Site Changes

We are in the process of making some Design Changes to the site. Don't worry, many of the special links and other resources will return shortly are still there, but now along the left side. as soon as we figure out some of the new features.

One of the things we wanted was the list of labels, and a better way of showing the archives.

So hopefully this is all for the better

Victoria MD wins prize for theories on megavitamins

From the Victoria Times Colonist

A retired Victoria psychiatrist who helped develop a mega-vitamin therapy for schizophrenia and other illnesses half a century ago was recognized with a $125,000 prize in alternative medicine this week.

"I was really quite surprised," said Dr. Abram Hoffer, 90. "It was like the Oscars. I had no idea I was going to win."

The judges of the first Dr. Rogers Prize for Excellence in Complementary and Alternative Medicine wrote: "His stubborn pursuit of non-toxic orthomolecular [megavitamin] approaches to mental and physical disorders has helped thousands of patients with conditions ranging from schizophrenia to cancer."

Hoffer, who worked with mega doses of niacin and vitamin C, attracted praise but says his relationship with the College of Physicians and Surgeons "wasn't friendly." Hoffer recalls being attacked in journals and the media by skeptical medical colleagues, although his hypothesis that mega-doses of vitamins could help treat the symptoms of schizophrenia was later advanced by Nobel Prize-winning physician Dr. Linus Pauling.

Although he no longer practises medicine, the author of about 30 books and 600 papers in medical journals says he is still busy consulting, writing and researching.

One of six children, Hoffer was born on a Saskatchewan farm in 1917 and completed his first degree in agricultural chemistry. His master's and PhD in biochemistry were based on research into the vitamin content of cereals, and his focus soon shifted to human nutrition.

Armed with a medical degree from Toronto, he became director of psychiatric research for Saskatchewan in 1950.

He'll never forget his time practising at three psychiatric hospitals in Saskatchewan. "It was absolutely awful and once you got in, you never got out," he said in a phone interview yesterday.

Half the 5,000 mental patients in Saskatchewan were schizophrenics, and at the time, experts blamed the illness on a host of causes, including homosexuality, masturbation, colon infection and more.

Hoffer was given the job of director of psychiatric research, and with a "free hand," spearheaded the use of mega-vitamin therapy.

He was joined by British-born research psychiatrist Dr. Humphrey Osmond, and the two became psychedelic pioneers -- and guinea pigs -- bent on discovering why hallucinogens created symptoms resembling schizophrenia.

The team's first breakthrough came when they developed a theory that people who undergo stress sometimes produce excess adrenaline, which oxidizes into adrenochrome. The latter chemical has psychedelic properties they suggested could induce schizophrenia.

Next, he theorized that niacin (vitamin B-3) could counteract the oxidation of adrenaline into adrenochrome, protect brain receptors and reduce adrenaline stress. B vitamins are now commonly referred to as stress-busters, but back then, the theory was revolutionary. Hoffer himself has taken three grams a day for 50 years.

"It keeps me alive, active and busy," he said, noting the amount of niacin in the average multivitamin is insignificant.

Hoffer then came up with the idea of combining niacin and the antioxidant vitamin C.

Hoffer will share a $250,000 prize pot with Dr. Alastair Cunningham of Toronto, creator of The Healing Journey, a non-profit program that helps cancer patients use relaxation and mental imagery to cope with the disease.

The two were selected from a field of 57 nominees by an independent jury of international medical experts.

While the judges had hoped to settle on a single winner, Hoffer said his prize should be shared with all the colleagues who worked with him throughout the years and the patients who allowed him "to get them well using vitamins."

California Attorney General Jerry Brown Statement Regarding Search Warrants Executed on Psych Khristine Eroshevich in the Death of Anna Nicole Smith

From the Website of the California Attorney General, Which also includes video in several formats.

Audio/Video for this Release

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Statement From California Attorney General Edmund G. Brown Jr. Regarding Search Warrants Executed Today In Connection With The Death Of Anna Nicole Smith:

“The California Department of Justice today served search warrants at various doctors’ offices, billing locations, and residences in both Los Angeles and Orange Counties, related to the death of Anna Nicole Smith. The locations searched today are related to doctors who provided medical treatment or prescribed drugs for Anna Nicole Smith or her associates.

On March 30, 2007, the California Department of Justice Bureau of Narcotic Enforcement commenced an investigation into circumstances surrounding the death of Anna Nicole Smith, including the prescribing and dispensing practices of several California licensed doctors and pharmacies. To date, agents have reviewed over 100,000 computer images and files, analyzed patient profiles and pharmacy logs and interviewed witnesses throughout the country and abroad.

The California Department of Justice is spearheading this investigation with regulatory agencies, medical professionals and law enforcement agencies, including: The California Department of Insurance, the California Medical Board, the U.S. Drug Enforcement Administration, the Seminole Tribal Police and the Royal Bahamian Police Force.

In view of the fact that the investigation is ongoing, we will not provide further details or report any findings at this time. The California Department of Justice will conduct a fair and thorough investigation and wishes to protect the identity of cooperating witnesses. When our investigation is complete, you will be provided as much information as possible about any suspects, arrests or criminal charges.

