Merrill Goozner is the director of the Integrity in Science Project at the Center for Science in the Public Interest. A former business journalist, he published the book The $800 Million Pill: The Truth Behind the Cost of New Drugs in 2004. Here he discusses the conflicts of interest between drug companies and the medical community; the pharmaceutical industry's power in Congress and with its regulator, the FDA; and the health insurance system's impact on psychiatric care. This is the edited transcript of an interview conducted on August 18, 2007.
- Interview Highlights
- The many forms of marketing off-label use of psychiatric drugs for kids
- Conflicts of interest between Pharma and the medical community
- Limitations of the few clinical trials conducted with children/teens
- The pharmaceutical companies-FDA relationship
- Insurance companies are more willing to pay for medications than for traditional therapy
[O]n the subject of the pharmaceutical industry, do you feel they have heard the criticism, the backlash against Pharma? Are they still sort of deaf to the problems in the industry?]
I wouldn't say they are deaf, but I think that they have an imperative which is no different than any other imperative of a for-profit corporation -- that is, that they want to sell more product. Unfortunately, we're dealing here with the public health good, which is ... [with] biotech drugs or medical devices that there's true debate about how useful they are and [in] what circumstances they ought to be used, and also how much they cost. ... In all of those areas, there's real debate going on, and of course, their interests are not ultimately in the scientific questions beneath that.
They know the scientific questions limit their ability to sell more, but their goal in the end is to sell more. And of course that influences how they view the science and influences how they behave in the area of providing health care to Americans.
Their interest is in selling more products. ... [T]heir goal really ought to be providing the best health care for people regardless of how much product ultimately ends up in the delivery of that health care.
[The industry has spoken] a lot about how much they've reformed; they heard the message, the outcry, and they've listened and have started to change their practices. Do you see evidence of that?
You could look at the FDA reform bill that's currently moving through Congress and probably will be law by the time this film comes out. They fought tooth and nail, for instance, against restrictions on direct-to-consumer advertising, which most observers would argue has been a real detriment in the marketplace and has been a real detriment to public health; that it has led to increased demand for drugs where drugs really shouldn't have been used, Vioxx being a classic example of that. ... They fought against stricter risk-mitigation strategies. ... So when you say they've heard the criticism, it strikes me that perhaps their lobbyists haven't heard that they've heard.
... [I]n the world of child psychiatry, where you can't directly market to kids medications that are used off-label, do you know how direct-to-consumer advertising works in trying to get more market share for children?
In a situation like that -- and frankly, I haven't looked lately at this -- but direct-to-consumer advertising takes many forms. Obviously, there are ads that appear on television or that appear in magazines, and there many of those.
But very often, there [are] also campaigns around disease awareness that drug companies launch. This can take the form of sponsoring nonprofit groups to raise a hue and cry about the terrible ravages of this particular disease, telling people about the symptoms of the disease and saying, "Ask your doctor if something can be done about this."
They're never really advertising the product per se, so it's not direct-to-consumer advertising. What they're trying to do is build a campaign even among health professionals, among nonprofit groups, to say, "Hey, we ought to be doing more about this." And it just so happens that maybe a year ago or two years ago, a drug was approved that could be prescribed for this particular indication. And of course, if you do end up going to ask your doctor about it, as a result of this generic campaign to raise awareness, the doctor, hearing this, maybe having been approached by a drug representative and saying, "If somebody comes in and asks about this, there is a new drug here that you could be giving for this," the doctor has been primed to respond to that request.
So even though there was no traditional direct-to-consumer advertising, an entire marketing campaign has been created that can have a tremendous effect both on the patient or the consumer who thinks they ought to be a patient, even when their actual symptoms maybe suggest that they're borderline or really that's not appropriate for them at all.
On the other side, the doctor has also been primed in order to prescribe the drug and not really look at what that person has and say, "Are they borderline, or are they not really appropriate?," maybe saying, "They're asking for it; I've got something; it's easy to give." Boom, they write the prescription, they're out the door, and the circle is complete.
