Dr.Daniel Carlat says goodbye to readers and blogging, appoints Dr.Steve Balt to Editor of Carlat Report

Dr.Daniel Carlat, who readers might remember as the doctor who had an epiphany, and as a mea culpa, counter-detailed the antidepressant Effexor that he once promoted in drug talks.The ex-Wyeth speaker Carlat counter-detailed to Kevin MD.

Dr.Carlat announced on his blog today, March 19, 2012 he is calling it quits in blogging, giving up the Carlat Psychiatry Report reins and heading off to D.C. with a new job. To ensure his lack of COI (conflict of interest)Carlat says:

"Because my current job as owner of Carlat Publishing creates its own potential conflict of interest, I am in the process of divesting myself of the company--hiring a new CEO, and placing the company in a blind trust. Although I will continue to own Carlat Publishing, I will receive no income from it, nor will I have any contact with the business in any way. I want to prevent any appearance that I'm joining Pew in order to increase my company's profits from non-industry-sponsored CME activities.

The Carlat Psychiatry Blog lives on in the form of Thought Broadcast, a blog written by psychiatrist Steve Balt, who is the new editor-in-chief of The Carlat Psychiatry Report.

I thank all my devoted blog readers over the years, and I intend to continue writing and blogging about medical conflicts of interest issues and psychiatry--though not in the context of the Carlat "brand."

So it's goodbye for now."-Dr.Daniel Carlat


I find Carlat's concern of appearances and details of COI possibility refreshing. In the day and age we are in of full disclosure, the Sunshine Act, and Pharma having to disclose payments to doctors, that's the way it should be.(in my opinion)

Dr. Daniel Carlat, as stated on his blog has 'turned over the reins' so to speak of his blog, declaring it alive and well and living on in Dr.Steve Balt's Thought Broadcast blog. It probably isn't Dr.Carlat's ethical responsiblity to report potential conflicts of interest for his new Editor in Chief of the Carlat Report or the 'alive and well' blogger transference channeled over to Balt's blog; but I do feel it is important for those readers and the paid subscribers of the Carlat Report to know the background of their new "Chief in Command". Carlat's voice in the blogging world is far different than Balt's. The blogs are written by 2 vastly different people, and I don't frankly see a connection to the two blogs, in the sense of one taking over for the other.

Dr.Steve Balt married a pharmaceutical drug rep as he reported in the Fall of 2011, and has just had his medical license returned after being suspended by the California Medical Board. The details are in Reporting on Health, by William Heisel:Q&A with Dr. Steven Balt, Part 1: Separating personal struggles from clinical success and part 2 Q&A with Dr. Steven Balt, Part 2: Physician discipline should be better targeted.

William Heisel's series is based on a series called "Doctors Without Discipline" he wrote for the OC Register in California, where he discovered Steve Balt was a doctor who was being monitored and a product of the program ending, leaving Balt without the discipline program.

Here's one of Heisel's questions to Balt:(from the article.)

"Q: Let’s go back to your residency at Stanford for a minute, because it gets to what you’re doing now. You weren’t able to complete your residency because you had another shoplifting incident, right in October 2006?"

Balt's medical license was suspended, and his probation according to the documents hosted here-ended in May 2011.

That's some pretty heavy background for a guy being given the key to the "city" in the Carlat blogging and Carlat Report world.



The question is, do Carlat's and Balt's readers deserve transparency? do the paid subscribers of the Carlat Report? ( Carlat Psychiatry Report link) I think so. But that's just my opinion.

What I enjoyed about Carlat's blog is that I knew where he stood, in his views, of how he openly talks about prescribing medications, he wrote about his Effexor days, etc.

There's a lot of recent talk about how psychiatry needs to change. The DSM-5 discussions are everywhere, Dollars for Docs database is alive and well, the Sunshine Act gives a little more transparency. People are expecting more and demanding the truth regarding data in studies, and many doctors question the validity of some study data (PAXIL 329 for example). The drug companies are exposed for illegal marketing schemes and fined by the DoJ... in other words, it's what people are beginning to see happen and expect.

Transparency and full disclosure at the minimum are the base for the word trust. It's the buzz-word pharma has began to use, and it's the word patients need and look for in healthcare.

Trusting pharma is one thing...trusting a doctor is another.

The trust of a doctor is a pre-requisite in healthcare.That begins with transparency and full-disclosure.

