A Look At The Testimony Given At Today's SOPA Lovefest Congressional Hearings... With A Surprise From MasterCard

from the they-said-what-now? dept

We already know that today's SOPA hearings for the House Judiciary Committee are totally stacked in favor of the bill. But with the hearings getting underway, we wanted to dive in and look at what's about to be said. Most of the testimony leaked out yesterday, allowing us to spend some time going through it -- it's all embedded below. However, here's a taste of what's going to be said... with some additional commentary (of course).

First up, the most troubling of all: Maria Pallante, the Register of Copyrights (aka, Head of the US Copyright Office). She should be here to defend the public and to make sure that massive regulatory capture by a couple of stagnant industries doesn't happen. But, that's not how the Copyright Office rolls. Instead, her testimony is basically the US Chamber of Commerce's key talking points (perhaps not a surprise, since the main lobbyist at the US Chamber who's in charge of shepherding this bill into law only recently worked at the US Copyright Office). If you had hoped for some reasoned argument about pushing back on the massive excesses of SOPA and the broad definitions, you're not going to get it from Pallante.

It is my view that if Congress does not continue to provide serious responses to online piracy, the U.S. copyright system will ultimately fail. The premise of copyright law is that the author of a creative work owns and can license to others certain exclusive rights – a premise that has served the nation well since 1790. Congress has repeatedly acted to improve enforcement provisions in copyright law over the years, including in the online environment. SOPA is the next step in ensuring that our law keeps pace with infringers....

[....]

The response provided by SOPA is serious and comprehensive. It requires all key members of the online ecosystem, including service providers, search engines, payment processors, and advertising networks, to play a role in protecting copyright interests – an approach I endorse. Combating online infringement requires focus and commitment. It should be obvious that we cannot have intermediaries working at cross-purposes.

In other words, the successful tech industry should be hindered and shackled because my friends in Hollywood are too clueless to adjust their business models. Really?

SOPA is also measured. It appropriately provides much broader tools and flexibility to the Attorney General than it provides to copyright owners. This is a sound policy choice at this time. The Department of Justice has experience fighting online infringers, will use resources carefully, must exercise prosecutorial discretion in bringing actions, and must plead its case to the court and obtain a court-issued order before proceeding. Put another way, while the copyright industries are extremely important (and certainly a point of pride with respect to the U.S. economy), SOPA recognizes that many sectors rely on, invest in, and contribute to the success of the Internet.

Almost none of that is accurate. It is not measured. It is vague, broad and dangerous. The Justice Department's "experience" going after infringers has been to take down websites with no notice based on false info from copyright holders... and then to threaten those who seek to appeal with criminal charges. This is not "using resources carefully," it's government sponsored censorship.

It is for this reason that SOPA puts only limited tools in the hands of copyright owners, and provides the Attorney General with the sole authority to seek orders against search engines and Internet service providers. This is not to say that we should not continue to assess Internet piracy and the impact of SOPA or whether additional measures or adjustments may be needed. Indeed, SOPA assigns ongoing studies to the Copyright Office and the Intellectual Property Enforcement Coordinator for these very purposes. But I do think SOPA provides the right calibration at this time.

First off, the "limited tools" include the ability to completely cut off funding to any website based solely on accusations. Perhaps I learned a different language from Pallante, but that's hardly "limited."

Furthermore, how the hell can she say that this is "the right calibration," when even she admits this issue has not been studied yet? The bill is completely "shoot first, measure later," with no details on how it's effectiveness -- or harmfulness -- will be measured.

As with any legislation, SOPA deserves and can only benefit from a robust discussion. As the Committee works to further improve and refine the bill, I know it will fully consider a variety of perspectives and suggestions, including from my fellow witnesses. This said, I believe that Congress has a responsibility to protect the exclusive rights of copyright owners, and I urge the Committee to move forward with this in mind.

Yes, a robust discussion that leaves out nearly everyone opposed to the bill, and only allows a single party -- one easily dismissed -- to speak about concerns on the bill. A robust discussion that leaves out public interest groups, despite Copyright's entire purpose being for the benefit of the public. This is a shameful bit of testimony from the Head of the Copyright Office, and one that guarantees her a tarnished legacy in her role.

From there, she goes on to defend the US blacklist of sites the Attorney General decides are dedicated to infringement by (1) repeating the US Chamber's debunked talking points, (2) praising ICE's highly questionable domain seizures, which are currently being litigated (a fact she conveniently ignores) and (3) quoting (of course) Floyd Abrams, leaving out that he was paid by the MPAA to give that opinion. Even worse, she quotes the really questionable part of his claim:

It also bears repeating that injunctions are not at odds with the First Amendment. As noted First Amendment scholar Floyd Abrams has observed, they are "a longstanding, constitutionally sanctioned way to remedy and prevent copyright violations."

