Saturday, February 9, 2013

Death by Drone

David Cole, a constitutional law professor at Georgetown, raises some good points in today's Washington Post about our government's use of drones to kill American citizens.

His basic point:  While perhaps some of our citizens need to be killed without due process for the greater good (i.e. keeping the rest of us fat dumb and happy in our American lifestyles), the government of a free country at least needs to acknowledge that it carried out the killings.  Our government isn't even doing that, and hasn't done it in the case of Anwar al-Awlaki, the American citizen Al Quaeda leader we droned off in September 2011.

At the end of the article he gives what is most likely the government's justification for refusing to take responsibility for the killings:  The countries that permit us to use their airspace to carry out these killings have given us that permission on the condition that we don't admit to them.

So I admit it's a dilemma, and I'll also admit that I don't have enough information to balance the pros and cons of the policy.  If the government knows for a fact that the only way to stop Al Quaeda from blowing up a few American cities with nuclear bombs is to kill a few citizens, and if the only way to kill those citizens involves making agreements with other countries that we won't acknowledge the killings, then perhaps the policy is justified.  A shame, a departure from the principles on which our country was founded, but possibly justified.

But the question remains:  Why exactly do we find ourselves in this position?

And one possible answer is: Because we have permitted corporations to dictate our foreign policies for way too long.

You might not have seen that coming, but here's my point:

I actually can't point to anything specific.  Osama Bin Laden hated us because of our policies relating to Israel, and I honestly don't know what the right answer is on that one, and I don't know whether our policy on Israel is dictated by corporations.  But much of our policy -- including the propping up of dictators over the years for the sake of oil, bananas, you name it -- has been dictated by corporations.  Those policies are why many people in many countries around the world hate us.  And that's why we have no credibility when we make tough moral decisions involving other countries, like Israel.

The goal after 9-11 should have been to change that.  But we are just making it worse.  The Iraq war was dictated by corporations like Bechtel and Halliburton, salivating at the chance to get in there and rebuild a country that we were going to destroy.  It had nothing to do with the morally-justified "war on terror."  The Iraq war led to Guantanamo, and Abu Ghraib, which caused more people to hate us.  In other words, ever since September 2001 -- when much of the rest of the world already had ample reason to hate us -- we have just just been throwing more fuel onto the fire of hatred.  The drones are simply one more example on a long list.  Not only are they causing us to lose further credibility abroad, but, as evidenced by Cole's piece, they are also causing thoughtful U.S. citizens to start to wonder what this country is coming to.

Cole gives a link to an article that gives a link to the Government's memo justifying the practice.  Amusing how just because the memo happened to be leaked to NBC, NBC has put its watermark all over it.  NBC has no proprietary right in the memo, as far as I can tell.

Tuesday, January 29, 2013

Amgen Buying State Legislatures to Prolong Profit Stream

The whole idea of a patent system is that (1) the public gives the "inventor" a monopoly for a period of time (currently 20 years from the application date, with the potential for extensions based on processing delays), and (2) AFTER that time is up, the patented product may be produced by anyone.  The idea is that after the patent expires, there will be unrestricted competition and prices will fall.  And in principle it works -- that's why you can buy Prozac at WalMart for $4 a bottle, when it used to cost hundreds.

But the problem is that the makers of drugs make SO much money while the patent is still in force that  they do everything in their power to keep that cash stream alive, even after the product should by all rights have fallen into the public domain.  There is a long list of shenanigans employed by branded drugmakers to illegitimately prolong those cash flows.  And now I've learned of one more.

As reported in yesterday's NYT, Amgen and other biotech companies are now lobbying states to prevent generic competition AFTER the patent has expired.  The argument is that the generics are not producing IDENTICAL products, but are merely producing "biosimilars," and who can be sure that those biosimilars are safe?

If safety of biosimilars is truly an issue, that is yet one more argument for federal control of the pharmaceutical and biotech industries.  To effectuate the patent bargain, after the patent expires, the federal government should just step in and TAKE OVER the biotech company's manufacturing process, and sell the results at generic prices, possibly through generic companies.  If this is considered a "taking" then perhaps the biotech company should get some "just compensation," pursuant to the Constitution's takings clause.  But that "compensation" does NOT amount to a prolonged billion-dollar-a-year monopoly for technology that should be in the public domain. 

Interesting facts from the article:  

1.  Biotech drugs are drugs that are produced by cells, as opposed to synthesized in chemical reactions.

2.  Biotech drugs now amount to one quarter of the $320 billion annual spending on drugs in the U.S. And that percentage is growing.

