Putting Lives Before Patents: India Says Pricey Patented Cancer Drug Can Be Copied

from the hello-compulsory-licenses dept

India has an interesting relationship with pharmaceutical patents. In 1970, India did away with drug patents entirely, believing it would help create a domestic drug industry. And it worked. As we discussed in the past:

2,237 licensed drug manufacturers in 1969-1970 grew to 16,000 by 1991-1993, production of drugs grew at an average rate of 14.4% per year from 1980 to 1993, India became a net exporter of pharmaceutical products, and the market share of foreign multinational corporations (MNCs) dropped from 80-90% to 40% (Fink 2005). In 1995, six of the top ten pharmaceutical firms in India were domestic, and employment in the sector had reached half a million people

Now, remember how people say that without intellectual property, industries protected by those monopolies collapse? Yeah, the opposite happened in India. And yes, many were producing generic versions, but not all of them were. Either way, despite all of this success, the international community, pressured by the big pharmaceutical firms, cracked down on such practices, and demanded that if anyone wanted to join the WTO -- an important organization for large countries to be a part of -- they had to recognize pharmaceutical patents as per the TRIPS agreement. India finally did so in 2005.

However, one key point in TRIPS that developing countries such as India and Brazil have paid close attention to is the fact that they can force a compulsory license on a drug patent holder in the interest of public health.

For the first time since re-instating patents on pharmaceuticals, India has granted just such a compulsory license, covering a kidney and liver cancer drug marketed under the name Nexavar. Indian generic drug company Natco requested a license, noting that Nexavar was in short supply in India and exceptionally expensive. A typical dosage costs around $70,000 per year in India -- something Bayer says is necessary to recoup the drug's R&D costs. However, reports show that it cost less than $300 million to develop this drug (not to mention that the US government subsidized the process) and Bayer has already made billions selling the drug around the world. In a detailed ruling (pdf and embedded below), India's Controller of Patents (nice title) granted Natco the right to make the same drug, requiring it to sell it at a significantly lower price than Bayer sells Nexavar for, and then pay back to Bayer a 6% royalty rate (which is actually at the high end of what the UN recommends). Natco has to make the drug itself and can't name it Nexavar, make it look the same or even state that it's the same as Nexavar -- but it can make its own version of the drug and sell it, and the license lasts the life of the patent. Bayer can and almost certainly will appeal, but this is going to be interesting to watch for a few reasons.

The real question here is how the US will react to this. The Obama administration has been trying to exempt drugs that treat non-communicable diseases (such as cancer medication!) from such compulsory license rights. In the meantime, the big (non-Indian) drug companies have been working hard to lock up the Indian drug market with patents. Not surprisingly, the Obama administration and the big drug companies have a cozy relationship when it comes to dealing with patents in India.

It's likely that you'll start to hear some rumblings from the US government about how this kind of ruling is a "problem" and how India isn't "respecting" international patent law. Expect to see diplomatic pressure placed on India to put limits on its compulsory licensing program, and potentially even noises about how India has to change its patent laws to "update" them and "harmonize" them with the world. Also don't be surprised if stuff like this leads India to jump up the charts on next year's Special 301 reports from the USTR, which list "naughty" countries. It's probably too late to make it into this year's list for this particular move. Is it really any wonder that India is so worried about ACTA? It knows that ACTA is entirely about ratcheting up enforcement, without any exceptions for things like this where something as important as saving lives comes into play.

Filed Under: cancer, compulsory license, health, india, nexavar, patents, pharmaceuticals, trips, wto
Companies: bayer, natco

Tobacco Companies Think Their Trademarks Are More Important Than Your Health

from the who-needs-lungs-anyway? dept

Back in January of this year, Techdirt reported on tobacco companies suing a local Australian importer of their products for covering up part of their logos with a mandatory health warning. At the time, a spokeswoman for the company involved, British American Tobacco, said:

As the matter is currently before the Court, BAT is unable to comment other than to say that this is a further demonstration that we will take all necessary steps to protect our valuable intellectual property.

