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."
Canadian Supreme Court Voids Viagra Patent as Insufficient Disclosure Means It Fails the "Patent Bargain"
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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:
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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.
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. Read the rest
Purdue Pharma is testing OxyContin on children six and up.
Oxy's gonna go out of patent some day, and shut down Purdue's gravy train. But if they test it on kids -- even it's never approved for use on kids! -- the folks at the FDA will extend their patent by another six months. "Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University" says "They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind.... That’s important for their bottom line." (via Techdirt
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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.
Reddit, I present to you: 10 years worth of Pharma Rep's free pens, very few duplicates [OC] (imgur.com)
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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:
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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.
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)
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Michael sez, "From a 1968 ad in Life
: 'Making beds, getting meals, acting as family chauffeur -- having to do the same dull, tiresome work day after day -- is a mild form of torture. These boring yet necessary tasks can bring on nervous tension, fatigue and what is now known as "housewife headache."'
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Jamie Love sez, "Senator Bernie Sanders (I-VT) has introduced legislation in the US Senate that would use prizes to reward medical R&D, and eliminate all drug monopolies. It includes an open source dividend of $4 billion per year."
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.
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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.
Marilyn sez, "Scientists in Erie, Pennsylvania, have found that minute concentrations of fluoxetine, the active ingredient in Prozac, are killing off microbial populations in the Great Lakes."
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
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.
(Image: Prozac, a Creative Commons Attribution (2.0) image from arenamontanus's photostream)
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American states are unable to execute their prisoners by lethal injection, thanks to an end to US production of sodium thiopental. Foreign health authorities prohibit selling sodium thiopental if it is to be used in lethal injections, and they will not buy drugs from pharma companies who sell sodium thiopental for that purpose. As a result, the sole US manufacturer, Hospira, has discontinued production of the drug, and no foreign manufacturer will sell to the US. Executions in California and Oklahoma have been delayed as a result of the shortage.
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.
(Image: Lethal Injection Chamber, a Creative Commons Attribution (2.0) image from blatantnews's photostream)
Lethal injection hurts - Boing Boing
What does stoning a person to death entail? - Boing Boing
Edison electrocuted an elephant 105 years ago today - Boing Boing
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has this map showing the most prescribed psychiatric drugs in America. Read the rest
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."
Top 25 Psychiatric Prescriptions for 2009
Previously:Why medical research isn't as useful to you as it could be - Boing ...
Pharmaceutical company funds documentary about over-eating
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United States District Court Judge Robert W. Sweet has invalidated Myriad Genetics's infamous "breast cancer patent" -- a patent on genetic mutations that cause breast cancer, which Myriad has exercised in the form of a high lab-fee for analysis on samples (Myriad threatens to sue any independent lab that performs the analysis).
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. Read the rest