This is true, but highly misleading. Injunctions are allowed against those infringing. But that's not what SOPA is about. SOPA is about issuing injunctions on innocent third parties. That's what we're concerned about. And for Pallante to ignore that point is really unfortunate.

She then goes on to defend the private right of action to kill off websites based on a single accusation. She claims, laughably, that because the private right of action only leads to injunctions, rather than monetary rewards, there's little incentive to abuse. Wait. Is Ms. Pallante totally ignorant of the past decade plus of the DMCA? The DMCA takedown process also is basically about blocking content and not about monetary relief, and yet it's widely abused, with some estimates suggesting that over 30% of DMCA takedowns are questionable. The problem with SOPA (totally ignored again) is that unlike the DMCA -- which targets the specific content -- SOPA will kill off entire sites.

Even more stunning: rather than suggesting that such abuses may come from copyright holders sending bogus takedowns, she worries instead that payment processors and ad networks may ignore such takedowns -- and hints that if anything, the bill may need refinement on that front. Whoa. It's like an alternative universe where everything is mirrored. Again, we know what happens. We have the less draconian DMCA already and see how widely it's abused. And we see that those who receive takedowns generally abide by them.

Speaking of the DMCA, she pretends -- totally against the text of the actual bill -- that nothing in SOPA will impact the DMCA. This is hilarious. Why would anyone use the DMCA to take down a specific piece of content when they can now kill off an entire site using SOPA? Amusingly, she points to the fact that payment providers and ad networks face no monetary liability under SOPA... but ignores that just two paragraphs above, she was hinting that perhaps the law should be changed to include such liability to make sure they comply. This is the ultimate in cynical, obnoxious politics. Put in that one clause that makes you able to pretend something is reasonable (no monetary punishment!) and then be ready to remove that the second the bill is in place.

Finally, she talks about how "pleased" she is that SOPA turns streaming into a felony. Apparently Pallante would prefer people no longer stream videos any more. Has she even used the internet? Amusingly, she cites YouTube as an example of a legal source for streaming... ignoring the fact that under SOPA, YouTube likely wouldn't have even existed. It's as if she doesn't even understand the bill she's supporting and what it will do to the technology world.

And people wonder why so many Americans think copyright law is a joke? Perhaps they should look at the Copyright boss.

Next, we've got MPAA VP Michael O'Leary. His testimony is really worthy of having been written in Hollywood, seeing as it kicks off with a tearjerker of a story about the poor, poor stunt coordinator, "who depends on the residual payments he earns to help support his wife and three children between productions." Of course, the rest of the world doesn't get to sit back and get a check for work they did in the past, but actually has to keep working to support their families. Of course, how much do random key grips, stunt coordinators and boom mic operators (the favorites for these multi-millionaires to exploit in this kind of way) really make from residuals? It's a lot less than these kinds of testimonies suggest.

O'Leary continues to pull at heart strings, by trying to rope all sorts of other businesses into the movie and TV industry including (I'm not joking) the dry cleaners that serve the cast and crew on location. Apparently, without movies, dry cleaners go out of business. Think of the poor dry cleaners!

Filed Under: copyright, copyright office, hearings, judiciary committee, maria pallante, michael o'leary, sopa
Companies: afl-cio, mastercard, mpaa, pfizer

House Judiciary Committee SOPA Hearings Stacked 5 To 1 In Favor Of Censoring The Internet

from the what-are-they-afraid-of dept

Apparently the folks behind SOPA are really scared to hear from the opposition. We all expected that the Judiciary Committee hearings wouldn't be a fair fight. In Congress, they rarely are fair fights. But most people expected the typical "three in favor, one against" weighted hearings. That's already childish, but it seems that the Judiciary Committee has decided to take the ridiculousness to new heights. We'd already mentioned last week that the Committee had rejected the request of NetCoalition to take part in the hearings. At the time, we'd heard that the hearings were going to be stacked four-to-one in favor of SOPA. However, the latest report coming out of the Committee is that they're so afraid to actually hear about the real opposition that they've lined up five pro-SOPA speakers and only one "against."

Why is the Judiciary Committee so afraid to hear the concerns of the wider internet industry?

The five "pro" speakers are the Register of Copryights, someone from the MPAA, someone from Pfizer, someone from MasterCard, and someone from the AFL-CIO. The choice of MasterCard is deliberate, since Visa is against the bill -- because Visa recognizes that supporting a bill that requires them to cut off customers based on accusations of infringement is going to be a huge burden, and one that isn't good for their own customers.

