"It's not fair. That's how I feel. That a person in America could go to the doctor, get a prescription, take Effexor, and all of a sudden be unable to quit." These comments were posted on March 23 by "Sean9" on the message boards of the British Social Audit website.
Continuing, Sean9 wrote: "[It's not fair] that the doctor didn't tell that person how difficult it would be to quit before they started medication; that the manufacturer didn't fully disclose the degree of physical pain an average user will experience when discontinuing Effexor; that neither the doctor or the manufacturer acknowledge how serious the withdrawal symptoms are and therefore, offer no advice on treating the symptoms."
A medical health problem is reaching epidemic proportions in the First World — depression, and other associated mental health problems such as generalised anxiety disorder.
Venlafaxine (VFX, marked under the brand name Effexor), a bicyclic antidepressant, is used in the treatment of mood disorders, including depression and anxiety. Sean9's experiences are not unique: Effexor is the most commonly prescribed drug by doctors in the treatment of depression — at least 8.5 million people are prescribed Effexor every year.
When a patient ceases taking the drug, he or she will most likely suffer from what are commonly known as "discontinuation symptoms". Physical symptoms include nausea, vomiting, intense fatigue, dizziness, chills, sensory disturbances and persistent insomnia. Psychological symptoms include anxiety, agitation, crying spells and irritability. More rare symptoms include paranoid delusions and hallucination.
These symptoms can last anywhere from a few days to many weeks.
Symptoms often subside upon reintroduction of the drug, which can prompt a roller coaster-like attempt to quit the drug, as patients find other ways to treat their symptoms. Many patients, after coming off Effexor, confuse their symptoms with the common cold or the flu, go to their GP and are prescribed a course of antibiotics. Some are prescribed strong pain-killers, increasing their incapacitation.
Social Audit reports a series of case studies in 1996. "Three cases are reported of VFX [venlafaxine] withdrawal, following both abrupt ... and very gradual cessation. Main symptoms were dizziness and ... distress, but one patient also experienced auditory hallucinations and bizarre dreams. It took her ten weeks from the initial attempt at withdrawal to discontinue VFX. Neither of the two other patients was reported to have achieved withdrawal."
Another study revealed that "four out of nine patients involved in an open 12-week trial of VFX... 'developed a troublesome withdrawal syndrome', despite gradual withdrawal of medication over four days to two weeks."
In other words, even patients who quit slowly by "tapering off" the dosage seem to experience the same withdrawal symptoms.
Disturbing report
Perhaps the most disturbing report was conducted by Wyeth Pharmaceuticals, Effexor's manufacturer. The study, conducted in 1997, studied "withdrawal reactions in 127 patients treated with VFX but did not report them". Why were these results not published?
The study also followed patients whose "medications were tapered over a period of up to two weeks. The report states that patients were evaluated 4 to 10 days after medication was discontinued, but results are not reported."
A later Wyeth-sponsored study reported that four patients' withdrawal symptoms were so severe, medical treatment was required. One episode of hypomania was reported.
The possibility of a withdrawal reaction is mentioned briefly in the manufacturer's data sheet, which states: "Discontinuation effects are well known to occur with antidepressants." However, it implies that such reactions are observed with doses of 150mg daily and above (the minimum dosage is 37.5mg, while the maximum is 225mg). It does not mention that venlafaxine withdrawal reactions have been reported after missing just a single dose.
Why are there so many patients who feel they were not properly informed of Effexor's side effects and discontinuation symptoms? Why is it that the number one prescribed anti-depressant is not even fully understood or researched?
Company samples
Current medical trends confuse the matter even more. The American Medical Association (AMA) estimates that only 22% of those who suffer from depression receive proper medical treatment, but those who do probably aren't receiving the right kind of treatment. The average consultation time between a US doctor and patient is 7-8 minutes, which poses the question: Can a frank and informed diagnosis really be made in that space of time, let alone a reliable assessment of the most appropriate method of treatment? More and more patients are walking out of their doctor's office with a script in hand, no closer to finding a solution to their problem. More importantly, this approach is putting the mental health of countless millions on the line.
Anecdotal evidence suggests that more and more patients are receiving their first course of anti-depressants in the form of samples of drugs given by drug companies to doctors. Once on the drug, common practice dictates that the patient's intake is slowly increased until the maximum dosage is reached, to determine whether the drug is appropriate.
If the drug is inappropriate or simply not working, it is ceased completely or tapered off, and discontinuation symptoms ensue. This entire process can take up to six months.
In other words, corporations like Wyeth are using the tactic of getting in early to prevent patients from using other drugs from different companies.The New York Times reported in September 2001 that the AMA "recently launched a campaign to remind its members about the AMA's ethical guidelines" and discourage them from accepting freebies and samples. "The campaign budget of $750,000 comes mostly from the pharmaceutical business", the NYT reported.
On the other side of this US$750,000 budget is the estimated $16 billion the US pharmaceutical industry spent on giving freebies and samples to doctors. These "gifts" are clearly compromising doctors' decision-making abilities and their patients' health. Further, healthcare should not be treated as an "industry" and money-making market influenced by profit-driven corporations like Wyeth and Pfizer.
While Wyeth reported its annual earnings as just over $2 billion for last year (up from $1.67 billion in 2002), the gap between the rate of depression and its treatment remains vast. (Wyeth's total profit last year would have been closer to $3.2 billion, had it not been ordered to pay $1 billion in a case arising from the death of Texas woman caused by one of its diet drugs.) Clearly more studies are required to determine the exact nature of venlafaxine withdrawal, focusing on drug-tapering regimes and symptom control during the withdrawal period.
Education of doctors on the severity and nature of withdrawal also needs to be employed as many, even psychiatrists, clearly do not believe that this exists and prefer often to put symptoms down to a "mystery virus" or patient neuroses.
These seemingly standard practices, which are commonplace with medications that treat strictly physical ailments, are simply not being undertaken with psychological drugs.
Without this kind of research the 8.5 million people who take Effexor on a daily basis are not just patients, but also guinea pigs.
From Green Left Weekly, June 2, 2004.
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