the right thing to do…

Posted on Thursday 29 May 2014

There’s a discussion going on in the comments of Dr. David Healy’s blog about the goings on with the EMA U-Turn on data transparency [a decision to reconsider…] between good guys who have their differences – Ben Goldacre and David Healy. It’s around the issue of the place of the Pharmaceutical industry in the negotiations about data transparency and how we’re to proceed. I realized, as I was adding my two cents, that I am surprisingly unconflicted on that point. I wish the good guys could get along, of course, but as to the place of PHARMA in data transparency, I don’t think they deserve any place at all. If fact, I don’t think they ever belonged in this issue in the first place. The pharmaceutical Industry arose from the patent medicine companies which literally created the advertising industry. They were dragged into legitimacy by increasing government regulation, but they never lost the morality of their roots. And their behavior in the era of clinical trials has been totally abysmal – riding the fine line between criminal and legitimate business and playing havoc with the practice of medicine. This is what I said in my comment:
… I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.
I’m no socialist, but if we have to socialize drug research, that’s fine with me. If we want to keep our current system and help industry along, we need to radically change how we do things and help them some way other than allowing them to have a say in the risk/benefit ratios we live with every time we prescribe. It’s hard enough in the best of circumstances, and the current conditions are anything but close to that standard. But continuing to allow them the opportunity to distort medical science or use the exaggerated advertising techniques [bending the truth] that are used to sell home washday supplies is just unacceptable.

People in the know [and I consider both Goldacre and Healy to be such people] have a variety of differences on how to proceed now that it’s very clear that we can’t even consider the possibility that PHARMA will be self regulating. I defer to their judgement on how to resolve their differences [so long as PHARMA has no seat at the table]. But quite honestly, if PHARMA were out of the way, I doubt that there would be any differences to resolve. I expect we’d all be out trying to practice decent medicine instead of fighting about drug marketing and deceitful science. As a doctor, I’d be willing to just live with the drugs I can trust right now until this all gets ironed out. We’ve been blackmailed and compromised long enough.

PHARMA betrayed our trust – patients and doctors. It’s just that simple. I have no clue how to get them out of the decision-making process, but I feel comfortable with saying that’s the right thing to do. And as for complicit doctors, send them to time-out too. If that’s a simplistic and naive attitude, I’m going to go out and buy me a simplistic-and-naive tee shirt and wear it proudly…
    May 29, 2014 | 11:52 AM

    If it were only that simple. The facts show that the FDA ignores the recommendations of their own scientific committees regarding drug approvals. When your regulator abandons scientific opinion – you are right back to laissez-faire capitalism and politics as usual. Of course politics is nothing but the personification of conflict of interest and politics not Big Pharma has been running American medicine for some time now.

    May 29, 2014 | 1:28 PM

    I agree completely in that there’s another couple of places where PHARMA doesn’t deserve a seat at the table – politics and the FDA. My simplistic-and-naive tee shirt remains on display…

    May 29, 2014 | 3:15 PM

    I’m all up for serious conversations about strategy but as I pointed out in my post, Healy is simply saying things that have no foundation in reality.

    David Healy says:
    “Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial. Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.”
    – This is complete and utter fantasy. Neither I nor AllTrials have signed up to this. David Healy will be unable to provide any evidence to show that we have. Consent forms being used to justify withholding information is exactly what I’ve campaigned against.

    David Healy says:
    “That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.”
    – This is completely bizarre. AllTrials simply calls for all trials to be registered, with their full methods and results made freely publicly available, and CSRs where they’ve been created. It is impossible to argue that this “locks academics into agreeing with GSK and other companies as to what the outcomes of their trials have been”.

    Differences are one thing, they’re great, I’m always keen to discuss them. But with the best will in the world, as above, David Healy misrepresents reality in such an unambiguous fashion, and I can’t see how it’s possible to have a serious conversation with someone who does that so blatantly.

    May 29, 2014 | 7:14 PM

    It appears that virtually read-only Open Desktop delivers the appearance of transparency while inhibiting utility. The fear of that sort of pharma-leaning compromise is well-founded.

    May 29, 2014 | 8:15 PM

    Dr. Goldacre,

    I am not well versed in AllTrials, not having had the time to spend on it, yet my question is really more for your opinion and that I can understand even now.

