How Many New Drugs Are Lemons? Ask Donald Light

This is a very important post because it refutes more conclusively than anything previously posted here the general position taken by the group we have come to call the "pharmapologists." These folks, as demonstrated in numerous earlier posts, argue that the pharmaceutical industry produces life-saving drugs and fantastic innovations in health, and when physicians get paid handsomely for working closely with Pharma, the result is more innovation and more lives saved. So it is against the public interest to derail the Pharma-medicine gravy train by imposing strict conflict-of-interest policies, etc. To the pharmapologists, the huge social benefits created by today's pharmaceutical industry are obvious; but the burden of proof is on us pharmascolds to document that any harm at all is caused by these wonderful drugs and the industry's marketing of them. Pharmapologist-in-chief Dr. Thomas Stossel of Harvard enjoys repeating that the pharmascold position lacks an evidence base because we cannot prove that there is anything about the marketing of drugs that causes bad patient outcomes.

What we offer in response to this confident pro-industry advocacy is often pretty mealy-mouthed. We fear being dismissed as Luddites and cranks if we deny that new drugs are largely useful. So we say, "New drugs are largely useful, but..." and then try to get on to our main point.

Well, there is nothing at all mealy-mouthed about my esteemed colleague Dr. Donald Light, medical sociologist and health policy expert based at University of Medicine and Dentistry of New Jersey and visiting professor at just about every place he can buy a plane ticket to. I will soon post about Dr. Light's new book (to which I conributed a chapter); but the text for today's sermon is a paper that Dr. Light delivered recently at the American Sociological Association annual meeting in Atlanta, August 17 (session 487), entitled, "Pharmaceuticals: A Two-Tiered Market for Producing 'Lemons' and Serious Harm." The paper is thoroughly documented and supported and I would like to see a Pharmapologists' factual rejoinder.

The entire paper is worth reading and I hope Don will get it into print soon. By way of trying to summarize, Dr. Light builds the paper around an economist's idea, Akerlof's theory of "a market for lemons." The idea is that when there is an imbalance in the information available to buyer and seller, sellers can take advantage by pushing inferior products off on buyers. This leads to a general distrust, with buyers being unwilling to pay top dollar because they fear getting a lemon. If you have a good product but know you can't get top dollar for it, then you will take your product elsewhere to be sold. Eventually, predicted Akerlof, the market will simply fall apart. Dr. Light shows why pharmaceuticals don't exactly follow the Akerlof prediction, and how it can work that a more or less permanent market for lemons characterizes the U.S. pharmaceutical business.

In the market that Akerlof originally looked at, used cars, we don't see any car company trying to produce lemons. Says Light: "[T]he pharmaceutical market for 'lemons,' differs from other markets for lemons in that companies develop and produce the lemons. Evidence in this paper indicates that the production of lemon-drugs with hidden dangers is widespread and results from the systematic exploitation of monopoly rights and the production of partial, biased information about the efficacy and safety of new drugs. The institutional practices differ profoundly from car manufacturers working tirelessly to produce safe cars but inadvertently discovering a serious problem, like Toyota discovering its sticking accelerator problem in 2009. The massive reaction, Congressional investigations, and recalls [in the Toyota case] involved less than 1/10,000 as many deaths as are attributed to prescription drugs every year." Light adds that the information asymmetry also characterizes the relationship between the drug companies and the government regulators, who now rely havily on industry user fees to fund their own operations, assuring that the FDA has little power to impede the "market for lemons" and instead becomes a sort of enabler, providing additional cover for the companies because they can always point to FDA approval in their own defense.

If one dispassionately surveys this institutional landscape, says Light, then it is easy to predict the outcome: "Companies will design and run their clinical trials to minimize evidence that their drugs cause adverse reactions and maximize evidence that they are not inferior to or [are] better than a placebo for the target indication. And companies will also learn from the regulatory body how to game accelerated approvals and condition[al] approvals with post-market studies by cutting corners and submitting partial evidence in order to get drugs on the market faster and put the regulator under pressure to approve and not to later rescind." Light might have added here that any company in today's highly competitive market that does not get good at playing these games will quickly lose market share and be put out of business, or gobbled up in a merger.

What, then, is the evidence that this account of Pharma's institutional environment is correct?