*Addendum: William Heisel of Reporting on Health also wrote about Dr.Daniel Carlat "Q&A with Dr. Daniel Carlat: Biting the pharma hand that fed him"

Glenn McGee resigned from Celltex: I have a few questions

This article written by William Heisel at Reporting on Health William Heisel's Antidote: Investigating Untold Health Stories, Slap: Celltex Threatens University of Minnesota For Ethicist’s FDA Letter is a good review and update of the Celltex stem cell controversy of which Glenn McGee, Carl Elliott and Leigh Turner are all key figures in the discussion.

Readers of my blog know I write about topics that interest me, especially regarding truth, transparency and health issues. As a parent of a child who was injured by psychiatric medicines that were illegally marketed to children and teens by pharmaceutical companies (which have been fined by the Dept of Justice for doing so)I have a special interest in drug approval by the FDA and its process, an interest in medical ethics, and more.

I became familiar with bioethicist Carl Elliott via his story in Mother Jones regarding the death of Dan Markingson and the AstraZeneca Seroquel CAFE trial at the University of Minnesota. The question remains a heated one of whether or not it was ethical for Dan Markingson to have been participating in the study at all, informed consent, and the fact that he killed himself--leaving his Mother, Mary Weiss to push, ask quesions and seek resolution and closure, only to endure a new battleground of advocating for a loved one up against pharmaceutical companies and the University of Minnesota.

Celltex and stem cell research has been brought into light with increased public awareness, due to the article Carl Elliott had published in Slate and the controversy over Slate retracting the article.

The William Heisel article in Reporting on Health has a good background with links to the recent events, be sure to go there for further background information, as well as this link to Heisel's articles on Dan Markingson.

I've been watching with interest, the back and forth 'tweets' between Glenn McGee and others involved in the Celltex story. I asked Glenn McGee if he would answer a few questions, and offered to post his response as to why he abruptly resigned from Celltex on my blog. He has responded with this:



Here are my questions from 1 tweet


1. I was shocked that you resigned, &wondered why.Was it political pressure?

2. Did celltex ask you to resign?

3. Who picked the IRB?



This June 2008 article in Scientific American highlights another time when Glenn McGee abruptly resigned from a position-- that one being Alden March Bioethics Institute (AMBI),Albany Medical College in New York.

The article brings up an idea of how McGee, because of his actions brought positive attention to the subject of bioethics:

"Other ethicists, however, applauded McGee for raising the profile of their growing field. "He's certainly one of the most important bioethicists of his generation," says Autumn Fiester, an ethicist and former colleague at the University of Pennsylvania Center for Bioethics in Philadelphia, where McGee served as associate director for education for nine years before taking the Albany position."-Scientific American

Glenn McGee has a new book Bioethics for Beginners: 60 cases and cautions from the Moral Frontier of Healthcare which isn't released yet. see Amazon link.

Admittedly, before the Celltex, stem cell controversy, I didn't know who Glenn McGee was, and now, thanks to the controversial removal of the Slate article and twitterisms from McGee... I know who he is, because yes, once again the subject of bioethics has been highlighted by his abrupt departure and resignation, this time from Celltex Therapeutics, effective 2-28-12, announced where else? on Twitter.

I offer my comment section here to a civilized conversation--skip the bashing please--for anyone wanting to discuss this topic, answer my questions, etc. including Carl Elliott, Leigh Turner and Glenn McGee.

Investigation: Rampant Prescription Errors at California Nursing Homes: antipsychotics, Seroquel

Investigation: Rampant Prescription Errors at California Nursing Homes

"Recent investigations by the California Department of Public Health found some shocking news about California nursing homes. In 18 out of the 32 investigations -- all but one in the Bay Area -- pharmacists responsible for reviewing the medication of nursing home residents regularly allowed medically inappropriate and potentially fatal antipsychotic medications and did not correct other dangerous drug irregularities.

In many cases, the nursing home residents were prescribed Seroquel, a powerful antipsychotic medication that is typically used to treat schizophrenia. Pharmacists would routinely overlook or approve prescriptions of the drug at unsafe levels and would approve the prescribing of other drugs that could interact harmfully with Seroquel.

In an especially egregious example, a woman with a history of seizures was prescribed Seroquel, which medical research has linked to an increase in seizures if prescribed along with other antipsychotic drugs. In addition, the woman was given Trazodone, an antidepressant linked to seizures in elderly patients, and an additional antipsychotic, Risperdal. The combination of Risperdal and Seroquel, according to investigators, can cause potentially fatal irregular heartbeats.



