FDA Asks for Voluntary Recall of Popular Generic Antidepressant

J B Reed/Bloomberg News(NEW YORK) -- The FDA's reversal earlier this week of its approval of a generic equivalent of the popular antidepressant Wellbutrin XL 300 ends a five-year saga that began with consumer complaints and a crusade by Joe Graedon, the co-founder of the consumer advocacy group the People's Pharmacy.

In 2007, Graedon began receiving disturbing complaints on his website from patients who had been taking the 300 mg dose of Wellbutrin and had recently switched over to the generic equivalent Budeprion XL 300. Budeprion products are sold by Teva Pharmaceuticals and made by Impax Laboratories, both headquartered in Philadelphia.

"People were saying, 'I've been on Wellbutrin for several years and things were fine and dandy, but once I was switched I started experiencing headaches, anxiety, depression and sleeplessness,'" he said. "People who had never been suicidal were all of a sudden reporting suicidal thoughts."

At first Graedon said he was skeptical. But after he had received a few dozen messages, he decided to write about it in his syndicated newspaper column. That's when the floodgates opened: Soon more than a thousand messages poured into the People's Pharmacy website describing the same symptoms, in intimate detail.

Alarmed, Graedon contacted Consumer Lab, an independent testing group based in White Plains, N.Y, and asked them to evaluate the 300 mg dose of the generic pill. The findings of the Consumer Lab tests suggested that while the active ingredient in the generic Budeprion XL 300 mg and brand-name Wellbutrin XL 300 mg products was identical, the rate at which it was released differed.

"In the first two hours of a dissolution test, we found Budeprion released 34 percent of the drug, while Wellbutrin released eight percent. At four hours, the Teva product released nearly half of its ingredients, while original Wellbutrin released 25 percent. The generic did not act like a once-a-day formula but more like an immediate release formula," Dr. Todd Cooperman, Consumer Lab's president, stated.

Cooperman said the problems arose because of an unusual circumstance where the patent on the drug itself had expired, making it available in generic form, but the time-release mechanism used in the original did not. The original pill has a membrane so that the drug seeps out over time. The Teva pill simply breaks apart.

Consumer Labs and the People's Pharmacy took their concerns to the Food and Drug Administration and requested information on the human drug trials that companies are typically required to submit for drug approval. After what Graedon described as "a lot of back and forth," the FDA revealed that the 300 mg product had never undergone bioequivalence testing even though this is typical agency protocol. Instead, their approval was based on tests of a 150 mg version of the drug.

Graedon said although it's well understood that different dosages of drugs frequently don't have the same results and can produce varied side effects, the agency stood by its approval of the 300 mg dose of the generic. However, they asked Teva to voluntarily perform its own trials involving people who had reported problems.

Citing difficulty recruiting subjects, the company never performed the tests. Then in 2010, the FDA took the unusual step of conducting its own independent trial of 24 subjects. It found that the maximum concentration of Budeprion XL 300 in the blood reached only 75 percent of the amount Wellbutrin XL 300 released.

"This discrepancy in dosage could render the drug less effective in treating depression and could explain the side effects we were hearing about," Graedon said.

When results of the trials became available recently, the agency sent both Teva and Impax communications asking them to voluntarily withdraw the drug from the market. Both companies have complied with the request.

FDA spokesperson Sandy Walsh stressed that this is not a recall, which is typically done when a drug is unsafe.

"This is a voluntary market withdraw by the company for a drug that may not work well for some people. It is one type of generic Wellbutrin XL in the 300 mg strength only, made by Teva. This does not impact the other manufacturers or the 150 mg strength pills," Wash said.

The agency estimates that only about two percent of people taking a 300 mg dose of a generic version of the antidepressant take the Teva pill. They have asked other manufacturers of generic 300 mg dose versions of Wellbutrin to conduct their own studies and submit their data no later than March 2013.

But is this voluntary recall just the tip of the iceberg? Does it mean there could be other generics in wide use that are either unsafe or ineffective? Dr. Harold Koenig, associate professor of psychiatry and medicine at Duke University said he doesn't believe this is the case.

