Evelyn Pringle December 6, 2006
In the run-up to the December 13, 2006, meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, to review the suicidality data from adult SSRI studies, a host of newly identified disorders have been popping up in the media, all treatable with SSRIs.
The committee is expected to vote on whether the association between the selective serotonin reuptake inhibitor antidepressants and suicide in adults should be included in a Black Box warning label on all SSRIs, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
In light of all these new SSRI treatable disorders in the news, advocates who have been campaigning for the Black Box warning are wondering whether the SSRI makers have received some kind of inside information from the FDA, or the advisory committee members, that is not known to the public.
In fact, its quite possible that the public will have no access to any information that will be discussed at the hearing until the last minute, because the FDA announcement says: “The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site.”
Critics say it seems odd that drug makers would be pouring money into studies to increase the use of SSRIs by finding new “disorders” to add to the DSM, at the very same time that stronger warnings to doctors and consumers on the use of the drugs are being considered.
The ever-expanding Diagnostic and Statistical Manual for Mental Disorders, was released in 1952, and had about 106 different mental disorders. It has since gone through 5 revisions and now has about 375.
The next version of what is referred to as the “Psychiatric Billing Bible,” is not due out until 2011, but there are definite sightings of new “disorders” already on the horizon.
For instance, to the “untrained eye,” a person afflicted with one of the newly identified ailments would probably be viewed as a typical and harmless everyday slob; but GlaxoSmithKline is apparently getting ready market Paxil as a cure for what a new study estimates to be 2 million everyday slobs in the US.
On November 10, 2006, HealthDay News discussed the study, published in the Journal of Psychiatric Research, that said Paxil is effective in treating people with a condition called “compulsive hoarding syndrome.”
The researchers claim it has 3 main features: (1) severe anxiety prevents patients from throwing out seemingly worthless items; (2) patients are prone to acquiring things, sometimes leading to buying sprees; and (3) there is excessive clutter in the patient’s home and work spaces.
Indecisiveness, procrastination and disorganization are also listed as other symptoms. Although the syndrome is found in patients with other diseases, such as dementia, Alzheimer’s, schizophrenia and anorexia, the researches note, it is most often seen in patients with obsessive-compulsive disorder (OCD).
According to Healthday, the research team is not yet certain whether compulsive hoarding is a subtype of OCD, or a separate disorder. The study included 79 patients with OCD, and 32 were found to have “compulsive hoarding syndrome.”
The good news is that the researchers say that both the hoarding and non-hoarding patients showed significant improvement in their symptoms when treated with Paxil.
Moving on to the next earth-shaking discovery, a study from Stanford University, in the October 2006, American Journal of Psychiatry, measured the prevalence of the dreaded, “compulsive buying disorder,” and found that more than 1 in 20 adults in the US suffers from this ailment.
On October 3, 2006, the New York Times reported that compulsive buying is not a recognized psychiatric diagnosis, “but it is now being considered for inclusion in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.”
Lorrin Koran, a professor at Stanford, and senior author of the study, told the San Francisco Chronicle on October 13, 2006, that the results were a surprise. “It was thought previously that this was a disorder that primarily affects women,” he said. “It turns out that it afflicts almost as many men.”
The study found that about 6% of women and 5.5% of men show symptoms of “compulsive buying disorder,” which is characterized by “an irresistible, intrusive and often senseless impulse to buy.”
A finding that doubles the number of “compulsive buying” patients had to be good news for Forest Laboratories, the company that not only paid for the study, but believes its top money making SSRI drugs, Lexapro and Celexa, can be used to treat the disorder.
“My hope,” Dr Koran told the Times, “is that people who think they have this disorder will seek help because available studies suggest that psychotherapy or medications help many compulsive buyers to stop.”
Critics say from an economic stand point, the amount of money that could be saved by seeking treatment would depend on the shopaholic. If weekly therapy sessions cost $200 and the prescription for Lexapro runs $250 a month, a patient might end up in the hole.
Then there is the little-known disorder called “night-eating syndrome,” discussed in an article titled, “Midnight munchies can signal big problems,” in the October 26, 2006 Courier-Journal.
“Those who skip breakfast, eat more than half the day’s calories after dinner and sometimes wake up and snack likely have this condition,” the Courier reported.
“It’s characterized by hormonal imbalances,” the article says, “that lead to disturbed patterns of sleep and eating.”
