Tagged: FDA

Ed Silverman: Dear Scott Gottlieb: Add new warnings to Paxil labels. You may save a life…


A little too late for many, however good to see someone of Ed Silverman’s character speaking out about the scandal of Seroxat/Paxil.

https://www.statnews.com/pharmalot/2017/05/01/paxil-suicide-warning-fda/?s_campaign=fb&utm_content=buffer12cb5&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer

 

D

ear Dr. Gottlieb,

As you inch closer to becoming the new head of the Food and Drug Administration, your list of challenges must be swelling. Here is one more item to add: Whether to insist on a stronger warning label for the antidepressant Paxil.

For the past decade, Paxil’s label has not carried any information indicating the drug poses a statistically significant risk of suicidal behavior for anyone over 25. Yet there is scientific evidence that such a risk is real (see table 16 on page 26). A jury in Chicago recently decided that that a label warning could have prevented the death of a 57-year-old man who killed himself while taking a generic version of Paxil.

For public health reasons, the FDA should pursue a warning.

“Even recognizing the limitations of the data (found in the relevant analysis), it’s hard to understand [why] the increased risk of suicidal behavior, or attempts, is not in the label,” said Dr. David Kessler, a former FDA commissioner and now a professor at the University of California, San Francisco, School of Medicine.

Here’s the backstory: Paxil is one of several antidepressants known as an SSRI, a group that includes Prozac and Zoloft. For many years, the drugs were mired in controversy over whether they increased the risk of suicidal behavior and thoughts. The FDA eventually ordered the companies to warn of such a risk for children and young adults.

But what about issuing a warning for adults older than 25? The opportunity was bungled.

Back in 2006, GlaxoSmithKline — which makes Paxil — actually offered to revise its label to indicate a risk existed for adults. But the FDA nixed that in favor of a class-wide warning, limited to children and young adults, for all SSRI drugs. This blunted the effect of the data Glaxo had submitted to the FDA — which showed that adults on Paxil faced a much higher risk than those on all but one other antidepressant.

Instead, the FDA suggested the company could submit a supplemental warning and schedule a meeting for review. This never happened because Glaxo did not follow up (see page 127). As a result, the Paxil labeling never included information about a risk to adults.

For its part, Glaxo does not deny that its studies showed an elevated risk for adults. But the company contends that it properly conveyed all the appropriate data to the FDA and says it was the agency’s call to create a common, class-wide label instead of developing a warning more specific to Paxil.

Now, let’s fast forward to a federal courtroom in Chicago, where documents detailing these developments have been filed.

A five-week trial recently took place over a legally complicated, but significant, question — whether consumers who suffer harm after taking a generic drug should be allowed to sue the company that makes the brand-name version of the medication. In this instance, the man who committed suicide took a generic version of Paxil, made by Mylan.

Glaxo was named in the lawsuit because Mylan had to use its label on the generic. Federal regulations do not allow generic companies to independently change labeling after learning of potential risks, unless a change has already been made to the corresponding brand-name drug. That regulation was upheld in 2011 by the Supreme Court.

As a result, consumers sometimes seek to hold brand-name drug makers responsible for injuries they suffer while taking generics, although more than 100 such cases have been tossed out by courts around the country. Only two survived and one is being appealed. This time, Glaxo was the loser and was ordered to pay $3 million to the man’s widow.

The company, however, plans to appeal, which raises the possibility that not much, if anything, will change. Meanwhile, countless adult Americans will continue to be prescribed a generic version of Paxil that does not contain a warning about the risk of suicidal behavior.

But this should not be the end of the story.

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Most consumers may not realize this, but drug makers legally own the right to the labeling on their medicines. Yes, the wording is developed during talks with the FDA, but a company can certainly consider adding an additional warning.

Glaxo “had the option to go further, but chose not to do so,” said Dr. David Healy, a Bangor University psychiatry professor who helped spearhead a campaign to upgrade suicide warnings on antidepressants, and who served as an expert witness on behalf of the widow in the recent trial.