Beyond this statement, no one involved in this investigation will have further comment at this time. Thank you for your cooperation.”

Bristol-Myers to pay $515,000,000,000 fine

Via the BBC and other news outlets

US drugmaker Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515m (£251.7m) to settle allegations of marketing certain drugs illegally.

The fines issued by the US Department of Justice mark the end of a probe into the firm's drug pricing practices that began a number of years ago.

[...]

The US DoJ concluded on Friday that the company and a wholly-owned subsidiary called Apothecon had used incentive schemes to encourage doctors and wholesalers to stockpile their drugs and so help Bristol-Myers achieve its sales targets.

This included maintaining "fraudulent and inflated" prices for a wide range of cancer and generic drugs knowing that federal health care programmes established reimbursement rates based on those prices.

Bristol-Myers was also accused of knowingly misreporting its best price for the anti-depression drug Serzone to Medicaid, the government-backed health insurance scheme.

In addition, the DoJ claimed that the company had promoted the use of the treatment-specific anti-psychotic drug Abilify to a wider client base than recommended by the Food and Drug Administration.

"Patients are entitled to unbiased decision-making from their physicians and should not have to worry that financial inducements or lavish entertainment have influenced their physicians' prescribing choices," said Michael Sullivan, the US attorney in Boston.

As part of the settlement, Bristol-Myers said it had entered into a five-year "corporate integrity agreement" with the government healthcare regulator, the Office of the Inspector General of the Department of Health and Human Services.

The agreement is designed to ensure the company adheres to its compliance programs relating to its US pharmaceuticals business.

Outspoken Official Critical of Delaware's Mental Health System Departs Amid Rumors She Was Forced to Leave

Of course, this could all be a legitimate departure for the reasons given. But nobody is talking on the matter, and it looks suspicious. As seen in this report.

An outspoken and well-respected critic of the state agencies responsible for treating the mentally ill -- including the Delaware Psychiatric Center -- is out.

According to the National Alliance on Mental Illness in Delaware, or NAMI, longtime executive director, Rita Marocco, is leaving her position with the advocacy group, "to pursue other interests."

For many patients and their families, Marocco was NAMI in Delaware. Marocco said she has yet to receive official confirmation of her status with NAMI-DE.

As she was preparing to testify Thursday night before a legislative committee investigating patient abuse and retaliation at DPC, several lawmakers told her they'd received a letter from NAMI-DE, which stated she was "leaving NAMI to pursue other interests."

Marocco has repeatedly stressed the need for systemic improvements at the state hospital, which caused several lawmakers to comment about the timing and possible motivations behind her dismissal.

"I've heard rumors that Secretary [Vince] Meconi has been involved, but I have nothing to substantiate that," Marocco told The News Journal.

But Meconi, secretary of the Department of Health and Social Services, said in an e-mail to The News Journal: "I have no information about Ms. Marocco's employment status. I would suggest you check with NAMI."

The News Journal sought to interview all 22 members of the NAMI-DE board of directors. Most refused to comment, or never returned phone calls.

"I'm not at liberty to talk about it," said board member Chuck Tarver.

"She wasn't fired," said board member Mary Berger, who added, "I don't feel comfortable answering questions."

Board member Julius Meisel said Meconi wasn't behind and changes to Marocco's employment status.

"That's bunk," he said. "This is an internal matter. I'm not going to comment further."

John P. Smoots, another board member, said nobody at the state orchestrated Marocco's departure.

"That's absolutely false," he said.

Edward N. McNally, president of the NAMI-DE board of directors, said "the board and Rita had a difference of opinion with regards to management of NAMI's housing operations, particularly our 55 group homes.

"As a result, when we could not reach an agreement on that part, she asked for a severance package and we worked it out."

Marocco presents a different version: "I did not receive the letter from the board, and I have not heard from them as of yet."

McNally said Meconi, whom Marocco has asked to resign, had nothing to do with the board's decision.

"NAMI-DE completely supports everything Rita had to say about the DPC situation," he said.

McNally sent the letter to the legislative committee investigating DPC because he "wanted everyone to understand about who to get in touch with if they had questions."

"What I was trying to do was head off the rumors," McNally said. "There's no tie to Rita's position on DPC."

Board member Janis Chester, a psychiatrist and past-president of the Psychiatry Society of Delaware, said she never witnessed any conduct by Marocco that could have merited discipline, or possible termination.

"She is NAMI-DE," Chester said. "I always saw her as a role model. I had the pleasure of working with her in a variety of settings. I always thought I should be more like her. She can get her message across in a strong assertive way, without ever being impolite. It's such a loss to NAMI. I hope it's not a loss to the mentally ill in Delaware."

"I joined the board and was recruited there because of Rita," Chester said. "She's really been a beacon and has been devoted and capable and irrepressible as an advocate for the mentally ill."

When The News Journal began investigating conditions at the Delaware Psychiatric Center, exposing cases of patient abuse and allegations of rape, Marocco expressed frustration with DPC administrators. She suggested there were coverups as well as shortcomings.