But help can be found in the old reliable SSRIs here as well. “Research at the University of Pennsylvania has found the antidepressant Zoloft helped,” the Courier reports, “along with therapy to change eating and exercise patterns.”
Considering the recent estimates that more than a third of all Americans are considered obese, with a good PR firm, Zoloft sales could go through the roof if the “night-eating syndrome,” gets enough publicity because according to the Courier, “some research has found that up to 28 percent of obese people have it.”
Zoloft is on a roll. In the October 2006, Journal of Clinical Psychiatry, researchers reported that low doses of Zoloft taken for 2 weeks before the menstrual period may be an effective treatment for moderate-to-severe premenstrual syndrome, or PMS.
Pfizer already managed to get Zoloft approved for the treatment of premenstrual dysphoric disorder (PMDD), referred to as a severe form of premenstrual syndrome.
Apparently, this study is meant to snag customers among the gals whose suffering is less severe. By the way, Pfizer paid for the study that found its drug helpful for PMS.
As for recruitment efforts aimed at the other gender, according to Health Day News on September 9, 2006, “SSRIs, which are used to treat depression and other psychiatric disorders, are now also used “off-label” as a treatment for premature ejaculation.”
However, the article reports that experts say continued use of SSRIs can have negative side effects, such as psychiatric problems, skin reactions, weight gain, and loss of libido.
But not to be discouraged, researchers have gone ahead and developed a new SSRI, dapoxetine, just for premature ejaculation. “This is the first drug specifically developed for premature ejaculation,” lead researcher Dr Jon Pryor, a professor and chairman of urologic surgery at the University of Minnesota, told Health Day News.
In a study, after 12 weeks, men taking a 30-milligram dose of the drug increased their time to ejaculation to 2.78 minutes, and men receiving a 60-milligram dose went for 3.32 minutes. For men taking a placebo, the time to ejaculation averaged 1.75 minutes.
Dr Pryor thinks this study will get people talking about the problem. “I hope this paper brings premature ejaculation out of the closet,” he told Health Day News.
Moving on to the next SSRI miracle, in what is sure to be an extremely successful widening of the customer base for Paxil and Effexor, doctors at the University of Rochester Medical Center, now claim that nearly half of all Parkinson’s patients suffer from depression, but they assume that depression is something they just have to live with.
Not so, say the doctors who announced a nationwide study to test the effectiveness of Paxil and Effexor with Parkinson’s patients, in a September 19, 2006 Press Release.
The doctors say the study is funded by the “National Institute of Neurological Disorders and Stroke,” which can mean one of two things. One, that tax payers are funding the research to find new uses for these drugs, or two, the drug makes are funneling money by way of contributions to the Institute, which the government Web site says it accepts.
The benefit that results from the funneling scheme is that when the doctors find the drugs effective, which they no doubt will, instead of saying the research was paid for by the drug’s makers, it lists the government as the funding source.
Either way, no tax dollars should be spent on this type of study. If there is funding available for research on Parkinson’s disease, it should be spent on finding a cure.
If GlaxoSmithKline and Wyeth want to go on a wild-goose chase looking for new uses for Paxil and Effexor, let them do it on their own dime and time. And after that, they need to apply for approval of any new use with the FDA, instead of using a trumped up study as justification for prescribing the drugs off-label.
In a completely different field of medicine, on October 30, 2006, Reuters reported that researchers at Jerusalem’s Hebrew University discovered what surely must be described as another scientific wonder. Their study found that depression can lead to brittle bones and the Israeli scientists suggest that SSRIs can be used to treat osteoporosis.
They reached this conclusion after they found that mice that were given drugs to induce human-like depression suffered a loss of bone mass, but after receiving SSRIs, their bone density increased, along with their level of activity and social interaction.
According to Reuters, an earlier study at the Forsyth Institute in Boston also found that Prozac increased bone mass – in mice.
When mulling over all the new “disorders” being considered for the DSM, it should be recognized that according to a study in the April 2006, Psychotherapy and Psychosomatics journal, 80% of the members on the expert panels, involved in approving most of the off-the-wall disorders for the DSM in recent years, had undisclosed financial ties to the drug companies whose drugs would be used to treat the disorders approved.
In fact, the review found that 100% of the experts involved in writing diagnostic criteria for depression and schizophrenia had undisclosed financial relationships with the drug companies who market drugs to treat those conditions.