Big pharma often commits corporate crime, and this must be stopped
by Peter C Gøtzsche professor
Nordic Cochrane Centre, Copenhagen, Denmark
British Medical Journal 2012;345:e8462 doi: 10.1136/bmj.e8462.When a drug company commits a serious crime, the standard response from the industry is that there are bad apples in any enterprise. Sure, but the interesting question is whether drug companies routinely break the law. I googled the names of the 10 largest drug companies in combination with the term “fraud” and looked for offences on the first page for each company. The most common recent crimes were illegal marketing by recommending drugs for non-approved [off label] uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud. All cases were related to the United States and involved huge settlements or fines, exceeding $1bn [£620.6m; €769m] each for four companies.
It was easy to find additional crimes committed by these same companies and committed outside the US. As the crimes were widespread and repetitive, they are probably committed deliberately—because crime pays. Pfizer, for example, agreed in 2009 to pay $430m to resolve charges related to illegal marketing of gabapentin [Neurontin], but as sales were $2.7bn in 2003 alone, and as about 90% was for off label use, such fines are far too small to have any deterrent effect. When Pfizer was fined $2.3bn for off label use of four other drugs, also in 2009, the company entered into a corporate integrity agreement with the US Department of Health and Human Services to detect and avoid such problems in future. Pfizer had previously entered into three such agreements in the past decade. Of the top 10 drug companies, in July 2012 only Roche was not bound by such an agreement. However, over 10 years in the 1990s, high level executives in Roche had previously led a vitamin cartel that, according to the US Justice Department, was the most pervasive and harmful criminal antitrust conspiracy ever uncovered. Roche agreed to pay $500m to settle charges, equivalent to about one year’s revenue from its US vitamin business.
Doctors are often complicit in these crimes, as kickbacks and other forms of corruption were common; they were induced to use expensive drugs and paid to lend their names to ghostwritten articles purporting to show that a drug works for unapproved conditions.
The disconnect between the drug industry’s proclamations—of the “highest ethical standards,” of “following … all legal requirements,” and providing “most accurate information available regarding prescription medicines”—and the reality of the conduct of big pharma is vast. These proclamations are not shared by the companies’ employees or experienced by the public. An internal survey of Pfizer employees in 2001 showed that about 30% didn’t agree with the statement, “Senior management demonstrates honest, ethical behavior.” When 5000 Danes ranked 51 industries in terms of the confidence they had in them, the drug industry came second to bottom, beaten only by automobile repair companies. A US poll also ranked the drug industry at the bottom, together with oil and tobacco companies.The consequences of these crimes are huge, including the unnecessary deaths of thousands of people and many billions in losses for our national economies every year. As doctors have access only to selected and manipulated information, they believe drugs are far more effective and safe than they really are. Thus, both legal and illegal marketing leads to massive overtreatment of the population. In the US, the most sold class of drugs in 2009 [in US dollars] was antipsychotics. Antidepressants came fourth, after lipid lowering drugs and proton pump inhibitors. It is hard to imagine that so many Americans can be so mentally disturbed that these sales reflect genuine needs.
It is time to introduce tougher sanctions, as the number of crimes, not the detection rate, seems to be increasing. Fines need to be so large that companies risk going bankrupt. Top executives should be held personally accountable so that they would need to think of the risk of imprisonment when they consider performing or acquiescing in crimes. To bring the crimes to light also outside the US, we need laws that protect whistleblowers and ensure they get a fair proportion of the fines. We also need to avoid the situation that, by settling accusations of crimes, drug companies can pretend they are innocent, which they often do. We also need laws requiring firms to disclose all knowledge about their drugs and research data, and laws that not only allow but require drug agencies to publish what they know, without hiding under some absurd “proprietary nature of companies’ trial results” clause, as happened with rosiglitazone—with the consequence that the public was not informed that the drug causes myocardial infarction. Last but not least, doctors and their organisations should recognise that it is unethical to receive money that has been earned in part through crimes that have harmed those people whose interests doctors are expected to take care of. Many crimes would be impossible to carry out if doctors weren’t willing to participate in them.
