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December 28, 2004. Gov. Codey's Wife Battles Depression WNBC TV. Mary Jo Codey, wife of acting N.J. Gov Dick Codey, recently sat down with NewsChannel 4's Brian Thompson to talk about her long, hard fight against depression. Video is available - viewing it requires Internet Explorer and Windows Media Player 9.
'SCARY' PAST OF N.J. GOV'S WIFE New York Post. Mary Jo Codey, the wife of Gov. Richard Codey, went public with details of her struggles with depression, including that she once thought about putting her "baby in my microwave."
December 10, 2004. Consumer Reports has added prescription medicines to the products it reviews. A new web site, Consumer Reports Best Buy Drugs just started with comparisons of proton pump inhibitors for heartburn and acid reflux disease, cholesterol-reducing statins and nonsteroidal anti-inflammatory drugs for pain. Each month, CRBestBuyDrugs.org will feature a report on another drug category. The reviews are free. Drug effectiveness information comes from the Drug Effectiveness Review Project (DERP) but Consumer Reports provides additional data and analysis.
Another pill review web site, from Public Citizen's Health Research Group is www.worstpills.org. It has free consumer tips and information on medications and the pharmaceutical industry. Public Citizen also has a paid monthly newsletter Worst Pills, Best Pills News, with information on drug safety and effectiveness, dangerous dietary supplements, drug-induced symptoms and drug interactions.
December 10, 2004. Study Pursues a Genetic Link to Depression By Benedict Carey in the New York Times. Scientists have discovered a genetic variation that could predispose people to depression and may help explain why some people who develop the condition get no relief from drug treatments. The findings in the journal Neuron, may allow researchers to develop a test for genetic vulnerability to depression and to create more effective treatments.
Genetic Defect Confers Risk of Major Depression, Resistance to SSRI Drug Therapy
Pharmalive.com December 9, 2004
Duke University Medical News
November 29, 2004. Contracts Keep Drug Research Out of Reach in the New York Times, on the front page, by Barry Meier
Academic institutions and researchers are widely viewed as the impartial, independent heart of the system used to test drugs. But that independence often comes with strings attached. The drug industry pays many academic institutions millions of dollars annually to run trials; the involvement of a leading academic researcher in a test gives it prestige and credibility. Medical researchers who attract studies reap the benefits of such rainmaking with bigger research budgets and career advancement. Recently drug companies refused to turn over data on anti-depressants in children to a group of researchers, even though these were the people who had helped come up with it. Drug companies say that because they pay for a trial they own the data it generates. In this case, medical schools, in agreeing to run the tests, had signed agreements with the drug makers that kept the data confidential.
An article in the New York Times by Richard Friedman, M.D. October 19, 2004. After the suicide of a patient, a psychiatrist asks What did I miss? Was there something I could have done differently? Bipolar disorder carries about a 10 percent lifetime risk of suicide.
An article in the New York Times by Gardiner Harris October 16, 2004. The Food and Drug Administration ordered pharmaceutical companies to add strong warnings to antidepressants, saying the drugs could cause suicidal thoughts and actions in some children and teenagers. These black-box warnings will appear in boldface type, framed by a black border, on information sheets for patients and doctors. They are the toughest requirement that regulators can impose short of banning a medication.
August 25, 2004. New Therapy on Depression Finds Phone Is Effective. New York Times. By Benedict Carey.
Most people affected by depression do not seek help at all. Those who do commonly neglect to complete counseling or drug regimens recommended by doctors. Forty percent of the people who begin antidepressant therapy quit within the first month. For at least a third of the people who try them, treatments of any kind fall short.
A new report in the Journal of the American Medical Association reported that doctors found they could significantly increase recovery rates for patients taking antidepressants by providing several 30- to 40-minute counseling sessions over the phone. This was the first study to test the effect of cognitive behavior therapy delivered entirely over the phone.
The author of the study said doctors should consider the telephone a powerful ally. Quoting "...not only using the phone, but being persistent, proactive, reaching out to people and finding them where they are. Depression is defined by discouragement; very often they're not going to come to you."
The New York State Attorney General has a web site, www.NYAGRx.com that let's you compare the prices of the 25 most commonly prescribed drugs at different pharmacies in your area. They warn however that only a small number of pharmacies are currently being surveyed and prices change frequently. Other web sites offering drug price comparison shopping are www.pillbot.com and www.pharmacychecker.com. A similar web site from the US Government is described below.
