Michael Geist writes, "Last year, the Canadian government trumpeted anti-counterfeiting legislation as a key priority. The bill raced through the legislative process in the winter and following some minor modifications after committee hearings, seemed set to pass through the House of Commons. Yet after committee approval, the bill suddenly stalled with little movement throughout the spring.
Why did a legislative priority with all-party approval seemingly grind to a halt?"
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In America, more under-6 kids go to the emergency room from accidental overdose than from car-accidents -- they get hold of medicine and drink the whole bottle. Since 2007, epidemiologist Dr Daniel Budnitz has campaigned for the use of flow-restrictors in children's medicine bottles, which dramatically reduce the likelihood of an OD; manufacturers started adding restrictors to acetaminophen in 2011, but stopped there.
Flow restrictors have not been added to bottles of antihistamines, ibuprofen, and cough and cold preparations -- even where they contain the same concentration of acetaminophen as plain acetaminophen tinctures. These other medicines account for about half of all overdoses by small children.
In a long, investigative piece, Pro Publica and Consumer Reports exhaustively document the effectiveness of restrictors, the intransigence of bottom-line-focused pharmaceutical manufacturers, and the real risks of children's medicine overdoses.
An FDA mandate would solve the problem of liquid overdose at the stroke of a pen, but the FDA refuses, preferring a voluntary approach that is demonstrably not working -- and putting kids at risk. The incidence of overdose in small children is not only widespread -- it's rising. Flow-restrictors are cheap, effective low-hanging fruit. Restrictors were invented to improve dosing and reduce spills in adult medicine, and are thus of benefit to everyone, not just parents.
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Anyone who tries to google skincare products hits a brick wall of fake reviews, SEO spam and hysterical pseudoscientific terror. Vogue's Christina Mueller writes that the blind-studied, peer-reviewed answer to your question is probably "Retinol":
Imagine for a moment that a revolutionary skin-care ingredient was discovered. It visibly smoothed out wrinkles and obliterated breakouts; it improved skin texture and tightened pores into tiny little nothings. ... Such an ingredient does exist, and chances are some form of it is currently languishing in a corner of your medicine cabinet. It’s retinol. It isn’t sexy. It definitely isn’t new. In fact, it was discovered 81 years ago, making it a veritable dowager compared with all the fresh new super-ingredients that have since come onto the anti-aging scene. For the past few decades, it has been hiding in plain sight—but with a few new developments, it is stepping back into the limelight.
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Public interest groups fly to Auckland, NZ to meet with TPP negotiators, are only allowed in the building to give a 15-minute joint presentation
Having been promised a chance to meet with the delegates at the secretive Trans Pacific Partnership treaty meeting in New Zealand, a representatives from nonprofit public interest groups around the world flew to Auckland. Once they arrived, the TPP announced that they would be granted 15 minutes, total, for all of the groups to make a statement.
TPP is a sweeping copyright treaty, a kind of ACTA on steroids, being conducted without any public scrutiny or input -- only governments and giant corporations are welcome in the negotiating room. It has profound implications for the future of medicine, Internet regulation, and privacy and surveillance.
The Electronic Frontier Foundation is one of the groups that sent a representative to Auckland. They've published an open letter signed by the public interest coalition protesting their shabby treatment at the hands of TPP's administrators.
Academics, experts, consumer groups, Internet freedom organizations, libraries, educational institutions, patients and access to medicines groups have flown a long way from around the world to Auckland, New Zealand, to engage with delegates in the 15th round of Trans-Pacific Partnership negotiations.
For the first time, however, we have been locked out of the entire venue, except for a single day out of the 10 days of negotiations. This not only alienates us as members of public interest groups, but also the hundreds of thousands of innovators, educators, patients, students, and Internet users who have sent messages to government representatives expressing their concerns with the TPP. All of us oppose the complete unjustifiable secrecy around the negotiations, but more importantly, the IP provisions that could potentially threaten our rights, and innovation.
These new physical restrictions on us are reflective of the ongoing lack of transparency that has plagued the TPP negotiations from the very beginning.
My latest Guardian column is "Why all pharmaceutical research should be made open access," and it makes the wider case for open access, beyond the obvious truth that publicly funded work should be available to the public:
One of the strongest arguments for public access in scholarly and scientific publication is the "public debt" argument: if the public pays you to do research, the research should belong to the public. That's a good argument, but it's not the whole story. For one thing, it's vulnerable to the "public-private partnership" counterargument, which goes, "Ah, yes, but why not ensure that the public gets a maximum dividend on its spending by charging lots of money for access to publicly funded research and returning the profit to the research sector?" I think this argument is rubbish, as do most economists who have studied the question.
The public good of freely accessible, unencumbered research generates more economic value for the public than the quick-hit sugar-rush you get from charging the public on the way in and again on the way out. This has held true in many sectors, though the canonical example is the massive public return from the US Geological Survey's freely usable maps, which have generated a fortune that makes the ransoms collected by the Ordnance Survey on its maps of the UK look like a pittance.