"Most generics work just fine and are as effective as the name brand. And they are a lot cheaper. So you cannot say, based on what happened with this one drug, that we should throw out all generics," he said.

However, Koenig said he thought the FDA's actions were significant. "It might open up a can of worms if this is the first time the FDA took their own look at the effectiveness of generic versus name brand. It could lead to a lot of other drugs being studied," he said.

For his part, Graedon said he is happy with the result even if it was a long time in coming.

"It took us five years and an awful lot of arm wrestling to help the FDA make this decision, but this is really a historic moment. If you think of prescription drug use in America, generics account for about 75 percent of them, and until yesterday the FDA has maintained they are identical to brand names."

Copyright 2012 ABC News Radio


Botox Helps Control Leaky Bladders

Altrendo Images/Thinkstock(NEW YORK) -- Becky Williams, a 68-year-old office worker from North Carolina, recalls her friends' reaction when she enrolled in a study that proposed injecting Botox into her leaky bladder.

"They said, 'You got to be kidding,'" Williams recounted. "They kind of freaked out.'"

She was nonplussed. "I'm up for a lot of stuff," she added."I didn't have any reservations."

Williams had been living with a leaky bladder for three years, and the condition was getting worse over time. Eventually, she was forced to wear incontinence pads every day.

So when her sister mentioned an ad that was asking for research volunteers with leaky bladders, Williams signed up.

The results of the study in which Williams participated were released Thursday. And it turns out that what's helpful for wrinkles appears to be good for leaky bladders, as Botox might be as good as or even better than standard medications used to treat bladder leakage.

The clinical trial, published in the New England Journal of Medicine, involved nearly 250 women with leaky bladders. Half the women received a Botox treatment to their bladders and a six-month supply of placebo pills. The other half received medication useful for treating leaky bladders and a saltwater injection instead of Botox. Neither the women nor the doctors knew who was getting what treatment.

The researchers monitored their leaky bladder symptoms and treatment side effects. What they found was that, in a six-month period, one Botox bladder treatment worked as well as daily pills to reduce daily bladder leakage. Moreover, women who got Botox were twice as likely to have their leaky bladder symptoms disappear when compared to women who took pills.

Leaky bladders -- also known as urge incontinence -- are caused by an overactive bladder muscle that contracts without warning leading to unexpected urine leakage, said lead study author, Dr. Anthony G. Visco, chief of the division of urogynecology and reconstructive pelvic surgery at Duke University Medical Center in Durham, N.C.

Leaky bladders affect nearly one in five older women across the United States. Women are twice as likely to be affected, compared to men.

Think of the bladder like a water balloon, Visco said. "The bladder itself is lined by a muscle," he said. "When that muscle contracts, our bladders empty."

In leaky bladders, he said, that muscle contracts on its own and unexpectedly.

"Botox works by relaxing or paralyzing that muscle," he said. "We try to use Botox to bring that [bladder muscle] back into balance."

Dr. Erika H. Banks, director of gynecology at Albert Einstein Medical School in New York City, who was not involved with the study, said, "It's impressively effective."

There are side effects, she said, but "if [patients] get relief, then it's worth it."

Despite the positive news from the study, however, Botox for urge incontinence will likely face several hurdles. One issue is that Botox is not approved by the Food and Drug Administration for treating this condition. Another hurdle, Visco said, is the potentially high price tag, which could run hundreds or even thousands of dollars.

"Even though it's a reasonable treatment option," he said, "it's prohibitively expensive for the average person to pay for it at this time."

There are side effects; one in three of the Botox users in the study developed urinary tract infections, and 5 percent of the Botox users needed to temporarily use a catheter to empty their bladders.

"Any treatment that slows the bladder will tend to impair bladder emptying," said Dr. Niall T.M. Galloway, a urologist and chairman for the National Association for Continence based in Charleston, S.C. "Incomplete emptying can lead to urinary infections or retention and the need to catheterize to empty."

And the relief that Botox provides is not permanent. "Like Botox for the face, the effects on bladder function last for six to twelve months for most patients," Galloway said. "So repeated treatments may be needed."

