Why Ebola spread in Dallas: Americanism

Lorenzetti’s Allegory of Good Government, 1339

We’re number one.  That’s what we always tell each other.

We have the best health care in the world.

Our public safety institutions are number one in the world.

We  are the richest country in the world.

We are supremely over confident.

How many people know that when Dr. Kent Brantley and Nancy Writebol returned from Liberia with ebola that their care was paid for by Samaritan’s Purse?  I’ll bet a lot of us just assumed that the US government picked up the tab for the flight, biocontainment units, ZMapp doses and hospital stays.  Not so.  So, who is paying for the transport and treatment of Nina Pham and Amber Vinson?

Probably a few more of us have questioned whether money was behind the shoddy care that Mr. Duncan got in Texas.  I have.  I’m betting that his lack of insurance and status as a foreign national had a lot to do with why he wasn’t immediately isolated when he first came to the hospital and why he was left in the ER for hours, some nurses say days, before he was transferred to a critical care unit.

As for the best health care in the world, the nurses were very unprepared for ebola.  The biggest chunk of the blame goes to the hospital.  It’s a hospital for the middle class and those who can afford the best health care in the world.  That’s where people go to have their babies and bypass operations.  Maybe they didn’t associate their kind of hospital with an epidemic in a third world country.  Bad things happen to THOSE people over there in Africa.  Not their kind of people in Dallas.  At best, that’s a benign form of American narcissism.  We’re so used to having clean water and streets and good food.  So, why should the hospital get all Girl Scouty and be prepared for a situation that will never happen to it?  Training for such an eventuality takes time from nurses doing their duties and time is money.  It’s the American way.

The CDC seems to have vastly overestimated the outcomes of our educational institutions, especially our K-12 schools, where everyone should have a pretty good understanding as to where Liberia is.  But then again, Liberia was a state created by former American slaves in the 19th century and Texas is a state notorious for trying to rewrite the past when white Americans might have done bad stuff to anyone.  But still, don’t these ER intake people, nurses and doctors watch the news??  At least one nursing supervisor seems to have been on the ball and insisted on moving Mr. Duncan to an isolation unit instead of letting him shed viruses all over the ER but she was shot down by her administration.  Still, you’d think that a hospital so concerned with its reputation and profits would have been more proactive in limiting the damage that his presence was causing.  Not so, apparently.

And what was the hospital thinking when they gave antibiotics to Duncan when they hadn’t bothered to find out whether he  had a bacterial infection that required them?  Does Texas Health Presby Hospital routinely overprescribe antibiotics?  Is this a hospital or a student health center?

What were Republicans and Democrats thinking when they cut the budget for the CDC by 12% and the NIH by 20%?  Friedan said yesterday that $30 million was restored earlier this year in an “anomaly”.  How the hell are you supposed to prepare for emergencies if you never know what your budget is going to be from one year to the next?  We complain about administrators making decisions for our health care instead of physicians but our bigger problem is that we have politicians making decisions for our disease fighting institutions.  Should the CDC and NIH know in advance what diseases are going to become epidemic on some kind of 5 year plan and ask for the right budget money in advance?  Or are their functions compromised by their unreadiness brought on by this reckless political posturing?

And everyone, politicians, journalists and people who should know better, is under some mistaken belief that the private sector is going to step up and perform the tasks in research and disease prevention that the CDC and NIH were created to do.  But they’re too busy trying to reap profits for the shareholders to engage in such money sucking activities like research. Meanwhile, we underfund the NIH and CDC.  Is that so Republicans can point to what a sh*%%y job government does?  Are they paying no attention to how our scientific infrastructure is being dismantled in this country and concentrated on a few narrow therapeutic areas?  They are leaving a gap that no one is able to fill.

This may be the richest country in the world but the riches are hoarded by some pretty selfish individuals and we don’t seem to be able to get our act together to force them to give up their loot for the greater good.

A little ray of hope came through yesterday when I saw that some television content providers are breaking away from the package deals offered by cable companies to allow viewers ala carte channel selection.  That’s great because eventually I will no longer have to subsidize right wing propaganda from Fox News or be forced to pay for Fox to mislead unsuspecting American viewers.  I’m betting that a lot of like minded individuals across the country will drop Fox from their lineup the second they are able to do it.