Read more: HERE

"Brown’s cozy friendship with pharmaceutical companies should concern every one of us"

VIA Brown University's The Brown Daily Herald:

McGoldrick ’12: Profiting from medicine

"Medicine — we love it, we praise it, we have faith in it, we take it, but should we trust it? Normally we think researchers, doctors and other health professionals have our best interests at heart, but all too often we forget how corrupting money can be, even in the most virtuous of professions. In recent years there has been a general growing concern about the ethical behavior of pharmaceutical companies and the universities that collaborate with them — unfortunately, Brown included.

In the 1990s, Professor of Psychiatry and Human Behavior Martin Keller conducted a study on paroxetine — a drug marketed as Paxil in the United States and as Seroxat in the U.K. — to see if the drug was a safe and effective treatment for depression in adolescents.
The study was funded by GlaxoSmithKline and the results, which concluded that paroxetine was safe and effective in adolescents, were published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry. With this stamp of approval, the drug was prescribed to thousands of people of all age groups — including teens — for ailments from depression to dizziness. Though it was one of GSK’s most profitable drugs, paroxetine soon racked up stacks of side-effect complaints as serious as dependence and suicide.

According to The Herald, part of the controversy lies in the claim that Keller used selective reporting — he discarded negative findings — to come up with his positive results. But another ethical concern is the alleged claim that a GSK-affiliated employee ghostwrote the study’s results. In other words, the accusation is that Keller accepted money from the pharmaceutical company in exchange for allowing the study’s findings to be written by someone paid by GSK and published under his name. While the jury is still out on this case, it’s a reminder that we shouldn’t assume that money can’t influence the health profession.
In fact, the very structure of this industry consistently puts profits before patients. In 2010 alone, Americans spent more than $307 billion on prescription drugs. Many pharmaceutical company apologists argue that these tremendous revenues are necessary to pay for the costs of research and development."

CONTINUE READING HERE.

*Addendum: see comment below in comment section, thus the added image snippet of the recent Out of the Black Box: Treatment of Resistant Depression
in Adolescents and the Antidepressant Controversy published article featuring the scandalous PAXIL 329 co -authors-Wagner,Keller et al as authors

AstraZeneca Files Suit Against FDA Over ANTIPSYCHOTIC Seroquel Drug ruling

Via Fox Business AstraZeneca Files Suit Against FDA Over Seroquel Drug Ruling

AstraZeneca ..."seeking an injunction barring the U.S. Food and Drug Administration from granting final marketing approval of generic forms of the drug, whose chemical name is quetiapine, until Dec. 2, or at least until a federal court has a chance to review the agency's action.

The suit seeks to overturn a ruling last week by the FDA that generic copies of the antidepressant would not have to carry the same warnings about possible side effects -- including suicidal thoughts and high blood sugar levels -- that were required of AstraZeneca."

----

It's about time that the mass media outlets understood what the drug is they are writing about--Seroquel is an antipsychotic, a neuroleptic with far more grave side effects than diabetes and weight gain. Blood clot risk, malignant neuroleptic syndrome, the list goes on and on. The drug was approved for indication of add-on to an antidepressant, the drug itself is NOT an antidepressant.

Seroquel, the antipsychotic that remains in litigation for over 26,000 lawsuits for diabetes that still is not resolved. Read more about the lawsuits HERE, at the Seroquel Lawsuit Blog

The Great American marketing scam: Antipsychotics are more popular for patients without mental illness

via the Washington Post-read article here:

"Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.

“It’s a total outrage,” said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. “These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug.”

Like Seroquel...

Merck receives FDA Bad Ad Program warning letter: Dr. Armando Favazza promoted off-label use SAPHRIS for MDD

The antipsychotic Saphris was promoted as a treatment for MDD, which is a not approved by the FDA by Dr. Armando Favazza who was speaking on the behalf of the maker of SAPHRIS, Merck. His oral statements were reported to the FDA Bad Ad Program. The antipsychotic Saphris has side effects such as sudden death!

