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An off patent miracle cancer cure?

Interesting news coming out of Canada from a Dr. Anselm at the University of Alberta about a well known chemical dichloroacetic acid (like vinegar with two chlorines!).

Cheap, safe drug kills most cancers – health – 17 January 2007 – New Scientist

It sounds almost too good to be true: a cheap and simple drug that kills almost all cancers by switching off their “immortality”. The drug, dichloroacetate (DCA), has already been used for years to treat rare metabolic disorders and so is known to be relatively safe.

It also has no patent, meaning it could be manufactured for a fraction of the cost of newly developed drugs.

Here’s the PubMed citation for the article, filled with biology I will have no hope of understanding! I read the press release on sciencedaily a few days back and did a little background digging.

A clinical trial conducted by Colombia University studying the effects of dichloroacetate on MELAs (stroke like symptoms) was halted early because everyone taking the medication showed significant effects of neural toxicity. This study was commented on by Dr. Anselm who theorized that the effect could be caused by a specific gene mutation not seen in a lot of the patients he works with.

So, there is some reason for caution on this wonder drug, it may be toxic at certain doses to certain people. Most chemotherapetic drugs are horrendously toxic too. But if this is not a concern, Dr Anselm, meet Sunil Shaunak and his wonderful proposal to setup an alternative pipeline for drug approval that does not involve big/small pharma. I Am sure between Bill Gates, or George Soros, a few million bucks can be rustled up for a cancer cure.

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    Melamine Adulteration investigation gets cracking

    FDA agents raid pet food plant, offices – Yahoo! News

    WASHINGTON – Federal agents searched facilities of a dog and cat food manufacturer and one of its suppliers as part of an investigation into the widening recall of pet products, the companies disclosed Friday. Food and Drug Administration officials searched an Emporia, Kan., pet food plant operated by Menu Foods and the Las Vegas offices of ChemNutra Inc., according to the companies. Menu Foods made many of the more than 100 brands of pet food recalled since March 16 because of contamination by the chemical melamine. ChemNutra supplied the manufacturer with wheat gluten, one of the two ingredients tainted by melamine used in recalled pet products. Both companies said they were cooperating with the investigation.

    The initial “let’s blame China for everything” drumbeat is subsiding a little as the FDA finally begins its inspections, and we find the tangled web of the food import business unraveling just a little bit. At this point in time, the charges are flying like crazy.

    The origin within China of the wheat gluten and rice protein concentrate remains murky. For example, ChemNutra’s source for the twovegetable proteins, Suzhou Textile Import and Export Co., told The AP that food ingredients aren’t part of its business — but that employees often take on side deals. Stern said ChemNutra dealt with the company’s president.

    Side deals? How quaint? The solution is simple: Quarantine every food item from China until it has been tested for melamine. You do not know the extent of the problem yet. It only seems to get worse everyday. Make the manufacturers pay for the testing.  Tighten up the paperwork, exercise tighter control over where the ingredients come from, get everything in writing.

    Meanwhile, the manufacturers are getting their press releases out. From Blue Buffalo foods…

    We at the Blue Buffalo Company have just learned that American Nutrition Inc. (ANI), the manufacturer of all our cans and biscuits, has been adding rice protein concentrate to our can formulas without our knowledge and without our approval. This is product tampering, and it apparently has been going on for some time. The can formulas that we developed, and trusted them to produce, never contained any rice protein concentrate. It appears that only an FDA investigation of ANI’s rice protein concentrate supplies forced them to reveal this product tampering to us.

    While this activity by ANI is in itself unlawful, the situation is further clouded by the fact that ANI has been receiving rice protein concentrate from Wilber-Ellis, some of which the FDA has determined to be contaminated with melamine.

    If this is true (and we don’t know that for a fact), it’s plain ol’ cheating and food adulteration. What does American Nutrition have to say?

    The FDA has urged American Nutrition to issue a voluntary recall of pet foods manufactured using Wilbur-Ellis rice protein. None of these products is sold under an American Nutrition brand, but are sold through other independent companies. No American Nutrition brands or other products they manufacture for other businesses are affected by this recall.

    Why would I trust the word of anyone who’s accused of adding ingredients off the label? This story gets curiouser and curiouser, and it is pretty clear that between the “side dealers” in China and some greedy middlemen suppliers here, we have plenty of blame to go around.

    Stay tuned for more…

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    You breathe in toxic chemicals too.

    Behind a frigging pay wall, as usual! Kelly et al. argue in Science that hydrophobicity, the tendency to favor oil over water (to break it down to the simplest explanation) is not the only factor that explains biomagnification. The underlying theory used to be that compounds that can dissolve in water would swiftly degrade (either chemically or biologically) and not be of any concern to humans. Compounds like dioxins, PCB’s, DDT, etc. accumulated in fat tissue of aquatic animals and these were the compounds that would biomagnify through ingestion (eating!). Kelly et al. uncover another pathway that probably made every scientist go “D’uh”! – Apparently, chemicals animals breathe in can also bioaccumulate if they are not cleared efficiently by the lungs. So, air breathing cows, chickens and pigs can also cause significant bioaccumulation of certain compounds. Which ones? I guess you’ll have to pay to find out more, but this Scientific American article adds some context. Turns out, it is about 10000 chemicals, not all of them known to be harmful, but because they were never suspect, their metabolism is unknown.

