your nose is growing longer…

Posted on Saturday 12 April 2014


MedPage Today
By David Pittman
Apr 10, 2014

Doctors haven’t disengaged from drug companies in the months since the tracking of financial relationships between them started, several pharmaceutical executives here said. The Physician Payments Sunshine Act required drug companies to track gifts and other payments to physicians starting August 1, making them public later this year – leading to fears that public shame or misunderstanding might come of doctors’ relationship to pharma.

But those ties have pretty much stayed put, different leaders of the drug industry said at the annual meeting of the Pharmaceutical Research and Manufacturers of America [PhRMA]. "We’ve seen virtually no change in the way we interact with physicians," Pfizer CEO Ian Read said at a press conference. Celgene chief Bob Hugin, who doubles as PhRMA board chair this year, said his company has seen the same thing, and the law has had "no impact on the way we deal with physicians."

Each man shook his head "no" when asked directly if doctors seemed more hesitant to interact with pharmaceutical companies now that the law was in place. The Centers for Medicare and Medicaid Services (CMS) will make public on Sept. 30 payments and other "transfers of value" drug companies report giving doctors. With a handful of exceptions, drug companies and group purchasing organizations must report payments or gifts in excess of $10 made to physicians on a yearly basis. The first year will include information collected between Aug. 1 and Dec. 31. CMS will allow physicians to review and protest inaccuracies starting this summer.

"Who wants to go to a doctor that is not the most well informed, the most aware of what’s happening?" Hugin said. "We really want to make sure that this act, which is designed to make things more transparent, does that but doesn’t change behavior because people misuse the data and apply in a way that implies something inappropriate." He suggested that the Sunshine Act may become an issue when and if people mischaracterize the data when it becomes public. That’s why companies and doctors must be proactive later this year when the data are released to make sure it is presented accurately and fairly, he indicated.

"We welcome the transparency, and I think physicians will welcome the transparency because the relationships are highly ethical between the industry and physicians," Read said. The Justice Department last year accused drug-making giant Novartis of kickbacks it paid to doctors by holding "educational events" on fishing trips and at Hooters restaurants that were little more than parties.
hat tip to Alto…
I always wondered what they talked about at a Pharmaceutical Research and Manufacturers of America meeting [PhRMA]. Besides the Sunshine Law, the image on the left from their website addresses another such topic – the academic·pharmaceutical·NIH Axis. Actually, when I followed the link on their site, there was an even bigger picture slide that included many other elements – almost all of the usual subjects:

It’s an impressive universe they have there. I noticed that they left out the ghostwriters. Maybe they’re the ones walking around outside on their virtual campus. On the site, there’s something called the CHART PACK with a number of charts which make the case that the PhRMA world is an unfairly oppressed place. Looks like an Insel blog. My editorial comment is the graphic on the right, but take a look yourself.

Well, what about the claim in the article that the Sunshine Act is having no effect on the doctors in the PhRMA service? Is it true? Or is this more spin to launch a campaign against the Sunshine Act itself? With this crowd, one can never know. I’m sure that for some doctors who have banked on PhRMA pay [another pun intended], losing some patients because of reporting is immaterial in the face of their PhRMA earnings. But the overall impact won’t be felt for some time. Who knows?

But one thing we do know right now. This is some remarkable copy written by the PhRMA PR department:
"Who wants to go to a doctor that is not the most well informed, the most aware of what’s happening?" Hugin said.

"We really want to make sure that this act, which is designed to make things more transparent, does that but doesn’t change behavior because people misuse the data and apply in a way that implies something inappropriate." He suggested that the Sunshine Act may become an issue when and if people mischaracterize the data when it becomes public…

"We welcome the transparency, and I think physicians will welcome the transparency because the relationships are highly ethical between the industry and physicians," Read said…
My mom would’ve said, "Pinochio, I think your nose is growing longer and longer!" I still wonder how adults can write things like that and deliver them with a straight face…

UPDATE: I couldn’t leave it alone. So here’s just one slide from the CHART PACK
  1.  
    Bernard Carroll
    April 12, 2014 | 12:39 PM
     

