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      Are humans good, bad or neutral? It’s an old philosophical debate, and not just in the West. Confucius thought they were born neutral, for example, while the later Confucian Mencius felt they were good, noting that everyone who saw a child fall into a well would be horrified. Others, including many Confucians and the Christian church, with original sin, have […]
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Wall Street + Stock Buy Backs => Cookies of the Apocalypse

Greed has consequences.  The definition of success also has consequences.  When people judge their success in life by how much money they are making instead of what they contribute to the well being of the society they live in, they can have unintended consequences for other people who they don’t even know in fields they couldn’t care less about.

Let’s follow this trail, shall we?

Matt Taibbi writes another scathing critique on the lack of character on Wall Street.  This is where the worldview is developed and the flawed value system starts.  In this little snippet about John Paulsen and his incredible haul of obscene gobs of cash, we are to feel sympathy for the pain he has suffered for all the gobs of cash he lost on bets that didn’t pan out last year:

Look, the financial services industry should be boring. It should be quaint. Let’s take the municipal debt business. For ages, it was a simple, dull, low-margin sort of industry, in which banks arranged municipal bond issues and made small but dependable profits as cities and towns financed improvements and construction projects.

That system worked seamlessly for decades, until people like Sherman’s interview subjects suddenly decided to make the business exciting. You know what happens when you make municipal debt exciting? Jefferson County, Alabama happens. Or, on a macro level, Greece happens.

When making a few points on mere bond issues stops being enough, and you have to cook up crazy swap schemes and indices to bet against those schemes, ingenious scams allowing politicians to borrow billions of dollars that they will never in a million years be able to pay back, you might end up getting a few parks, schools, and subways in New York.

But what you get everywhere else is a giant clusterfuck that costs the rest of us years and even more billions of tax dollars to remedy.

This is what the protests are all about – it’s anger that Wall Street has been profiting from an imaginary economy that leaves bankers overpaid, but creates damage everywhere else. Sherman doesn’t get this. He seems to subscribe to the well-worn straw-man position that protesters are simply upset that bankers and financiers make a lot of money. Take for example his view on John Paulson, the hedge fund titan who was involved in Goldman’s infamous Abacus deal:

In October, a thousand protesters stood outside John Paulson’s Upper East Side townhouse and offered the hedge-fund billionaire a mock $5 billion check, the amount he earned from his 2010 investments. Later that day, Paulson released a statement attacking the protesters and their movement …. The truth was, Paulson was furious that the protesters had singled him out. Last year, he lost billions of dollars on bad bets on gold and the banking sector. One of his funds posted a 52 percent loss. “The ironic thing is John lost a lot of money this year,” a person close to Paulson told me. “The fact that John got roped into this debate highlights their misunderstanding.”

Hey, asshole: nobody misunderstands anything about John Paulson. They’re not mad that he made billions the year before, and they’re not happy that he lost money this year. They’re mad that the way he made his money in previous years – which involved putting together a born-to-lose portfolio of toxic mortgage bonds and then using Goldman Sachs to dump them on a pair of European banks, who in turn had no idea that Paulson was betting against them.

Matt Taibbi is using harsh curse words.  How declasse.  The fundies react with shock and horror.  Is there no civility on the internet?  Paulsen is rich.  Surely this man deserves respect.

Moving on.

Derek Lowe at In the Pipeline wrote a rather longish post for him about the pharmaceutical companies buying back stock in what looks like a desperate attempt to push up the stock price and keep more for the executives.  Lovely.  And this is made easier by assuring investors that they have cracked down on research costs, by golly.  We’ll have none of that wasteful spending here:

He has some figures from our own industry: From 1997 to 2009 “Amgen did
repurchases equal to 99 percent of R&D expenditures, Pfizer 67 percent, Merck 62
percent, and Johnson & Johnson 57 percent.” It could be worse – companies in the IT sector have often managed to spend even more than their R&D budgets on repurchases, partly because they increased the number of shares outstanding so hugely during the dot-com boom years.

One complication with the market-manipulation view is that stock buybacks don’t correlate very well with total stock returns. If anything, the correlation is negative: companies (and sectors) that spend the most on repurchases have lower returns. Of course, there’s a correlation/causation problem here – perhaps those returns would have been even lower without the buybacks. But there’s clearly no slam-dunk financial case to be made for repurchases.

Except one: that they’re often the easiest and least controversial use of the money. Companies get criticized if they sit on cash reserves, and they get criticized for missing earnings-per-share numbers. Why not try to address both at the same time? And without having to actually think very hard about what to invest in? I think that Pfizer’s Ian Read is being truthful when he says things like this:

Pfizer declined to make an executive available to discuss its policy. But in a statement, the company said it “remains committed to returning capital to shareholders through share buybacks and dividend payments.”

As for the cut in research spending in February, Pfizer said it has “accelerated our research strategy and made important changes to concentrate our efforts to deliver the greatest medical and commercial impact.”

In a conference call with analysts this month, Pfizer’s chief executive, Ian C. Read, said his company would “continually look” for acquisitions that would increase revenue growth. But in deciding how to use the proceeds from recent asset sales, he said “the case to beat is share repurchase.”

And that, truly, is a shame.

Oh, well, it’s not like the executives are going to stick around to see what a shame it is.  As the following animation suggests, they will be sitting on a beach in the Cayman Islands ideating and leaving the company to hobble toward some finish line on its own:

{{catching breath, wiping eyes, clearing throat}}  Ahem, geek humor and all that.  Too funny, or it would be if so many of us “ancient ones” weren’t out of work.

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.

Sunday shorty on SOPA

Update: This has probably occurred to others but just hit me that SOPA is really just an election year shakedown.  The Republicans are raking in money from the media congloms while the Democrats are raking in money from, er, everyone.  It’s no lose legislation, or so they think.  It’s like playing with fire and the average American is going to get burned.

Can we get rid of all of them?

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

Politico reports (or reimagines) that Obama is walking a thin line on SOPA.

