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FDA cannot find anything in China

Byoliveridley

FDA Finds Chinese Food Producers Shut Down – washingtonpost.com

American inspectors who arrived in China last week to investigate the two companies that exported tainted pet food ingredients found that the suspect facilities had been hastily closed down and cleaned up, federal officials said yesterday.

“There is nothing to be found. They are essentially shut down and not operating,” said Walter Batts, deputy director of the Food and Drug Administration’s office of international programs.

Well, we gave them plenty of warning, did we not!

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Duke Energy and Cliffside

Byoliveridley

NC Warn produces a good cheatsheet on Duke Energy‘s deceptions about the Cliffside coal fired power plant.

For more than a year, Duke Energy has tried to sell the idea that building a large coal-fired power plant near Charlotte would somehow be “good for the environment.” Following the January 29th state approval for construction to begin, the deception increased. By masking the new unit’s pollution behind upgrades already required by state law at an existing Cliffside furnace – and the retirement of four very small units that sit idle most of the time – Duke has misled the public, media and elected leaders into thinking that building a new unit will reduce a range of harmful emissions.

GreenscamAlert-AMythFactHandout

To summarize, CO2 emissions are set to increase significantly (factor of 12) if this plant is approved. So, in my book, this is a loser project that does not deserve even consideration. The facts are simple. This country is less than two years away from putting a price on carbon through some kind of carbon cap-trade scheme. All three major candidates for president support some kind of scheme, though McCain does not seem to know if the legislation he supports has an emissions cap or not (typical of him, he does not have any policy expertise or attention to detail whatsoever). So, the ground rules on what constitutes a cost effective option and what represents a major money making boondoggle are going to change very soon. Our state officials, thanks to the miracle of the internets, have all the knowledge to make a decision based on a reality that is coming soon. So, their reluctance to consider CO2 is puzzlingly short sighted. Duke Energy has some vague promises to sequester the carbon. But the fact of the matter is that the technology does not exist, and there’s no guarantee that it will exist any time soon in any cost effective fashion.

Even if you’re a big believer in the technology advances that will no doubt occur into the future, you have to admit that carbon emissions cannot be free any more. So, unless the federal government puts a price on the carbon, you cannot objectively support a project that will give these emissions away for free. Don’t tell me that Duke Energy will have to pay for the carbon it emits from Cliffside. It may have to, but it will pas all costs along to consumers and win anyway. So the tax payers of North Carolina are stuck with an expensive, dinosaur technology power generating option that is incredibly polluting for years to come. All because the state officials did not have the foresight to wait a year or two.

You can make the same argument for mercury. The current EPA “plan” for mercury is in tatters as it violates the clean air act. A change in administration (no McCain this time, only Clinton or Obama) is no doubt going to cause a tightening of mercury rules, a long overdue prospect. Why would the state approve a plan that would result in an increase in mercury emissions knowing fully well that federal regulation in this matter is unsettled? What ever happened to the conservative wait and watch approach?

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Republicans Block Renewable Energy Legislation

Byoliveridley

3 people stand between the US and a sensible energy policy, the radical notion that subsidies should support up and coming, good for the environment renewable energy instead of the oil industry.

Wired News – AP News

But Republicans complained that it was too harsh on the oil industry and could lead to oil companies reducing investments in new oil refineries and production. They also said that it could lead to higher prices for consumers.

“When you put a tax on a business it gets passed on to consumers,” argued Sen. John Kyl, R-Ariz. “Instead of reducing gasoline prices, this bill is going to add to the cost of gasoline.”

Kyl had earlier sought to sidetrack the tax measure, but that effort failed.

The bill’s supporters dismissed suggestions that the new taxes on an industry that has had record profits in recent years would cause either less oil production or lead to higher prices at the pump.

Oil companies earned $111 billion in profits last year and at that rate stand to earn $1 trillion over the 10 years covered by the tax package, said Sen. Jeff Bingaman, D-N.M., rejecting suggestions that “this is an undue burden” on oil companies.

Kyl claims that the point of energy legislation is to reduce the cost of gasoline to consumers. Really? I thought the point was to come up with a coherent policy that maximizes the efficiency of energy use and minimizes its impacts.

Benzene in Soft Drinks – Analytical Artifact?

Byoliveridley

An update on the benzene story from last month.

