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Martin Shkreli is low hanging fruit

frances-mcdormand-marge-olmstead-gunderson-fargoSo, Martin Shkreli has been arrested, but not for being the biggest parasite on sick people “all for a little bit of money”.  It was for sucking a startup dry in order to cover up his hedge fund losses.

There’s a reason why I’m not in pharma anymore. My options were limited and one of them was to go into a startup where the nature of the work is the same, the overhead is very high, the money is super tight and there is always the possibility that the vulture capitalists will treat the company as an object and not composed of real people. With real lives. And real careers. And real children.

But Martin Shkreli’s “Mine, Mine, All Mine!” business model is not unique. Before I explain what currently drives the drug industry, let me make two things clear: 1.) it wasn’t always like this and 2.) the lab rats are not to blame.

Basically, the drug industry has moved away from small molecule drug discovery. The industry is moving towards biological drugs for cancer and orphan diseases. There are a couple of reasons for this. They are easier to get through the drug approval process. If there are major side effects, the patients are the last people in the world to sue or complain. And the patients are desperate. They will pay whatever it takes.

Now, I’m all for biologicals for many good reasons. They have a good chance of working in the case of cancers and metabolic diseases. But while  all of the capital has flowed to these types of therapies, the stuff that most people suffer with on a day to day basis have gone without funding, and the people who used to work on those therapies have been out of a job.

So, if you have high blood pressure, schizophrenia or need an antibiotic, you are SOL.

The thing about Martin is that he’s just the most visible and egregious example of greed. And I’m not letting the left off the hook for this disaster. If it hadn’t been for the notorious class action lawsuits (please, don’t even start, you know what I’m talking about. We’re not talking criminal negligence here) we might not have ended up here.

I’ve written about what I think is going to happen to the cost of drugs before and one of these days, I’m going to properly tag and categorize my previous posts on the subject. But let me recap it here. Drug prices of all types are going to continue to rise. The new biological drugs are going to start off being astronomically expensive. The cost of generics are going to go up and up and up. Here’s why: brand name drugs and blockbusters are going off patent rapidly. Ohhh, you say, that means the generics that they turn into will be cheaper. Ha! Say I, you forgot your basic economics 101 course section on supply and demand.

The supply of new drugs with fewer side effects is going to go down. New small molecule drugs get approved rarely and the patent time left for them is short. So to recoup the cost of research, which is substantial, the cost of the drug will be high. Meanwhile, the brand names that have become generics are going to become the play things of people who are much more sophisticated and low profile than Martin Shkreli. The drugs still need to be made in FDA inspected and regulated facilities. That costs money. That money can’t be recouped from a cheap generic. And without blockbusters to keep the lights on, the cost of the generics will need to increase.

I’m just picturing a series of rolling blackouts on some of these drugs in the future. You need a blood pressure med? Darn, that production facility needed to be taken offline for maintenance. It might not be maintenance but there will be some excuse for why there is a shortage and the price needs to go up. And up. And up. They’ll start blaming it on regulation. Hey! A Twofer. If the shortage of your blood pressure med is caused by the federales, why not make it easier to get that drug made in China? It’s generic, after all. You’ll never know the difference. And besides, what would you prefer? Some outdated federal regulatory process on a brand name drug that has gone generic or a stroke?

I don’t know about you, but I want my drugs regulated.

This is the financialization of the pharma industry. Twenty years ago, we wouldn’t have been concerned about hedge funds getting involved in pharma to the same degree that they have. That was before the MBA’s moved in ad decided that R&D staff had it too easy, they weren’t working hard enough and luxuriated in spacious labs instead of cramped cube farms like the accountants and marketing people in the business unit down the road. (yes, I have actually heard this childish and clueless complaint from the MBAs) It should be against the law for petty selfish people to run an industry as important as the drug industry. But you can be sure that the big players are glad for Martin Shkreli to take one for the team so they can get back to business in peace and quiet.

They don’t need the attention.

Well, until the bacterial apocalypse arrives

More Whineter, STEM and being a dick with peppers

It’s March already. Why is it still snowing? Why is it 15º outside?? The other day, it rained and melted some of the snow. The sump pump was going off every 90 seconds. I timed it. I started to see the ground. This morning, I woke up and there’s another layer of snow out there. WTF?? I have about a cup of rock salt left and there’s none to be had for miles. It’s too much. Make it stooooop.

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

In other news, PA Governor Tom Wolf visited a school in Chester yesterday to find out about its STEM programs.

