"Dr. Nemeroff has a track record of unethical behavior that has harmed the standing of our field" says petition to ADAA

PHARMALOT has this story up about Charles Nemeroff and a petition to the ADAA (Anxiety Disorders Association of America)Board of Directors asking for his removal.

Here's why:

"Dear ADAA Board of Directors:
As clinicians and researchers in the field of anxiety disorders, we would like to express our disappointment with the addition of Dr. Charles Nemeroff to the ADAA Board of Directors. Dr. Nemeroff has a track record of unethical behavior that has harmed the standing of our field, the credibility of some of its treatments, and risked the well being of millions of patients. The recent U.S. Congressional investigation resulting in his dismissal from Emory University has been widely publicized.

We understand the Board of Directors must evaluate many factors when considering candidates for membership and that the case for Dr. Nemeroff’s involvement might be compelling, if not for his history of ethical violations. In determining its position on the issue, the Board apparently overlooked or questioned the severity of the case against Dr. Nemeroff. Nonetheless, we do not believe the Board’s position represents general sentiment within the professional community, nor does it erase the public record upon which many potential supporters of ADAA will determine their opinion.

The concerns expressed in this letter are not based on knowledge of any current unethical behavior or Dr. Nemeroff’s present level of contrition regarding past behavior. Our objection is based solely on a well-publicized history of unethical behavior and its potential damage to the credibility of ADAA within the general and professional community. By selecting Dr. Nemeroff to represent the organization at its highest level, the Board sends the wrong message to ADAA’s membership and to the public at large regarding the organization’s values and commitment to integrity in patient care, research, and education. ADAA is not immune to the public distrust and decline in professional membership inevitably associated with decay of an organization’s credibility.

As individuals concerned with the welfare and future direction of the organization, we call upon the Board of ADAA to rescind the appointment of Dr. Nemeroff. This would demonstrate to the membership of ADAA and to the public at large that the organization is committed to maintaining the highest ethical standards."

Link to petition Dear ADAA Board of Directors

Texas Risperdal settlement resolved: whistle-blower Allen Jones, "I have done all that I can to expose Johnson & Johnson"

via and hat tip to PharmaGossip Finally! Texas judge finalizes $158 mln Risperdal settlement | Reuters:

Whistle-blower Allen Jones will receive 17% reward from the $158 million fine from Johnson & Johnson, and has said he has done all he could to expose the company. See the article HERE.

Thanks to Allen Jones for standing up for what is right, and exposing the TRUTH.

~

From 1 Boring Old Man says it all with great perspective, as usual:


...."I’m glad this is finally going to be settled, so we can stop looking at court proceedings and dollar figures, and focus our attention on what matters – how J&J/Janssen was able to get away with this throughout the span of their patent’s lifetime – and start figuring out ways to prevent this story from having any more reruns...

"By the time this case is over, we will prove to you that Janssen lied about Risperdal’s dangers just to make money" says attorney for Arkansas

Risperdal state of Arkansas lawsuit news

via Pharmagossip March 27, 2012 J&J Duped Arkansas Doctors Over Risperdal, Lawyer Tells Jury - Bloomberg

"Johnson & Johnson (JNJ) officials repeatedly misled Arkansas doctors about the safety of the antipsychotic drug Risperdal, and the drugmaker should be held responsible for those deceptions, a lawyer said.
J&J’s Janssen unit made misleading claims about Risperdal’s health risks and effectiveness in a letter to more than 6,200 Arkansas doctors, violating the state’s deceptive-trade practices law, one of the state’s lawyers told a jury in Little Rock today. Arkansas is seeking more than $1.25 billion in penalties over the campaign.
“By the time this case is over, we will prove to you that Janssen lied about Risperdal’s dangers just to make money,” Fletcher Trammell, an attorney for Arkansas, told jurors in opening statements in a trial over J&J’s Risperdal marketing tactics.
It’s the fifth jury trial over states’ claims that J&J, the second-biggest maker of health products, hid Risperdal’s diabetes risks and tricked Medicaid regulators into paying millions of dollars more than they should have for the medicine. J&J ended the most recent trial in Texas with a $158 million settlement in January."

