing. She said products containing pseudoephedrine were linked to seizures, mostly in children younger than 2, and that the antihistamines caused sedation in children. In most cases, she said, the adverse reactions resulted from overdoses.

Speaking from her hotel room after the committee adjourned in Maryland, Joad said that while most pediatricians tell parents not to use the drugs, 80 percent to 90 percent of parents do anyway. "They really believe it works," she said. "But colds are diseases that get worse for a few days and then get better. You don't have to give them anything." Joad added, "Why would you give them something that might kill you, or cause a seizure or a cardiac event?"

Part of the problem, said Joad, is that the products' labels can be very confusing for consumers. She noted, for example, that while Tylenol used to be synonymous with acetaminophen, a non-aspirin pain and fever reliever, Tylenol-labeled products now may contain many other ingredients that have nothing to do with addressing pain or fever symptoms. Cold products for kids also vary dramatically in terms of the active ingredient concentrations, their dosing and dispensing instructions, she said. "We recommended there be standard concentrations and that everything should be measured in milliliters, not teaspoons," she said.

In addition, Joad said the committee wants the industry to stop depicting young children on packaging and to clearly state that the products have not been shown to be effective and have been linked to severe adverse effects. Pediatric cold medicines were approved in the early 1970s, despite almost no evidence that they worked, because regulators assumed that drugs that worked in adults would also be helpful in children. Physicians now know that is not necessarily true. The bottom line, Joad told the committee, "is that children are not little adults."


Bishop too fat for surgery

In general, discrimination on the basis of weight sounds to me no different from discrimination because of skin colour. But I have to agree with the doctors here. The vast weight of the man would undoubtedly be a factor in why his knee has collapsed and leaving the weight as is could well make a replacement knee largely futile

A BISHOP who has dedicated his life to the church has been refused surgery by a Victorian hospital because he is too fat. Bishop R.J. Gow of St Mary's House of Prayer, at Elaine, west of Ballarat, is in desperate need of a left knee replacement. "It's my praying knee," the good humoured priest said. "I'm having a lot of trouble walking and standing at the altar."

Three months ago the clergyman, 66, was referred to an orthopedic surgeon. "The surgeon said the waiting list at Ballarat Hospital for that surgery was two years, but he was now doing surgery at Bacchus Marsh hospital so to go there," Bishop Gow said. "I made an appointment, but within five minutes of them seeing me they said "unless you lose weight you won't be having surgery here". Bishop Gow, who stands six feet tall, weighed 147kg (330 lb.). Since that first appointment he lost 15kg in 11 weeks and is now 132kg. "They told me to lose 17 kilos before I came back," he said. "But when I came back they told me I'd have to lose another five before I see the anaesthetist on October 26. "The only way I can do that is to starve myself."

Bishop Gow said he was annoyed at the level of discrimination towards overweight people. "This is a hospital discriminating against people who are overweight," he said. "They're excluding people and I'm not the only one. I heard them saying to the person in front of me that they would also have to lose weight before an operation. "I questioned her about it and she said it was hospital policy. She showed me a copy of minutes of a meeting where it was stated they would only operate on patients who had a BMI (body mass index) of below 40. "This is discriminatory. Obesity is a disease caused by pyschological or physical factors - people don't get fat because they want to. "But what really annoyed me was I had a look around the hospital and there were empty beds. What's happening with our health care?"

Bishop Gow, who has spent more than 20 years working with the poor, sick and disadvantaged, said his knee was deteriorating and he was in a lot of pain. "But I haven't private health insurance and the operation would cost thousands of dollars," he said. Bacchus Marsh Hospital's Acting CEO David Grace said the hospital had a policy on surgery for the obese "for patient safety. We use an objective BMI assessment. "If someone is higher than the cut-off point of 40 they're considered a high anaesthetic risk and we wouldn't allow treatment." He would not comment on a specific case, but said he didn't consider the practice discriminatory. "It's about patient safety," he said.



Just some problems with the "Obesity" war:

1). It tries to impose behavior change on everybody -- when most of those targeted are not obese and hence have no reason to change their behaviour. It is a form of punishing the innocent and the guilty alike. (It is also typical of Leftist thinking: Scorning the individual and capable of dealing with large groups only).

2). The longevity research all leads to the conclusion that it is people of MIDDLING weight who live longest -- not slim people. So the "epidemic" of obesity is in fact largely an "epidemic" of living longer.

3). It is total calorie intake that makes you fat -- not where you get your calories. Policies that attack only the source of the calories (e.g. "junk food") without addressing total calorie intake are hence pissing into the wind. People involuntarily deprived of their preferred calorie intake from one source are highly likely to seek and find their calories elsewhere.

4). So-called junk food is perfectly nutritious. A big Mac meal comprises meat, bread, salad and potatoes -- which is a mainstream Western diet. If that is bad then we are all in big trouble.

5). Food warriors demonize salt and fat. But we need a daily salt intake to counter salt-loss through perspiration and the research shows that people on salt-restricted diets die SOONER. And Eskimos eat huge amounts of fat with no apparent ill-effects. And the average home-cooked roast dinner has LOTS of fat. Will we ban roast dinners?

6). The foods restricted are often no more calorific than those permitted -- such as milk and fruit-juice drinks.

7). Tendency to weight is mostly genetic and is therefore not readily susceptible to voluntary behaviour change.

8). And when are we going to ban cheese? Cheese is a concentrated calorie bomb and has lots of that wicked animal fat in it too. Wouldn't we all be better off without it? And what about butter and margarine? They are just about pure fat. Surely they should be treated as contraband in kids' lunchboxes! [/sarcasm].


No comments: