Techdirt. Stories filed under "drugs"

Big Pharma Firms Seeking .pharmacy Domain To Crowd Out Legitimate Foreign Pharmacies

Mike Masnick — Fri, 17 May 2013 09:29:43 PDT

For years, we've noted that the big drug companies like to conflate legitimate foreign pharmacies (often based in Canada) that sell back into the US (the so-called "reimportation" or "parallel import" market) at cheaper prices with out and out bogus or counterfeit online pharmacies. The drug companies like nothing better than when people lump the two very different beasts together and label them all as "counterfeit." Of course, for many Americans, relying on cheaper legit drugs from Canada is the only way they can survive, and there have been efforts made at times by US politicians -- including President Obama -- to support more parallel importation to ease the high cost of drugs in the US.

However, there's an interesting tidbit coming out in the ongoing battles over new top level domains. It appears that the National Association of Boards of Pharmacy is seeking a .pharmacy domain, which (obviously) they would then only bestow upon pharmacies that they like. That could be a big issue, because it's likely they wouldn't allow that for certain Canadian pharmacies and other foreign legitimate pharmacies that may offer cheaper drugs. Both Demand Progress and Public Citizen recently filed comments with ICANN about why NABP should not be allowed to control .pharmacy.

From Public Citizen's filing:

Granting the .pharmacy domain to NABP would confer legitimacy on pharmacies sanctioned by NABP, to the detriment of those that are not.

NABP has proposed an unfair standard that would bar online pharmacies that serve US consumers but are located outside of the United States from using the domain (see NABP’s application at Section 18(a) IV*). This would exclude many licensed pharmacies which offer American consumers low-cost medicines of quality.

Whether a pharmacy is located in the United States does not determine whether a pharmacy is licensed and provides medicines of quality.

Consumer access to medicines depends in significant part on price and competition. It would be inappropriate to allow NABP to control such an important gTLD while it maintains exclusionary plans for the domain, which work against the consumer interest in a robust market of quality affordable pharmaceuticals.

And, from Demand Progress's filing:

The pharmaceutical industry has prioritized trying to shut down legitimate pharmacies selling safe Canadian drugs to U.S. consumers (as currently allowed by the U.S. Food and Drug Administration). But their tactics to achieve these anti-consumer goals involve censorship regimes allowing government seizure of domains, blacklists of sites, or suspended hosting services for legitimate competitors.

NABP supporters have justified their actions by preying on consumer fear of counterfeiters, when their real goals include shutting down sites providing cheaper legitimate drugs. Pfizer joined the assault on the Net in 2011, testifying to Congress that: "The major threat to patients in the U.S., however, is the Internet..." ...

NABP's supporters define "fake pharmacies" as those not registered with VIPPS, rather than only those selling actual counterfeit goods.

The Demand Progress comment also points out how the big pharmaceutical companies supported SOPA and PIPA, since they knew that it, too, would be useful to use as a sledgehammer against foreign online pharmacies that sold legitimate drugs back into the US.

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Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents

Glyn Moody — Mon, 1 Apr 2013 15:13:00 PDT

Back in October last year, in the context of India showing itself increasingly sceptical about pharma patents that drive up drug prices beyond the reach of its citizens, we wrote about an important court battle over Novartis's drug Gleevec, sold as Glivec in India. The definitive judgement from India's Supreme Court was announced today, reported here by The Guardian:

The Indian supreme court has refused to allow one of the world's leading pharmaceutical companies to patent a new version of a cancer drug, a decision campaigners hailed as a major step forward in enabling poor people to access medicines in the developing world.

Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too.

The key issue at stake is a practice known as "evergreening": making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer's control over it. It's a way of cheating on the implicit bargain of patents: that a government-backed monopoly is granted in exchange for the invention entering the public domain at the end of the patent's lifetime.

That's what makes today's decision so important. It's not just about allowing Indian generics manufacturers to offer Glivec for a fraction of the Novartis price; it's equally about establishing the principle that "evergreening" patents won't be as easy in India as it is elsewhere, where the practice is common. This will allow India's pharma companies to produce a wide range of drugs at low prices that can then be sold to emerging countries unable to afford Western prices.

Doubtless, many lives will be saved as a result, but that doesn't seem to be any comfort to the head of Novartis in India, who is quoted in a press release as saying:

"We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs," said Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited. "We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."

That's pretty much what you'd expect him to say, since we've heard it here on Techdirt so many times before: without patents that allow monopoly pricing and big profits, there will be no investment in new drugs, and everyone will suffer etc. etc. But this simply isn't true. Much of the fundamental research that leads to important new drugs is done in public laboratories, paid for by taxpayers around the world, not by pharma companies.

Here, for example, is the story of how Novartis came to gain its highly-lucrative monopoly on Gleevec/Glivec, as told by the key researcher who actually developed it: Brian Druker, chair of Leukemia Research and professor of medicine at the Oregon Health and Science University Cancer Institute. He explained how the crucial initial research was carried out in an opinion piece published on the Livemint site in 2007:

The basic research that led to the identification of enzyme inhibitors for CML [Chronic Myeloid Leukaemia -- the main condition that Glivec is designed to treat] dates back to 1960 with the identification of the Philadelphia chromosome in patients with CML by researchers at the University of Pennsylvania, Peter Nowell and David Hungerford. In 1973, Janet Rowley at the University of Chicago determined that the abnormal chromosome was due to a translocation of genetic material.

No pharmaceutical companies seem to have been involved in this early work, and they were also minor players in the crucial move out of the laboratory, into product development, as Druker explains: In 1993, I moved to Oregon Health Sciences University in Portland and had a single goal of finding a company that had the best inhibitor for Bcr-Abl [the cancer-causing protein] and to bring it into clinical trials. My work in Oregon on a therapy for CML was primarily funded by public sources, particularly the National Cancer Institute. My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the development of imatinib on their agenda despite uncertainty from product managers.
So not only was the drug developed largely thanks to public funds, but the pharma company that ended up making all the profits from it wasn't even hugely enthusiastic about the project initially: it was only Druker's "persistence" that led to the drug being approved. And if you're wondering about his views on the current world of pharma, with its stratospheric prices and a habitual recourse to evergreening to extend patents way beyond their original life-span, here's what he wrote back in 2007: Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.
The fact that many key drugs have only been possible thanks to those "vital investments made by the public sector" is nearly always overlooked by defenders of the pharma patent system. It's another reason why the Indian Supreme Court's decision is not only right, but just.

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UPS Coughs Up $40 Million Because It Delivered Drugs From Rogue Pharmacies

Mike Masnick — Fri, 29 Mar 2013 17:37:00 PDT

Whenever we talk about things like "secondary liability" and why it doesn't make sense to blame a company for something their users do, we'll often use examples like pointing out that it's inappropriate to blame AT&T if someone makes a bomb threat over the phone, or to blame Ford for someone driving too fast. Another example in the "of course that's silly" list may have to removed however: the inappropriateness of blaming UPS or Fedex for what's in the packages they deliver. That one now has to be retired. Because the good old US government has made UPS forfeit $40 million to the government for shipping drugs from "illegal internet pharmacies." Details on what actually happened here are sparse, but the DOJ will be celebrating this one, despite almost none of the important details being shared.

UPS put out a statement that doesn't sound even remotely forced upon it by DOJ people holding guns.

"We believe we have an obligation and responsibility to help curb the sale and shipment of drugs sold through illegal Internet pharmacies," said Susan Rosenberg, a UPS spokeswoman.