Perhaps Glaxo bet it would not face lawsuits from consumers who took the generic. Nonetheless, the possibility of harm has existed all this time. And that is something the FDA should have realized. (An FDA spokeswoman told me the agency would not comment.)

So, Dr. Gottlieb, as you look over your to-do list, consider the lack of information in the Paxil labeling. And move to fix it. You might save a life.

More Dolin Trial Bombshells: Former FDA Offical Testifies That Paxil Is Not Safe And Doesn’t Work!…


“…David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients.

Amid the objections from King & Spalding’s Andrew Bayman, he answered,

“No. I don’t believe that it works and I don’t believe that it’s safe.”….


Well, well, it seems that as the days go by more and more shocking revelations come out from the Stewart Dolin ‘Paxil Induced Suicide’ Trial in the US…

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-89-suicide-increase-for.html


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.

There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9.  It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.

Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.

His evidence started with 6 points about GSK’s responsibilities (or lack of…)

1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.

2. GSK was not upfront about Paxil’s suicidal behavior risk.

3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.

4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.

5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.

6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.

Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.

Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”

Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.

Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”

Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”

He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”

Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!

Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.

I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.

This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.

Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!

Nice ethical company, huh?

I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”

Trial continues tomorrow.

For now, it’s time for a Guinness, in honour of Stewart Dolin.

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

The Never Ending GSK Corruption….


http://www.raps.org/Regulatory-Focus/News/2016/07/01/25265/FDA-Commissioner-Listed-in-CMS-Database-for-Receiving-Payments-from-GSK-AstraZeneca-in-2015/

FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015

Posted 01 July 2016 By Zachary Brennan

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In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday.

The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than $5,000 consulting fee from AstraZeneca in 2015. In 2014, when he was not working for FDA, Califf received almost $32,000 from companies and in 2013, he received more than $28,000.

An FDA spokesperson told Focus: “We can’t immediately confirm the accuracy of data that dates back to 2015, but Commissioner Califf wasn’t on travel or at such an event on that date.  Throughout his government service, he has strictly adhered to federal ethics requirements and has no financial ties to industry.  We are examining whether the entry was made in error.”

As The New York Times reported in September 2015, ahead of his confirmation as commissioner, Califf has received about $215,000 in consulting fees from 2009 to early 2015, though as many physicians note, academic doctors are often paid consulting fees as their universities conduct clinical research.

And though Califf is the only FDA leader listed (that Focus could find), former commissioner under President George H. W. Bush, David Kessler, received $40,000 from Immucor, while FDA’s commissioner under George W. Bush, Andrew Von Eschenbach, received more than $50,000 from Chugai Pharmaceutical Co., Eli Lilly and E.R. Squibb and Sons.

FDA’s former deputy commissioner for medical and scientific affairs Scott Gottlieb, a resident fellow at the American Enterprise Institute, also was included in the database and pulled in $199,951 in 2015, including more than $60,000 from GlaxoSmithKline, more than $50,000 from Daiichi Sankyo and more than $65,000 from Vertex Pharmaceuticals. Gottlieb told Focus that he sits on the GSK research and development board, serves on the board of directors for Daiichi and acts as a senior adviser to Vertex.

Seroxat Study 329 Opens The Pandora’s Box For All Bogus Anti-Depressant Studies….


http://www.madinamerica.com/2016/05/researchers-deconstruct-ghostwritten-industry-trial-for-antidepressant/

Interview: Researchers Deconstruct Ghostwritten Industry Trial for Antidepressant

Researchers, Jon Jureidini, Jay Amsterdam and Leemon McHenry, have taken a closer look at the data from a randomized control trial of citalopram (Celexa) that was ghostwritten and then used by the manufacturers to support claims of the drug’s efficacy and safety in the treatment of child and adolescent depression. Their analysis used 750 recently-released court documents from a lawsuit against Forest Labs concerning the marketing and sales practices involved in the off-label promotion of Celexa. Drs. Jon Jureidini and Jay Amsterdam were expert witnesses in the case. The article is published, open-access, in the International Journal of Risk & Safety in Medicine. 