3.  Biotech drugs are generally dispensed in the doctor's office, not through pharmacies.  Nevertheless, it's obviously worth the biotech companies' while to stop pharmacies from selling generics whenever they can.

4.  Amgen and Genentech are the two biotech companies that are writing the legislation.  As documented here and here, if Amgen were a human being, it would probably be in jail for fraud.  But since it isn't, its money is still good in state legislatures (and, of course, Congress).

5.  Two of Amgen's biggest sellers are the anti-anemia drugs Epogen and Aranesp. As documented elsewhere (see links in 4, above), Amgen has successfully and dishonestly caused both of these drugs to be over-prescribed.

6.  Other Amgen drugs are Enbrel, Neupogen, and Neulasta.  Enbrel is for psoriasis and rheumatoid arthritis; Neupogen and Neulasta protect chemotherapy patients from infections.  

7.  Genentech (owned by Roche) makes Rituxan, Herceptin and Avastin, all of which are top-selling anti-cancer drugs.

8.  The patents on all the drugs listed in 6 and 7, except for Enbrel, will expire very soon.

9.  The state legislators introducing the bills at issue admit that they were written by Genetech and/or Amgen.

10.  The Virginia house of delegates voted 91-6 in favor of such a bill. 




Sunday, January 20, 2013

Another $500M Pharma Giveaway -- Senate to Amgen


From today's NYT, in an article by Kevin Sack and Eric Lipton.

About a  month ago, Amgen pled guiltyto having fraudulently, illegally marketed one of its anti-anemia drugs, Aranesp.  It agreed to pay criminal and civil penalties totaling $762 million.
But what the government taketh away, the government giveth right back, if you know what you're doing.  The government -- led by Orrin Hatch, Max Baucus, and Mitch McConnell -- has now given back $500 million.  It's only a matter of time before Amgen gets the other $262 million back, with interest.

In case Amgen sounds familiar to readers of this blog, it was only in July 2012 that I posted about the billions of dollars of profits it had made by endangering patient health by encouraging physicians to overprescribe Epogen, another anti-anemia drug.  http://pricefixer.blogspot.com/2012/07/anemia-drug-scam.html

How did this latest grift happen? Amgen is still the world's largest biotech firm.  That gives them enough money to hire 74 lobbyists, and contribute tons of money to Senators like Orrin ("never met a drug company I didn't like") Hatch ($59,000 plus large donations to "OrrinPAC" and Utah Families Foundation), Max Baucus ($67,750 plus large donations to "Glacier PAC"), and Mitch McConnell ($73,000).  Dan Todd, one of Hatch's top aides, was a lobbyist for Amgen before he switched to Hatch and started working to prevent Medicare price controls from applying to Amgen.  Amgen lobbyists Jeff Forbes and Hunter Bates are former chiefs of staff of Baucus and McConnell, respectively.

And that in turn enables them to ensure that legislation that threatens their income stream for the sake of patient health and Medicare savings doesn't actually apply to them.

The legislation at issue was actually the "fiscal cliff" bill, which most ordinary people probably thought had something to do with trying to save money for taxpayers.  But instead, it delays by two years imposition of Medicare price restraints on Sensipar, Amgen's flagship, overprescribed dialysis drug.  Sensipar is not mentioned by name -- that would be too obvious -- but instead is the most important member of a small class of drugs that benefit from the provision.

The provision is projected to cost Medicare up to $500 million over those two years.

Who pays for Medicare?  YOU and me.  And the excuse of the the bought-and-paid for political hacks who gave Amgen our $500 million?  Per the New York Times, they said: "it was necessary to allow regulators to prepare properly for the pricing change"; "it would give the Medicare system and medical providers the time they needed to accommodate other complicated changes in how federal reimbursements for kidney care were determined."

So let's just keep on paying Amgen too much -- we're just not ready to pay them less!

According to the NY Times, there has been an ongoing "five-year effort in Washington to control the enormous expense of dialysis for the Medicare program by reversing incentives to overprescribe medication."  So really, they've already had five years to prepare to start paying less.

More specifically, the effort started in 2008, when Congress figured out that providers had a big incentive to overprescribe dialysis drugs (see link re Epogen above), since they were being reimbursed separately from the dialysis treatment.  Congress realized that by bundling reimbursement for dialysis with reimbursement for dialysis-related drugs, it could cut down on such overprescription and save money and ensure that providers made more responsible decisions regarding patient health.  But Congress will never snatch away drugmaker profits too quickly -- it tried to ease them into it, including by making sure that the "bundling requirement" would not apply to Amgen's Sensipar until 2014. The current legislation extends that to 2016.  Let's hope eight years will be enough for regulators to prepare for this change. 

