Already Famous? Nemeroff And His Keynote Bio

the mess continues

QUOTE: "Whether he will have any conflicts to disclose when he makes his presentations remains to be seen."

Ouch!

Be nice, now.

Well, this little tidbit could explain the choice being a country club:

http://dida.library.ucsf.edu/pdf/oxx10h10

He seems to like steak and country clubs, especially when paid by GSK for speaking and training "dinners".

I failed to find in Nemeroff's current bio any mention of his involvement with Corcept Therapeutics. See

http://tinyurl.com/2g2dsad

The company's clinical research program for psychotic depression is enrolling volunteers. See

http://www.corcept.com/about.htm

The study is advertised under Clinical Trials on the Psychiatric Times website, here:

http://www.psychiatrictimes.com/mdd

Click on the link and go to "45 study locations." The list shows that numerous investigators withdrew or were terminated from the study. Can anyone comment on the reasons for the high turnover in investigators?

I couldn't find this in his bio either: the patent for the Li patch

http://www.pharmcast.com/Patents/Yr2002/April2002/042302/6375990_Lithium042302.htm

Title: Method and devices for transdermal delivery of lithium

United States Patent: 6,375,990

Inventors: Nemeroff; Charles B. (Atlanta, GA); Kilts; Clinton D. (Atlanta, GA) Assignee: Emory University (Atlanta, GA)

"A method and device for treating acute mania or bipolar disorder is disclosed, by transdermal delivery of Li+ at substantially constant rate through the skin via a dermal patch."

This is left out of his bio too:

http://www.medicalnewstoday.com/articles/50675.php

Journal Editor Resigns After Failure To Disclose Conflict Of Interest

"Charles Nemeroff has decided to resign as editor of the journal Neuropsychopharmacology after he co-authored a favorable article on a chest implant that treats depression and did not disclose his financial ties to Cyberonics, which manufactures the device, the Wall Street Journal reports."

He really does not need any introduction does he?

I checked out this meeting earlier this week and found the resort is on the ocean front. By August that probably won't be too great a place to party.

Also, I have a hard time believing that anybody is still willing to pay to listen to this quack. Or do the drug companies pay people to attend?

I know for myself, I wouldn't want to put Nemeroff's name down and claim I should get CME credits for attending. But that's just me.

I'm watching Pharamlot closely to see where it takes us information-wise on the Nemeroff scandal.

You guys have great sources!

If psychiatrist Nemeroff is the poster child for financial irregularities, Florida is fast becoming known as the hotbed for well-publicized troubled psychiatrists.

Fernando Mendez-Villamil - top prescriber in the state - being investigated by the feds.

Sohail Punjwani - no consent on drugging Gabriel Myers with a cocktail of psych drugs.

Steven Kaplan - losing Medicaid funding for his involvement in the death of a youngster.

William J. Johns, III - in the looney bin for attacking a mother with a child on the street.

et al.

Excuse my language but what a crazy looking bastard!!!

Stephany,

That's an incredible document: http://dida.library.ucsf.edu/pdf/oxx10h10

I'd like to see an animation of the country showing the lines of Nemeroff's travel and the amount he got at each stop. Boston to Tampa to San Fran to Ohio to Kentucky, etc. etc. etc. etc.

Talk about a Drug Whore! Wow! And that's just one drug company!!

I excuse your language Wendy and share your sentiments.

You'd think that a guy who was pulling in millions of dollars under the table by giving chats over all those fancy dinners and attending meetings in exotic locations would look a lot better, hey?

Ken, is this the same Sohail Punjwani, MD, who served as principal investigator on “A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features?” See

http://tinyurl.com/22pq5c4

OMG. I just learned from that document link above that Nemeroff made a sweep through Wisconsin back in 2004 and was pushing Paxil out at the County run Mental Health Center in the County I live in.

I don't know Evelyn. If that Punjwani is from Florida - yes. There's only one licensed in the state. Here's more of his drug trials:

Speaker for Lexapro - Gabriel was on this drug - surprising this drug company wants him after all the press! http://lexaproworkshops.com/Registration_Form.aspx?id=15542

________________________________________

http://www.clinicaltrials.gov/ct2/show/NCT00103727?term=SOHAIL+PUNJWANI&rank=1 Clinical trial on Risperal sponsored by GlaxoSmithKline

________________________________________

http://www.trialscentral.org/studyoftalnetantv-condtrid-19019.htm Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia Source : GlaxoSmithKline