To get the background on this story, we connected with Dr. Leemon McHenry, an investigator in this study and a lecturer in philosophy at California State University, Northridge.

Citalopram_film-coated_tablets

Can you discuss how you first came across this citalopram study and what caused you to look into the claims in more detail?

I am a research consultant for the law firm of Baum, Hedlund, Aristei & Goldman in Los Angeles, California that takes up cases against pharmaceutical companies. This law firm is committed to exposing the misdeeds of drug companies by making sure that the confidential documents produced in the course of litigation are ultimately released to the public and independent researchers.

Following the revelations of Study 329, in which Glaxo Smith Kline (GSK) misreported the efficacy and safety of paroxetine (Paxil)  for adolescent depression, we began to look at all of the studies that came out during this push by pharmaceutical companies to get psychiatric drugs approved for pediatric use.  So, what your readers may already know in this case is that paroxetine did not get licensed, and so all of the prescriptions of this drug to adolescents were “off-label.” That is legal for doctors to do that but it is illegal for pharmaceuticals to promote drugs for off-label uses.  Forest’s citalopram was in the same situation.

Citalopram study CIT18 was one study that was used to get approval for escitalopram (Lexapro) use in adolescent depression, so that made this study particularly important. Ultimately, the FDA granted the license based on two studies that were supposed to be positive, but it turns out that this study CIT 18 that we wrote about was, in fact, negative, and the other one was questionably positive.

This study was used to justify the FDA’s approval of citalopram for the treatment of depression in adolescents. In your estimation, should the FDA have made this approval given the existing evidence?

I don’t think that the FDA was fully aware of the extent to which this trial had been misrepresented.

This is the kind of thing that comes up in litigation where lawyers file suit, and the companies are obligated to make these document productions available as evidence. So you are going through millions of pages of documents and, you know, the FDA just doesn’t have the manpower to do anything like that. The FDA pretty much has to trust that the companies are giving them reliable data when in fact they are not. Therein lies the problem.

Only a relatively small number of the documents, in this case, were made available, and we posted these on the University of California San Francisco website,  Drug Industry Document Archive,  (DIDA). Those documents provided the opportunity to critique study CIT 18 and write this paper.

What is “medical ghostwriting” and how does it affect research on psychiatric drugs?

I think ghostwriting is the vehicle for misrepresenting the actual study results. There are hundreds of these medical communication companies proliferating all around the world, but in particular in the United States, England, and Australia; they are basically public relations companies engaged in marketing.  These are the businesses that employ the medical ghostwriters who produce articles for the publication plans of pharmaceutical companies.  This includes all of the articles they plan to publish based on their clinical trials, and it is the ghost writers at these medical communication companies who do all of this work writing up articles based on the data summaries provided by the statisticians.

Then what happens is that articles go through a lot of drafts, maybe 10-15 drafts, that get passed around between the statisticians and the marketing people at the companies and then, after most of this has already been written, they go looking for the so-called “author” of the paper. What often happens is that the academic physician they identify, the so-called “author,” doesn’t even see the article until it has already been drafted and revised by all of these people internally at the companies. This is just a dirty little secret of how marketing in medicine works. The ghostwriters are these individuals who are completely invisible in this process of promotion.

What is the potential harm done in this case?

Well, first of all, what we want is a system that is transparent and honest – and that’s what we don’t have because all of this ghostwriting is meant to be kept secret from the public. Even prescribing doctors don’t know that this is going on. If you tell prescribing doctors that the medical literature that they rely on is ghost written by agents of the pharmaceutical companies, most won’t have the slightest idea what you are talking about. They might look at you as if you’re crazy.

So, first of all, there is a question about scientific honesty, transparency and academic integrity. What we have is a situation where these academic physicians at universities work as “key opinion leaders” for the pharmaceutical companies. They will have as much as seven hundred, eight hundred, or even nine-hundred publications on their curricula vitae. They are supposed to be models for professors to emulate at their universities, but this is essentially academic plagiarism. They might not have done any of this writing at all. They might not have even checked the data, and they certainly have no idea whether the data that is being reported in these studies is accurate or not.