Given that stance, it will come as no surprise to learn that tobacco companies are now threatening to take on the European Commission as well:

EU Health Commissioner John Dalli will face legal action if he tries to reproduce Australia's plain-packaging proposals for cigarettes in Europe, a tobacco industry representative warned this week.

The approach is the same as in Australia:

One likely focus of attack is intellectual property rights, since plain packaging has a smothering effect on companies' logos and trademarks.

I'd like to think that the word "smothering" was taken verbatim from some tobacco company representative, because it sums up nicely the industry's attitude: that any breathing difficulties or respiratory diseases that you may develop as the result of smoking pale into insignificance compared with the outrageous "smothering" of their logos and trademarks.

That's a particularly callous attitude, because those logos and trademarks are only valuable to the degree they have been attached to products that have caused death and disease: the "best" brands are those with a track record of selling – and hence killing – more people than rival products. In effect, the tobacco companies are complaining that all their hard work getting people addicted and smoking themselves to death will be wasted if the plain-packaging proposals for cigarettes are implemented.

The cynical posturing of tobacco firms as the victims in these continuing attempts to undo and avoid the social harm they cause underlines once more how easily intellectual monopolies can be twisted for purposes far from any original justification they may once have had. Patents can kill: so, it seems will trademarks, if tobacco companies get their way.

Follow me @glynmoody on Twitter or identi.ca, and on Google+

Filed Under: health, smoking, tobacco, trademarks

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

from the conflating-legal-and-rogue-foreign-pharamacies dept

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.

Filed Under: canada, drugs, health, healthcare, pharmacies, sopa
Companies: rxrights

Report Commissioned By EU Parliament Members Shows ACTA Will Increase Health Risks Worldwide

from the signing-on-to-kill-people dept

The members of the Green Party in the EU Parliament commissioned a report to look at the public health impact of ACTA. A draft of that report has been released and it warns of potentially severe negative impacts on public health. At issue: it will force member countries, including developing nations (which even WIPO has admitted are better off with more lax patent rules in order to deal with public health issues) to ratchet up enforcement of patents. Thus it is likely to "negatively impact public health worldwide." The report also points out that part of the problem is the secretive nature in which ACTA was negotiated, in which those who would have warned them of these public health problems were excluded from the negotiations. Furthermore, the report notes that the process ignored nine specific demands from the EU Parliament for transparency. The whole thing is a condemnation of ACTA, and should raise serious questions about why any country would sign on.

Filed Under: acta, health

Public Health Official Forced To Shut Up On Twitter, Blog For Daring To Speak Honestly

from the real-names? dept

We've been discussing lately the importance of allowing for pseudonymity, rather than requiring real names, and Todd McDermid points us to another reason why pseudonyms can be useful online. Apparently a guy named Rene Najera has been blogging and tweeting about epidemiology while at the same time being employed by the Maryland Department of Health and Mental Hygiene. Apparently, he was quite good at it, and many folks found his posts and tweets to be useful and informative.

However, he recently got into a Twitter discussion in which he defended vaccinations. I recognize this is a touchy subject to some, but only to those who don't pay attention to what the science actually says (or those who ignore that the main report anti-vaccination folks use was later found to be fraudulent). Given the serious health problems created by parents now refusing to vaccinate their children due to clueless anti-scientific fear-mongering, you would think that a government Department of Health would be thrilled that one of its employees was defending vaccinations and talking back to someone who was arguing against vaccines.

Instead, however, it appears that after the guy he was arguing with sent a barrage of emails to higher ups at the agency, Najera was told to stop "all social networking activity related to public health."
Now, it seems there are two issues here. One, as the article points out, this shows yet another situation where the ability to blog/tweet/etc. pseudonymously might help. If Najera was doing that, the person he was debating with wouldn't have been able to bombard his employer. That said, neither platfrom that Najera seemed to mainly use (Twitter and Blogger) does require real names, so he could have gotten away with being pseudonymous on those platforms (and perhaps will come back some other time doing so).