August 10, 2004. The Wall Street Journal. Fake-Drug Sites Keep a Step Ahead - One Is Busted for Selling Bogus Pharmaceuticals; New Vendor Grabs Address by Heather Won Tesoriero
Counterfeit drugs sold on the Internet is an expanding problem. Internet drug vendors often begin by selling legitimate drugs without a license, then move to diverted drugs (made outside the U.S. and unapproved for domestic sale) and finally to counterfeits. The web sites hire Internet technicians to shade their physical location and cover their cyber tracks. Some web sites claiming to be Canadian are based elsewhere. Investigations are limited by the extensive resources required to prosecute these cases. One web site selling fake drugs is WorldExpressRx.com. In many cases, the FDA found the fake drugs contained too much active ingredient, making them potentially harmful.
August 10, 2004. The Wall Street Journal. Drug Cocktails Hit Psychiatry - In Largely Untested Method, Doctors Mix Several Medicines To Treat Some Mental Illness By Leila Abboud.
Psychiatrists are increasingly crafting drug cocktails of multiple medicines to treat depression, bipolar disorder and schizophrenia. The approach, called "polypharmacy," aims to help people who don't respond to a single drug by putting them on several drugs that target different brain chemicals. The approach is driven in part by the shortcomings of many available medications. The causes of mental illness remain largely a mystery. Little research has been done about how to administer polypharmacy or whether it even works in some cases. Doctors arrive at the right mix by tinkering with a sequence of different drugs based on past experiences, word of mouth and drug-company marketing.
August 6, 2004. The Wall Street Journal. Pfizer Finds Two Failed Trials Equal One Coup for Zoloft By Barbara Martinez and Christopher Windham. Page B1.
In 1998 Pfizer sought a six-month extension of its patent on Zoloft. The FDA told the company to conduct two clinical trials on depressed children. Pfizer spent almost a year working with the FDA to design the trials. Upon completion of the tests, Zoloft failed to show better efficacy than a placebo, according to the standards laid out by the FDA. Pfizer did not seek approval to market Zoloft for use in depressed children and doesn't make the individual study results available to doctors or patients.
However, in 2003 an article based on those two trials was published in the Journal of the American Medical Association. The article said that Zoloft is an "effective" treatment for childhood depression. Zoloft is the most widely prescribed antidepressant for children and adolescents. How a positive article came to be, based on failed studies, is the topic of this story in the Wall Street Journal.
August 5, 2004. The FDA has approved Eli Lilly's Cymbalta (duloxetine), a new adult antidepressant. Cymbalta targets both norepinephrine and serotonin and should be on pharmacy shelves by late August 2004. It was approved to treat major depression for up to nine weeks. Cymbalta will come in capsule form and can be taken once a day. The average wholesale price is expected to be $2.85 for 60 milligrams, the usual daily dose. Lilly said this is comparable to Effexor.
May 28, 2004. Lilly's New Pill For Depression Reopens Debate By Leila Abboud in the Wall Street Journal. Page B1. In the summer of 2004, Eli Lilly will introduce a new antidepressant, Cymbalta. Like Prozac, it boosts the levels of Serotonin, but it also works on norepinephrine. Serotonin is believed to affect mood and anxiety, norepinephrine is important to energy. Another neurotransmitter, dopamine, is involved in attention and feelings of pleasure. Effexor is also a dual-action antidepressant. However, the scientific literature on whether dual-action antidepressants are superior to SSRIs is sparse and contradictory.
In reviewing this article, MDSG's Medical Advisor Dr. Ivan Goldberg points out that there are an estimated 350 neurotransmitters in the brain and it is unknown how many of them play a role in causing depression. Effexor is known to work on serotonin and norepinephrine, but Dr. Goldberg says it is not known how many other neurotransmitters it also impacts.
June 15, 2004. The New York Times reviewed the book The Ups and Downs of Raising a Bipolar Child: A Survival Guide for Parents by Judith Lederman, Candida, Md. Fink, Candida Fink.
June 2, 2004. Millions of young people are prescribed antidepressants yet data on the effects of these drugs in adolescents is sparse. A new study, sponsored by the National Institute of Mental Health, was the first to compare psychotherapy and drug treatment for depressed adolescents.
The study found that Prozac helps teenagers overcome depression better than psychotherapy (specifically, Cognitive Behavioral Therapy or CBT), but a combination of the two treatments produces the best result. Talk therapy (CBT) by itself was no more effective in reducing the depression than placebos. However, when combined with drug treatment, psychotherapy appeared to provide added benefits and to reduce the risk of suicide.
The study was notable both for its size and the fact that it was carried out without financing from a drug company (see the story below about Glaxo and Paxil).