So that’s one problem. Now the other problem is the potential harm that comes from this situation and ghostwriting has been documented as a vehicle for misrepresenting results when there are serious safety issues. The most famous case, of course, is Vioxx. That drug contributed to all kinds of deaths and serious harm to people and then it was discovered that the one key article on this drug that was distributed to prescribing physicians all over the world was ghost written.  The lead author on that paper said afterward that he didn’t write the paper and that he just trusted the data he was given.

The same thing has been going on with the SSRIs and, in particular, when you’re dealing with a very vulnerable patient population such as children and adolescents, you have a real problem concerning trusting the medical literature. This is not only an issue for prescribing doctors, but it is also a problem for people who set health care policy in government. Also, these articles are very often used in court when the pharmaceutical companies try to defend themselves. So, not only do you have fraud on the medical community but you also have potential fraud in the courts.

So, when you talk about harm, you can point to cases like Merck’s Vioxx or GSK’s Avandia or to cases of antidepressants like Paxil or Zoloft that have contributed to birth defects and, it turns out, that these manuscripts were ghostwritten.  Those are the most egregious cases. With regard to children, you’ve got the problem of suicidality. There is a definite association between SSRIs and these episodes where you get these uncharacteristic suicide attempts or successful suicides shortly after antidepressant therapy. Now it is tough to demonstrate a causal link between these two, but it is concerning enough that the FDA did put a black box warning on the SSRIs.

What is it like trying to get the criticism of misleading studies like this published in major journals?

I personally think that medical journals are not scientific journals. They have not acquired the same status as journals in physics, biology, and chemistry, which are rigorously critical of any kinds of results from scientific testing. Now, you’ve already got the problem that medical journals knowingly act as vehicles for misrepresentation through ghostwriting. But when you try to correct the scientific record, and you go to a medical journal with sound evidence that an article has been ghost written and has fraudulently reported data, the journals still won’t retract the articles. That happened in the case of Study 329, and it is happening right now in the case of this article that we are currently discussing that reported on study CIT 18.  A major problem with this is that the article will continue to be cited in the medical literature, hundreds of times, as evidence of the safety and effectiveness of these drugs. What they are doing, in fact, is citing an article that is fraudulent.

Now, if you try to publish criticism of a fraudulent article, what you’re going to find is that you are certainly not getting published in one of the high-impact medical journals, like BMJ or Lancet in the UK, or JAMA or NEJM in the US.  First, there is a very deep concern that pharmaceutical companies will file libel suits and in the UK, where the libel laws favor those allegedly defamed; they are very cautious about publishing anything that could lead to such a suit. In the US, you’ll find that the lawyers advising the journals will suggest that they not publish critical pieces like this. So this has far-reaching consequences for the integrity of the medical literature.

But, another problem is that these journals are taking on vast quantities of money from pharmaceutical companies in the form of drugs advertisements, CME courses, reprints and supplements and that is what I would consider a considerable conflict of interest when it comes to editorial decisions on critical manuscripts submitted to the journals.

So what does all of this mean for that state of the medical literature and research on psychiatric drugs?

I think that one of the most important things going on here is that we are supposed to live in an age of Evidence-Based Medicine, and physicians are keen to suggest that they have an evidence-based practice — that they are in fact following the results from the golden standard of scientific evidence, randomized placebo-controlled clinical trials.

So, how can you possibly claim to have evidence-based practice if it turns out that what you are relying upon is medical journals that are publishing ghostwritten misrepresented results from clinical trials?  The vast majority of studies published are industry-funded studies. You have a serious problem here for evidence-based medicine.