That's why Goldacre's work is important to this discussion. The reason pharma companies should be required to publish their results isn't that they've received a public subsidy for the research. Rather, it is because they are asking for a governmental certification saying that their products are fit for consumption, and they are asking for regulatory space to allow doctors to write prescriptions for those products. We need them to disclose their research – even if doing so undermines their profits – because without that research, we can't know if their products are fit for use.
Canadian Supreme Court puts Viagra in the public domain because Pfizer wouldn't disclose enough of its workings
Michael Geist sez,
The Supreme Court of Canada this morning shocked the pharmaceutical industry by voiding Pfizer's patent in Canada for Viagra. The unanimous decision provides a strong reaffirmation of the policy behind patent law, namely that patents represent a quid pro quo bargain of public disclosure of inventions in return for a time limited monopoly in the invention. The Supreme Court describes it in this way:
"The patent system is based on a "bargain", or quid pro quo: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the Act. The patent bargain encourages innovation and advances science and technology."
Ben "Bad Science" Goldacre's new book Bad Pharma: How drug companies mislead doctors and harm patients ships today, and Ben has posted the foreword, including this helpful paragraph, which explains the book's entire thesis in one handy blob:
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in its life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.
Ben's got a real knack for combining rigor and readability. He's one of the few people who can use a phrase like "I think you'll find it's a bit more complicated than that" without sounding like a smug jerk. If you want to get a sense of how the book unfolds, you can check out the excerpt the Guardian published earlier this week.
Pharmaceutical companies deliberately mislead doctors into prescribing useless and even harmful meds
Writing in the Guardian, Ben Goldacre reveals the shocking truth about the drugs that doctors prescribe: thanks to aggressive manipulation from the pharmaceutical companies and passivity from regulators, doctors often don't know that the drugs were ineffective (or harmful) in a majority of their clinical trials. That's because pharma companies set up their trials so that they the right to terminate ones that look unpromising (or stop them early if they look promising and report on the result partway through as though it reflected the whole trial), and to simply suppress the results of negative trials.
As a result, doctors -- even doctors who do their homework and pay close attention to the published trials, examining their methodology carefully -- end up prescribing useless (or harmful) medicines. And according to Goldacre, this is true of all doctors in every country, because every country's regulators allow pharmaceutical companies to cynically manipulate research outcomes to increase their profits. As Goldacre points out, a 2010 Harvard/Toronto study showed that "85% of the industry-funded studies were positive, but only 50% of the government-funded trials were" -- and in another analysis, industry-funded trials of statins "were 20 times more likely to give results favouring the test drug."
What's more, when scientists blow the whistle on this life-threatening criminality, they're smeared and hounded by the pharma companies, as happened when Danish scientists published a study critical of industry-funded trials in the Journal of the American Medical Association. After the study was published, Lif, the Danish pharmaceutical industry association, called for professional misconduct investigations into the researchers, though they couldn't provide any evidence of the alleged misconduct. Though the researchers were cleared of all wrongdoing, their employers were given copies of the accusations of scientific dishonesty, as did "the Danish medical association, the ministry of health, the ministry of science and so on."
This long piece is an excerpt from Goldacre's forthcoming book, Bad Pharma: How drug companies mislead doctors and harm patients.
Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.
Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it's dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.
And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug's effectiveness that's been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.
In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we'd expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.
Just read it. There's so much more. Paroxetine, a drug that was known to be ineffective for treating children, which had a risk of suicide as a side-effect, widely prescribed to children, because GlaxoSmithKline declined to publish its research data after an internal memo stated "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."
From Reddit, hxstr's photo of "10 years worth of Pharma Rep's free pens, very few duplicates." The comments on the photo contain a blazing fight over its provenance, though it may be the personal collection of a Cedars-Sinai cardiologist.
Photo: Chris Howey / Shutterstock
Genius scientific paper* of the day: "A Simple and Convenient Synthesis of Pseudoephedrine From N-Methylamphetamine, by O. Hai and I. B. Hakkenshit." (PDF).
A response by annoyed Sudafed users to the onerous demands by pharmacies for ID and tracking, due to the fact that this helpful and common over-the-counter drug can be used to manufacture crystal meth.
Snip from the paper:
A novel and straightforward synthesis of pseudoephidrine from readily available N-methylamphetamine is presented. This practical synthesis is expected to be a disruptive technology replacing the need to find an open pharmacy.
Pseudoephedrine, active ingredient of Sudafed®, has long been the most popular nasal decongestant in the United States due to its effectiveness and relatively mild side effects . In recent years it has become increasingly difficult to obtain psuedoephedine in many states because of its use as a precursor for the illegal drug N-methylamphetamine (also known under various names including crystal meth, meth, ice, etc.)[1,2]. While in the past many stores were able to sell pseudoephedrine, new laws in the United States have restricted sales to pharmacies, with the medicine kept behind the counter. The pharmacies require signatures and examination of government issued ID in order to purchase pseudoephedrine. Because the hours of availability of such pharmacies are often limited, it would be of great interest to have a simple synthesis of pseudoephedrine from reagents which can be more readily procured.
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Update: More in the NYT, including details on the drug sponsorship deal.