The FDA Bad Ad Program warning letter to Merck-2-28-12

RxISK a new data based site to research,report medicine side effects: Healy & Whitaker on the medical research team

This is a new, free, non-pharma funded website for patients, pharmacists and doctors to research medicine side effects, and to report side effects. The data cloud listed for each drug (look up your psych meds)has different words to click on to read the data reports on things such as suicide,deaths,diabetes,age,gender...etc. go to the site RxISK: Making medicines safer for all of us and bookmark it! The medical research board features Dr.David Healy, Robert Whitaker, Dr. Kalman Applbaum, and more.

Maria Bradshaw is featured

Maria Bradshaw lost her only child, and son to SSRI induced suicide: from the site

"The important thing is that we file the information so that we can learn about the risk and safety profile of these drugs, and adjust prescribing practices, and monitoring practices, as a result of what we know.

And so I would encourage everybody out there to fill out the RxISK Adverse Reaction Reporting form and be part of collecting the data we need to make sure that people’s health, well-being and safety is protected."-Maria Bradshaw

Risperdal settlement:J&J's Drug Settlement for $1 Billion Is Rejected by feds

VIA Wall St Journal

"Federal prosecutors in Washington, D.C., have rejected a roughly $1 billion proposed settlement to resolve allegations that Johnson & Johnson promoted the antipsychotic drug Risperdal for unapproved uses, according to people familiar with the matter.

J&J and the federal prosecutors in Philadelphia who had reached the tentative deal now must go back to the drawing board, because the officials in Washington are seeking a larger settlement, the people said.

Since 2004, federal prosecutors have been investigating Risperdal marketing by J&J's Janssen Pharmaceutical unit. Under federal law, firms can market a drug only for uses approved by the ..."

Canadian sufferer: Prescribed Seroquel for insomnia, now diabetic

A comment found at the Seroquel Lawsuit blog, March 7, 2012 is a sad commentary on the antipsychotic being prescribed off-label with horrific side effects happening to innocent people:

"I'm in Canada and didn't know about the law suits regarding Seroquel/Quetiapine. At age 69 in Feb of 2011 I was prescribed Quetiapine for severe insomnia that was leading to hallucinations from sleep deprivation. I took four doses, one each night for four nights and on the fifth day fainted and fell on my kitchen floor and in Emergency it was determined that my blood sugar was high (9 in Canada or 162 in US) and even though I never took another dose I have been left with type two diabetes. My blood sugar has always been normal until I took this drug and I'm furious. I've had so many complications associated with diabetes in this past year including peripheral neuropathy and psoriasis and a toe that will not heal from having the nail removed on January 11, 2012 (it's now March 7th) even though I'm controlling my blood sugar very well. Why was this stuff ever approved in the first place when it can cause permanent life threatening side effects and they knew about it?"

HHS re: Drugmakers:"The corporate integrity agreement is not sufficient to deter further misconduct."

via Pharmagossip via USA Today

Drugmakers have paid $8 billion in fraud fines – USATODAY.com

"via www.usatoday.com
WASHINGTON – The nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade, but they remain in business with the federal government because they are often the sole suppliers of critical products, records show.

"We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."

In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said.

To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said his organization, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement. That could begin with cases being investigated now, he said."

----

Until the individuals are penalized in ways that are not to be ignored, the CIA'a are as worthless as birdcage liners, 'cause it appears that paying fines is built into the business plan! and people suffer as as result. (and government is ripped off besides)

Here is the link to the entire LIST of Corporate Integrity Agreements, and it is not just the Big Pharma cos, it is doctors, pharmacies and hospitals....etc.

Starry Night interactive animation

Could an antibiotic treat the symptoms of Schizophrenia?

I found this via Pharmagossip this morning.

An antibiotic used to treat pneumonia and acne Minocycline which is a broad-spectrum tetracycline antibiotic could be a new way to treat schizophrenia according to this article there are studies being done around the world based on a case study of a patient treated in a hospital with the antibiotic who was suffering from paranoia and delusions. Interesting study, and it's not promoting a 'new block buster antipsychotic' so it might be worse watching for outcome results.

Basic information about Minocycline here.

Carl Elliott responds to the Slate article retraction

VIA The Chronicle of Higher Education March 1, 1012

By Carl Elliott
"Just over a decade ago, a new financial opportunity appeared in the field of bioethics. Pharmaceutical and biotechnology companies were giving away money. Some companies had started making contributions to bioethics centers; others paid bioethicists to work as consultants and advisers; still others funded endowed chairs and branded awards.