I know, I know, stop laughing.  When has Obama ever walked a thin line on  any legislation that the major media conglomerates want so badly they are nearly peeing themselves with anticipation?  AND it’s an election year.  Can’t you just see him weighing his options?  Should he piss off Google, Wikipedia and Mark Zuckerberg who are trying to keep the internet relatively free of interference so it can continue to grow and flourish, or Disney, Sony and the other media conglomerates who refuse to evolve?  The bottom line is the thin line he’s looking at. Donations, donations, donations.

Says Politico:

The administration did not take a definitive position on SOPA or PIPA on Saturday. But it was clear that the White House — while calling pirated movies and knockoff pharmaceuticals on the Web “a real problem” in need of a legislative solution — isn’t enamored of either bill.

“While we believe that online piracy by foreign websites is a serious problem that requires a serious legislative response, we will not support legislation that reduces freedom of expression, increases cybersecurity risk, or undermines the dynamic, innovative global Internet,” the administration officials said. “Any effort to combat online piracy must guard against the risk of online censorship of lawful activity and must not inhibit innovation by our dynamic businesses large and small. “

Yeah, just like NDAA should not include innocent US citizens who are mischaracterized as terrorists just because they protest.

Ok, I’m just not following the pharmaceutical industry’s angle on this.  But that may be because the industry’s lobbying group is listening to its IT departments’ recommendations on how to keep proprietary information proprietary.  From a scientist’s point of view, this could be a big mistake- for the scientists while providing a useless placebo to the MBA class who think they finally have it all nailed down.

For one thing, Big Pharma’s IT departments are bloated organisms that do one thing extremely well: service the MBAs at the expense of R&D.  Everyone must have the same stupid image of Windows on their desktops, while scientific applications, which is what you might *think* are business critical, are treated like redheaded stepchildren.  “Linux?  How do you spell that?”  No, seriously, I actually had that question from the Helpless Desk one time.  When we point out that it might behoove them to get a separate system admin to service the in silico sciences people, they always scream that it’s going to cost too much and they give us a part time contractor without a system password.  Then, they turn around and hire some flunky who will maintain a version of Internet Explorer that died sometime during the Jurrasic.  In other words, the people the MBAs have been laying off have been the wrong people but since IT keeps Excel and the email services functioning, they were more than happy to pour obscene gobs of cash into the Microsoft money pit.  The system is not secure, it’s out of date, and IT takes forever to update and secure anything.  SOPA is not going to help keep the bad guys out of the corporate intranet.  Everyone knows this but the guys in the executive suites.

Secondly, the corporate lawyers who are supposed to be keeping up with technology so they can tailor contracts accordingly, can’t handle anything outside of a Windows environment.  I heard about this problem last year when I went to a conference on Proteins in San Diego last year.  There were several sessions on computational environments and everyone had the same complaints.  The legal eagles in the R&D departments understood that Amazon’s cloud service hired much better security experts than the Big Pharma folks could ever hope to find.  The R&D legal eagles had no problem signing off on cloud service contracts and new technologies.  It was the corporate legal team that stumbled, again and again, because they were used to Microsoft contracts and anything new looked like Martian to them.  How does SOPA address either of these issues?

Then there is the issue of outsourcing your work to China.  Ahhhh, maybe THIS is the problem.  Well, yes, this is a problem.  This is what you get when you *think* you can keep a few “stellar” {{snort!}} designers and intellectual property here in the US, kill off the careers of all of the other people who once did the design and lab work and ship the hands on work off to China.  For some strange reason, the MBA class appears to believe that people who work in laboratories are mindless drones who assemble drug molecules like a factory worker assembles widgets.  What they neglect to understand is that people who go into science because they actually like it are probably not going to be happy as widget assemblers.  Their minds are too active for that.  Not only are their minds too active, they tend to start wondering why they’re living like slaves and doing this very hard work for some rich asshole MBA in Connecticut.  Are they going to be content to just look at the structure of the molecule they are supposed to make and never wonder what it’s for?  Or let’s say they know what the target is.  Are they supposed to just sit on that information and not try do some scaffold hopping and lead optimization?  What’s to prevent them from doing that?  The contract?  And that’s going to be enforceable by whom?  China?  Riiiighht.  It’s almost as if the MBAs cannot possibly imagine that anyone other than themselves would be any good at exploiting loopholes and outright theft. They might speak a different language but it would be foolish to assume that they don’t know opportunity when they see it.

As it turns out, you can’t ship your lab work off to India and China for a quick profit the way the MBAs thought they could.  We tried to tell them this but they wouldn’t listen.  It takes a long time and lots of hard work to get a new drug.  You can hire cheaply there but you will have to hire more people to get the economy of scale in research you were hoping for and *still*, you will be at the mercy of the fricking organism.  Cells just do not cooperate the way you think they should and there’s no performance incentive scheme you can chain them to in order to make them docile and compliant.  Threatening to starve cells if they don’t produce doesn’t usually work.  In the meantime, you have completely dismantled your US research infrastructure, poured billions into new facilities in Asia and your pay off may still be decades away.  Congratulations.  You may have to go into hiding in a few years when the stockholders come after your heads.  Heads up, Congresscritters, you really need to address this NOW. Novartis just laid off a bunch more this week and it’s not over yet.  There are hundreds of thousands of researchers out there who can’t find work and we are just going over the patent cliff.  Wheeeee!

So, what does this have to do with SOPA?  Damned if I know.  Whatever it is the management of Big Pharma is trying to accomplish will probably just backfire on them.  They haven’t had a very good track record in the last 15 or so years.  And now that they’ve fired us all, there won’t be anyone else to blame.

In the meantime, what can we expect of Obama?  I imagine it will go something like his recent signature on the NDAA.  He will express reluctance and regret and deep reservations.  He’ll be torn.

And then he’ll sign it.