What you find in pediatrics is the academic investigators in the industry-sponsored clinical trials who have prescribed the SSRIs off-label to children and adolescents see some evidence that these drugs are helpful. But then, they get negative results in the clinical trials. So now there is a contradiction. Are they going to trust their own experience or the results of the placebo control trials, that turn out to be negative? Well, you can’t claim to believe in Evidence-Based Medicine, if now you’re going to ignore the results of the trials. So this is where you get the slicing and dicing of data. The company scientists and academics investigators  might start to move the outcomes around and say, “well maybe these secondary outcomes are what we really want to focus on, so we’ll just forget the negative primary outcomes and focus on this.”  But, if they are looking at data in order to get it to match what they have seen in their prescribing experience, that’s got things backward.   They can’t claim to be engaged in the serious scientific testing of medicine. We often see that the study drug fails to beat placebo, but often prescribers don’t consider that they might be seeing a placebo effect in practice.

When you have researchers who are seeing this glaring contradiction between the results of these trials and what they think they see in their practice, it almost like a pilot that can’t trust the instruments on his airplane anymore. In their defense, they might really believe that these drugs are safe and effective for adolescents, but there is a sort of confirmation bias going on where they are discounting the evidence to the contrary.

 

*

Jureidini, Jon, Amsterdam, Jay, McHenry, Leemon, The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance, International Journal of Risk & Safety in Medicine. 2016 28[1]:33-43. (Full Text)

Mad In America : The FDA Is Hiding Reports Linking Psych Drugs to Homicides


In my wildest dreams, I could never have imagined being drawn into a story of intrigue involving my own government’s efforts to hide, from the public, reports of psychiatric drugs associated with cases of murder, including homicides committed by youth on the drugs. But that is precisely the intrigue I now find myself enmeshed in.

The saga began several years ago. My child had the misfortune of being born during the last month of eligibility for kindergarten, and was subsequently labeled with A.D.H.D. – which stands for August Date Hikes Diagnosis. While other Americans with the same chronological impairment such as Man Ray and Robert Ringling managed to make something of themselves despite being born in the month of August, it seemed my child was doomed to failure from the get-go, unless provided lifesaving stimulant medication.

With an abiding uneasiness about both the alleged disorder and its miracle remedy, as they were presented to me, I set out to understand as much as I could about stimulant medications, prescribed disproportionately to the youngest children in the class.

It wasn’t long before I stumbled upon the FDA Adverse Event Reporting System (FAERS), also referred to as MedWatch. The FDA publishes quarterly FAERS data files on its website containing hundreds of thousands of reports of various drug adverse events. Though unencrypted, the FAERS files might as well be, as the data appear hieroglyphic to the average person who is not a database expert, including myself at the time.

With the aid of the internet and with a lot of trial and error, I taught myself to write Structured Query Language (SQL) code to decipher the FAERS files. I first plumbed the depths of the adverse event data searching for reports of pediatric fatalities associated with stimulant medications, and found hundreds of them. Expanding my queries to include all psychotropic medications, I eventually identified nearly 2,000 pediatric fatalities. (More on the pediatric psychotropic fatalities in a future post.)

As I contemplated the gravity and the scale of the human tragedy, I began to wonder what drug side effects these children experienced at the time of their deaths. The FAERS data files yielded answers: cardiac arrest, respiratory arrest, hepatoxicity, multi-organ failure, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Neuroleptic Malignant Syndrome, completed suicide, homicide . . . Wait, what?  Homicide, as a drug side effect? Then I saw it again: Murder.

The light bulb went off. I performed a query for homicide or murder as a drug side effect. To my astonishment, there were over 700 reports in FAERS of homicides linked to psychotropic medications.

In October 2014, I submitted a Freedom of Information Act (FOIA) request to the FDA to obtain copies of the FAERS homicide reports. After ten months of “Foot Dragging and Alibis,” which is what Rep. Joe Barton (R-TX) once suggested the agency’s acronym stood for, the FDA still had not produced a single report. Frustrated with the FDA’s stonewalling, I filed a federal lawsuit in August 2015. Within three months of filing the FOIA lawsuit, the FDA coughed up over 3,000 pages of FAERS reports.