________________________________________

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm072181.pdf Depakote Abbott

________________________________________

Apparently Segal and Punjwani go back a ways. Segal Institute apparently took mention of Punjwani off their website. Fired him? Earlier this link had the below info. It doesn't exist there now: http://www.segaltrials.com/index.cfm?fuseaction=home.introduction Dr. Sohail Punjwani, Board-Certified in Psychiatry, Neurology and Child and Adolescent Psychiatry, serves as Principal Investigator for outpatient and inpatient clinical trials, Phases I-IV, in Fort Lauderdale and has conducted over 120 clinical trials.

http://jobs.trovit.com/jobs-by-company/mount-sinai Compass Health Systems is looking for mount sinai Psychiatry Opportunities: , P.A. was founded in July 1990 by Scott D. Segal, MD, and joined by Sohail Punjwani, MD in 1991. Its first office was opened at the Mount Sinai Medical Staff Pavilion in Miami Beach. Since then, Compass Health Systems has grown to cover a tri-county area

http://www.centerwatch.com/news-resources/research-centers/profile-details.aspx?ProfileID=1440&mp=hepfi Dr. Scott Segal, co-founder of Segal Institute and sole founder of Compass Health Systems, is Principal Investigator for several of Segal Institute’s trials. Board-Certified in Psychiatry, Neurology and Child and Adolescent Psychiatry, Dr. Segal has conducted over 200 multi-centered, Phase I-IV clinical studies in outpatient, inpatient, and residential care facilities settings. Dr. David Flaherty, Board-Certified in Psychiatry and Neurology, is Principal Investigator on several Phase I-IV outpatient and inpatient clinical trials. Dr. Sohail Punjwani, Board-Certified in Psychiatry, Neurology and Child and Adolescent Psychiatry, serves as Principal Investigator for outpatient and inpatient studies, Phases I-IV, in Fort Lauderdale and has conducted more than 100 clinical trials. Newer principal investigators include Dr Eduardo Cifuentes, a Board-Eligible psychiatrist in Psychiatry and Neurology, and Dr. Steven Lopez, a Board-Certified psychiatrist in Psychiatry and Neurology and Board-Eligible in Child and Adolescent Psychiatry. Both Drs. Cifuentes and Lopez are based out of the Segal Institute Charleston, South Carolina research site.

________________________________________ http://www.psysolutions.com/facilities/ftlauderdale/medical.html Psych Solutions Dr. Sohail Punjwani, MD Board Certified Adult, Child and Adolescent Psychiatry American Board Psychiatry and Neurology

________________________________________

Scott Segal (Punjwani's boss) http://www.segalinstitute.com/clients.cfm Many Drug companies listed

Videos of Segal: http://www.segaltrials.com/video/News/1/video.html http://www.segaltrials.com/video/News/2/video.html http://www.segaltrials.com/video/News/3/video.html

Photo: http://www.atlanticshoreshospital.com/ash_staff.html

http://www.segaltrials.com/index.cfm?fuseaction=home.introduction about us

The government here is inquiring whether Punjwani is doing clinical trials on foster kids:

See here: http://www.psychsearch.net/psych_news/?p=43

Evelyn, I assume you were referring to the document that Stephany posted: “Exhibit A: Speaker Event and Professional Programs Databases.”

According to the document, Charles Nemeroff spent some time in Dallas as well. He made one presentation at (Stephany, this one’s for you) Chamberlain’s Steak and Chop House....

http://www.chamberlainsrestaurant.com/index.php

Scott Segal and Eduardo Cifuentes served as principal investigators on “A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features” as well. See

http://clinicaltrials.gov/show/NCT00637494

To view the list of investigators, click on “History of Changes.” Then uncheck the two boxes at the top of the page.

It appears that Scott Segal is still recruiting volunteers for the mifepristone study (NCT00637494) at the Hollywood FL study site.

Investigators are recruiting individuals with depression and psychosis. Volunteers will not have taken ‘excluded’ medication for at least 7 days prior to randomization. Volunteers are randomized to receive mifepristone or placebo for 7 days, followed by antidepressant.

Fourteen days is a long time to wait for relief, especially for someone who has depression and psychosis. Are the volunteers monitored in a hospital setting? What are the ‘excluded’ drugs? Does anyone happen to have a copy of the consent form?

Charles Nemeroff needs no introduction in the psychiatric community. He is every psych’s hero: A professor on the pharmaceutical payroll. Nemeroff has accomplished the ultimate psychiatrist wet dream: to suckle off both public and private tits. Why is he featured at Georgia Psychiatric Physicians Association CE? Why was he hired to the psychiatry chair at the University of Miami medical school? He is revered by the psych community for his consistent ability to get rich disregarding the laws of the land and the best interests of humanity.

