Healthy Skepticism Library item: 4531

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cassels A.
Depressed or anxious? Switching pills for your ills a dangerous practice
Common Ground (Vancouver) 2006 Apr 1
http://www.commonground.ca/iss/0604177/cg177_cassels.shtml

Full text:

The story of benzodiazepines is of awesome proportions… a national scandal. The impact is so large that it is too big for governments, regulatory authorities and the pharmaceutical industry to address head-on, so the scandal has been swept under the carpet.
Phil Woolas MP, British House of Commons, December 7, 1999.
In Selling Sickness, Ray Moynihan and I discussed how the pharmaceutical industry, ever vigilant to expand new markets for its products, has worked in tandem with the medical profession to widen the boundaries of illness. We described a world where “new” conditions are painted as “dire,” and where risk factors in our bones or blood are promoted to full-fledged diseases, in and of themselves, hence becoming prime targets for pharmaceutical intervention.
In painting this picture, however, we touched only briefly on a very important aspect of selling sickness: the methodologies used to shift patients from older, cheaper, off-patented drugs to newer and more expensive patented products. The best example to demonstrate this phenomenon is the recharacterization of anxiety into depression and the wholesale switching of older, anti-anxiety drugs, largely benzodiazepines — drugs like Ativan, Valium and Xanax — to newer SSRIs, selective serotonin reuptake inhibitors, such as Paxil, Zoloft or Prozac. The switch to newer treatments is partially due to the “newer is better” thinking that permeates so much of our consumer culture. The fact that older drugs tend to carry more baggage also has a lot to do with it. We have learned about those drugs and their warts and blemishes simply because we have had more experience with them.
Shifting patients from more established and better understood therapies to newer ones that we have less knowledge about may sometimes have a strong medical rationale. It may be because there is a clearer understanding of the condition. An older drug’s side effects may be intolerable, with the newer one marketed as being “safer.” Any extra cost involved may seem justified. But switching patients’ drugs is a potentially dangerous practice, which may accomplish nothing more than exchanging one set of problems for another.
According to the British Medical Journal, “The growing search for blockbusters in the 1970s resulted in a trend to rubbish earlier drugs in order to put new patent-protected drug classes on the market.” The BMJ points out that, in the case of treatments for mood and anxiety disorders, “Despite clear evidence that benzodiazepines were effective, they were dismissed as drugs for neurotic women, who then become addicted.” After a brief flirtation with tricyclic antidepressants, which were also quickly considered to have too many adverse effects, the world bent to embrace the brave new world of the SSRI antidepressants.
In the 1960s, drug companies were not at all interested in depression; they didn’t think it was marketable. (David Healy’s books, including Let Them Eat Prozac, lay this out in fine detail). Depression was considered an easily self-cured problem, so the real market was always anxiety. With the rise of the SSRIs in the mid ’80s, depression became the drug makers’ ultimate target, and the sales of anti-anxiety drugs plummeted. Since 1990, no drugs patented in the mood and anxiety area have reached the US market.
I decided that in order to dig deeper into this issue, I needed to see the “switching” phenomenon in action. A great opportunity arrived via email when I was invited to participate in an online course for pharmacists to learn about new treatments for panic disorder. Now, I’m all for continuing education. I enjoy taking courses that are designed for pharmacists, not because I’m a pharmacist, but because as a pharmaceutical policy researcher I have a deep interest in knowing what pharmacists are learning: what kinds of messages they are getting about new diagnoses, and how the effects and side effects of new treatments are conveyed to them.
In many ways, pharmacists are among the most underappreciated members of the medical team. For many consumers, the first place they go for medical advice, or to ask a question about a drug, is the pharmacy. Pharmacists do what is arguably one of the most important jobs in the medical system: they try to get people to use prescription drugs properly.
In this vein, I took an online course in the treatment of panic disorder designed for pharmacists. Continuing pharmacy education (CPE) is like continuing legal education (CLE) for lawyers, or continuing medical education (CME) for doctors, an important way for professionals to stay on top of new developments in their discipline.