Part of the reason is that psychiatry is poor. Departments are hard to maintain because there’s little revenue stream – institutional, governmental, or fee-for-service. So when KOLs show up that can raise pharmaceutical revenue, it’s hard to turn down. My own university tolerated the boss of bosses, Dr. Charles Nemeroff, for 19 years because he was a master at financing the department. And when that revenue becomes essential, it becomes "institutional." That happened in psychiatry more than in other specialties of medicine, and was the mechanism that supported a lot of the bad stuff some of us write about every day now. The same thing happened in the APA and other organizations in the field. So reform doesn’t just solve current problems, it unearths the forces that facilitated their development. That said, step one is still to stop being often complicit, and pretending that we were induced to allow the corruption of the last three decades. The fact that poverty breeds crime doesn’t justify it. Put the criminals [including accessories] in jail, and if they’re doctors, also pull their licenses.
Pharma is ridden with crime – in both its research and its marketing.
But the buck stops with the prescriber.
It’s the responsibility of psychiatry to know better, to “first, do no harm.”
Duane
Psychiatry cannot be repaired.
It needs to be replaced.
In short, it’s “time to buy a new car.”
Duane
And the skeptics might say, “Well, also the disorder started appearing when atypical antipsychotics were put out on the market.” Do you think that that coincidence had any impact?
I really don’t feel that there’s a connection at all. I could see how one could make that link. But you could argue that prior to that, we’ve had lithium, for example, since the middle of the 20th century. We’ve also had anticonvulsants, carbamazepine and valproate used for many years before the mid-90s.
So I don’t really think there’s a connection precisely. The connection that one might think about is that there are studies coming out now showing that these treatments are effective. Not all these studies have been published yet. For example, the study with olanzapine just got published this month as far as a large trial with children with bipolar disorder comparing an active agent — in this case, olanzapine — to placebo.
So going back to your earlier question, the one connection would be then, well, these are pharmaceutical industry-generated studies, not the government. The government gave them incentive to do these studies and sometimes require these studies to be done, but without these companies, would these studies have been done? And then would people now be recognizing bipolar as much, because then there wouldn’t be these studies?
So there might be an indirect link. But I think overall, the final effect is good. We are generating research with medications that now are showing efficacy, and also we’re understanding more of the safety of these medications, because they’re going to be used no matter what, because the families are desperate. The children are failing out of school; they’re doing horribly at home; they’re using substance; they’re not able to function; they don’t have any friends. They’re completely derailed from a developmental standpoint, a psychological standpoint, a social standpoint, an academic standpoint. They’re going to get medications, and we need to know what these medications are doing.
http://www.pbs.org/wgbh/pages/frontline/medicatedchild/interviews/chang.html
Some people would argue that the increase in diagnosis is because there are now drugs approved for that diagnosis and that such drugs are being promoted.
Without just flat out saying that is complete lunacy, there is some concern about pharmaceuticals’ involvement to the extent where now pharma is reluctant to even market such drugs towards children, regardless of the indications for children, because of the fear of the backlash. If anything, I think that kind of backlash will be negative and that we are going to start missing diagnoses and missing treatment opportunities because people are so fearful that they may be looked upon as agents of the pharmaceutical industry.
Before the last 2 years, nothing was indicated for bipolar disorder in children other than lithium, and that was only down to age 12. There are still children who need treatment. I think it is a little bit of an incorrect kind of accusation.
http://www.primarypsychiatry.com/aspx/articledetail.aspx?articleid=2587
Then this:
http://www.primarypsychiatry.com/aspx/articledetail.aspx?articleid=2823
AACAP Back to Project Future Research Subgroup:
Neal Ryan, Leader
Kiki Chang
Melissa Del Bello
Mary Margaret Gleason
Young Shin-Kim
Daniel Pine
John Walkup
Bonnie Zima
http://www.aacap.org/galleries/default-file/BPF_FAQs.pdf
I’ve watched the mis-deeds of BigPharma and its shills (KOL, academic leaders, ‘prestigious’ journals that provide educational resources to doctors) for quite some time. I agree that a corporation (a non-person, despite Supreme Court definition) is not criminal; the decision-makers within that construct are the criminals and need to be treated accordingly. But, as a non-doctor, my perception is that doctors (or at least many of them) are facilitators. No prescription for any drug can enter a patient’s hand without a doctor willingly putting pen-to-prescription-pad. This is just another problem in a complicated healthcare maze that must be addressed. The question is: how?
