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It’s my Birthday and I’ll Blog if I Want To

Tuesday: ExasperationThis has been a rough week. Don’t even ask. It’s like 2 steps forward and one yank back. I *hate* that. The good thing is I *finally* have a job making a decent wage and I have health insurance again. When I say decent, I don’t mean anywhere near what I was making before and I have to teach myself a whole new technology. Not to worry, I can do this. I like challenges. But I will always miss my old job, not that there’s anything for me to go back to. Oh, look, drug resistant bacteria dragging us back to the dark ages. Lovely. If only there were a pool of drug designers, chemists and biologists who had been diligently working on new antibiotics for the past four years…

What am I saying?? That’s crazy talk to a shareholder.

But anyway, it’s my birthday and I’m going to the Oakmont Bakery for a Doughsant with something really decadent in it. I might even buy a pepperoni bread. Oh, yeah, I’m wild. I can’t be stopped. Because this is what you do after you’ve been shut out of the job market for 4 years. You spend no money on anything. In fact, my first goal, now that I have a regular salary is… to save up for my next layoff! Welcome to America, Dr. Krugman!

From the looks of the last thread, there is still plenty to say about terrorism, strategy, ISIS and many other things. RU Reddy needs to cut back on the caffeine though. I approved the pending comments. Sorry about that. I don’t spend as much time on the blog as I want to. Too many other annoying and disturbing things are taking my attention. The saga continues. There’s a book in here somewhere. I have already written a Hollywood ending and want someone thinner to play me. Preferably, someone who doesn’t go to the Oakmont Bakery to fill up on pastry.

Today’s the day I say what I really think. Hence the title. So, at the risk of hurting anyone’s feelings, I don’t approve of any plan that excludes Syrian refugees from the US. By the way, I have actually met and talked to a genuine Syrian refugee. He was a building manager in Syria and his wife was a dentist. He had a sponsor bring him to Pittsburgh where his wife can’t practice and he is washing dishes in a restaurant. His son is autistic. He was frantic, overwhelmed, bereft, angry, frustrated and nearly hysterical. The fact that he would pour out his heart to the lady in the retail store (at my previous underpaid and stupid job) is indicative of his desperation. He told me about his culture, how it was being destroyed. It was making him crazy. He worried about his son. He tried to tell me about what it was like. He was so distraught. I couldn’t know what that was like because I had never lived in a war zone. But the fact that he spent 30 minutes talking to a perfect stranger about it gave me contact anguish.

Why would I want to exclude people like this from my country? I want them to feel safe and protected so they can regroup. I don’t care if he’s Muslim. He’s a human being. We don’t tag human beings, by the way. That’s a dangerous slippery slope.

As for ISIS, I would like to do a Dresden on them. And that’s why I’m not in charge. Because to do that could have downstream repercussions that I haven’t even thought of yet. So, strategy is key, as is timing. And maybe we don’t have to bomb them back into the stone age. But to do nothing or exclude the people who need our help the most only encourages IS to keep doing terrorism because they would know it works. So, we can’t be afraid and we can’t bomb the shit out of them. We have to be clever and deadly and brave.

We used to be good at that before we stupidly got into a land war in Asia. I guess if I had one birthday wish, I would rewind the clock back to 2003. I would destroy the super funded right wing scream machine that twisted consensus reality and made everyone think we needed to go to Iraq and I would invent a device that would deliver a dope slap to every ditzy American who thought we were going to go back to gas at 50 cents a gallon by kicking Saddam Hussein’s ass.

But that’s just me. What about you?

For the rest of my day, I am going to binge watch The Man in the High Castle. Number one child called to say Happy Birthday. That made my morning. Now, if I can only hear from the other kid, that would make my day.

 

 

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#antibiotics : somebody should do something

I’m blogging from my iPhone while I wait for my car to be inspected. Expect imperfection, although, some of you may not notice a difference.

To those of you on the left who are finally paying attention to pharma research, head on over to In the Pipeline. Derek Lowe has another story that illustrates the state of R&D research in the era of shareholder value and its potential impact on the rest of us.

This recent event is about Merck acquiring antibiotic research company Cubist. Cubist in-licensed much of its pipeline and had a small early discovery research team of 120 people. It has now been announced that those 120 researchers have been laid off.