Many bioethicists welcomed the money, arguing that it would support the good work being done by the field; others thought that it might present a conflict of interest, but one that was manageable as long as the source of the money was disclosed. My own reaction was slightly different. To me, the pharmaceutical industry was the serpent in the garden, and its head would need to be crushed."

Read the entire article here at Chronicle of Higher Ed.

William Heisel: Pressure From Politically-Connected Stem Cell Firm Celltex Leads To Slate Retraction

Here is William Heisel's take on the Slate retraction of Carl Elliott's "Celltex Affair" article. (remember that Carl Elliott wrote about the Dan Markingson suicide and the AstraZeneca Seroquel trial gone bad...)

Via Reporting on Health

Pressure From Politically-Connected Stem Cell Firm Celltex Leads To Slate Retraction:

In part

"Celltex recently hired the editor of AJOB, Glenn McGee, and other bioethicists have charged that McGee has been running the journal while working for Celltex. Following the criticism, McGee announced today that he has quit Celltex.

The company works in a medical and ethical gray area, harvesting adult stem cells from fat and injecting them into other parts of the body without solid evidence that the procedures work. Bioethicist Leigh Turner at the University of Minnesota has suggested that the company’s work looks exactly like something that would prompt action by the U.S. Food & Drug Administration. And on Wednesday, David Cyranoski at Nature wrote that “there is evidence that the company is involved in the clinical use of the cells on U.S. soil, which the FDA has viewed as illegal in other cases.” The company so far has escaped regulatory scrutiny, and its CEO, David Eller, is very politically connected. He is a major donor to Texas Gov. Rick Perry, and Perry is Celltex’s most famous patient."-William Heisel

Glenn McGee resigns from Celltex Therapeutics effective 2-28-12

Source: Glenn McGee via Twitter

After this press release a few weeks ago Celltex Announces Glenn McGee, Ph.D. as President of Ethics and Strategic Initiatives

And much talk in the bioethics world see Fear and Loathing in Bioethics

Slate pulls article today Celltex Affair article pulled

There's something wildly brewing in this story....

Slate pulls the Celltex Affair article

via Slate:Editor’s Note
Slate withdraws "The Celltex Affair."
By David Plotz|Posted Wednesday, Feb. 29, 2012, at 9:43 PM ET
On Feb. 17, 2012, Slate published an article titled “The Celltex Affair: An Ethics Scandal Strikes the World of Bioethics.” Because of shortcomings in the editorial process, the article did not meet Slate’s standards for verification and fairness and should not have been published. We withdraw the article and apologize to Dr. Glenn McGee.

Reminds me of the Stan Kutcher incident with the Halifax newspaper retraction a while back...

Slate pulled this article already posted on this blog: "The Celltex Affair" by Carl Elliott "An ethics scandal strikes the world of bioethics"
This is a must read by Carl Elliott via SLATE:"The stem-cell tourism industry is not exactly renowned for ethical probity, much less scientific rigor. Given its reputation for peddling untested remedies to desperate patients, not to mention its starring role in several sting operations on 60 Minutes, a few eyebrows went up when one of the nation's leading journals of medical ethics relocated to the offices of a commercial stem cell clinic in Sugar Land, Texas. In December, the editor of the American Journal of Bioethics, a man called Glenn McGee, took up a new job with Celltex Therapeutics as its president for ethics and strategic initiatives. He now works for a new business venture..."

** Addendum Glenn McGee resigned from Celltex Glenn McGee resigns effective 2.28.12.

For readers of now in hiatus Furious Seasons: Remember commenter Rosie of SSRI stories? Interview by David Healy

First, I am truly sorry to read that Rosie has terminal cancer. I want to thank her for all of the hard work and dedication to SSRI stories as well as for all of the comments I enjoyed over the years at Furious Seasons.

VIA Dr.David Healy's BLOG:The story of SSRI stories:

Rosie Meysenburg’s story

For anyone interested in the effects of drugs, the website SSRI stories has been an inspiration. Rosie Meysenburg, its creator, was recently diagnosed with cancer and is terminally ill. The story of how she came to create SSRI stories shows what people can do to hold the powers that be to account.
—David Healy

DH: How did you get started with SSRI stories ?

--
Read the entire interview here, at Dr.David Healy's blog.

Use the SSRI stories as a resource full of information HERE.

Here's a post from Philip Dawdy's Furious Seasons where Rosie enlightens the readers with information in comments: December 08, 2009-Oh, Paxil, You Personality Changer!

All of my best to you, Rosie.