The irony of putting this in the fiscal cliff legislation -- which has to do with balancing the budget after all -- is too rich.  We could have bought TWO bridges to nowhere for this amount of money.  

The NYT explains that it got through as a result of the political clout of Amgen-owned Finance Committee Members Senate Minority Leader Mitch McConnell, Republican of Kentucky, and Senators  Max Baucus, Democrat of Montana, and Orrin G. Hatch, Republican of Utah.  For some reason, these buffoons "hold heavy sway over Medicare payment policy as the leaders of the Finance Committee."

And where was the Obama administration?  Amgen's lobbyists have logged over a dozen White House visits since 2009, and according to the NYT, Amgen lobbyist Tony Podesta's firm has "unusually close ties to the White House."  And Amgen employees donated more than $141,000 to Obama's reelection, although of course they probably donated just about that much to Romney as well. The Company says it didn't contact the administration about this particular piece of legislation, and the administration says it had nothing to do with the provision.

Of course, hardly anyone knew that the provision was in there.

Really, I should let the Senators defend themselves.  Here's Baucus's defense, via spokeswoman Meaghan Smith: “What is the best policy for Montanans and people across the country lies at the heart of every decision Chairman Baucus makes . . . .  It’s as simple as that.”

--

So let's take a minute to absorb this.  The entities that we put in charge of our nation's health -- the drug companies -- are guided by a profit motive (that's capitalism, after all), that causes them to engage in criminal conduct.  Their thirst for profits causes them to suppress studies that contradict their health claims, and to encourage doctors to prescribe drugs that patients don't need, or which are affirmatively harmful to patients.  When caught, they pay the fines and then are immediately back to their old tricks, ably assisted by the Congress.

I'm not blaming the drug companies.  That's how capitalism works and it's how capitalism is supposed to work, and somewhere in there, we decided we'd get the best drugs through a capitalist system, aided by patents, which of course, suppress one of the best things about capitalism -- competition.

But this again raises the question:  Is this patent-assisted capitalism -- especially in an era of a Congress all-too-willing to sacrifice patient health for campaign contributions -- really the best way to cause new and useful drugs to be produced, and moreover, to cause the right drugs to be prescribed, in the right doses, to patients?

In capitalism, the market takes care of all that.  Producers produce what customers want, and they do so in competition with other producers.  That ensures that customers get what they want, at the lowest possible prices.  This is working better than ever in today's internet age, where the theoretical notion of "perfect information" is becoming more and more of a reality.  I can go to amazon and read customer reviews and compare products and prices in ways I never could before.  And I can buy great things more cheaply than ever before.

But that doesn't work with drugs.  With drugs, there is nothing approaching "perfect information."  The "information" is often suppressed by the drugmakers, or distorted in their efforts to get doctors to continue to prescribe -- and overprescribe -- their drugs.  And all of the market incentives tell the drug company to keep on pumping out bad information, because that is what will keep prices and sales high. Consumers have no way to tell whether an on-patent drug is better or worse than something that's off-patent.  

If we could simply figure out a way to compensate drugmakers on a one-time basis when they come up with a valuable drug, all of the distortions would disappear.  The drugs would instantly become generic, and true free competition would reign.  And all drugs would cost $4 a bottle.  Yes, we would have paid a huge premium up front for the drugs, but after that, the market would ensure the most effective and proper distribution of the drugs.  All the distortions would be over.  This is what the think tanks should be figuring out.  

UPDATE Jan. 29, 2013:  The NYT reported yesterday on Amgen's efforts to get State legislatures to restrict generic competition for biotech drugs.

Saturday, December 15, 2012

Gun control by GPS, RFID, Fingerprints -- Sample Letter to Congress


As usual, when I think of a solution to a problem (see, e.g., my "invade Switzerland" post), someone else has gone there before me.  This time, after considering the Connecticut school shooting tragedy -- carried out by possibly-autistic-graduated-from-high-school-three-years-early-wicked-smart-doesn't-make-eye-contact-20-year-old Adam Lanza (now deceased) -- the idea of putting a GPS microchip in ALL guns occurred to me.

I don't want to seem callous.  Before going further, let me assure my readers that just thinking about this shooting devastates me anew every time.  Although I haven't actually seen any image, my brain conjures them up and it is painful beyond description.  I have raised or helped raise 5 different kids through that age and it is truly an age of innocence and wonder.  The whole thing just make me sick beyond words.

