The January edition of the New York Review of Books has an excellent article on the pharmaceutical industry and the corruption of medical ethics that summarises the recent revelations of fraud, undisclosed payments, data burying and off-label promotion that pervade the industry.
The piece is by Marcia Angell, who spent 20 years as editor of the New England Journal of Medicine and is now a senior lecturer in Harvard Medical School.
Rather disappointingly, although not particularly surprisingly, is the fact that psychiatry holds pride of place in the drug company corruption and unethical dealings stakes, with the large part of the article focusing on the marketing of major psychiatric drugs.
Marketing in the pharmaceutical industry not only relates to advertising and payments to doctors – in the form of money or gifts – but also to the published research which is often specifically designed to show the drug in the best possible light, or is deliberately buried if it doesn’t.
One person who has been instrumental in uncovering some of the most recent revelations is US Senator Charles Grassley who has spent the last year digging into payments to doctors and has uncovered large undisclosed sums paid to the biggest names in psychiatry.
The New York Review of Books article is a fantastic potted guide to the whole sordid business and is well worth a read if you want an update on the latest techniques used to market psychiatric drugs.
Link to NYRB piece ‘Drug Companies & Doctors: A Story of Corruption’.
4 thoughts on “Drug corruption: a rough guide”
If the pharmaceutical lobby can influence what kind of medication is prescribed i wonder if they can influence the introduction of certain psychiatric diagnosis over others in manuals.
Over at Crazy Meds we’ve been discussing these issues for years. In addition to what was brought up in the article I have links to a Yale study that found even double-blind studies & trials will almost always have results favorable to the sponsor.
Parke-Davis sponsored so many studies for the off-label uses of Neurontin that a meta-analysis could be done of their studies, independent studies and case reports. Turns out it doesn’t work all that well after all.
The average amount of money Big Pharma spends marketing medications to individual practices has been steadily increasing each year, from $10,000 in 2000 to over $17,000 a year in 2006.
Direct-to-consumer(DTC) marketing is bad enough, especially when it comes to disease mongering, but it’s the direct-to-physician marketing that is truly harmful. All of those pens and notepads, which have finally been banned, the conferences in vacation spots to present the studies sponsored by Big Pharma, the dinners and gifts, and all plethora of ads in the journals have a profound influence on how too many physicians prescribe medications. As well as how and where medications show up on insurance formularies, the treatment algorithms published by respected sources, and even medical schools. Thus the current generation of doctors are more apt to prescribe an expensive atypical antipsychotic for someone with classic bipolar 1 when cheap, reliable lithium carbonate is more likely to work better.
There is a paradox in the US when it comes to psychiatric medications. Per the article and books discussed here there are too many people being prescribed medications that they do not need. Either their conditions are not severe enough to require medication (looking deeper into the trials of antidepressants vs. placebos found that only people with severe major depressive disorder consistently benefited from the antidepressants) or they are the victims of disease mongering. Yet there are far too many people who can’t take medications due to cost, if the newer meds are the only ones that will work, or won’t take them because of the dual stigmata of having severe brain cooties and taking the medications required to control them.
And every time someone is prescribed a medication they don’t need, or the wrong medication, in the cause of drug company profits instead of consumer health, the chances increase for another anti-psychiatry crusader to be born. Which, in turn, makes it more difficult for someone who truly needs the correct medications to get them.
Everyone who needs these medicine should have the right ones. But why should we continue to separate “psychiatric” from “medical” disease? Hardly any of these problems are psychogenic. Let the psychiatrists be relegated to adjunct support and have medical physicians learn to properly prescribe these medicines. We don’t need someone trained in psychoanalysis to do that.
On the other hand, all chronic disease does make coping difficult and we do need professionals who are available to help people cope with whatever problems their illness causes. So we don’t need to get rid of psychiatry altogether. Just give them their proper place: adjunct therapy for most diseases. A few anxiety conditions can be solved mostly through cognitive behavioural therapy, good effort from the patient, and a good support system. But not any of the disease that require the medicines here described.
Of all doctor specialties, psychiatrists receive the most cash from pharma companies. About their research:
Pharmaceutical corporations, since the 1990s, have utilized what are called contract research organization s (CROs) to conduct their clinical trials for the drug company’s existing and pending medications. These CROs are supposed to be assessed and monitored by what are called institutional review boards (IRBs).
These clinical trials and their monitors, by the way, are often if not entirely created with the business models being of marketing rather than science. They cater and sell themselves to companies within the pharmaceutical industry as the apex of what is known as the pharmaceutical company‚Äôs publication planning.
Components of such plans consisting of clinical trial research design by such drug companies involve the formulation of what are seeding trials. Seeding trials are those designed by drug companies to give the impression of a desire to acquire knowledge, but in actuality are implemented as a significant marketing element of the drug company that becomes the sole sponsor of these trials.
The drug company chooses the investigators of these clinical trials involving the drug company‚Äôs promoted products, as well as the locations where these trials will be conducted as well. Often, the investigators are simply family practice doctors with little if any research experience, and are selected by the trial sponsors, the pharmaceutical companies.
The drug company creates clinical trials involving human subjects to acquire if not create favorable results from these trials illustrating the incredible benefits of their drugs which are involved in the clinical trials. Afterwards, these results are shared with those relevant to the drug involved with these clinical trial results, which include targeted prescribers and medical journals.
CROs are outsourced companies that provide research services for those in the pharmaceutical industry. Their relationship with their clients, the drug companies, is that of independent contractors. Because of the nature of this relationship, the drug company is exonerated from any potential liability involving the research they are paying for and controlling.
The CROs are either owned by, or are in fact advertising agencies that have a medical communications element. They above all else execute the publication plan of the sponsor with a team that is responsible for manipulating the media, and the public, as well as the medical community. Familiar names of CROs include Quintiles and Covance.
Most clinical trials conducted by pharmaceutical companies at this time are done so by CROs presently. Maybe two or more decades ago, the same clinical trials were performed by various academic institutions. CROs are progressively increasing in both size and number today. It is believed that the CRO industry is now a 20 billion dollar a year industry.
CROs and their sites that they, upon the wishes of their clients, include for the clinical trials are supposed to be evaluated and monitored by IRBs to, most importantly, assure the safety and protection of the human subjects in these trials. The IRBs, which are often for profit companies as well, are registered with the Department of Health And Human Services (DHHS) before it may conduct business.
The DHHS often if not entirely registers IRB applicants without apparently any evaluation of these for profit regulators- the IRBs.
The IRBs market themselves to pharmaceutical companies as being the IRB of choice for them due to their guarantee for fast approvals of research protocols designed by these drug companies. A for profit IRB can make 10 million dollars a year presently due to their aggressive marketing to pharmaceutical clients in collusion with CROs.
The IRB may charge around 1500 dollars for a clinical trial protocol review.
Because the IRB is for profit in many cases involving clinical trials, they, as with CROs, are primarily concerned with pleasing their sponsors, which are the drug companies. As such, the IRB in the past has failed to discontinue a flawed clinical trial, or intervene in a sponsored clinical trial if it is suspected of participating in wrongdoing, nor is any action taken by the sponsor of such a clinical trial.
So what exists with this corrupted research which fails to utilize the scientific method appears to be works of fiction as the clinical trials are conducted and planned. The profit element of all involved with these clinical trials leaves a welcome sign for these organizations to perform unethical manipulation of the clinical trials that again involve human beings. One could safely conclude the research being conducted today in this manner is both dangerous and flawed to unbelievable degrees with great concern.
Regulation is largely absent as this activity you have read is conducted more often than most realize. It is my hope that this activity will stop as it is implemented today for the safety and health of others,