[Video Link] Never would have seen this coming. Paula Deen is said to be planning to step back from being the public face of her "Southern comfort food" empire to become the celebrity endorsement personality for a diabetes drug, in a "multimillion-dollar" deal with a pharmaceutical company. Deen is famous for popularizing creations like the “Lady’s Brunch Burger” seen in the remixed video above. A beef hamburger patty topped with bacon and a fried egg, served on a glazed donut. It's a "sometime food." (via @attackerman)
"Housewife Headache" (Thanks, Michael!)
Both bills would eliminate all legal barriers to the manufacture and sale of generic versions of drugs and vaccines. The more ambitious bill is the Medical Innovation Prize Fund Act, which would apply to all prescription drugs. The narrower proposal is the Prize Fund for HIV/AIDS Act, which would only apply to treatments for HIV/AIDS. The Medical Innovation Prize Fund would create a prize fund equal of .55 percent of US GDP, which is more than $80 billion per year at current levels of U.S. GDP. The HIV/AID Prize Fund would be funded at .02 percent of U.S. GDP, which is equal to more than $3 billion per year at current levels of U.S. GDP.Senator Sanders introduces two medical innovation prize bills in U.S. Senate to de-link R&D costs from drug prices (Thanks, jamielove!)
The federal government and private health insurance companies would co-fund the prizes, according to formulas set out in the bills. The cost of the prize funds would be more than offset by the savings from the introduction of generic competition for products.
Both bills have some similar features to Senator Sanders' earlier prize fund bills, but there are also a number of changes. Among those changes are the introduction of an open source dividend element to the bills, which would have at least 5 percent of the prize money going to persons or communities that put knowledge, data, materials or technology into the public domain, or provide royalty free and non-discriminatory access to patents and other intellectual property rights. Annually, this would be more than $4 billion for S. 1137, and $147 million for S. 1138, at 2010 levels of GDP, as an incentive to open source research.
Killing off bacteria might seem like a good thing. "Your immediate thought is, 'well, that's good, because they're not supposed to be there anyways," said Mercyhurst College microbiologist Steve Mauro, whose team found fluoxetine in low doses in water near Lake Erie's beaches. "But what about all the other bacteria that are supposed to be there and part of that ecosystem?"Prozac Killing E. coli in the Great Lakes (Thanks, Marilyn!)
Treating clean lake water with similar strength doses killed off E. coli and enterococcus bacteria, both of which can cause serious infections in humans.
The fluoxetine found in Lake Erie is at very low levels--about one nanogram per liter of water, Mauro said. "It doesn't appear to be at a level that would be harmful to humans," or invertebrates, for that matter, though Mauro suspects that fluoxetine combined with other chemicals could be having a cumulative effect on the lake's ecosystem.
ImageShack discovered that they were being used by fake pharmacy scammers to host images for their crappy websites and spam. So ImageShack now serves this warning image for all the pharma referrers they can find.
Now the US manufacturer, Hospira, says that it will stop production entirely after a bid to start making sodium thiopental in Italy stalled when the Rome government said it would only license manufacture if the drug was not used in executions.Lethal injection drug production ends in the US
Hospira said it intended to manufacture sodium thiopental to serve hospitals but "could not prevent the drug from being diverted to departments of corrections for use in capital punishment procedures".
"We cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment," the company said.
IMS, a market research firm, has tallied up the most popular psychiatric prescriptions in the USA for 2009. Notes Gary Price, "The list itself sees Xanax remain at #1 with over 44 million superscription written. Lexapro is at #2 while Ativan is at #3. Several new medicines debuted on the list."
The suit was brought by the ACLU and the Public Patent Foundation, who argued that US Patent and Trademark Office was wrong to grant patents on genes, as these are not patentable subject matter. The judge agreed, saying that gene patents are patents on a "law of nature" and called the isolation of genes and filing patents on them "a lawyer's trick that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."
Which sounds to me like a precedent against all patents that rely on isolated genes. Of course, this isn't over: the pharma/biotech stalwarts interviewed in the linked NYT piece are talking appeal, and I'm sure they'll try to go all the way to the Supreme Court.
I think that the problem here is in the untested idea that imparting exclusive rights to the genome will incentivize more research than allowing anyone to build on discoveries in the genome. It's clear that some exclusive rights provide an incentive so some people to do work. But these exclusive rights also scare off people who have good ideas but are worried about being bankrupted by someone who beat them to the patent.
Combined with that is the natural abhorrence many of us feel at the thought that genes might be patented. Genes aren't a good subject for propertization. Your genes aren't even yours -- you didn't create them. Your parents didn't really create them, either. You're your genes' steward, as are we all, and so many of us have a strong intuition that when someone else claims to own something from our genome, they're being ridiculous, or evil, or both.
Myriad Genetics, the company that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit.ACLU Challenges Patents On Breast Cancer Genes: BRCA
Judge Sweet, however, ruled that the patents were "improperly granted" because they involved a "law of nature." He said that many critics of gene patents considered the idea that isolating a gene made it patentable "a 'lawyer's trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."
The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.
(Image: Dna rendering, a Creative Commons Attribution (2.0) image from ynse's photostream)
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