I guess you could say, well, Cubist in-licensed much of their stuff anyway. But those 120 people presumably have many accumulated years of experience from working on antibiotic research and that experience will largely be lost because companies are not really investing in antibiotic research. Where are they going to go?

Some of them are going to get a nice payout from Merck but even if they pool their resources, it’s not going to be enough to make a dent in the hole of antibiotic research. It will mean starting from scratch-again- for many of them. Or casting around for another hard to keep job in one of the most expensive housing markets in thtalee country.

In the meantime, there goes some badly needed talent to combat multi drug resistant bacteria.

If only there was an institution big enough to fund research in the public interest…

 

 

Stupid Drug Discovery Advice, $2 Billion dollar prizes and Antibiotics.

The NYTimes posted a column from Ezekiel Emmanuel, Vice Provost at the University of Pennsylvania, on the subject of antibiotic resistance and how to encourage more companies to develop antibiotics. He wants to reward the successful researchers with a $2B prize. BUT, he says: “no payment for research that fizzles. Researchers win only with an approved product.” Oh, and he says that the bragging rights would be great! Yes! That would make the starvation diet so much more meaningful. Funny, we don’t expect any other employed person to live on nothing for close to a decade on something that might not pan out or may need to be sold to a big company to keep our little startup from declaring bankruptcy.

He’s identified the problem. Companies don’t want to invest a ton of money in a treatment that’s only going to be used for a short period of time. By the way, that’s the new business model. Back in the olden days when I first started working in pharma, we had all kinds of therapeutic areas to choose from. But during the mergers and acquisition years during the 90’s to the mid Naughties, those therapeutic areas had to be eliminated to make room for shareholder value. Ok, I don’t want to get into this too deeply because it’s territory I’ve covered before but I might touch on it towards the end.

As I’ve discussed before, the antibiotic shortage problem was bound to come up. Bacteria mutate. It’s what they do. They are masters of natural selection, if you believe in evolution. If you don’t, an infection might just be one of those mysterious things that happen to people who do not pray enough. See, there’s another topic I don’t want to get into right now.

Here’s the problem: as Derek Lowe at In the Pipeline has pointed out, the molecule space around the typical antibiotic therapy has been exhausted. There are other targets than beta lactamases but they are not low hanging fruit anymore. There are new mechanisms that we have to learn, like quorum sensing for example.

When a new target is identified, it takes many years for that project to reach any semblance of what Silicon Valley industries would call fruition. In fact, the most promising project I was ever on started back in 2006. I don’t know what its status is at this point. It was promising enough that I think there was a drug there. But I’m betting it is still in the early phases of clinical development even now. That’s almost 10 years later.

This is the problem that a $2B prize does not solve. You can’t incentivize research like this. The reason is that the money has to be spent up front. That is the problem that almost all R&D, both academic and industrial, is grappling with right now. The scientists have to be hired and paid, the reagents have to be ordered and paid, the equipment has to be bought and maintained, and the people funding all of this have to have the patience of saints while the scientists churn through iteration of iteration of assays, high throughput screening, medicinal chemistry and drug design, pharmacology, ADME/T optimization and scale up. It takes a long time and it’s expensive. What will the R&D staff live on in the meantime? What are they supposed to use to get their work done? It’s like marooning a bunch of scientists on a desert island and telling them to come up with a drug using sand and chewing gum. Or hitting their “friends, families and fools” up for early funding as the American Chemical Society encouraged us to do when we first got laid off.

There are ways to reduce costs. For example, don’t make everyone live in Cambridge, MA or San Francisco. That right there would save the funding agent a bunch o’cash. Move people back to the mid-west from whence they came 25 years ago. You know, those places like Kalamazoo and Cinncinatti or even Pittsburgh. It’s cheap to live here and there is such a thing called the internet. We might even use web meetings to interact with each other. Wow, I believe I even used to do that with my colleagues in France and Germany once upon a time about 5 years ago! Let’s face it, there is not a big melting pot of exchange going on in Cambridge when everyone has signed confidentiality agreements. The only reasons to relocate there is 1.) it allows the MBAs who were once bio majors but sold out for the big bucks to live vicariously and 2.) I have absolutely no idea. No one I know actually wants to relocate to Cambridge. But I’m getting off topic.