Although a pharmacist doesn’t write prescriptions, her job is to make sure that people use dispensed pharmaceuticals in an informed and intelligent way. She therefore requires up-to-date, professional education to help her better counsel people to avoid drug related problems.
The CPE module taught me a lot about panic disorder, but it wasn’t panic disorder, per se, that fuelled my curiosity. What I was really interested in, was why a drug company, through an “unrestricted educational grant” was spending thousands of dollars to support this module. What was in it for the company? I mean, pharmacists can’t prescribe.
The module set-up provided some clues. The program featured a “case study” of a woman in her late 20s, who was taking a drug called alprazolam (also known as Xanax) to deal with her panic disorder. Xanax is a classic benzodiazepine that has been around for at least 40 years, and is often prescribed for anxiety or sleep disorders. In 1981, alprazolam was the first medication approved for panic disorder, yet some experts question whether panic disorder was even a diagnosable illness, distinct from other kinds of mental illness. But let’s put that controversy aside for a bit.
The case study was set up with the woman showing obvious signs of panic. She chokes and has difficulty breathing. She sweats and has clammy hands. She had just returned from visiting her psychiatrist, who suggested she try Effexor (venlafaxine), a newer SNRI (serotonin noradrenalin re-uptake inhibitor).
Ah, there’s the rub. The patient wants the pharmacist’s advice on whether she should be switched to Effexor, a newer, more expensive treatment made by — whoa, wait a minute, that’s the same company that’s paying for this pharmacy education module I’m working on. OK, it’s starting to make some sense.
So let’s assume Effexor “works” for panic disorder. What is the rationale for switching someone from one drug to another? The learning module characterizes it in this way: “Antidepressants are often first-line for panic disorder because of their broad spectrum efficacy against common co-morbid conditions including depression…” and “the lack of associated abuse and dependency liabilities that are associated with benzodiazepine administration.”
Allow me to translate: The reason we are recommending that you switch from a benzo to an SSRI or SSNI is because these newer ones are effective against other things you might have while you are depressed and because the benzos are addictive.
According to UK-based physician C. Heather Ashton, one of the leading experts on benzodiazepines, as many as half of long-term benzo users may be able to stop without symptoms, but it depends on how long one has taken them. If someone has taken them for a year or so, she is likely dependent, and ending that dependence can mean severe, serious withdrawal effects that require weaning and individualized tapering.
Some have said that withdrawing from benzos is like having four or five other diseases at the same time. People experience anxiety, insomnia, irritability, gut-wrenching stomach cramps, or sensitivity to light and noise. They can become confused, depersonalized, delirious, psychotic and insomniac. It can be nasty, nasty stuff.
Luckily, the learning module does include some helpful information on trying to wean people off benzos — and a pharmacist can be really helpful here — but quitting can be a long, frustrating and difficult process. In our case study, the patient is being encouraged to move to Effexor, but what kinds of side effects might be expected?
The approved product labelling for Effexor notes that it is also associated with potentially severe withdrawal side effects, which could include fatigue, nausea, dizziness, headache, insomnia and nervousness. In fact, symptoms of withdrawal can be so significant that in March 2000, the US FDA ordered Effexor’s manufacturer Wyeth-Ayerst to add additional labeling: “Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment… It is therefore recommended that the dosage of Effexor be tapered gradually and the patient monitored.”
In case I’ve lost you, remember this: weaning yourself off Xanax so that you can be moved to Effexor may mean a whole new set of nasty withdrawal effects. Sounds eerily like we are trading one set of symptoms for a whole ‘nuther set. There is also the issue of suicide. One of the original reasons to get people off benzos was because the drugs could be the cause of suicide by overdose. This has always struck me as a red herring, an inducement to get people to switch to the newer stuff. But let’s look at the information Health Canada released in June 2003: “Health Canada is advising Canadians that all newer anti-depressant prescription drugs, known as selective serotonin re-uptake inhibitors (SSRIs) or serotonin noradrenalin re-uptake inhibitors (SNRIs), now carry stronger warnings. These new warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others. In other words, the two concerns prompting a switch from benzos — addiction and suicide — also apply to the recommended replacement drug.