Additionally, some women might balk at the procedure itself, which involves a doctor inserting a lighted scope with a camera and little needle on the end through the natural opening in the urethra. Once inside the bladder, the doctor performs multiple injections on the inner muscle surface.

Williams, however, said that her procedure was "unbelievably pain-free."

During the study, Williams said, her leaky-bladder symptoms pretty much went away and the effect lasted for about a year.

"It was wonderful," she said, adding that seeking help for her leaky bladder changed her life. "I would tell anybody that has an opportunity to get treatment for it."

Copyright 2012 ABC News Radio


Rare Fungal Meningitis Outbreak Grows

Hemera/Thinkstock(WASHINGTON) -- A rare form of fungal meningitis has killed five people and sickened 30 across six states, and more are expected, health officials said today.

The outbreak of aspergillus meningitis has been linked to spinal steroid injections, a common treatment for back pain. A sealed vial of the steroid, called methylprednisolone acetate, was found to contain fungus, according to the U.S. Food and Drug Administration.

"FDA is in the process of further identifying the fungal contaminate," said Dr. Ilisa Bernstein, acting director of the FDA's Center for Drug Evaluation and Research Office of Compliance. "Our investigation into the source of this outbreak is still ongoing."

The steroid came from the New England Compounding Center in Framingham, Mass., a specialty pharmacy that has recalled three lots of the drug and shut down operations. Calls to the pharmacy were not immediately returned and their website is down.

Twenty-five of the meningitis cases -- three of them lethal -- have been in Tennessee, where more than 900 residents received the drug in the past three months.

Cases have also been reported in Virginia, Maryland, Florida, North Carolina and Indiana.

Roughly 75 clinics in 23 states that received the recalled lots have been instructed to notify all affected patients.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said Dr. Benjamin Park of the U.S. Centers for Disease Control and Prevention, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea and slurred speech, are subtler than those of bacterial meningitis and can take nearly a month to appear. And if left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn. "There's no such thing as mild aspergillus meningitis."

The disease is diagnosed with a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

Unlike bacterial and viral meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

The FDA has, however, advised health providers to stop using any product made by the New England Compounding Center during the investigation.

"We're urging clinics to discontinue use of all products from the New England Compounding Center," said Bernstein, adding that purchase records can be used to identify the suspect products. "Given the severity, we believe this precaution is warranted."

The outbreak has raised questions about the safety of drugs from state-regulated compounding pharmacies, which combine drug ingredients for customized medications.

The U.S. Food and Drug Administration warned the New England Compounding Center in 2006 that repackaging drugs opens the door to contamination.

"The moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed and previous studies supporting the standard are compromised and are no longer valid," the agency wrote in a letter to the pharmacy.

"The agency did issue a warning letter to the pharmacy in 2006, but it didn't address compounding problems that are at issue today," said Kathy Anderson, acting director of the FDA's Office of Unapproved Drugs and Labeling Compliance.

Copyright 2012 ABC News Radio


A's Pitcher Mourns Death of Child, Autopsy May Give Clues

J. Meric/Getty Images(OAKLAND, Calif.) -- Oakland A's baseball pitcher Pat Neshek, whose team was on its way to taking the American League West title from the Texas Rangers, witnessed the birth of his newborn son in Florida -- calling it "the sweetest play off birth of my career."

But 23 hours later that joy turned to tragedy when the baby died of no apparent cause.

The wrenching story went online in real time as Neshek tweeted first his excitement of the birth and then the death Wednesday of their seemingly healthy 8-pound, 5-ounce son, Gehrig John Neshek.

"Please pray for my family," he wrote on Twitter with an accompanying photo of mother and son. "Tonight my wife and I lost our first and only son 23 hours after he was born with no explanation."

"This happens sometimes," said Dr. Edward Bell, professor of pediatrics and director of neonatology at the University of Iowa, who is not involved with this case. "Fortunately, it's very rare."

"I don't know the circumstances, but it's pretty unusual to find a baby dead in the bassinette in the hospital because usually the parents or the nurse notice something and the baby gets transferred to intensive care," said Bell. "I don't know if anything like that happened in this case."