Teva launches generic antipsychotic Seroquel in the U.K.

via in Pharm Same day AstraZeneca lost patent protection:

"Teva has launched a generic version of the antipsychotic Seroquel on the same day AstraZeneca loses patent protection on its drug.

The generic forms of Seroquel (quetiapine) and the prolonged release Sondate XL (quietiapine XL) are now available in the UK for the first time.

The former is indicated for schizophrenia and the treatment of moderate to severe manic episodes, while the XL version is approved for schizophrenia and bipolar disorder, and add-on treatment for patients with major depressive disorder who have not responsed to antidepressant monotherapy.

The 300mg high dose of Seroquel currently costs £170, but Teva will charge just £25.50 for the same dosage of its generic.

The price difference for Quetiapine XL is much more narrow, with the high dose 400mg generic costing £169.65, and AstraZeneca’s branded price being only slightly higher at £226.20.

The NHS in England spent £93 million on Seroquel in 2010 - the second highest spending on any antipsychotic.

The NHS and can now look forward to significant savings from generic quetiapine tablets over the coming years.

AsraZeneca's patent loss comes one year after Lilly lost protection on its antipsychotic Zyprexa (olanzapine) in the UK.

The NHS in England spent £114 million on the drug in 2010, the highest spending on any antipsychotic in the country.

Kim Innes, commercial director at Teva, said: “With the launch of Quetiapine and Quetiapine XL, we’re making more medicines accessible for more people.”

She added that Teva has now launched ten new products in the past 11 weeks, including seven on day one of patent expiry.

This includes its generic version of Pfizer and Eisai’s Alzheimer’s drug Aricept (donepezil), which was launched in the UK last month.

The Seroquel brand is AstraZeneca’s second-best seller behind cholesterol drug Crestor, and accounted for 17% of the company’s $33.6 billion worth of sales last year.

Losing patent protection will be a big blow to the global sales of the firm, and will be particularly painful for its UK business."

J&J Texas Risperdal case returns to court: "They are trying to produce a chilling effect on the ability of whistleblowers"

Says Allen Jones, according to this March 25, 2012 Chilling! in Texas; Johnson & Johnson heading back to court | Reuters--via Pharmagossip:(via Reuters)

(Reuters) - "Representatives of Johnson & Johnson and the state of Texas will head back to court on Tuesday over a $158 million settlement agreement announced in January involving the drug Risperdal, a spokesman for Texas Attorney General Greg Abbott said on Sunday.

"As far as we knew, we had a solid settlement," said Tom Kelley, Abbott's spokesman. "We'll have more information on Tuesday about what has caused (Johnson & Johnson) some concerns."

A spokesman for Johnson & Johnson did not immediately respond to questions about the hearing before state District Judge John Dietz in Austin.

Johnson & Johnson said in January that it would pay $158 million to settle a Texas lawsuit that accused the drugmaker of improperly marketing its Risperdal anti-psychotic drug to state residents on the Medicaid health program for the poor.

The settlement would fully resolve all Risperdal-related claims in Texas, the company said at the time. The agreement -- the largest Medicaid fraud recovery ever in Texas -- was specific to the Lone Star State and did not involve other state or federal Risperdal litigation.

The deal marked the first Risperdal settlement with any U.S. state. It settled claims brought by Texas in 2004 involving alleged Medicaid overpayments during the years 1994 to 2008. The settlement was to be paid to the original plaintiff, his attorneys, the state of Texas and the federal government, which provides Medicaid reimbursements, the company said in January.

Tom Melsheimer, a lawyer for plaintiff Allen Jones, said on Sunday that the hearing on Tuesday is "just to finalize the settlement."

