Saturday, August 27, 2016

Epipen, Generics, and the Challenge to the AAP

Now everyone knows Epipen, the auto-injectable allergic anaphylaxis antidote whose manufacturer is now price-gouging patients who need it. Little Pharma (generic manufacturers, as opposed to Big Pharma, with the blockbuster brand names) has finally, perhaps, gone too far, just as Jose Canseco, Mark McGuire, and Sammy Sosa finally broke the steroid back way back when. A generic company has an old drug that was cheap for years, and instead of simply continuing to charge what it charges and make a normal profit, since it holds a monopoly on manufacturing the drug, it blithely raises the price to the rafters. Those needing the drug have no choice but to pay a lot more than they used to. The biggest difference with McGuire et al., I guess, is that Major League Baseball had the tools to enforce reform. With the federal government prostrated before pharma, the arrow in the quiver is not so apparent. A new arrow will have to be manufactured, because the government can't now price fix in a (fictional) free marketplace for medicines.

I first heard about the generic issue a few years ago when my med school roommate, now an ophthalmologist in Anchorage, told me the price of an ophthalmic generic he uses in the office had gone through the roof. Then there were articles in the media, and pediatricians on our American Academy of Pediatrics SOAPM listserve started complaining that mebendazole, a great and formerly cheap medicine for pinworms, now cost $600. Sneering Martin Shkreli then entered public consciousness by raising the price of daraprim by 6,000% or something, and even Congress had to become aware of the gap in the law. And now Mylan Pharmaceuticals, headed by Heather Bresch, the daughter of conservative West Virginia Democratic Senator Joe Manchen, says she is “just running a business,” but in the process has stepped on the snake of allergic families, who are too numerous to be ignored, by boosting an Epipen two-pack to $600, a supply that has to be renewed every year and a half, and which quite often needs to be paid directly by the patient because of their high-deductible policies. Congress is once again “Shocked! Shocked I tell you, Ricky!”

What a charade. What a charade. You are a professional organization dedicated to the health and well-being of children and their families, but you evade an issue as long as you can, do nothing, have no plan, don't give a crap, really, crocodile tears up to the knees. When the issue finally comes to a head, led by an on line petition from patients, not professionals, patients – they publish a “me, too” statement from our president that commiserates with the financial burden of patients and says not one stinking word about the general subject. No outrage, just hand-wringing.

At the AAP, they tell us don't say “they,” say “we,” “we are the AAP!” OK, I'll say “we.” We are full of crap. We knew it was going on – the listserve had it on there time after time. I suggested to our Committee on Child Health Financing that we compile a list of affected generic drugs and press this on our government. I suggested it publicly on the Listserve. At least confront Congress with the scorecard. Good luck with that.

So the Listserve erupts along with the public over Epipen. One participant points out that the issue was number four in priority in last year's ALF – the Annual Leadership Forum – where the top ten are supposed to be acted upon. Acted upon. That means, taken up as a priority. Something done about it. I said, great, an ALF resolution. Duck and cover, crouch and shelter, because here comes the earthquake of AAP intervention! Right, the Listserve commentator wrote to me privately, it's really a shame what happens to ALF resolutions.

My friend Christoph, Chairman of SOAPM, a courtly and energetic young man from North Carolina whom I like, whom I indeed urged to run for the position, forwarded the issue to another competent and amiable young man (they're all getting young to me, sigh) who heads the AAP Washington office, whom I also like. He responded:

  • we have been thoroughly engaged in working with public policy makers, the company and others to address the burdens the high cost places on families and the barriers it creates to accessing this crucial medicine.

  • we are working with Congressional staff to help them understand the issues. Since ALF, we have been pursuing an advocacy agenda, led by the AAP Committee on Drugs, and have participated in Congressional hearings as well as HHS meetings on Epi Pen and other drug pricing issues. We have also formally joined an AMA task force on pharmaceutical costs. 

  • With AAP support, one of our members ... took our concerns right to the COO and CEO of Milan (sic) earlier this summer.
  • To keep up the pressure, Dr. Dreyer is issuing a media statement today.
So I responded:
­Mark, why haven't we heard anything about this?  Why is the President's column in the AAP News always about helping the poor (not that there's anything wrong with that)?  What has the AAP been doing?  Is testimony effective?  What has it been, anyway?  Have I just been inattentive?
There is a whole list of drugs that have gone up and up and up, Schkreli-ized.   What is the AAP perception of the problem?  As someone has said, it's not what's illegal that should be stopped, but what's legal that should be stopped.  What is the AAP preferred solution?  Or at least, where is the AAP explanation of the difficulties of having a solution?
Is the AAP modus operandi to be a soft voice inside the tent, or to make common cause with parents and patients outside the tent?
Is it better for the AAP membership to be left out of the action?  It may be, that's a viable position, but it probably conflicts with the concern for membership numbers.
I have a lot of respect for our Washington people ....  I'm less secure in the AAP's traditional avoidance of public controversy in political matters, and this is a political matter, with lots of money and power on the other side (pharma), some of which spills into AAP coffers, I imagine.  That can lead to an organizational dilemma.

There are lots of questions here.  But at this stage, I think it should be embarrassing for the Academy to be upstaged by an on-line parents' group in a matter that relates directly to the health and well-being of children.

budd shenkin

More discussion followed. Christoph observed that lots went on that we won't know about but that this is appropriate, because the Listserve is available to many people who work for pharma. Some truth in that, but only some. Christoph expressed his confidence in the AAP, which I don't share. But he is congenitally trusting and I'm suspicious, a learned habit.