Back to the GPS-on-guns point.  I just googled it, and it's not an automatically-filled-in google search, but some hits come up.  Here's the first one, from "thetruthaboutguns.com", in March 2011.  Apparently legislation has even been proposed (in Massachusetts) to "study" the feasibility of GPS chips in guns.  In other words, it's obvious that true legislation on this is politically infeasible, but at least some politicians have had the guts to propose a study, to perhaps show that this might be a viable method of preventing -- or minimizing the damage -- done by some of these tragedies.  And of course, another byproduct would be that many many other gun crimes would become much easier to solve.

Let's start by acknowledging that there are technical problems to using a GPS tracker that might still take years to overcome.  GPS tracking devices use power, and so need batteries, and the batteries will eventually need to be recharged.  Currently, an emitter sending a regular GPS signal on a regular battery will only last a day or so before needing a recharge. And even I don't think it makes sense to put the onus of keeping the GPS device charged on the gun-owners.  They'd simply let the charge run out before going on their shooting spree.

The other option is the idea of putting a RFID chip -- a transponder that can be read by an external reader, e.g. like what stores put on their merchandise, and what's inside an EZ Pass -- and then have readers all over the place (e.g. on telephone poles), especially near schools and malls.  The readers would feed their information into a program that would be able to detect if the gun is moving in an unusual manner, e.g. toward a school.

The only "downside" to something like this (as explained in the blog) is that the government will be able to track the movements of people who are carrying guns.  I don't trust the government any more than the next guy, but I have no problem with the government knowing where all the guns are.  Sorry, I just don't.  If you're using or carrying your gun legally (as Barack Obama says the Second Amendment gives you the right to do), then that's fine, but that doesn't mean the rest of us can't know where you are.

In fact, I'd be perfectly happy if the whole thing -- a giant database where all the guns are -- were available to EVERYBODY at all times, over the internet, on their iphones etc.  The one exception I'd make is that if you've got a gun at home, the database would NOT report on its location, even if it knew it.  It only becomes visible when you take it out.  That should actually comfort gun owners, because it helps level the playing field -- i.e. they can look on the internet and see if people with guns are coming near their house, but those people won't know which houses have guns in them.  That way, everyone can have an alarm any time a gun is nearby.  And of course, the police have the info too, and can both prevent and solve crimes with it.

I'd propose that the GPS or RFID chip be buried so deep in the gun that it's impossible to take out without serious work.  Perhaps it's even possible to do it so the gun won't fire without the chip, or such that taking the chip out would cause great problems for the gun itself.  And of course, the penalty for having a chip-free gun would be very steep.

We'd have to backfit all existing guns, and perhaps those backfitted devices would be easier to remove. But again, there would be steep penalties for doing so and for having such a gun, no matter how "innocent" you think you are.

It looks like the bill the blog was complaining about died soon thereafter, in 2011 (links below).  So not even a study can get through the liberal Massachusetts state legislature.  What hope is there for federal legislation?  That's up to you (see below).

I see a Yahoo open forum questioner had a similar idea in the wake of the shooting yesterday.  This person suggests having guns lock up near schools, malls, and government offices, and also mentions that they already have guns that will only operate after checking the user's fingerprint.  I didn't know about the fingerprint option; that could help in some cases -- including this one, where the kid got the guns from out of his mother's gun collection (at least according to early reports).

Anyway, now would be the chance to get Congress to take seriously at least the idea of "studying" a technological solution to gun control.  Why not let them?  They spend so much time and money studying other stuff, why not let them study something that might actually lead to lives being saved?

And here's one last idea:  have the study include a chance for public input in the end.  In other words, present findings plus options to the public after it's over.  And then have a means for the public to "vote" on which option they like best.  The public's vote obviously wouldn't count for anything -- this is a representative democracy after all -- but, if "votes" like this were to become a regular feature of our democracy, it would help the public see just how out of step its politicians have become, and might become a force for causing politicians to become more accountable to their publics on issues that really matter.

OK, I've run out of time to study the issue, but there doesn't seem to be much on it on Google YET.

YOU can make the difference -- Write your Congressperson now, and make this a campaign issue!

