Can Universities Make Sure That Drugs Based On Their Research Are Licensed Reasonably?

from the probably-not dept

Joseph Franklin has written about how a group of universities have agreed to some basic principles (pdf) about providing drugs to developing nations at reasonable costs (or even free) in the interest of better global healthcare. However, Franklin wonders how well this will work in practice, and why it should only apply to developing nations, and not domestically as well. It's an interesting question, made more complicated by the fact that many drugs have their research started at universities -- frequently backed by government money -- but are later taken over by pharmaceutical companies who have no interest in such principles. I tend to think that such "principles" are nice to speak about, but are rarely effective in actually creating change. I would think that a much stronger argument is showing the economic benefits in keeping people alive. If you could rid some developing nations of certain diseases, you'd be able to open up vast new markets for other industries. Hell, imagine if you could get companies in other industries (food, clothing, transportation, etc.) to pay for drugs for the poor in developing nations, knowing that keeping them healthy will help those nations build their economy so they can start purchasing the same food, clothing and transportation...

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As The FTC Goes After Bloggers, Doctors Making Millions Promoting Drugs With Little Oversight

from the feeling-healthy-yet? dept

Clay Shirky points us to a column from a few months back by Marcia Angell, which explains why clinical research on drugs isn't even remotely trustworthy, as it all-too-often seems to involve doctors who have serious conflicts:

Or consider Dr. Alan F. Schatzberg, chair of Stanford's psychiatry department and president-elect of the American Psychiatric Association. Senator Grassley found that Schatzberg controlled more than $6 million worth of stock in Corcept Therapeutics, a company he cofounded that is testing mifepristone--the abortion drug otherwise known as RU-486--as a treatment for psychotic depression. At the same time, Schatzberg was the principal investigator on a National Institute of Mental Health grant that included research on mifepristone for this use and he was coauthor of three papers on the subject.

Angell notes that this is pretty common:

Indeed, most doctors take money or gifts from drug companies in one way or another. Many are paid consultants, speakers at company-sponsored meetings, ghost-authors of papers written by drug companies or their agents, and ostensible "researchers" whose contribution often consists merely of putting their patients on a drug and transmitting some token information to the company.

And as the relationship between doctors and pharma has gotten deeper and deeper, it means that the results of those all important "clinical trials" -- which the pharma supporters always insist are so important -- are highly suspect:

Because drug companies insist as a condition of providing funding that they be intimately involved in all aspects of the research they sponsor, they can easily introduce bias in order to make their drugs look better and safer than they are. Before the 1980s, they generally gave faculty investigators total responsibility for the conduct of the work, but now company employees or their agents often design the studies, perform the analysis, write the papers, and decide whether and in what form to publish the results. Sometimes the medical faculty who serve as investigators are little more than hired hands, supplying patients and collecting data according to instructions from the company.

In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors' drugs--largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome. It is not unusual for a published paper to shift the focus from the drug's intended effect to a secondary effect that seems more favorable.

And yet the FTC is more worried about a mommy blogger recommending a book that a publisher sent her for free?

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Biologic Drugs Likely To Get Separate 12-Year Monopoly Protection Beyond Patents

from the and-for-that,-we-all-suffer dept

A few weeks ago, we noted that some biotech firms were pushing hard to get a separate monopoly on biologic drugs, that went beyond patent protection, as if that wasn't enough. While we had some thoughtful comments from some industry insiders, claiming that the issue could be more about liability. If that's the case, then deal with the liability question, not the monopoly protections. Either way, Robert McClelland alerts us to the unfortunate news that our elected officials have caved in to what the big pharma companies wanted and agreed to a new plan that would give a twelve-year monopoly on these sorts of "biosimilars." It's still not clear why this is needed at all, other than to wipe out competition and make drugs much more expensive. The two congressional reps who pushed this through were Representatives Anna Eshoo and Joe Barton. This is no surprise from Barton, but Eshoo, who represents part of Silicon Valley should know better than to be increasing monopoly protections.

Oh wait... a quick look over at OpenSecrets.org shows that (take a guess...) the single largest contributor to Eshoo's election campaigns has been (yup) pharmaceutical companies. Oh, and they've already been the largest contributors to her 2010 re-election campaign. And people wonder why Larry Lessig's Change Congress movement is getting attention. Even if she's being totally sincere in her position, how else can you look on this without saying it smacks of corruption with bought-and-paid-for legislation that gives pharma companies an extra monopoly to gain significant monopoly rents at the expense of the public?

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Patents Not Enough Of A Monopoly, According To Biotech Firms

from the say-what? dept

Apparently, a bunch of big biotech firms feel that the patent monopolies they already have over certain drugs aren't enough, and they are demanding Congress enact laws that also stamp out any competition from similar drugs (known, back here in the real world, as competitors). You would think that after centuries of understanding how bad monopolies are for the market that the gov't wouldn't kowtow and simply hand over such things -- but it is. Of course, the biotech firms already have patents, so it's questionable why they also need an additional gov't granted monopoly period to block out "biosimilar" drugs, other than the fact that they don't like competition.

