Paxil linked to cardiac birth defects

WEDNESDAY, Nov. 29 (HealthDay News) -- A group representing America's obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects.
The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis.
ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible," read the statement, which is in the December issue of Obstetrics & Gynecology.
The guidelines come a full year after the U.S. Food and Drug Administration (FDA) issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy.
This warning was based on two studies. The first found about a 2 percent risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared with a 1 percent risk in the general population.
The second study found that the risk of heart defects was 1.5 percent in babies whose mothers took Paxil in the first three months of pregnancy, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester. The most common defects were cardiovascular.
"Since the FDA warnings a year ago, most ob/gyns have been trying to avoid Paxil during pregnancy," noted Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. "This is just a formal statement by ACOG."
The initial FDA warning came in September of 2005. In December of the same year, the FDA instructed Paxil's maker, GlaxoSmithKline, to reclassify the drug from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women have demonstrated a risk to the fetus.
Other reports had indicated that SSRIs, the category of antidepressants which includes Paxil as well as Celexa, Prozac and Zoloft, may cause newborns to have withdrawal symptoms.
ACOG acknowledged that these potential problems must be weighed against yet another study which found that pregnant women who discontinue their antidepressant medication are five times more likely to relapse into depression than women who continue with the medication.
"Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications," the statement said.
Women of reproductive age have the highest prevalence of major depressive disorders, with ACOG experts estimating that about 1 in 10 will experience a bout of major or minor depression sometime during pregnancy or the postpartum period.
Ideally, these issues should be considered before a woman becomes pregnant, the ACOG panel said. But, given that about half of all pregnancies are not planned, many decisions regarding treatment will inevitably happen after the woman has conceived. Fetal echocardiography, which looks for heart trouble, should be considered for women who were exposed to Paxil in early pregnancy, the statement recommended.
"Women who have certain health problem such as depression really should try to plan their pregnancies with their ob/gyn and psychiatrist," Wu confirmed. "The major danger will be to women who have an unplanned pregnancy and don't realize it until they're two months along. There's a lot of organ development during that time, and exposure to certain SSRIs may pose some dangers."

That Wacky Kramer

The Reverend Jesse Jackson feels that Michael Richards needs psychiatric help:
First he went on national television to apologize for his racial tirade against two black hecklers. Now Michael Richards is taking his contriteness to the next level: he's hired a public relations expert with deep contacts in the black community.
New York publicist Howard Rubenstein took on Richards as a client Wednesday after being contacted by the actor-comedian. He then arranged for Richards to call the Revs. Jesse Jackson and Al Sharpton.
"Clearly he needs some race sensibility training, and some psychiatric help. His anger is volatile and dangerous to himself and others," Jackson said.

The number of children on Psych meds is increasing

The New York Times reports on the increasing number of children on psychiatric meds. Many children are now taking combinations of 3 or more psychiatric medications:
There is little doubt that some psychiatric medicines, taken by themselves, work well in children. For example, dozens of studies have shown that stimulants improve attentiveness. A handful of other psychiatric drugs have proven effective against childhood obsessive compulsive disorder, among other problems.
But a growing number of children and teenagers in the United States are taking not just a single drug for discrete psychiatric difficulties but combinations of powerful and even life-threatening medications to treat a dizzying array of problems.
Last year in the United States, about 1.6 million children and teenagers — 280,000 of them under age 10 — were given at least two psychiatric drugs in combination, according to an analysis performed by Medco Health Solutions at the request of The New York Times. More than 500,000 were prescribed at least three psychiatric drugs. More than 160,000 got at least four medications together, the analysis found.

Sleep deprivation and driving

Sleep Review reports:
A recent online article from ABC News reports that Stanford University researchers have found that staying awake for 24 hours has the same effect as being legally drunk. Clearly, sleep deprivation can be pretty strong stuff. We know it leads to mood swings, confusion, impaired motor coordination and more. But can going without sleep for 24-hours make you, say, slur your speech and wear a lampshade on your head? Steven Howard, associate professor of anesthesia and an expert on sleep deprivation and fatigue teamed up with colleagues to study 24 nurses and 25 doctors who worked the 12-hour graveyard shift at Stanford Hospital. Half were given a 40-minute nap break at 3am, in the middle of their shift, and the other half worked straight through. At the end of their shifts, study participants took a variety of tests including a simulated 40-minute drive. Those who had not napped—but were instead sleep-deprived—turned out to be dangerous drivers. According to the researchers, the non-nappers crashed “over and over again.” The nappers did much better when it came to memory, dexterity, and mood as well. They outranked the non-nappers on a written memory test and a simulated insertion of an intravenous tube. Both groups even took a test designed by NASA that measured different mood states like confusion, fatigue, anger, and vigor. On the test, the nappers showed fewer performance lapses, less fatigue, and more vigor.
Both sleep deprivation and alcohol intoxication make driving more dangerous. Combining the two is especially dangerous.