    A few things to let you know. I actively loathe the behavior of large corporations in all fields, but particularly in medicine. Yet, I am pragmatic and have been in two clinical trials. In both cases, my care was better than what I would have received had I not been in a study. So, I am trying to find open studies for some issues I am dealing with currently.

    With that said, are you satisfied with what GSK delivered in their virtual portal and, if not, what would you like to see them do differently?

    May 30, 2014 | 6:48 AM

    I am having trouble keeping the acronyms straight. A useful blog would be to review All Trials vs RIAT, etc. and to identify the various players including their main interests as well as where they overlap and diverge.

    James O'Brien, M.D.
    May 30, 2014 | 6:13 PM

    90%+ new drug and medical device advances worldwide in the last forty or fifty years came from the US. I think that explains the folly of “socilaized” drug research.

    This is a bridge too far for me. We can complain about pharma profits but if it weren’t for Big Pharma, AIDS would still be a quick death sentence.

    Now we are in an emergency situation with antibiotics (and antidepressants and antipsychotics I would argue, admittedly due to the mediocrity of the current choices). I’ll put up with a few Schatzbergs and Kupfers if it means a new antibiotic that would work for all types of MRSA. I’m not condoning the ethical conflicts of interest, I’m just saying it’s way too easy to overreact and do something punitive and radical that shuts down progress completely.

    James O'Brien, M.D.
    May 30, 2014 | 6:27 PM

    Oh, and another reason I have no confidence in the government or the FDA to get things right…they killed two of the more effective antidepressants I have had success with in patients…Merital and Serzone…based on the ridiculous idea that psychiatrists were too incompetent to get follow-up blood tests. Their whole reason for existence…thalidiomide…was a drug they eventually repermitted.

    Central planning never works…especially when you’re asking a company to risk 1.5 billion dollars and 15 years, for all their work to be struck down on a whim. And while smart doctors working independently often come up with unique solutions.

    BTW, if the FDA weren’t forced by ACTUP and others to shortcut approval on the AIDS drugs, millions more would have died due to their bureaucracy. So they are no heroes to me.

    Aspirin, a drug I take EVERY DAY (and that kills thousands a year) would have ZERO chance of getting approved by the FDA today…they have no sense of risk reward…it’s all overreacting to fear.

    May 30, 2014 | 8:28 PM

    I thought that your comment on Dr Healy’s original post was the most poignant and pertinent that I have seen. Dr Healy and Ben Goldacre should be on the same page but to be honest, from what I have observed – Ben Goldacre refuses to have a dialogue and resorts to churlishness. He posted the eact same comment which he posted here on my blog, Healy’s blog and another blog. That’s not a sign of someone who is even reading, digesting or engaging with other people’s opinions- he is merely blanket posting a generic response in order to extinguish any little sparks of criticism or opinion on Alltrials that he finds . I have yet to have a dialogue with him, despite his many comments on my blog and tweets to me, he doesn’t enter into conversation, he merely posts to defend his position or attack Dr Healy. I find this very immature and disheartening but it is good to see that there are others who are very much up for debate and have no problem in entering into constructive dialogue…

    May 30, 2014 | 9:02 PM


    I second your thoughts about Dr. Nardo’s comment. I loved the simplicity and focus of the bottom line, and that it is all that really matters, not the egos of those involved.

    I also noticed that Dr. Goldacre had posted the exact same comment on both blogs, and now yours, a third. When I asked my question above, I thought he might be open to one from some random member of the public, and although it was an honest question, I never expected an answer.

    May 30, 2014 | 9:15 PM

    Dr. O’Brien,

    A couple of things to look at, por favor? Note, I make no claim to the sources.

    Where Do New Drugs Come From? U.S. Biotechs Lead the Way

    The Make-Believe Billion.

    James O'Brien, M.D.
    May 30, 2014 | 9:59 PM

    Timothy Noah is a far left radical writing for Slate which is a far left site. He has been wrong on every aspect of the ACA. There is no other sources making those kind of absurd cost claims. The claim that pharma is exaggerating by 1000 percent of so would show up in their quarterlies.

    Here’s Forbes, admittedly on the other side of the spectrum, talking about the difficulties and cost with Phase III trials:

    Psychiatrists like to talk about empathic failure. What would you do if you had over a billion dollars and there was a good chance to blow it all?

    I say cut out phase III and keep banging on the cheaters, like this blog does.

    This is the wrong time in history to cut the pipeline. There will be a serious antibiotic resistance epidemic that will kill people we know.