My point is that the investment has to be made up front. It doesn’t do much good if it comes afterwards, especially if there are side effects and litigation that need to be covered. This is the case with all drugs. To get the drug discovery mechanism rolling, the fuel has to come early in the process and be committed to seeing the process through. That’s what we don’t have anymore. Once the drug is discovered and marketed, the profits can be reinvested in the next drug. That’s what used to happen.

Note that in this scenario, it is the R&D professionals who are important, not marketing, finance or shareholders. The researchers aren’t in it for the big bucks. You will have to take my word for this. Almost no one I ever worked with went into chemistry or biology with the intention of becoming an entrepreneur or cashing in big on their first blockbuster. Pushing us to become what we are not may be hampering the drug discovery process. Do you want someone in the lab making discoveries or do you want that person negotiating with contractors and venture capitalists? You can’t have both. There may be a few people who have the energy for both but they are exceedingly rare or exceptionally lucky.

And here is where I revisit the cause for why antibiotics, and other therapeutic areas like CNS, Cardiovascular and reproductive health, have been abandoned. It was the frenzy to merge that caused this to happen. All of those mid-size labs were joined and then a purging went on when the executive bonus class and shareholders took their cut. They created “efficiencies” by cutting out R&D and imposing cost cutting measures on research. They made research departments compete with outside vendors for services. They destroyed the collaboration between departments and exacerbated the complexity of the problem to be solved. They looked at their post-merger portfolios and said, “Antibiotics are not chronic therapies. We can’t make money on those. Let’s cut them.”. That’s what happened, Mr. Vice Provost.

And THEN, to top it all off, the mergers and acquisitors decided that academic researchers were so much less expensive. Why not scrap the R&D group altogether and let grad students do it?? Not that I have a problem with grad students but realistically, you have to do industrial research and follow a project from start to finish (if that’s possible without being interrupted by a merger or layoff) before you actually “get it”. Solving a drug discovery problem is one of the most difficult problems in science. Pretending it can be done on the cheap or rewarded afterwards when the vulture capitalists are going to demand their cut is not really understanding the nature of the problem.

A $2B prize is not a solution. It is the definition of success from a country that thinks the only reward is money. THAT is the bigger problem that we have not solved and the reason why new antibiotics are in short supply.

The answer is money

And time.

This is another boring post on drug discovery but ignore it at your peril.

Derek Lowe has another nice post up about the discovery of new antibiotics.  Summary: it’s really hard.  But I think even Derek might be glossing over something that seems pretty obvious.  Discovering new antibiotics and getting over the rate limiting step of not finding anything new or effective for a long period of time is going to take a massive infusion of money.  That money is going to have to come from somewhere.  My recent conversation at a user group meeting resulted in shrugs from the participants.  We have no idea who is going to pick up the tab for the research, which we already know ahead of time is going to be massively expensive and fruitless for a long time.

But here’s the thing, if you don’t take the time (and money) to do it right, when will you have the time (and money) to do it over?  Do we need a new version of the plague to light a fire under the responsible parties to get this party started?  On the other hand, it was the plague that got the Renaissance started when it wiped out a lot of the naysayers that stood in the way of the experimentalists…

Yes, I know the low hanging fruit has been picked.  Yes, I know we need to educate the helicopter moms out there to stop dosing their kids with amoxicillin every time they get colds.  Yes, yes, yes, there are a million reasons why bacteria are hard to kill.  But the primary reason we are failing in drug discovery is the one we have been talking about for a while now.  The shareholders don’t want to spend money on it.  They’d rather look for get rich quick schemes.  Meanwhile, there are tens of thousands of experienced American scientists who are vastly underemployed right now.

The next presidential candidates for 2016 better have policies to deal with this problem because the day of reckoning is fast approaching.

Tuesday: The state of science

Staph Aureas colonies growing on what looks like a blood agar plate

Guys, the state of science in this country is truly messed up.  Pharmageddon continues with the big research companies still laying off in high numbers, especially here in the US, and getting out of certain research areas. (Jeez, 2009 was a very bad year for US scientists.  58,000+ of us let go in an industry where hiring freezes have been the norm for over a decade.) Some of those research areas might be important to you even if you don’t know it right now.

For example, did you ever wonder how your great grandparents coped without antibiotics?  We’re only a couple of generations away from the dark ages when unchecked infections lead to gangrene and amputation, sepsis and death.  But have you ever wondered how little it would take to get that whole ball rolling?  Well, here’s one modern account that should chill you to the bone.