Furthermore, the "one" against SOPA is going to be Google. This is a strategic choice, because the pro-SOPA folks know that Google is easy to dismiss on this topic, because they'll claim (not accurately) that Google just wants to profit from infringement. Google is already under a lot of scrutiny in Congress, and so it makes it much easier for pro-SOPA supporters to say that "ah, the only opposition is Google." And, yet, that's not true. Companies throughout the tech and internet industries have expressed concerns. Facebook, Twitter, Mozilla, eBay and over 160 startups have all come out against the bill. This isn't "just a Google issue." This is an issue of the entertainment industry trying to change the fundamental legal and technical framework for how the internet has functioned -- and in doing so, creating tons of liability and compliance costs for the part of the economy that is growing and has been creating jobs. Just because Hollywood is jealous, doesn't mean that they should get to use Congress to punish the industry that's doing well.

Either way, it's quite stunning that the Committee has decided to go so far in stacking the deck, and it shows just how unwilling they are to hear the real concerns about the bill.

Filed Under: copyright, fairness, hearings, industry, lamar smith, sopa
Companies: afl-cio, google, mastercard, mpaa, pfizer

According To Pfizer, A Clinical Trial Is A 'Marketing Strategy'

from the our-regional-sales-rep-will-help-you-gather-your-data dept

It seems like only yesterday (but it wasn't -- it was actually June 28th) that we were discussing the pharmaceutical industry and its general abuse of numbers to keep itself afloat. (In a pool full of money.)

Some more drug company ugliness has surfaced in a report published in the Archives of Internal Medicine. Examining documents uncovered during the Franklin v. Pfizer case, researchers came across details of a marketing ploy disguised as a Phase IV trial of gabapentin, a drug used for treatment of seizures and neurological pain:

"The Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)" study was a so-called seeding trial, in which the stated objective was to assess the safety and efficacy of gabapentin, but the actual aim was to increase prescribing of the drug by duping the very physicians recruited to conduct the "trial," according to three medicolegal consultants involved in litigation against the drug's manufacturer.

In the STEPS trial, Parke-Davis recruited 772 physicians to prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were not completely controlled by other drugs. The drug company purposefully recruited "site investigators with little or no clinical trial experience [and] provided insufficient training," and limited enrollment to about four patients per investigator.

The study design was uncontrolled and unblinded, and its rigid titration protocol led to the exclusion of 87% of the study subjects. One institutional review board that twice rejected the STEPS application to be conducted at their medical center stated that "the entry criteria and outcome measures are too vague to allow any scientific conclusions to be reach[ed]." Parke-Davis sales representatives collected and recorded individual subject data. In a clear example of data tampering, they not only attended epilepsy patients' office visits (under the guise of "shadowing" the clinician), but also actively promoted the use of Neurontin and blocked the use of competing medications, particularly lamotrigine (Lamictal), at those visits. They also rewarded participating investigators with free lunches and dinners.

In addition(!) to the data tampering, exclusionary tactics, unethical recruitment practices and low-level bribery, the researchers also found that Parke-Davis' (a subsidiary of Pfizer) own internal documents referred to STEPS as "a marketing strategy" and that the trial's findings were secondary to "increasing market share in new prescriptions":

"Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it," according to Dr. G. Caleb Alexander. As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report.

When contacted about its ethics breach (an understatement along the lines of the "Titanic's hull breach"), Pfizer spokesman Christopher Loder responded with a canned response that he quite possibly copied right off Neurontin's (gabapentin) promotional pamphlet:

"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than 2 decades and there is an extensive body of publicly available literature on its safety and its use."

True that, I suppose. But at this point you can add "as well as a growing body of publicly available literature on its unethical testing procedures and another in a long series of black eyes for the pharmaceutical industry" to the end of that little blurb any time you want, Chris. "Now" would be good.

Filed Under: clinical trial, marketing, pharmaceuticals
Companies: pfizer

Pfizer, Novartis & Eli Lilly Received A Bunch Of Illegal Pharma Patents In India

from the jacking-up-the-price-on-known-medicines dept

As you may or may not know, India only recently changed its patent laws (under sever pressure from foreign countries and pharmaceutical companies) to allow pharmaceutical patents. Before that, pharmaceuticals (for the most part) were unpatentable there. Of course, contrary to what patent system supporters would tell you, India had a thriving pharma industry. Yes, a lot of it was in generic drugs, but according to patent system supporters if people can just copy each other, no one will even bother to get into that business. Reality shows that wasn't true. But, of course, the big pharma companies were quite upset by all of this, and got their governments to put pressure on India to "join the world community." In 2005, India's new patent laws went into effect, and while the results of all of this are still being analyzed, one thing that politicians smartly put into the law were sections 3(d) and (e), "which restrict protection being granted to already known and long-ago patented drugs and their combinations." This upset pharma industry sympathisers, but it's hard to fathom who could reasonably be against such a rule. You simply should not be able to patent things that are already known or patent the simple combinations of drugs that are already known. This is just common sense to prevent pharmaceutical firms from getting monopolies on drugs already out there.