Yet is that the best thing for both the patient, for the cost of the health care system and also just overall for public health in the country on a population basis? Is treating all these marginal people, people who are having these kinds of symptoms in this way the best way to get at what these people are complaining about? That may not be the case at all.
[Are things changing in some areas of conflict of interest? Isn't Pharma scaling back on inviting doctors on cruises or invitations to play golf?]
There may be some cutting back at the margins. ... And of course most of the worst abuses of the past have been the subject of numerous documentaries, have been the subject of many articles in newspapers.
Let me just say that those kinds of gross abuses are actually not the worst part of the system. Even by scaling back on it, you're not going to get at some of the worst abuses of the system, which are institutional.
When you have, say, physicians who belong to professional societies, who are speakers for the pharmaceutical industry or doing research for the pharmaceutical industry, and then those very same people sit on clinical practice guidelines that their professional societies come up with in saying, "How should we treat this disease?," and then those clinical practice guidelines are printed in the most prestigious journals in their fields and then are widely distributed by the drug representatives to individual practicing physicians who are very far away -- they live out in the country at large, and they're very far away from the national headquarters of the professional society or the thought leaders who are on the industry's payroll -- so they receive all this information and they think, "Ah, this is the best practices, these are the institutional ways that have not been touched at all by some of the cutbacks, if indeed they've taken place. I'll take the drug industry's word that they have taken place."
But that doesn't get at the real sort of institutionalization of the drug industry's pervasive influence over the practice of medicine in this country.
You're talking about key opinion leaders?
Yes.
Who are they, and how have they and Pharma joined forces to get more kids to take more medication?
If you read the medical journals, you'll find that there is a steady string of studies that appear in the medical literature written by physicians, psychiatrists who perhaps are experimenting with these drugs either on children or on adults, and looking for the latest information on how they might be effective.
Now, many people who are far more expert than I and the results of many of these trials say that the effects of these drugs are quite marginal when you actually look at the data. And yet even [for] a marginally effective drug, a study can appear in the literature, OK?
So the person who ... was part of the team that wrote the study, he will now be approached by the pharmaceutical company saying: "Wow, your professional society is going to be holding a meeting. Ten thousand psychiatrists may be coming to this meeting. We're going to be holding a symposium at the morning session of the meeting. We would like you to give a talk. We will pay you $2,000 to give a talk," or more. They build up these key professional leaders.
Now, let's look at this. This person is giving talks at the professional meeting. This person is writing studies that [are] appearing in the literature. Perhaps the professional society's journal is being underwritten by advertising by the drug company. Now the professional society says, "You know, we really ought to update the clinical practice guideline for treating this condition." So they put together a large committee of key opinion leaders.
Are you going to leave out this person? Why, he's published a lot of studies. They were industry-funded studies, but we're going to put him on the committee along with others. So he'll sit [in], and it's a self-fulfilling designation in which people who are in large part funded by the pharmaceutical industry and promoted by the pharmaceutical industry end up becoming the key opinion leaders in their fields, and then end up writing the guidelines that other physicians read about in their professional journals. It becomes a closed circle of information that is really influenced by the product manufacturers at every turn.
I know you're not an expert in the psychiatric pharmaceutical side of things, but can you name an example?
... There are literally dozens upon dozens of people in the field of psychiatry who are in our database and who are out there, who have taken money, who are thought leaders.
... If you looked at, for instance, the obsessive compulsive disorder latest guidelines [in the DSM-IV, the Diagnostic and Statistical Manual of Mental Disorders] for how to treat this, it was something like 10 out of 11 physicians on the panel had conflicts of interest in that they had taken money from antidepressant manufacturers or from drug manufacturers who had made antidepressants that had indications for treating obsessive compulsive disorder.
