Tuesday, June 30, 2009

Florida Senator Ronda Storms speaks out about child drugging

 
Senator Ronda Storms
Florida Senator Ronda Storms speaks out about child drugging.
 
Listen to a clip of FLORIDA ON THE LINE radio show here: http://www.youtube.com/watch?v=FuqRNRCX8Zc
 
FLORIDA ON THE LINE
with Host Margie Menzel
After the tragic death of seven-year-old Gabriel Myers in April, the Department of Children and Families began a review of children in state custody taking psychotropic drugs. In more than 16 percent of cases where children were given these drugs, DCF lacked the legal consent of a guardian or judge. Fifteen percent of Florida foster children are on one or more such drugs. Our guests include Sen. Ronda Storms, chair of the Senate Committee on Children, Families and Elder Affairs; Dr. Toni Appel, an attorney and neuropsychologist; and children's advocate Karen Gievers, also an attorney. A member of DCF's Gabriel Myers Task Force will also appear.
You can listen to the full hour program here:
 

Wednesday, June 17, 2009

Another disgraced psychiatrist

 
Our nomination for filthiest, scummiest, most criminal psych of the year.
 
 
 
Daytona Beach News Journal
Failed transplant leads officials to Ormond fugitive
June 08, 2009
By JULIE MURPHY
Staff Writer

Erwin Langier was promised a lifesaving liver transplant when he traveled to the Philippines last year, but federal officials say instead the Canadian lived out his last days in a foreign hospital, away from his wife.

She stayed behind to handle the financial arrangements for her dying husband. And, nearly $100,000 later, what she is left with are memories tainted by the knowledge she was duped by a former Ormond Beach psychiatrist who investigators say started scamming people internationally more than 40 years ago.

When the FBI tracked down Jerome Howard Feldman, 68, in the Philippines in February, he had already eluded prosecution in the United States for nearly 10 years, and close to $50 million in federal fines went unpaid.

According to court documents, among other illegal schemes, Feldman ripped off the Medicare and Medicaid system in a billing scam at three clinics he owned in the mid-1990s, including one in Daytona Beach. Feldman would bill the Medicaid program for large quantities of AIDS infusion therapy drugs, but never provided the drugs to several patients and even billed for patients no longer being treated, officials say.

As Feldman hid from his legal troubles, a judge in 2001 ordered the fugitive to pay the federal government $46 million, damages and civil penalties, to the Medicare and Medicaid programs. The same year the Attorney General's Office also charged him with racketeering, conspiracy to commit racketeering, fraud, grand theft, money laundering and dealing in stolen property.

Feldman's medical license was revoked in 2002.

LIVER TRANSPLANT SCAM


While it may be no consolation to his grieving widow, it is because of Langier's death that Feldman -- who used at least nine aliases -- was ferreted out.

Investigators believe Feldman operated a human organ transplant scheme while living as a fugitive from justice in the Philippines. He used his many aliases to run his online organ transplant brokerage, www.liver4you.org, and continued to bait potential victims until he was arrested.

According to the FBI, Feldman conducted different aspects of the business as Alberto Jennaro Gomez, Alberto Gomez, Al Gomez, Mitch Michaelson, Mitchel Michaelson, Dr. Mitch Michaelson, Michael Adams, David Smith and David Dow Smith.

His web of deception began to unravel when the Dewitt (N.Y.) Police Department took a complaint from Victoria Langier, who paid for the liver transplant for her 55-year-old husband. She contacted Dewitt police because all of her payments were wire transferred to a bank there.

Erwin Langier and a family friend traveled to the Philippines for his transplant less than a week after the procedure was paid for with money wired to "Alberto Gomez" at the instruction of "Dr. Michaelson" -- May 31, 2008. His health deteriorated shortly after their arrival and his friend brought him to the local emergency room, court documents show.

It was then that Feldman demanded more money from Victoria Langier, via "Dr. Michaelson," so another doctor could perform the surgery within two weeks, a report states. This was done, though neither Victoria Langier nor the family friend spoke to any hospital personnel who knew "Dr. Michaelson" or his alleged associates, or of any arrangements made on Erwin Langier's behalf, the report states.