Unless it doesn’t pass at all.  I hear that Jan. 18 is an internet blackout day.  Hmmm…

Heads Up, Research Professionals

Believe it or not, no one knows you exist.  Oh, some people have vague notion of your existence, but it’s on the level of how pre-packaged chicken ends up in your grocer’s meat department chiller.  Clearly, somebody shrinkwrapped the suckers but all the grody chicken shit details are sanitized for your protection.  In a similar way, prescription drugs just sort of magically appear on the pharmacy department shelves.  And they are always produced by some big, evil Big Pharma company.  {{boo, hiss, boooooo!}}  And while even *we* are disgusted by the behavior of all some of our companies’ CEOs (see below for more on this), the CEOs have about as much knowledge of how drugs are discovered as the average Joe the Plumber.  Most people (and pharma executives)do not see the years and years (and years) of hard work, and SciFinder searches and hours in the lab and repeated failures and serendipitous eureka! moments that are subsequently dashed to smithereens by a CHO cell receptor that simply refuses to cooperate or the dog liver enzyme assay that stays stubbornly stuck on an ambiguous borderline measurement.  (There, there, don’t cry.  It happens to everyone.)

But YOU are like that mythical chicken sexer at a big mysterious chicken farm.  Most people don’t see that part of the chicken making procedure.  You do not really exist in any tangible way.

This is a problem for us.  Because as you know and I know, the Research industry has been devastated by clueless CEOs who love their sales and marketing departments but see YOU as the equivalent of field hands.  You may work with your brains all the time but if you work with your hands at all, you become the hired help.  While the executive cafeterias have dozens of expertly prepared lunch choices, nutritionally balanced, full of color and flavor ,and access to a registered dietician who will customize your menu (I actually witnessed this one day), YOU will be served the equivalent of a high calorie meat and potatoes meal in your dingy cafeteria at the “labs” down the road.  Yes, you may as well be a Welsh miner grabbing a tiddy oggie on your way down the shaft from which you will eventually emerge covered in coal soot. Your parking lot consists of Dodge Caravans and Nissan Sentras.  THEIR parking lot has dozens of shiny new BMWs and Lexus SUVs that start a $50000 a pop in spite of a shockingly insufficient number of cup holders.  You wear a labcoat with the  spreading blotch of something yellow on the edge of the right pocket.  THEY wear suits.  You spent your college years in labs that were supposed to last three hours but, er, didn’t because you knocked over the titanium tetrachloride in your glove bag and couldn’t see what you were doing and somebody dumped their sodium sand in the sink (it wasn’t me).  THEIR labs consisted of how much beer they could fit into one of those yard long funnels.

You get the point but if you didn’t, here it is: They have a very misplaced view of their worth to the company, as well as an inflated conception of their own personal self worth.  They do not give a shit about you because to them, the chicken shows up shrinkwrapped.  Do you ever see them coming down to the lab to see how things are going?  Can you even imagine one of those condescendingly, snippy women from accounting or purchasing talking to you nicely as if you were a normal human being deserving of respect, breathing the solvent scented air?  No, of course not.  The bigwigs only see you as they flyover in their helicopters.  Any real on site inspection happens after you go home (You have to be finishing your work past 7pm to catch the whomp-whomp-whomp of their whirlybirds).

But what you may be surprised to find out is that the left doesn’t give a shit about you either.  I have been beating my head against a brick wall trying to get the attention of bloggers who really should know better to get the word out about how our industry has been devastated.  I have been talking to people until I am blue in the face to get them to understand how many hundreds of thousands of us have been laid off and are underemployed or working in contract positions for vastly reduced salaries and benefits.  But what do I hear back?  Silence.  The silence is deafening.  In fact, I get the distinct impression that some of the people on the left who should be extremely concerned with our labor problems think that we should be ashamed of what we do.  It is hard for me to believe that the left could be so incredibly heartless and dim about this but for some mysterious reason, the fact that you work and study hard to find actual cures for people is a shameful thing.  They have this “holier than thou” idea of what constitutes an honorable profession and we ain’t it. These people on the left think that because you work for the assholes up the street (or you have worked for them), that you are responsible for the increasingly boneheaded and greedy decisions they make.  They don’t understand that you have kids and mortgages and retirements of your own and that drugs come shrinkwrapped only after you’ve beaten your head against a wall for half a decade before you pass it along to the clinical people.

I thought 2008 was bad.  This is worse.  The level of concern they have for you is truly reprehensible.  Not only that but I have actually spoken to many average Joes who seem to think that STEM workers’ job prospects are unlimited.  Yes, I know, it’s incredible.  They think that the world is our oyster.  We can just breeze into any lab in the country and demand a job for a high salary.  It would be funny if it weren’t so tragic.  The news media has swallowed the propaganda hook, line and sinker once again.  Oh, it will sink in eventually when the number of students who want to get a job in chemistry dwindles to zero because you won’t be able to convince a 20 year old to study organic chemistry, molecular biology, calculus and linear algebra for four years to wind up making $12/hour with no bennies and be happy they’ve got that.  You would think that students who are smart enough to study STEM majors will be smart enough to figure out that there’s no living wage in it anymore.  I’m not sure that the politicians and business people pushing the “We need more STEM workers!” line have figured it out yet.  But by that time, your career will be ruined and you will have moved on to reupholstering flea market furniture for a living or teaching the chemistry you could do in your sleep to class of suburban brats.  *Your* dream job of bliss in a lab discovering the wonders of nature are over.

So, do not expect anyone else to get the word out that you are in as much trouble as any other laid off worker in the country.  Nobody knows you exist.  You will have to make yourselves visible.  That means talking to strangers on a train or going to an occupation or marching in the street with your labcoat on.  That’s what it will take.  The message *is* finally trickling out in dribs and drabs.  My face to face conversations have been quite successful.  Once people understand what is happening, they are generally quite alarmed and sympathetic.  And in the end, this is not harder than getting up in front a bunch of cocky assholes you work with to explain in 30 minutes what ground breaking work you have been doing for the last six months.

As it happens, there is a march in NY City this afternoon.  Don’t expect anyone else to do it for you.  I’ve done several marches already and it’s fun.  But to make our point, we need as many people in labcoats to go as possible.  If you can’t make this one, plan to attend another one.  We are the 99% too, fergawdsakes.  We don’t make anywhere near the salaries of the 1%.  We don’t live off our investments and once they kick us out of the system, it’s bloody hard to get back in.  So, get out there and show them where those chickens come from.