“The answer is not blaming pharma, but educating community physicians better and supporting more research in the field to discover biological markers that will ultimately aid in better diagnosis and parsing this disorder to more meaningful subtypes.”
http://www.primarypsychiatry.com/aspx/articledetail.aspx?articleid=2823
“Therefore, one of the fundamental problems that needs to be addressed is how to treat patients earlier before the illness progresses. Early diagnosis and treatment is an increasing challenge as the age of onset of illness decreases to adolescence and even young children. The notion of recognizing the illness earlier and treating it with sustained long-term prophylaxis to avoid developing rapid cycling has considerable merit.”
http://www.cnsspectrums.com/aspx/articledetail.aspx?articleid=861
“but the System Psychiatry itself needs a long hard look, internal and external, and frankly could use some help…”
Drs. Mickey Nardo, Bernard Carroll, Jon Jureidini, Ben Goldacre, and Healthy Skepticism,
The 10th anniversary of the last published comments on Study 329 in the JAACAP, the Ryan/Keller et al author response, is in May.
Dr. Andres Martin’s editorial handling of this, namely choosing to do nothing, is unusual and notable.
Perhaps it deserves an unusual and notable response.
There is another means by which you could make the readership of JAACAP aware of need to address extant issues in the literature:
JAACAP
Display Advertising Rates
Inside front or inside back cover
or back cover full color $4,000
Inside front or back cover
(two color or black and white) $3,500
Full Page $2,000
Half Page $1,600
Third Page $1,100
Fourth Page $700
They could choose to run an open letter to readers. Or, they could choose not to.
Either way it would make a statement that would likely generate very useful attention.
From Dr. Ben Goldacre Book “Bad Pharma” (choice of fragments and capitalization are mine; my apologies for taking the liberty):
“But the need for an amnesty does not end with trial data.
What are we supposed to do, for example, with the ghostwritten papers of the past?… Some may need to be formally retracted, but at the very least, let us go back, annotate the literature, and see which academic papers were covertly written by paid industry staff. Let us see which were the product of undeclared publication plans. At the very least, tell us which academics were ‘guest authors,’ …. but most important, tell us their names, SO WE KNOW HOW TO JUDGE THEIR OTHER WORK.
Because the medical academic literature isn’t like a newspaper: it’s not a transient first draft of history, or tomorrows chip wrapper. Academic papers endure…..
So, if we’re to make any sense of the mess that the pharmaceutical industry – and my profession – has made of the academic literature, then we need an amnesty: we need a full and clear declaration of all the distortions, on missing data, ghostwriting, and all the other activity described in this book, to prevent the ongoing harm that they still cause. There are no two ways about this, and THERE IS NO HONOUR IN DODGING THE ISSUE.”
Or, as stated in a journal that chose not to attempt to dodge the issue
( http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf ):
“Clearly, the entire concept of peer-reviewed literature, systematic topic reviews, and evidence-based clinical decision-making rests on the assumption that the published literature being reviewed has sufficient integrity to make the exercise worthwhile.”
“The core of our professional faith, as Spengler points out, is to first do not harm. It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.”
“Biased and Corrupted.” Not the Straw Men of “fraud” or “misconduct.”
The core of professional faith. The message of that last paragraph is the heart and soul of why this fight, and it is a fight, for the soul of these professions matters so. That paragraph should be brought to every pediatrician, family practitioner, nurse practitioner, or psychiatrist who works with children.
There are those who believe that that soul is already rotted. All of you have worked with enough of these professionals to know that is not the case and that this fight is not over.