Though the Filipino government placed Erwin Langier on its transplant eligibility list, he died there of liver failure on July 11. Even worse, Victoria Langier was required to pay more than $20,000 in hospital fees -- on top of the $70,000 total she sent to Alberto Gomez, which was to have been an all-inclusive fee.

Several messages left at the home of Victoria Langier were not returned.

There are at least six suspected victims worldwide who were taken for a known $324,985, and money was transferred to "Michael Adams" as well as to Feldman's wife and children, according to reports.

FLORIDA CLINICS SCAM


Besides billing the Medicaid program in the 1990s for large quantities of AIDS infusion therapy drugs that were never provided, investigators believe Feldman recruited elderly and poor patients -- insured by Medicare, Medicaid or both -- from assisted-living facilities and private residences for group therapy.

He had them taken by van to one of his facilities in Orlando that is described in court documents as an "abandoned warehouse in disrepair with no running water or kitchen facilities" where they would be for six to seven hours a day, five days a week.

Investigators contend Feldman hired unlicensed individuals to provide the group therapy, including his (then) teenage son, a maintenance man and the van drivers who brought the patients to the facility, according to court documents. They also contend many of the patients didn't need group therapy or didn't have afflictions where group therapy would have been a benefit, and the sessions were deemed "social, recreational and diversionary rather than psychotherapeutic."

Feldman wasn't around when his medical license was revoked in 2002.

Court records show he left "in or about" 1999, when investigators began looking into his Medicare and Medicaid billing practices as well as his treatment of patients, and could not be located until the FBI tracked him down to the Philippines last year.

Feldman won't be extradited to Florida to face criminal charges here until he stands trial in New York on federal wire fraud charges. He was extradited to Syracuse on April 1 from Guam where he was held after being arrested early in February.

Investigators obtained search warrants for a Yahoo account used by Feldman that may reveal how he went about his business.

In an e-mail message to one of his sons dated June 17, 2008 -- one day before Victoria Langier made her second payment to "Alberto Gomez" -- Feldman wrote, "In the past 9 months I have made about $30,000. It is harder than pulling teeth to get money out of people even if they face severe health problems or even death, without my help. I am trying to get another $30,000 from the above person, but it ain't a sure thing."
 
 
Multiple scams

Jerome Feldman, 68, a former Ormond Beach psychiatrist, has been involved in more than one medical scam, according to the FBI, including one in which he brokered live organs internationally, in part, by using as many as nine aliases. Here are some of the details that led the investigation to Feldman.

FAKE ID's: "Alberto Gomez" opened both a UPS box and a bank account in Dewitt, N.Y., to conduct his organ transplant scheme. He produced a Mozambique international drivers permit, a photo identification, which investigators compared to a known photograph of Feldman. Another alias, "Michael Adams," whose British passport photo was also compared to Feldman's, used a credit card to make purchases in Manila, and a phone number linked to Feldman. Adams also had a joint bank safe deposit box with Feldman's late mother-in-law.

FAMILY PROBLEMS: E-mail messages between Feldman and his wife, Bonnie Feldman, show them bickering about money, with her complaining that he wasn't sending her enough. He said he didn't leave the United States because of her demands for him to make more money, but to avoid a "25-year vacation."

LEGAL TROUBLES: That "25-year vacation" is possible if Feldman is convicted on Florida charges that he filed 1,776 false claims to Medicare for partial hospitalization services, and 5,750 false claims to Medicaid for psychiatric services. He is also charged with the illegal purchase and resale of stolen pharmaceuticals that netted him nearly $2 million.

— Julie Murphy

SOURCE: FBI

Sunday, June 14, 2009

Psychiatrist sued - video/FDA oks drugs for kids/Lilly & elderly/Autism & Antidepressant

http://gabrielmyers.wordpress.com/2009/06/04/south-florida-family-sues-p
sychiatrist-for-sons-death/

June 4, 2009...12:24 am Video
South Florida Family Sues Psychiatrist for Son's Death


http://www.opednews.com/articles/Start-Your-Engines-Drug-Re-by-Martha-Ro
senberg-090612-970.html

Start Your Engines Drug Reps! FDA Panel Says Yes to Seroquel, Zyprexa
and Geodon for Kids!