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On a related note, I followed a link from Derek Lowe’s blog In the Pipeline (make a note of it, left blogosphere) about the Nance Trophy nominations for the worst Biotech CEO of 2011.  There are several worthy nominees but my favorite has to be this guy:

Gregory Divis Jr., K-V Pharmaceutical

Divis wrote the CEO manual this year on how to screw up a new drug launch in every conceivable way. His was a performance of idiocy on a grand scale that may never be matched. Even Dendreon’s Gold looks like a drug-marketing superstar next to Divis.

The drug launch Divis botched was Makena, an injectable form of the hormone progesterone used to reduce the risk of premature birth. For years, doctors have been able to prescribe the same drug made by compounding pharmacies, costing just $10 to $20 per injection. K-V priced Makena at $1,500 per injection.

K-V also claimed market exclusivity for Makena because the drug was granted orphan status by FDA, so the company’s lawyers threatened to sue any compounding pharmacy that dared continue to manufacture the cheaper version.

Divis’ aggressive tactics backfired big time. Doctors got mad, worried that their patients would no longer be able to afford the medicine they needed. The March of Dimes accused K-V of profiteering at the expense of at-risk pregnant women. The FDA questioned the company’s tactics. Politicians blasted K-V and called for investigations into the company’s marketing practices.

Needless to say, the Makena launched bombed. K-V was forced to backtrack and cut the drug’s price, but even that conciliatory gesture was met with skepticism and scorn.

Friends, that is unmitigated shamelessness in all of its glory.  It’s hard to top it.  Which bright, young Wharton graduate thought of acquiring a generic drug at $10 per dose and remarketing it for $1500 per dose?  Those are the kind of people who attend Obama fundraisers because that kind of pricing strategy takes a certain kind of audacity. That takes a coldblooded cost-benefit analysis of how much people would be willing to pay to keep their babies out of the neonatal ICU.
Karma is a bitch.  It turns out that women and their doctors would find perhaps less effective and riskier alternatives than pay $1500 a pop for a $10 a dose drug.  But it’s not just the patients and their children who will suffer.  Nooooo, now whatever research staff K-V actually has, will feel the effects of the catastrophic failure of the bizness wunderkind.  This is the pattern in Big Pharma.  Someone makes a bad acquisition, puts all of their money on a drug that doesn’t get approval while ignoring every other project, or invests in some “get rich quick” promising but undeveloped technology in Massachusetts hoping for money for nothing and their chicks for free.  And when it all falls apart, the labrats get the ax in order to maintain “shareholder value”.  Typical.  Nevertheless, it’s hard to get more cynical and greedy than K-V.  My vote goes to Gregory Divis Jr.

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Lipitor went off patent yesterday.  Good luck to all of the labrats working at Pfizer.  I mean, all of the ones that are left.  That weren’t laid off when Wyeth was bought by Pfizer.  Which were every single one of my friends and former colleagues.  {{sigh}}

Anyway, good luck to you all.  I see that the share price gapped up this morning.  But as you know, they’ll use any excuse when the time comes.  Hang in there.

Monday: The instapaper queue

Turkey Tetrazzini for dinner? hmmm...

How was everyone’s Thanksgiving?  Did everyone get enough to eat?  I brought the desserts this year and much to my surprise, no one in my family likes Lemon Meringue but me.  I’m not complaining but I did find it weird when my sister told me that it was a summer pie and why didn’t I know that??  Not to fear, we had pumpkin as well.  And a custard fruit tart brought by someone else that was also delicious.  It went fast.

My sister and her husband are into this foodsaver gadget and they shrinkwrapped the leftovers into neat little packages.  I have to get one of those suckers.  They gave me a package of turkey (white meat, yummmm) to take home with me.  Guess what’s for dinner tonight?

Anyway, I have a lot to do today.  I need to finish reading some papers, return a coat I decided I could live without and basically take care of some other stuff that I’ve been putting off.  So, I thought I’d let you in on my instapaper queue.  For those of you not familiar with instapaper, it’s an app/utility that allows you to save links to interesting webpages so that you end up with something like your own frontpage.  It comes with a button that you put on your browser bar and when you see something you want to read later, you just click on “read later” and it saves it to your instapaper account.  Later, you can peruse your links at your leisure.  Highly recommended.  They even have a Browse section of recommended links of things you may be interested in reading based on your current selections.

So, here’s a few things in my instapaper queue:

How do you define who’s homeless during a recession?  The Atlantic

All the Angry People- The New Yorker

Estee Lauder Heirs Tax Strategies Typify Advantages for Weathy- The New York Times (I guess they don’t need my money after all.  Did you know that Estee Lauder owns Clinique, M.A.C., and Origins as well?)

Team Obama Gears Up for 2012 – The New York Times (This one is unsettling.  Milk Bars and droogs come to mind)

So, What did Lipitor do for Pfizer? Or its Shareholders?- In the Pipeline (Or, “How the finance MBA executive class screwed the pooch in pharma, destroyed research, set the shareholders up for HUGE losses later and made the entire world hate drug discovery’s guts”  It’s hard to believe a group of arrogant, hierarchical Ivy League educated individuals could botch things this badly but it’s become clear to me that the Democrats have been taking lessons from them.)

More Parents are Opting out of Vaccines – The Atlantic  (Did you know that Raold Dahl’s 7 year old daughter Olivia died from encephalitis because she was not vaccinated against measles?  True story.  It’s hard to believe there are selfish, ignorant and arrogant parents out there who would expose other very young children to that because they won’t vaccinate their own kids.  It’s immoral.)

The Branding of the Occupy Movement- The New York Times (There’s a better article on Kalle Lasn somewhere but I neglected to instapaper it.  Try The New Yorker, New York Magazine or The Atlantic)

Payroll Tax Cut will Top Political Theater- Roll Call (yes, Virginia, they *are* still playing games instead of raising taxes on the rich)

Iran: We’ll Fire 150,000 Missiles at Israel if attacked- YNet (and we’ll turn Iran into a smoking cinder if it does.  I think there was a cold war term for that)

Pakistanis burn Obama in Effigy and US Flag- Sky News Australia (Ok, now I think we know why we have marines stationed in Australia.)