Ok, I know Wolf didn’t ask for my opinion but when has that ever stopped me from giving it? (There’s a proposal at the end of this little rant so stay with me.) Here it goes:

There’s no living wage in STEM jobs. Even the people who have good jobs are constantly worried about losing them. They’re forced to move to very expensive parts of the country and can never relax. The fear of losing a job just after they might have already lost one is not a good way to live. This happened recently to people I used to work with who were transferred to Massachusetts after the layoff, and then lost their jobs- again.

Jumping from job to job after a short period of time means people in pharma and biotech R&D will not achieve the degree of experience that they need to be really good at their jobs. It takes a long time for R&D professionals to gain enough experience to be really useful to their company. That means starting and staying with a project over a long period of time, like, 5-6 years. At that point in time, they will have just about enough seasoning to be useful to the company and laying them off is a tragic waste of talent. There is no cheap substitute, as this country will begin to realize (and may already realize, judging from the ads I’m seeing for computational chemists with at least 5 years of industrial experience).

Unfortunately, this is not what the finance industry had in mind. It thinks we can all work under their crazy employment rules like they do on Wall Street. That means flexibility at all costs. That’s a losing game for the R&D professional in terms of living standards, skills and passion for research.

If the R&D professional doesn’t get a good paying job in Cambridge or San Francisco, the alternatives can be grim. Academic research associates with PhDs and industrial experience make between $37-$54K/year. I know because I have the job postings to prove it. You can live on this in the midwest but academic research is subject to grant availability. If the grants don’t materialize, the jobs don’t either.

A potential place where a governor can productively intervene is at the small start up level. Pennsylvania would be a good place for startups, especially in the Pittsburgh area, which has a university/medical culture and a renaissance in the east end. There’s good mass transit, affordable real estate, and an educated population. BUT what every state of the country lacks at this point is access to affordable R&D resources. That is, there are some things that any start up is going to need access to but probably can’t afford. In my case, as a consultant, I can’t get access to a lot of scientific literature. I don’t have a license to Elsevier, ACS publications, etc, which can cost millions of dollars to a large university. I also can’t afford the vendor licenses to do my modeling work. I can ask vendors to give me demo licenses, for which I must sign an agreement to not use them for research. They’re only for evaluation purposes and to keep myself current. If I want a license so I can make money, well, I can’t afford the license.

So, verily I say unto Tom Wolf, if you want to attract STEM startups to Pennsylvania, (and why not? It’s a heck of a lot more affordable than Cambridge) you need to fund a license bank. Ok, I don’t know what else to call it. Make it more affordable for startups and consultants to access the licenses they need to get their work done. At this point in time, the only entities that can afford licenses for literature and proprietary software are large multinational companies and universities, leaving the rest of us to smuggle papers and cobble together software solutions from publicly available sources. That leaves us at a disadvantage in the beginning phases of research where the start up costs are already astronomical.

I don’t know if a license bank has ever been done or what a configuration might look like but here’s one possibility: Put the licenses on a PA server, start a consortium, and allow startups and consultants to ping the licenses for a fee based on number of papers downloaded or amount of time licenses are checked out. Or make us fork over a cut of anything we discover to the state. I could agree to that. Wouldn’t Tom Wolf like to be a partial recipient of the next antibiotic patent? Yes, this would be an investment for the state. It could cost several millions of dollars. No, Republicans won’t like it because… I don’t know why they wouldn’t like it. They’re always going on about helping small businesses but they want us to somehow use magic to afford the start up costs. I’m beginning to think that Republicans aren’t being honest with us about their love of entrepreneurs and small business people… Is that possible?

But the payoff could be substantial for the state if it attracts businesses and the patents generate money. That money could be used to fund education while some of it could be used to buy other things early discovery researchers might need. It could be self funding down the road because if you run for two consecutive terms, you could leave a nice little pile of patent shares for the state by the end of your them.

And since I need a real job, I will gladly work for the state setting up this system for a decent living wage. No, no, don’t thank me. See my LinkedIn profile.

So, there you have it. I have given you a possible solution to a pressing problem that doesn’t involve the governor making pointless visits to schools to encourage innocent children to go into professions in which they can’t make a living. As for teachers of STEM subjects, that’s where some of my former colleagues are going now that they can’t make a living in research. So, you know, you’ll have plenty to choose from.

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

Finally, Titli Nihaan has a recipe for a hot dip on a cold day. Pay attention. 😉

Tuesday: Questionable strategies

Richard Dawkins has a strategy to move politicians away from catering to the religious- ridicule their beliefs:

Now, I know there are some believers on this blog who will take offense by Dawkins statement but I think he has a point.  AronRa, youtube atheist blogger, was arguing with the faithful at the Reason Rally and put it something like this: science doesn’t rule out the existence of a god.  We’re just waiting for evidence.  But that book?  That bible?  Yeah, *that* God doesn’t exist.  Everything that is in that book has been proven to be a fable.