Meet Lucy Eades, youtuber extraordinaire.  Lucy has been documenting her family’s evolution in intimate detail for several years now.  Lucy and I have wildly dissimilar lives.  She’s young, blond, pretty and busy with three children under the age of five.  She’s into homebirths, cloth diapers and attachment parenting.  I like dropping in on her channel because it’s like watching a documentary on some exotic culture I will never visit.

Last November, just after Thanksgiving, her daughter Jacelyn scratched herself below the waistband of her underwear.    No biggie, right?  Wrong:

The day after on Saturday she asked why it was so itchy as she was trying to find comfort while rubbing & scratching at it. I talked to her about how wounds can itch as it heals & it’s best not to touch because any open wound could become infected & that would result in an ouchie…more so in kid friendly terms.

Sunday she pointed the area saying it hurt & upon inspection I noticed a pimple. Not sure if it was a pimple or not, ant bite, or what, but a small pimple look alike bump that hurt. Nothing more.

Monday morning after she woke we immediately looked it over & noticed a small black dot in the middle of it. Aside from that nothing else had changed. We were thinking maybe a spider bite? Never know when you stay in a hotel. Called the Dr and we brought her in later that day during one of their open “sick” appointment time frames. Dr said it could be staph, we’ll keep an eye on it. Since we had just battled staph (what 2 weeks ago? if that?) that it was a likely that even if it wasn’t staph it could turn to staph. She prescribed us some oral & topical antibiotics and gave us instructions for hibiclens, etc. for if we needed to use them eventually we wouldn’t have to bring her back in & expose her to more winter illnesses being passed around. She was fine at this point. Nothing hurt, we went about our day.

Tuesday-Wednesday is when my memory starts to fail me. At some point she becomes uncomfortable & it’s confirmed staph. We were told staph is on every surface every person & we naturally have it on our skin because of this.Some are effected while others are not. Some people with open wounds are more susceptible to staph than others for no known reason. Jacelyn is one I guess. We go fill the script at the pharmacy on Wednesday and resort back to warm soaks in the tub & attempting to squeeze out the infection with no success. Dr office swapped patient information & called in wrong prescriptions. We received anti-fungal meds.

Thursday we call the Dr office back still trying to get the right meds & to inform them that the infection appeared to be spreading. She had a fever, her hip/leg hurt, & it was no longer draining the way it should resulting in a massive hard rock like lump. Her skin was even starting to look raw in that area. They said she needed the antibiotics for a while & it would help. That evening I told Joel I wasn’t comfortable with the situation & I was taking her to the children’s hospital.

It was officially Friday by the time we arrived here (still here). She was running a 102 fever at arrival. They set up the IV’s & talked about procedure in depth with me. They had to sedate her using three different types of medicine. We talked about all our options, pros, cons, side effects, etc. The whole works. I apologized for being annoying but told him I wanted to be as informed in this process as I could be.

In walks 2 nurses, the Dr, a medic & 2 other employees. This goes from being scary to serious feeling. It was like one those ER episodes where 50 rush in the room all doing something different. One dose of sedation was enough to put a grown 200+ lb guy under.

What follows is a nightmare of bad reactions to sedation, two surgeries to remove dead tissue and drain the wound, and a hospital quarantine.  Jacelyn has MRSA, Methicillin Resistant Staphylococcus Aureus.  MRSA has developed resistance to standard antibiotics and some strains of MRSA are resistance to Vancomycin, which has been considered the last line of defense.  Ironically, MRSA is dangerous because of the overuse and improper use of antibiotics.  Nevertheless, you would think that the drug companies would be all over this area of research, designing new antibiotics or different approaches to combatting bacterial infections.

You would be wrong.  This is one of the therapeutic areas that big pharma can’t wait to dump, along with reproductive health and central nervous system (CNS) drugs.  That’s because they’re difficult, expensive to develop, have narrow safety profiles, or, in the case of women’s reproductive health, prone to class action lawsuits.  Women have been their own worst enemies when it comes to reproductive health.  Some feminists have a tendency to see every therapeutic agent as a weapon of the patriarchy to control their bodies.  As if.  And side effects are unavoidable, although we’re getting better.  But the cost of defending what was intended to cure has become so expensive that pulling out of these areas is more cost effective than sinking more money into research.