So again, what is going on out there? You asked me about individual studies that I'm familiar with. ... Back in February, I think it was February of [2004], the Food and Drug Administration held a public hearing on the suicidality risk of antidepressants, a new class of antidepressants and the [selective] serotonin reuptake inhibitors [SSRIs]. They had published some studies that the industry had submitted in the lead-up to meeting, that the industry had submitted to the FDA in order to get patent extensions for their drugs.
One of the laws that we have in this country that drug manufacturers can take advantage of is that if you have a drug that's on patent and your clinical trials for getting its original approval was based on clinical trials in adults, if you do a clinical trial on children to show what should the dosing be for children, and is this useful in children, you can get a six-month extension on the patent life. Because these are very lucrative drugs, what they call blockbuster drugs, billion-dollar sellers plus, they have a big self-interest in spending a few millions of dollars, perhaps even tens of millions [of] dollars, because an extra six months of patent life can be, if it's a billion-dollar drug, $500 million. It's a very good return on your investment.
Well, they had conducted these trials. They submitted them to the FDA. The FDA put a reviewer on it, took a look at them and indeed saw that, not reported in their results of those trials, but if you actually aggregated all the results and took a look at it, that you saw that there was a risk of suicidality. And he published those results.
Now, I went back and took a look at all the clinical trials that had been done in children by the pharmaceutical industry that had been published in the academic literature [to see] if any one of them had addressed the question of suicidality risk in children.
I have to double-check the exact numbers, but as I recall, around 70 trials that appeared in the literature, which is not a very large amount when you really stop and think about the number of trials that have been done on the antidepressants overall -- there were literally hundreds, if not more than 1,000 trials that have been done in adults, and here you had about 70 where it had been done in children published in the literature -- not one of which had addressed the issue of the risks of suicidality in children, which was the subject of this hearing.
Yet the vast majority were funded by the drug industry, and all it had addressed [were] the issues of "Are they useful? Are they useful? Are they useful?" That's what made it into the literature. Nobody had ever conducted a trial specifically to look at the risks of how these might impact children or teenagers, which is a big user of these drugs.
... So they submit this data because they want a patent extension. And what does the data show?
The data probably showed that the drugs were either effective or not effective. They don't even have to show anything. When you submit a trial to the FDA, if it's a really powerful result, you could say to the FDA, "Oh, and by the way, please give us an indication on our label that this is useful for this."
Look at the data. It showed that these worked in children, but they never actually went in to get those indications put on their labels, because the results of most of the antidepressants are quite marginal, even in adults. It's very difficult to get one approved.
You have to conduct a fairly large trial. Most of the trials in children are quite small -- large enough to perhaps show that dosing doesn't give a toxic short-term effect, which is a useful thing to know in the larger scheme of things, but certainly doesn't give you good, hard data about how effective they are in treating the condition for which children might end up taking it.
They don't have to show that. They just merely have to conduct a trial that's really aimed at what are safe doses for children. We still operate at the FDA that a drug that's good for adults is also good for children with the same condition, and the only real question is how big should the dose be.
Shouldn't we be having more clinical trials on giving kids medications without knowing if they work -- trials to see if it works better than a placebo, if it doesn't work at all, and if it's safe?
I would have to [double-check] -- you could correct me if I'm wrong -- but have any of the antidepressants specifically been labeled for use in children?
Just Prozac.
So this is the evidence then. For all the trials done on children -- and this was already more than two years ago when I looked at it and five dozen is not a lot of trials -- you had about 15 trials submitted to the FDA that they used. We have one drug that has actually gotten to the point where they're making a claim on the label that it's effective in children, which means all the uses of these [other] drugs [in kids] are off-label.
And these off-label uses of drugs, there is circumstantial evidence or clinical trial evidence in the literature suggesting they work, and that's what most of these trials showed that appeared in the literature.