Cozy Winter Recipe: Pasta e Fagioli– The Kitchn (Apartment Therapy)

Charge Separation in Molecules Consisting of Two Identical Atoms: Size Matters – Science Daily (For the hard core polarity fans)

Finally, here’s a video on Pittsburghese, which is a distinct American dialect.  The host of this video is fresh, energetic and cute, but her accent is not anywhere near as heavy as my cousins’.  Still, if you ever wondered what it meant to “red up your house”, pay attention.

She forgot to say “keller” when she really means “color”.  And is it “UM-brella” or “umBRELLa”?

Finally, “Physician, Heal Thyself”.  Digby is absolutely right about dehumanization but it’s really odd that she and the rest of the left had no problem with it when the 2008 elections made old, uneducated, unattractive, working class, racist, latently Republican, menopausal women out of Hillary Clinton voters.  I mean, when you think of them *that* way, no wonder the Obama hooligans piled on.  Who wants to sit at that lunch table?  Dehumanizing those voters made it a lot easier to ignore their votes and violate their delegates with harrassment and threats at the convention.  They almost deserved it. Right, Digby?  Right, Duncan?  Right, Jay?  If you don’t take your own side to task for acting like flaming assholes, then others might find your newfound concern with “dehumanization” a bit hypocritical.  It was an election with far-reaching consequences not only to the economy but to voting in general. (Didn’t you guys ever figure out why Obama is ignoring his voting base now?  The answer is that you let him get away with it in 2008 so he knows he can do it again.) You guys should have been a lot more vigilant.

(No, I am not going to get over it.  If it were Howard Dean’s voters who got the Hillary treatment, you’d be all over this for decades to come. “Oh, but they’re different”, you’ll say. Exactly.  I rest my case.  “An injustice anywhere is an injustice everywhere”.  Also, Karma is a bitch.)

Resolving drug shortages shouldn’t be a political “opportunity”

The cancer hourglass runs fast

Barack Obama is finally starting to notice that there is a shortage in the production of some older prescription drugs and is offering some carrots and sticks to resolve the problem:

WASHINGTON — President Obama will issue an executive order on Monday that the administration hopes will help resolve a growing number of critical shortages of vital medicines used to treat life-threatening illnesses, among them several forms of cancer and bacterial infections.

The order offers drug manufacturers and wholesalers both a helping hand and a gloved fist in efforts to prevent or resolve shortages that have worsened greatly in recent years, endangering thousands of lives.

It instructs the F.D.A. to do three things: broaden reporting of potential shortages of certain prescription drugs; speed reviews of applications to begin or alter production of these drugs; and provide more information to the Justice Department about possible instances of collusion or price gouging.

Such efforts are included in proposed legislation that has been pending in Congress since February despite bipartisan support for its provisions.

The order, the first since 1985 by a president to affect the functions of the Food and Drug Administration, is part of a series of recent executive orders involving such disparate issues as mortgage relief and jobs for veterans. They are intended to show that the president, plagued by low approval ratings, is working to resolve the nation’s problems despite a Congress largely paralyzed by partisan disagreements.

Yes, by all means, let’s wait until there is a chance to shore up low approval ratings before we do anything.  After all, that colon cancer isn’t going anywhere.

Do you ever get the feeling that the president is playing “whack-a-mole”?  “Drug problem?  Didn’t we go after medical marijuana and that Mexican drug cartel?  What do you mean people can’t get their chemo?  WTF??  I’ve got three, no, two wars to deal with and these bankers breathing down my neck and those pain-in-the-ass occupiers who ruined my fund-raising dinner in the Bay area last week.  How am I supposed to keep up with all of this?  Wait!  How many months are there until the election?”

Um, yes, Barry, there are people who aren’t getting their chemo.  The FDA has been a disfunctional agency for years.  Politicized?  You betcha!  We can’t decide whether to make a spectacle of Plan B and regulation when we’ve got a bunch of looney Republicans in charge or to grandstand about drug safety to scare the hysterical consumers to hyperbolic levels in order to demonize Big Pharma (which hasn’t done itself any favors lately in the PR department).

Let me tell you, Barry, my dad died of cancer 15 years ago, that mother works fast when there is nothing to keep it in check.  Patients do not have the luxury of months.  And this stuff just pisses me off:

The president’s order is a modest effort that, while possibly helpful, is unlikely to resolve the problem soon or entirely. Administration officials characterized it as one step in a long and complicated effort. Indeed, Mr. Obama eschewed more ambitious proposals — like government drug stockpiling or manufacturing — that would have injected the government more directly into the nation’s drug market and cost more but that might have been more effective. [yes, by all means, let’s do as little as possible]

Still, Mr. Obama’s order and others he has issued recently reflect his belief in the power of government to improve people’s lives.  [which campaign operative dictated *that* line?] By contrast, top Republican legislators and presidential candidates have almost uniformly argued that resolving the nation’s economic and other problems depends mostly on scaling back or ending government regulations to allow the free market to function more effectively. No regulatory agency touches people’s lives more thoroughly than the F.D.A., which regulates 25 cents of every dollar spent by consumers.

I don’t need a political operative to tell me that Republicans are criminal.  No, really, they are.  The drug industry needs regulation.  It would be helpful if those regulations were updated to reflect changes in technology and the FDA is way past due for a modern overhaul of its data systems in general.  But if any Republican is out there beating a drum against regulations for pharma, they really should be in jail.  It’s not that the industry is deliberately bad or negligent, despite what the class action lawyer contingent would have you believe.  It’s not.  And I’d like to keep it that way.  Better to be safe than sorry.  But let’s get the damn agency working efficiently please.