It takes a long time and a lot of clinical trials to get a new antibiotic approved.  Not so much with oncology where the life or death nature of the disease leads to speedier approval of new drugs. And in the case of cancer treatments, there are far fewer lawsuits when the drug doesn’t work out quite as well as hoped.  Patients’ families are grateful for any extension of life.  So, that’s where pharmaceutical companies are putting their money. It’s a callous and mercenary business decision.  It wasn’t always like this but this is what results after mergers, quarterly earning mania, a quirky, capricious, anachronistic FDA and the high cost of defending lawsuits have worked their own special magic for a couple of decades.  No more research on antibiotics.  Don’t expect that big pharma will care about your staph infections or birth control after you’ve sued their asses off.

Yes, they’re greedy bastards at the top but that’s a different topic.  They weren’t always this bad.

So, sports fans, we’re getting perilously close to the days when a simple break in the skin could kill you.  Lovely.

********************************

Katiebird sent me a link to this article about scientific publishing and plagiarism by two University of Kansas bioinformatics researchers.

In the technical world of bioinformatics, the two University of Kansas computer scientists were riding high in 2009.

Mahesh Visvanathan and Gerald Lushington published three articles with an international audience. They were invited to make a poster presentation at a conference in Sweden.

Although a lack of airfare kept them from going, their real problem wasn’t a tight travel budget — it was plagiarism.

Portions of all three of their articles had been lifted from other scientists’ work. The entire summarizing statement in their presentation had come from someone else’s journal article.

In an endeavor such as science that relies on original work and trustworthy information, plagiarism and fraud seem out of place. But misconduct is being detected with increasing frequency. And while it may be that the scientific community is just getting better at sussing out fraudsters, some scientists fear the problem is growing.

Competition among researchers has taken on a harder edge, they say. More scientists are competing for limited grant money, faculty appointments and publication in top journals. This intense rivalry makes it tempting for some to cut corners and fudge results.

The number of scientists caught committing fraud remains small, but each case can cause real harm, from wasting time and resources of other scientists who follow false leads to putting lives in jeopardy with bogus health findings.

There is a difference between the kind of plagiarism that the Research Works Act is supposedly trying to address where researchers frequently lift methods, diagrams and pictures from other papers routinely.  That’s a kind of excusable plagiarism because new work frequently is dependent on older work.  In that respect, the RWA could have a chilling effect on scientific publishing if it were rigorously enforced.  It’s quite another thing when your conclusions and whole paragraphs of explanatory text are lifted straight out of someone else’s publication.

But the pressure to publish is intense and, unfortunately, there are a lot of unscrupulous people out there who rationalize about what they’re doing.  While I can’t comment on how rife the academic world is with examples of plagiarism from other people’s publications, I suspect that the practice is alive and well in the corporate setting where the Wall Street financier’s value system has trickled down to the laboratories.  Well, you can hardly blame the more senior people for doing it or rationalizing about it later.  Their pedigree and PhD creates a field of excellent and  superior brainwaves around them that the more junior people can’t help but pick up and be influenced by even when the senior person has done little to nothing on the project.  Sort of like Lady Catherine DeBourgh in Pride and Prejudice who credits herself with a sensitive prodigy’s talent in music and would have been a great musician had she only learned to play.  Or the rationalizer’s work/family circumstances are more important than the person’s who actually did the work.  Or the rationalizer needs a green card.  Or <fill in the blank>.

If you have the power to steal a colleague’s work, the reasons for doing so aren’t hard to conjure up.  It’s your word against theirs.  With the patent lawyers sitting on publications and project data for so long, it’s easy to slap your name on a paper or patent when the actual inventor is out of the way.  All the skullduggery and credit stealing happens before the paper ever hits the journal or patent office.  Who’s going to know?  I’ve even heard that in some companies and departments credit is awarded to favorite underlings like a reward for loyalty.   Those favorites can swoop down on a project in its final stages and hog all of the years of credit to themselves at the last minute.  You’d think this would be an ethical problem requiring accountability and punishment. Not so.  It’s just the way things are done.  Not all companies operate this way but the current layoff environment makes it more common and brazen.  Yep, research is a sick business.

Well, it will all sort itself out in the end and the researchers who are left can always go into sales if they are ever exposed.