But the damage may already be done.  The Senate may fall into Republican hands this November and in the next two years, the predators who have been stalking us since FDR got us out of the Great Depression will finally be able to finish us off.   The willfully ignorant elderly and angry white males will finally stick a fork in us, and allow the extremists to carelessly destroy Social Security, roll back women’s rights and plunge us back into recession with unrestrained austerity.  The only thing that will stand between the power extremists and us will be Barack Obama.  That right there is a very depressing scenario.  But maybe he will have the courage to stand aside when we finally pick up our torches and pitchforks.

We have been living a myth of our greatness.  We’ve been in denial about how government works.  We have told ourselves lies about how we can “starve the beast” that once made our country a formidable force of good around the world.

I’m only glad that the ebola crisis here will be under control before the next session of Congress begins and before the gung-ho, American exceptionalists who take over show us just how unexceptional we are to the hunters who prey on the young, old, and weak.

Section from Lorenzetti’s Effects of Bad Government, 1339

 

More speculation and budget numbers at Angry Bear Blog.

Another thing that irks me

Vox has a new post about Frances Collins remark that if the NIH had better funding, we would have an ebola vaccine by now.  Vox says this isn’t true.  I think this was addressed briefly during the hearing.  The NIH went for years looking for a partner for vaccine research in the private sector and couldn’t find one.  Finally, they got GSK and another company interested in development.

Here’s what Vox doesn’t understand about drug discovery research and I have seen this repeated time and time again until it has become ingrained and hard to dislodge:

The NIH is not the only player necessary to take vaccines to market. The agency’s role in pharmaceutical development is usually basic research, giving scientists grants to look at how diseases function and what can stop them.

When it’s time to use that science to build a vaccine, that’s where drug companies typically come in, paying for the trials and manufacturing. We don’t know whether, in a world where the NIH had more funding, a pharmaceutical company would have stepped forward to do this. There’s decent reason to believe there wouldn’t have been; a vaccine to treat Ebola, an infrequent disease that hits low-income areas of the world, is hardly a blockbuster.

This is the conventional wisdom but it is incorrect.  The NIH does provide valuable basic research but the key word here is basic.  It’s not like the NIH develops a vaccine that just needs to be “built” by private industry.  It’s the same thing with drugs for cancer or any other illness.  The NIH provides very basic starting points.  After that, private industry has to pour massive amounts of money into research to fill out the details to get it to the point where it can be built.

What Vox and others do not understand is that private industry research is Real RESEARCH.

Now, if Vox wants the NIH to do the same kind of research that private industry is doing, starting with basic nuggets performed in NIH sponsored labs and publishing work that frequently can not be reproduced in private industry labs (I have been there, Ezra Klein), then it will need a lot more funding.

And this may be necessary anyway because private industry has decided that Real RESEARCH is way too risky and it would prefer not to do it anymore. (Hence the hundreds of thousands of layoffs that we refer to as Pharmageddon)  So, if we want a vaccine for anything, it may eventually have to come from the NIH.  That is what Collins is referring to.  NIH can only go so far without a private partnership.  If the partnership isn’t there and funding is cut, guess  what?  No vaccine.

This has been another episode of a former drug discovery researcher fruitlessly trying to correct the record.

Clueless scientist asks a very dangerous question

How the world sees scientists. Thank you, Underdog.

Note: Congressional hearings on the US Ebola efforts are going on right now with representatives from CDC, NIH, BARDA, FDA and others.  You can watch it here.  If anyone wants a live blog, let me know.  I invite other geeky types to watch and summarize, especially those of us with knowledge of the drug discovery/biotech area.

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No, it’s not me.  I admit to being clueless sometimes but not when it comes to the distribution of information.

I’m talking about Leonard Adleman who wrote an Op/Ed in the NYTimes about how easy it would be to revive smallpox.  The reason it would be theoretically easy is because the sequence for the smallpox virus is available online.  So, some really clever evil genius with a garage lab could potentially order up a copy of the gene from one of the synthetic gene specialists in South San Francisco and piece the sucker together using, oh, I don’t know, a variola, vaccinia or orthopox virus just hanging around.  It sounds complicated and might take some time, and if the independent researcher was born in the 80’s, there’s a good chance he’ll die of the disease if he’s not careful.  But it is possible.