by Martha Rosenberg
12 June 2009


http://www.NaturalNews.com/026429_heroin_drugs_Bayer.html

FDA Approval of Antipsychotics for Children Mirrors Bayer, AMA Approvals
of
Heroin as Cough Medicine for Children
Thursday, June 11, 2009 by: Mike Adams, the Health Ranger, NaturalNews
Editor


http://www.miamiherald.com/business/story/1095411.html
Lilly sold drug for dementia knowing it didn't help, files show
Unsealed internal company documents show that Lilly marketed an
antipsychotic
drug to older patients with dementia, an unapproved use for it.
BY MARGARET CRONIN FISK, ELIZABETH LOPATTO AND JEF FEELEY
Bloomberg News
13 June 2009


Study Says Antidepressant Does Not Help Treat Autism
Morning Report
2 June 2009
(Attached)

Thursday, June 11, 2009

Florida Press this Week

4-Jun-09 Miami Herald Lawsuit links psychiatric drugs to Tamarac child’s death http://www.miamiherald.com/news/miami-dade/story/1082376.html

4-Jun-09 Youth Today FDA Committee to Rule on Psych Meds for Youths http://www.youthtoday.org/publication/article.cfm?article_id=2944

7-Jun-09 Palm Beach Post Kids and drugs. Too much, too little? http://blogs.palmbeachpost.com/opinionzone/2009/06/05/kids-and-drugs-too-much-too-little/

5-Jun-09 News Press Children in foster care taking psychotropic drugs higher than originally thought. http://www.news-press.com/article/20090605/NEWS01/90605025/1075

7-Jun-09 St. Petersburg Times EDITORIAL: Foster care failures http://www.tampabay.com/opinion/editorials/article1007779.ece

8-Jun-09 Miami Herald Drugging foster kids shows more neglect http://www.miamiherald.com/news/southflorida/story/1086735.html

7-Jun-09 Sarasota Herald Tribune Portrait of a child at risk http://www.heraldtribune.com/article/20090607/OPINION/906071021/-1/NEWSSITEMAP#

7-Jun-09 Sarasota Herald Tom Lyons: System doesn’t always foster good parenting http://www.heraldtribune.com/article/20090607/COLUMNIST/906071065/-1/NEWSSITEMAP

8-Jun-09 Sun Sentinel THE ISSUE: Death raises concern about psychotropic drugs. http://www.sun-sentinel.com/news/opinion/sfl-psychotropic-drugs-editorialsbjun08,0,2212606.story

5-Jun-09 Palm Beach Post Editorial EDITORIAL: Owning up, cleaning up http://www.palmbeachpost.com/opinion/content/opinion/epaper/2009/06/05/a14a_dcf_edit_0606.html

9-Jun-09 Miami Herald Drug rules to protect kids were ignored, DCF says http://www.miamiherald.com/457/story/1090000.html

10-Jun-09 Gainesville Sun DCF: Drug rules for foster children were ignored http://www.gainesville.com/article/20090610/ARTICLES/906109967/-1/MAGAZINE?Title=DCF-Drug-rules-for-foster-children-were-ignored

10-Jun-09 Miami Herald DCF: Drug rules for foster children were ignored http://www.miamiherald.com/news/florida/AP/story/1090371.html

10-Jun-09 Lakeland Ledger Portrait Of a Young Man http://www.theledger.com/article/20090610/NEWS/906105001/1036?Title=Portrait-Of-a-Young-Man

9-Jun-09 Tampa Tribune Panel probes DCF drug rules http://www2.tbo.com/content/2009/jun/09/na-panel-probes-dcf-drug-rules/news-metro/

10-Jun-09 St. Petersburg Times We must all make children a priority - Letter by Douglas Bonar, Pinellas Park http://www.tampabay.com/opinion/letters/article1008632.ece

10-Jun-09 St. Petersburg Times What are we doing to the children? - Letter by Irene Sullivan, Pinellas-Pasco Circuit Court judge, Pinellas Park http://www.tampabay.com/opinion/letters/article1008632.ece

11-Jun-09 TC Palm Editorial: State agency must pay greater attention to detail for children in foster care http://www.tcpalm.com/news/2009/jun/11/editorial-state-agency-must-pay-greater-to-for/

 

Saturday, June 06, 2009

New Details Emerge on Foster Drugging in Florida

 Click here to make comments!