"It's going to be important to have an inquiry into what may have precipitated the event," he said. "That may be very helpful for the parents if they are looking for answers -- if not spare them the heartbreak. But at least it will give them some idea of why it happened."

It was not immediately clear if the death occurred in the hospital, where newborns are usually kept for 24 hours, or at their home after an early release.

The first step in getting answers will be to "look back and find clues," said Bell. "They will start with the where and when and how did it happen – what was going on. Was the baby at home or at the hospital? What happened just before he died."

"There are a lot of things that can threaten the life of a newborn, including birth defects, infection, genetic disease and even unfortunate things like accidents and suffocation," he said.

Doctors say that there has been a move toward early discharge but hospitals generally prefer not to send the baby home before 24 hours because of these types of cases.

"It's hard to know anything without more information," said Dr. Ian Holzman, chief of neonatology at Mount Sinai Hospital in New York City. "We need to know where the baby was found dead. Babies can have obstructed airways feeding or being put down wrong way."

"Of course, we don't want to blame the parents," he said. "It's horrible what the parents are going through."

Even a child born with birth defects can look normal at delivery, according to Holzman. Congenital heart defects may not be picked up at first. "There can be genetic reasons why a baby all of a sudden dies, but it's very rare."

Neshek, 32, had been given leave from the A's to attend the birth and missed the team's dramatic winning games. He has been a Major League pitcher since 2006.

He runs his own website and is also an avid blogger.

Pat Neshek last pitched for the A's on Sunday. The former Twins reliever had a 1.92 ERA in 19 2/3 innings for Oakland this season. The A's are set to face the Tigers in the ALDS beginning on Saturday.

Copyright 2012 ABC News Radio


Surgeons Report Progress Against Dangerous Hospital Infection

Pixland/Getty Images(CHICAGO) -- Surgeons have found a new treatment that may help put a stubborn hospital-acquired infection on the run.

Hospitalized patients are at risk for developing healthcare-related infections, and one of the most dreaded is Clostridium difficile colitis, a virulent bacteria that affects about 336,000 patients per year, causing diarrhea, fevers, and occasionally sepsis and death.  It is easily passed around the hospital, especially since it is one of very few bacteria that cannot be killed by the alcohol-based sanitizers that are fixtures in every hospital for hand hygiene.

There has never been any medical treatment available to prevent this infection.  But in findings presented Thursday at the 2012 Annual American College of Surgeons Clinical Congress in Chicago, surgeons report success using a medicine called intestinal alkaline phosphate (IAP) to prevent C. difficile infections in tests on mice.

“According to the CDC [Centers for Disease Control and Prevention], C. difficile is linked to about 14,000 U.S. deaths every year,” says Dr. Richard Hodin, a surgeon at Massachusetts General Hospital and the principal investigator of the study.  “Estimates are that we spend at least $1 billion in extra costs to the health care system due to C. difficile, and probably a lot more.”

The bacteria may live naturally in the colon and is kept in check by the rest of the natural, “good bacteria” in the gut.  But occasionally, when patients are given antibiotics, may of the “good bacteria” get killed off and the C. difficile takes over, causing symptoms like diarrhea, fever, abdominal pain and colitis.  While antibiotics typically can treat the bacteria, an unrecognized infection may progress to a dangerous disease called toxic megacolon that requires emergency surgery and a removal of the entire colon.

“The paradox is that it is caused by antibiotics, but antibiotics don’t always work to cure it,” says Dr. Angela Moss, a surgery resident at Massachusetts General Hospital and one of the co-authors on the study.  “Then it becomes a life-threatening problem.”

Unfortunately, because C. diff may be lying dormant in any person’s colon, almost every patient on antibiotics can be at risk for C. difficile colitis.  Researchers therefore have been searching for a way to prevent this infection before it starts.

In the study, Hodin and colleagues found that giving IAP to mice on antibiotics resulted in a 10-fold decrease in C. difficile bacteria in their stool, as well as a 10-fold decrease in an inflammatory marker called IL-1.