But Jones, a whistleblower on J&J's marketing practices, said the sticking point is that Johnson & Johnson wants to reduce the amount of the settlement that he and his attorneys receive.

Johnson & Johnson "has reneged on the agreement and it's back in court," Jones said. "They are trying to produce a chilling effect on the ability of whistleblowers to come forward."

Arkansas Risperdal trial begins Monday, March 26, 2012

Hat tip PharmaGossip:

Antipsychotic Risperdal trial for alleged concealed health risks and illegal promotion

via Trial set for Ark. suit over anti-psychotic drugs


"LITTLE ROCK, Ark. (AP) — A jury trial is scheduled to begin Monday over accusations that a pharmaceutical company illegally marketed an anti-psychotic medication in Arkansas.

Arkansas Attorney General Dustin McDaniel filed a lawsuit against Johnson & Johnson, claiming that its Janssen Pharmaceuticals subsidiary concealed the potential health risks of the drug Risperdal. The suit also alleges that the company promoted it for unauthorized uses in violation of Arkansas' Deceptive Trade Practices Act and the Medicaid Fraud False Claims Act.

Risperdal is used to treat schizophrenia and bipolar disorder.

If the company is found to be in violation of the law, the state could possibly see an award of about $1 billion, the Arkansas Democrat-Gazette (http://bit.ly/GNDDkA) reported on Saturday.

It's the fourth time Johnson & Johnson has gone to trial over a state's complaints about Risperdal since they first arose in 2004. The most recent trial, in Texas, ended with a $158 million settlement.

In a final appearance before Circuit Judge Tim Fox on Friday, both sides said settlement talks are over. Fletch Trammell, one of the attorneys representing Arkansas, described negotiations between both sides as "unfruitful.""

PharmaLive: Senators Press for Solution to Painkiller, Antipsychotic Abuses

VIA PharmaLive PharmaLIVE

Senators Press for Solution to Painkiller, Antipsychotic Abuses [the Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (March 23, 2012)

March 23--WASHINGTON -- Fearing an "epidemic" of death and defects from the illegal use and improper prescribing of painkilling and antipsychotic drugs, senators Thursday pressed a panel of doctors and health-care officials about how to stop the problem.

"It is tragic, it is sad, it is needless, it is fraudulent, it is horrible," said Sen. Jay Rockefeller (D.,W.Va), chairman of the Finance subcommittee on health. "And it is costing so much money that could be spent elsewhere."

The Centers for Disease Control and Prevention used the term epidemic in the fall in reporting that deaths from overdoses of painkillers had more than tripled in the last decade and surpassed heroin and cocaine deaths combined. State and federal authorities have tried to arrest those running so-called pill mills, at which painkillers are sold illegally.

Likewise, some of the highest-profile criminal and civil cases in the health-care fraud realm have involved pharmaceutical companies illegally promoting antipsychotic drugs.

The Justice Department will not comment, but it reportedly wants Johnson & Johnson to pay what would be a record $1.8 billion to settle charges that the company illegally promoted its antipsychotic drug Risperdal.

J&J paid $158 million to stop a trial and settle a case brought by the state of Texas, which learned of Medicaid fraud -- including promotion of antipsychotics for unapproved use in children and payments to officials -- from whistleblower Allen Jones, who had discovered similar problems while working for the state of Pennsylvania.

Texas and Pennsylvania (but not New Jersey) were among the states that responded to letters from Sen. Charles E. Grassley (R., Iowa) in 2010 and again in January, asking for information about the top 10 prescribers who worked through Medicaid, the health-insurance program for poor Americans administered by states and the federal government.

Grassley noted that one Nevada doctor wrote nearly 6,800 prescriptions over two years, costing Medicaid $2.75 million.

"While some of these outliers are legitimate providers in high-volume practices such as in mental hospitals, many could not be explained," Grassley said.

Texas Medicaid chief Billy Millwee testified at Thursday’s hearing that in response to the information generated by Grassley’s request, four prescribers were excluded from the Medicaid program, 39 were under investigation, three were referred to the state attorney general, and two were referred to the licensing board.