Pre-Traumatic Stress Disorder

NORFOLK, VA—Pre-traumatic stress disorder, a future-combat-related psychological condition previously thought to afflict only young soldiers drafted against their will, is now found in growing numbers among National Guard members, Army, Navy, Marine, and Air Force reservists, semi-retired officers, and the newly recruited, according to a government study released Monday.
"When soldiers are put in the extreme situation of facing the possibility of large-scale death and shocking violence, many experience sleeplessness and outbursts of anger," said Walter Reed Army Hospital psychologist Capt. Sidney Mullenthauer. "We're seeing more victims experience vivid, ultra-realistic flash-forwards of roadside bombings that tear through a group of innocent children, or rocket attacks on their convoys that leave fellow soldiers charred and smoldering."
The study, conducted by the Department Of Future Veterans Affairs, found that 80 percent of part-time soldiers reported no signs of Pre-TSD while carrying out their obligatory one weekend of duty a month, but quickly developed severe symptoms upon receiving orders for active combat.
In addition, a significant number of those who will enter a war zone say they are plagued by repeated visions of atrocities, torture, and the CNN logo.

Risperidone approved for autism

The Food and Drug Administration has approved risperidone for treatment of irritability associated with autism. This approval addresses aggression, deliberate self-injury, and temper tantrums in children aged 5 years and older, and in adolescents.
In an interview, Dr. Christopher J. McDougle characterized the FDA approval as a major development. “There is no drug currently approved for autism, so it's a tremendous breakthrough,” said Dr. McDougle, the Albert E. Stern Professor and chairman of the department of psychiatry at Indiana University, Indianapolis.
The new indication is based in part on a multicenter, randomized, double-blind study that showed significant behavioral improvements among 49 children treated with risperidone, compared with 52 given a placebo (N. Engl. J. Med. 2002;347:314–21). Researchers assessed response using the Irritability Subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions-Improvement Scale. There were 33 responders in the risperidone group and 6 responders in the placebo group.
In an open-label, 8-week follow-up study, the 46 nonresponders to placebo were given risperidone, and 30 responded. Researchers then monitored all responders and demonstrated that the benefit of treatment persisted for these patients out to 6 months (Am. J. Psychyiatry 2005;162:1361–9). The authors added, however, that discontinuation after 6 months “was associated with a rapid return of disruptive and aggressive behavior in most subjects.”
These studies were sponsored by the National Institute of Mental Health. The benefit of treatment persisted out to 6 months in the 63 of the children who had a positive response at 8 weeks.
Dr. McDougle emphasized that the approval is not for treatment of autism across the board. “It's important for people to realize the drug is approved for associated symptoms—not the core social and communication symptoms,” he said.
The percentage of pediatric patients with autism who display aggression, deliberate self-injury, and/or temper tantrums is probably in the range of 20%–30%, Dr. Scahill said. He characterized that range as sizable.
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I have several adult patients with autism, and have found risperidone effective for treating their hyperactivity and self-injurious behavior.

Doctors are like Convicts

"They make you feel like a convict" is what doctors say about the people, commissions, agencies and departments we must answer to, every month, for the rest of our lives, or be stripped of the right to practice medicine (as well as the ability to earn a living). Every doctor lives under continuous scrutiny from federal, state, hospital, insurance company, specialty board, medico-legal, and professional conduct organizations. Hundreds of pages of forms must be filled out, hundreds of thousands of dollars spent, hundreds of hours of study and examination must be completed every year — just to stay in practice — and that's after Board Certification, a process at then end of ten years of intense training, study, work and examination.
Each of these burdens is placed on the doctor in the name of "protecting the public", but everyone in the medical business knows the plain truth: that not one of these actually helps us treat patients, not one makes us better doctors. You become a better doctor when you notice patterns, when you get out of your own way enough to hear real complaints and treat them. You might scrub in with a friend who does a new procedure, go to an interesting course (the good ones often don't give CME — mandated continuing medical education — credits) or you might become a better doctor in your room at night with your old books that you see in a new light because you've seen a certain case that day. Every doctor knows this: however it happens, professional growth does not take place via "administrative compliance." The public is not protected at all by these things. What they do protect is the livelihood of an entire class — the millions who make their livings in the public and private "administration" of American medicine. Do I want to feed my little girl to this beast? I don't think so.