But if you actually disaggregate the data and take a look at the trial, and go beyond the language written up in the abstract that appears online or you look beyond the conclusionary paragraphs that maybe a doctor might read, because he's busy, he gets his journal; ... he sees this study here. It's about drug A and how it affects kids with ADHD. He looks at the abstract, and he looks at the last couple of paragraphs in the conclusion. He doesn't look at the detailed charts to see that perhaps out of the 100 kids that got this, actually 60 really didn't benefit much, and 40 might have had a benefit. And in the placebo arm, 38 claimed at the end of the day that they were doing just fine.
So yeah, they might have written ... that it was beneficial in this journal, but the reality is that it was marginally effective at best. And a lot of the trials, when you actually look at them, are kind of like that.
Are the pharmaceutical companies interested in conducting clinical trials in kids, or are they shying away from it for some reason?
There's no question that the drug industry is interested in promoting its drugs. When you have clinical trials appearing in the literature that suggest that an off-label use is effective, then those are precisely the kinds of documents that wind up in doctors' offices, psychiatrists' offices, handed out by the drug representatives, who can't by law promote the off-label use of a drug, but there's nothing to stop them from handing out a reprint from a journal that they respect that suggests that off-label use is effective. And that's what they do.
Now, what's the self-interest of the drug rep in doing that? Obviously, it's the equivalent of the off-label promotion without them ever talking about it. What's the interest of the journal in publishing such a study? Why, the drug company will come along and order 20,000 or 30,000 or 40,000 reprints at so many dollars per reprint. That's a good stream of revenue source for the journal, so that there's no real break on the system at all. This is the kind of institutionalized promotion of drugs that is really a far deeper problem than inviting doctors to eat a fancy dinner at a golf resort, which absolutely every study has shown. ...
Somebody gives you a gift. You can claim all you want that this has no effect on my judgment; I'm above all of that. But the studies have shown you do have a kind of obligation effect built in, so when something comes up, you don't even think about it. You say, "Well, yeah, I'll prescribe that." You don't think, "They took me to dinner; therefore, I'll prescribe it." But it's built into the quid pro quo: "Yeah, I can do something nice for them."
If it is illegal to market off-label use, what are drug reps for off-label drugs doing in child psychiatrists' offices?
... [T]he FDA regulates this, so you should talk to the FDA. Just yesterday, the FDA sent a letter to a drug company saying the palm cards that were being handed out by the drug rep alluded to the idea that this drug they were talking about was safer than other drugs on the market.
It was an Alzheimer's drug. And the FDA said to them: "You can't say that. Indeed, we put a warning on that label. You didn't even put the warning in your message that you were handing out. So therefore you've got to pull back that message that you're sending out and send out a correction" .... They cannot, by law, do it.
Does the FDA police all of the efforts that are going on out there and catch them all? Well, that's part of the problem with our underfunded FDA. The Food and Drug Administration's drug division gets nearly half of its revenue from the drug industry itself in the form of user fees. This was a law passed in 1992 in order to expedite the approval of new drugs. It succeeded very well in getting the agency revenue, and, if they're approvable, [to] approve new drugs faster.
But the law also earmarked the money for that purpose. Meanwhile, Congress has shortchanged the agency in terms of its oversight functions. The safety division is tiny, the drug advertising review division is almost nonexistent, and the drug marketing review system is tiny. As a result, there's not enough people, cops on the beat, taking a look at these issues.
That's why, when you look at the drug reform bill moving through Congress right now, many people in the consumer movement who are pushing safer drugs feel it's far too weak. It should have cut the ties and just appropriated the money straight up. Because I think the public would understand that money spent on drug safety and on reviewing the literature that the drug industry uses for marketing would be money well spent in terms of protecting public health.
... [I]t's tricky stuff. [Big Pharma is] powerful, and has money, and psychiatry is sort of the ugly stepdaughter of medicine. And psychiatrists aren't that well paid.