    Well, if anything, it will keep the biomonitoring folks busy for a while!

    Chemical Consequences — 317 (5835): 165g — Science

    Global regulators of commercial chemicals apply a scientific paradigm that relates the biomagnification potential of the chemical in food webs to the chemical’s hydrophobicity. However, Kelly et al. (p. 236; see the news story by Kaiser) show that current methods fail to recognize the food web biomagnification potential of certain chemicals. Certain chemicals do not biomagnify in most aquatic food chains, but biomagnify to a high degree in air-breathing animals, including humans, because of low respiratory elimination. Thus, additional criteria for evaluating biomagnification and toxicity in chemicals that biomagnify are required.

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    India Rejects Obvious Patents

    Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for the elite?

    Setback for Novartis in India Over Drug Patent – New York Times

    Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday.

    Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies’ efforts to improve their products.

    At issue is the degree of innovation required for a drug to be regarded as truly “new”, where there is a significant enough chance for failure that the company would never develop it unless afforded monopoly rights for 10 years. A very well known tactic by drug companies is to make a slightly different formulation of an existing drug, say an extended release form of a drug which takes a little longer to dissolve, and hence is available to the body at a different time. Under US patent law, this qualifies for full patent protection on the extended release form. By now, the science of making an extended release tablet is well known, it’s just a question of formulating the drug with a different set of inactive ingredients that take longer to dissolve, or sometimes, through a differently engineered tablet. The chemistry of this change is predictable, published and not really innovative. Why should these small changes have patent protection?

    Bonus Note: Madras is my home city, so I’m glad it was decided there!

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  • Doctors Take Bribes to Prescribe Drugs

    This is the headline I would have used on this story. An incentive scheme to use a paticular product in a situation like this is a bribe.

    Doctors Reap Millions for Anemia Drugs – New York Times

    Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

    The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

    Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

    So how does this kickback scheme work?

    Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

    Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.

    The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

    Wow, that’s a scheme that would be illegal in almost any situation. I buy 10 widgets from the manufacturer for $100. The manufacturer then gives me $50 in “rebate”. I charge the person on whose behalf I am buying these widgets $200 even though I am not supposed to make a profit on this transaction, and pocket $150 from a transaction. I also promise to use more of this widget, on people who may or may not need it, but on whom I have such a knowledge gap and power gap that I know that they will use it whether it is actually good for them or not. I also promise not to use a competitor product even though I know that there are cases where one product will be better than the other. Well, who pays, all of us in increased health insurance premiums and healthcare costs so a bunch of rich doctors can drive their Range Rovers around.

    The USA is no different from India when it comes to schemes like this. The money involved is greater, and somehow, this is not called a bribe by the media.

    What does the pharma spokesperson have to say?

    Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.

    Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.

    Yes, it’s competitive out there, and to ensure that our product gets used, we will bribe people.

    The “consumer” is the person who pays for the product or service. The “consumer” here is the end user, the patient. The patient does not get the rebate, instead having to pay high prices so doctors can add to their six figure incomes. Nice!

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    Circumcision and AIDS – Revisited

    condom.jpg

    A post I wrote quite a while back on circumcision and AIDS remains my most commented post ever. In it (if you’re too lazy to click) I said that while research indicating a reduction in HIV infection in circumcised men was promising, there were a couple of concerns. One, that this could be a distraction from the single most effective prevention measure (no, not abstinence!), condom use. And two, that in certain cultures, especially among Hindus, this would be an absolute no no because circumcision is identified with being Muslim.

    Anyway, in a review article, the Cochrane Centre in South Africa summarizes results from a meta analysis of a number of trials indicating a 50% reduction in HIV incidence among circumcised males. At this point in time, it is clear that circumcision is effective in reducing HIV incidence among heterosexual males. Based on this, the institute encourages the widespread use of circumcision as an AIDS prevention strategy.

    So, am I still circumspect? Absolutely. I am still concerned that this research will be misinterpreted in a way that discourages condom use. In fact, the authors note that circumcised men indulged in more risky behaviour. Also, the incidence of HIV in the women these men were sleeping with increased from 9.6% to 13.8%, a 40% uptick. This increase was not statistically significant. No arguing with that, though the study was stopped early once it was clear that the men were helped, never mind the women, or reaching statistical significance in their case.

    Given that it is very unclear what the effects of circumcision are on anything other than circumcised penises, which are only one half of the equation (or less!), I don’t think it is responsible to call for widespread use of circumcision as a public health strategy for the prevention of HIV until its effects on the other parties are known. While people are aware of this issue, I don’t think the science or the cultural landscape promote the use of circumcision as a HIV prevention strategy until its proven that women are not at risk from increased HIV incidence either biologically from a yet unknown mechanism, or socially from increased risk taking.

    Men have more power in most societies to demand and receive sex on their terms. So the male centric nature of this research, and the conclusions drawn are disturbing. How irresponsible is it to encourage a public health strategy that appears to increase risk taking behaviour among men when the effects on the women are yet unknown, with only a statistically “insignificant” 40% increase in HIV incidence among women being observed?

    I am. for very good reason, still circumspect on circumcision.

    Whisky flavoured condoms courtesy bruno  girin’s photostream used under a creative commons license. Now how’s that for a turn on, whisky!

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