Chemical & Engineering News: Latest News – Dispute Over Benzene In Drinks

In late 2005, FDA began analyzing beverages containing benzoate and ascorbic acid. The majority of samples contained either no detectable benzene or levels below 5 ppb, says Robert E. Brackett, director of FDA’s Center for Food Safety & Applied Nutrition. FDA’s results are preliminary. After its survey is complete, the agency will determine what, if any, additional action is necessary, Brackett wrote to EWG. Changes in FDA’s analytical procedures may account for the differences in results. To collect benzene in the earlier tests, FDA used a purge-and-trap method, in which the samples were heated to 100 °C for 30 minutes. Recently, the agency has been using a static-headspace methodology, which does not involve much heat. In the earlier tests, the high heat was probably creating benzene, says an FDA source who asked not to be identified.

The explanation seems to make sense. Low level analysis is riddled with instances such as these, where the analyte you’re looking for is  introduced into the sample after the fact. It is impossible to decide without looking at the protocol whether this happened or not. Since the source of the benzene is from the reaction of ascorbic acid (aka Vitamin C) and benzoate salts, notably sodium benzoate, it would have been clear to anyone doing the analysis to avoid conditions that would result in the formation of benzene during the analysis, or maybe not…

Static Headspace analysis usually involves some heating as well, at much lower temperatures for shorter periods of time, though in the case of something as hydrophobic as benzene, not much heat would be required. So, the artifacts in static headspace would in this case be lower than in purge and trap analysis.

Still not a concern in the grand scheme of aggregate benzene exposure.

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Flame Retardants and Hyperthyroidism in Cats

Byoliveridley

Caveat Emptor: They found a correlation, not a causative mechanism. But Polybrominated Diphenyl Ethers (PBDEs, yum!) have structures that can mimic endocrine hormones. Because hormones signal at very low doses and continuously, our whole toxicological risk testing structure of looking for acute effects at high doses and trying to extrapolate those effects to low doses is flawed for endocrine disrupting compounds. We are finally beginning to see some new research, especially with other toxics such as Bisphenol A, which test for chronic conditions and subtle gene and hormonal signalling effects at low doses. After all, small changes in hormone regulation especially at childbirth and a young age can have very serious effects later on in life.

Inside Bay Area – NEW: Flame retardants linked to thyroid disease in cats

A mysterious epidemic of thyroid disease in cats may be linked to flame retardants common in carpets, foam furniture and mattresses, according to U.S. Environmental Protection Agency researchers, who suggest that scientists have underestimated the damaging health risk the chemicals pose to humans.

The research, published Wednesday in the journal Environmental Science and Technology, does not prove these compounds, known as PBDEs, caused the rash of hyperthyroidism in the nation’s household cats over the past 30 years.

Rather, it lays out a hypothesis, showing that cats are heavily contaminated by these compounds, which leach from household products and are found everywhere, particularly household dust. Cats, meticulous cleaners, ingest PBDE-contaminated dust daily.

The case of fire retardants is especially difficult because they save many lives, so manufacturers can always point to that fact and resist change. The logical fallacy, however is as follows:

  1. Fire retardants save lives (therefore good)
  2. PBDEs are fire retardants
  3. Therefore, PBDEs are good!!

The search for a safer fire retardant needs to continue, and will not happen unless the old ones are under pressure of being phased out.

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What can the U.S learn from homeopathy?

Byoliveridley

Homeopathy was all around me growing up in India, so I read this article with interest as it jogged many memories of visiting the family homeopath with my parents.

Faith Healing with Homeopathy — In These Times

Homeopathy rests on three unproven tenets: First, “Like treats like.” Because arsenic causes shortness of breath, for example, homeopaths prescribe its “spirit” to treat diseases such as asthma. Second, the arsenic or other active ingredient is diluted in water and then that dilution is diluted again and so on, dozens of times, guaranteeing—for better and worse—that even if the dose has no therapeutic value, it does no harm. And third, the potion is shaken vigorously so that it retains a “memory” of the allegedly curative ingredient, a spirit-like essence that revives the body’s “vital force.”

Fooey, the description of the science is hilariously pseudoscientific, but homeopathy is no laughing matter in India. It is estimated to be a Rs. 250 Crore (that is 2.5 billion rupees or about $58 million) industry as of 2002-2003.  I do not think this includes doctors and clinics. This website lists 158 colleges in India offering the  valid (it is like an MD!) degree of Bachelor of Homeopathic Medicine and Surgery, or BHMS. My parents swear by it, most of my family living in India has either visited, or regularly visit one. It is hugely popular for hepatitis and liver disease, more so than conventional medicine in India.