    James O'Brien, M.D.
    May 30, 2014 | 10:46 PM

    Takedown of Timothy Noah and Light and Warburton:

    So if the costs are so low, why aren’t they ramping up applications and why are they cutting back? You would think such absurd profits would attract even more criminals.

    The reason is that the math is garbage.

    Criticize bad studies and pharma influence, but radical antipharma will get us killed.

    Joseph Arpaia, MD
    May 31, 2014 | 1:06 AM

    @Dr. O’Brien

    Just wondering about your thoughts on Solvadi the new drug for Hep C. The glowing reports about effectiveness may have been quite overblown, yet the company wants $1000 per pill.

    From MedPage Today:
    An evidence-based medicine consulting group’s report on the hepatitis C drug sofosbuvir (Sovaldi), covered by MedPage Today reporter Michael Smith, generated a whole new controversy in addition to the one already raging over the product’s cost — the report questioned whether sofosbuvir is really as effective as is commonly believed.

    James O'Brien, M.D.
    May 31, 2014 | 2:19 AM

    I think I’ve made my thoughts perfectly clear.

    Keep them honest and maintain scrutiny. But don’t economically destroy them and for God’s sake don’t turn over research to the socialism, which has a horrible track record.

    But when I hear statements like Arby, “I actively loathe the behavior of large corporations in all fields, but particularly in medicine”, by someone using a computer made by a corporation, using 20 products a day made by corporations, and actively “loathing” the very entities that make like comfortable, this kind of attitude strikes me as adolescent immaturity and ingratitude, a terrible quality. Do I love all corporations? No but more specifically my negative feelings are toward the people who run them (Facebook, Google, the LA Clippers would be good examples). Corporations are abstractions anyway, they are designed to afford limited liability so that people can take risks. That is a good thing in society to have in general. That doesn’t mean you trust them at their word or you act as an idiot consumer, but its the best system we have.

    Really, all corporations in ALL fields are deserving of HATE? How has Starbucks ruined your life? The pharma that made the antibiotic that saved you from death as a child when you had an ear infection? This is the kind of talk that is fashionable at the university, but distorts reality. Personally, I could care less about being one of the cool kids at my age.

    May 31, 2014 | 7:55 AM

    Dr. O’Brien,
    You have made your pints clear but so has Mickey who has articulated here and in so many posts, the problems with the market driven approach to drug development. Do you think that market forces have no role in our challenges with antibiotic resistance?

    James O'Brien, M.D.
    May 31, 2014 | 10:33 AM

    Antibiotic resistance is an overprescription problem based on patient ignorance, and is not primarily a pharma promotion problem. The same might be said of a lot of psych drug prescriptions so you might want to tread lightly. Certainly patient satisfaction surveys and flawed approaches like that do not help. If you want me to join you in banging on Press Ganey and fussy opinionated mothers of kids with viral illness, I’m all in.

    I never said the free market solved anything. I said that I don’t know an approach that is working better anywhere else in the world. Utopia isn’t an option, especially when the straw man critics apparently aren’t brewing their own life saving medicines in their basement.

    I assume most of the posters here are psychiatrists who are happily giving out antidepressants that might work about 10 percent better than placebo. I just want to remind that many of these same criticism can be pointed straight at psychiatry.

    Big pharma acts in its best financial interest, which is what the prospectus requires. I don’t expect them to be archangels. Mostly I blame the KOLs for most of the mess of the last twenty years. Most of the KOLs in psychiatry are in academia and are not the stereotype of the corporate bogeyman or strawman, which seems to be a common argument here.

    Antibiotic resistance is the main reason I am worried about reflexive pharrma bashing. It’s going to get some of us killed. I want the shareholders of the company who puts a halt to MRSA to become rich. Allowing the process to work by the ordinary slow method would have killed millions of HIV patients.

    James O'Brien, M.D.
    May 31, 2014 | 11:55 AM

    Oh and let’s not forget who made Press Ganey financially important:

    Your federal tax dollars at work…

    One point that seems to be lost in the pharma bashing…is that all medical research whether private or publicly funded is pretty much garbage. The replication study even in a field as objective as oncology is just horrible:

    Too many not too bright people doing too much useless work at too many research centers. I suppose this was inevitable with the expansion of universities in the past fifty years.

    May 31, 2014 | 12:43 PM

    Dr. O’Brien,

    I appreciate your critique on the one article and your links to others. I realized it was going to be contentious simply by reading “Big Pharma” littered all over the page. Yet, I did not have the background to parse the numbers; that is why I asked you.