But wait, there’s more!  I’ll bet that Obama isn’t even paying any attention on the thousands of R&D professionals that lost their jobs only last week.  Merck, Schering-Plough, Amgen and Novartis are only the lastest pharmas to toss their researchers to the curb adding to the hundreds of thousands of us already out there.  That means that there won’t be very many new drugs coming on the market in the forseeable future.  With Big Pharma falling off the “patent cliff” this year and next, the executives are throwing the labrats overboard at Wall Street’s behest in order to serve the shareholders and protect their compensation packages.  China and India are not ready to take on hardcore pharmamceutical research and many Asian companies are content to just make me-too drugs.  Expect a lost decade while we cool our geeky jets and seriously consider finding other professions instead of finding new cures.

Of course, it didn’t have to be this way.  Barry was so over his head when he came into office that looking out for the researchers was probably the last thing on his mind. Besides, who listens to the labrats?  They don’t make huge contributions to your campaign.  They never get invited to the White House to tell you exactly what’s going on.  No, why should the president listen to a bunch of disgruntled R&D workers who will only tell him how catastrophically their industry has been managed by the guys who hobnob over some “shrimp, cod and lentil soup” and creme pie with chocolate truffle shavings?   We just become part of clueless Jeffrey Immelt’s plan to outsource absolutely everything.  After all, if we had opinions and concerns what were important, we wouldn’t be laid off losers, would we?

And the patients and scientists pay the price.

So, what is Obama going to do to enforce his executive order?  He’s sending some sternly worded letters to make  sure manufacurers voluntarily comply.  {{rolling eyes}} Way to go, Barry.

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Damn, even in death, Steve Jobs never stopped inventing.  Best final words ever.

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On the Occupation front, Occupy Oakland is calling for a General Strike on November 2, 2011.  I think I will join this strike and urge the rest of my fellow recetnly unemployed researcher contingent to wear your labcoats on Wednesday in solidarity.  We’ve been screwed over by Wall Street too.

Love the solidarity orange.

Here’s a video of the California longshoreman’s union occupier throwing his support behind the strike (Copied shamelessly from Atrios’ page):

OccupyPharma and other cures

We are also the 99% Meeeeneeeemeeep!

Reader bemused_leftist pointed me to a defense of the control network that I posted about yesterday from a guy who works in one of those companies on the network.  Here are the money quotes from the defense from Andrew Drucker at Made from Truth and Lies: I’m annoyed at the sensationalist financial reporting:

I happen to work for one of those 50 companies, which gives me a little bit of perspective (even if I am very far down its hierarchy). And I can tell you that most of those companies aren’t in that position because of a conspiracy of control – but because you have a pension. AXA, Legal and General, Aviva, Sun Life, and many many more of the companies on there are there because ordinary people put their cash into life insurance or pensions, and that cash is then invested in the stock market so that it can make payouts in the event of either problems (for the insurance) or retirement (for the pensions). And because many of these companies provide pensions either for millions of people, thousands of large companies, or both, they are managing massive piles of cash.

Which doesn’t mean that they’re actually running the companies they own lots of shares in. Most pensions/insurance/life companies are terrified of telling the companies they own shares in how to behave – they want to own shares in something successful so that they make profits, but they don’t have the time to micro-manage them, and they really don’t want to get involved in anything that smells even slightly political.

This actually leads, sometimes, to insufficient control over the directors of large corporations – because if you’re in the FTSE 100, you’re going to find your shares are owned by a lot of investment companies, who just want you to churn out profits, without paying too much attention to, say, board-level renumeration. So you can get away with paying your high level people a lot without a share-holder rebellion. If they were owned by a few ordinary people then they’d find themselves subjected to a lot more scrutiny, and a lot more control.

Well, Andrew, speaking as a former employee of one of those companies that the network node companies are terrified to micro manage, I call bullshit.  The pharma industry has been micromanaged to death by the node network guys.  When they’re not totally onboard some gutwrenching merger or acquisition, they’re telling the CEO to cut more from research.  Yeah, that’s the ticket to a successful, money making pharmaceutical company!  Dismantle the research apparatus.  Do it quickly, like before the next quarter.  Andrew, please do not tell anyone in the pharma industry who has either lost their job or about to lose their job (those are the only two categories at the present time), that the pension fund managers and big banks and other financial sector players have not had a profound effect on the way pharmaceuticals run their businesses.  We have been at the Town Hall meetings when the head honchos have told us directly and to our faces that you guys have been leaning on them- heavily.  It’s not bad enough that pharma has been shooting it’s own image in the foot with lobbyists and high drug prices, that you financial types skim from, or that it is constantly under attack from the left for being less than perfect (as if there is such a thing as a perfect drug, there isn’t).  No, what really pisses the labrats off is yet another boneheaded restructuring plan brought on by some nitwit Wharton School graduate who just has to take the latest management trend out for a spin to teach those damn researchers that research costs money, by golly!  How dare they consume so many pipettes, order so many tests and break so many instruments.  Don’t they know that those costs go into the debit column??  Well, they’re going to have to learn a thing or two or we’re not going to make our quarterly estimate.

It’s been done to every one of the companies I’ve ever heard of.  If the companies aren’t shedding research jobs to hire cheap contractors, they’re shedding research jobs to just get out of unprofitable therapeutic areas.  Well, who needs antibiotics anyway?  The latest news is that Abbott is spinning off the pharma unit altogether.  Oh sure, they’ve got a blockbuster that will keep them afloat for awhile but most likely, they’ll get swallowed up by a bigger shark and where will the cost savings come from?  That’s right, the research unit.  These days, companies buy products, not the group that actually discovered the product.

More joy is on the horizon for 380 Amgen employees who learned just last week that they are going to lose their jobs.  (pharmas are either tricklers or gushers when it comes to cutting jobs.  Amgen is a trickler; Pfizer is a gusher.  But it’s all the same in the end)  Really, guys, do the rest of us unemployed labrats need more competition?  And Merck, the beacon of stability, that has been holding off the financial analysts bravely for the past couple of years while the rest of the pharmas have done what their masters ordered, seems to have finally thrown in the towel.  They are going to be making an announcement next week about reorganizing. Derek Lowe’s blog, In the Pipeline, has some of the details and this complaint from Derek:

And on a similar topic, here’s a post from John LaMattina asking what many people have at one point or another: how come Wall Street analysts get so much influence over how much a drug organization spends on R&D? His examples are Merck, Lilly, and Amgen, and his take is:

“Now, I am all for monitoring R&D budgets to maximize the returns from these investments. And I am all for accountability – asking the R&D organization to deliver new candidates to the pipeline, having formal goals with rigorous deadlines, and for running clinical trials as expeditiously as possible while keeping a close eye on costs. But for Wall Street to reward a company for lowering R&D spending and attack those that want to commit to R&D is absurd. Like it or not, R&D IS the engine that powers a pharmaceutical company. It is also a high-risk endeavor. Furthermore, given all of the hurdles that now exist especially with regard to ensuring safety and having sufficient novelty to justify pricing, R&D is more expensive than ever. But, if you want to succeed, you have to invest – substantially. There are no short cuts.”