What’s the deal? Why is it so popular? I think Terry Allen is on the right track, this sentence here, buried in the middle, hits the nail on the head…

Part of the effect comes from the ritual of consultation with a practitioner who treats the patient like a person rather than a body part on an assembly line.

Allen does not quite grasp the significance of this sentence and tracks away into placebo effects and evil pharma. But here’s the deal: A lot of Indians (who can afford $4-$5 consultation fee) visit their homeopath every month. When I tagged along with my parents, we would go on a Sunday afternoon at 2 PM to this homeopath’s office, which was a wing of his house (a big house, I might add!). It was a relaxed and leisurely time, he spent 10-15 minutes with each of us (yes, my parents made me!) talking about the previous month, what we were up to, how stressed we’d been, how our ailments from the previous month were doing, had we noticed any changes to our health over the month, etc. We would be interrupted occasionally by his little kid, or his assistant relaying a message from his wife, it was as far removed from a doctor’s visit as possible. And yes, he would take your blood pressure, run simple blood tests, etc. At the end of it, he would give you little sugar pills/sugar coated powder formulations to take home. The formulations were individually dosed, it was all categorized and labeled for you.

This is like having a mini physical every month. Surely, just the act of talking to someone made you feel better, the act of ritually opening up little packets of “medicine” and following detailed instructions for 5 days helped, surely the homely and relaxing atmosphere of visiting a family friend helped, I don’t know.

Metrics? both my parents occasionally had their hypertension treated with homeopathy. This worked as long as they were borderline, and simple stress management would get the numbers down. This doctor was/is very good at stress management because he talked calmly, yet firmly, he would listen and tease their little everyday stressors out of them and that was probably good for a 10 point reduction. But I remember the homeopath sending mom off to a doctor for a more conventional treatment regimen as soon as she hit 160.

It never ever worked for me because I was way too sceptical to buy into the process, so I would not listen, or relax enough to talk. I would take my pills, but it would make absolutely no difference whatsoever. Of course, he was trying to treat me for severe sinus related issues probably brought on by pollution, and by sleepless nights spent on a beach looking for turtles!

I am sure that for every good homeopath, there were two bad ones who just handed out pills of sugar. But my parents’ homeopath was, and continues to be part Dr. Phil, part candyman, part cheerleader!

Homeopathy probably “works” because it makes people take the time to think about their life and what’s ailing them. It’s a lesson that American primary care providers could do well to learn.

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FDA decides to breed super bugs

Byoliveridley

Well, what else can you say about it. This is insanely moronic. Read this sierra club release about the overuse of antibiotics brought on by the overcrowding of animals in food production factories (aka “farms”). Read the whole article and see how much everyone will be endangered so that Intervet, Inc. can make money.

FDA Rules Override Warnings About Drug – washingtonpost.com

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency’s own expert advisers that the decision will be dangerous for people. The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine’s last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

Note, a powerful and potent antibiotic that works well, but is not used much because it’s the last line of defense. But the drug company that manufactures this product cares little about long term efficacy. Their only goal is to maximize short term shareholder value. I don’t blame them, I blame the government for not doing its job, that is, to balance these short term and long term goals and protect the people that pay them a lot of money for this protection.

The wording of “Guidance for Industry #152” was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.

Cefquinome’s seemingly inexorable march to market shows how a few words in an obscure regulatory document can sway the government’s approach to protecting public health.

There’s a reason this present U.S government works in secrecy, so these “obscure” (I am sorry, but nothing that directly affects human health can be called obscure) rule changes will not hit the public eye before it’s too late. Apparently, the FDA can now only consider resistance to food borne diseases in considering an application. That’s like saying that a hospital will only treat victims of food borne diseases, so if you catch the cold, we won’t treat you! This is the Food and Drug Adminstration (all food and all drugs), not the food borne disease protection council.

This drug is absolutely unnecessary for the following reasons:

  1. The disease it treats (respiratory distress in cows) is brought about by insane levels of animal overcrowding
  2. There are currently a dozen antibiotics for this particular problem, none of which are considered susceptible to resistance
  3. The FDA has previous history with similar public health threats with fluoroquinolones
  4. This drug is considered a last resort drug for antibiotic resistant strains of diseases in cancer patients – So strains resistant to this drug will evolve shortly after the antibiotic is overexposed . This is a death sentence for a lot of very vulnerable people.
  5. A similar drug used in Europe for the last 10 years has resulted in an increase in resistant strains of bacteria.

This is what you get when you vote for an ideology that hates government. You get a government that hates itself and is busy pawning parts of itself off to its cronies.