Personally, I’m more concerned about reviving the 1918 influenza strain and getting it to go airborne, which, if I recall correctly, was successfully done a few years ago in Europe.  From what I remember, the researchers on that team suppressed the sequence.  Funny, I can’t seem to google that info.  Hmmm…

But getting back to Adleman, he’s not so keen on us just publishing the sequences on public databases.  Maybe it would be better if we just restricted access and only let the professionals see them.  That’s just nuts for a couple of reasons.  The first is that through the years, I have noticed that the sciences are full of people with psychopathic tendencies.  Fortunately, most of them get promoted out of the lab into management.  But just because they might be working at a prestigious lab with unrestricted access to information doesn’t mean they’re not out to get us.  After all, we still don’t know who did the anthrax attacks and I’m pretty sure it wasn’t a garage biologist.

The second reason is, referring to smallpox especially, we have a vaccine for that.  Oh sure, there will be plenty of thirty year olds who may be at risk but an outbreak would be limited.

And for the people who have extraordinary skill in making lethal viruses, I have a perfect solution: HIRE THEM!  Jeez, why in god’s name would you lay off hundreds of thousands of talented people and have them stew over the MBAs and shareholders who wrecked their careers??  Especially when there are auction sites where they can buy discounted equipment from mothballed labs?

I can’t see a teenager doing this, although we do have a lot of malicious computer viruses so who knows.  But they would have to be trained.  Just getting the sequence is not enough.  It’s not like writing code and you can’t get all your information from a book.  Maybe grad students would be capable if they’re motivated, so you tyrannical PIs out there should be on your guard.  But cooking up stuff in a lab takes practice and some good mentors to teach you how to do it.

In other words, it is possible that some well funded hostile country could fund this kind of work by sending some grad students to study in Dr. Adleman’s lab, for example.  He and his students would always have access to sequence data. But smallpox is not a threat and the other diseases are not so easily made.

But the best reason for not restricting access is that it once again takes out of the public domain millions of sequences for genes and proteins that the independent benevolent researcher has access to.  I think it’s great that the US publishes to the NIH PubMed and the European Mol Bio Organization provides this information for free to anyone who wants it.  Without sequence information, and the tools to process it, small, entrepreneurial companies would not have access to it without paying a fee.  That fee, like the high costs of accessing journal articles, could be a substantial barrier to admission to new businesses and new cures for diseases.

Think of it this way, without the information from sequence databases, Mapp Biopharmaceuticals, the company that discovered ZMapp, might never have gotten off the ground.

It’s unlikely that I’m going to produce an ebola protein in the lab but I’m glad that someone published the sequence data so that another lab could make them, crystallize them and publish 47 different protein crystal structures to the web for anyone to access, including a former drug designer in Pittsburgh.  That means a lot to me.  And maybe some crazy kid out there who likes looking at these things and enjoys protein folds and modeling as much as I do will be inspired to find a cure for ebola and other diseases.

What worries me is that the fear that Adleman is producing will lead to those sequences being locked away forever so that only the rich and well connected have access to them.  It would be the equivalent of the Patriot Act.  We wouldn’t know what we had lost until the new Dark Ages descended on science.  Do we really want to leave this information in the hands of only those who can afford to access it?

 

 

Freaky Weird Prescience (Ebola Post)

Well, it’s not looking good on the ebola front.  We still don’t know why the nurse in Dallas has ebola despite all of her precautions but I’m still not panicking.  My relatives in Houston are probably safe, though what did they say during the Black Death?  Run fast, go far, stay long?  Ok, that’s not really funny and is only encouraging a kind of hysteria that isn’t helpful.  Two ebola patients in Texas does not an epidemic make.  Then again, it’s Texas.

Nevertheless, there is a some speculation that the virus has become more virulent.  Peter Jahrling of the National Institute of Allergy and Infectious Diseases says this may be due to the increased viral load in infected individuals:

You’re seeing all these patients getting infected, so people think there must be aerosol spread. Certainly, it’s very clear that people who are in close contact with patients are getting a very high incidence of disease and not all of that can be explained by preparation of bodies for burial and all the standard stuff. But if you are to assume that the differences in virus load detected in the blood are reflected by differences in virus load spread by body secretions, then maybe it’s a simple quantitative difference. There’s just more virus.