“We were surprised to find that this naturally occurring enzyme was a regulator of the gut flora,” says Hodin.  “If this works in humans, like it does in mice, then we think it could be used as an oral supplement in almost all patients who are taking antibiotics.”

Fortunately, IAP is a naturally occurring gut enzyme, so it is likely completely safe to take.  A previous study using IAP in patients showed no side effects.  Researchers are hopeful that clinical trials in humans can soon begin, allowing progress to be made on preventing this dangerous infection.

Copyright 2012 ABC News Radio


Spa Cosmetic Procedures Can Be Risky

WPLG/ABC News(NEW YORK) -- A Florida woman's quest for more youthful skin turned deadly this past July when her face became dangerously swollen after she received vitamin injections at a day spa.

Isabel Gonzalez paid nearly $900 for "facial rejuvenation" injections at Viviana's Body Secrets Spa in Doral, Fla.  After receiving the treatments, her face started to swell and became infected, and she soon landed in the hospital for more than two months.  Doctors fear her face may be permanently deformed.

According to the Doral police department arrest report, the spa owner, Viviana Ayala, was arrested this past week on a slew of charges including aggravated battery and practicing medicine without a license.  Ayala wasn't trained or certified to deliver facial injections and has denied all charges through her lawyer, Milena Abreu.  She wasn't even a licensed massage therapist as she advertised on her website.

Experts are alarmed at how often this scenario has been repeated.  According to the organization Cosmetic Plastic Surgery Research, more than eight million people underwent cosmetic treatments to freshen up their appearance last year.  Treatments included Botox, chemical peels and laser skin resurfacing, and consumers might not be aware of the risks.

"Cosmetic procedures are now so mainstream there's a misperception that it's like getting your hair done," said Dr. Leo R. McCafferty, a board certified plastic surgeon who is president of the American Society for Aesthetic Plastic Surgery.  "They are inherently safe, but this is predicated on [their] being delivered by properly trained professionals in a properly equipped facility."

ASAPS recommends that cosmetic procedures be performed only by board certified plastic surgeons or dermatologists in an accredited facility, although some states also allow registered nurses and physician's assistants to deliver therapies under doctors' supervision.  Members of the ASAPS, and similar professional organizations, are required to operate only in certified centers or hospitals.

Some spas meet these criteria, but even if a facility brands itself a "medispa," that's no guarantee of proper oversight.  A clinic may claim it's affiliated with a board certified plastic surgeon, but a surgeon might only show up to check charts once a month.  Or a spa may try to pass off a practitioner who has no medical training as a cosmetic surgeon.  Although this is illegal in some states, McCafferty said, no one's really checking.

Dr. Nima Patel, a plastic surgeon at Maimonides Medical Center in Brooklyn, N.Y., said spas can mislead consumers in other ways, too.

"Most people know they probably shouldn't get an injection from the same person who gives them a massage but don't think twice about letting a dentist or a physician who doesn't have intensive training in a cosmetic specialty give them an injection," she said.  "In some spa settings, this is who is delivering the services."

Patel also emphasized the importance of making sure the attending professional maintains privileges at a nearby hospital and remains on the premises when cosmetic procedures are done.  If there are side effects or complications, a patient can be transferred to the emergency room.

Copyright 2012 ABC News Radio


Man Loses 100 Pounds in Four Months: What’s His Secret?

Photodisc/Thinkstock(NEW YORK) -- You could say Edwin Velez is a man on a mission.

After looking at photos of himself from a cruise to the Bahamas with friends last November, the 26-year-old from Albertville, Ala., knew he needed a drastic lifestyle change.

With nearly 300 pounds on his 5-foot-6 frame, Velez made a vow to himself that he would be in better shape in time for his next planned vacation the following March.  But he didn’t just plan to get in shape, he set the almost seemingly impossible goal of losing 100 pounds in those four short months.

“It was almost as what we call cold turkey,” Velez told ABC's Good Morning America.   “I woke up one morning and I was like, ‘I’m going to do this.  I’m going to do this now.'”

“I would go to the local track and start walking in the morning, and go that afternoon, every day,” he said.  “I went to the track because [I was too] self-conscious to go to the gym…so I just would go to the track by myself and I started there until I felt comfortable enough to go to the gym.”