Wall Street’s answer, which may be hard to refute, is that if you want the access to capital that the stock market provides, then you have to accept the backseat driving as part of the deal. But do we get the same degree of it as other industries, or more?

That is the rule, Andrew, not the exception.

Now, I know that a lot of people at OccupyWallStreet don’t much care for pharma.   I know it takes a lot of milk of human kindness to love us but try, people, try.  It’s really important that you try to understand this problem.  Because if there was ever an industry that needed to be liberated from Wall Street it would have to be pharmaceutical research.  Wall Street and pharmaceutical research are about as incompatible as two entities can get.  Wall Street is all about short term profits and paying the shareholder.  Pharma research “used” to be about developing cures through science and long term committments.  The Wall Street crew does not care if there is a research industry left in this country.  It is not interested in your excuses that research takes time and human organisms and their cells are very complex.  They are deaf to the pleas that we are being squeezed by the FDA to make our imperfect drugs perfect and need to carry out more and more expensive clinical trials that will cause some drugs to fail to advance.  All Wall Street cares about is whether the quarterly estimate will be hit or not.  And the MBAs who populate pharma’s corporate office suites are there to see that it is done.  That’s why they make the big bucks.

This is an opportunity, occupywallst, to take pharma back and make it work for the public.  Don’t pass this one up.

Moving on to cures of a different kind:

The people at ApartmentTherapy are starting the 20/20 Home Cure on Monday.  It’s 20 minutes a day for 20 days.  Each day features a different project to get your house back in shape.  You can sign up at ApartmentTherapy on Monday.  Here’s Maxwell’s introduction video to explain what it’s about.  If you are a bit more ambitious and need more structure in your home clean up routine, check out the 20 minutes for 30 days plan.  You can add these tasks to your favorite productivity tool (I’m testing out Home Routines for the iPad) and they can come up on a regular basis.  I have heard that if you do something for 21 days, you’re more likely to make it a lasting habit.  So, if you’re like me and you spend  a bit too much time hunched behind your computer, join ApartmentTherapy on Monday for the Home Cure.

Apartmenttherapy is just a great site to add to your daily routine anyway.  If you’re looking for a way to change your home environment in some way, they have the answers, ideas, DIY projects and plenty of design inspirations from people on budgets, updated frequently throughout the day.  They have several sibling sites too that cover everything from renesting, food, and parenting to planning your next high tech gadgets.  Another blog of visual relief for the home is Design*Sponge by Grace Bonney and her crew.  Highly recommended.

On the menu for a cool fall evening, Roast Pumpkin with Cheese Fondue.  I made this last year.  Dead simple to assemble, delicious.  Should be served in front of a toasty fire with salad and a crisp white wine.  Yummm.

Dead Space in the Pharma Pipeline

This article is a few months old but just now showed up in my LinkedIn updates.  It’s another indication of disintegration in the pharmaceutical industry as it heads towards the “patent cliff”:

Scientists warn on “dead space” as pharma giants shuns neuropsych:

European experts are sounding an alarm about the recent pullout of GlaxoSmithKline and AstraZeneca from the brain disorder arena.  David Nutt, a professor Imperial College London, and Oxford’s Guy Goodwin are calling for a rapid response to what they term a collapse in R&D spending in the field.

“What we have forgotten, and must not forget, is if we stop this research we will have a dead space of 20 to 30 years before we can re-tool again,” Nutt tells The Guardian. “Despite the public health imperative, not only has EU research funding remained very low, but–even worse–big pharma is increasingly coming to see research into better neuropsychiatric drug targets as economically non-viable.”

That effectively sums up the position of GSK’s Andrew Witty, who has explained that the huge risk associated with developing new drugs for neuroscientists is just too high to justify the investment necessary. The Guardian notes that the average time it takes to develop a new drug for a brain disorder is 13 years-considerably higher than the average program and significantly more expensive.

The article goes on to say that the authors have proposed that pharmas be encouraged to give this area of research to academic labs and that government make an effort to protect small labs and companies who agree to do this research.

The reason why neuropsychiatric medications are so “economically non-viable” is because the body protects the brain from foreign, potentially toxic substances with a physiological feature known as the “blood-brain barrier”.  Basically, there is an extra “layer” of protection around the central nervous system that drugs have to cross in order to reach their targets.  That means, the compounds that might be the most effective have to first be bioavailable to the body and then have to have  certain additional physical properties to cross the blood-brain barrier.  Developing these kinds of drugs is very time consuming and has a high failure rate.  Messing with the brain is not for the faint of heart.  There are specificity issues to deal with as well.  I once worked on a project where the drug was initially developed to target a serotonin receptor in the brain in order to reduce appetite.  It turned out that it also caused severe priapism in primates.  We must be very, very careful or someone’s going to lose a penis.

For those of you who might be hoping for a treatment for Alzheimers, schizophrenia, bipolar disorder, epilepsy or stroke, the authors of this article are saying that the research in these areas are so expensive for big pharma that they are mothballing the projects.  Starting them up again, and finding chemists who understand what it takes to make compounds that cross the blood-brain barrier is going to set back research by 20-30 years.  Then, if a company or academic lab does decide to take this on, they’re going to need governmental protections, to keep them from going under while they work out the kinks.  Presumably, this would include some kind of insurance against the inevitable class-action lawsuits as well as some kind of patent protection.