Antidepressant Seen as Effective in Treatment of Adolescents By Gardiner Harris in the New York Times
June 2, 2004. New York State Attorney General Eliot Spitzer brought a lawsuit against drugmaker GlaxoSmithKline claiming fraud regarding information about adolescent use of Paxil. The suit alleges that Glaxo withheld negative information concerning Paxil and misrepresented information about the drug's safety and effectiveness. The company is said to have conducted at least five studies on the use of Paxil in children and adolescents, but only published and disseminated one of them. The other studies failed to show that the drug was effective and also demonstrated increased risks of suicide. In response, Glaxo claims that all pediatric studies were made available to the FDA and regulatory agencies worldwide. The only antidepressant approved to treat depression in children is Eli Lilly's Prozac, but physicians can prescribe Paxil as they see fit.
MDSG's medical advisor, Dr. Ivan Goldberg comments on this issue:
"Unfortunately, all drug companies usually publish only research that shows their drugs in a good light. Much drug company sponsored research that turns up unfavorable evidence about one of their drugs never is published. Because of the bias found in drug studies sponsored by drug companies, the NIMH should have its budget expanded, so it can sponsor studies of drug safety and effectiveness. Such studies would be free from the bias that in inherent in drug company-sponsored research."
To read more about this story:
June 15, 2004. The issue of drug companies suppressing studies with
unfavorable results continues in the news:
Medical Journals Weigh Plan for Full Drug-Trial Disclosure By Barry Meier in
the New York Times. An organization of top medical journals is considering a proposal that would require drug makers to register clinical trials at their start in a public database in order for results, whether successful or not, to be later considered for
publication. Pharmaceutical companies are not generally required now to disclose results of a trial or even whether one was conducted. Some academic researchers have long argued that fuller registries of drug trials are needed because companies, as well as medical journals and scientists, tend to spotlight only trials that show positive results.
June 21, 2004. The New York Times. Medical Journal Quandary: How to Report on Drug Trials by Barry Meier. Quoting: "Like most medical journals, The American Journal of Psychiatry does not require company sponsors of drug trials to divulge information about all relevant trials of a medication. But that may soon change, as some leading journal editors try to address what they see as shortcomings in the way clinical tests are designed and analyzed by the drug industry, and how test results are disclosed." The article discusses how drug companies bury the results of clinical trials with unfavorable results.
FYI: The National Institutes of Health maintains a web site, www.clinicaltrials.gov that provides information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.
August 27, 2004. Glaxo has agreed to post the results of all clinical trials involving its drugs to its web site. Eli Lilly has agreed to post the results of clinical trials for their approved drugs.
Emerging Teen-Depression Treatment Teaches Kids How to Handle Anxiety By Michael Waldholz in the Wall Street Journal, Health Journal column. May 25, 2004.
About 10 million children and teenagers suffer from some form of psychiatric illness. As the debate over the safety and effectiveness of antidepressant drugs for children heats up, psychologists and therapists who treat youngsters are beginning to embrace Cognitive behavioral therapy (CBT). CBT has been used mainly in adults to treat anxiety disorders. Several studies have shown that CBT can be as effective as other forms of therapy, including drugs. It involves a four- to nine-month course of weekly discussion sessions and requires a therapist with specialized training. CBT assumes that teens can be taught to recognize and react to stresses in a positive, appropriate manner. The aim is to teach adolescents how to alter their tendency to respond negatively to difficult experiences. CBT is not concerned with why some children develop a habit of viewing life through a dark filter. Instead, the goal is to help the child accept that their situation is under their control. Even CBT's advocates say that it isn't a cure-all. See the New York Times article described above from June 2, 2004 for a study that says CBT was not very effective in children.
For more or to find a Cognitive Behavioral Therapist see: the Academy of Cognitive Therapy, the National Association of Cognitive Behavioral Therapists (800) 853-1135, the Association for Advancement of Cognitive Therapy, the American Academy of Child and Adolescent Psychiatry or Behavior OnLine.
The
New York Times. May 25, 2004 by Mary Duenwald Psychiatrists say it is unwise for people who are taking antidepressants simply to quit on
their own. Stopping cold turkey can cause an array of symptoms: dizziness,
flu-like feelings, including nausea, headache and fatigue, anxiety, irritability
and/or sadness. Some patients experience tingling or burning in various parts of the body; ringing in the ears; blurred vision; or flashing lights before their eyes. Some people even describe a feeling of shock waves pulsing through their arms and legs, as if they had been zapped with a jolt of
electricity. To avoid such symptoms, or at least hold them to a minimum, the drugs need to be tapered gradually in most cases, and that means quitting under a doctor's supervision.