Jahrling says that HIV was actually a hotter disease, primarily because carriers weren’t obvious and were able to spread the disease easily.  It also helped that HIV attacks cells in the immune system, which prevents a vigorous response.  But it’s a little hard to make this argument when comparing it to ebola.  HIV is a long, slow death and we now have drug cocktails to treat it.  Ebola is quick, excruciating, bloody and the lethality is alarming, especially because the treatment options are so few.

Which brings me to the next bit of bad news.  Frances Collins of the NIH says we might have had a vaccine for ebola except our politicians, with anti-governmental fervor, cut funding to those very institutions that might have helped to develop one.  I’d heard from researchers I met in Cambridge who had recently been to the CDC that morale was pretty low and disorganization was high.  Then, I lived through the summer of sequester when university research groups lost a sizable chunk of their funding as grants became more and more unattainable.  Layoffs quickly ensued.

One of the reasons I have been reluctant to pursue a job in research is because the money isn’t there anymore and I’m really sick of layoffs.  And let me make it clear that while scientists like to get paid fairly for the work they do, they don’t work for the money, for the most part.  They just like the work.  It can be frustrating and maddening and discoveries take a long time.  But it is also intensely rewarding in a way that money isn’t.  That’s not to say that we don’t have our own caloric requirements and shelter needs.  Also, no one likes to be exploited.  But bankers and Jack Welch types don’t understand the nature of science or the vast majority of people who do it for what is turning out to be a vanishing living.  But I digress.

The problem is that the patent cliff spooked pharma shareholders and they abandoned American research in search of get-rich-quick schemes and foreign research that isn’t ready for prime time.  At the same time, rabidly anti-government Republicans, abetted by complacent Democrats, have been slashing research budgets.

This is not the same America that we had in the post World War II days.  This is an infrastructure that is rapidly being gutted.  If you have any doubt of how bad things are, consider that Mapp Pharmaceuticals is virtually the only company on the planet with a possible treatment for ebola (we won’t know how the GSK vaccine is doing for awhile yet) and it is a small company in San Diego facing a logistical nightmare.  How does it grow the monoclonal antibodies and purify them on a scale to meet the urgent need of thousands of patients around the world?  Where is the CDC/NIH/Private Industry SWAT team that can get this off the ground?  We are asking this company to do the impossible on a massive scale in such a way that would attract every class action lawyer in the country if there wasn’t a health care emergency.

But it’s even worse than that.  As Collins says, ebola is only the tip of the iceberg.  The vast majority of us will not die of ebola.  We’re going to suffer from other maladies that no one is studying right now.   The funding is low on antibiotics, certain central nervous system disorders, heart disease, etc.  Companies just stopped working on these diseases because the research was expensive and shareholders didn’t think the profits were high enough.

All of this is happening when there is a revolution in biology.  The most ironic aspect of this problem is that thousands of trained researchers have been sidelined right at the same time that there is more than enough work to keep every one of them extremely busy for the rest of their lives.  There’s a profound disconnect between the people who are experienced enough to do the work and the funding mechanisms, either private or public, that will allow it to get done.

I see a lot of fuming on the ebola twitter feed about how scientists should just step up and get it done.  We’re all going to be saved by scientists.  How this is going to happen without funding is anybody’s guess.  It takes money to buy the equipment and reagents and research the papers and feed these scientists who everyone seems to think are going to be self-sacrificing for the betterment of mankind and to save their asses from some exotic African disease.  But as soon as the crisis is over, will we go back to chain sawing through the NIH budget?

From what I can see, neither private industry or our political leaders are taking the threat seriously.  So, I stand by my earlier prediction.  It’s going to take a plague to focus the nation’s attention on our crumbling research infrastructure.  It might as well be ebola.

 

Once upon a time…

Merck chemists go into exile

Once upon a time in New Jersey about 20 years ago, there was a company called Merck that everyone I knew wanted to work for.  The streets of Rahway were paved with gold.  We jokingly referred to our own company as a training facility for Merck and Bristol Myers.  The best of the best worked there for two years and then went to Merck.