Velez says he walked from light pole to light pole around the track to keep himself motivated and moving forward.  As the pounds dropped off he began to jog and then, once he got in the gym, added weightlifting and abdominal work to his workout.

Velez also changed his diet, going from the sweets and the Hispanic food native to his heritage to avoiding food that was white in order to lower the carbohydrates in his diet, and also eliminating sugary drinks and anything carbonated.

“Being Hispanic made it extremely difficult because rice and beans and tortillas and breads and pastas are big part of our food,” he said.  “And with it being the holidays, right around Christmas, I made my own meals and went and bought my own food, like grilled chicken and fish, so my family would have their food and I had my food.”

Velez made it through the holidays and in March, just a few days before he left for his planned vacation to Puerto Rico, he stepped on the scale again.  This vacation, he weighed just over 100 pounds less, reaching his goal and then some.

“I would say the switch from drinking nothing but water was, like, the first 10 to 15 pounds and that came off probably within the first two to three weeks,” Velez told GMA of his rapid weight loss.   “Adding the cardio to it -- which, to me, unless you sweat, it’s not a workout -- on a daily basis really helped with the weight loss, as well as watching what I ate.”

Today, nearly a year later, and on the eve of his 27th birthday, Velez weighs 155 pounds and has maintained his healthy lifestyle.  He even started his own blog to document his progress and help others achieve the same.

“I worked super hard to get it off so I’m going to work super hard to keep it off,” he said.  “It’s not a diet, but it’s more of a lifestyle change.  My body is used to eating healthy so I choose healthy choices.”

Copyright 2012 ABC News Radio


Maternal Hypertension Linked to Lower IQ

Comstock/Thinkstock(NEW YORK) -- High blood pressure during pregnancy can cause low birth weight and early delivery, and a new study suggests it may have lasting effects on the baby's brain.

The Finnish study of nearly 400 men found that those born to hypertensive mothers scored an average of four points lower on cognitive tests later in life.

"Hypertensive disorders in pregnancy predict lower cognitive ability and greater cognitive decline over decades in the adult offspring," the authors wrote in their study, published Thursday in the journal Neurology.

One in 13 pregnant women has high blood pressure, according to the National Institutes of Health.  And while most of them will have healthy babies, hypertension can lead to preeclampsia -- the leading cause of fetal complications.

"It's a fairly serious problem and one we often have to manage in the field of high-risk obstetrics," said Dr. David Hackney of UH Case Medical Center in Cleveland, Ohio.  "If a woman develops preeclampsia, the treatment is to deliver the baby.  But obviously you don't want to do that if it's too early."

Previous studies have linked preterm birth and low birth weight to low IQ in adulthood.  But the new study suggests high blood pressure may be the earlier instigator.

"Our results may also offer mechanistic insight into why short length of gestation and small body size at birth are linked with lower cognitive ability, as hypertensive disorders are among the key reasons for prematurity and intrauterine growth restriction," the authors wrote, adding that the "propensity toward lower cognitive ability has its origins in the prenatal period, when the majority of the development of brain structure and function occurs."

Although hypertension during pregnancy can be managed with certain drugs, Hackney said women of childbearing age should eat healthy and stay active to lower their risk.

"It's important to remain healthy through early life and maximize health prior to becoming pregnant," he said.

The National Institutes of Health also recommends limiting salt intake, maintaining a healthy body weight and getting good prenatal medical care.

Copyright 2012 ABC News Radio


Student Who Got 'Gay Cure' Sues California Over New Law

Comstock/Thinkstock(SACRAMENTO, Calif.) -- A college student who claims he once had same-sex attractions but became heterosexual after conversion therapy has filed a lawsuit against California, which has enacted a law that bans so-called "gay cures" for minors.

The lawsuit, also joined as plaintiffs by two therapists who have used the treatments with patients, alleges that the law banning the therapy intrudes on First Amendment protections of free speech, privacy and freedom of religion.

The student, Aaron Blitzer, who is studying to be a therapist in that field, said the law would prevent him from pursuing his career, according to court papers filed Monday in the U.S. District Court for the Eastern District of California.