• It has been documented numerous times that of all the so-called "new drugs" put onto the market annually, only a few are actually novel chemical structures, and of those, only a handful are real advances over existing drugs. An estimate of 10-15 percent actually being significant advances in one way or another would be highly generous.
• With 85-90 percent of new drug discoveries not counting as real advances, it is herefore clear, as Light notes, that "company R&D goes largely to a marketing strategy that does not meet societal needs or the needs of patients."
• Drug companies constantly whine that they spend so much on R&D, taking huge risks of wasting money on drugs that don't work, that their profitability is always in jeopardy. Garbage, replies Light. R&D in the US drug industry rose during the decade between 1998 and 2008 from $18.9B to $47.4B. Societally speaking, this was a huge waste as so few real drug innovations resulted as noted above. But drug industry profitability did not suffer at all during this period (even though, as I reported in HOOKED, it looked a bit grim for a while in the early years of the 2000s).
• Extrapolating from the best available figures, the US suffers about 111,000 deaths annually from adverse drug reactions (that is, drugs prescribed and administered correctly, and leaving aside deaths from medical errors), or more than twice as many fatalities as from auto accidents. This puts adverse drug reactions as the 4th leading cause of death, and besides, adverse reactions lead to about 1.5M hospitalizations per year (the total damage toll being underestimated because we lack good data for nonhospital settings).
• If the industry produced drugs, many of which offer no real advantage over existing drugs, and then urged the maximum possible caution in their use, we could perhaps avoid some of this swath of death and destruction. But such, of course, would hardly suit the company bottom line; so instead we have what Light calls the "risk proliferation syndrome." Company-sponsored research talks up the efficacy and the safety of the drug. Marketing then tries to get physicians to prescribe the drug to as many patients as possible, including those (such as the elderly) inherently at higher risk for adverse reactions, and those who have less and less chance of actually benefiting (because their disease is mild, or for whom nondrug therapy would work better, etc.) The industry does everything possible to speed up FDA approvals of new drugs and to slow down any threatened FDA action to remove an unsafe drug from the market or to restrict its use. The end result is that as many patients as possible are put at risk, while revenues go steadily up. (More on this particular phenomenon later on when I have the chance to blog about a paper that Dr. Light and I co-authored, which is currently awaiting publication.)
• The financial power of the drug industry allows it to "colonize" medicine in the same way that it has effectively taken over the FDA. This means that more and more of medicine turns into a commercial enterprise placed at the service of industry profits. New diseases are "discovered" that require drugs to treat them. The medical literature becomes indistinguishable from the industry marketing juggernaut. And so on, as this blog has documented ad nauseam.

I lack the time and space here to reproduce Dr. Light's extensive list of citations, but while awaiting the end of the embargo imposed by the ASA before I was permitted to quote from the paper, I reviewed 6-8 of the key papers he cites and was impressed with the depth of the data that support his conclusions.

Bottom line: Let's put the burden of proof where it belongs. When anyone says that the drug industry, in its present form, is a benefit to society, we ought to reply, "prove it." Or, to put the matter in another (and perhaps kinder and more moderate) way, we must not mistake the level at which the bad stuff happens. When new drugs end up killing people instead of healing them, it is not something that just happens around the edges. The reasons for those bad outcomes are much deeper into the structure of the industry today than most of us (even pharmascolds) want to admit.

Continuing Our All-Carl-Elliott Issue: More on the Dan Markingson Case

Back in April I blogged about the tragic case of Dan Markingson and the so-far-futile efforts of his mother, Mary Weiss, to get justice from the University of Minnesota:
http://brodyhooked.blogspot.com/2010/04/u-minnesota-evading-responsibility-for.html

Carl Elliott's book (mentioned in the last post) contains a brief synopsis of this case; but he goes into more detail in an article in the current Mother Jones, "Making a Killing." (To access, go to the Mother Jones current issue website, http://motherjones.com/toc/2010/09, and look for the title "Making a Killing." Click on that and you'll get a screen that will allow you to register for free access.)

In "Making a Killing," Carl not only describes the sad case but also puts it in the context of the pressure placed on universities today to compete for grant dollars with commercial research entities, all funded by a drug industry that is looking for marketing, not science. As Carl summarizes:

"If these experts [who have reviewed the study in which Dan Markingson was enrolled, and have declared it to be scientifically next to worthless] are right, then then the study in which Dan Markingson committed suicide was not simply a matter of inadequate informed consent, or financial conflicts of interest, or even failure to monitor a subject's care. The ethical breach was built into the study from the start. It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goal of [the sponsoring drug copmpany] AstraZeneca."