At local conferences, the Merck people showed up in a pack, smug, condescending, and cast an otherworldly pool of light around them.  THEY wrote their own proprietary modeling software.  Even as late as two years ago, when Pharmageddon got its groove on, there was something magical about Merck people.  They were like fading elves.

Alas, all good fairy tales come to an end and so it was with Merck this week where the rumor is that medicinal chemistry, that is the research part that makes your drugs from scratch, oh best beloveds, has been decimated at Merck.  The rest of the story at Merck is unclear at this moment.  We’re still trying to piece together whether Merck is going to outsource their synthesis to poorly paid foreign PhDs or whether management, who hasn’t synthesized anything but performance standards and political fantasy baseball for years, is going to don their too tight lab coats and nitrile gloves and go back to the lab.  That should be interesting.

Once upon a time, the US had world class public research.  Then the big companies decided they didn’t want to do research anymore and they would pharm out their research to academic labs.  And they wrote policies about how this would be accomplished and the politicians said it was good because many of them didn’t know what the heck they were voting for.  And then the Republicans decided to “drown government in a bathtub” and because they are like Godzillas in Tokyo, they were pretty indiscriminate about what they were knocking down.  It turns out that the NIH keeps getting hit pretty hard and grants are harder and harder to come by with higher and higher bars to jump over and endless hours slaving over documents.  That time could be used to invent new techniques but research is very expensive and someone has to pay for it.  So the academic scientist spends much of his or her time begging to keep the reactions going and the lab rats paid.

Recently, during the government shutdown, Francis Collins, the head of the NIH, said this about the sequester and the tragedy of what is happening to this country’s life sciences infrastructure:

The sequester hitting as it did in the middle of the year meant that about 640 grants that would have been supported and highly regarded by peer review are now not going to receive funds. And those ideas are not going to happen. And breakthroughs that they might have represented will not occur. We will not know what we’ve missed because it’s gone. Imagine 640 bright, motivated scientists on the brink of doing something powerful that could have changed the way in which we diagnose, treat, and cure cancer or influenza or diabetes or some rare disease that desperately needs an answer; it’s just not going happen. I would argue with anybody who says that’s a minor consequence. It’s not; it’s a major negative outcome and a tragedy for what had been the world’s most successful search-engine in biomedicine.

Other countries, meanwhile, have read our play book and see their future in trying to do what we used to do. As we seem to be backing away, they are increasing their support. And if people care about American leadership, they should be worried.

Unless something (it’s called C-O-N-G-R-E-S-S) stops the next set of cuts in the sequester, the problem is going to get a lot worse.

I don’t see a happily ever after ending to the story right at this minute but, you know, I’m a Tolkienist so I’m not ready to give up hope yet. The situation at the present time is this. We have private industry pulling out of research because the shareholders are like opium addicts who expect bigger and bigger quarterly hits.  Long term investment doesn’t play nicely in the sandbox with an “ownership society” where everyone and their grandma is expected to put their savings into mutual funds that analysts and managers can gamble with.  And we have idiots like Rush Limbaugh who yee-haw that the sequester is the best thing since sliced bread because liberals are sucking on it.  I wouldn’t wish a Charlotte Corday situation on my worst enemy but I wouldn’t think twice about wishing a drug resistant version of Fournier’s Gangrene on Rush Limbaugh.

In the meantime, some of us still can’t quit science.  After two years in the desert, I have to pinch myself because I now have access to all the journal articles I can eat.  I’m afraid to click on the “Full Journal Article” button sometimes.  It’s almost not real, like ruby slippers.  {{Oh, wow, oh, wow!}}  But it’s almost cruel too because it’s so uncertain these days.   What is granted can so easily be taken away, like coaches that turn into pumpkins at midnight.  Sometimes, I think I might have been better off if I’d taken my academic advisor’s advice and studied law.  Then I think I’d rather eat glass than study torts.

So, science, yeah.  You can barely make a living at it anymore and yet can’t quit the habit. The best I can do at this point is try not to frighten the new, untested, warriors in training that there be dragons out there and to pass on what a wizard once told me, “Don’t let anybody steal your bliss.”

