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Chip Implants Linked to Animal Tumors

Thinking about implanting an RFID microchip under your skin? Don’t do it! Why would the FDA approve something that was linked to cancers in rats?

Chip Implants Linked to Animal Tumors – washingtonpost.com:

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients’ medical records almost instantly. The FDA found ‘reasonable assurance’ the device was safe, and a sub-agency even called it one of 2005’s top ‘innovative technologies.’

But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had ‘induced’ malignant tumors in some lab mice and rats.

‘The transponders were the cause of the tumors,’ said Keith Johnson, a retired toxicologic pathologist, explaining in a phone interview the findings of a 1996 study he led at the Dow Chemical Co. in Midland, Mich.

Leading cancer specialists reviewed the research for The Associated Press and, while cautioning that animal test results do not necessarily apply to humans, said the findings troubled them. Some said they would not allow family members to receive implants, and all urged further research before the glass-encased transponders are widely implanted in people.

To date, about 2,000 of the so-called radio frequency identification, or RFID, devices have been implanted in humans worldwide, according to VeriChip Corp. The company, which sees a target market of 45 million Americans for its medical monitoring chips, insists the devices are safe, as does its parent company, Applied Digital Solutions, of Delray Beach, Fla.

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    The real terrorist: Pollution

    It is true. A staggering number of people die every year due to lack of access to clean water, air or food. Aggregate statistics like these are a good way to summarize the humongous nature of the problem. While reams and reams of coverage and attention are focused on “terrorists”, people all around the world die of much more mundane causes such as bacteria in water, smog, poverty, starvation, malnourishment, etc.

    ScienceDaily: Pollution Causes 40 Percent Of Deaths Worldwide, Study Finds

    About 40 percent of deaths worldwide are caused by water, air and soil pollution, concludes a Cornell researcher. Such environmental degradation, coupled with the growth in world population, are major causes behind the rapid increase in human diseases, which the World Health Organization has recently reported. Both factors contribute to the malnourishment and disease susceptibility of 3.7 billion people, he says.

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    Break the link between employment and healthcare!

    Cross-posted from Interrobang:

    The US Supreme Court ruled along political lines on the 30th of June, 2014 that “closely held corporations”, over 90% of all US businesses, are now free to discriminate against women (and it was specifically women and birth control) if their religion leads them to believe birth control kills babies, or that women who use birth control are Satan’s spawn (the belief does not have to be factual).

    The Supreme Court says corporations can hold religious objections that allow them to opt out of the new health law requirement that they cover contraceptives for women.

    The justices’ 5-4 decision Monday is the first time that the high court has ruled that profit-seeking businesses can hold religious views under federal law. And it means the Obama administration must search for a different way of providing free contraception to women who are covered under objecting companies’ health insurance plans.

    Salon AP coverage

    I am not going to debate the wrongness of this decision, the notion that businesses can have religious beliefs, and can use them to discriminate against certain types of people is not up for debate. And, the discrimination is very specific and targeted…

    The other, more ubiquitous discrimination is in the notion that the health care you get has anything to do with the work-for-pay arrangement you have with the organization you work for. I am probably the millionth person to mention this, and whole books have been written on the subject, but, the link between healthcare and your employer is wrong because it anchors discrimination. This particular egregious case goes one step further and discriminates based on gender as well, not just work status.

    The US had a chance to sever health benefits from employment when they had a three-year debate on expanding health insurance coverage. Thanks to the ability of small political minorities to filibuster and block action, and a corporate-funded reluctance for change, the US kept their employer-based health insurance system in place, and with it, all the discrimination that entails. Uwe Reinhardt reiterated a number of these points recently in the New York Times.

    Back Home

    Is BC any better? Yes and no. Thanks to Canada’s Medicare, parts of our health care system are universal and not subject to employment ties. But, there are several exceptions making us a two-tier health care system:

    1. The health insurance tax or MSP (what our government cutely calls a “fee” in order to not call the yearly increase in this fee a tax increase): Many employers will pick up part/all of this tax for their employees, whereas one that doesn’t can pay more than 1000 dollars a year for a family. While there is an element of progressiveness to the pricing with very low-income people paying less/nothing, it is weak, families making > 30K per year pay full price.
    2. Drugs: For some reason, drugs are not covered by our “universal” healthcare system and are provided by workplace “supplemental benefits”, as if taking a thyroid pill every day is a “supplement”. The CCPA makes an excellent case for universal pharmacare, if you need more convincing. 10% of Canadians cannot fill prescriptions for financial reasons.
    3. Our public health insurance system assumes people don’t have eyes or teeth. So, if you want your cavities filled, a root canal, or want to see clearly, you need “supplemental benefits”, and these are mostly employer-provided. Oral health is a clear marker of health inequality.
    4. Mental health is not covered, this is inexcusable, as Andre Picard notes.
    5. Treatments that improve overall health, like massages, are not really covered. Once again, your employment status determines whether you have the “luxury” of holistic preventative measures to reduce stress, pain, and many other issues.
    6. Historically and currently oppressed groups, Canada’s indigenous people for example, get a short shrift on the benefits like massage, nutrition, counselling and holistic treatment they need because of disparity in employment availability.