Science is baaaaaad  for you, children, Very bad.  You’ll spend years working and studying on project for which you will get no credit and end up flipping burgers at McDonald’s. Run away! Run Away!

*************************************

Susie Madrak cites a post today about how 3 female regulators’ warnings about the impending financial crisis were ignored.

Bies was a central bank board member from 2001 to 2007. Several times in the transcripts she said she was worried about the housing bubble.

Bies warned fellow board members that exotic mortgages — for instance, negative amortization loans in which balances become bigger and not smaller over time — were too dangerous for consumers.

She warned about the Wall Street-created securities backed by risky mortgages.

“I just wonder about the consumer’s ability to absorb shocks,” she said at Fed meeting in May 2006.

“The growing ingenuity in the mortgage sector is making me more nervous as we go forward in this cycle, rather than comforted that we have learned a lesson. Some of the models the banks are using clearly were built in times of falling interest rates and rising housing prices. It is not clear what may happen when either of those trends turns around.”

Later in 2006 she told Fed board members: “A lot of the private mortgages that have been securitized during the past few years really do have much more at risk than investors have been focusing on.”

Bies is an economist and was a former Tennessee banker. But the two most powerful men at the Fed and the Fed staff dismissed her concerns.

That May meeting was Ben Bernanke’s second as chairman of the Fed. He said the cooling off of the housing market was a “healthy thing.” And that “so far, we are seeing, at worst, an orderly decline in the housing market.”

In June 2006, Tim Geithner, then president of the Federal Reserve Bank of New York, said that “we see a pretty healthy adjustment process under way. … The world economy still looks pretty robust to us.”

A Fed staff report said: “We have not seen — and don’t expect — a broad deterioration in mortgage credit quality.”

Tim Geithner, Tim Geithner… Where have I heard that name before?  No, no don’t tell me.  Let me work this out…

Tol’ja

White House vs Women: Joe Biden Does it Wrong

Obama and Women: Two views

Um, I’m glad that the rest of the blogosphere is starting to pay attention to the way womens’ expertise is ignored in the public sphere and especially by the Democratic White House and party in general.  We here at The Confluence have been covering this very thing for a couple of years now, including one post that cited the story about the female musicians who get orchestra seats after they’ve auditioned behind a screen.   Wow, that’s an old reference.  You’d have to look long and hard to find it, unless someone already found it for you in other posts, like:

The Gender Gap and Female Bodied People

Yeah, why *did* we do that?

WTF?? Another example of how Sexism costs us all

Bairly Downgrading the FDIC

There are many more on the topic.  Try keywords “Sexism Costs” or “Costs of Sexism”.  Well, it’s not like it’s plagiarism or anything.

Unless someone is going to say they invented the Plum Line Metric too.  (that would be here, and here as well) Then I will have to raise a snit.

Welcome Susie!  We will send out our complimentary new members package complete with white sheet (‘cos an accusation of racism is just around the corner) and you starter pack of hormone replacement therapy.   No, no, don’t thank us.  Most members don’t.

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.

wednesday: sugar, antibiotics and chemotherapy

sugar

So, the other day, there was a story from another insider about the nature of the discussions between Christine Romer and Tim Geithner on the size of the stimulus package. Romer made the case that size does matter (she’s one of the few women who will say that out loud). Geithner compared money spent by the government on stimulus projects as “sugar”, while irresponsibly helping his diabetic friends in the financial industry mainline. Romer disagreed that government money was “sugar”, she said it was more like an antibiotic to prevent infection.

I wish these two would stop acting like doctors. The correct answer is that more stimulus money could have been like a shot of vitamin B12 to a patient suffering from pernicious anemia .  The B12 is not a cure for the disease but will keep the patient functioning until a cure can be found.

But anyway, we now know that Romer was right, as is the case of many women who make a good case based on knowledge, insight, research and experience but are hobbled by idiots like Larry Summers who long ago decided he wasn’t above denigrating their expertise and so may have inadvertently sent our economy into a lost decade….
Where was I?