This is one of the great unexplored areas of this whole field that you're dealing with -- and I'm talking here now in many ways as a parent. I'm on my second family. I've got two adult children, and I have one daughter who's just going into high school.
You can't have raised children in the last 30 years and not have been aware of this whole trend with increased diagnosis -- childhood disorders, psychiatric disorders, learning disabilities and all of these kinds.
And the parents ... look to professionals like the psychiatry profession; like our government, the research that's being done at the National Institutes of Health; at our media, for instance, that talk about these issues. They're looking for some kind of guidance: "Where can I go for help? What is the appropriate help?"
All of those things have pointed to the drug solution because of the influence of the drug industry. And of course the psychiatry profession has been led down that path as well -- when I was much younger, the people who used to go to the psychiatrist, you would sit there and you would have sessions, and you would have talk therapy.
In our health care system today we don't pay for that anymore. So the psychiatrists really lost the insurance underpinning of their profession, as I understand it. I'm not an expert in this, but [as] I understand it, that's what was happening. Now you don't get 10 sessions, or 20 sessions of therapy.
So if there's no more talk therapy, [and] I can only get them for a session or two, I'll talk to the kid; I'll talk to their parents. I'll say: "Well, here's a drug. Maybe this will help, and if it doesn't, come on back." That's what's happened.
So what we don't have is a real understanding of what's the most effective interventions for these diseases, or these conditions. [I'm] hesitant calling them diseases, because you listen to many of the stories that the parents tell ... and say, "All right, I remember when I was growing up, I remember a kid who was sort of like that, and we didn't diagnose him in those days like that." But yes, the kid was perceived as different, and they sort of muddled through childhood as being different that way, and they ended up ... in whatever role in life they ended up taking, which maybe didn't maximize their intellectual capacities.
... [T]hese are huge societal questions that we just sort of handed over to the drug industry to answer with a simple answer -- "Take a pill" -- instead of saying, "What these kids really need is counseling or intensive intervention or more acceptance." And every one of these situations is different, but I think our emotional intelligence got robbed on these issues. Rather than seeing these kids as part of the community and saying, "How do we help these families out?," we end up leaving them on their own, medicalizing the condition and saying, "Take a pill."
And many parents, you could understand why, even if they have intellectual qualms about it, or even moral or physical qualms about the whole thing, it might be at this point in time the only option they're being given. That, to me, is really maybe the biggest, saddest part of this whole story.
[The psychiatric drug market -- how has it grown since these drugs were introduced in 1994, the year when most of them came out?]
There's been a vast expansion of a whole range of psychiatric drugs -- atypical antipsychotics, the SSRIs. New ones come out; new indications are sought. If there's been a dialing back by the medical profession in terms of the use of these drugs, I certainly don't recall reading any great stories about it.
Many of [these drugs] now are beginning to approach the end of their patent life. One of the great ironies of this is that we've seen in the past with other classes of drugs -- not in this field, but in other fields -- where when drugs start to go off patent, all of a sudden the interest of the pharmaceutical industry in promoting those drugs goes away.
... [T]he drug reps are not touting them, OK? The studies stop appearing. The research and development departments don't fund studies about it. And as a result, the physicians don't get the reinforcements that they're getting now in terms of wanting to prescribe these drugs.
Then prescriptions for them when they become generic, the generic company rushes in to get that market. But they, of course, don't spend that kind of money on marketing. They don't fund any clinical trials. They're just hoping to get the continuing business of the doctors who are hopefully being forced, from the generic manufacturer's point of view, by the insurance companies to buy the generic and not the brand-name drug anymore.
... The insurance companies are pretty good at that. So the sales fall off in terms of dollar sales dramatically; the number of prescriptions, not. But then, over time, I suspect that the prescriptions start falling off fairly rapidly, too, because there's nobody out there promoting them the way they used to be promoted.