    This quote from the Andre Picard article I mentioned summarizes the discrimination.

    The well-to-do pay. The middle-class scrape together the money the best they can, sacrificing so their child can get care. And those without the means wait, or do without care.

    There are other side-effects. Because “benefits” are expensive, companies have a vested interest in only having certain “valuable” employees benefit. The rest get treated as contractors, have their hours strategically reduced, and much more.

    It’s almost as if there’s an unspoken moral argument here, you don’t deserve good teeth or a massage if you don’t work for a living.

    Yes, you can buy individual supplemental insurance, or pay per use, but neither of these are cheap because you as an individual have no bargaining power.

    We in BC also have a long way to go to break the link between healthcare and employment. Will it cost the average BC resident more money? Let’s consider:

    1. A simpler system with one buyer is administratively efficient. It takes the thousands of decision points every HR administrator or group in every company/union has to make and transfers that to a single entity. Public universal plans are about four to ten times more efficient (pdf) than fragmented private plans.
    2. A bigger entity can negotiate much better rates for you, whether it is for drugs, or for dentistry, or for anything else (a bigger risk pool). If all of Canada administered one simple pharmacare system, we would negotiate much lower prices with pharmaceutical companies. We would also have better funding to run and evaluate effectiveness studies.
    3. Funding preventative, holistic healthcare means fewer hospital visits. In a universal system, there are no artificial barriers between a massage, drug treatment, surgery, stress reduction counselling, or ergonomic counseling for back pain. You don’t have to prove your work injured you in order to get the right treatment, your first point of contact with a medical professional (not necessarily a doctor) decides which path works best. You do not have to get sick enough to go to the hospital before you get treatment covered by insurance.

    Pitfalls

    There are concerns with a universal single-payer system:

    1. As Vox points out, if a government administering the single-payer system decides not to pay for contraception, then no one gets it. So, getting good universal healthcare is about constantly winning political battles. The good thing about universal healthcare in Canada is that it is incredibly popular, polling near 90% approval (pdf). So once quality is improved, governments will find it hard to cut back.
    2. Like any other public system, the quality of the institutions drafting policy and administering the system is vitally important. Well run public systems are efficient. But conservative movements in the last 30+ years have worked hard to dismantle the quality of public institutions and trust in such institutions. In this reality of shrinking budgets and staff levels where bureaucrat is a term of insult, ensuring that public system expansion is handled efficiently is no given. There is an entire industry of political parties, think tanks and media devoted to tearing down the concept of a publicly administered good, and ready to pounce on every little misstep (Remember the Obamacare roll out anyone?)
    3. Will employers raise wages from all the savings they get from not providing health benefits, and will these raises cover the increase in taxes we will pay for universal healthcare? Probably not right away, but it will happen eventually.

    Transitions

    Clearly, we can’t transition tomorrow. A public system would need to be in place and functioning before our employers get out of the health insurance business. I would phase universality in the following order:

    1. Drugs
    2. Teeth and eyes
    3. Preventative and palliative care.

    We would also need to rethink the”fee for service”, where healthcare providers are paid per widget, and think about a different system closer to a salaried model, more on that in future blog posts.

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    Snake Oil Comes a Full Circle

    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…

  • Biologic Generics Closer to Market

    Congress Seeks Compromise on Generic Drugs – New York Times

    Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion. Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original. Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.

    It is a complex issue, and clearly, proteins and large molecules that would not be synthesized, but “grown” are subject to larger batch by batch variation, especially when the generic company does not have access to the top-secret proprietary information that genentech, or J&J used to grow their molecule. So, some level of judgment is going to be required on the part of the FDA, which has the information from both the original, and the generic manufacturers. It looks like the FDA needs to, and is prepared to deal with each generic on a case by case basis, which is how it should be.

    Protein characterization and analysis have come a long way in the last 10 years, with your fancy mass spectrometers and proteomics. It is a lot easier now to compare proteins with each other, to look for changes and differences. Mass spectrometric technology, improved electronics and huge increases in data processing and computing power make protein characterization increasingly routine. It would be up to the FDA to decide at what level of change would a protein behave so differently that its effect on humans could change significantly from the original drug, but they seem to be ready to do it.

    “Some level of clinical testing should be required in all cases,” said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech. Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: “I would never take a biologic that had not been tested in humans. The risks are too high.”

    Yes, I would absolutely trust the word of the people who had the most to lose in this case, no conflict of interest here! To be fair, Dr. Siegel is understandably cautious. We have enough problems even with small molecules (think Vioxx!). But as I mentioned previously, it should be possible to come up with good enough metrics to decide when/where human re-testing is appropriate, instead of doing it always.