Carl throws a couple of other scary passages at us. When Ms. Weiss attempted to sue the University and its psychiatrists (a suit that was dismissed based more or less on a variant of sovereign immunity), her attorneys deposed the director of the U's Institutional Review Board (IRB) or research subjects ethical review committee, Moira Keane. The attorney asked what she thought was a routine question--didn't the IRB have the responsibility to protect human research subjects?--before proceeding to the issues under dispute. But Ms. Keane refused to admit that the IRB had any such responsibility. The attorney thought she had misunderstood (after all, the U-MN website says the purpose of the IRB is to "protect the rights and welfare of human research subjects") but Ms. Keane stood firm. In the end, all she would admit was that it was the role of the IRB to make sure that research investigators at the U had a plan to protect human research subjects. As Dr. Elliott then notes, this is as good as saying that the IRB at U-MN doesn't do a thing--since it was precisely to protect human subjects from the dangers of an overzealous investigator that IRBs were first created.

The next scary quote relates to how you can end up with a study like CAFE (the study in which Markingson was enrolled), which is basically jiggered from the start not to answer any legitimate scientific question, but to provide the drug company with marketing spin to sell their drug, and which can more or less be guaranteed to produce the answers that the company wants. In HOOKED and previously on this blog, I have described in detail some of the tricks used by study designers to rig outcomes. But the march of progress continues, and as journal editors, however belatedly, start to catch on to these little games, the goal posts move. Summarizing a 2006 study of research on atypical antipsychotics, Carl notes, "Much of this manipulation came from biased statistical analyses and rigged trial designs of such complexity that outside reviewers were unable to spot them."

The CAFE study, for those interested, appeared as: McEvoy JP, Lieberman JA, Perkins DO, et al. Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison. American Journal of Psychiatry 164:1050-60, 2007.

New Book of Interest from Carl Elliott

I have been privileged to receive an advance copy of Carl Elliott's White Coat, Black Hat: Adventures on the Dark Side of Medicine (Boston: Beacon Press, 2010, ISBN 978-0-8070-6142-8; $24.95 hardcover, 211 pp.). I have only just dipped into it, and may post more after I have read it all, but wanted to waste no time in getting the word out.

Carl, who has been mentioned in these parts previously, is an MD who then went on and got a PhD in philosophy and has taught bioethics at a number of world universities, currently at University of Minnesota. He's published his essays in such places as The New Yorker and The Atlantic Monthly, and I feared at first that this book would be merely a collection of those essays, but I see he's reworked the material for this book specifically.

Carl is concerned about the cast of characters that populates the "dark side of medicine" where business and market values seem to have taken over from any sort of professional commitment to the care and well-being of patients, with a special focus on Pharma. His chapters deal, respectively, with professional guinea pigs who volunteer for one research study after another;
the "ghosts" who actually write ghost-written articles; drug reps; medical "key opinion leaders"; marketers; and finally, a group that Carl has practically made a career of irritating, bioethicists like Carl and me who (unlike Carl and me) get seduced into signing on with corporate boards and taking corporate cash, assuming that the corporations actually want us to tell them what's ethical, and might listen if we tell them (while meanwhile we get to fly to their meetings first class and stay in five-star hotels).

The book is nicely illustrated with anecdotes and interviews, such as this nice quote from former drug rep Jordan Katz, about how the code of ethics introduced by PhRMA in 2002 actually made things worse: "The companies that tried to follow the guidelines lost a ton of market share, and the ones who didn't gained it. The bottom line is that if you don't pay off the doctors, you will not succeed in pharmaceuticals. Period."

I think it's a safe bet that readers who find this blog interesting will like this book.

British NHS Backtracks on Diabetes Guideline--What Are Pharma Implications?

My thanks to Marilyn Mann and Jerry Hoffman for the contents of this post.