 

Bookmark this page http://gabrielmyers.wordpress.com/ for the latest developments on child drugging in Florida.

 

 
Miami Herald
Lawsuit links psychiatric drugs to Tamarac child's death
The doctor who prescribed psychiatric drugs for a child who committed suicide was sued Thursday by a mother who claims that he overmedicated her son.

June 5, 2009

By Carol Marbin Miller

A Tamarac mother sued Fort Lauderdale Hospital and a psychiatrist who worked there, saying they overmedicated her teenage son with a cocktail of mental health drugs -- some of which have not been approved for the treatment of children.

The boy, Emilio Villamar, died of a sudden heart attack. He was 16.

Emilio, a swimmer and water polo player, was diagnosed with bipolar disorder by Dr. Sohail Punjwani in March 2002. Within the next year, the teen was given 16 different psychiatric drugs, six of which were still being administered when he died, said Michael S. Freedland, who is representing Emilio's mother, Norma L. Tringali.

Punjwani had also been treating 7-year-old Gabriel Myers, a foster child who had been prescribed several psychiatric drugs before he hanged himself in April. In the wake of Gabriel's death, the Department of Children & Families has launched a wide-ranging investigation into the agency's dispensing of mental health drugs.

Norma Tringali, 56, said she asked Punjwani and other medical professionals why her son was being given so many powerful drugs -- including six separate anti-psychotic drugs, typically used to treat schizophrenia, and one drug, called Cogentin, that is used primarily to curb the side effects of other drugs.

''[Punjwani] said he needed them,'' Tringali said.

''He was over-medicated,'' Tringali said of her son. ``He was like a zombie, walking with heavy paces, always tired.''

Attorneys for both Punjwani and Fort Lauderdale Hospital did not return messages Thursday afternoon seeking comment.

NEW DETAILS

On Thursday, DCF administrators released new details on the investigation, saying 3,068 children in the agency's care were taking mind-altering drugs -- 118 of them infants, toddlers or youngsters under age 6. That comprises 13 percent of all the kids in DCF's care.

Teenagers, those aged 13-17, make up 31 percent of the dependent children prescribed mental health drugs. That amounts to 1,695 children taking at least one psychiatric drug, according to the numbers released Thursday.

Thursday's count includes almost 400 children who were not recorded when DCF released a census of children on medication a week ago. At the time, DCF Secretary George Sheldon acknowledged the census was a bit of a moving target, and agency leaders expected the numbers to rise.

''I have no confidence in the data that was released in 2007 and 2008,'' Sheldon told The Miami Herald Thursday, referring to reports DCF submitted those years to the state Senate in response to a 2005 law that required better oversight of dependent children being administered psychiatric drugs.

`WORK IN PROGRESS'

''This is a work in progress,'' Sheldon added. ``We've got to get it better.''

Among the new findings: Of the 50 children in state care younger than age 6 whose files were reviewed by DCF, in not one case had parents or a judge provided informed consent for the use of mind-altering drugs, Sheldon said. ``That's disturbing.''

The 2005 law required the consent of a parent or judge before foster kids can be administered mental health drugs.

''A parent of a child who has been removed will, for all practical purposes, sign anything,'' Sheldon said, noting that gaining meaningful permission from a parent overwhelmed by the removal of a child is next to impossible.

Tringali's lawsuit alleges that Punjwani provided healthcare to Emilio that ''deviated and departed from the prevailing professional standard of care exercised'' by most doctors by failing to monitor the effects of anti-psychotic drugs on Emilio's heart, failing to do regular cardiac testing, and failing to consult with a cardiologist or other doctor with more experience with the heart-related side effects of anti-psychotic drugs.

''These are incredibly powerful drugs, and they require a tremendous amount of monitoring,'' said Freedland.

FOUND AT HOSPITAL

Emilio was found slumped over in his room at Fort Lauderdale Hospital -- where he was being treated for his mental illness -- with blood dripping from his mouth or nose, Tringali said. He was taken by ambulance to Broward General Hospital, where he slipped into a coma.

The teen died March 29, 2003.

''Of course, I was in shock,'' Tringali said. ``Can you imagine: 16 years old? He was doing sports. He was a good swimmer. He played water polo. He was a very good student.

