Tasty food is bad for you(?)

Now the food Fascists want to make our food less tasty, apparently. Note that Kessler is too much of a nut even for California. He was unceremoniously fired last year as Dean of the medical school at the University of California, San Francisco. So treat his colourful assertions with caution. Food producers undoubtedly have some role in what we eat but your weight is mostly genetically determined

JUNK foods such as Snickers bars and ketchup really are irresistible. Manufacturers have created combinations of fat, sugar and salt that are so tasty many people cannot stop eating them even when full, according to America’s former food standards watchdog. David Kessler, former head of the US Food and Drug Administration (FDA), has warned that snacks, cereals and ready meals devised by food scientists can act on the reward centres of the brain in the same way as tobacco.

He argues that manufacturers are seeking to trigger a “bliss point” when people eat certain products, leaving them hungry for more. “It is time to stop blaming individuals for being overweight or obese,” said Kessler. “The real problem is we have created a world where food is always available and where that food is designed to make you want to eat more of it. For millions of people, modern food is simply impossible to resist.”

While at the FDA, Kessler was best known for his attacks on the tobacco industry, which he accused of manipulating cigarettes to make them even more addictive. In a new book, The End of Overeating, he suggests food manufacturers have achieved a similar result using precise combinations of fat, sugar, salt and texture to make foods “hyper-palatable”.

Kessler cites Heinz tomato ketchup and Starbucks white chocolate mocha Frappuccino as examples of the thousands of modern foods that have been engineered to stimulate feelings of pleasure. A study carried out by Kessler with researchers at Yale University using functional magnetic resonance imaging techniques, showed that about 50% of obese people and 30% of those who are overweight were prone to so-called “excessive activation”. “The right combination of tastes triggers a greater number of neurons, getting them to fire more,” said Kessler. “The message to eat becomes stronger, motivating the eater to look for even more food.”

In other research, scientists have used rats to study how different combinations of fat, sugar and salt trigger the release of neurotransmitters in the brain’s pleasure centres. The most powerful combination involved sucrose (table sugar) mixed with chocolate and alcohol – the same mixture found in desserts such as tiramisu.

Kessler said: “Many of us have what’s called a ‘bliss point’ – the point at which we get the greatest pleasure from sugar, fat or salt. “As more sugar is added, food becomes more pleasurable until we reach the bliss point, after which it becomes too sweet and the pleasure drops off.” The same thing happens with fat and salt. At the optimum point, food stimulates many people’s appetites instead of suppressing it, according to Kessler, who ran the FDA from 1990 to 1997 and is now professor of paediatrics, epidemiology and biostatistics at the University of California.

There have been a series of warnings about obesity in Britain. A landmark report by the National Audit Office in 2001 found that 20% of adults were obese – a figure that has since risen to 25% – while a further 38% were overweight.

The findings alarmed Sir Liam Donaldson, the chief medical officer, so much that he warned of a “health time bomb” – particularly among children. In 2007 the government’s science-led Foresight report said: “The wide variety and appeal of modern foods, with their increased palatability and ability to heighten sensory stimulation, drive us to reward ourselves with more food.”

Experts claimed that such evidence showed the need for state intervention. However, when Gordon Brown announced the Healthy Weight, Healthy Lives strategy early last year, he said: “There should be no doubt that maintaining a healthy weight must be the responsibility of individuals first – it is not the role of government to tell people how to live their lives.”

Tim Lang, professor of food policy at City University and a government adviser, said politicians’ obsession with promoting “choice” was damaging public health. “If I walk to my local park for some exercise,” he said, “I pass more than 30 food outlets before I get there. It’s that combination of availability, advertising and seductive taste that makes modern food so addictive. ”

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Obama's FDA wants to class a vitamin as a drug so it can ban it until it has undergone many years of testing

That it is therapeutically useful has already been established in proper double-blind studies -- e.g. here -- JR

Kidney disease causes almost 500,000 Americans to require dialysis or a transplant.22 Diabetes is the leading cause of end-stage kidney disease.23 With today’s epidemic of type 2 diabetes, the market for a drug that protects against diabetic complications is huge.

Based on scientific data documenting its remarkable biologic effects, a drug company paid for studies to prove the efficacy of pyridoxamine in protecting against diabetic complications.

One of these studies showed that pyridoxamine slowed the rate of rise of a marker of kidney failure (creatinine) by 68% and improved certain parameters of kidney function in humans. This company spent about $100 million funding various pyridoxamine studies before it ran out of money. The FDA wants to protect pharmaceutical financial interests, even if pyridoxamine is never approved as a new drug. According to the FDA, pyridoxamine cannot be marketed as a dietary supplement because: “pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public…”

The FDA’s twisted position is that if vitamin companies can offer low-cost pyridoxamine supplements, then there is no incentive for a drug company to invest hundreds of millions of dollars getting it approved as a prescription drug. Said differently, to protect the financial interests of a pharmaceutical company, the FDA is willing to deny every health-conscious American access to the life-saving benefits of pyridoxamine, which include preventing the very disease the drug company is seeking to have pyridoxamine approved to treat!