Marilyn sent me a very nice blog posting:
http://www.straightstatistics.org/article/how-overtreatment-diabetics-may-have-cost-lives
--in which is described the backtracking of the British NHS after one year from a practice guideline that called for GPs to try to control their diabetic patients' blood sugar so tightly that the hemoglobin A1C level (a measure of long term control of sugar) would be below 7.0%, down from a previous target of 7.5%. These guidelines are used to determine financial bonuses for GP practices for "quality" care and failing to meet this guideline could cost a GP practice 3000 pounds annually.

At the time this guideline was announced, there were already studies published in the literature making it clear that tighter control of blood sugar in Type 2 diabetes was not helpful in improving patient outcomes and was instead associated with greater risk of harm (as I've covered in several previous posts). So there were loud critics when the guideline first went into effect; and those same critics, while glad that the NHS guideline people have backed off (returning to the 7.5% target) point out that almost certainly, patients died during this past year due to the application of this inappropiate guideline.

What does any of this have to do with ethics and Pharma? Here we come to a comment Jerry Hoffman made to me some time back that is pertinent--that the whole idea of "pay for performance," which the NHS has embraced eagerly and which bandwagon US insurers including Medicare are now eager to jump onto, has obvious advantages but some downside risks that are often hidden. Specifically, in the olden days, if drug companies wanted to sell drugs, they had to figure out a way to influence 800,000 free range US physicians. They figured this out, of course, quite well, but it cost them a ton to hire the 100,000 detail people (at the peak of their population) thought to be needed to do the job. If pay-or-performance comes to be, we have made Pharma's job much easier. They will simply have to figure out a way to influence 1000 or so physicians--the ones who write the guidelines on which the P4P targets are based. As I've pointed out before, there is a huge accumulation of evidence that the name of the game in treating Type 2 diabetes ought not be blood sugar control; yet we keep hearing of new drugs designed to provide better blood sugar control, and guidelines keep being written (usually by authors with financial conflicts of interest) advocating better blood sugar control. If that all seems like a way to sell drugs rather than to treat patients properly, we might wonder how that could have come to pass.

Are Electronic Health Records Medical Devices? Who Is Monitoring Their Safety?

I see it's been more than a year since I posted about Electronic Health Records (EHRs):
http://brodyhooked.blogspot.com/2009/05/briefly-back-to-emr-another-market.html

--so maybe it's time for an update. Those of you unsure what EHRs have to do with ethics and the pharmaceutical industry, please hang on for a second, and all shall be revealed.

This week's New England Journal of Medicine offers two perspectives on the EHR. David Blumenthal, the Obama administration's lead EHR advocate, and Marilyn Tavenner talk about "meaningful use" regulations for EHRs, while Surgeon General Regina Benjamin tells how she became an EHR believer after her rural clinic was first washed away by a hurricane and then burned down. Do these cheerleading articles tell us the full story about the EHR? I wish.

First you can consult a recent post on our friends, the Health Care Renewal blog:
http://hcrenewal.blogspot.com/2010/07/open-question-on-moral-authority-and.html

"MedInformaticsMD" provides us with some telling clinical insights about what happens when a hospital or clinic buys EHR software off the shelf and then tries to go live with it with minimal time and effort devoted to staff preparation and training. He happened to be in the hospital with a sick relative when the prescription order-entry system "went live," and he observed at first hand the ensuing pandemonium, making careful note of the impact this could easily have had on the safety of the patients then hospitalized. None of them, he noted, gave their informed consent to be experimented on in this way; is that ethical, he asks?

MedInformaticsMD knew whereof he spoke because he had described in detail how his mother had suffered from a similar mishap-- but let him talk:

A newly-admitted patient who needed urgent heparinization did not receive the medication promptly. The patient's physician could not order it, as nursing had not yet "admitted" the patient and entered data such as weight. Physicians found no way to override, despite calls to the help desk, attempts by on site IT people and users from the parent hospital, etc. In the end, the pharmacist simply provided the med using a weight estimate despite no "official" order having been entered into CPOE.
This story sticks in my mind as it was due to disappearance of an anti-arrhythmic med on my mother's ED admission med list at the parent hospital, without any alerts that a medicine she'd been on for years was somehow removed as an 'active medication', that led to her needing heparin acutely. The iatrogenic need for heparinization then led to an iatrogenic cerebral hemorrhage and emergency craniotomy, followed by many complications.

