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Antibiotics, R&D and patent reform

gram stained Staph aureus

I followed the link from Derek Lowe’s blog, In the Pipeline, to this abstract of a paper that was published in May of this year  about the dearth of antibiotics in big pharma’s pipeline:

The world is running out of antibiotics. Between 1940 and 1962, more than 20 new classes of antibiotics were marketed. Since then, only two new classes have reached the market. Analogue development kept pace with the emergence of resistant bacteria until 10-20 years ago. Now, not enough analogues are reaching the market to stem the tide of antibiotic resistance, particularly among gram-negative bacteria. This review examines the existing systemic antibiotic pipeline in the public domain, and reveals that 27 compounds are in clinical development, of which two are new classes, both of which are in Phase I clinical trials. In view of the high attrition rate of drugs in early clinical development, particularly new classes and the current regulatory hurdles, it does not seem likely that new classes will be marketed soon. This paper suggests that, if the world is to return to a situation in which there are enough antibiotics to cope with the inevitable ongoing emergence of bacterial resistance, we need to recreate the prolific antibiotic discovery period between 1940 and 1962, which produced 20 classes that served the world well for 60 years. If another 20 classes and their analogues, particularly targeting gram-negatives could be produced soon, they might last us for the next 60 years. How can this be achieved? Only a huge effort by governments in the form of finance, legislation and providing industry with real incentives will reverse this. Industry needs to re-enter the market on a much larger scale, and academia should rebuild its antibiotic discovery infrastructure to support this effort. The alternative is Medicine without effective antibiotics.

Imagine a world without effective antibiotics.  {{shivver}}

Note that the abstract says that the industry could be developing “another 20 classes and their analogues“.  To the public, those analogues might look an awful lot like “me too” drugs.  But that’s ok in this area because bacteria mutate at such a good clip that a moderately modified analogue could seriously throw them off kilter.  So, while it is important to also develop drugs that hit different bacterial targets, the analogues are still very necessary and important.

It’s not like there is a shortage of projects that the nation’s laid off overeducated geeks could be working on and like I said before, if the big pharma entities want to pass on antibiotics because they are too expensive and litigious, there are more than enough of those geeks who would happily work for the government for decent wages commensurate with the level of difficulty of our work.

What I’m worried about is patent reform.  There are proposals right now that would reform the patent system so that the patent goes to the person who files first and not the first to innovate.  The issue is of special importance to the software and cellular data industry who are getting tired of being sidelined by patent trolls.  But what if you’re a tiny biotech that just spent your kid’s college fund and granny’s nest egg discovering a potential drug?  On the surface, this seems very fair until you realize that many entrepreneurs, some of them involuntarily liberated from big pharma, don’t have large departments of expensive patent lawyers they can call upon to file an air tight patent.

Getting to the first to file stage may be close to impossible for many small biotechs to achieve without making a deal with a very big devil who is making them an offer they can’t refuse.  It could seriously dampen any enthusiasm for drug discovery in small companies especially if those companies are doing research in therapeutic areas that big pharma has abandoned like antibiotics and CNS drugs.

I just wish I had the confidence that the Congress members who are reviewing the reform legislation knew what they were doing and were committed to making the system fair for the little guy.  At the very least, we should study whether the “first to innovate” patent structure leads to more innovation than the “first to file” system of other countries.   What may save social media may end up causing a lot of infections down the road.

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While NJ struggles with flood waters the White House tells us how to observe Sept 11

We’re still drying out here in central NJ. Route 206 now appears passable but Bound Brook, Manville, parts of Somerville and Neshanic Station are still flooded. I took a ride around town yesterday to see the extent of the damage. Despite the water in my basement (which didn’t even happen during Floyd in 1999), my area of town doesn’t flood. I have a big retention basin next to my house. I’ve seen that sucker fill to nearly overflowing but my basement is still dry. I think the power failure contributed to the watery basements because no one’s sump pumps were working.

But there are still parts of the area that are inaccessible. I couldn’t get into Neshanic Station. There’s a bridge over the South Branch where the water overflowed the top of the road bed in Floyd. That was pretty impressive. I’ll try to get some pics when the road opens to give you an idea of how high the water was. Parts of Manville and Bound Brook are under water, again. After Floyd, there was a $130 million flood control project built to prevent it from happening again. The water level this time was the same as with Floyd, which makes me wonder how much worse it could have been. News choppers have been whump-whump-whumping overhead for the past couple of days but roads to that area are blocked so no pics. I still have no Internet connection.