    You have to hand it to PhRMA – their PR machine is very slick. In the Disney World-like diagram of Drug Development World that you reproduced from the CHART PACK, notice how they anchored corporations at the center, making other players peripheral. You noticed the absence of Medical Education and Communications Companies (MECCs). Some other missing players in this fantasy land are Clinical Research Organizations (CROs are much more than just trial sites nowadays); and Madison Avenue for direct to consumer advertising; and Key Opinion Leaders (KOLs generally have little if any role in actual drug development). Oh, and they left out the U.S. Department of Justice and the States’ Attorneys General who have successfully prosecuted the PhRMA industry to the tune of umpteen billion dollars lately for bad behavior.

    As I scanned the CHART PACK from your link, I saw self-serving distortions on almost every page. This is the well-financed and entrenched system we are up against. Thanks for the links.

  2.  
    April 12, 2014 | 12:57 PM
     

    The information in the MedPage article can be interpreted in several ways:

    1) A very brilliant public relations move by PhRMA to reassure doctors their peers have no compunctions about taking favors — presenting no evidence but the organization’s own statement that this is happening. Thus, trying to overcome the promotion-chilling effects of Physician Payments Sunshine Act.

    2) On the other hand, several studies have shown that doctors think of themselves as immune to persuasion by goodies, advertising, etc., so maybe they haven’t changed their ways at all.

    3) Doctors are not deterred from taking pharma favors because they don’t expect any repercussions from the Physician Payments Sunshine Act. They think their patients don’t care about it, if they know about it. They don’t expect to lose any business on the basis of being on some list.

    4) Individual doctors are not deterred from taking pharma favors because they see their KOLs doing it all the time, much more profitably, and think of themselves as tiny little fish whose nibbles are of no account.

  3.  
    April 12, 2014 | 1:05 PM
     

    Alto,

    And maybe all of the above. So the Sunshine Act will have to be only step one of many if it’s to have an impact.

  4.  
    wiley
    April 12, 2014 | 1:12 PM
     

    target level: The acceptable level of a hazard in the final product, such as the regulatory level of mycotoxin in a product description.

    Nah, that’s not it. This isn’t about risk management, it’s about therapeutic drug levels.

    Yet— In launching a program, managers often start with an idea of the dollar profit they desire and ask what sales levels will be required to reach it. Target volume (#) is the unit sales quantity required to meet an earnings goal. Target revenue ($) is the corresponding figure for dollar sales. Both of these metrics can be viewed as extensions of break-even analysis. . . . Increasingly, marketers are expected to generate volumes that meet the target profits of their firm.

    A little of each perhaps? In that context, “target levels” could refer to the number of patients raised by the lowering of a therapeutic level, which could be a perfectly scientific medical goal to treat more patients more effectively, but pharmaceutical companies and the PR companies that serve them, are talking to stockholders here.

  5.  
    April 12, 2014 | 2:24 PM
     

    Transparency is seldom a solution to the appearance of conflict of interest, The case in point is the US Congress. You can get detailed information on any member and they are generally very active in the same areas where the COI exists. (opensecrets.org database) In many cases their lobbyists have a high degree of access and much input into legislation. Amazingly some of them seem to act like they are standard bearers for ethical approaches to conflict of interest. From that angle transparency is meaningless.

    The second issue is that many physicians enjoy working for Big Pharma. Granted there is a PR spin on anything, but it is also possible that they get a lot out of it besides bribery. There are consulting fees that are legitimate. I have know several very bright physicians who eventually made the transition from clinical medicine to work within the pharmaceutical industry. Simple bribery of physicians is a rather naive interpretation of what many physicians get out of the relationship. The level of intellectual stimulation in some of the pharmaceutical scientific environments is unparalleled and you won’t find it in clinics or hospitals anywhere.

    The business methods critiqued in the above post are everywhere and certainly no worse than Wall Street managing clinics, hospitals, and doctors. Target volume and reimbursement is exactly how hospital managers decide to throw patients out in a set number of days. You don’t think there is any science behind that do you? That same hospital has a PR department advertising themselves as one of the top hospitals in the US – just like half of the other managed care hospitals.