Oh, yes. Then I saw the partial transcript of an interview between Fareed Zakaria and Ann Coulter and immediately thought that Geithner and Ann have been sucking down pigs-in-a-blanket at the same cocktail party. Courtesy of Digby, we get this snippet:

ZAKARIA: OK, let me ask – let me ask – we’ve got to go, but I have to ask Ann this, which is there’s – there is a strong case that he has made – Obama has made, which is about Medicare. And, on that issue, I want to know whether you think it will work. Not – I know that you wish that he didn’t say it and that the Democrats’ took entitlement reform more seriously, and I happen to agree with you there.

But, when you ask the American people, should – are you willing to deal with the budget deficit by cutting Medicare, 78 percent say no. I mean, I don’t think you can get 78 percent of Americans to agree on the time of day.

COULTER: Right.

ZAKARIA: Where do (ph) –

COULTER: It’s the utter irresponsibility of former Democrats. It’s hard to take treats away from people, and that’s what we’ve done. And Democrats set up a Ponzi scheme with social security and Medicare, and it’s running out now. And, yes, it’s very hard to take the treats away once you start giving them away, which is why it was utterly irresponsible for Democrats long dead and gone to set up these systems that could never last.

But, you know, it would be very helpful –

Whoa, Ann, treats?  The government already took those treats away when it increased my payroll taxes in 1986, the year I started working full time as a chemist.  I could have used that yummy treat to buy a car that had an automatic transmission and power steering.  I could have sent my kid to a better summer daycare center.  I could have stuffed that money in a bank account and bought a CD with it.  But some Republican told me, no, *assured* me, that if I did the responsible thing and put that money away in the Social Security Surplus fund, there would be plenty of money for me to live on when I got to be too old to run around  the lab to move heavy gas tanks and sniff solvents all day.  Wasn’t that what was promised?

Ann, was your party lying to us?  Was it a “treat” back then or was it just a clever ploy to soak young workers out of thousands and millions and BILLIONS of dollars that were then given to the rich in the form of tax cuts?  Because, Ann, I call that fraud.  Do we look stupid to you?  Ok, the people who read your books look stupid to you, but the rest of us are not stupid Ann.

Tim Geithner, do you agree with what Ann, the Dishonest and Fraudulent Republican, is saying?  Is our taxpayer money only “sugar” and a “treat” to those of us who gave it to you in the first place?  It’s one thing to lose your looks, Ann, it’s quite a bit more devastating to lose your integrity.   I thought Republicans were all about “we should spend our money on the things we choose”.  So, if the majority of Americans want to spend that money on Social Security and Medicare and more stimulus, that seems pretty much in keeping with the Republican creed.  It’s OUR money because WE are the government and WE choose to spend it on fiscal stimulus and social safety net insurance programs.

I paid my premiums, I want my insurance, Ann.  It’s not a treat.  If MetLife pulled this shit, they’d be out of business.  As for Geithner, he’d better snap out of it.  People who were once employed and relatively prosperous get very angry and restless when their hard work is vanished and have to listen to some idiot who thinks having a steady paycheck is “sugar”.  FDR wanted to avoid that but Obama and Geithner are oblivious.  You guys need to get out more and meet new people.  I know a lot of very bright PhDs who are cooling their jets right now because they can’t find jobs. Why don’t you go talk to THEM?  Want their LinkedIn IDs?  They could be working on cures for schizophrenia and cancer but they’re at home, wasting their research time looking for jobs that never materialize and losing access to the scientific journals that will keep them on top of their game.

Meanwhile, Derek Lowe at In the Pipeline, points to a disturbing convergence of outsourcing, plant failures, counterintuitve GMP and FDA regulations and corporate cost-benefit analyses that are leading to a shortage of chemotherapy agents.  That problem is just getting started.  It’s only going to get worse.  And we on the left have to ask how we might have contributed to the problem.  The drug industry needs regulation, no doubt about that.  But have we regulated recklessly?  Have we not studied the consequences of regulation?  Don’t we want regulations that avoid this kind of thing where cancer patients are now hanging on for dear life hoping and praying the shortages are temporary?  That’s not to say that regulations are the only source of the problem here.  There are others.  There are fewer and fewer incentives for companies to operate in a socially responsible manner.  Profits are, well, profitable.  No one has told the shareholders what this is going to cost us as a society.

This is a shameful and sad legacy of our inability to deal with the drug industry in a rational manner.  I’m disgusted by all of us.  I’d wish a plague on all of our houses but in that eventuality, we’re all screwed.  There’s probably a shortage of tetracycline too.