Oh what the heck.  I'm going to spend 10 more minutes and write you a form letter to send to your Congressperson. You can find out who your representatives are by punching in your zip code here:

http://www.house.gov/representatives/find/#listrep

And then you click on their names and you'll find something that says "contact me," and that should give you a method of emailing them.  I just went to Jim Moran's site, and it's that easy --

https://moran.house.gov/contact-me/email-me

(I spelled out those links so you can tell they are legitimate, and can click them without fear)

Here's a form letter for you to use -- feel free to modify and personalize:

Dear Rep./Sen. _____:

I was devastated by the attack on schoolchildren that occurred in Connecticut on December 14, 2012.  I cannot help but wonder if the attack could have been prevented through a combination of legislation and technology.  I see that last year, State Senator Anthony Petruccelli introduced a bill in Massachusetts (S. 1224) to study the idea of putting GPS locators on firearms.  That idea sounds very good to me, but the bill seems to have died in Massachusetts.  It's time for serious, national attention to this issue.

So I am asking you to propose -- or support proposals -- that Congress seriously study the idea of using modern technology to track the locations of guns and to otherwise help prevent these eminently preventable massacres.  GPS trackers might not be the right answer at this point in time -- they might not be technologically feasible, because of power requirements.  The study should also consider the costs and benefits of putting RFIDs into guns, so that gun locations can be tracked by external readers.    It should also study the pros and cons of keying guns to the registered owner's fingerprint, so that only the legal owner can operate the weapon.  Of course, the study should not be limited to these ideas.

I have no problem with people having guns in their homes for self-defense, and I have no problem with people using guns for hunting or target practice in designated areas.  But if we have the technology to prevent people from carrying out murderous attacks on innocent children, I think we need to study it in a very public way, and figure out what will work and what won't.  After the study is reported, then let the people decide.  Yesterday, a lot of parents started thinking about gun control in ways they never had before.  And parents are voters.

Perhaps there is a solution that helps safeguard the "privacy rights" of gun owners, while also protecting our children.  If we don't do the study, we'll never know, and more innocent lives will be lost.

If you do not support legislation for studying the idea of using technology to track firearm locations, I will have a very hard time voting for you next time around.

Sincerely,


___________
(name)

___________
(zip code)



You can also send or email the same letter to the President as follows (lifted from http://www.whitehouse.gov/contact/write-or-call#write):


Write a letter to the President

Here are a few simple things you can do to make sure your message gets to the White House as quickly as possible.
1. If possible, email us! This is the fastest way to get your message to President Obama.

2. If you write a letter, please consider typing it on an 8 1/2 by 11 inch sheet of paper. If you hand-write your letter, please consider using pen and writing as neatly as possible.

3. Please include your return address on your letter as well as your envelope. If you have an email address, please consider including that as well.

4. And finally, be sure to include the full address of the White House to make sure your message gets to us as quickly and directly as possible:
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Finally, feel free to start a White House petition ("We the People") on this issue:





Friday, November 30, 2012

Extroverts Often Just Plain Rude

Just noticed that the film "Quiet - The Power of Introverts, Episode I" -- inspired by Susan Cain's book "Quiet - The Power of Introverts in a World That Can't Stop Talking" -- was put up on youtube 3 days ago and has accumulated over 300,000 hits.  And it's narrated by a computer-generated voice.

Did a quick Google search and didn't find any obvious links from popular sites, so it's likely that it spread that quickly just through social networking.  Pretty impressive.

This is just Episode I, but it seems to make the main points from Susan Cain's book, which I read and liked some time ago.  The main point is that the modern world favors and rewards extroverts and often dismisses introverts as "shy" and "boring," whereas introverts are often simply "better" than extroverts.

I remember having only two beefs with the book -- one was her gushing (well, it was gushing for a self-declared introvert, anyway) description of Tony Robbins, but I suppose reasonable minds can differ on that.

The other was her failure to even mention the one thing that I find most frustrating about being an introvert in an extroverted world:

Whenever I am in a meeting with more than about 5 people, I find it almost impossible to get a word in edgewise.  And the reason is simply this -- extroverts (and, presumably, all of those introverts pretending to be extroverts) simply don't wait for a speaker to finish talking before starting to speak themselves.  Sometimes it's a blatant interruption, but more often it's a matter of jumping in at the precise moment that the speaker is winding down and it's clear that they've made their point.

This might not be so bad if the jumper-in always stayed on the same topic that the speaker had addressed.  If that were the case, then all the extroverts could talk themselves out on the topic, and then, when they are done, the introverts could jump into the pause and add in whatever the extroverts overlooked.  But what often happens is that the first or second extrovert responds to the original topic, and then uses the "floor" to change the topic to something else.  This necessarily leaves all of the introverts in the room in the dust -- it is often simply too late to revisit the earlier topic, because the meeting has moved on.

And it's not always just a random jumper-in who changes the topic.  Often it's the person who is nominally in charge of running the meeting him or herself.  That person often ends up thinking that the meeting is being held for their benefit, and they often think that they know when one topic is "played out" and it's time to move on to the next one.