WHEN MIGHT PYRIDOXAMINE BE AVAILABLE AS A PRESCRIPTION DRUG?

Even under the FDA’s fast track program, obtaining new drug approval can take decades. In the case of pyridoxamine, which has been around since life evolved on earth, there are numerous hurdles that have to be cleared before it becomes an official “drug.”

Assuming successful completion of a Phase IIb trial—this assumes an end-of-Phase II meeting and formal vetting of Phase III (pivotal, registrational) trial design(s) and associated study endpoints—and assuming at least two Phase III trials involving 1,500 patients studied for at least six months (and at least 500 patients studied for at least one year, and at least 200 studied for two years), with estimates for Phase III trial recruiting of 12 months and a nine-month turnaround time from the FDA following NDA (new drug application) submission, an estimated timeline would suggest that pyridoxamine might be available around 2014.

Until these clinical trials are completed, an outside FDA review committee recommends approval, and FDA bureaucrats grant approval, pyridoxamine will never be available to American citizens. The death toll from heart attack, kidney failure, and a host of other diseases preventable with pyridoxamine may then reach into the millions.

The FDA pretends to “protect the public health.” This cruel hoax is once again exposed by this bureaucratic edict that seeks to deny Americans access to a critically important disease-fighting nutrient.

Pyridoxamine is Found Naturally in Our Food! Pyridoxamine occurs naturally in fish, chicken, walnuts, carrots, eggs, and other foods. People ingest small quantities each day. The FDA apparently feels so empowered that it thinks it can by proclamation ban an ingredient people obtain in their normal diet.

By defining the safest form of vitamin B6 (pyridoxamine) to be a “new drug,” the FDA has once again capitulated to pharmaceutical financial interests at the expense of the public’s health.

What if Pyridoxamine is Approved as a Drug? On March 25, 2008, the company seeking to have pyridoxamine approved as a “drug” stated that it will be conducting a Phase IIb study on diabetic patients with kidney disease. The estimated study completion date is August 2010.

If this study demonstrates a successful clinical outcome, it will then be submitted to the FDA for so-called “fast track” approval. It could take several years, if ever, before FDA approval is granted for pyridoxamine. In the meantime, according to the FDA’s Byzantine logic, no American is “allowed” to have pyridoxamine, effectively condemning millions to needless suffering and death.

If pyridoxamine is ever approved, it will only be for very limited indications, such as end-stage kidney failure and diabetic neuropathies. Unless you happen to suffer from these diseases, you will find it difficult to obtain a “pyridoxamine prescription.” Then again, the cost of “prescription pyridoxamine” will be so astronomical that few will be able to afford it anyway.

If pyridoxamine becomes a new drug, the federal government will spend millions of tax dollars paying full retail price for it via the corrupt Medicare Prescription Drug Act, which adds another absurdity to the FDA’s proposed ban.

More than 26 million Americans over age 20 suffer chronic kidney disease, which represents 13% of the adult population! Diabetes and poorly controlled blood pressure are the leading causes of kidney failure, meaning this epidemic is largely preventable with early detection. Annual blood chemistry tests and regular blood pressure checks can identify deteriorating kidney function early and enable one to initiate corrective actions. Unfortunately, millions of Americans do not have regular blood tests (or blood pressure checks), resulting in the silent development of end-stage renal disease. For too many victims, they don’t find out their kidneys have failed until admitted to a hospital emergency room with severe symptoms.

End-stage renal disease is the name for kidney failure so advanced that it cannot be reversed. End-stage renal disease means that kidney function is so poor that the patient cannot be kept alive without aggressive and often only partially effective treatment.

There are 336,000 Americans receiving chronic dialysis treatment right now. Another 136,000 Americans are surviving with a kidney transplant.22 These treatments can induce serous side effects that shorten the patient’s life span. The annual cost of dialysis alone is about $70,000, most of which is borne by Medicare (which is facing near-term insolvency)...

The FDA is seeking to ban pyridoxamine, which has been demonstrated to significantly delay the progression of kidney disease. Pyridoxamine has been shown to slow the elevation of creatinine, a blood marker of kidney function by 68%.24 These data indicate that many of those destined to perish from kidney disease will be dying prematurely because of the FDA’s draconian actions to keep pyridoxamine away from the public....

We know that pyridoxamine was used as a dietary supplement in the early 1990s. If we can prove that pyridoxamine was sold in the United States prior to October 1994, the FDA will not be allowed to ban it. The Dietary Supplement Health and Education Act protects supplements marketed prior to October 1994.

If you used pyridoxamine prior to October 1994, please let us know so we can add your name to an affidavit and use any evidence you have to overturn the FDA’s proposed ban on pyridoxamine.

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