"It's obvious they're not adhering to any standards known to good-quality care," she said at one point. "What we expect from a psychiatric hospital is that their people work toward providing what's best for the patients in their care. In my opinion, they've come up short."

Asked Friday if she regrets her statements, Marocco said no.

"I've gone over and over it in my mind," she said. "I can't think of a single thing I'd have done differently."

Iowa to pay subjects $925K for stuttering study - 1930s experiment tried to cause speech issues by baiting, belittling orphans

Via this report on MSNBC - Sadly, not nearly enough for ruined lives.

The state [of Iowa] has agreed to pay $925,000 to unwitting subjects of an infamous 1930s stuttering experiment — orphans who were badgered and belittled as children by University of Iowa researchers trying to induce speech impediments.

Johnson County District Court Judge Denver Dillard issued an order approving the settlement Friday morning; it still must be ratified by the State Appeal Board, which next meets Sept. 4.

The six plaintiffs, who said the experiment left lifelong psychological and emotional scars, had originally sought $13.5 million.

“We believe this is a fair and appropriate settlement,” Attorney General Tom Miller said in a statement. “For the plaintiffs, we hope and believe it will help provide closure relating to experiences from long ago and to memories going back almost 70 years.”

He said it was a prudent outcome for the state because of the high costs of litigation and the difficulty of finding witnesses to events so long ago. He noted that the settlement provides a resolution for plaintiffs who are now in their 70s and 80s.

‘The Monster Study’

The 1939 experiment has come to be known as “The Monster Study” because of its methods and the theory researchers set out to prove — that stuttering is a learned behavior that can be induced in children.

Over a six-month period, Dr. Wendell Johnson, a nationally renowned pioneer in the field of speech pathology, and his staff tested his theory on 22 children who were in the care of the state-run Iowa Soldiers’ Orphans’ Home. Some were subjected to steady harassment, badgering and other negative therapy in an attempt to get them to stutter; the rest served as a control group.

According to the study, none became stutterers, but some became reluctant to speak or self-conscious about their speech.

Hazel Potter Dornbush, 84, of Clinton, who was 15 when she was chosen for the study, said she is relieved the case is settled.

“It was awful stressful all these years. I’m just glad it’s over,” she said. “How would you like to have them turn over all your past for the last 80 years?”

Dornbush said she recalls 22 children being taken from the state-run Iowa Soldiers’ Orphans’ Home to be used in the research. She said many of the children were told they stuttered even if they didn’t, and the researchers said they were there to help them stop.

“I call that brainwashing. I don’t care what anybody else calls it, that’s my language. I was wise to it right away, but I cooperated. You know we weren’t in no position to argue with nobody. We had nobody to lean on to help us out.”

The university kept the experiment and its methods from the former subjects for decades. It was not until 2001 when the San Jose (Calif.) Mercury News published an investigative story about the study and its methods did the former subjects learn about the experiment’s true purpose. The newspaper based its story on statements made by Mary Tudor, one of Johnson’s former research assistants, who lived in California at the time the story was published.

The university apologized for the experiment in 2001; the plaintiffs sued in 2003.

The settlement pays $900,000 to five of the plaintiffs, Dornbush, Kathryn Meacham, the Betty Romp estate, the Clarence Fifer estate and the Phillip Spieker estate. The state also will pay $25,000 to the sixth plaintiff, Mary Nixon.

Psychiatrist Group Names DSM Task Force

With a Tip of the Hat to the PharmaLot Blog

In a move that is likely to be closely scrutinized, the American Psychiatric Association today named its new task force for overseeing development of its 5th edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM-V. [...] The task force has 27 members, who rep scientists from psychiatry and other disciplines, clinical care providers, and consumer and family advocates.

This task force, which will revise the DSM over the next five years, holds a great deal of sway, since their actions influence prescribing habits in the US and elsewhere. But it’s more than that. The DSM is where a condition is officially sanctioned as a disorder, which of course, also determines treatment. For these reasons, the APA has come under fire - as have other doctors - for ties to industry.

Of the 27 task force members, the APA says eight had no relationship with industry and 19 disclosed relationships with industry during any of the 36 months leading up to their nomination.

[...]

The APA, by the way, has been embroiled in the controversy over antidepressants and Black Box warnings, which the FDA mandated in early 2005 after the drugs were linked to suicide in youngsters. Since then, the APA has repeatedly urged regulators to rethink their position over concerns that patients and doctors are being scared away from using meds. As a result, though, some patient advocates charge the APA is too quick to side with industry.

The press release with the announcement can be seen here

The detailed list of members of the taskforce with their disclosures can be seen here

We remain extremely skeptical.

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

From the FDA Press release dated Wednesday, May 2nd, 2007

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

For more information:

Antidepressant use in children, adolescents, and adults, including the draft labeling and draft Medication Guides
www.fda.gov/cder/drug/antidepressants/default.htm

FDA's Psychopharmacologic Drugs Advisory Committee, including transcripts from the December 2006 meeting

www.fda.gov/ohrms/dockets/ac/cder06.html#Psychopharmacologic