Well, I don’t know about EVERYTHING, but just about everything in the first five books of the bible is mythology.  Sorry, believers.  That’s just a fact.  There was no Adam and Eve or Tree of Knowledge or talking serpents.  Noah might have been based on a real person but his account can be found in a Sumerian document that was written about a 1000 years before Genesis.  Even Moses might have been fictional and the rules in Deuteronomy were penned by some self serving priests.  That’s what archeology tells us.  I’m a personal fan of Jesus but only his parables, sermons and the occupation events he staged during his last week.

If more believers could just put that Judeo-Christian god in its proper context and move on to God 2.0 or no god at all, we could get this country back on the right track and stop this ridiculous charade every four years where the presidential candidates stoop to out-holy each other and use religion as an excuse to deregulate anti-discrimination law protecting women.

The proscriptions against gay people, the submission of women, the silly rules about crustaceans and fabrics, the harsh punishments, all that is based on Bronze Age culture.  Um, we don’t live in the Bronze Age.  Four hundred years ago, we stopped believing that the earth is the center of the universe but for some reason, despite all of the evidence to the contrary, we still believe that humankind emerged from two naked people in a mythical garden.

It’s only with time and distance that we can see the bible as it really is.  Once you’ve reached that tipping point, the whole construct falls apart.  It’s ridiculous to expect modern people to run their lives and governments based on Bronze Age writings and drug induced hallucinations of a dude stranded on an island off the coast of Turkey.

So, unfortunately, I think Dawkins is right.  For all we know, we and the people around us have only one life to live on this earth.  The biggest sin we can commit against them is to ignore the suffering of others because the end of the world is coming any minute now or treat the disenfranchised like second class citizens because of who they love or what plumbing they have.  What a waste of talent.  And if there is a God, it would be really stupid to exclude good people from making a difference in the world because God can use all the help she can get.

Anyway, these days, when I hear the religious go on about how evolution is wrong and Adam and Eve are right, and that a convicted conman in NY found a bunch of golden tablets, that no one else has ever seen, and translated them into English from Reformed Egyptian and that this is the basis upon which we control women because they are less than fully adult, this is what it sounds like:

Sounds unbelievable, doesn’t it?

That’s because it is.

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

Yesterday, the Supreme Court set aside a lower court ruling awarding patents for two breast cancer genes to Myriad Genetics.

I have mixed feelings about this. On the one hand, discovering a gene that already exists in nature is not the same as discovering a small molecule drug to treat disease. That would be like patenting some exotic species of plant collected by some ethnobiologist on a field trip. I can see how you could patent an analog (structural modification) of a chemical that the plant produced but the plant itself? Any scientist should be able to study that plant and use it for research. The plant isn’t novel and wasn’t made by man. Same with genes.

I think many of us in research have run into the problem of trying to work around a patent like this. About a decade ago, I was on a project that had to get around a patent on a protein structure. That’s right, the competition had patented their protein structure. It was available in the publicly available database but researchers couldn’t use it for drug design while the validity of the patent was still in dispute. So, even if the patent holders eventually lost their rights, they would still have had a substantial lead over their competition who would spend months and years trying not to look at the binding site of the patent structure. It’s like blindfolding your competition.

On the other hand, it’s bloody expensive to do research. Mindboggling, ridiculously expensive. If you do manage to isolate a gene and plan to use it for commercial purposes, you should be able to recoup the cost of your discovery efforts. Up to this point, companies like Myriad Genetics license their technology to other companies. Academic institutions also do this with their proprietary assays which are expensive and take many months of negotiations and lawyers to acquire. Without the licensing fees, these institutions will be asked to turn over their discoveries for the good of mankind with little compensation, or invest in discovery efforts, which they may not have the money or expertise to do. Companies will start firing their staff and going overseas where it’s cheaper to hire people. It won’t be faster or better. Just cheaper. And the scientists who are thrown out of work over here will just stop doing science altogether because it is impossible to have a stable domestic life.

In recent years, many big pharma companies have turned to biologics and shed their small molecule drug discovery efforts. That’s because small molecules have to be defended against patent infringement and the class action lawsuits that follow the release of every new drug. The companies thought they had a winner in biologics and they may still. But this case may put those discoveries at risk if they turn out to be nothing more than the product of nature. They should expect a lot more patent challenges. And without their small molecule drug discovery units, which have been mercilessly obliterated by the short term goals of the financial class, they may find themselves on the bitter end of ever diminishing returns. In this case, karma works against everyone who is hoping for a cure from modern medicine.