''It has been very bad for the family, very bad,'' she said. ``I don't live one day, not one day, without thinking about Emilio.''

 

 

Sign the petition to stop psychiatric harm and abuse of children:

 

 

Foster care failures

 

St. Petersburg Times
Foster care failures

A Times Editorial
In Print: Sunday, June 7, 2009

 

Two disturbing facts about the Florida foster care system have emerged following the suicide of a 7-year-old boy on psychiatric drugs. First is the extraordinary prescription rate for children under the supervision of the Department of Children and Families. Second is the alarming revelation that a 2005 law aimed at tackling that problem has been repeatedly and systemically ignored.

So far, DCF Secretary George Sheldon, eight months into the job, is to be commended for the openness and urgency he has brought to the agency's investigation. But his true challenge will be altering the culture of an agency that failed to implement the safeguards already in place.

Agency critics have long argued that too many foster children are being medicated for the convenience of caregivers. As of Friday, an ongoing review of DCF's foster care database found that at least 400 more children are taking psychiatric drugs than initially thought. That means at least 3,068 — or 15 percent of the 20,000 foster children — are receiving the drugs, compared to 5 percent of the state's children.

What's more, DCF acknowledges at least 14 percent of the children received the drugs without the informed consent of the parent or the court. Sheldon believes the percentage is higher, because he suspects many parents weren't adequately informed of potential side effects of such drugs or didn't speak to the physician.

Sadly, the revelations come four years after concerns about pediatric use of antipsychotics and antidepressants — few of which have been tested or approved by the FDA for use by children — prompted legislative action. A 2005 law requires that all foster children's prescriptions be approved by a parent, or if parental rights have been terminated, by the court. The law also made clear that DCF was to monitor children on such drugs.

In response, DCF included questions about medications and parental consent on its database software. Local providers use the program to create the official state record of each child. But time and again, Sheldon acknowledges, caseworkers have failed to fully complete the forms or lied about obtaining consent.

DCF's failure to follow the law was laid bare by the tragic death of Gabriel Myers, a 4-foot-tall, 67-pound boy who hanged himself from an extendable shower hose at a South Florida foster home in April shortly after having his medication changed. He was taking Vyvanse, an ADHD drug, and Symbyax, a combination of the antipsychotic Zyprexa and the antidepressant Prozac. Symbyax carries a "black box" warning that it might lead to suicidal behavior among children and adolescents, especially when first prescribed. Neither his parent nor a judge had approved the prescriptions. And his death came after 10 days of tumult: His mother had lost visitation rights. He had been in two foster homes, changed therapists, and been told he would be going back to Ohio, where he had been sexually abused.

Since his death, caseworkers across the state have been ordered to go through their files and remedy shortcomings — from updating the state database to reaching out to parents whose consent was never sought for their child's medications. DCF has also convened a panel of experts aimed at addressing what else might be done. Among the likely outcomes, Sheldon said, are new protocols before a child is given powerful psychotropic drugs, such as requiring a review by a second doctor.

Such changes will only work if Sheldon succeeds in changing a culture that ignored such safeguards. DCF relies heavily on nonprofit local providers to do its work. Those providers need to fully understand what is at stake, as do their employees. Four years after the Legislature thought it had addressed this problem, a 7-year-old's suicide is a stark reminder that the system is still terribly flawed. How long will it take to get it right?

Monday, June 01, 2009

Psych Sex - Former President of the American Academy of Child and Adolescent Psychiatry


 
 
Trial started today - former President of the American Academy of Child and Adolescent Psychiatry, William Ayres,
accused of molesting seven of his young male patients.

Florida Department of Children and Families' records on foster children taking psychiatric drugs raise doubts

St. Petersburg Times

By Kris Hundley

Saturday, May 30, 2009

The agency in charge of Florida's foster kids thinks it has finally gotten a handle on how many of its charges are on powerful psychiatric drugs.
But a closer look raises serious questions about the validity of the recently updated database.

While Florida's Department of Children and Families said Thursday that a review of case files found 2,669 children on psychotropic medications, the supporting data are shaky.
 
DCF's records include such unlikely scenarios as an eight-year delay between the time a court approved a drug and the date it was actually prescribed.


In another case, a child started taking a drug for attention deficit hyperactivity disorder nine years before the judge gave consent.