Then what you get is a lot more of the studies finally start to appear: Oh, there was this risk; oh, this started happening to these people. And then the drug, it's generic, and it gets literally pushed out of the market entirely. Nobody's using it anymore because we now know -- now, after years of patented life and high sales -- we finally find out when it goes generic that, indeed, there [were] side effects that probably made this a less-than-optimal agent for this kind of condition.
Do you have a sense at all as to the psychiatric medications versus the rest of pharmaceuticals out there? ...
That's an interesting question. I don't spend a lot of my time looking at psychiatric drugs, to be honest with you. ... I spend much more time looking at cardiovascular drugs, blood pressure medication, diabetes drugs, which are actually much larger markets. [But] what I'm saying about the psychiatric drugs goes in spades for all of them as well. ...
[H]ere's the great irony about many of these drugs. We've begun to see studies in the literature that are saying that some of the older psychiatric drugs are just as effective, if not more effective, than some of the newer ones that have been highly promoted in recent years. Well, just as many of those highly promoted ones are beginning to get to the point where they're going to go off patent and become the generics.
Many of these new studies that do the comparisons are government-funded studies, where people on NIH grants take a look at these things, finally. It's kind of a sad story that you don't get these comparisons on the front end, when the drugs first come to market. When a drug first comes to market -- and this was true for all the antipsychotics and all the antidepressants -- they usually compared in their clinical trials to placebo. They're not compared to the older therapies.
Well, it really would have been useful if the FDA had a requirement that they compared to the existing therapy at the same time that they compared to placebo for their own effectiveness, because if you had that kind of three-arm trial in every case, that really showed how it compared to what's already out there, then physicians and people who are writing the clinical practice guidelines would have a much better set of data for which to make their prescribing decisions.
Look, if the newer drug is better, then [the payers] don't have grounds for standing there and simply saying, "You're not allowed to buy it because it's more expensive." That really wouldn't be good medicine. But if the older drug, which is now generic, is just as good, then a payer, like an insurance company or Medicare or whoever it might be, will then have a scientific basis for saying, "Dear Mr. Physician, we're only going to reimburse if you prescribe that medication because that's just as effective."
And that's the kind of information our science system is not providing when most of the clinical trials are being done by the drug industry. Or when the drug industry does do the clinical trials and funds the clinical trials, they're not done under rules that [require] that they provide the sound scientific base the physicians really need.
If these pharmaceutical companies are giving so much money to the FDA, can the FDA do their job properly? ... [I]s the FDA a regulator of the pharmaceutical industry or a partner?
... [T]he FDA is an agency that is filled with very good scientists, very good physicians, people who really are trying to uphold the law. The primary law when it comes to drugs is that drugs be safe, number one; number two, that they be effective. Those are the two great requirements that, in the 20th century, were put on the drug industry. Today, when they sit down to take a look at a drug, that's what they're evaluating.
The fact that the industry pays user fees to the agency to pay the salaries of the people who do that I don't believe in a direct way influences the very good scientists they have. That would be a real slander, and I'm not seeing anybody responsibly make that claim. But put yourself in the people at the FDA's shoes. Along with those fees came a requirement that you get the review done within a certain amount of time.
And at the top of the agency, every year you've got to scramble for more money [on] which all of your jobs depend. Now you're faced with a decision, a marginal decision: Should we approve this drug? Should we take a hard line with the drug company? It's sort of like the inverse of the gift situation. A doctor never has his prescribing patterns directly influenced, like a bribe, that "If I get a gift from the drug company that somehow I'll prescribe their drug." No. There's just something in the back of his mind that says, "Well, they were nice to me once, and there's no reason not to prescribe their drug, so why not be nice to them?"
Similarly at the FDA, ... they get a substantial slug of their money from the drug industry. They operate under rules to expedite the delivery of their decisions to the drug industry. They realize if you take a hard line with a new drug that's coming down into the agency, that maybe it will be hard; they'll think twice about even bringing one here. We'll get less work, less user fees, maybe could affect my job down the road. It just creates an unhealthy environment for them to operate in. That's why the user fees, in my view, if we're going to use them, should be divorced entirely from the operations of the agency or any requirements on the agency.