Of course, what is an "illegal internet pharmacy"? There's a bit of an issue there because the DOJ thinks that an illegal internet pharmacy includes that Canadian pharmacy that is much cheaper, but which is making perfectly legitimate drugs and then shipping them -- gray market style -- into the US. That's a very different picture than the "illegal internet pharmacy" selling sugar pills or worse. But, here's the thing about all that: for all the talk of the risks and dangerous of illegal internet pharmacies there are amazingly few stories of any actual harm. And, in fact, various random tests of the drugs coming from "illegal internet pharmacies" suggest that, for the most part, they're safe (and frequently appear to actually be what they say on the box). So what is the DOJ protecting us from here? The scourge of more affordable legal drugs?

The bigger issue, however, is the question of secondary liability. I don't want UPS going through my packages to make sure they're not illegal drugs. Perhaps the government showed direct plans and strategies by UPS to attract illegal pharmacies, but from the outside, given the information that's been revealed, it looks like the real problem is why is the DOJ even bothering? If UPS and Fedex are going to have to start checking what's inside packages to avoid getting itself fined again, that's a really bad and dangerous precedent.

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Federal Judge Alex Kozinski Talks About Using Tor To Surf Silk Road & The Armory For Drugs, Weapons And Hitmen

Mike Masnick — Fri, 1 Mar 2013 11:50:00 PST

While I don't always agree with him (who do I always agree with?), like many folks who follow legal issues, Judge Alex Kozinski, the chief judge of the court of appeals for the 9th circuit, is one of my favorite judges. Known almost as much for his ability to entertain as for his clear, well-written (and frequently funny) judicial rulings, one thing that's always been clear is that, unlike some judges, Kozinski is both down to earth and really inquisitive when it comes to understanding how things really work, rather than just accepting common wisdom. Last night, Judge Kozinski gave a lecture at Santa Clara University on "The Two Faces of Anonymity." As I expected, it was entertaining and insightful, with a few Kozinski-esque surprises thrown in.

By far the most entertaining part of the evening was Kozinski sharing (with screenshots) his experience exploring the "hidden web." He claims that when he told his children about the topic of the talk, they told him he needed to explore the hidden web. So, "with some trepidation," he downloaded Tor and dove in, starting out at Silk Road, which still remains the most well known hidden website out there. As we've noted in the past, for all the excitement and press attention Silk Road has received for being a totally anonymous online marketplace used mainly for buying and selling drugs and other illicit goods, it still is a fairly small business. Still, Judge Kozinski detailed his exploration of the market, including checking out various drugs (including many he'd never heard of before). He also looked into the ability to buy forged documents and lots of counterfeit software. From there, he moved over to Silk Road spin-off, The Armory, to see what weapons they had for sale, including 6lbs of C4 explosives. Of course, this is the point that we realize that Kozinski's claims of just having done this recently are probably a fabrication, given that The Armory shut down last summer. It's possible he didn't actually do any of this, but got screenshots from elsewhere online, but there's just something amusing in thinking about Judge Kozinski sitting at home surfing through these sites. He showed a few sites for hiring hitmen, and joked that two of them had such similar language and pricing that he was tempted to report them to the FTC for likely collusion.

He marveled at how much like regular online stores these sites were -- including things like seller ratings -- and compared it to his experiences with eBay. Of course, he also noted that it's entirely possible the whole thing is a front by the feds to track these kinds of things, but if so, he was impressed with the level of detail.

While much of this was entertaining, the point (I think!) was to highlight all of the kinds of things that anonymity enables -- but it wasn't in a necessarily negative or judgmental way (even if he's suggested his concerns in the past). Instead, it was more of a realist approach to what's happening out there and how there are interesting challenges presented concerning both anonymity and privacy -- which he notes are related but not the same thing. To show the difference, he discussed your neighbors across the way, where they may not be anonymous to you, but what they do in their bedroom is kept private from you. Yet, take a random couple in Times Square on New Years Eve doing the same thing -- and they may be "anonymous," but not private at all.

While he did express some concerns about where all this leads, including a dig at anonymous comments online, his biggest concern appeared to be about government abuse thanks to technology. He spent a fair bit of time on the NSA's infamous spy center in Utah, which is supposedly storing a ridiculous amount of information on us all. He pointed out that having that much information in the hands of government is dangerous, and suggested it's likely to be abused. As an example, he pointed to the story from all the way back in 2001 when he and other federal judges discovered that the feds were monitoring their internet usage, something the judges had never been told about.

He explained that the software had been put on the computers to protect the judiciary intranet from being attacked by hackers from China or whatever, but most of the time they weren't doing anything at all, so it wasn't long before the scope began to creep, and someone realized that, hey, if that monitoring software is on those computers, it could also be used to spy on what sites judges were surfing. The judges only found out about it when a judge was called out for his inappropriate surfing habits.

While he didn't say anything explicitly about it, it seems like this should be a pretty clear warning to folks who are supporting laws like CISPA. When you increase information sharing to the government for one purpose, you can almost guarantee that there will be scope creep over time. Someone will point out that "hey, we're already doing this for security, so why not for spying on people...."

Similarly, Kozinski is worried about how all this number crunching and data collection by governments means that people are going to be "targeted" for heightened scrutiny based on some algorithms, even if their activity is perfectly legal. He even noted that he's assuming that his own decision to download Tor and check out Silk Road and other sites probably means that he set off some alarms and may be in for heightened scrutiny. When asked about that later during the Q&A, he admitted that it might just be his own paranoia, but he wouldn't be surprised if it was true.

When asked about how to push back on all this government surveillance, he said that everyone keeps pointing to the courts, and saying that it's their responsibility to limit the government's powers, but suggested that the courts are limited, because it's not clear that anonymity and privacy are really Constitutional issues. Or, he said, if there is a basis for them in the Constitution, it's fairly weak, and could easily be overcome by "other concerns." Personally, I think that he downplayed both the First Amendment's protection of anonymity as confirmed by the Supreme Court, as well as the 4th Amendment's (too often ignored) protection of privacy. Still, he seemed to think that this was really an issue where it was up to Congress to prevent abuses. That's kind of depressing if you remember Congress' recent "debate" and subsequent rubberstamping of the FISA Amendments Act, giving the NSA much more power to spy on Americans with little oversight.

One other bit of useful info: he seemed fairly convinced by Justice Sotomayor's statements on the 3rd party doctrine in the US v. Jones case about GPS tracking. If you don't recall, the 3rd party doctrine basically says that you don't have privacy rights in information that you've left in the control of a third party. That's obviously quite problematic in an age of cloud computing, where all your data is probably in the hands of third parties. The government has been relying on this fact to access all sorts of data with little oversight for quite some time. It's good to see Kozinski hint at the idea that the 3rd party doctrine just isn't reasonable any more in the information era.

There were plenty of other tidbits, but basically it was an interesting discussion of privacy and anonymity, with a strong focus in how the government is collecting way too much information on us all these days. There was also some brief talk of how much information companies are collecting too -- including his apparent uncomfortableness with things like Google Maps' Street View and Satellite View (he joked about how you can see him sunbathing nude if you can find his house). But, for the most part, he seemed to think that this was an area where the government was doing a better job keeping companies somewhat in check.

Oh yeah, and one other amusing tidbit: in talking about how easy it is to track us all due to our mobile phones, he asked how many people had smartphones (or, more specifically, "phones with email on them") and noted that when he talks to lawyers, they all do. He noted that lawyers always had their email near them to respond to clients quickly, because otherwise you get fired, but this cool tool "given to you by work" just shackles you while also denting your privacy. And then he claimed that when work gives him a smartphone, he gets it without a sim and then sells the device on eBay. Maybe he should try selling it on Silk Road next time...