    Mickey – I would be interested in what you would consider the “next steps” to be. An outright ban of physician contact with Big Pharma? An outright ban of physician contact with managed care would eliminate much more conflict of interest that is harmful to patients. But of course that would never happen. Managed care is thoroughly backed by politicians and in some cases state statutes.

    I wonder how that happened?

  6.  
    wiley
    April 12, 2014 | 3:09 PM
     

    I’ve no doubt that there are perfectly valid and evidence-based reasons for what is discussed in this post, but that doesn’t invalidate most of the other posts here. There is, undoubtedly, a problem with corruption in medicine which has a whole lot to do with pharmaceutical companies, their influence on doctors, and flawed to fraudulent drug company funded research and “education” about drugs. The corruption is especially bad in psychiatry because it doesn’t have a lot of the checks and balances built into general medicine and other specialties.

    Of course, BigPharma and medicine, even psychiatry, isn’t completely corrupt— precious little ever is— it could hardly be as corrupt as it is if there weren’t a lot of fears, dreams, and good intentions being manipulated. It also wouldn’t be as corrupt as it is without money and prestige as rewards for going along with the status quo unquestioningly.

    Managed care is certainly a problem, but I suspect there were other problems before managed care. No system is going to be perfect. What we’ve got here is “a racket” and every single player in the game is required to support it. Pharmaceutical companies wouldn’t be trying to find another tune for the pipers if it weren’t profitable and expedient to do so.

  7.  
    wiley
    April 12, 2014 | 3:12 PM
     

    Oh, and some lobbyists actually write laws that Congresspersons put their names to, just like some psychiatrists put their names on more studies per year than they could have possibly authored themselves.

    http://www.nytimes.com/2012/02/13/opinion/the-big-money-behind-state-laws.html?_r=0

  8.  
    Arby
    April 12, 2014 | 3:18 PM
     

    The industry push to be perceived as something other than what they are.

    Perhaps this morethanmedication is for the good of mankind, but we would be better served by them changing their pricing structure than spending our money on this type of thing. I can get this information from other sources.

  9.  
    Arby
    April 12, 2014 | 3:23 PM
     

    Apologies. Corrected URL More Than Medication

  10.  
    April 12, 2014 | 3:41 PM
     

    So WIley – are you actually arguing that writing federal law has less of an impact than somebody falsely putting their name of studies they have not authored and that are read by practically nobody? Some of those laws written by lobbyists have resulted in the current financial services industry that acts like a substantial hidden tax on everyone, just like health care legislation. Certainly putting your name on something that you did not do is a substantial ethical problem but it pales in comparison with what happens in Congress.

  11.  
    wiley
    April 12, 2014 | 4:03 PM
     

    You aren’t trying to put words in my mouth are you?

    Oh, I think the law can be used to support corruption in any capacity; like out of state lobbyists fighting to get the Arkansas Supreme Court to reverse a decision against Johnson & Johnson.

    http://www.arktimes.com/ArkansasBlog/archives/2014/02/03/friends-of-the-court-no-gift-to-legislators-to-join-suit-over-law-mcdaniel-says

    And I think what lawmakers do for the benefit of private enterprise, pales in comparison to almost anything else. Had a glass of water in North Carolina, lately?

  12.  
    wiley
    April 12, 2014 | 4:40 PM
     

    GlaxoSmithKline was busted for bribery by the Chinese government, which may have had other motivations for doing so, like their own plans to manufacture generic drugs themselves, but for American corporations bribes to foreign governments are tax deductible.

    The purpose of a publicly owned corporation is to provide profits to the shareholders. Of course the shareholders must feel like the corporation is both legitimate and profitable. What difference does it make to shareholders in Johnson & Johnson if the drugs are over-prescribed? Well, it starts to make a difference when the company is sued repeatedly by states for MEDICAID/Medicare fraud to the tunes of billions— that’s money that doesn’t go into the shareholders pockets or to give CEOs the ability to command fortunes and live as lords whether they’re competent or not. They can get tens to hundreds of millions of dollars for leaving their jobs. I’d leave mine for a hundred gran and would be leaving my client a whole lot more alive than what I found him; but such is life.