    But Dr. Woodcock (of the FDA – inserted for context) said: “Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.”

    People tend to forget that we’re experimenting on humans here, thanks Dr. Woodcock! Note that this is an issue where the established biologicals companies can use the safety card with impunity to protect their enormous profits. But they are not the ones who get to decide, it’s the FDA, and ultimately, Congress.

    The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.

    Oh really, how many times has this argument been raised, and proven to be false (see plutocracy-protectionary principle!). To believe this argument, we would have to believe that the 1984 generics law completely killed the small molecule industry. Not really, Glaxo, Pfizer, etc are still bigger and badder than ever.

    Assuming a multiple sclerosis treatment costs $20,000 a year (from the article). If generics come in and there’s a 10% (low end) decline in price for the treatment, the amount saved is $2000 per patient. MS is estimated to have a prevalence rate of 0.1% in North America. So, that makes 0.3 million in the US. If half of them are on this treatment (random fudge factor), you (or your insurer) will save $300 million on one disease treatment option per year (and the biologics manufacturers will lose some portion of that). This is pretty big money, no wonder they’re throwing up roadblocks!

  • Brazil offers AIDs drug factory to Mozambique

    Brazil is positioning itself as a major manufacturer of generics, and offering to build this factory is a very good move because it will provide AIDs treatment options for Mozambique at affordable prices (well, better prices than the pharma giants would provide, at any rate). Is there expertise available in Mozambique to staff this factory and run it at the level of quality a pharmaceutical production facility needs? I don’t know the answer, but I sure hope so. Alternatively, is there any plan for Brazil to train and equip the personnel as well? It is good news, at any rate.
    Brazil offers drug factory to AIDS-ravaged Mozambique – Yahoo News

    Brazil has offered to build a $23 million pharmaceutical plant in Mozambique that will provide drugs to treat HIV/AIDS, malaria and other diseases, Mozambique’s national newspaper said on Tuesday.

    Brazil, a leading pharmaceutical manufacturer, will monitor quality and transfer technology to the proposed plant, which would produce a range of drugs, including generic antiretroviral drugs (ARVs) to fight HIV/AIDS, Noticias reported.

    The plan was presented to the Mozambique government by Brazil’s ambassador in the southern African nation.

    Mozambique, one of the poorest nations on the continent, is struggling to find the money to rebuild its dilapidated health-care system, which was neglected during a 17-year civil war that ended in 1992.

    The former Portuguese colony has been hard hit by the AIDS epidemic, with an estimated 1.6 million of its 18 million people infected with HIV. Only a fraction of those requiring ARVs are on treatment, with most of the drugs imported from India.

    The offer to build the pharmaceutical plant was first raised by Brazilian President Luiz Inacio Lula da Silva during his 2004 official visit to Mozambique. Lula said he wanted drugs from the plant to be available to other African nations as well.

    Brazil claims the use of generic anti-retrovirals has cut its AIDS mortality rate in half.

    Mozambican Health Minister Ivo Garrido said the government would decide next month whether to approve the Brazilian proposal. “We will have to study it very carefully,” he was quoted as saying by Noticias.

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    Hog Factories are Evil Part 1232

    This rather interesting study tracks the movement and evolution of antibiotic resistance from hog cesspools (lagoons) caused by factory production (hog farming) of pig meat. You see, in order to pack that many hogs together and not cause them to keel over and die from disease, they have to be pumped full of antibiotics. Guess where the antibiotics end up? In their “refuse”.

    As always, I leave you with The Meatrix if you want to know more about factory farming.

    Antibiotic Resistance Tracked From Hog Farms to Groundwater

    The routine use of antibiotics in swine production can have unintended consequences, with antibiotic resistance genes sometimes leaking from waste lagoons into groundwater, according to new research from the University of Illinois.

    Researchers report that some genes found in hog waste lagoons are transferred, “like batons,” from one bacterial species to another. This migration across species and into new environments sometimes dilutes, and sometimes amplifies, genes conferring antibiotic resistance, they say.

    The new report, in the August issue of “Applied and Environmental Microbiology,” tracks the passage of tetracycline resistance genes from hog waste lagoons into groundwater wells at two Illinois swine facilities.

    Tetracycline is widely used in swine production. It is injected into the animals to treat or prevent disease, and is often used as an additive in hog feed to boost the animals’ growth.

    Its near-continuous use in some hog farms promotes the evolution of tetracycline-resistant strains in the animals’ digestive tracts and manure.

    This is the first study to take a broad sample of tetracycline resistance genes in a landscape dominated by hog farming, said principal investigator R.I. Mackie, a professor in the University of Illinois-Champaign department of animal sciences and an affiliate of the Institute for Genomic Biology.