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FDA and European regulators in information sharing agreement on food

Byoliveridley

Good, I guess. The Europeans demand a lot of testing on their food, and if they can share information with the FDA on general trends, and even specific batches of food ingredients, the FDa gets a lot of information without having to setup any kind of infrastructure, or have manufacturers scream at them for insisting they perform tests they’re already performing for the European market!

In regulation, the strictest one eventually wins as long as it has enough of a market that it cannot be boycotted/ignored.

FDA inks deal with Europeans over food safety | Health | Reuters

The U.S. Food and Drug Administration said on Monday it signed a pact with European regulators to share more information about the safety of the food supply.

The FDA said the agreement with the European Food Safety Authority would pave the way for formally sharing confidential scientific information and that it would help protect confidential information under both regions’ laws.

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Folklore Based Medicine?

Byoliveridley

Breast cancer theory supports African folklore – CNN.com

While they stressed that women should always get screening and quick treatment for breast cancer, they said their theory could also help explain the belief, widespread in parts of Africa and the United States, that removing a tumor can hasten death. “I must say that I am sure there is more to this than just a myth,” said Michael Retsky of Children’s Hospital and Harvard Medical School in Boston, Massachusetts. His latest hypothesis, which he admits is not supported by any new direct research, is published in the International Journal of Surgery. He stressed that any woman with breast cancer should get the tumor removed. And he noted that in the United States, the women who could be considered at risk of having their cancer spread now get chemotherapy anyway, which would stop cancer’s spread.

Note, no direct evidence, no double blind trial, just a story? C’mon, you’re a Doctor. Surely, you know that CNN and the other media will take your qualifications, reservations and cautions  and shove them up your you know what to get a nice headline. Most people don’t read past the first two lines anyway, so nothing you say about your reservations will be transmitted to the public.

I hope you get the funding to prove/disprove your contention. Race based differences in treatment outcomes are not well studied, and are potentially very important. It is vital that more people look at this issue. But speculation based on modeling studies does not belong on CNN.

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Snake Oil Comes a Full Circle

Byoliveridley

Ah, back to the good old days of snake oil..

ScienceDaily: Snake Venom As Therapeutic Treatment Of Cancer?

This certainly sounds unusual, but Dr. Son and colleagues report on the effectiveness of the snake venom toxin (SVT) Vipera lebetina turanica in the inhibition of androgen-independent prostate cancer (AICAP) in the journal Molecular Cancer Therapeutics.

These novel findings suggest that SVT can inhibit the growth of AICAP through the induction of cell death.

I am glad they put the question mark at the end, lest people extrapolate from a few cells in a petri dish (or a small animal study) to a cancer cure, as happened recently with dichloroacetate! Health reporting is very tricky because the average reader cannot understand much more than the headline. It almost seems like every health article should have the following things clearly labeled:

  1. Human, animal or cell?
  2. Clinically tested, or anecdotal?
  3. Double blinded, controlled, etc, or not?
  4. Any chance that this result applies to people?
  5. How far away are we from a real cure?
  6. DO NOT TRY THIS AT HOME!

At least viper venom is hard to find! The Madras crocodile bank helped start a venom extraction cooperative run by the Irula Tribe, so I’ve seen viper venom being extracted, pretty cool. India is home to two vipers, the Russell’s and the Saw Scaled vipers.

Russell's
Russell’s viper

saw scaled
Saw scaled viper.

The Russell’s is 3-5 feet long, and slow, but a big hisser! The saw scaled viper is tiny, a feet or two, but aggressive and very venomous. One of my favorite wild snake sightings was a saw scaled viper, looked very innocuous curled up in a parking lot in Pondicherry.

Cool, snake oil and venom for all…

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Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

Byoliveridley

As I mentioned previously, compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies for governments to authororize the bypassing of drug patents. Thailand threatened to do it recently, Brazil goes one better.

Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

President Luiz Inacio Lula da Silva took steps Friday to let Brazil buy an inexpensive generic version of an AIDS drug made by Merck & Co. despite the U.S. drug company’s patent.

Silva issued a “compulsory license” that would bypass Merck’s patent on the AIDS drug efavirenz, a day after the Brazilian government rejected Merck’s offer to sell the drug at a 30 percent discount, or $1.10 per pill, down from $1.57.

The country was seeking to purchase the drug at 65 cents a pill, the same price Thailand pays.

This story fits the script in every possible way. Here’s the drug company’s “disappointed” response:

Amy Rose, a spokeswoman for Whitehouse Station, N.J.-based Merck, said earlier that the company would be “profoundly disappointed if Brazil goes ahead with a compulsory license.”

“As the world’s 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease,” Merck said in a statement after Silva’s announcement.

Ah, the irony of a large pharma company appealing to Brazil’s sense of fairness!

The usual US government/chamber of commerce type’s scold and threat to withold further foreign investment:

But the U.S.-Brazil Business Council said the decision was a “major step backward” in intellectual property law and warned it could harm development.

“Brazil is working to attract investment in innovative industries … and this move will likely cause investments to go elsewhere,” the council said in a statement.

Who are the US-Brazil Business Council? It is an affiliate of the U.S Chamber of Commerce. Its website reveals it to be a lobbying and networking group of high powered U.S executives “fostering” U.S-Brazil trade relations. Hmm, I wonder who’s side they will take!

But, we forget what this is about, the health of thousands of AIDs patients (and the money it costs to treat them).