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Senator Hatch Says Global Fund Advocating For Generic Drugs To Solve Healthcare Crises Is Abusing Funds

Mike Masnick — Wed, 13 Feb 2013 12:46:53 PST

We've written a few times about governments around the globe seeking to make use of lower-priced (and often more widely available) generic medicines for responding to serious diseases, rather than sticking with the more expensive name brand. Current international agreements, like TRIPs, allow countries to effectively "opt-out" of promises to respect other country's patent laws for the sake of supplying such medicine and, you know, saving lives. It's pretty clear that breaking the patent on these drugs is quite effective, driving costs down on a massive scale, making this part of healthcare much more cost-effective.

Of course, the pharma companies don't like this at all. So it should hardly be that big of a surprise that Senator Orrin Hatch directly tried to put pressure on Hillary Clinton and the Obama administration to stop efforts to promote more widespread use of generics in the developing world using these methods. The link above highlights that Hatch sent then Secretary of State Hillary Clinton a letter that suggested he's quite upset that the US-funded "Global Fund to Fight AIDS, Tuberculosis and Malaria" was training people in different countries to explore compulsory licenses of drugs or other ways to make use of generics.

Of course, if you just read Hatch's letter (embedded below), you'd be forgiven for being confused. In it, he claims to be outraged that the Global Fund is encouraging various countries to buy more expensive generics of "cheaper" brand name drugs. Huh? In what environment do generic drugs cost more than the brand name? Also, he appears to just be wrong. Part of the data that he based his complaint on comes from a presentation (embedded with the letter) from the Global Fund, in which they have a few graphs showing that (as you would expect if you were anyone but Orrin Hatch) the generic versions are, in fact, cheaper, which is obviously why they were recommending making use of the option.

So, even as Hatch's letter is full of bluster about misspending money, the details actually seem to suggest that they saved money.

In the letter, Hatch also claims that the presentation directly calls on countries to "disregard" the TRIPS Agreement. But, again, the attached presentation appears to tell the opposite story, with a specific call to seek solutions that comply with TRIPs.

Recipients must procure their products in accordance with national and international laws. The Global Fund encourages recipients to apply the flexibilities provided within national laws and in the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property rights (TRIPS)...

In other words, directly contrasting Hatch's claims, the Global Fund appeared to tell countries to comply with TRIPs, but (correctly) noted that there were some exceptions built within the law that allowed them to seek compulsory licensing and the use of much cheaper generics. Still, there may have been some behind-the-scenes maneuvering as well. As the IP-Watch report notes, soon after all of this, the executive director of the Global Fund, Michel Kazatchkine, resigned. The report suggests this was due to US pressure over Global Fund's daring effort to tell developing countries what their international agreements actually allow. Also: the replacement, Mark Dybul, is a US official, likely to make sure that the Global Fund works in the same manner as Hatch would like -- artificially keeping the big drug makers happily without competition and with artificially high profits, even as healthcare in the developing world might suffer.

Incredibly, Hatch actually seems to be arguing that by suggesting developing countries explore generics, it's putting people at risk because... well, there's a gap in the explanation, but it appears to be due to big pharma companies feeling they need such subsidies to make the drugs in the first place. From the letter:

By advocating for developing countries to disregard the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) through issuing compulsory licenses to gain access to Global Fund grants, we are abusing the system. Access to these products is vital to our success in fighting the war on HIV/AIDS and actions inconsistent with patent law such as these will only hinder our ability to work in partnership with the companies that have provided the intellectual property rights to develop generic versions of their products.

Got it? If you're a developing nation seeking to stem the AIDS epidemic by making AIDS drugs actually available to those with the disease, you are are actually decreasing the success of the war on AIDS because [something, something, something] big pharma will take their ball and go home. Of course, there's no actual evidence to support this, and tons of evidence that shows that developing countries who actually set a compulsory license on drugs related to critical diseases, actually do help deal with serious problems. There is no evidence that this suddenly scares companies into not making the drugs at all. They still make plenty of money in the developed world off of those drugs.

Just to summarize, though, an actual US Senator, Orrin Hatch argued that, by having the Global Fund advocate for better, cheaper generic medicines, as clearly allowed under international agreements, that the Global Fund is somehow paying more for medicines (they're not) and convincing big pharma to fail in the war against these diseases (they're not). It's no secret that politicians aren't always in sync with the truth, but this is significantly more blatant a misrepresentation than is normal.

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Court Says Pfizer May Be Liable For Side Effects Of Drug, Even Though Man Took Non-Pfizer Generic Version

Mike Masnick — Wed, 6 Feb 2013 23:57:57 PST

An interesting case in the Alabama Supreme Court has ruled that a man who developed a movement disorder (tardive dyskinesia) after taking a generic version of the drug Reglan can sue Pfizer, the maker of Reglan, even though it did not make the actual generic he had taken (he took generics from both Actavis and Teva, both of whom he's sued as well). This one is a tricky one on the question of secondary liability, thanks to the oddities of the pharmaceutical world. While, naturally, it sounds absurd that Pfizer can be sued for a drug it didn't make, the regulatory world makes it slightly more complicated -- in part because current law says that generic drug companies could not be sued over failures in labeling of risks, because they're basically copying the labels from the brand name manufacturer. Other courts have ruled that the brand name manufacturers can't be sued -- so in theory that could leave the takers of generics with no legal recourse if there were failures to accurately label the drugs they took. Given that, it seems slightly more reasonable to think the brand manufacturer may be more responsible for what's on the label -- but since they can't monitor quality control of the generic, the whole thing seems like quite the legal muddle all around.

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First Big Pharma Company Announces Support For Clinical Data Transparency Campaign: Who's Next?

Glyn Moody — Wed, 6 Feb 2013 00:11:46 PST

It would be something of understatement to say that the spiralling cost of healthcare has become a highly-charged political issue in the US (and elsewhere). But wherever people stand on the funding of medicine, there is an implicit assumption that it works, and is worth even the exorbitant prices that pharmaceutical companies may charge. Sadly, that's often not true.

The reason is that drug approval is frequently based on partial or even misleading evidence from the crucially-important clinical trials that are conducted to check that a new treatment is safe and efficacious. Similarly, prescribing doctors often only have access to incomplete information when they are choosing drugs for a patient. Not knowing all the facts about medicines not only leads to a huge waste of money, since ineffectual or inappropriate drugs are sometimes prescribed, but can have life-threatening side effects. Here, for example, is a recent case involving the pharma giant GlaxoSmithKline (GSK) and its diabetes drug Avandia:

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug's harmful effects.

Here's why that critical data isn't always to hand: companies and researchers can withhold the results of clinical trials even when asked for them. The best available evidence shows that about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely to be brushed under the carpet.

This is a serious problem for evidence based medicine because we need all the evidence about a treatment to understand its risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.
That comes from a site called AllTrials (disclosure: I am on the advisory board of the Open Knowledge Foundation, which is one of the supporters of AllTrials). It has a very simple, but very ambitious aim: The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials -- past, present and future -- on all treatments currently being used.
If doctors have the full facts about all the drugs they can prescribe, they are in a better position to choose wisely. That will almost certainly save both money and lives. Despite that undeniable fact, pharmaceutical companies continue to withhold data from clinical trials, defying a US law that requires them to provide it: Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance.
Of course, it's not hard to see why drug companies don't want all that data out there: it would mean that independent analyses could be conducted, with the danger that they might come to very different conclusions about the efficacy and safety profile of the medicine in question. Against that background of the pharma industry's dogged refusal to cooperate in the opening up of clinical data, this announcement, from the same GSK discussed above, was unexpected: GSK today further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign. The campaign is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs) to help drive further scientific understanding.
Specifically: GSK is committing to make CSRs publicly available through its clinical trials register. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies. From now, GSK will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.