They claim, of course, that they need this exclusivity to recoup their costs in developing the drug. However, the deeper you look at the details, the less true that really is in practice. Much of the really core biotech work is done under gov't grants anyway, and often at research institutes. These private firms pick up the trail later in the game in a lot of cases -- but still get full patent rights. The actual cost of developing these things has been massively overstated, often lumping in marketing costs to R&D. It is true that clinical trials are crazy expensive and a huge burden on biotech and pharma companies, but that's a separate issue. There are numerous proposals about ways to take the clinical trial burden expense away from pharma. Lumping those mandatory gov't induced expenses into basic R&D is misleading. Furthermore, even in the face of competition, time and time and time again, we've seen that the original provider still commands a large and noticeable premium, from which it can easily recoup its costs. This is nothing more than blatant monopoly rents with a Congress too clueless about basic economics to resist.

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Since When Is Driving With Infringing DVDs A Crime?

from the this-is-a-good-question dept

Last year, we pointed out that the RIAA was going around telling district attorneys and other law enforcement folks that they should start looking to see if they could use "piracy" charges as a front to get search warrants of suspected drug houses when there wasn't enough evidence to get a warrant having to do with drugs. It seems that some in law enforcement are following through on that. Michael Scott points us to a troubling lawsuit involving just such a situation. Apparently, narcotics officers were told to try to pull over a certain vehicle on any sort of traffic infraction, on the belief that there were drugs in the vehicle. While there was a tiny amount of marijuana, it wasn't enough to do anything. However... there was a big box of what turned out to be counterfeit DVDs. The guy was arrested and a warrant was issued to search his house -- and eventually he was charged with copyright infringement for the DVDs. The guy argued that the search of his car and house were a violation, but the link above includes an important point by Shourin Sen:

Mere possession of infringing DVDs isn't illegal. You can drive around with a truck full of them. You just can't reproduce or distribute ten or more infringing copies of a copyrighted work which have a total retail value of more than $2,500. If it wasn't the marijuana, what in fact was the Defendant arrested for? And was there probable cause to search the defendants house based only on the possession of material he was legally allowed to carry?

These are all good questions...

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Not Your Every Day Tech Exec Scandal

from the um.-wow. dept

While the good folks over at Valleywag might have you believe otherwise, most tech execs lead rather boring lives. There aren't that many "scandals" that happen around these parts -- and the ones that do happen, tend to be rather mundane. Some stock option backdating and maybe a bit of lying on the old resume, seem to be about as scandalous as it normally gets. But Henry Nicholas of Broadcom apparently decided to go with the more made-for-Hollywood sort of scandal. There is the option backdating issue here, but that's nothing compared to the fact that he's now been indicted for also keeping a warehouse full of drugs which he used for things like putting ecstasy in other tech execs' and customers' drinks, as well as supplying speed, cocaine and pot to tech execs. And then there were the prostitutes. Oh yeah, and the sex lair that leaked to the press last year. There's definitely a movie coming out of all of this one day. In the meantime, though, I think I prefer the Silicon Valley with more mundane executive scandals.

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LA Includes Piracy With Drugs, Gangs, Prostitution And Gambling As 'Detrimental To Public Health & Safety'

from the but-of-course dept

Various laws have allowed local governments to declare specific property "detrimental to public health & safety" when that property becomes overrun with drugs, gangs, prostitution or gambling. However, the entertainment industry's hometown gov't in Los Angeles has now expanded the list to include music and movie piracy as well. Whatever you think of unauthorized copying of content, it's difficult to see how you can, with a straight face, claim that it is the equivalent of property being overrun with drugs, gangs prostitution or gambling.

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Chinese Drug Counterfeiters Even Set Up Fake Government Web Site?

from the it's-the-shadow-fake-gov't dept

There have been all sorts of stories about counterfeit goods and knockoffs made in China. Last year, we even had the amazing story of how counterfeiters had set up an entire fake version of the company NEC. Rather than just knocking off the products, they built an entire fake Chinese version of the company, complete with offices and business cards. By doing so, they were able to appear much more convincing as producing real NEC products. It appears that other Chinese counterfeiters are learning to go above and beyond in trying to make their fake goods appear as real as possible. Reuters is reporting that the makers of a fake diabetes drug aren't just touting the wonders of the medicine, but have created an entirely fake version of China's FDA website in order to make it appear that the fake drug had been approved by the real Chinese Food and Drug administration. Of course, even the official quote from a Chinese FDA official sounds somewhat fake (or sounds like it should appear in The Onion): "This site is definitely not for real. These lawbreakers have got some balls!"

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