Not everyone experiences withdrawal symptoms and different drugs are, well,
different. These withdrawal symptoms do not mean that antidepressants are
addictive.
MDSG's Medical Advisor, Dr. Ivan Goldberg maintains a web page on Depression
Central devoted to SSRI Withdrawal Syndrome
Two Countries, Two Views on Antidepressants
The New York TImes. May 25, 2004. by Sally Satel, M.D. After examining 13 clinical trials
drug regulators in Britain urged doctors not to use certain antidepressants, among them Paxil, Luvox and Zoloft, for childhood depression because the risk of self-harm and suicidal thoughts was judged to be too great.
In the United States, the Food and Drug Administration, relying on the same clinical data,
has yet to decide on the safety issue, and doctors here continue to prescribe antidepressants to
children. Practically no one disputes that antidepressants are only minimally effective in children,
the issue is whether antidepressants truly worsen the potential for suicide. American doctors are five times as likely as British doctors to prescribe antidepressants to children.
Why the different approaches? Much of the answer lies in contrasting medical cultures.
The same phenomenon can be seen in the treatment of attention deficit hyperactivity disorder.
Also, in the United States, managed care, with its strong emphasis on cost-saving, creates its own demands. Pills are cheaper than
psychotherapy.
The US government just started a web site documenting the variation in prices for scores of prescription drugs at thousands of pharmacies around the country. The Web site is intended to help Medicare beneficiaries choose a drug discount card, but anyone can use the site. In many cases, the prices offered to Medicare beneficiaries, with the help of new drug discount cards, appear similar to the prices available to any consumer using online pharmacies. A survey by The Washington Post found that an Internet pharmacy, Drugstore.com, offered lower prices than the discount cards on six of 10 widely prescribed medications.
A day after the web site went live, there were reports that it was full of inaccurate and erroneous information. For example, according to Express Scripts, their price for a 30-day supply of Vioxx is $85.93 but the web site shows it as $159.32. Walgreens said that about half their prices were inaccurate.
Are You Bipolar? Mild bipolar disorder may be to this decade what depression was to the nineties, thanks to a new drug and an expanding definition. But when do ordinary peaks and valleys become pathological? By Vanessa Grigoriadis. Cover story in the March 8, 2004 issue of New York Magazine. The author of the story attended MDSG support groups, describes them and quotes Dr. Ivan Goldberg, our medical advisor. Quoting: "...mild bipolarity has become the new diagnosis for a slice of society that includes hard-to-treat depressives and some with a personal disposition that perhaps hedges into ordinary moodiness. Actually, many doctors believe that the widespread prescription of antidepressants over the past decade has been instrumental in uncovering, and even exacerbating, bipolar conditions. “As more and more people are taking antidepressants, more and more bipolarity is being exposed, because anyone who becomes hypomanic on antidepressants is bipolar,” says Ivan Goldberg ... " Dr. Goldberg maintains a web page Screening for Bipolar Spectrum Disorders. It is a questionnaire designed to screen for the possibility of a disorder in the bipolar spectrum in individuals, 18 or older, who have had at least one depression severe enough to have caused them distress and/or interfered with their functioning at home, work, school or in their interpersonal relationships. |
A Dying Trend The four NYU students who’ve jumped to their deaths grimly illustrate new research: Suicide can be a fad. By Vanessa Grigoriadis in the April 5, 2004 issue of New York Magazine. Suicide can be contagious ... Research has shown that those who are most at risk after a suicide within a particular community are not the initial victim’s immediate circle of family and friends but those who did not know the deceased at all ... Those who are most susceptible to this contagion are 15 to 24 years of age ... Late adolescence is often the age at which serious psychological disorders, like bipolarity and schizophrenia, first manifest, and psychiatrists note that a suicide in the midst is a trigger mainly to those already thinking about suicide.
Australian researchers publishing in the April 10, 2004 issue of the British Medical Journal conclude that trials of newer antidepressants such as SSRIs for children and teens contain such "disturbing shortcomings" that they "cannot confidently be recommended as a treatment option for childhood depression." The examined six randomized controlled trials of Effexor, Prozac, Paxil and Zoloft that had been published in refereed journals. They concluded that the benefits were exaggerated and that the side effects -- including suicidal thoughts -- were not well-documented. The researchers added also that the studies were sometimes funded by the drugmakers, or that the researchers had been compensated by pharmaceutical companies.
Practicing psychiatrists, however, are dismissing the newest allegations. "One has to keep in mind that 4,000 children and teenagers have participated in clinical trials, and there hasn't been one suicide among those 4,000 kids," said Dr. Harold Koplewicz, director of the New York University Child Study Center.