 

Calling all medicinal chemists, time to contact Virtually Speaking

I was mulching my flower beds, listening to the latest Virtually Speaking with Dean Baker and Jay Ackroyd when I heard the same moronic bullshit about how drugs are REALLY all discovered in academic labs using government money and the drug companies just put the finishing touches on them, develop them and charge a small fortune.

I’ll give you the fortune bit, for sure.  There’s no doubt that the marketers and finance guys are charging what the market will bear and then some.  They’re greedy, ruthless and cruel.  The whole drug industry has pivoted to serve the owners and the owners want money.  That affects what gets researched, promoted and sold and at what cost.

BUT

There is absolutely no truth to the idea that academia passes on almost fully formed drugs to industry where we researchers add our special sauce flourishes and then cash in big.

I repeat.

There is absolutely no truth to the idea that academia passes on almost fully formed drugs to industry where we researchers add our special sauce flourishes and then cash in big.

If Dean Baker and Jay Ackroyd and Yves Smith want to propagate this myth, they can knock themselves out.  But it’s no more true that the idea that Bill and Hillary Clinton did something nefarious with a land deal in the Ozarks.

Maybe it’s what they want to be true, maybe it fits their worldview, maybe it’s wishful thinking but it not true.  And I should know because I’ve worked in both industrial and academic settings and I actually DO the kind of drug discovery that Jay and Dean talk about so confidently but have no clue about.

The truth is that academia rarely submits a fully realized drug entity to industry for development.  What it submits is frequently just an idea.  Sometimes, that is just a target (a protein, receptor, gene, etc) and sometimes, it consists of some very basic building blocks.  Those building blocks will not resemble the final drug product until industrial medicinal chemists spend years and years rescaffolding it, making new appendages for it, and developing whole libraries of potential drug compounds that may not resemble the initial compound in the least when they are finished.

So, yes, the NIH funds a lot of research but, no, that research does not result in anywhere near effective or consumable drugs until industrial chemists get their hands on it and bend it to their wills.  By the way, those industrial chemists used to be academic chemists.  It’s not supposed to be an adversarial relationship.

Anyway, for all you pharma researchers out there who are pissed off by the “everybody knows” truthiness and yet more dissing of your shrinking profession and want to set the record straight, let Jay Ackroyd at Virtually Speaking know.  God only knows why Jay won’t simply invite someone like Derek Lowe on his show to tell it like it really is.  It’s almost like they don’t want to hear the truth, that somehow by sticking their fingers in their ears and singing “la-la-la, I can’t HEAR you”, that that’s going to make the poor graduate students working for peanuts into unsung heroes and pump lots of righteous indignation into the put upon American people.  Well, those graduate students ARE unsung heroes, but so are many of my former industrial colleagues in medicinal chemistry and drug design who have slaved tirelessly for years wrestling some academic’s decidedly un-druglike molecule into a real drug that can be developed.

I’m really insulted by this poor performance by Ackroyd and Baker.  The left deserves people who are not lazy and who will actually go out of their way to get to the truth.  Otherwise, the drug industry will continue to fail, drugs will continue to skyrocket in price and no one will be able to do anything about it because they’ll all be off chasing wild geese or red herrings or whatever it is you call it that is just a waste of time and energy.

Jay and Dean aren’t even seeing through a glass darkly at this point.  If they would only come and actually, you know, talk to us, we could tell them what’s really going on so they could talk more intelligently about a subject they clearly know nothing about at the present time.  I’m not sure what is holding them back.  Is it the absurd notion that those of us who work(ed) for industry  are as greedy, ruthless and conservative as the guys who laid us all off?  Even if that were true, (it’s not, not by a long shot) is that a good reason for ignoring what we have to say?

You can’t fix a problem if you are totally ignorant.

Here’s Jay’s links if you want to set the record straight.

Jay on Facebook

Jay on Twitter

VS Guests on Twitter

VS in Second Life

VS Ning

VS on BlogTalkRadio

VS on Facebook

VS on Itunes

And here is Dean Baker’s twitter feed.