The FDA has approved Risperdal for use in children aged 5 and older only for autism-related problems. But doctors can prescribe what they like, and there have been reports of toddlers and infants being prescribed antipsychotic drugs.

Millwee said Texas revamped its foster-care program to better monitor any prescriptions written for young children. A doctor cannot write a prescription for antipsychotics for a child age 3 or under without calling to discuss the situation with Medicaid authorities.

"That’s a big difference in where we were 10 years ago," Millwee said after the hearing. Asked about the larger lesson of the Risperdal trial, he said: "It goes to looking at the information we’re given about drugs. After digging into the case, you walk away really suspecting and saying, ‘I’m going to ask more questions and be more skeptical.’ It’s very difficult for us when you have advocates that are being paid by the drug companies to speak out about something. That taints your belief in the system."

Contact David Sell at 215-854-4506 or dsell@phillynews.com or Twitter @PhillyPharma. Read his PhillyPharma blog on philly.com.

------

(c)2012 The Philadelphia Inquirer

Visit The Philadelphia Inquirer at www.philly.com

Distributed by MCT Information Services

Antipsychotics database missing: PLoS, and Dr. Erik Turner

ANTIPSYCHOTICS: News regarding this story-Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database from PLoS, today comes the news that the antipsychotics databased used is REMOVED, MISSING.

See Silent takedown of the pharma trials database…and more: from PLoS blogs

"Those of you with more than a passing interest in publication bias and other threats to the integrity of the research literature may have noticed the publication of a study in this week’s PLoS Medicine which looks at the effects of such bias on apparent efficacy of antipsychotic drugs. While the article was in press at PLoS Medicine the lead author, Erick Turner, noticed that a database, initially set up by PhRMA (Pharmaceutical Research and Manufacturers of America) to “serve the valuable function of making clinical trial results for many marketed pharmaceuticals more transparent….” had mysteriously disappeared from the internet – thank you for the hat tip to Erick. (The authors had included this database, amongst others, to try to identify all trials conducted on the antipsychotics they investigate in their analysis). Cynical readers can view an example of what the database used to look like at this page through the Internet Archive – the database used to be present at http://www.clinicalstudyresults.org/).

At the time that Clinicalstudyresults.org was set up, PhRMA touted the initiative as an important venture for achieving transparency and access to the results of all phase III and IV studies (both positive and negative) which had been conducted on PhRMA-member company approved drugs. The last version of the clinicalstudyresults.org website in internet archives seems to suggest that PhRMA now views this database as irrelevant, commenting that other databases have “expanded dramatically, including the National Library of Medicine’s www.ClinicalTrials.gov”. However, the clinicalstudyresults.org website is now entirely inaccessible, and previous versions of it available through internet archiving give no obvious information about plans for rehousing data previously held by clinicalstudyresults.org in public repositories. "

"It’s clear that voluntary mechanisms adopted by pharma – and even unenforced government mandates – are not currently solving the perennial problem of publication bias."

Read more HERE.



Again,it seems our healthcare system is based on hidden data, buried data,BS and more BS all spun up to the American public as "healthcare".

We live in a corporate ran America, there is truly nothing left called patient safety,compassion or concern for human kind, no it is all about $profit$ over patients, and don't forget it. You are a dispensible marketing target.



What is this all about? listen to this interview with Dr.Erik Turner from Oregon Health & Science University:

Erik Turner, M.D.

AstraZeneca's antipsychotic Seroquel diabetes lawsuit: the client saga continues--was this a Miller Firm "client dump"?

The story continues to unfold on the Seroquel Lawsuit Blog--of the client's payout for injury from taking the antipsychotic Seroquel and becoming diabetic as a result.

This blog, written anonymously has been a one-of-a-kind source and resource for Seroquel Lawsuit information. The litigation that Bloomberg called "settled" in the summer of 2010 is far from that. Over 26,000 lawsuit plaintiffs continue to wait for payment compensation.