    When pharmaceutical companies, academia, and the medical establishment become indistinguishable, the organization with the deepest pockets, largest army of lawyers, and least obligation to the public is the one most likely to win, for the sake of making profit— not in order to make the world healthier.

    Which is why it’s important for government regulators to make strict and clear laws that must be followed by every company in a category so that no single company can benefit by cutting corners that have been declared to be too negatively consequential to the public when cut— like rigging drug tests so that the effectiveness of a drug is misrepresented, burying negative test results, and hiding adverse effects.

    Whether a clinician or researcher is taking drug money to knowingly engage in bribery or is innocent makes no difference to the people harmed by a drug. I believe that many doctors believe that they aren’t influenced by drug company propaganda and are simply wrong. No one, even scientists, is as guided by reason and evidence as they think they are. This is the human condition. Even with a deliberate and evidence-based approach to one’s own unconscious biases, the methods of influence and volume of information to choose from, is more than one person could stay on top of. Also, how many independent physicians and researchers can afford access to all the journals and all the studies that they would need in order to make a reasonably sound decision about any option of treatment?

    I think All-Trials is one excellent approach to the problems of too much data, and too little regulation. It’s made up of volunteers which makes it an NGO like The Bulletin of Atomic Scientists. A group of dedicated scientists— a non-profit think tank— can light the way for developing best practices and shaping regulations for the greater good.

    The rules, should not depend on the intentions of different actors and should do everything they reasonably can to discourage malfeasance and even unintentional harm.

  13.  
    wiley
    April 12, 2014 | 5:07 PM
     

    And, on top of all that, decisions are often made with considerations that aren’t conscious and might be denied if pointed out, on behalf of one’s own beliefs about being objective and having good intentions. Below is an example:

    A disturbing demonstration of depletion effects in judgment was recently reported in the Proceedings of the National Academy of Sciences. The unwitting participants in the study were eight parole judges in Israel. They spend entire days reviewing applications for parole. The cases are presented in random order, and the judges spend little time on each one, an average of 6 minutes. (The default decision is denial of parole; only 35% of requests are approved. The exact time of each decision is recorded, and the times of the judges’ three food breaks— morning break, lunch, and afternoon break— during the day are recorded as well.) The authors of the study plotted the proportion of approved requests against the time since the last food break . The proportion spikes after each meal, when about 65% of requests are granted. During the two hours or so until the judges’ next feeding, the approval rate drops steadily, to about zero just before the meal. As you might expect, this is an unwelcome result and the authors carefully checked many alternative explanations. The best possible account of the data provides bad news: tired and hungry judges tend to fall back on the easier default position of denying requests for parole. Both fatigue and hunger probably play a role.

    Kahneman, Daniel (2011-10-25). Thinking, Fast and Slow (pp. 43-44). Farrar, Straus and Giroux. Kindle Edition.

    We all do this. It’s normal, but could be countered with individual and group efforts at consciously overcoming influences that color a decision. Money and prestige could easily and morally be taken out of the decision-making progress for the betterment of all.

  14.  
    April 13, 2014 | 1:26 AM
     

    i loved dr carroll’s comment. it’s so true.
    it’s like a capitalist’s dream: a doctorless society where “there’s a pill for that”
    and “golden bullets are in aisle 3”

  15.  
    April 13, 2014 | 9:22 AM
     

    Dr. Dawson,
    I find your arguments to read like “Everyone else does this so it is not that bad.” Your animus toward managed care may be appropriate (being basically a Medicaid doc, I have limited experience), but I am not sympathetic to the argument that the doctor knows best. That just hasn’t been the case. Doctors flocked to using all of the new drugs even though the evidence (even the evidence that was made public) did not support the marketing claims. This happened with valproic acid (Depakoe) and many of the new antipsychotic drugs. I worked in psychiatry before managed care and I saw many instances where people were kept in one hospital until magically -at the day their insurance ran out, oh my! -they were considered ready for discharge. Doctors have been swayed by marketing forces just like every other person.
    I think drugs need to be checked by outside groups who have no COI. Even better, I am persuaded by Healy’s argument that we should make everything OTC and get doctors out form being the middle men(women).