So here is an anecdotal example of one patient (the author's mother) having a stroke caused by a screw-up in an EHR, and another patient being put at risk of a serious event, including a possible stroke, due to a screw-up in an EHR. Are these rare events? No, says the Huffington Post:
http://www.vuvox.com/collage/detail/02b26ea6c3

This little slide show illustrates how, despite an increased number of warnings from sensible and authoritative people about safety issues in EHRs, the political juggernaut to adopt EHRs universally presses forward, aided and abetted by a corporate lobby that is trying to ward off any significant government safety oversight.

What does this have to do with Pharma and ethics? Regular readers of this blog may be surprised that I'd be holding the pharmaceutical industry up as a paragon of virtue; but at least Pharma recognizes that at some level, it has a moral corporate responsibility to submit to appropriate oversight to make sure its products don't kill people. This level of understanding that human health is at stake here appears thus far to have escaped the software firms that now make up the EHR Industrial Complex.

Reply to My Article on COI-Coke-AAFP

The "Policy and Medicine" blog has recently posted a lengthy rebuttal by Thomas Sullivan--
http://www.policymed.com/2010/08/aafp-childhood-obesity-patient-education-program.html

--to my own article on conflict of interest in the AAFP-Coca-Cola matter:
http://www.annfammed.org/cgi/content/full/8/4/354

The rebuttal is carefully done, but you can get a sense of it from the last summary paragraph:

We need to build a culture of trust. To begin that culture, we need to trust that the leadership at the AAFP is motivated to conduct this program to help children and families. Trust the physicians participating in the program who are almost desperate for tools to help these children and families. In the end we are all trying to do what is best for patients; working with industry resources to accomplish this goal is good for everyone.
In the end, our efforts and energy should not be concerned “about the development of a corporate culture within a medical professional society,” because doctors and physicians are trained to avoid such motivations. For the overwhelming majority of doctors, especially those in family medicine, the only role corporate culture plays is helping physicians conduct the research, training and education needed to make families healthier. As such, we should be encouraging the funding from and collaboration with industry to help physicians carry out their moral duty to their patients, which includes working with industry to find new ways that can help treat diseases like obesity.

OK, let me see if I get it. We are supposed to trust the AAFP leaders, because we believe that they are trying to do what's best for patients and for the general public. What about the evidence that getting into bed with a for-profit company that has a financial interest in selling beverages that add to the risk of obesity might be contrary to those goals, and motivated less by what helps patients and more by AAFP's own financial bottom line? Well, don't believe that evidence. ("Who are you going to believe--me, or your lying eyes?") Why not believe it? Well, it cannot be true. Why? Because "doctors are trained to avoid such motivations." Even when they seem to have given into those motivations? Well, just trust us.

"For the overwhelming majority of doctors, especially those in family medicine, the only role corporate culture plays is helping physicians conduct the research, training and education needed to make families healthier." Oh, really? The only reason for-profit companies fork over those bucks is because they want to make families healthier? There is nothing in it about making more money by selling more drugs or other products? There is no evidence that drug company-sponsored research is tilted away from the true scientific questions about human disease, and toward whatever will give the company's marketing a leg up? There is no evidence that any company ever tried to hide important scientific data that might interfere with sales?

I was tempted to end this post with, "Just what world do these people live in, anyway? Because maybe I'd like to buy a condo there." But that would be a churlish response to a commentary which is, after all, written in a completely polite fashion. So in an attempt to offer an equally polite reply, I will say that it makes excellent sense, in assessing the ethics of medicine's relationship with industry, to weigh the pros against the cons. But in order to do so, one has to be willing to admit that there are both pros and cons. A group of defenders of the recent status quo, on the other hand, appear to be unwilling to admit that there are any cons at all. On their view, there is nothing but good that can come from a close financial relationship between medicine and industry. But that does not strike me as a rational way to conduct an ethical analysis.

Getting our $100 Worth: Special Correspondent Reports from AAFP Meeting

Talk about getting your money's worth... I donated $100 to Oregon medical student Richard Bruno so that he could buy stickers to distribute at an AAFP students' and residents' meeting, to protest AAFP's "deal" with Coca-Cola:
http://brodyhooked.blogspot.com/2010/07/aafp-and-coca-cola-continued-how-i-just.html

For that sum I not only allowed the purchase of some materials (as you'll see below) but also secured Richard's services as this blog's Special Correspondent at the meeting. Herewith the Special Correspondent's report:

***
Wow, what an incredible experience. We fought hard, but our "end the coca cola alliance" resolution lost by one vote! I'll give you a rundown of what happened, but considering no one has ever done anything like this at the conference, I think we made quite an impact.