Brazil provides free AIDS drugs to anyone who needs them and manufactures generic versions of several drugs that were in production before Brazil enacted an intellectual property law in 1997 to join the WTO.

But as newer drugs have emerged, costs ballooned and health officials warned that without deep discounts, they would be forced to issue compulsory licenses.

Efavirenz is used by 75,000 of the 180,000 Brazilians who receive free AIDS drugs from the government. The drug currently costs about the government about $580 per patient per year.

Brazil is doing absolutely the right thing by bargaining and playing hardball. it wants to pay the same prices Thailand pays, and should continue to bargain till it gets there. There’s no sense in being a sovereign powerful nation if you can’t shakedown a pharma company, is there!

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Brazil successfully hardballs Abbott on AIDs drug

Byoliveridley

I mentioned in May that Brazil had introduced compulsory licensing on a Merck AIDs drug Efavirenz, and heartily recommended that Brazil and other third world countries continue to play hardball with big pharma whenever they could. It looks like Merck decided to not bargain, but Abbott did on Kaletra. Note that Abbott got into a similar controversy with Thailand, and agreed to drop the price when Thailand rejected the Kaletra patent.

Keep it coming, third world countries. Bargaining is perfectly acceptable in the marketplace!

Brazil says Abbott to cut price of AIDS drug | Health | Reuters

razil’s health ministry said Wednesday that Abbott Laboratories Inc. agreed to cut the price of its Kaletra AIDS drug by 29.5 percent.

The lower price for the drug, also known as lopinavir and ritonavir, will help Brazil supply free drugs for its AIDS treatment program.

In May, President Luiz Inacio Lula da Silva authorized Brazil for the first time to break the patent on an AIDS drug, one made by Merck & Co.. It then started importing a generic version of the drug Efavirenz from India.

Under WTO rules, countries can issue a “compulsory license” to manufacture or buy generic versions of patented drugs deemed critical to public health.

Drug makers often reduce prices to keep countries as clients and avoid compulsory licenses.

FDA proscribes Chinese toothpaste

Byoliveridley

The FDA follows its proud tradtion of Friday afternoon recalls!

The issue is the adulteration/replacement of glycerin with diethylene glycol, which tastes similar, but is very poisonous. This story has been well covered in the last few weeks.

My question is, why only toothpaste? I would have extended the ban on all products containing glycerin. But, the FDA is a cautious beast, so things happen slowly and incrementally, if at all.

FDA News Release

The U.S. Food and Drug Administration (FDA) today warned consumers to avoid using tubes of toothpaste labeled as made in China, and issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the United States.

DEG is used in antifreeze and as a solvent.

Consumers should examine toothpaste products for labeling that says the product is made in China. Out of an abundance of caution, FDA suggests that consumers throw away toothpaste with that labeling. FDA is concerned that these products may contain “diethylene glycol,” also known as “diglycol” or “diglycol stearate.”

FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG.

FDA has identified the following brands of toothpaste from China that contain DEG and are included in the import alert: Cooldent Fluoride; Cooldent Spearmint; Cooldent ICE; Dr. Cool, Everfresh Toothpaste; Superdent Toothpaste; Clean Rite Toothpaste; Oralmax Extreme; Oral Bright Fresh Spearmint Flavor; Bright Max Peppermint Flavor; and ShiR Fresh Mint Fluoride Paste. Manufacturers of these products are: Goldcredit International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited. The products typically are sold at low-cost, “bargain” retail outlets.

Based on reports of contaminated toothpaste from China found in several countries, including Panama, FDA increased its scrutiny and began sampling toothpaste and other dental products manufactured in China that were imported into the United States.

FDA inspectors identified and detained one shipment of toothpaste at the U.S. border, containing about 3 percent DEG by weight. In addition, FDA inspectors found and tested toothpaste products from China located at a distribution center and a retail store. The highest level found was between 3-4 percent by weight. The product at the retail store was not labeled as containing DEG but was found to contain the substance.

DEG poisoning is an important public safety issue. The agency is aware of reports of patient deaths and injuries in other countries over the past several years from ingesting DEG-contaminated pharmaceutical preparations, such as cough syrups and acetaminophen syrup. FDA recently issued a guidance document to urge U.S. pharmaceutical manufacturers to be vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with DEG.

FDA continues to investigate this problem. If FDA identifies other brands of toothpaste products containing DEG, FDA will take appropriate actions, including adding products and their manufacturers to the import alert to prevent them from entering the United States.

Autism epidemic not caused by shifts in diagnoses; environmental factors likely

Byoliveridley

California’s sevenfold increase in autism cannot be explained by changes in doctors’ diagnoses and most likely is due to environmental exposures, University of California scientists reported. The scientists who authored the new study advocate a nationwide shift in autism research to focus on an array of potential factors in the environment that babies and fetuses are exposed to, including pesticides, viruses and chemicals in household products.

Autism epidemic not caused by shifts in diagnoses; environmental factors likely — Environmental Health News

One of the most common arguments you will see about a lot of mental health diagnoses is that doctors have changed their diagnostic practices significantly. While there is evidence of this occurring in diagnoses of childhood depression, anxiety, or even bipolar disorder due to the millions of dollars involved in medication and the attendant corruption, autism is different.

This population study used 17 year data in California and concluded that diagnostic changes were only responsible for a 2 fold increase, not the seven fold increase seen. The rest is unexplained, and the authors attribute it to a confluence of environmental and genetic factors.

And no, for the last time, VACCINES DO NOT CAUSE AUTISM!