In addition, while there are practical challenges, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
If GSK follows through on those promises, and really does provide all that data in a timely fashion, this is potentially huge. As Ben Goldacre, author of the book "Bad Pharma" about the betrayal of doctors and their patients by drug companies through the withholding of vital information, and a prime mover of the AllTrials campaign, explains: The eccentric position is now not supporting alltrials.net. There is no serious defense for withholding information about clinical trials from doctors and patients. It is simply unethical, and it harms patients.
GSK's move is a breakthrough for the campaign because it negates arguments that it's simply not possible to provide detailed clinical trial information as a matter of course. This means that the pressure will be on the other pharmaceutical companies to follow suit -- or to give the impression they have something to hide about their products.

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Bayer Fights India's Compulsory Licensing Of Cancer Drug By Claiming It Spent $2.5 Billion Developing It

Glyn Moody — Mon, 4 Feb 2013 05:40:46 PST

Back in March last year, the Indian government announced that it was granting its first compulsory license, for the anti-cancer drug marketed as Nexavar, whose $70,000 per year price-tag put it out of reach of practically everyone in India. Nexavar's manufacturer, the German pharmaceutical giant Bayer, naturally appealed against that decision, and the hearing before the India Intellectual Property Appeals Board (IPAB) has now begun. Jamie Love has provided a useful report on the proceedings; here's his summary of what's at stake:

The outcome of this trial, which focuses on the cancer drug Nexavar, is a matter of first impression for the IPAB, and is expected to set precedents on a wide range of issues, including the permissible grounds for granting compulsory licenses, the relationship between the India patent law and the TRIPS Agreement, and the setting of terms and conditions for the compulsory license, including the royalty rates.

Clearly, then, this is a crucially important battle for both sides, and Bayer has started throwing around some huge R&D numbers in an attempt to convince the IPAB that it should be allowed to retain its monopoly in India to recoup those costs: Bayer presented a January 9, 2013 affidavit from Harold Dinter which made the claim that from 1999 to 2005 Bayer had spent "2 billion euros (approximately US$ 2.5 billion) in the identification and development of anti-cancer molecules leading to the successful approval of Nexavar in 2005." Dinter did not provide detailed support for the numbers, but said they were based upon Bayer's general R&D outlays for anti-cancer drugs, including but not limited to Nexavar, and that the estimate was supported by a new December 2012 study by Jorge Mestre-Ferrandiz, Jon Sussex and Adrian Towse, published by the Office of Health Economics (OHE). Despite its name, the OHE is not part of the government, but rather a largely industry funded private consulting firm. The study itself was paid for by AztraZeneca. Dinter and Bayer's lawyer also made extensive reference to the work of Joseph DiMasi, an academic who is also a drug company consultant.
In other words, it's the usual "don't worry about the details, just take our word for it" lack of transparency that characterizes the entire pharma industry. But this $2.5 billion is insanely high, even for an industry that regularly inflates the outlay on drug development by an order of magnitude. As well as the generic implausibility of such a high figure, Love cites a number of specific reasons why it's extremely unlikely. You can read the details in his post, but here's a key section: Bayer's partner in the development of Nexavar is Onyx Pharmaceuticals. Onyx published annual estimates of its R&D spending on Nexavar.

…

Bayer paid for all research from 1994 to 1999 ($26.1 million), and this included research on several compounds in addition to the one now marketed as sorafenib/Nexavar. From 2000 onward, Bayer and Onyx split the R&D costs 50:50, and Onyx's share of the R&D costs were $134.8 million. The outlays on the entire R&D program that lead to the 2005 approval of Nexavar for Kidney cancer were $26.1 + (134.8 x 2) = $295.7 million. Of the $295.7 million, only a fraction was spent on the development of Nexavar for kidney cancer, and some of that benefited from a 50 percent tax credit under the US Orphan Drug Act.

To the put the entire $295.7 million into perspective, ignoring the tax credits, that represents a little more than one quarter of the current global sales for sorafenib/Nexavar, a product that will maintain its monopoly in most markets through 2020.

$295.7 [million] is also just 11.8 percent of the $2.5 billion estimate that Bayer wants the IPAB to accept as its R&D costs.

No wonder that Bayer was unwilling to explain how it arrived at that extraordinary figure. But it's hard to see how the pharma company expects to win this case citing numbers that are basically an insult to the intelligence of India's experts.

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Pharma Companies Try 'DRM' For Drugs As A Ploy To Stymie Generics

Glyn Moody — Wed, 16 Jan 2013 13:19:09 PST

One of the striking features of the drug world is how pharma companies become noticeably more inventive immediately before their patents are due to run out and their drugs are about to enter the public domain. That's because they need to find a way to differentiate themselves from the generic manufacturers that are then able to offer the same medicines for often vastly lower prices.

Usually this takes the form of modifying the formula of a drug slightly, patenting it, and then seeking to convince the medical profession that the new formulation is better in some way. But sometimes it involves more novel approaches, as here:

In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.

But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills' narcotic payloads.

As the New York Times article quoted above reports, having introduced these "tamper-resistant" designs, the pharma companies are now pushing to get a ban on generic versions that lack this feature. If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.

The drug companies have dressed this up as a service to society, but some aren't buying it:

While companies like Purdue Pharma insist the public's health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection. In court papers filed in response to Endo’s lawsuit, the F.D.A. described the company's action as a "thinly veiled attempt to maintain its market share and block generic competition."

There's no doubt that the abuse of painkillers is a significant problem, but according to another recent story, in The Washington Post, alarming levels of addiction to OxyContin and similar painkillers may be partly the drug companies' fault. For instead of warning doctors about this issue, the latter were assured that there were "minimal risks of addiction and dependence" if they prescribed these kinds of drugs for their patients: according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims [about minimal risks] were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.
So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

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Japanese Police Arrest 2Channel Founder Because Users Talk About Illegal Stuff Occasionally

Timothy Geigner — Thu, 20 Dec 2012 11:04:42 PST

As we wrap up 2012, I think it's an appropriate time announce the first annual "Most Incorrect Law Enforcement Action Of The Year" award (yes, I just made that up). While it would be obvious hyperbole to claim that law enforcement in general is somehow inept or evil, it's been a hallmark year for silly LEOs. We once again saw several countries attempt to make it illegal for citizens to film police in action, despite such filming often occurring in public places. We also discussed how the German government whoopsie'd its way into informing the world of all the ways it monitors its citizens. Seriously, if you're going to go all 1984 on us, at least have the capability to not shove it in my face. These are just a few examples we've seen this year.

That said, for the truly deficient aficionado, you just can't beat the Japanese police, who recently announced charges against the founder of 2Channel (the super popular Japanese forum site), named Hiroyuki Nishimura, because some users of the site have been found to discuss illicit narcotics. And it all appears to have stemmed from one nonsense news report on one single little 2Channel post.

Since last year 2channel, Japan’s largest internet forum, has been subject to pressure from Tokyo police. According to a January 2012 post by Avery (2channel Fights Police Pressure, So-Called “Viral Marketers”), the whole police investigation began after Fuji TV aired a sensational news report about drug dealers making posts on the site. The news report was aired only a few days after 2channel users helped organize street protests condemning Fuji TV’s alleged anti-Japanese bias.

"Their evidence for the drug trade was a single post from 2010 that used code words to refer to MDMA, marijuana, and cocaine….investigators are calling 2ch a “hotbed of crime” because moderators did not delete the single post from 2010. (Over 1,800,000 posts are made on 2channel every day.)"