Let the agency decide where to deploy its resources. Maybe some of those user fees should be used [for] monitoring ads, or the safety department needs many more people to monitor the use of the drugs once they go out into the market, which is to look for safety problems that were not identified in the clinical trials.
These are the parts of the agency that are being systematically underfunded today. And those are the things, you either get rid of them entirely or cut the ties between the payment of those fees and how the money gets used. It can have subtle, hidden and large and subtly negative effects on the behaviors and attitudes of the people at the agency. And I don't think that that's in the public interest or in the long-term interest of the public health of the nation.
The pharmaceutical industry is also responsible in educating the doctors -- what are they doing, funding all the Continuing Medical Education of doctors across the country?
Well, it's kind of a sad story as well. CME [Continuing Medical Education] is -- I forgot the last number I saw -- is 80 percent or more now funded by unrestricted education grants from the drug industry. And of course, the accreditation counsel for Continuing Medical Education, which accredits the institutions that provide the Continuing Medical Education, a wholly voluntary organization made up of physician groups and hospital groups and others, they have fairly strict rules regarding how the drug industry cannot influence the actual content of a CME, Continuing Medical Education, activity.
Yet the anecdotal reports are that many of these CME activities are thinly disguised discussions about situations in which you would wind up using the company's product who is sponsoring the CME activity. So all the guidelines in the world around the Continuing Medical Education seminar or whatever it might be are of no help if the entire premise of the seminar is to educate doctors about a condition that the drug industry itself created through a kind of mass-marketing campaign.
So in essence, the CME activity has become another extension of the marketing arm of the drug industry, and sanctioned within our state laws. State laws require your continuing license as a medical professional to take so many CME credits. The CME provider must be accredited by the accrediting agency. The accrediting agency says the drug industry can't really control the content of the CME activity. And yet ... again, it becomes a sort of self-fulfilling prophecy.
When the clinical practice guidelines in the field have been written by people on the drug industry's payroll, these people become the thought leaders that are hired by the CME provider, on his own volition, with the educational grant provided by the drug company to bring this thought leader, who himself may have a conflict of interest because he is on the payroll of the drug company to give speeches in other contexts, [and] he's now providing the CME activity.
And in this case, he's being paid by the unrestricted education grant. He declares at the beginning of that seminar that yes, I am a consultant for the XYZ drug company. So all the laws and the regulations have been provided for, and yet here we have a system in [which] the drug company's money has completely pervaded the entire process.
There's nobody with an objective view of what's going on here who's got a role in this closed system. They become outsiders and critics, like myself, who look at it all and just say, "There's something fishy here." Everybody who's in the process is on the take, you know?
It is mind-boggling. I came at my work after a whole career in journalism. I spent a quarter of a century as a financial journalist and an economics reporter, OK? But I started out as a business-section journalist, covering company annual meetings. It was rule number one [in writing a story]: ... [Y]ou don't own the company; you don't own stock in the company; you don't have any financial dealings with the company at all.
But a physician who's trying to figure out how do you treat a condition and then wants to write that in a guideline or give a talk to all the other professionals in his field sees that as no problem that he might get tens of thousands of dollars a year from a company who's selling the product to treat that condition.
I find the ethics of all of this just completely mystifying to me. It is an absence of ethics. It is amoral. It says that money shouldn't matter in our profession, and yet it's the only profession that says that, as far as I can tell.
Is anything being done about it?
Well, the way to handle most of this is disclosure. That's what the medical profession has constantly said for 25 years now: "As long as we disclose, it's all OK." So there it is in six-point type at the end of the journal article. There it is: "Yes, I'm a consultant for XYZ company. Now let me tell you about how to treat this condition." And the lecture goes on for another hour. Does disclosure get at the root of the problem? I don't think so.
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