The lawsuit names as defendants California Gov. Jerry Brown, as well as 21 other state officials, including members of the California Board of Behavioral Sciences and the California Medical Board.

The other plaintiffs are Donald Welsch, a licensed family therapist and ordained minister who operates a Christian counseling center in San Diego; and Dr. Anthony Duk, a psychiatrist and practicing Roman Catholic.

Both say the law would restrict their counseling practices, according to the lawsuit.

"It's an egregious violation of the rights of young people feeling same-sex attraction, and of parents and counselors who feel it would be beneficial for the individual needs of a young person," said Brad Dacus, president and attorney for the conservative Pacific Justice Institute, which asked a federal judge to prevent the law from taking effect.

"The legislature had an errant assumption that every individual struggling with same-sex attraction is caused by their DNA," he said. "It ignores thousands, including the plaintiff, who have gone through therapy and are now in a happy and healthy heterosexual relationship."

Dacus declined ABC News' request for direct access to the plaintiffs.

Just this week, California lawmakers voted to outlaw therapy aimed at changing the sexual orientation of minors who say they are gay, making California the first state to adopt such legislation. The law is set to go into effect Jan. 1, 2013.

The bill's sponsor, California state Sen. Ted Lieu, said the therapy -- called "conversion therapy," "sexual orientation therapy," "reparative therapy" or "sexual orientation change efforts" -- amounts to "psychological child abuse."

"I read the lawsuit and, as a matter of fiction, it is a good read," Lieu said in a prepared statement after the suit was filed. "But from any reasonable legal standard, the lawsuit is frivolous. Under the plaintiffs' argument, the First Amendment would shield therapists and psychiatrists from medical malpractice and psychological abuse claims simply because they use speech in practicing their medicine. That is a novel and frivolous view of the First Amendment."

Lieu is not named as a defendant in the lawsuit.

Several members of the California Board of Behavioral Sciences and the California Mental Board were named in the lawsuit.

"Our board voted to support that piece of legislation after working with the author's office to further define sexual orientation change efforts," said Kim Madsen, executive officer for the sciences board, which licenses and oversees therapists.

She had no comment on the lawsuit, but said the board would investigate any complaints of conversion therapy after Jan. 1.

The law's critics say that it infringes on the rights of families and therapists, particularly young people who have same-sex attractions as a result of being victims of sexual abuse.

Dacus said the law makes them "victims twice, as a result denying them counseling and healing."

He said that counseling in "direct violation" of religious or personal beliefs "only precipitates greater confusion and depression and the likelihood of suicide."

"This legislation is a classic example of psychiatric ignorance combined with political neglect," he said, complaining of "compromises" that members of the California Psychiatric Association made with state legislators to enact the law.

"They clearly say that one size fits all and ignore the complexity of same-sex attraction and varying degrees of such attraction, depending on age and background," said Dacus. "It's out of place for the legislature to put such restrictions on it."

Members of the California Psychiatric Association have "mixed feelings" about the law, according to Randal Hagar, director of government relations for the organization.

"There is no psychiatrist who would engage and practice it and, if they did, they would be subject to ethical sanctions," he said.

The American Psychiatric Association has outlawed conversion therapies for more than a decade, insisting they are harmful.

On the other hand, said Hagar, the CPA is concerned about any bill that "basically prescribes any kind of treatment" or one that might lead "downstream" to someone legislating against another practice "they don't like."

"The difference here is that there is a very strong public policy argument that says why this practice ought to be limited," he said. "There is no evidence it does what it purports to be. It is, in essence, fraud ... and there is other evidence that it does harm. It concerns us greatly."

The CPA negotiated for months with legislators to hone language on the bill so that therapists could address "legitimate" talks on sexual orientation and gender identity issues, according to Hagar.

"We were wary of a form of the bill where they can't possibly engage in a discussion," said Hagar, who noted that the association supported the final version of the bill.

They also leaned on another precedent: Electroconvulsive shock therapy is highly regulated with judicial oversight.

"You can't give it to minors -- period," he said.