About 100 court approvals were signed on weekends.


And of more than 5,000 prescriptions, only one child was reportedly taking Symbyax, a combination antipsychotic and antidepressant that has been on the market since 2004. Symbyax was one of the psychotropic drugs being taken by a 7-year-old foster child who committed suicide in South Florida last month.


DCF is required by law to track foster children on psychiatric drugs because of potentially dangerous side effects. Previously, the department had reported that fewer than 2,000 kids were on such prescriptions.


In this week's review, DCF also admitted that one in six of those children did not have legally required approval by either a parent or a judge to have such a prescription.
But in hundreds of cases in which a judge's consent reportedly was obtained, the date of that order came either long before - or long after - the prescription started.

For instance:
· In 10 cases around the state, DCF's records show judges signing consent orders for a variety of drugs in January 2001, but the children's prescriptions did not start until 2009.
· A 16-year-old in Marion County was approved for the antipsychotic Risperdal in August 2005, but the prescription didn't begin until May 2009.
· A 15-year-old in Duval County had a judge sign off on another antipsychotic, Abilify, in January 2007; state records show the prescription began in May 2009.
John Cooper, DCF's acting assistant director of operations, acknowledged shortcomings in the state's database but said the medication start date could simply reflect the most recent prescription for a long-standing medication.
Andrea Moore, a longtime advocate for foster children, said that's no excuse. State law requires judges to regularly review the appropriateness of psychotropic prescriptions, she said, especially if the medication is changed.


"A consent signed two years earlier is not a valid consent,'' said Moore, former executive director of Florida's Children First. "That's particularly important when you're talking about atypical antipsychotics where serious questions have been raised about their long-term side effects."
Conversely, in more than 100 cases, there was an unusually long delay between the medication start and the court order.


· A 14-year-old in Brevard County reportedly on the ADHD drug Adderall since 1999 received court approval in November 2008.
· A 16-year-old in Hillsborough County began taking Seroquel, an antipsychotic, in October 2005, with a judge's consent receivedthis January.

 
DCF Secretary George Sheldon ordered a thorough review of all kids on psychotropic drugs last month after the suicide of Gabriel Myers. Myers, who had been in state custody for 10 months, was on Symbyax, as well as Vyvanse, for ADHD.


The state's database shows only one other foster child, a 14-year-old in Marion County, currently taking Symbyax. DCF's Cooper declined to comment on why the drug did not appear more frequently.


Symbyax has not been approved for children, although the practice that employs Gabriel Myers' psychiatrist is currently recruiting adolescents for a clinical trial of Symbyax for bipolar depression.


The most popular medicine on the state's database is Adderall. The next three most prescribed drugs, Risperdal, Seroquel and Abilify, are all antipsychotics
DCF's data show the sense of urgency among caseworkers as they scrambled through files in the aftermath of Gabriel Myers' suicide. Of the 2,433 court orders in the report, 187 of them are dated after April 16, the day the boy took his life. That includes the record of a 7-year-old in Palm Beach County who had been taking Adderall since November 2005.


The agency's database showed that 1,653 of the 2,669 foster children taking psychotropic drugs have multiple prescriptions. However, the state's tracking system is unable to easily identify kids on several different drugs at one time rather than multiple prescriptions for the same drug.


"We've noticed there are system limitations," said DCF's Cooper, who added that the system requires users to work through 12 screens to enter data. "As part of the Q.A. (quality assurance) process, we're trying to get a better idea of what's going on."
Moore, the foster child advocate, wonders why DCF released the data before checking it against Medicaid's records of the same children, a step DCF promises to take.


"When we've compared those two databases in the past, we've found significant under-reporting by DCF," she said. "At least Secretary Sheldon is trying to put pressure on them to get it right. But there's no reason, in my opinion, to trust the data they currently have."   

28,609 petition

 

 

Sign the petition to stop psychiatric harm and abuse of children

www.cchrflorida.org/pledge 

 

Blog on Gabriel Myers: http://gabrielmyers.wordpress.com/ 

Yes, we're still shocking people with electricity to "cure" them. Now THAT'S insane!