To have an example as clear and egregious and Study 329, the 2001 JAACAP paper, and the 2003 author response that followed, stand without any annotation in its journal of origin, much less one that would show up in pubmed, much less a retraction, that simply should not be allowed to stand.
These messages needs to be spoken within the original journal.
If they need to be paid for that to happen then so be it.
If they refuse that would work too.
But this issue has been dodged long enough.
The deadline for advertising in the May/June is March.
But the issue coming out in time for the AACAP’s national conference in the Fall would do.
Early diagnosis and treatment is an increasing challenge as the age of onset of illness decreases to adolescence and even young children. The notion of recognizing the illness earlier and treating it with sustained long-term prophylaxis to avoid developing rapid cycling has considerable merit.”
Bunk. There is always something “promising” when it comes to a whole demographic of people with power being prescribed expensive drugs. No one even begins to understand what effects psychiatric drugs and combinations of psychiatric drugs has on a developing nervous system. In order for the risks to be justified, there had better be a serious problem. The idea that early medication would prevent mental illness is, at best, a weak hypothesis . Medication doesn’t even stop most psychosis now, and even schizophrenics aren’t psychotic 24/7— they can have lucid spells even without medication.
people without power. People like children.
If the systems theory is likened to a car, then i guess psychiatry can Shift but cannot steer.
Treating patients ‘early’ is a frighting example. It took me a good two years just to figure out what psychiatry thought it was treating. The ‘Mind’ isn’t exactly a physical part of the body. If I had to conjecture, I would say the Mind is a product of neurons in an organ called the brain performing something called “information processing’. I would guess if the neurons are malfunctioning in any particular way, the brain would malfunction and thus the ‘mind’ it produces would appear to malfunction. However, I’m sure PTSD throws up some questions that still wouldn’t be completely answered by this.
It puzzled me why psychiatry would seemingly randomly disrupt the nervous system while leaving it completely unmonitored (despite the existence of QEEG and other functional tests). As far as I can tell, this is how all psychiatric treatments always ‘worked’. That is to say, they produced merely a subjective effect, even if the effect seemed good, that doesn’t mean insulin shock therapy didn’t only work by inducing severe brain damage. Could you imagine if it turned out antipsychotics cause brain volume reductions in children?
It’s hard to say if insulin shock therapy was psychiatry’s fault or a pharmaceutical marketing scam. I have seen modern publications trying and failing to explain if the treatment did or didn’t work and why it continued for so long as it did either way. Every new treatment seems to be a continuation of that legacy. A subjective observation that can’t tell the difference between for example sedation or ‘improvement’. Except now pharmaceutical companies get sued regularly for felonies like Illegal marketing and fraud. That stands out.
The APA went against science with the DSM-5. Instead of prescribing a blood test for a B-12 deficiency, a depressed person will instead get whatever the current Zoloft is.
Psychiatry needs an entirely new car.
Right on, Spec.
Personally, I can deal with a degree of sedation because sleep-deprivation is what upends me, and I have the good fortune of working with someone who takes medications and side-effects very seriously. She accepts my disagreement with one of my diagnoses and listens to me. I trust her to gauge how I’m doing when she sees me.
I’m not radically opposed to all psyche meds, but what has been happening since the DSM-4 is madness. It’s very hurtful. It’s wrong.
“Last but not least, doctors and their organizations should recognize that it is unethical to receive money that has been earned in part by crimes that have harmed those people whose interests doctors are expected to take care of. Many crimes would not be possible to carry out if doctors weren’t willing to participate in them.”
Professor Gøtzsche’s article should be read by everyone in position of political power, responsible administrations everywhere, also by the international community of psychiatric survivors, friends and families, many of whom already know, but it’s a treat to read Gøtzsches clear message.
The article can easily be copied and sent to prime ministers, ministers of health and social services, parliamentarians, state and council members, doctors, hospitals, your members of Congress.
We know. It’s their duty to know, to be informed, and know that we know. Let us help. Copy. Send, just as the good dr Mickey Nardo. Thank you!
I think we should just outlaw all psychotropics now and let people wean off their meds in a reasonable fashion, then find these unintrusive, simple access, and incredibly efficacious interventions that do not need any mental health providers.