Democrats hate Mississippi

A Mississippi congressman says Rep. Charles Rangel of New York owes the southern state an apology, and he asks if insults are what Mississippi should expect when Democrats take over leadership in Congress.
Rangel, a Democrat, was quoted in The New York Times on Thursday saying: "Mississippi gets more than their fair share back in federal money, but who the hell wants to live in Mississippi?"
Rangel said he didn't intend to insult the state, but Rep. Chip Pickering, R-Miss., issued a sharp statement criticizing the choice of words.
"I hope his remarks are not the kind of insults, slander and defamation that Mississippians will come to expect from the Democrat leadership in Washington, D.C.," Pickering said.
via Drudge
the image is from this website.

Gov gives with one hand and takes away with the other

On November 1, the Centers for Medicare and Medicaid Services (CMS) issued its final rule for the 2007 Physician Fee Schedule. The rule increases Medicare relative value units (RVUs) for office visits and other undervalued evaluation and management (E/M) services. The RVUs are one of the factors that Medicare and many other payers use in setting their pay rates. The RVU increases will result in Medicare paying approximately $4 billion more for E/M services than it has in the past. CMS’s decision to increase the RVUs was due in large part to the College’s efforts, supported by other physician organizations, to document that the typical complexity and work involved in these services has increased substantially.
Regrettably, though, the initial beneficial impact for patients that result from paying more for personalized, primary care services will be undermined because of Congress’ inexcusable failure to act to avert a 5 percent cut mandated by the flawed sustainable growth rate (SGR) formula. In fact, CMS now projects that the SGR cut will more than cancel out the 2007 dollar improvements internists would have received from the RVU increases.
The 5 percent payment cut results from the SGR formula, which was created in 1997 and ties physician payment to growth in the overall economy. When growth in physician expenditures exceeds growth in the economy, the difference is subtracted from physician payments. This results in an across-the-board cut in Medicare payments to physicians.
The College agrees with CMS that by paying physicians more for the time they spend talking with patients about their health care and by emphasizing personalized care, patients will benefit from better outcomes and more efficient use of resources. The College also believes that the improved RVUs, if not offset by the Medicare SGR cut , would begin to address long-standing inequities in how Medicare pays for services that are contributing to the imminent collapse of primary care medicine in the United States.
One result of the SGR cut is that many internists, who are already struggling to keep their practices open, will find that Medicare payments will continue to fall behind their costs. A new 2006 randomized survey of ACP’s membership found that if a 5 percent cut goes into effect, 27.6 percent of those surveyed will decrease the number of new Medicare patients accepted into their practices; almost 40 percent of those who are self-employed or in private practice reported that they would decrease the number of new Medicare patients they would accept . Other specialties will experience even larger reductions in Medicare payments, which will also lead to reduced beneficiary access.
It is not too late, however, for Congress to act to avert the SGR cut and assure that internists and your Medicare patients get the full benefit of the RVU increases for E/M services.
Congress will be returning in a matter of days for a post-election “lame duck” session to complete action on “must pass” legislation before adjourning for the year. We need your help to assure that legislation to halt the SGR cuts is among those “must pass” bills.
We ask you to help us prevail upon each and every member, including those in the congressional leadership and on Medicare authorizing committees, to enact legislation to:
Halt the 5 percent cut in Medicare payments that will result from a flawed SGR formula and replace it with a positive update, and
Support implementation, without delay, of CMS’s final rule to increase Medicare relative value units (RVUs) for office visits and other undervalued evaluation and management (E/M) services.
Each and every member of Congress is critical – we need your help today. Time is of the essence as Congress will reconvene this coming Monday, November 13 and may only remain in session for a few days. Please take a few minutes and use ACP’s Legislative Action Center (LAC) to contact your members of Congress, http://www.acponline.org/lac . [To logon, use your email address as the username and ACP as the password, unless you’ve personalized it.] A sample message is available for you to personalize and forward to your federal lawmakers. Different messages are posted for medical students, associate members, and internists. Even better, please take a few minutes to call your members of Congress in their Washington offices. Use AMA’s toll-free grassroots hotline at 1-800-833-6354 and press 1, then enter your zip code and ask for the member’s health legislative aide. If you have problems, please contact Tracy Novak at tnovak@acponline.org or by phone at 800-338-2746 ext. 4532.
Many thanks to those of you who contacted your legislators previously this year but I urge you to contact them again now. Many of you were told by your lawmakers that they would fix the SGR problem after the elections – we must hold them to that promise. Without immediate Congressional action, primary care will suffer and the intended improvements for patients that would result from emphasizing the value of personalized, primary care will not be realized. We work too hard to provide the best care possible to our patients – we can’t let Congressional inaction change the paradigm. Thank you in advance for your help.
Lynne Kirk, MD, FACPPresident, ACP