The patent reform act that was signed recently will probably not be a friend to small labs.  The change from “first to invent” to “first to file” puts a lot of burdens on small labs that may not have a fully staffed patent department to work through a patent application.  That leaves them vulnerable to large pharmas who will make them an offer they can’t refuse.  If I were reforming the patent problem, I would have split off biomedical patents from other patents and then, counterintuitively, extended the patents for new drug entities.  Before you get your knickers in a twist, hear me out.  One of the reasons that drugs are so expensive is because they spend a lot of time in development and clinical trials and those trials eat up the time left on the patent.  These days, the FDA requires more safety data and clinical trials before a drug is approved.  (I *know* there will be some readers who will insist that drugs are fast tracked but they are not paying attention.  Fast tracked drugs are mostly oncology drugs where there is a bargain between patients who are terminally ill who may be willing to forgo the additional safety requirements.  Fast track for all other drugs is very rare)  The longer the drug sits at the FDA, the greater the potential high cost to consumers and marketing executives, seeing an opportunity to increase share holder value, may pad that price even more, using the FDA holdup as an excuse.

Pharma is also not well served by the frenzy of the financial markets to produce higher profits every 3 months.  When push comes to shove, the human body will do what it damn well pleases.  You can’t force Mother Nature to perform on a quarterly basis.  See Derek Lowe’s post on GSK’s mystifying new scheme for creating a pharma division with a racecar fuel manufacturing facility.  We have no idea what GSK is thinking but we are aware of some computer chip manufacturers complete cluelessness when it comes to drug research.  You can’t research a drug the same way you research a chip.   And MBAs who do not understand their business will do dumb things when they are under pressure to produce profits.  Biomedical research is unlike any other form of high tech research.  You can’t pair the two and expect that the cells that the biologists are working with will suddenly get a clue and get with the program.  And this is why the patent problem is also different for the pharma industry because shortened research cost recuperation times leads to a lot of very stupid short-term thinking.

If I were to reform patents, I’d stop the patent clock while the drug was going through the clinical and approval process and resume it after approval.  Then make a deal with the pharma industry to ease up on pricing in exchange for longer exclusivity.  This accomplishes two goals: it takes the pressure off of pharma to price the hell out of the drug and it steers them back towards long term planning.  If they know the patent cliff isn’t looming a few years down the line, the pace of mergers and restructuring might slow down and research would have some breathing room to get back to business.  It’s a theory.  There’s always a way for the financial class to game the system so thinking this through carefully and plugging the loopholes would be very important.  But that’s what I expect from my congressmen- careful, meticulous examination of the problem with reasonable solutions.  Changing the first to invent to first to apply rule did not do that and may have inadvertently exposed entrepreneurial labs to additional risk and expense.  Well, inadvertently to Congress; opportunistically to the big pharma vulture capitalists.  Hey, it’s a business.

Anyway, it’s something to think about.  It’s not just CNS drugs.  Antibiotics are also losing their shine with the big pharma giants.  Too many lawsuits.  Oh, well.

Ooooo, SNAP!

Here’s a David and Goliath story that will give you some insight as to how senseless and stupid the decimation of the pharmaceutical R&D industry has been and how insensitive upper management can be. I found the link at
Derek Lowe’s In The Pipeline blog.
It’s about a medicinal chemist who worked on a project that resulted in the discovery of a block buster drug for a company that was bought out by another company. You can probably guess the rest. Yes, his site was closed down and everybody on the project was laid off. Congratulations for discovering this shareholder value enhancing drug. Please meet me in the cafeteria at 9am and then go away.

So, the chemist did go away. Many years later…

I got recently contacted by a patent litigation attorney from a giant pharma company, a company that is advertising on TV every night and whose name rhymes with “Mergers and Massacres”: They have a drug that is selling over a billion a year and now the key patent for this drug is facing a challenge from two generic competitors. Since I am on the patent (there is about dozen authors) the lawyers wanted to prepare me in case that I get subpoenaed by those generic companies challenging the patent. They offered me a free legal representation in the hearings and they proposed to pay me as a consultant (“at my usual rate”) for talking to them and for the deposition – should this subpoena happen.

The detailed history of the invention seems important in this case because the patent that sets the invention priority (and thus affects the date of the drug monopoly expiration) is being challenged on several fronts. It appears that their legal team has been having some difficulty piecing together the exact timeline of the project – who proposed/synthesized what and when (even as they have all the notebooks and employment records in their possession). Apparently no-one from the original team is employed with the company anymore: We were summarily laid off when our research site was shut down. (The chemistry director was actually forced out, under rather contentious circumstances, shortly before the site closure). Only a handful of employees was re-hired elsewhere within the company. And surprisingly, it seems that some of my ex-colleagues are not getting in touch with the patent litigation team now…

I am also not calling the lawyers as they repeatedly urged me to – instead I wrote to them and shared some of the impressions and experiences that I had while being – briefly – a part of their company – and I also reminded them of the class-action lawsuit that my ex-colleagues brought against them, when the company reneged on their severance payments after the layoffs. (The company settled out of court and apparently paid in full the promised amount, about 2 years later.)

Also, I reached out to the two generic companies involved in this litigation and informed them about this legal team approach from my former employer – and I offered to answer questions about the history of this drug discovery and I gave them the names of the few important inventors on the patent who could be perhaps more helpful than me. Then I wrote back to the legal team of the large company and I let them know that I contacted the two generic companies. I explained that I don’t want their money but maybe they could re-evaluate how they are going to treat the R&D inventors in the future. You know, in case they need them again.

I hope milkshake doesn’t mind me quoting him in his entirety. The story is just too, um, well, let’s just say that the week after I was laid off, an official email was sent around to all the staff from the bean counters who congratulated themselves at meeting and exceeding their proposed cost cutting targets for the quarter. I guess I was supposed to feel good about how my job was sacrificed to achieve that goal. The dudes who made that performance objective probably got a bonus that was roughly equivalent to my salary. Yes, yes, party on.

So, anyway, that was pretty nervy. I am in awe and bow to his surplus of balls and everlasting righteous indignation. Score one for the geeks.

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.