In such cases, I usually end up having to make a decision -- was the extra thing that I had to say so important that I need to bring it up specially at the end of the meeting?  Do I need to circulate it in writing?  Or do I just let it go?  Either way, I end up looking somewhat inept.  Often the point is a good one, but it's not necessarily worthy of bringing up later in the meeting or in writing.  And the bottom line is I've gone through another meeting, looking like I've had nothing to contribute.

Any book that one reads about communications and running meetings etc. makes it clear that this "extroverted" behavior is not just counterproductive, but it's also just plain rude.  Those of us who've read those books and actually allow other people to finish their sentences end up seeming like dummies, compared with the people who got in there and really "contributed" to the meeting.

Here's what's most annoying of all.  Often, I will see a critical point at a very early stage in the meeting.  I will try to express it -- even to the point of starting to speak as someone else is winding down -- but I get beaten to the "interruption" punch by another extrovert.  And then some extrovert starts talking -- usually without thinking, usually just to hear him or herself talk -- and then, after rambling this way and that, stumbles on my idea!  That's the most frustrating of all.  The extrovert who stumbled on the idea by subjecting the rest of us to his "thinking out loud" then gets credit for the idea, even though I had it first, and my politeness -- my observance of the rules of engagement for proper meetings and conversation -- prevented me from articulating it and getting the credit (and saving the meeting a lot of time).

My solution would be as follows:

People in meetings should not only be able to talk, but they should also be able to type their thoughts out on their tablet (or whatever) and project those thoughts on a screen -- or just the wall -- as they occur to them.  That way, every voice would get heard, and everyone would get the credit due to them.

Technologically speaking, we are already there.  One could simply use virtual meeting software - i.e. a chat room type thing -- and project it on one screen at one place in the room.   Or, since everyone would be "in" the chat room already, projection might not even be necessary -- everyone would see the point on their laptop or tablet.  This would almost certainly make meetings more productive, and it would go a long way to leveling the playing field between introverts and extroverts.

If nothing else, an introvert could tell the meeting chair that he's got something else to contribute on a particular topic, so the meeting chair would not be tempted to move the topic on himself.

And since meetings like this are often the way that senior managers evaluate their subordinates, it will result in introverts getting more of the recognition that they deserve.

Wednesday, November 28, 2012

Another Straw Man Argument About Sex and Power


From "The Chemistry of the Suppression of Desire: What is going on in the brain of a cheater?" by Brian Alexander and Larry Young in yesterday's Slate:

"As always happens when a powerful married man is revealed to have been hiking the Appalachian Trail, finding Freudian uses for cigars, or supporting his maid’s child, there’s been a lot of speculation about the psychology of honcho guys. What is it about the powerful?

"This noodling is off-base on several counts. First, it neglects the fact that roughly one-quarter of married people—approximately equal numbers of men and women—report having had an extramarital affair. They aren’t all powerful. It’s true that the successful may indeed be more likely to commit adultery, but not for the reasons usually cited, such as their supposed sense of entitlement."

And now the Petraeus affair spawns yet another straw man.  As already discussed ad nauseam in previous posts, too many people (especially in the Washington Post) have gone off on their usual rant of "it's just sex, why fire him?"  Again, this was much more than that.

And now these guys -- who have written a book on sex and science -- are telling us that the Petraeus situation is causing everyone to wonder what it is about powerful men that makes them have sex.  As far as I can tell, that's not what people are speculating and noodling about.  If you noodle about it for about 10 seconds, you'll quickly realize that there is no single explanation of why powerful men sometimes have sex outside of marriage.

In Petraeus's case, it wasn't about a sense of entitlement -- it was an attractive, fawning, star-struck, much-younger woman who was almost certainly throwing herself at him.  The natural inclination of all but the most happily married 60-year-old men would be to succumb to that temptation.  And for the Petraeuses of the world, that opportunity only comes around so often.  I'm sorry, although Petraeus is a great general, and he has risen to the rank of alpha male, he really does not have that alpha male look or bearing.  Women have not been throwing themselves at him.

Now Clinton was different.  He might well have had that sense of entitlement (if what Paula Jones and various Arkansas State Troopers said was true, then he almost certainly did), and he seemed to have a kind of compulsion to have sex with as many different women-not-his-wife as possible.

It's just plain silly to compare Clinton and Petraeus sexually, and as far as I can tell, nobody but these guys is doing it.

I don't have enough information about either Arnold or Mark Sanford to even try to speculate on why they strayed, so I'm not going to.