So, let's get the obvious stuff out of the way, because then we can really have fun. 2Channel is Japan's largest internet forum. It's huge. Policing every post on it would be similar to owners of a private beach checking each individual grain of sand on their property. If such forums are going to exist, forum operators need to be protected from these kinds of charges in order to survive. On top of that, just as with Craigslist, dedicated law enforcement officers should be able to make at least some use of the forums themselves for their own activities, but not if they attack the site's owners.

Great, the normal stuff out of the way. Now let me explain why these charges are really stupid.

Nishimura will be charged with abetting drug dealing. However, some twitter users have pointed out that the statute of limitations for the drug law in question is 3 years, and Nishimura sold 2channel more than 3 years ago.

Oops. So charges are being brought against the guy who simply founded the site that someone else may have once used to talk about something illegal, even though he sold the site 3 years ago and the statute of limitations has expired. I'm certain Unites States LEOs will soon be bringing charges against the long-rotting corpse of E.L. Cord, founder of American Airlines, since terrorists used a plane of his to attack the World Trade Center. I mean, they really have no choice at this point, assuming they want to make a late entry into this year's "Most Incorrect Law Enforcement Action Of The Year" award.

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After India, Now Indonesia Introduces Patent Licenses For Generic Versions Of Drugs

Glyn Moody — Thu, 18 Oct 2012 03:17:48 PDT

As we noted a couple of weeks ago, when we wrote about India's moves to issue compulsory licences for the production of generic versions of expensive, patented drugs, the big fear for Western pharmaceutical companies was that other countries might follow suit. It looks like that's happening in Indonesia, where the country's president has signed a decree authorizing low-cost versions of key HIV drugs:

the measure would introduce widespread generic competition and generate major cost savings in the world’s fourth most populous country. The decree licenses patents for a slate of HIV medicines, and represents one of the most robust uses of pharmaceutical patent licensing power by a country since the World Trade Organization 1995 Agreement on Trade-Related Aspects of Intellectual Property (WTO's TRIPS).

Again, the concern for the major drug manufacturers must be that this latest move will encourage even more countries to start granting patent licenses for drugs needed by their populations, but which are currently unaffordable thanks to Western-level pricing. Indeed, it's hard to see what can stop that happening now that India and Indonesia have shown the way by invoking the right of countries to issue compulsory patent licenses, as enshrined in TRIPS.

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Emerging Countries Take Note: Big Pharma's Losing Patent Battles In India

Glyn Moody — Fri, 5 Oct 2012 03:24:32 PDT

Techdirt has been following the important story of the kidney and liver cancer drug marketed under the name Nexavar since March, when India granted a compulsory license for the first time since re-instating patents on pharmaceuticals. Naturally, the patent holder, Bayer, fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost:

Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which is responsible for hearing appeals on patent applications, rejected a petition by German pharma major Bayer AG, seeking a stay on an order of India’s Controller of Patents granting a compulsory licence (CL) to Indian generic drug maker Natco Pharma Limited, for a drug used to treat liver and kidney cancer.

It's quite possible that Bayer will try to appeal to a higher court, but what's noteworthy is that this is just one of several other important pharma cases in India at the moment. For example, the Delhi High Court held that Roche’s patent on the cancer drug Tarceva was valid, but that an Indian generics manufacturer had not infringed on it because it had only been selling a variant of the drug. Another high-profile case concerns the blood cancer drug Gleevec, sold as Glivec in India, whose manufacturer, Novartis, is fighting India's refusal to grant it a patent. Here's the background: The legal dispute in the Glivec case centres around a provision of India’s 2005 patent law, called Section 3(d), which states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." The dispute brings to the fore a fundamental question: what is an "invention"? Or more precisely, how much innovation is required to obtain a patent in India?
Novartis insists that it is not fighting in order to get more money, but to vindicate its "honor". What this probably means is that it is trying to establish the principle that patents can be given for new forms of drugs, even if they provide no enhancement over earlier versions. If it loses the Gleevec/Glivec case, that could have serious repercussions for future patent applications by the company in India.

More generally, this current round of high-profile drug patent cases may well have major knock-on effects in other regions of the world. Western pharma companies are probably worried that their recent failures in India to gain certain patents or block local manufacturers of generics could be repeated elsewhere as emerging countries wake up to the flexibilities within the TRIPS agreement that India is currently exploiting. The Intellectual Property Watch article mentions three nations that are already considering this -- Botswana, South Africa and Swaziland.

An article in the leading medical journal The Lancet agrees that India's growing success might well encourage others:

In trying to limit compulsory licences and avoid efficacy tests on products, the Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage. The TRIPS Agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems facing access to and rational use of medicines in India but the provisions within the country's patent laws, if more extensively and properly applied, should help rather than hinder such access. India's laws and experiences could provide a useful example for low-income and middle-income countries worldwide.

Watch this space.

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Forget The Death-Star Anti-Mosquito Lasers, Here's How Nathan Myhrvold Can Help Tackle Malaria -- And Improve His Image

Glyn Moody — Tue, 4 Sep 2012 12:31:00 PDT

Nathan Myhrvold is trying to rustle up a little positive PR for Intellectual Ventures (IV) by appointing a VP of Global Good (although it's hard to see how anyone lumbered with such a daft job title is going to be taken seriously anywhere.) You can gauge just how touchy Myhrvold is on this topic by his rather waspish response to some commentary on that move.

As Techdirt reported, Myhrvold came up with what he obviously thinks is a winning riposte whenever people criticize IV's business model based on industrial-scale patent trollery. He asks them: "How big is your malaria project?" His point being that IV does does have a malaria project, so this somehow makes up for all the bad stuff it does. There's only one slight problem: that project offers little more than fantasy solutions. For example, here are some details from Intellectual Ventures Lab's malaria page about a cool-sounding "photonic fence" designed to keep out mosquitoes:

The system would create a virtual fence made out of light -- we call it a "Photonic Fence". Light Emitting Diode (LED) lamps on each fence post would beam infrared light at adjacent fence posts up to 100 feet (30 meters) away; the light would then hit strips of retroreflective material (similar to that used on highway signs) and bounce straight back toward the illuminator. A camera on each fence post monitors the reflected light for shadows cast by a hapless insect flying through the vertical plane of light.

When an invading insect is detected, our software identifies it by training a nonlethal laser beam on the bug and using that illumination to estimate the insect's size and also to measure how fast its wings are beating. Using this method, the system can not only distinguish among mosquitoes, butterflies, and bumblebees, but it can even determine whether a mosquito is male or female! (Females are significantly larger than males and have slower wingbeats.) This is useful because only female mosquitoes bite humans.

However impressive all that technology might be, there's the obvious problem that mosquitoes could just fly over these "photonic fences". Perhaps conscious of this flaw, the page describes several other equally ingenious -- and equally impractical -- approaches to tackling malaria including the use of magnets to make mosquitoes explode and an "engineered blood substitute" to draw them away from humans (also useful for regions plagued by vampires, presumably.)

This impracticality rather undermines Myhrvold's taunting of lesser mortals that don't have their own malaria project, since his lab projects seem unlikely to make any significant contribution to combatting malaria in the short term, if ever. Clearly, to tackle malaria in real-life situations, what is needed is not some super high-tech approach that looks good in TED talks, but something rather more simple and effective -- something like this, perhaps:

The University of Cape Town’s Science Department believes that it has found a single dose cure for Malaria.

This was announced by researchers that have been working on this compound, from the aminopyridine class, for several years. Unlike conventional multidrug malaria treatments that the malaria parasite has become resistant to, Professor Kelly Chibale and his colleagues now believe that they have discovered a drug that over 18 months of trials "killed these resistant parasites instantly".