 

 

 

 

Hacks and thwaks

Yesterday, for some bizarre, unknown reason known only to Yves Smith, I was accused of spouting PR for the pharmaceutical industry.  It appears that it goes against left of center dogma to say that the NIH does not just hand over perfect drug entities to the drug industry, already tested and bioavailable and efficacious, and that all the industry “R&D” divisions (well, what’s left of them) do is add a few finishing touches and charge everyone an arm and a leg for them.  Yes, that is what pharmas do.  They don’t really do research.  We just accept these gifts of government largess and when they arrive on our front door steps all glistening with ingenuity and brilliance, we stand around and marvel at them like they are alien creations.

Ok, the chemists can stop laughing now.  No, really, you’re going to hurt yourselves.

The truth is that NIH grants allow for some good science and many new discoveries.  But very rarely do they get to the stage where a new drug is delivered to a pharmaceutical company as a fully formed entity that requires no modification.  My experience (>20 years in the industry) is that NIH grants fund a lot of basic science on targets.  Then, if those targets (not drugs, protein targets) look interesting, they’re picked up by a pharmaceutical R&D, or more likely, several pharmaceutical R&Ds because the information is public, and all those different companies work on the target at the same time.  That’s how you get “me too” drugs. Just because someone beat you to market doesn’t mean you can trash all your hard work. Besides, your drug might actually be better.  It is strange that it is only in the pharmaceutical industry that “new and improved” is looked on as a bad thing.

Now, I am not going to argue that the pharmaceutical industry doesn’t charge an outrageous amount of money for new drugs these days.  And I won’t argue that they haven’t done much of anything to put new drugs on the market.  Or that they haven’t gone back into their old compound libraries  or that they reformulate things.  Sometimes, those reformulations are meaningful and sometimes they are not.

But I do know that research is expensive.  Ridiculously expensive.  That’s why big pharma has been cutting back on research as a counterintuitive business model.  That’s why there’s nothing coming out of the labs.  They are spending less money these days and they are relying on academic groups more often now.  The reasons are many but chief among them is that after having spent many billions of dollars on research, very few new drugs were approved by the FDA.  And that could be a result of higher safety standards that didn’t exist when the project was started or the constant mergers and acquisitions and bad management and the explosion in biology in the past couple of decades and the new and trendy things that snake oil salesmen corporate ladder climbers sold to their bosses as the next big thing that weren’t ready for prime time.  In fact, if Yves had been reading the posts I have written in the past several years on the pharmaceutical industry, or Derek Lowe at In the Pipeline has been writing (check the archives, Yves) or even someone like Anthony Nicholls at Openeye has been writing, she would have gotten a more complete picture of what is really going on.

What is really going on is that the big pharmas are going “weightless”.  They think they can exploit little start up companies and academic groups and turn those compounds into drugs.  And they want a cheap workforce.  I mean REALLY cheap.  Like $37K/year is their ideal top of the salary band for post docs who will never find a job in industry.  So they have been pushing this nonsense to the White House and Congress that what we need is more students who will sacrifice themselves to STEM professions and forget about having a stable job or family life because it is the patriotic thing to do.

Meanwhile, there really are academic groups that are trying to create new drugs.  They consist of former industry professionals who have taken incredibly steep cuts in their salaries and work in facilities where their resources are vastly reduced compared to their formerly corporate lab environments.  The pharma industry has them right where they want them, using their decades of expertise to cobble together drugs out of shoestrings and bubblegum.  And those dedicated scientists spend a lot of time applying for grants from the NIH but the money is very hard to come by and can’t pay for all the things and people they need to do their jobs.  These people are amazing and I can’t say enough good things about them.

But they are the exceptions, not the rules.  The rule is that the vast majority of NIH funded research provides germs of ideas.  They are hints of possibilities, a bunch of gel slides and some correlations.  I have been on many projects that started with a few interesting papers from NIH funded research.  We spend a lot of time on these shiny little nuggets setting up assays and crystallizing proteins and screening millions of compounds and synthesizing new compounds only to find out that the NIH funded studies did NOT have all of the answers.  The initial studies had only part of the answers and didn’t know about all of the other pathways and upregulation or the initial study was just off and the assays don’t work like they should and the project has to solve a different problem before it circles back to the original problem.  In the process, the industry research uncovered many aspects of the biology that the NIH scientists didn’t have the time, money or urgency to discover by themselves.  Many millions of dollars have been spent chasing NIH beginnings that ran into brick walls and had to be abandoned.  In any pharmaceutical company, there were dozens and dozens of these kinds of projects going on all at the same time.  Many projects are started but bloody few succeed and the vast majority of drugs that are produced from the germ of an idea that came out of an NIH study originated in the compound library of the pharmaceutical company itself.