The rest of the article talks about how oxytocin (the "cuddle hormone") helps men stay faithful to their comfortable wives, long after the initial sexual attraction has subsided.

And then they get to their point, which is that there is a gene that seems to correlate with both ambition (and therefore success) and infidelity:

"A version of that gene known as 7R+ has been implicated in drug addiction, impulsive behavior, risk taking, and gambling. But it’s also been found to be prevalent in people who are migrants, innovators, the ambitious—people who have key traits for success. (There has been no study so far of its prevalence in four-star generals or political leaders.) In one sample of 181 young adults, those who had at least one copy of 7R+ had 50 percent more instances of sexual infidelity than noncarriers."

So it's not a sense of entitlement (as above, with Petraeus it never was), but it's a gene.  Science explains everything!

By the time they get to the conclusion, they don't have much to say:

"We’re not automatons. We are responsible for our actions. But our baked-in biases can make us susceptible to infidelity. Our brains can be a battlefield of competing interests, and sometimes desire wins. It may win more often in people like Petraeus whose bold, creative thinking we so admire can come with a bias toward behavior we don’t. That doesn’t make him special, it makes him human."

Here, they are meandering a bit, but I think they are kidding themselves into thinking that they've taught us some science here.  I think the "baked-in biases" they are talking about is the 7R+ gene described above that some of us have.  But if they think THAT's the reason that Petraeus strayed, they are barking up the wrong tree.  First, although he was certainly ambitious, the rest of the traits don't add up.  And second, as I've already explained, just about ANYONE in his circumstances would have succumbed.  The temptation was just too great.

Sunday, November 25, 2012

GSK's Misleading Avandia Study As Symptom of Bigger Problems of For-Profit Pharmaceutical Industry


The WashingtonPost today has an excellent article ("As drug industry’s influence over research grows, so does the potential for bias") on the basic problem of Pharma-funded research, which echoes some of what Dan Ariely says in "The Honest Truth About Dishonesty" (although my earlier posts on that book might have seemed critical, I am going to get through it, and it is a worthwhile read in many respects) about how it is very difficult for researchers with a financial stake in an outcome to do impartial research.

The article describes the fate of Glaxo-SmitkKline's Avandia, an anti-diabetes drug that was the clear victor in comparative trials described in a 17-page New England Journal of Medicine article in 2006.  Problem was, all eleven authors of the article received funding from GSK, and they all missed the fact that taking Avandia correlates to an increased risk of heart attack.  Because of that side effect, Avandia is now off the market.

[Aside -- This is one more example of how the modern Republican "free-market-uber-alles" mentality simply won't do.  The "free market" means that "capitalists" can purchase literally whatever they want -- including positive reviews of their drug products by respected scientists in a respected medical journal.  And although theoretically the fact that they might be liable for the harm caused if the "research" turns out to be wrong (or to miss something), that theoretical possibility counts very little against the immediate profits that can be realized by going forward with promoting and selling a blockbuster drug].

Here's an important quote from the article:

"The billions that the drug companies invest in such experiments help fund the world’s quest for cures. But their aim is not just public health. That money is also part of a high-risk quest for profits, and over the past decade corporate interference has repeatedly muddled the nation’s drug science, sometimes with potentially lethal consequences."

The article also notes:

"Years ago, the government funded a larger share of such experiments. But since about the mid-1980s, research funding by pharmaceutical firms has exceeded what the National Institutes of Health spends. Last year, the industry spent $39 billion on research in the United States while NIH spent $31 billion."

I'm quoting that because it's a shame that the article doesn't give exact statistics.  It's pretty weak to just say the government funded "a larger share" "years ago."  Based on the succeeding sentence, I assume it means that the government used to fund more research than Pharma, but there is a lot of data missing.

What saddens me is that this sort of "point" was not made in any significant way during the debate about Obamacare.  Instead, the legislation passed in part because the pharmaceutical companies were assured that they would be able to continue to do business as usual.   In fact, the more people get access to healthcare, the more Pharma will profit.

The last part of the Washington Post article is actually kind of sickening.

Apparently, GSK knew that Avandia caused increased levels of bad cholesterol and coronary blockage and yet suppressed that information.  The trial that was reported in the article -- ADOPT -- was done in response to a request by the FDA that GSK study potential heart problems with Avandia.  And yet the authors of the study (who, as above, already were financially-biased to begin with) were not told that this was an aim of the study (actually, the non-GSK authors and GSK disagree on this factual point), and were not told of about the information that GSK itself was actively suppressing on the subject.  The result was that ADOPT wasn't designed to detect cardiac issues; it was just a comparison between the benefits of Avandia and those of two older anti-diabetes drugs.