Unlike potentially blinding lasers, the new compound is claimed to be safe, with no adverse side effects. Of course, lots of clinical tests still need to be run to establish that and its efficacity. Then, a way to manufacture and distribute the drug to malaria victims will need to be found. The worry has to be that traditional drug companies won't be interested in helping here, since the drug must be sold cheaply if it is to reach the millions of people most affected by malaria, and that means few if any profits -- not something pharma companies are happy with.

So here's a suggestion. If Myhrvold really wants to burnish the image of Intellectual Ventures through philanthropic activities, he should forget about appointing his VP of Global Good, and drop his fun but useless malaria program. Instead, he and his company should offer to pay all the costs for carrying out the clinical tests of this new anti-malarial drug, and for setting up a large-scale manufacturing program sufficient to treat everyone in the world that has the disease, or is at risk from it. Helping to circumvent problems caused by drug companies' obsession with patents and exorbitant profits would be a truly fitting way to atone for the sins of Intellectual Ventures.

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DEA Gets Lawsuit Dismissed Because It Couldn't Cope With Two Terabytes Of Evidence

Mike Masnick — Tue, 28 Aug 2012 07:13:55 PDT

Catching up on some older stories, Aaron DeOliveira points us to the bizarre news that the DEA sought (and got) dismissal of a case against someone involved in a online pharmacy prescription drug scam (basically prescribing the drugs without ever seeing the patients) because the DEA was sick of storing all of the evidence, both electronic and paper. How much evidence?

More than 400,000 documents and two terabytes of electronic data that federal authorities say is expensive to maintain....

[....] "Continued storage of these materials is difficult and expensive," wrote Stephanie Rose, the U.S. attorney for northern Iowa. She called the task "an economic and practical hardship" for the Drug Enforcement Administration....

[....] The evidence took up 5 percent of the DEA's worldwide electronic storage. Agents had also kept several hundred boxes of paper containing 440,000 documents, plus dozens of computers, servers and other bulky items.

Two terabytes is enough to store the text of 2 million novels, or roughly 625,000 copies of "War and Peace."

None of this makes much sense. You can pick up a two-terabyte drive for a little over $100 (I was just looking to pick up a couple for a backup system). The fact that it can store 2 million novels is meaningless. The idea that it's expensive to store that much seems silly -- as does the claim that 2 terabytes represents 5% of the DEA's "worldwide electronic storage." I recognize that government procurement is a ridiculous process, but if there's any truth to this, then the DEA is even more dysfunctional than originally believed.

As Scott Greenfield noted in the link above:

The revelations from this motion, if true, are amazing and appalling. Given the scope of electronic data involves in investigations, the claim that two terabytes constitutes five percent of the DEA's storage capacity is laughable. It suggests that they're screwing with us, and have no ability to do 90% of the things they claim or we fear they're up to.

Indeed, while we worry about their creating mirror images of hard drives of thousands of computers, or obtaining digital evidence from hundreds of thousands of cellphones, this isn't conceivably possible if the total storage capacity of the DEA is 40 terabytes. It just can't be.

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Google To Help Take On Mexican Drug Cartels

Timothy Geigner — Fri, 20 Jul 2012 16:26:08 PDT

Normally when we talk about Google 'round these parts, it's to discuss issues of privacy and piracy. But, according to an ABC News report, Google is going on the offensive to help take down Mexican drug cartels.

"Eric Schmidt, Google's executive chairman, has taken a keen interest in Mexico, where more than 47,500 people have been killed in drug-related violence since President Felipe Calderon launched an offensive against the cartels in 2006. Schmidt recently visited most of Mexico's most violent cities, Ciudad Juarez, where civic leaders asked if he could help.

"Defeated, helpless, these people have been so hardened in their experience with cartels that they have lost battles and they have lost hope," Schmidt told a conference on international crime this week. "They were looking for a universal hammer to protect them. For me the answer was obvious. It was technology.""

At the conference in California, put on by both Google and the Council on Foreign Relations, a variety of ways technology and Google could help the Mexican authorities tackle their drug cartel problem were discussed. Some of the strategies may raise eyebrows for privacy-minded citizens of any country: sharing real-time intelligence with police, identifying through Google's data how individuals are connected with one another, and even showing links between criminals or corrupt politicians and potentially implicated bank accounts.

But, in my mind, the real winning ideas probably won't raise any of those privacy concerns: creating an anonymous network through which anyone can report drug cartel information or activity, so as to avoid reprisal, and creating community web platforms so citizens can share information about the criminals and publicly chastise them.

If I had to guess, that's where you're going to have the most success. Using technology to empower the police can be a good thing, but using technology to empower the citizenry, that's how you can really have an impact.

Of course, it will take more than Google's help to take down drug cartels, something Eric Schmidt recognizes:

""I think at the end of the day, there really are bad people, and you have to go in and arrest them and kill them," he said."

Still, empowering the Mexican people with technology should produce a step forward in the fight against the drug cartels, and that's a good thing.

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Court Reverses: Paying Competing Drug Companies Not To Compete Is An Antitrust Violation

Mike Masnick — Thu, 19 Jul 2012 03:09:42 PDT

A few years ago, we wrote about a ridiculous situation in which big pharmaceutical companies were keeping prices artificially high by paying other drug companies to delay entering the market with generic drugs. The really scary part about this was that the big pharma companies would abuse patent law to force smaller drug companies into these deals. They'd file a patent infringement lawsuit, where they knew they had no leg to stand on, but the infringement filing forces the smaller generic maker into negotiations, where they often agree to a "license" which includes the delay -- but the money flows in the opposite direction of a typical license. In other words, the whole lawsuit and the license is basically a sham to try to hide the agreement to prevent competition in the market. And, of course, as you probably know, when there's no generic competition, drug makers are able to charge absurdly high prices for their drugs. As soon as there's competition, the price often falls by more than 90%. Thus, the big drug companies have plenty of incentive to buy off the competition like this.

Many people have believed that such deals are clear antitrust violations -- and a lawsuit against big pharma Schering-Plough (owned by Merck) tested this theory, only to be dismissed by the district court. That original ruling really twisted logic in a few knots to come to its conclusion -- and the good news is that, two years later, the 3rd Circuit appeals court has reversed the ruling. The ruling is long, but interesting. It starts out by noting that other court's ruling on this matter seem to take the concept of "patent validity" way too far. As we've discussed in other contexts, patent validity says that you have to assume a patent is valid -- but in these cases, the court notes that this unfairly biases the situation in which the bogus patent infringement lawsuits are filed to extract these "pay-for-delay" deals.

First, we take issue with the scope of the patent test’s almost unrebuttable presumption of patent validity. This presumption assumes away the question being litigated in the underlying patent suit, enforcing a presumption that the patent holder would have prevailed. We can identify no significant support for such a policy. While persons challenging the validity of a patent in litigation bear the burden of defeating a presumption of validity, this presumption is intended merely as a procedural device and is not a substantive right of the patent holder.... Moreover, the effectively conclusive presumption that a patent holder is entitled to exclude competitors is particularly misguided with respect to agreements – like those here – where the underlying suit concerned patent infringement rather than patent validity: In infringement cases it is the patent holder who bears the burden of showing infringement.

The court then discusses the Hatch-Waxman Act, which is at the heart of these disputes, noting that its intent (to increase availability of generics) seems to be the exact opposite of what happens with these pay-for-delay deals. But where it gets interesting is that the court says that having one company pay another to delay market entrance should be seen "as prima facie evidence of an unreasonable restraint of trade." This is definitely a big ruling -- though its potential disagreement with other courts may get this issue over to the Supreme Court before too long.

It's nice to see the court get it right after the lower court seemed so confused by the issue.