The Human Face of the FDA’s Failure to Investigate Risky Medical Devices

 

On April 8th, the Food and Drug Administration announced its intention to finally require manufacturers of medical devices marketed prior to 1976 to submit evidence of the devices’ safety and efficacy. These devices had been “grandfathered” in and despite the FDA’s assessment that they posed serious risks to health, they were never required to undergo any clinical safety trials (as have devices sold in the past 33 years). One of these risky devices is the electroconvulsive therapy (ECT, or shock treatment) device.

 

Major media such as the New York Times and the Wall Street Journal quickly picked up on this story. Bloggers in particular zeroed in on the ECT device, with the general theme of incredulity: How could it that such a drastic procedure---applying electricity to the human brain to generate a dozen or more grand mal seizures---had been allowed to be used on a generation of patients (that’s over 3 million people even by the most conservative estimates) without ever having been tested to see if it were safe?

 

Indeed, this is the case; and it’s not news to readers of Linda Andre’s new book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, published just a month before the FDA’s belated admission that it had essentially abdicated its responsibility to protect patients from harmful treatments.

 

The book is a history of shock treatment, with the emphasis on the history of the treatment since the 1970s. The author argues that this was a critical time for the shock industry, in part because the FDA’s assumption of the regulation of medical devices in 1976 and its classification of the ECT device in the high-risk Class III category in 1979 meant that---according to the law---the devices were to be subject to a safety investigation. No one knew at the time, nor could anyone have dreamed, that that day would not come for thirty years. The industry, Andre says, knew their treatment could not survive such scrutiny, so they adopted a public relations solution to what was essentially a scientific problem: They would make repeated claims for safety over the years, while lobbying the FDA to prevent any safety investigation from taking place. 

 

At the same time former patients permanently damaged by shock treatment, as well as concerned citizens and scientists, lobbied the agency to conduct such an investigation. They lost, but not for lack of trying: They offered up their own brains for CAT-scans. They proposed animal brain scan studies. They submitted three formal citizen petitions to the agency, which the FDA essentially ignored...but in the process built up a public docket on the ECT device which takes a week to read (the author did so). They enlisted politicians and public health advocates as allies. They kept steady pressure on the FDA in every way they could think of for decades---but in the end the agency bent to the stronger pressure of the wealthy and powerful American Psychiatric Association.

 

It’s a dramatic David and Goliath story unparalleled in the history of medicine; and just last week, David was finally proven right.

 

It’s too late for a generation of patients who experienced permanent extensive amnesia and permanent cognitive disability, with the attendant loss of sense of self and of life chances. The author lets these former patients speak for themselves:    

 

“I often feel as though a very vital part of my life ‘died’ as a result of these treatments.” “I do not think I will ever again be as intelligent a person as I was before.”

“ECT changed my life forever---and not for the better.”

“My personal belief is that an investigation is in order to prove that ECT is indeed beneficial and not brain damaging. How can I feel differently when that so-called therapy has wrecked a major portion of my life?”

 

“Doctors of Deception” makes clear that, at least in the case of the ECT device, the FDA’s failure to protect patients was not simply a matter of neglect or oversight; the agency had ample knowledge of the risks of the device and actively ignored repeated calls and opportunities to either conduct its own safety investigation or require the device manufacturers to do so.

 

The author reminds us that the FDA actually did call on shock machine manufacturers once before, in 1995, to prove their devices safe, but when the manufacturers simply ignored the call, the FDA did nothing. If history is any indication, the FDA is very likely to simply reclassify the ECT device to a low-risk category without any safety information or investigation at all rather than incur the wrath of the American Psychiatric Association.

 

At the very end of this cautionary tale, Andre writes: “Now that we know this history, now that what mostly hadn’t been written is written down in one place, maybe---just maybe---we can keep from repeating it. One thing is for certain: there will continue to be opportunities for the history of electroshock to take another turn.” Whether this will happen at the Food and Drug Administration or not, we will soon find out. 

 

Links:

 

http://online.wsj.com/article/SB123920937438601763.html

“Medical Devices Face New Scrutiny from FDA” Wall Street Journal, April 8

 

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html

“FDA to Review Medical Devices Marketed Prior to 1976” April 8

 

http://psychcentral.com/blog/archives/2009/04/15/with-fda-change-ect-may-go-the-way-of-the-dinosaur/

“With FDA Change, ECT Machines May Go the Way of the Dinosaur” April 15