But on a close examination conducted by Steven E. Nissen, a Cleveland Clinic cardiologist, the data from ADOPT did show an apparent increase in cardiac risk, which was missed by the study's authors as well as the peer reviewers.  Nissen had seen potentially troubling results in an earlier study (called DREAM), but the sample size was too small to say anything definitive.  When he saw the same trends (increased cardiac events as well as increased levels of bad cholesterol) in the ADOPT study, he asked GSK for data from other studies relating to Avandia, and GSK refused.  Luckily much of that data was publicly available as a result of an investigation by Eliot Spitzer.

[Aside: As to GSK's refusal to release its data to Nissen, in principle, I could agree that the data is "proprietary" -- GSK paid for it, so it should be able to control it.  But that's just one more problem with having all the pharmaceutical research "privately funded."  If all the research were publicly funded, then the data would be free for everyone to look at, and everyone could study it and make independent evaluations of the risk.  And in effect, the data IS publicly funded, because it's bought and paid for by the patent system -- i.e. by the fact that we pay dollars for drugs that cost drug companies pennies to make.  Pharma keeps reminding us that the reason patented drugs costs so much is that they have to do all the expensive research.  That argument in effect concedes that the public is "paying" for the research.  The result should be that the public owns it.]

Nissen published his results in the New England Journal of Medicine. As part of the peer review process, Professor Stephen Haffner, a "Glaxo ally," received a confidential copy.  In an apparent breach of confidentiality, Haffner promptly faxed a copy to GSK, which then prepared a full-bore rebuttal, including a prematurely-released counter-study (called RECORD) designed to muddy the waters.  GSK's rebuttal did not withstand scrutiny, and Nissen was ultimately vindicated as more data came in.

And of course, despite its rebuttal, GSK knew all along that Nissen was on the right track.  From the article:

"More than 40 company executives would learn of [Nissen's article's] contents [as a result of Haffner's breach]. They prepared a meticulous response to its publication that suggested that Nissen’s results were plain wrong.

“'GSK strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations,' the news release said.

"But internally, scientists and statisticians at Glaxo largely agreed with Nissen’s calculations, the company e-mails released by the Senate show.

"'To a great extent the numbers are the numbers, the Cleveland analysis is very similar to our own,' one of them reported via e-mail."

There are a rash of points beyond just the skewed-for-profit-research to be made for nationalizing the pharmaceutical industry.  I'll list them here briefly but will flesh them out (and more) in a subsequent post:

1.  The fact that drugs cost pennies to make, but millions if not billions to research.   The assumption is that the patent system is the only way to ensure that the research will be done.  But the patent system is very anti-free market -- it results in lengthy monopolies and suppression of competition legally for the term of the patent, and leads to all kinds of questionable practices designed to perpetuate the patent monopoly:

a.  Evergreening of patents

b.  Reverse settlements with generics in Hatch-Waxman litigation

c.  Special legislation to extend the life of lucrative patents

2.  Use of attractive Pharma Reps and other enticements to influence doctors to peddle specific drugs.

3.  Use of misleading (but "free speech") advertising to influence consumers.

4.  Steering consumers and doctors to patented drugs as opposed to off-patent versions.

5.  Inefficient and and suboptimal use of research dollars -- while competition is generally good, our pool of "research dollars" -- i.e. the premium the healthcare consumers and taxpayers (think Medicare and Medicaid) pay for research -- is very inefficiently spent, since it it divided among a number of pharmaceutical companies that are sometimes pursuing the same goals (and could thus benefit from knowledge of each others' research) and which are also pursuing the goals that are likely to be the most lucrative for them, as opposed to those that are in the best interests of public health.

And yes, nationalizing the pharmaceutical industry would not be easy, and it is difficult to predict that it will even achieve the best results.  After all, government is notoriously bad at running things.  The whole idea behind the patent system (and ancillary provisions like the Bayh-Dole Act) is that the government is not going to be good at getting needed innovations out to the public.

But I have to think that it can be done.  This is not about producing widgets, it's about saving lives.  A nationalized pharmaceutical industry might well attract the very people we want -- dedicated researchers whose life goals are to fight diseases and ease the suffering of mankind, and who have the tools and talents to make real progress on those fronts.  Right now, those people (the ones that don't work at the NIH) are working in the pharmaceutical industry, and getting mixed up in debacles like Avandia and Vioxx.  Wouldn't it simply be better to get rid of the distortions caused by the profit motive, and let them focus on getting the best medicines to the people?