The Food and Drug Administration asked the makers of 10 antidepressant drugs to add the caution to their labels; patients should be closely monitored for the warning signs of suicide. The FDA's investigation into a possible suicide connection initially focused on children given the drugs. This warning is aimed at both adult and pediatric use. The FDA stressed that it is not clear that the drugs actually do lead to suicide. Depression itself can lead to suicide.
They issued a public health advisory for doctors, patients, families and other caregivers, to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of anti-depressant therapy or whenever the dose is changed. There is said to be a period of risk just after starting to use the pills, before the depression is really alleviated but when some patients experience more energy. The drugs at issue all effect the brain chemical serotonin: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.
Quoting from the FDA advisory: "Although the FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy."
March 9, 2004. NightLine on ABC TV did a show on depression prompted by the apparent suicide of actor-writer Spalding Gray whose body was found two months after he jumped off a ferry. Gray's life had been plagued by tragedy and depression including a suicide attempt in 2002. His mother committed suicide at age 52. His tragedy brings attention to a much larger problem. Approximately 19 million American adults suffer from depression. Ted Koppel talks with those whose lives have been affected by the disease.
February 17, 2004. The New York Times. By Richard A. Friedman, M.D. Like most diseases, bipolar disorder comes in different shapes and sizes and can be difficult to diagnose. Bipolar disorder is potentially fatal, 10 to 20 percent of patients commit suicide. A mild form of mania, called hypomania, is not obvious at all, especially in someone who happens to be temperamentally dramatic and lively. That is because hypomanic people feel very happy, have lots of energy, need little sleep and are generally fun to be with. And they certainly do not run to doctors complaining of happiness. The article discusses the downside of hypomania and the definition of bipolar type 2 disorder. Read the article.
January 13, 2004. The New York Times. Dealing With Depression and the Perils of Pregnancy Although there are known risks to taking antidepressants in pregnancy, and there may be unknown risks, mental health experts do not advise all pregnant women or those planning to conceive to stop their drug regimens. For some women, especially those with a history of significant depression, the risks of abandoning antidepressants during pregnancy may be far greater to the mother and the fetus than taking the drugs themselves. Those who abruptly stop taking their medications, often on the advice of their obstetricians, put themselves in danger of a relapse. Others who switch to lower dosages may still suffer depressive symptoms.
January 6, 2004. It is often thought that the best treatment for depression is both talk therapy and drugs. A recent study scanned the brains (using positron emission tomography) of patients who had received only talk therapy and those that received only Paxil. The therapy was cognitive behavioral therapy which teaches patients to recognize and derail negative habits of thought.
Previously, therapy was speculated to have a "top down" action on the brain: changes beginning in the cortex, the area dealing with higher reasoning, go on to affect other areas of more basic functioning. In the scans, the therapy patients showed changes in the frontal cortex, changes that did not occur in the Paxil treated patients.
Previous research suggested that antidepressants work as "bottom up" agents, working first on areas like the limbic system that play a big role in memory and basic emotions. In fact, the Paxil patients showed changes in the brain stem and parts of the limbic system where the cognitive therapy appeared to have no effect.
One of the researchers said that depression stems from a malfunction not in a single spot in the brain, but rather in a network or circuit of brain connections. The study was small, there were 14 people who received therapy (15 to 20 sessions) and 13 people treated with Paxil. The mapping may provide a first step toward using brain scanning to determine which patients should receive antidepressants and which should receive psychological training, a decision that is now often based on trial and error.
2004 started with a number of stories about celebrities and their depressions:
April 19, 2004. Journey To The Center Of The Mind. By Joan O'C. Hamilton in Business Week magazine. "Functional" MRI is yielding a clearer picture of what thoughts look like. This article is available on their web site only to subscribers of the magazine. The benefits in psychiatric diagnosis and treatment for functional MRIs may be revolutionary. One study is imaging the brains of depressed patients taking Effexor. It has found that the drug works specifically on the anterior cingulate, a region of the brain involved in focused attention and conflict. Depressed patients whose anterior cingulates were more active before taking the drug responded better to it. The hope is that, in the future, doctors will be able to predict which patients will be the best candidates for antidepressants by looking at brain scans.
January 4, 2004. Researchers at McLean Hospital tested a form of magnetic resonance imaging (MRI) on 40 patients who suffered from bipolar disorder. The results indicated that using an MRI on depressed patients makes them feel better. Fully 77% of patients who underwent the extremely weak magnetic field MRI felt better after the brain scan.
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Depression in the News 2004