Meanwhile, back at the NYTimes, it looks like the editorial board has finally turned on the Obama administration. Maybe that was scheduled to happen anyway but they’re getting an early start. I can just picture some editor dude in a pinstripe Oxford, sleeves rolled up, tie loosened, peering over his glasses at his calendar watch, “Well, it’s a week before Labor Day. It’s a little early to be pulling the trigger but what the hell. The honeymoon is over and it’s good copy when he loses his cool.”

So, this twist of the knife has to do with the White House instructions to all of us on how we should commemorate 9/11 , because just like Michelle assumes we don’t know that fresh vegetables are good for our children, and the Obama operatives assume we haven’t figured out that the Lily Ledbetter Law hasn’t significantly improved our working lives, it also assume that we have NO Idea who caused the terrorist attacks on 9/11 or what the country’s response to it was. For those of you who have been asleep for the past 10 years, it was Al Qaeda and the country reacted with the equivalent of anaphylactic shock.

But take a look at how the piece is written. I find it very telling:

” The White House in recent days has quietly disseminated two sets of documents. One is framed for overseas allies and their citizens and was sent to American embassies and consulates around the globe. The other includes themes for Americans here and underscores the importance of national service and what the government has done to prevent another major attack in the United States. That single-page document was issued to all federal agencies, officials said.

After weeks of internal debate, White House officials adopted the communications documents to shape public events and official statements, and they sought to strike a delicate balance between messages designed for these two very important but very different audiences on a day when the world’s attention will be focused on President Obama, his leadership team and his nation.

The guidelines list what themes to underscore — and, just as important, what tone to set. Officials are instructed to memorialize those who died in the Sept. 11, 2001, attacks and thank those in the military, law enforcement, intelligence or homeland security for their contributions since.

“A chief goal of our communications is to present a positive, forward-looking narrative,” the foreign guidelines state.

Copies of the internal documents were provided to The New York Times by officials in several agencies involved in planning the anniversary commemorations. “The important theme is to show the world how much we realize that 9/11 — the attacks themselves and violent extremism writ large — is not ‘just about us,’ ” said one official, who spoke on condition of anonymity to describe internal White House planning.

Some senior Obama administration leaders had advocated a lengthy program of speeches and events to mark the anniversary, but the final decision was for lower-key appearances by Mr. Obama and other senior leaders only on the days leading up to the anniversary and on Sept. 11 itself.

Mr. Obama in his weekly address on Saturday said that this year’s anniversary will be one of “service and remembrance.” ”

Oh, gawd, spare us the lengthy Obama teachable moment speeches. The less he says about 9/11, the better. I don’t want him trying to emote over a script constructed by Jon Favreau. Can we get Carolyn Maloney or Kirsten Gillibrand to do this? Here’s the speech I want him to give: “I can’t possibly do justice to the memory of those who lost their lives during 9/11. Seriously. I don’t [insert air quotes] “feel your pain”. So, I’ve been told by my political staff to let the victims’ families speak for them. I will be in the Oval Office that day, working diligently [by my standards] and with [what we hope to be perceived as] reverential silence, on a plan to put Americans back to work. Kirsten can take it from here.”

I don’t know if this piece was written with the intent to throw us off our Obama kibble (when we’re already anorexic) or whether the journalists and editors responsible are simply getting into fine horse race coverage condition and they aren’t giving it a second thought. They’re probably dog whistling to Andrea Mitchell. Jay Rosen has had quite a bit to say recently about the failings of journalists during campaign seasons But if this is what we have to look forward to for the next 15 months, it’s going to be ugly and brutal. It looks like Obama will be getting the full Hillary treatment minus the misogyny. While I can’t say he doesn’t deserve it, do we?

A little more news, people. A little less poli-operative tea leaf readings. We’ve still got high unemployment of overeducated geeks, and floods, and no sentient being needs another lesson on September 11 or how condescendingly cynical the Obama administration is.

Now, back to the basement…