However, Jamie Love points us to the news of a new report that found that the Indian patent office has gone against this law and issued such patents quite frequently and, no surprise, the main recipients are among the world's largest pharma companies, including Pfizer, Novartis and Eli Lilly. Is it any wonder that they've all been pushing to dump sections 3(d) and (e) all along? Remember, pharma patents are not about drug discovery, but about jacking up the prices on drugs.

Filed Under: india, patents, pharma
Companies: eli lilly, novartis, pfizer

How Pfizer And The US Gov't Set Up A Fake Subsidiary To Take The Brunt Of Lawsuit Over Falsely Marketed Drugs

from the don't-you-feel-healthy-now dept

The pharmaceutical industry is a huge mess, which has little, if anything, to do with making people healthy. The way the system is currently designed, if it's more profitable for a pharmaceutical company to put you at greater risk, it will do so. And sometimes the US gov't will help them brush it under the rug. Reader Bill Pickett points us to a recent investigative report concerning the big, high-publicity lawsuit the US gov't filed against Pfizer, after the company blatantly went against FDA approvals and marketed a drug for all sorts of alternative uses, which the FDA had specifically noted could be dangerous and could put people at greater risk.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain. Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe....

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.... But an internal marketing plan called for training physicians "to serve as public relations spokespeople."

Where the story gets scary is in what happened when all this came out. Federal officials announced a criminal case over this, but they didn't actually sue Pfizer directly. Instead, they sued a (not kidding) subsidiary of a subsidiary of a subsidiary of a subsidiary of Pfizer, which was basically set up just take the brunt of this lawsuit:

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.

But it was only that last one, Pharmacia & Upjohn Co. Inc., that was sued -- and the report also notes that this company just happened to be set up the same day that Pfizer and federal officials worked out a deal for it to plead guilty -- even though it, as an entity, hadn't done anything.

Why did they do this? Well, if Pfizer itself had been found guilty then it would be barred from Medicare and Medicaid, and prosecutors figured it would effectively close down Pfizer -- and Pfizer was deemed "too big to fail" like that. Why? I have no idea. If the company really did have to close down, it seems likely that others would have picked up the company's various products -- and perhaps done so without putting people's lives at risk.

Really, the problem here is the way the entire system is set up. The FDA requires expensive and involved clinical trials. This is very good, because we want to make sure that any drugs actually do what they're supposed to do, and don't have serious side effects or cause even worse problems. But, the system is currently set up so that the pharmaceutical company itself is in charge of paying for and running those clinical trials, which creates two very problematic situations. First, it gives the company all sorts of incentives to fudge the results or to pretend the results said something different than they really did (see the example above, or Merck with Vioxx) and second, it contributes to the "expense" that a drugmaker can claim comes from developing a new drug, which is part of why it demands patent rights. But if you break out the costs of the clinical trials, the marketing-hidden-ad-development-costs, and the amount of research that's actually funded by gov't grants -- you find that pharmaceutical firms really aren't spending nearly as much as they claim. A big part of the issue is the clinical trials, and that's leading to all sorts of questionable behavior. In the past, some have suggested that such trials should be conducted by the gov't, rather than by the pharma companies themselves. While I'm not sure that's the answer, it's pretty clear that the existing system is not working, if our end goal is to make people healthier.

Filed Under: off-label, pharma
Companies: pfizer

Pfizer Sues Viva Viagra Rocket Crackpot Over Trademark

from the you-just-got-him-a-lot-more-attention dept

It's amazing that companies still don't recognize when it's probably best to shackle up the lawyers. A guy in New York who drove around Manhattan with a 25-foot-long fake missile with "Viva Viagra" painted on its side, has been sued by Pfizer, the maker of the drug Viagra for trademark infringement. It's questionable how Pfizer convinced a judge that this is use "in commerce," but apparently it worked as a judge has barred him from driving around with the missile any more. The bigger question, though, is why bother. All this lawsuit has done is draw a lot more attention to this guy and his faux missile. Pfizer's claim that people might be confused into thinking this is an advertisement for Viagra, and that could harm its brand, seems like a long shot at best, but apparently it convinced the judge. Oh, and in case you were wondering (we know you were) why this guy was driving around with the rocket, we'll let him explain: "Once in a while you want to have fun, and that's what it's all about: fun." Don't worry, though, he may end up being back with some other faux rockets, as apparently he's got a few more, including the "Obama-Oh Mama" and the "Viva McCain," which recently got him detained for a few hours by the Secret Service when he drove them around Washington DC.

Filed Under: crackpots, trademark, viagra
Companies: pfizer