Depression is one of the fastest rising diagnoses made by office-based physicians; visits to a physician for depression have almost doubled since 1994. Furthermore, in 2004, 81 percent of depression-related visits resulted in a recommendation for an SSRI or a related drug, and the cost impact has been enormous. From 1993 to 2000, drug sales have increased 347 percent, and we have seen an increase in prescriptions for both benzos and SSRIs. In BC, from 1996 to 2002, benzo use increased by 11 percent, yet the use of antidepressants increased by 73 percent over the same time period.
Janet Currie of Victoria is probably one of Canada’s leading experts on benzodiazepines and the effects of SSRIs. She recently wrote a report entitled The Marketization of Depression: the Prescribing of SSRI Antidepressants to Women (see www.whp-apsf.ca/pdf/SSRIs.pdf), wherein she notes that the drugging of depression and anxiety is largely a female issue, since two-thirds of SSRI users are women. Further, “The clinical trial results for SSRIs raise many questions about their effectiveness, and yet hundreds of thousands of Canadian women are being exposed to these potent brain chemicals, sometimes for many, many years despite their many risks and side effects.”
She would agree that shifting patients from benzos to antidepressants is not just costly, resulting in huge profits to big pharma, but it often ignores the alternatives, such as talking to someone or engaging in exercise therapy, both which may be effective as non-drug treatments for anxiety or depression.
Currie reminds me that history can be seen to continually repeat itself. Citing the 10-20-30 rule — that it takes us about 30 years to realistically view a class of drugs in its entirety, both the benefits and the harms — she points to Joseph Glenmullen’s book The Antidepressant Solution: A Step by Step Guide to Safely Overcoming Antidepressant Withdrawal, Dependence and Addiction.
Following the arrival of a new class of drugs on the market, it takes at least a decade for physicians to even become aware of its most serious side effects, partially due to the fact that regulatory agencies such as Health Canada have such weak systems for monitoring side effects. When serious effects are noted, the pharmaceutical companies go into denial, and it takes another decade to actually collect enough data and study what the serious problems may be.
Although patient advocates are now sounding the alarm, it will take another decade before regulatory agencies and professional organizations act to change treatment guidelines and prescribing patterns. By that time, 30 years hence, what was “new” has become old, and drug companies have come out with an even “newer” — read more patented and therefore profitable — drug. We have seen this with the benzos and the tricyclics, and we’re starting to see the same pattern with the SSRIs, as new treatments, such as Effexor, arrive.
Currie sees that one of the biggest holes in the health system is its failure to provide people the help to get off unneeded or harmful drugs like the addictive benzodiazepines. She helped start the Psychiatric Medication Awareness Group (www.psychmedaware.org), and is one of the West Coast’s brightest lights for raising awareness and disseminating knowledge about psychiatric drugs.
While my online pharmacy module may guide pharmacists to address the issue of dependence and withdrawal for drugs like Xanax, in Canada, no government-funded services are available to help people safely withdraw from benzodiazepine addiction. While you’re basically on your own, you could get in touch with groups around the world doing this work as part of the benzo awareness network. Two notable groups are www.benzo.org.uk, a UK-based group focused on benzodiazepine addiction, withdrawal and recovery, and Tranquilliser Recovery and New Existence (TRANX) in Australia, www.tranx.org.au.
The pharmacy module dryly sums up the situation: The “…present case serves to illustrate the potential severity of alprazolam rebound and how its long-term use can exacerbate the symptoms for which it was originally administered.” Fine enough, but what about Effexor’s side effects? Is it actually useful for panic disorder?
Listed side effects for Effexor include anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania.
Plus ccedil;a change, plus c’est la même chose.
Alan Cassels is the co-author of Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All into Patients, and a drug policy researcher at the University of Victoria. He has spent most of the last 10 years studying how clinical research about prescription drugs is communicated to policy makers, prescribers and consumers. He is also the founder of Media Doctor Canada (www.mediadoctor.ca), which evaluates the reporting of medical treatments in Canada’s media.