The world will be a better place today, who needs to wait for tomorrow, because dreams and fantasies are not bounded by reality, eh?!
gimme a break, for every legitimate argument how meds have hurt people, there are equal examples of people who benefited. Railing away about what we know even back in 2003 will not change fairly much anything unless you all want to go to extremes and put people at risk in general.
So, ready for that mob chant of “let my prescriptions go”?
“For every legitimate argument how meds have hurt people, there are equal examples of people who benefited.” Really?
Please, dr Hassman. Who counted – who kept track of the facts? Numbers please, and names, dates, research, published articles…?
It’s true there’s more evidence the psychotropic medications, in particular, are poorly effective, and they do have side effects that harm people – often far worse then the illness they treat. The C.A.T.I.E study was truly frightening. The Black Box warning on Antidepressants is disturbing too. These have been around for years and have not had much of an effect on prescriptions.
– But cancer treatments are poorly effective Yet they are only prescribed to people with cancer. Why are people being prescribed an anti-psychotics for insomnia by the wrong type of doctor?
What truly matters is what’s causing the rampant over-prescription of psychotropic drugs, and the corruption and bias that creates that situation?
What we want to do may not be so relevant, rather it’s what can we do that actually gets an effect?
Given the huge anti-psychiatry movement that already exits, and the state of science publications, it may just be a matter of time – but it’s a long time to wait, maybe 35 years. The interest groups involved are quite complicated.
Psychiatry will need help getting out of this mess. A lot of help.
Also, a lot of drugs are being prescribed to treat the side-effects of the drugs prescribed before. I consider myself to be on the “critical psychiatry” side of things, but one of the reasons I have chronic sleep problems now, is because of the drug cocktails I had taken for a few years. I’d rather take antidepressants (amitriptyline for sleep and nerve pain) and trazodone— both very old and inexpensive) than benzos. Perhaps it’s best to remind people that sedatives can do a lot of damage too.
I essentially curse the day I started taking psychiatric medicine, on one hand. On the other hand, counseling with psychiatrists and psychologists was profoundly beneficial to me, before I got diagnosed as clinically depressed for an iron deficiency.
I’m fortunate enough to be more angry and wary than bitter.
Ever think about the fact that most people who have positive experiences are less likely to make comments at sites? Hell, when you read reviews about people/places/businesses, what percentages are positive versus negative? Let’s face it, comments are about incredibly wonderful or terrible moments. It does not account for the shades of gray in between.
Have people here forgotten the adage “no news is good news”?
So I am to conclude because people here have had bad experiences with medications, that generalizes to fairly much everybody has as well?
Thank you all for discounting the numerous people I have seen get better, many of them lower or even discontinue the use of prescription meds, and move on with their lives. Note the last part of that sentence!
Bloggers and commenters all have reasons for doing what we all do, the doctors among us too, doing what you can in waters that never were clear, but are willfully muddied by those whose main interests were and are to make money. Tons of money have made this kind of psychiatry dumb and dangerous, corrupted much of the field and many men, some women too, I think.
My reason for reading these illuminating, critical blogs, is to stay better informed than I would otherwise be, 1boringoldman, madinamerica, psychrights, mindfreedom, good helpers in gathering corn from enormous amounts of ignorance, dust and misinformation.
The international community of opponents and critics of standard bio-psychiatry, survivors, bereaved family members, friends and health care professionals, sociologists, lawyers and political scientists among us, are soundly protesting and fighting the industrialized inhumanity and degradations of Big Pharma and their many lackeys. It’s a political fight for dignity and human rights and good health care for all in a globalized world, caring for people in need, animals and environment.
We should not have to worry about eating meat or fish caught from fjords close by. But I resent mightily that people, soil and water and food here are contaminated by products doing less good and more harm than can be seen by one doctor at a time in his office. The bigger numbers are coming in. People are fighting back. Politicians are gradually forced to pay heed. When is USA “land of the free”? Whenever someone uses his freedom without encroaching on the freedom of others? I’m learning ever so much more from this blog and the commenters. Thanks!