"I think the bill is clear and clean and did have a definition of supportive exploratory therapy that leads [minors with same-sex attractions] to be accepting and see themselves as a person of strength rather than a flawed person," he said.

Copyright 2012 ABC News Radio


Hormone Therapy Study Has Doctors Buzzing

Medioimages/Photodisc/Thinkstock(ORLANDO, Fla.) -- Medical experts are buzzing about a new hormone therapy study that shows short-term estrogen and progesterone treatment is safe for some menopausal women -- and the study data isn't even out yet.

Results from the Kronos Early Estrogen Prevention Study, or KEEPS, will be presented Wednesday night at the North American Menopause Society's annual meeting in Orlando. Researchers reported finding that hormone pills and patches relieved patients' symptoms, such as hot flashes and night sweats, but didn't necessarily increase their risk of heart problems, as other studies have shown.

"We're so excited about results that are going to be released in just a few hours," NAMS Executive Director Dr. Margery Gass said from Orlando. She said the KEEPS data is preliminary and the paper hasn't been written yet, but doctors all around her are talking about the summary they've seen. "This study, however, is looking more at the immediate effects of hormones on quality of life issues and then markers of chronic disease... It's not the final results, such as broken bone, a heart attack or a stroke because those things don't really happen that much in this age group."

Findings released to the media this week in a press release include that the hormone therapy did not affect blood pressure or hardening of the arteries, and it had a neutral or positive effect on cholesterol. However, when ABC News requested the data behind these conclusions, KEEPS officials said it was not available.

Although some doctors are convinced KEEPS results will change current guidelines, which recommend as little hormone therapy as possible, others think the study is too different from previous studies to confirm hormone therapy is safe -- particularly in the long run.

Most notably, KEEPS follows the ongoing Women's Health Initiative study, nicknamed WHI, which looked at 160,000 women ages 50 to 79, but was halted in 2002 when researchers found that patients taking progestin and estrogen were more likely to develop aggressive breast cancer. Researchers released follow-up results of WHI as recently as 2010. By contrast, KEEPS was a four-year study of 727 women between the ages of 42 and 58.

"The results are not surprising, particularly as they contrasted to the results of the WHI," said Dr. William White, president of the American Society of Hypertension. "The dose of estrogen is lower than what was used in WHI, the patient population is younger and at low [cardiovascular] risk. Hence, it is good news that low dose estrogen replacement can be safe and effective for women recently undergoing the menopause for up to four years of treatment."

Dr. JoAnn Mason, chief of preventative medicine at Brigham and Women's Hospital in Boston, was one of the KEEPS authors. She said KEEPS does not challenge WHI, but "addresses entirely different questions." She said the trial was too small to make conclusions about whether hormone therapy increases patients' risk of heart problems or cancer.

"The WHI tested the role of hormone therapy in predominantly older women," Mason said. "In KEEPS, women were much younger… and many favorable effects of hormone therapy were found in the newly menopausal women participating in KEEPS."

Medical experts said they are comfortable prescribing hormone therapy in the short term, but the long term still caries cardiovascular risks.

"I would stick with the recommendation that short term HT is a reasonable option to consider if she had moderate to severe symptoms up to five years," said Dr. Jacques Rossouw, chief of the Women's Health Initiative branch of the National Heart, Lung, and Blood Institute. "[It] should not be considered longer term or in older women for prevention of cardiovascular disease."

Several doctors said the study is reassuring to women already on hormone therapy. There were 38 million women in 2010, according to IMS Health. Most prescriptions, 26 million, were for estrogen-only products, but 5.2 million were for progestin-estrogen products, and 5.3 million were for progestin-only products.

"These findings WILL change guidelines," Dr. Katherine Sherif, director of the Drexel Center for Women's Health, wrote in an email. "The pendulum is swinging back to the middle, partly due to women who benefit from hormones."

Wolf Utian, who founded and heads the National American Menopause Society, called the study the "foil to consistent negative statements" on hormone therapy, and emphasized the quality of life data in the study.

The preliminary findings are being announced in Orlando.

Copyright 2012 ABC News Radio

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