Those are just the facts, Yves.  You can talk to anybody who has ever worked in pharma in the past 20 years and they will confirm this.  Yes, some remarkable things have come out of academia but very few of them  came directly from some academic lab untouched.  All of the other drugs were industry generated.

The reason why drugs are so expensive and are going to get more expensive is because more companies are abandoning their small molecule drug discovery efforts, because they couldn’t get approvals and recoup their investments before the patent clock expired, and are now moving into biologicals, the next big thing.  Oh sure, there will be some small molecule efforts in areas like oncology but this is due to a very cynical calculation on the part of the bean counters.  Oncology drugs are fast tracked and the safety profile is relaxed. People with death sentences on their heads are more than willing to become human guinea pigs and put up with a lot more toxicity than average non-sick people. They’re less picky about formulations.  Sure it would be great if the drug is oral and easily bioavailable but if you have to take it by IV, that’s OK too. If the drug extends life by even a few months, some families would consider that a success and they’d be willing to pay whatever the market wants.  And best of all, patients don’t complain and file class action lawsuits.  If the treatment succeeds, everyone is happy no matter how much the liver is shot.  If it fails, well, the patient was going to die anyway.  The relatives chalk it up to fate. The shareholders are happy.

Biologicals are a whole different animal with their own share of problems from humanizing mouse antibodies and aggregation problems to all kinds of new and different things that no one even knew about the cell.  It’s going to be interesting and very expensive.

The rest of the non-wealthy people will have to live with generics, which are bound to get more expensive.  Yves is smart enough to figure out why because she understands scarcity, supply and demand.  But these will be older, less efficacious drugs.  Well, the public put it’s foot down about “me too” and demanded a higher level of perfection than any small molecule drug is likely to ever deliver and this is what happens.  No more new small molecule drugs.

There are many facets to this problem.  Everyone sees the issue they are closest to.  If you only consult one “expert”, you only see one part of the problem.  There is no reason to distrust those of us former industry professionals who have a different version of events.  Believe me, we are not going to tell you a lot of flattering things about the pharmaceutical industry that stupidly laid off all of its expertise.  But unless you find out what is really going on and who is doing what with which resources and how successful those resources are, you can’t develop a complete picture of the landscape of this problem.  And more importantly, you can’t *solve* the problem. That smacks of a very unscientific approach to solving problems and, in the end, it doesn’t serve the patients or American citizens well at all.  In fact, not gathering as much information as you can from different sources is precisely what Big Pharma wants you to do.  It’s asymmetrical information at its best.  You only have one part of the picture and they just sit back and laugh at your righteous indignation while you rail against them.  How is this different from the finance industry?

By the way, I am no finance person and I didn’t much care for economics.  But I took the time to read books and ethnographies and visited wonky sites and read Yves and waded through all this money crap that interests me not even in the slightest.  And although I don’t know everything, I know much more than I did four years ago.  I know what motivates the bastards now and what incentives need to be changed to make the system function again.  That’s a positive step, right?

So, maybe closing your ears to differing points of view is not a good thing, Yves.  You’re not helping us beat this thing.  And that is something no pharma PR rep would ever say.

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And now for some IKEA hacks!

This first one is from one of my new favorite YouTubers, goodbrowngravy, who despite being a white southern male with an accent, appears to be not the ignorant redneck that some lefties think all white southern men are.  (Do we condescend and stereotype much?  I think we do.)

Here’s goodbrowngravy’s IKEA hack of a Rast dresser into a campaign style side table.  Nice work!

And here is a hack of an Expedit unit turned into a stereo system from Apartmenttherapy.

Speaking of IKEA, if you are in the area tomorrow of the Elizabeth, NJ IKEA, you can drop off some badly needed items for the NYC/NJ survivors of Hurricane Sandy. IKEA is teaming up with the RedCross and other organizations to provide furniture and funds and also to collect items from customers who are shopping on Sunday. Check here for a list of items that would be much appreciated.  The collection will start at 11:00am.  And I really need a Rast…

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