Re:

http://www.segaltrials.com/video/News/3/video.html

I question the ethics of advertising care in clinical research as “free,” and placing individuals on medications that they will not be able to afford when the study ends.

Wasn't Punjwani busted for running bad clinical trial on kids with Pfizer's Geodon too? Or maybe it was mentioned and I missed it.

Full disclosure of his affiliations should be demanded. If he is being paid off by big pharma or other groups with an agenda, then we have the right to know. Otherwise this becomes an ethical situation as he will not be able to communicate an unbiased, truly educated viewpoint on the subject he discusses.

Yeah, the FDA warned Punjwani. See here:

http://www.miamiherald.com/2010/03/16/1531156/psychiatrist-gets-warning-from.html?story_link=email_msg

FDA warns psychiatrist who treated dead foster child The psychiatrist who treated the Broward foster child who killed himself last year is now in hot water with the FDA. BY CAROL MARBIN MILLER cmarbin@miamiherald.com

A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed ``to protect the rights, safety and welfare'' of children enrolled in clinical drug trials.

In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.

Another, a 13-year-old, ``experienced sedation and dizziness during the study,'' the letter said.

The warning letter, a harsh and rare form of discipline by the agency, says Punjwani failed to ``adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.''

``Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects' rights, safety and welfare,'' the letter says.

Punjwani did not return calls from The Miami Herald seeking comment.

Punjwani, who practices in Tamarac and has offices elsewhere in South Florida, was treating 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a Margate foster home. The boy's death prompted a yearlong probe by a Department of Children & Families task force, as well as proposed legislation before the Florida Senate.

Before Gabriel's death, Punjwani had prescribed several powerful mental health drugs -- some of which had not been approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children.

Punjwani also was sued last summer by a Tamarac mother who claims her son, 16-year-old Emilio Villamar, died after being over-medicated with a group of mental health drugs at a Fort Lauderdale psychiatric hospital.

The letter mailed to Punjwani does not specify the names or types of drugs the doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, said such details are kept confidential to protect drug companies.

Walsh said the FDA does not send out such warning letters often, and the agency considers breaches of its regulations to be ``very serious.'' The letter was signed by Leslie K. Ball, a doctor who heads the compliance office of the Division of Scientific Investigations, and Constance Cullity, a doctor who is also a compliance officer.

For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.

In a trial for one drug that was not identified, Punjwani gave one child dosages ``in excess of... specified limits,'' the letter says.

The child was discontinued from the trial before it was completed, the letter says, ``due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.'' The girl was ``overdosed'' on the drug for more than two weeks.

The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. ``However,'' the letter says, ``we are concerned that the response is not adequate to prevent future recurrence of the violation.''

The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child's weight, the letter states. But for six of seven children -- chosen at random -- who received one of the tested drugs in Punjwani's study, the dosage exceeded what was spelled out in the protocol.

One child who weighed 103 pounds, for example, ``was overdosed on study medication for 20 consecutive days while participating in the study,'' the letter states. The child is identified only as ``Subject 1001.''

A child identified as ``Subject 1003,'' who was 15 at the time of the trials, ``was overdosed on study medication for 21 consecutive days while participating in the study,'' the letter says. ``Subject 1004,'' a 16-year-old, ``received doses in excess of the maximum target dose for 3 consecutive days while participating,'' the letter says.

A 10-year-old, identified as ``Subject 1007,'' was ``overdosed'' for nearly two weeks while on the study, the letter states.

Department of Children & Families Secretary George Sheldon, who appointed a task force last year to study Gabriel's death, said Monday he is asking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani's clinical trials. Sheldon said he was acting on concerns that children in state care may have been involved in clinical trials, which is against state law.

The FDA letter, Sheldon said, ``raises clear ethical issues and judgment issues that we need to clearly understand.'' If foster kids were enrolled in clinical trials, he said, ``we will need to take it to another level.''

Read more: http://www.miamiherald.com/2010/03/16/1531156/psychiatrist-gets-warning-from.html?story_link=email_msg#ixzz0rsSpXnKo

Well if you all liked the internal document showing where he did his "dinner" talks for GSK, then you might like this one:

http://dida.library.ucsf.edu/pdf/oxx09k10

Emory starts to unravel for him...I wonder how long it will take for him to be booted from U of M?

If you want a visual of who we are talking about

http://www.youtube.com/watch?v=Ib32WSTOPaw&feature=related

Charles Nemeroff on YouTube talking about psychiatric stigma!