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DailyDirt: Better Living Through Chemistry

Michael Ho — Tue, 5 Jun 2012 17:00:00 PDT

Occasionally, we talk about problems with big pharma companies and how they sometimes hinder innovation. There are lots of ways to develop new drugs, and apparently plenty of people out there are willing to ingest experimental drugs for fun (and then maybe eat other people's faces). Here are just a few examples of some innovative folks doing some chemistry.

Underground chemists are making synthetic versions of recreational drugs that are technically legal to possess and sell. This has been going on for years, but recently, there have been increasing political efforts to make these "chemically-similar" drugs illegal. [url]
Amateur scientists are working on all kinds of crazy biological experiments and ideas such as rewriting the DNA of an acorn so that it grows into the shape of oak furniture. The zombie apocalypse might not come from a megacorporation, but from biology experiment gone wrong in a garage... [url]
Albert Hofmann discovered LSD had interesting effects in the 1940s, and he said that it spoke to him: "Don't give me to the pharmacologist, he won't find anything." And lots of people have tried LSD since, including Steve Jobs and Aldous Huxley. [url]
To discover more interesting science-related stuff, check out what's currently floating around the StumbleUpon universe. [url]

By the way, StumbleUpon can recommend some good Techdirt articles, too.

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Generics Drive Down Drug Prices In India, TPP Trying To Stop That

Glyn Moody — Wed, 23 May 2012 20:01:00 PDT

Back in March, we wrote about an important development in India, where a compulsory license for Bayer's Nexavar anti-cancer drug was granted. Bayer, of course, is fighting back:

in its 37-page appeal to the Intellectual Property Appellate Board, Bayer has "demanded the withdrawal of the country’s first compulsory license given to Natco Pharma, arguing that a three-fourths reduction in the price of the anti-cancer drug by another Indian firm has made the permit redundant and its patent itself is vulnerable to being revoked," the Economic Times, India’s leading business newspaper, reported on 19 May. Bayer says CIPLA’s new price "will render Natco’s price unreasonable and defeat the purpose of compulsory licensing," according to the newspaper.

As that shows, there's been an interesting twist in this story. Cipla, another Indian manufacturer of generics, has announced that it too is coming out with a version of Nexavar, pricing it at $125 for 120 tablets. That's even cheaper than Natco's price of $163, to say nothing of Bayer's $5,128 for the same course. A key difference is that India's Patent Controller has granted a compulsory licence to Natco, but not to Cipla. In fact, Bayer has said that it is taking Cipla to court over its production of a cheap version of Nexavar.

Bayer is employing some very strange logic here. On the one hand, it is saying that Cipla's cheaper version of Nexavar means that Natco's licence is no longer needed, and should be revoked. On the other, Bayer is suing Cipla because it has produced Nexavar without the compulsory license that Natco has. Clearly, Bayer hopes to get the best of both worlds -- the revocation of Natco's compulsory licence, and a court ruling against Cipla, which would leave Bayer once more as the only supplier of Nexavar.

Bayer seems to be trying to make that outcome more palatable by emphasizing that it has already reduced the price of Nexavar for some people:

Bayer stresses that to facilitate access for patients to innovative treatments, it has had a Patient Access Programme in place since the launch of Nexavar in India in 2008. Bayer says that this programme, last expanded in April 2012, reduces the price for the monthly treatment with Nexavar for qualified persons to about a tenth of the regular pharmacy price (Rs 280,000 or $5,128) for the complete duration of treatment.

But it's not clear how many patients have actually benefited from this program. And in any case, the reduced price of $512 per 120 tablets is still three times higher than Natco's pricing, which would put it out of the reach of many poorer patients. Compulsory licensing, by contrast, has driven down the price to $163, and maybe even to $125 if Cipla is allowed to offer it too. In other words, the availability of indigenous alternatives has caused the price to drop from completely unaffordable levels to ones that are more realistic for the India market -- exactly as generics are supposed to do: Health advocates and cancer patients are happy that the fight between the big brand-name pharmaceutical producers and local generic drug makers is making cancer drugs cheaper. The vast majority of Indians don’t have any form of health insurance and out of pocket payments continue to be among the highest in the world. Cancer has also become one of the ten leading causes of death in India today. It is estimated that there are nearly 2 – 2.5 million cancer cases at any given point in time in the country.
Against that background, provisions in TPP that will make it much harder for local manufacturers to produce low-cost generics legally are troubling. They represent a clear attempt by the US to prevent the kind of access to vital patented drugs that India's compulsory licensing has permitted. Western pharmaceutical companies and their shareholders may rejoice if that happens, but many of those in emerging economies who are unable to afford life-saving medicines will die as a result.

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DailyDirt: I Want A New Drug...

Michael Ho — Tue, 27 Mar 2012 17:00:00 PDT

Many mind-altering drugs lead to trouble at some point. But what about treatments that help improve memory or intelligence? Forget those energy drinks, serious scientists are working on ways to improve memory and learning skills. Here are just a few examples.

A protein named the brain-derived neurotrophic factor (BDNF) seems to be correlated with exercise and improved memory. But exercise is hard, so there'll be plenty of BDNF pills and 'Flowers for Algernon' situations to look forward to. [url]
Taking drugs like Ritalin and caffeine might provide a temporary boost to mental abilities, but R&D efforts to discover a pill that permanently improves brain function are likely futile. Pharmaceutical companies benefit more from treatments rather than cures, anyway. [url]
Air Force researchers have figured out a way to reduce training time by 50% -- using mild electrical currents delivered to pilots' heads. The technique uses transcranial direct current stimulation (TDCS), and the treated pilots have been reported to say, "I know Kung Fu" in a Keanu-like way. [url]
To discover more interesting articles on the human mind, check out what's currently floating around the StumbleUpon universe. [url]

By the way, StumbleUpon can recommend some good Techdirt articles, too.

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DailyDirt: Tiny Drug Factories

Joyce Hung — Tue, 28 Feb 2012 17:00:00 PST

Brand name pharmaceutical drugs are ridiculously expensive, but how much does it really cost to manufacture a drug? A potentially low-cost method is to use microorganisms -- which are plentiful -- to synthesize chemical compounds. For example, synthetic insulin is now made using genetically modified bacteria. Here are a few other examples.

Are you depressed? You can use open-source DNA code from the Registry of Standard Biological Parts to genetically engineer yogurt bacteria to make Prozac. The process takes 4-5 days, and anyone can purchase the DNA code online. [url]
Researchers at the Salk Institute for Biological Studies have created a strain of bacteria that can incorporate artificial amino acids into proteins at multiple sites. This could be used to engineer bacteria to produce a variety of synthetic chemicals. [url]
Green algae could be a cheaper alternative to bacteria in the manufacture of therapeutic drugs. While bacterial cultures require lots of energy and nutrients to maintain, the algae need only sunlight and carbon dioxide in the air. [url]
To discover more interesting science-related stuff, check out what's currently floating around the StumbleUpon universe. [url]

By the way, StumbleUpon can recommend some good Techdirt articles, too.

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Making AIDS Drugs Affordable With Prizes, Not Patents

Glyn Moody — Wed, 7 Dec 2011 15:41:46 PST

Of all the dysfunctional parts of the patent system, drug patents are arguably the worst, since the exorbitant prices that patent monopolies allow mean that millions of people simply cannot afford medicines that would keep them alive or would improve their quality of life substantially.

One riposte to this criticism is that such high prices are needed in order to pay for costly research, but as Techdirt has noted before, that's just a myth. Another is that even if the system has its problems, there's no other way. But there is. In both the US and EU, the idea of replacing pharma patents with pharma prizes is gaining adherents.