I think the bigger issue is that a Department of Health would reprimand him for such actions and tell him to stop speaking about public health issues. Does the Department of Health really prefer that the actual experts stay out of these discussions, leaving them to those who aren't informed?

Filed Under: epidemiology, health, maryland, real names, rene najera, speech, vaccines

'War' On Fake Drugs Really An Excuse To Boost Big Pharma; Putting The Poor At Risk

from the realities-of-patents dept

We've pointed out similar things before, but Oxfam has come out with a new report, claiming that the claims from developed nations about the need to fight "fake drugs," is quite frequently really just an excuse to protect big pharma firms from generic competition. No one is denying that actual fake drugs can potentially be harmful. But, the problem is that the various efforts, including ACTA, to deal with the issue often lump together actual dangerous fake pharmaceuticals with drugs that are simply cheaper but perfectly safe. Oxfam would like to see a legitimate strategy for getting the real fake drugs out of the market, but says the current strategies are all about boosting patent protections, increasing prices for the poor and developing nations and better protecting big pharma against upstart competitors.

The European Union and the United States continue to focus almost exclusively on eliminating counterfeit medicines which form only a small part of this public health problem -- but which are a serious concern for their multinational companies. They have used the crisis in medicine quality in developing countries as an excuse to push for new intellectual property rules that will boost the profits of pharmaceutical giants at the expense of affordable medicines for the poor.

Of course, this becomes important when you realize that ACTA was specifically designed to pressure developing nations into adopting these types of new, more stringent patent and copyright laws. Oxfam is hoping that those countries won't be bullied:

At a time when poor countries struggle to ensure that their populations can get affordable, quality medicines it is outrageous that rich countries and drug companies are pushing 'solutions' that will do more harm than good to patients and public health. It is critical that poor countries ignore rich-country pressure, and focus instead on solutions that will ensure both quality and affordability of medicines.

Filed Under: acta, counterfeits, drugs, generics, health
Companies: oxfam

Doctors Against Patients Having Direct Access To Test Results

from the too-much-information-access-makes-the-gatekeepers-angry dept

The title of this article is a tad melodramatic, claiming "Big Brother doctors say patients don't need to see their imaging test results," but the conclusion from a study of a small sample set of radiologists and referring physicians is that these medical professionals are against empowering their patients with their own information.

This isn't too surprising knowing that the entire healthcare system is wrought with ill-conceived ideas against efficient and ready access to patient health records.

Physicians with a "Big Brother" mindset apparently think people having imaging tests are incapable of dealing with the outcomes without suffering from so much anxiety they must be protected from seeing the results.

It's not clear exactly that this attitude is akin to an Orwellian state, rather than simply an elitist mindset.  Many "experts" feel that people outside of their field have no business reviewing their work (look at the commenters on Techdirt who claim others should not comment on music/patents/laws/newspapers if they aren't a musician/inventor/lawyer/journalist).

The attitude of these physicians is just one reason of a whole host as to why the healthcare system is one of the last industries holding out against the IT revolution.  The argument that patients will freak out being exposed to the core information that leads to diagnoses is ridiculous.  If someone is going to be overly anxious, it isn't because they have information; they'll be anxious because they have symptoms and a diagnosis, but little-to-no information.  They'll be anxious because the medical industry is unwilling to have a two-way conversation with the patient themselves.

There are many examples of this elitism when it comes to sourcing and analysis of information. Why is it that experts fail to recognize that more points of view have a greater opportunity for catching errors and bringing different perspectives to the forefront?  In addition, bringing the patients into the conversation gets them involved in their own health stories, leading to many long term benefits and ultimately lower healthcare costs.  But maybe this is another one of the reasons the healthcare industry is unwilling to change?