What pharma needs is a long term strategy and relief from some class action lawsuits. I know the left doesn’t want to discuss tort reform but in an industry where perfection and customization for each individual is not possible yet, the prospect of class action lawsuits has had a chilling effect on discovery and approval of some drugs. There are many other problems with drug research companies that I have outlined before but there is no doubt that the system is broken and may take a long time to fix without incentives to shift to a long term strategy. Research isn’t cheap and researchers need to eat. Drugs can’t be free but we may be able to make them affordable if we develop new strategies for discovery.

Something’s got to give.

 

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.

Bernie Sanders and the $1Million dollar drug innovation prize

Bernie Sanders sent out a tweet yesterday pointing to a Slate article from 2008.  It’s a proposal for revamping the patent system.  The idea is to reward drug innovators with a $1Million dollar prize instead of a patent.

 

When I told the BFF about it, he said, “Great!  What do we do on day 2?”

Seriously, Bernie, this is not necessarily a bad idea.  There are a lot of drug innovators out of work right now, or their work situations are very precarious.  This is especially true of medicinal chemists who specialize in transforming chemical scaffolds into drugs.  Then there are people like yours truly who design drugs who are vamping until our next gigs.

The problem is that drug research is incredibly expensive.  Any idea we have has to be ordered or made, and then tested.  There will have to be multiple assays run to verify structure activity relationships and biological activity.  Then there is the gauntlet of safety analyses required by the FDA.  It could work in a virtual environment but it requires the drug innovator to assemble a pharmaceutical company by themselves and presumably that $1M prize would have to be used to pay all of the contributors back.  After all, pharmacologists have to eat too.  What I fear would happen with the prizes is that desperate innovators would end up signing all their rights away to venture capitalists in order to make payroll while they’re starting up and going through the necessary iterations to prove a concept.

In other words, it’s not enough to live on or start to innovate, especially when one considers that it takes years and overhead expenses of the painstaking trials and errors to bring a drug to market.  Incubators have a very high failure rate.  I’m sure that the incubator model is just perfect for someone out there looking to feed on carrion but for labrats with families?   Ehhhhhh, not so much.  How do you bring down the startup costs?

I have a better idea.  The government can start its own companies.  Right now, pharmaceutical companies are trying to shed or tear down their labs in the US.  They want to rent the space to incubators but frequently, the price is too high for little companies.  In the end, it’s cheaper to just demolish them.  Buy the suckers up along with the equipment.  Better yet, snap up the old labs in the midwest.  That way, the scientists you need to hire to run the places can afford to live there on reasonable salaries.  Give us a place to do what we love and let us make the management decisions without the constant restructuring and mergers.  Then, we’ll sell the patents back to the government for a dollar.  That’s the going rate at the old pharma I used to work for.  It’s a fair deal.  You get dedicated scientists who can focus on their work without worrying about losing their houses and their kids’ college funds and you get the patents you need to bring the costs of prescription drugs down.

While you’re at it, reform and update the FDA so new drug entities can come to market.  You’re also going to have to level with the public about drug safety.  It is going to have to assume some level of risk or new drugs will never make it.

The big pharma companies won’t like it much.  In fact, I can already hear them howling and marshalling their army of lobbyists.  In general, I’m sympathetic to their predicament but if they hadn’t bet the pharm on short term solutions instead of the hard work to fix a broken system, they wouldn’t be in mess they’re in.  This is where we are in terms of drug innovation: research for antibiotics, cardiovascular, CNS and reproductive health drugs are getting severely scaled back by big pharma.  The big companies are going after biologicals, which have their own set of problems.  Well, alright then, let the pharmas knock themselves out on antibodies and have the government focus on the other therapeutic areas they have decided to pass on.

So, go, Bernie, but think this through thoroughly. You want to set it up in a way that makes it resistant to political games.  What pharma research needs is stability in order to innovate.  Any potential public-private partnerships need to be set up in way that protects and preserves this country’s scientific infrastructure and allows innovation without the chaos of the quarterly earnings report.  In other words, R&D has to be sequestered from the pressures of the business environment to some extent.  Just as you don’t want your insurance company deciding your medical treatment, you don’t want MBAs directing research.

Make sure to consult people in the R&D industry who are already in the process of setting up their own mom&pop drug companies in their garages.  That means you need to talk to the people who actually do the work, not the management class.  You will get a completely different assessment of what is broken in the current system and how to repair it.  You will have to compensate us well enough to induce a future generation of scientists to discover drugs.  That’s because this is hard work, requiring years of study and lab experience.  It has to be rewarded appropriately.  Health care and pensions would be very attractive.  But in the end, it could be a bargain.