As the letter above states (image via the Seroquel Lawsuit blog)that client's case was closed. Read the story behind that at the Seroquel Lawsuit blog.

Story also found at Pharmagossip.

Addendum: A.M.3-22-12

I have questions, I asked Alison Frankel from Reuters

About the litigation

And

VIA Twitter See tweets here.

U.K.High Court rules AstraZeneca's patent on antipsychotic Seroquel XR invalid

via U.K.Courts net High Court rules AstraZeneca drug patent invalid

"Pharmaceutical giant AstraZeneca has suffered a blow after the High Court ruled a patent protecting one of its key drugs was invalid in the UK. Seroquel, which is used to treat mental disorders like depression and schizophrenia, has annual sales of approximately £3.6bn worldwide, including £1.8bn in the US. The UK patent was challenged by rival pharmaceutical firms Accord Healthcare, Intas Pharmaceuticals, Hexal AG and Sandoz, Teva UK and Teva Pharmaceutical Industries. The patent for Seroquel has been challenged before in Holland, where it was upheld, and further trials have been held in the US and Spain, where rulings have yet to be made. The US patent is due to expire this month, while the patent has already expired in Canada, where there are now several generic versions on the market. A statement said: “AstraZeneca is disappointed with the court's decision. However, the company remains committed to defending its intellectual property protecting Seroquel."

Also via Reuters The High Court has found the patent to be invalid on the extended-release version of Seroquel, AstraZeneca's (AZN.L) blockbuster antipsychotic, dealing a further blow to a highly profitable franchise.

"The High Court is the first to rule that the Seroquel XR (extended-release) formulation patent is invalid, AstraZeneca said, and the decision comes after the District Court in The Hague, the Netherlands, reached the opposite conclusion earlier this month.

The Anglo-Swedish company is fighting to protect the Seroquel franchise in multiple markets. Earlier this month it said it was suing the U.S. Food and Drug Administration in a last-ditch attempt to stop generic versions of Seroquel IR."

H/T Pharmagossip

Could a probe by FDA of CellTex be in the future? :"FDA may probe TX firm that held Perry's stem cells"-CBS news

VIA CBS news: FDA may probe Celltex:

"FDA may probe TX firm that held Perry's stem cells

WASHINGTON — "The Food and Drug Administration has received a complaint against a company that stored adult stem cells from Texas Governor Rick Perry for use in an experimental procedure to treat his back pain.

A University of Minnesota professor is calling on the FDA to investigate the safety and legality of services offered by CellTex Therapeutics, a company which banks patients' own stem cells for future use in medical procedures.

"I think there's a role here for the FDA to ensure that people are receiving safe and effective treatments," said Leigh Turner, an associate professor of bioethics, in an interview with the Associated Press. "I think a lot of these stem cell therapies seem like 21st century quackery."

Turner believes the Houston company's business model runs afoul of FDA regulations governing human stem cells, though the area is subject to multiple rules

A spokeswoman for the FDA declined Wednesday to comment on the letter or say "what, if any, investigation would take place based on the concerns submitted."

Turner said an agency official contacted him last month to say that the Feb. 21 letter is being "taken seriously." CellTex is only one of multiple U.S. companies offering to store stem cells for untested medical procedures, Turner said.

While pursuing the Republican presidential nomination last fall, Perry revealed that he had stem cells taken from fat in his body, grown in a lab and then injected into his back during a July operation to address back pain.

News of the procedure triggered criticism last November from medical experts who said untested stem cell treatments carry a host of potential risks, ranging from blood clots to infection."

Read more here.



The tangled web continues to intrigue...

Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

VIA PLoS: Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

Methods and Findings

FDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.

Conclusions

The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs."

Note the research funding:

Funding: Grant support: Stanley Medical Research Institute, grant number 08D-1892 (http://www.stanleyresearch.org/dnn/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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"

*commentary is based on my opinion

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."

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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."

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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