Filed Under: doctors, health, medicine

More Bands Look To Give Reasons To Buy

from the fun-to-see dept

I have to admit, it's been really fun to watch various bands experiment with neat new ways to give people real reasons to buy -- each one different than the last, but each one equally as creative. What's really cool, too, is how many different musicians (both well-known and not so well-known) have been reaching out to us lately, to share their own experiences, and to talk about how this site and the various talks I've given have inspired them to experiment further. It's really humbling to see so much creativity in action. Here are two more examples.

The first is that the band the Flaming Lips are offering both free studio downloads with any concert tickets, but also a promise that they'll send you a link after the show you attend to download that recording as well. The band is clearly recognizing that it's the concert ticket that matters, and the actual music just makes that ticket more valuable (infinite goods increasing the value of scarce goods... where have we heard that before...).

Then there's the band Health, who has a new album coming out, and in order to convince people that it's worth buying the actual album, they've put special prize tickets in 66 of the albums. The tickets grants the buyers certain unique prizes, including the grand prize of a weekend in LA to hang out with the band (including round-trip flight, and hanging out with the band at an amusement park and the zoo). Other prizes will get you (among other things):

personal gifts, t-shirts, locks of a band member's hair, fur from a band member's cat, and posters or records signed by the band in their own blood.

After that, there are a bunch of other oddities:

• We will get steadily inebriated with you over i-chat while working on a project together
• A historical themed phone call from the band
• A recording of BJ (band member) covering a 90's song of your choice
• A recording of a short story read by a band member
• We'll personalize your voicemail greeting
• A bouquet of flowers from the band
• An astrological consultation with Jupiter's mother
• A copy of John Famiglietti's student film
• An uplifting phone call from Health's manager
• A personality test hand completed by a band member
• A bag of Jupiter's cat hair, plus a photo of her
• BJ's old little league jacket
• A childhood toy
• Knitted scarf made by Jake's Mother
• Band member fingerprints
• Mixed tape/cd hand decorated by the band
• Health's high school band's cd mixtape
• A painting by John's mother
• Learn a magic trick from our manager via video chat
• We conference crank call a prominent indie musician together

In many ways, this is like Josh Freese's unique offering, but rather than getting people to buy the big prizes, you just buy the album with a chance to win those packages. Yet again, another band having fun, connecting with fans and giving them a reason to buy. Hmm... I wonder if these ideas can inspire more options for our own little CwF + RtB experiment.

Filed Under: flaming lips, health, reasons to buy

Online Gamers More Physically Fit Than Average?

from the wonders-never-cease dept

It's been a good week for video gamers and a bad week for stereotypes of video gamers, apparently. Earlier we wrote about a study talking about how video gamers were actually quite social, and now a new study suggests that online gamers are more physically fit than your average American (perhaps not saying much). No one seems to think that there's a causal relationship here, as it may just be that video gamers tend to be wealthier and more educated -- who also tend to be in better shape. There's also the issue that this appears to be based on self-reported stats, which may not be that accurate. Still, it appears that studies are starting to chip away at the stereotype of the overweight, social loner video gamer.

Filed Under: fit, health, video gamers, video gaming

ER Doctors Warn About Walking While Texting; When Will We Start Seeing Laws?

from the they're-coming dept

Anyone want to take a guess on when we'll see the first laws proposed to ban the practice of walking-while-texting? We've already seen a few proposals that would ban walking and talking in a crosswalk. And, to add some fuel to the fire, some ER doctors are warning people who walk and text at the same time that it's risky behavior. The doctors say they're seeing a rise in reports of people walking and texting at the same time, leading to some sort of injury, including two people who were hit by a car after paying more attention to their phone than oncoming traffic. Since technopanics always seem to start with a news article, just wait for someone to propose a law against this -- rather than insisting that perhaps it's time to institute a little common sense. Update: Apparently, I'm too late. At least one state has already proposed just such a law.

Filed Under: doctors, health, technopanic, texting, walking