    I was a little surprised by your second answer. I think you are fighting a different argument with me that has no basis in reality. Parse the words in my sentence. I don’t “hate” “ALL” corporations. I specifically used the words “large” and “behavior” and I wrote it not to be cool, but to lay my cards on the table. I got a laugh out of the line you drew between Marxism and I. It is funny because I am actually a scorned capitalist. My anger comes from the fact that we are pretty far afield from a competitive, free market and that what keeps capitalism running, trust and honesty, is almost entirely ignored.

    For the personal attack, I freely admit I’m immature. It is a character flaw I struggle with daily. However, I am certainly not alone in this, and I don’t mean you; you strike me as a mature individual. I do disagree with your gratitude assessment though. I am very grateful for many things. However, I can’t let my gratitude blind me to the harmful things these large corporations are doing, Their medicines are both saving our lives and killing us.

    I trust the government no more than I trust Corporate America, and why you thought I was pushing socialism, I don’t know. Even in your scenario, simply the act of making the large pharmaceutical companies more honest, if they deem that too costly to abide by, they will get out of the drug market entirely whether or not the next big antibiotic is in the making in their lab. In working with computers, the optimal thing you do is to develop something different in parallel, and then once it is running you take down the old. What I am pushing is less reliance on the idea that only the big named pharmaceutical companies can find the holy grail antibiotic; given their history and, given the importance of antibiotic resistance, adopting a multi-prong strategy instead of placing all your faith in the current big players in pharmaceuticals would be the wiser choice.

    From your multiple comments, I can see I hit a nerve with you, so I’ll stand down. I really have no say in this matter either way.

    James O'Brien, M.D.
    May 31, 2014 | 1:53 PM

    I didn’t mean it to be personal, but one has to realize that large corporations have made life easier than at any time in human history. That doesn’t mean I like them all but I don’t like blind corporation bashing. No my major point was that Noah, who has zero credibility based on his blogging about ACS, is insanely wrong in his analysis, because if he were right pharma would be pouring money into R and D and not buying back their own stock.

    I think complaining about pharma profits is the wrong tack. It’s like complaining about sharks feeding. It’s what they do. It’s what they have to do according to their prospectus. I direct most of my anger at the KOLs, who are the moral and scientific gatekeepers who should have known better.

    I remember going to a pain management lecture in the 1990s and the lecturer from Stanford (it wasn’t Schatzberg) had a bunch of Purdue slides on his Powerpoint. He pushed that flawed Porter and Jick study showing something like only 4 out of thousands of patients on chronic opioids developed addiction. I raised my hand in a room of hundreds and challenged that study because they never interview collateral sources, they just trusted patient self reports. The reaction in the room, by doctors who should have welcomed the Socratic debate, was one of icy cold stares. Being prophetically correct didn’t mean squat to them.

    The problem with doctor blogs and sites like KevinMD etc. is that physicians when they were young were the most conformist 23 year olds in the country. You aren’t rewarded for asking challenging questions or upending stasis.

    Doctors are not temperamentally suited for open rebellion and challenging authority, even obvious targets like Price Ganey which should have been shamed out of existence.

    Solutions to the antibiotic problem? I have suggested elsewhere that a billion dollar prize as described in the book “Longitude” for a MRSA or other Ab resistant treatment under the condition that a 10 day course be affordable. Right now pharma has no rational incentive to make a pill you only take for 7-10 days.

    BTW, I consider Ab resistance a problem far worse than global warming. I would not have wanted to live in the pre Ab era.

    May 31, 2014 | 2:51 PM

    Thanks Arby..

    Yes, Goldacre has posted the exact same response- literally- word for word on 4 blogs. That’s not a sign of someone who wants to discuss these issues. It is a shame because it seems to me that the only ones who do well in this corrupt system are doctors, psychiatrists, drug company personnel, and people who write best selling books about how corrupt it all is… the patients are being harmed in massive numbers yet very few people give a damn. The patients get zilch out of this corrupt system. I admire Healy, and I am skeptical of Goldacre because Healy engages with everyone, he responds and he interacts, whereas Goldacre sits upon an ivory throne of celebrity and ego… no wonder bad pharma is a best seller… maybe we could all learn lessons in self promotion from Ben Goldacre… only for those that are that way inclined though, of course…

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