  16.  
    wiley
    April 13, 2014 | 10:12 AM
     

    That’s funny, Arby. Why More Than Medication®? Indeed, why more than medication with a registered trademark? Some people need a ® with their Zyprexa.

  17.  
    Steve Lucas
    April 13, 2014 | 3:34 PM
     

    When I look at this issue I see:

    Doctors view drug reps as friendly support.

    Doctors also view drug reps as medical providers.

    Doctors have also worked themselves into a corner by setting up a belief system that they, and only they, can associate with other medical providers.

    No doctor today in practice has to worry about filling that practice.

    With the above in mind there is no reason for a doctor who is currently taking drug rep money or trinkets to stop. I know of one doctor whose practice was sold and one of the first issues was the free stuff the drug reps brought for everyone one to use. This doctor honestly asked; where are we going to get our pens?

    Studies have shown that doctors that see drug reps write more prescriptions for patented medicine driving up cost for the system and their patients.

    Pharma knows this and has worked for decades to produce the smoothest most palatable message possible so as to produce the most outsized profits of any industrial group in business today.

    Pharma has no reason to stop and the doctors receiving side income have no reason to stop.

    Steve Lucas

  18.  
    Arby
    April 13, 2014 | 6:15 PM
     

    I understand addressing issues in psychiatry as the area where those here have the greatest knowledge of and can have the greatest impact in. However, speaking as a member of the public, I often wonder if the reform of the field would gain more traction if it was aligned with a larger reform movement of heath care as a whole. Therefore, unless I am reading him wrong, the impression that Dr. Dawson is saying that everyone else does this, doesn’t read as an excuse to me, but rather as a wake-up call. Just like when cross-discipline issues are brought up in the articles here.

    I don’t mean to dilute the cause, yet the sheer numbers of medical patients vs those seeking help with emotional issues speaks to trying to reach the public in ways that they can relate to and that directly impact them. Of course, with what people endure as medical care these days, I don’t hold much hope for this approach either. I really wish there was some actual journalism going on in mass media or a decent movement by physicians themselves, or better yet, both.

  19.  
    wiley
    April 13, 2014 | 6:19 PM
     

    This doctor honestly asked; where are we going to get our pens?

    There’s a whole new take on “penury”.

    wacka wacka wacka

    First, whether they’re conscious of it or not, they feel obligated to return that “kindness” and “generosity” of being offered a token pen with a drug company’s logo on it by prescribing the drug— with that pen— then they forget how they got pens before and were left asking helplessly, “Where does anybody get pens?! My, GOD!!! It’s just impossible!”

    I am exaggerating for effect, but their dependency goes much deeper than that. There probably is a pill for that, but I wouldn’t recommend it.

  20.  
    Arby
    April 13, 2014 | 6:21 PM
     

    Wiley, that was very good, picking up on the trademark. It didn’t really register with me (no pun intended).

    Having worked in marketing for several years, I can spot spin a mile away, but I am also numb to it in many ways. Self-preservation, I guess.

  21.  
    April 13, 2014 | 10:04 PM
     

    I’ve been thinking quite a lot lately about the parallels between KOLs and US politicians, many of whom end up using their influence and connections to get rich rather than serving the needs of the people.

    (However, I emphatically do not believe the gummint is to blame for everything bad in society, and those that argue that are short-sighted. It’s pretty obvious pharma pretzels itself to avoid regulation, as do corrupt KOLs and, for that matter, corrupt politicians.)

    What’s appalling about this showing up in medicine is that historically, medicine has been so much more altruistic than politics. Not so much anymore, I guess.

  22.  
    Steve Lucas
    April 14, 2014 | 6:10 AM
     

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