One of the early attempts to do that came from Senator Bernie Sanders. At the time, we were rather sceptical because of the bureaucracy that seemed to be involved in this $80 billion scheme. Now he's back with a slimmed-down version of his idea:

I introduced a bill in the Senate that would test this new approach on drugs developed to treat one disease: HIV/AIDS. The measure (S. 1138) would eliminate legal barriers to generic competition for HIV/AIDS drugs and reward innovation directly, through a $3 billion a year prize fund.

< ...>

The prizes would be funded by the federal government and private health insurers in an amount proportionate to their share of the HIV/AIDs drug market.

Sanders claims the savings would significant: he hopes that the $10 billion US market for AIDS drugs could be supplied at generic prices for between $500 million to $1.5 billion. He also notes other benefits:

It will give larger rewards for drugs that improve healthcare outcomes and smaller or no rewards for duplicative, "me-too" drugs that are medically insignificant. It also would eliminate incentives to engage in wasteful marketing activities. Prize fund rewards will be based on evidence that drugs actually work and work better than alternatives.

Those "me-too" drugs and the huge marketing efforts that have to be put behind them to get them used instead of similar products from competitors are further symptoms of the patent system's failure to promote true innovation. The present scheme still leaves the problem of how to decide when drugs work "better than alternatives," and how much to pay for them, but at least the field has been narrowed down, which should make judgements easier.

As with his previous proposal, Sanders' latest bill doesn't stand much chance of being realized in the current political climate. But it's good to hear a US senator framing the issue in terms of patent monopolies and their distorted pricing:

The cost of the prize fund would be considerably less than the cost of buying drugs at monopoly prices.

Once people recognize that patents (and copyright) are monopolies, with all the disadvantages and abuses that implies, they might want less of them.

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SOPA Will Have Grave Effects On The Health Of Hundreds Of Thousands Of Americans

Lee Graczyk — Wed, 16 Nov 2011 02:41:12 PST

This is a guest post from Lee Graczyk, lead organizer of RxRights, a national coalition of individuals and organizations concerned about the high cost of U.S. pharmaceuticals.

The House Judiciary Committee today is holding a hearing to examine the Stop Online Piracy Act (SOPA), a bill that proposes to address online copyright and trademark infringement by denying services to registrants, owners or operators of Internet sites. There has been much discussion on the technological implications of this bill, but Congress and the media have overlooked SOPA's major health implications--it would take away Americans' access to safe, affordable prescription medications from licensed, legitimate Canadian and other international pharmacies.

No one would disagree that websites illegally distributing "knock-off" goods, which include rogue online pharmacies, are a public menace. However, SOPA's definition of an Internet site that endangers public health (even worse than in its Senate counterpart, the PROTECT IP Act) is so vague and broad that safe, legitimate Canadian and other international pharmacies could be shut-down "in the dark of night."

This is because SOPA inappropriately groups together real pharmacies--licensed, legitimate pharmacies that require a doctor's prescription and sell brand-name medications--and the rogues, who sell everything from diluted or counterfeit medicine to narcotics without a prescription.

This oversight is extremely dangerous for Americans (I am one of them) who rely on legitimate Canadian and other international pharmacies to import safe, affordable prescription medications they need to survive. For example, 90,000 people in Florida alone would lose access to safe, affordable prescription medications because of SOPA.

Each year, hundreds of thousands of Americans import safe, affordable prescription drugs because they cannot afford the same brand-name medications that are sold in the U.S., which cost at least twice as much. Others refuse to pay the exorbitant costs of prescription medications when there is a more economical way that is just as safe.

The bottom line is that pharmacies accredited through organizations such as the Canadian International Pharmacy Association, Pharmacy Accreditation Services and Pharmacy Checker are the "real deal." They sell brand-name prescription medications made by top manufacturers.

A recent study by the Commonwealth Fund highlights the need for drug importation. According to the survey on health insurance coverage, a staggering 48 million Americans ages 19-64 did not fill a prescription due to cost in 2010, which represents a 66 percent increase since 2001.

Americans, especially those without insurance and seniors living on fixed incomes, should not have to make choices like whether to fill their prescriptions or buy groceries for the week. Everyone, including those in the tech community with whom we agree on the overall negative impact of SOPA, should bear in mind the severe health implications of this bill, which would affect the well-being of patients across the U.S.

If Americans don't take action to protect their right to safe and affordable medications, they could lose their access to safe, legitimate pharmacies and, therefore, vital medications they need to stay alive.

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Cocaine Ring Used Universal Music's Interscope Label To Ship Drugs & Cash

Mike Masnick — Tue, 20 Sep 2011 19:01:00 PDT

It's no secret that there was a close connection between major record labels and drugs in the past -- but people keep insisting that's all ancient history these days. So it's interesting to find out, via a federal prosecution of a cocaine ring, the news that the effort apparently hid the shipping of cash and cocaine around the country by using concert "road cases" and shipping them to and from Interscope Records' offices. Interscope, of course, is a Universal Music sub-label, which is home to the likes of Eminem and Lady Gaga.

Department of Justice prosecutors this week provided defense lawyers with shipping records detailing “pickups and deliveries” made at Interscope’s Los Angeles office by a cargo firm that was used to transport the music cases, which were alternately stuffed with kilos of cocaine and upwards of $1 million in cash.

Perhaps, rather than worrying so much about the impact of "piracy," the folks at Universal Music should be paying attention to the drug dealing happening via its own offices. Just saying.

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Sex, Drugs... And Facebook? Moral Panic Police Blaming Social Networks For Kids Being Kids

Mike Masnick — Fri, 9 Sep 2011 07:27:20 PDT

Ah, the moral panic police are out in force yet again. A recent report from the "National Center on Addiction and Substance Abuse" is getting some attention for a study which claims that teens who spend more time on social networking sites like Facebook are five times more likely to drink, smoke and take drugs. The study also found that kids who watch reality shows are also more likely to take drugs as well. And, of course, they seem to automatically assume the causal relationship is in that direction:

"The anything goes, free-for-all world of Internet expression and suggestive television programming that teens are exposed to on a daily basis puts them at increased risk of substance abuse," said Joseph A. Califano, Jr., CASA Columbia's founder and chairman, in a statement.

It seems we have a classic conflation of correlation and causation. You could just as easily suggest that taking drugs, smoking and drinking lead teens to spend more time on Facebook. Or, more likely, it's a third factor. The general type of teen who is more likely to be active on a social network is also more likely to be active in the sort of social activities that teens are involved in -- which (despite some adults' denial) still includes drinking, smoking and taking drugs (sex too, I imagine). But pinning the blame on social networking is silly. I would bet that the same kids probably use text messaging more often. Would CASA also say that text messaging "puts kids at increased risk." Correlation is not causation and since the "National Center on Addiction and Substance Abuse" is based at Columbia University, you'd think that someone there was familiar with this basic concept.

Oh, and... obligatory xkcd:

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Wasn't The PATRIOT Act Supposed To Be About Stopping Terrorism?

Mike Masnick — Thu, 8 Sep 2011 10:30:00 PDT

The PATRIOT Act was all about stopping terrorism, right? We were told that special provisions that ate away at our civil liberties were needed specifically to catch dangerous terrorists -- and that the reason for such an abdication of our rights had nothing to do with simply giving the government more useful surveillance powers. Aaron DeOliveira points us to a fascinating chart that shows how often law enforcement has been using "sneak-and-peek" warrants. These warrants let officials search private property without letting the target of the investigation know. Again, we were told that these expanded powers were needed to stop terrorism. So what have they been used for? Take a look: Yup. They're all pretty much being used in drug cases. Now some might make the argument that it's important to go after drug dealers -- but that's not how the PATRIOT Act was supposed to be used.

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