Last Tuesday I spent a few hours getting quotes for stickers and postcards. I placed an order for 250 "no coke" stickers for $75 to be delivered to the Kansas City Marriott on Friday. Looking back I think it would have been better to pay the extra $25 to have overnight shipping and have had them there on Thursday so we could have gotten them out to more people. But I was also placing an order for 500 postcards ($75). As soon as I placed it, however, I received a call from Dr Amy McGaha, asst director of medical education for the AAFP. She informed me that someone had forwarded her [our] blog post on our campaign efforts and let me know that we would not be able to hand out any materials at the convention center, parking lot, or hotel, without reserving an exposition booth.

In what was likely a hasty move, I cancelled the postcards, not knowing how we would manage to get them signed by attendees if we were going to have eyes on us all weekend. Just to be sure, I emailed the Oregon Health and Science University family medicine residency director asking if he would allow us to distribute materials from the residency program booth. He assured me that he believed in our cause, was equally outraged at the partnership, and that we could have materials on their table.

Our resolution was coming along nicely, and was a collaborative effort from 4 OHSU students and 4 students at other medical schools (with input by a resident Lenny Lesser). It was submitted on Thursday before I arrived. I gave testimony to the Reference Committee hearing on Friday, and there were 4 AAFP board of directors there to hear it. Afterwards, Dr Ted Epperly (Idaho), former President of AAFP and current board member, came up to me afterwards. I had met him in the fall when he came to speak at OHSU and gave him a stack of scientific papers implicating sugar-sweetened beverages as the number one cause of obesity. He vowed to take them back to the board of directors and later told me that he was the lone voice of dissent on the board. After the hearing, he told me that he had spent a lot of time considering the board's position, and that he has finally seen it their way, as a necessary step for financial stability. I was definitely disappointed he had changed his position, but vowed that I would never trade my values for what is status quo, or even what is "politically feasible."

I had also submitted a resolution to "establish a single payer task force," which I thought would be a small but important step toward the AAFP endorsing universal healthcare. Dr David Ellington, another board member approached me after the hearing and told me that he was actually a single payer supporter, but that we would have to agree to disagree on the coke partnership. He also cautioned me not to confuse ethics with justice. I had apparently miffed him when I brought up the question of ethics during my testimony, though I relied more on the conflict of interest strategy as outlined by your AFM article.

After the hearing I picked up the stickers which had arrived at the hotel, and started getting them out to everyone from OHSU. There were a number of parties being thrown by various residency programs in hotel ballrooms and meeting rooms across the city, and we made our way to many of them, proudly displaying our "no coke" stickers. It was amazing to see what kind of reaction it got from folks. I did not carry enough with me--they went very quickly. I told people to come Saturday morning to vote on the resolution (because even if the reference committee did not adopt the resolution, which I assumed they wouldn't, I would extract it for debate and open it up for a vote among the entire congress of delegates).

Saturday morning came, and before the general session, I stood on the street corner and handed out stickers for half an hour. More folks took them than didn't and I felt pleasant about bringing awareness to those who didn't know anything about it. During the congress of delegates meeting, I extracted the resolution (along with my other resolution on single payer) and it went through some lively testimony from me and many other students. About half of the AAFP board of directors was there--I know they were very interested to see how things would shake out. After about half an hour of debate, the vote came down and we lost by one.

I'm confident that our voice was heard, and that the board will put a little more thought into the student viewpoint when engaging in decisions like this. I still believe the partnership compromises the integrity of the organization, and will continue to fight it. I'm pleased to know that the Oregon and Washington Academies both have similar resolutions that were passed and will be brought before the national congress of delegates in September.

I am really grateful to your support which lent momentum to our efforts. I would like to return the $25 we did not use.

***
Richard, please keep the $25, your long message was worth it to keep our readers updated! (Even those readers who are keeping an eye on this blog to tip off AAFP leaders to upcoming demonstrations!) Also, perhaps one of the intellectual lights on the AAFP board of directors could explain to me exactly what is meant by "not confusing ethics and justice."