What kind of an organization are we (“we are the AAP”)? I think we are not a shit-kicking, obstreperous organization, which can be OK. As long as we press forward and stick to achievement. But all organizations need to guard against being a blame organization, where the chief objective of members of the organization is to avoid blame and thereby to keep one's job. There is a difference between patience and complaisance.

Mark's reply is CYA – we have fulfilled our responsibilities to the membership, here are our activities. Our theory? Dunno about that. Our endpoint? A rollback of Epipen prices for a while? That's pretty limited.

In fact, the problem with generics is generic, not particular. What do you do about the phenomenon? It's a puzzle. In a past era of corporate responsibility, corporations did not identify their actions the way the Mylan CEO does, as simply increasing shareholder value. Instead, they saw their responsibilities as extending to the welfare of their clientele, their workers, their community, their country. They identified their actions not in reference to what was legal, but to what was right. Not all of them, and not all of the time. But the feeling was expressed by Charlie Wilson, president of General Motors, when he was asked in his confirmation hearing to be Secretary of Defense in 1953, if he could make decisions as Secretary of Defense that were adverse to the interests of GM, said yes he could, but that he could not conceive of that situation “because for years I thought what was good for the country was good for General Motors and vice versa.” Or think about the relationship of Eastman Kodak to Rochester, New York. So in those days, unlike today, shareholder interest was important, but not decisive.

Not that the 50's were definitive of greatness. The auto industry declined in serving the public well, their organizations became blame organizations, and it took the Japanese for the industry to start serving the public well again, and it's not clear that Detroit ever really caught up. Industries decline – nations decline, for that matter. The point is, for decades the generic industry functioned well. When the patents on brand-named medicines terminated, generics took their place with much lower prices, the public was well served, and the new manufactures made a reasonable profit. Now, like Detroit in the 70s, the generics industry is in moral decline, driven by the nefarious Wall Street perception that the only boundary for industry action should be legality that can't be evaded, and if it can't be evaded, legal change can be bought. Epipen is just a symptom.

Every change in profit-seeking is buttressed by an ex post facto ideology. The current ideology is that of the radical free market, to an extent that Adam Smith never dreamed of. Narrow self-interest has been deified as socially responsible. “Greed is good” prevails. But this is new. In fact, as current debate on the course of capitalism illustrates, there has always been conflict between capitalism and democracy. Democracy sets the playing rules for competition so that it serves the public interest, and democracy also erects such public protections as labor laws, financial regulations, and welfare systems. (see unfortunately behind a pay wall, )

And because economics is never stable for long, there need to be constant readjustments. The surprise over the depth of Trump and Sanders support reveals once again how unstable capitalism is, how there are always losers, and how limits always need to be set on the winners. One need not be a Marxist to understand how the triumphs of today lead to the contradictions of tomorrow – how will we pay our populace as robots edge toward the nirvana of less and less boring work? But I digress.

The point is, if custom and moral social responsibility will not regulate a company that finds itself in possession of a monopoly product, how can we restrain the rents obtained? (that is, profit based on monopoly rather than competition and costs.) One way would be to bust up the monopolies by easing entry into the field (reform the FDA), or even subsidizing the creation of competitive entities. This would be nice, but oligopoly is not a great solution to monopoly, much as we welcome the self-regulating mechanism of competition. Oligopolists also enjoy rents. Another would be to regulate profits of the generic industry – difficult, but it could be done by clever economists. I could imagine other solutions as well, but whatever, it is crystal clear that something needs to be done.

How does this relate to the AAP? For government to act, there needs to be public pressure. As FDR said when meeting with a convincing case presented in his office (paraphrase): “You've convinced me. Now you need to go out there and make me do it.”

If you want to keep your job, you can follow procedures. You can refer an issue to the Committee on Drugs (what did they do, I wonder?). You can “meet with Congressional staff,” which means bring the issue up when you are meeting with them anyway. Etc. You can “maintain your relationships” with your counterparts in government. You can defend yourself before your constituents by citing procedures followed.

Or you can make the case and build up pressure. The NRA has no problem doing that. They educate their members on the issues at hand, they meet forcefully with representatives in Congress, they threaten vengeance on non-adherents. They aren't lovable – Wayne La Pierre is probably psychotic – but they sure are effective.

The AAP (I forgot - “We”) could make the case to our membership. What pediatrician is not enraged by these price increases, but these suddenly unavailable medicines? Instead of sending out email missives “let your Representative know!” “we” could really organize and bring it to them. We could get our task force moving in important districts. We could have a position, for God's sake – currently all we have is hand-wringing. We could have a newsletter that mentions the issue now and then, and actually elucidates the general problem so that there really is a general consciousness and understanding within the organization members.

We” could generate a sense of outrage. Here are companies that act against the general welfare under the guise of “doing business,” as thought that were clearcut. “We” could push as though we meant it. “We” could actually stand for something against the weight of pharma. Think it's dangerous to do so? David probably did also, thousands of years ago, but he seems to have done pretty well.

Google says, “Don't be evil.” The AAP could say, “Don't be pusillanimous.” In both cases, it's naming the temptation to be avoided.

Or maybe I'm all wrong. Who knows? Maybe the spontaneous patient uprising was covertly ignited by an AAP agent. Wouldn't that be a great surprise?

Budd Shenkin

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