However, hundreds of pages were completely redacted, while many hundreds more were heavily redacted. A letter from Deputy Director of Information Disclosure Policy Howard Philips attested that the records were redacted in accordance with the FOIA statute, and other applicable laws. The FDA claimed that the redaction of information was justified under FOIA’s privacy exemption.

To add some perspective, according to the HHS Freedom of Information Annual Report, among 10,145 FOIA requests the FDA processed during fiscal year 2015, the privacy exemption was applied only 24 times. Federal regulations require the FDA to “make the fullest possible disclosure of records to the public” in response to FOIA requests.

All but the case numbers were redacted in 47 of the FAERS homicide reports that the FDA released. The FDA had suppressed all of the report information for these cases: age, gender, drug name(s), reported drug reaction(s), case narrative, etc. The wholesale censorship of entire FAERS reports turned out to be an untenable action on the part of the FDA.

Pursuant to 21 CFR 20.81, the FDA cannot properly withhold any record that contains data or information that have been previously disclosed in a lawful manner to a member of the public. The age, gender, drug name(s), and reported drug reaction(s) had already been publicly disclosed in FAERS data files available on the FDA’s website. It was based on this publicly available information that I was able to ascertain and request the case reports involving homicide in the first place.

I fired off a letter to then-Acting Commissioner Stephen Ostroff, protesting the FDA’s improper withholding of public information, citing the federal regulation prohibiting such conduct. A month later, I received a second production of records totaling over 3,000 pages. The agency did not acknowledge any wrongdoing, or even explain what was different about the new document dump. This time around, though, the FDA had not redacted age, gender, drug name(s), and reported drug reaction(s), but the case narratives remained entirely redacted.

Insofar as the FDA had released the case narratives of hundreds of the other FAERS homicide reports, albeit heavily redacted at times, I surmised that the case narratives of these 47 reports in particular must contain information that was damaging either to the pharmaceutical companies, the FDA, or both.

Here are four examples of medication-linked homicide case narratives that were being withheld.

Case 10213469

The narrative in this case report, when it was initially sent to me, was completely redacted by the FDA. This is what I received:

10213469

However,  I knew from the FAERS data files that the case involved a 10-year-old taking Vyvanse (lisdexamfetamine), a stimulant drug prescribed to a million children in the U.S. for ADHD. The girl had reportedly experienced a drug reaction that led her to commit homicide. The FDA would eventually send me a lesser-redacted version of the report, confirming the information in the FAERS data files, but the case narrative was still completely redacted.

Then, on April 12th of this year, the FDA presented a Vyvanse pediatric safety review to the Pediatric Advisory Committee. In advance of the meeting, the FDA’s “Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review” was made public as part of the briefing materials posted on the agency’s website. The safety review contained a bombshell case narrative summary.

Homicide (n=1) 

Case # 10213468, USA, 2014: A 3-month-old female infant was left alone with a babysitter’s 10-year-old daughter. Lisdexamfetamine was prescribed to the 10-year-old daughter of the babysitter; the 10-year old girl had ADHD, ODD, and attachment disorder. The infant sustained various injuries. The autopsy reported the cause of death was “asphyxia and suffocation,” as the result of “homicide.” Additionally, the infant’s blood contained traces of amphetamine (lisdexamfetamine).

In an appendix, I noticed that one of  the FAERS reports that I had requested (10213469), which had been completely redacted, was only one digit off from the FAERS report quoted in the Vyvanse pediatric safety review, and was also listed as a duplicate report.  And then I put one and one together:  The FDA had represented to the Court handling my FOIA lawsuit that the case narrative of the FAERS homicide report I had requested—number 10213469—was exempt from disclosure under a FOI request for privacy reasons, yet now the FDA had publicly disclosed the case!

On April 13th, the day after the Pediatric Advisory Committee met and considered the FDA’s Vyvanse pediatric safety and drug utilization review, I fired off an email to the Assistant U.S. Attorney on the case, copying the FDA’s Assistant Chief Counsel, demanding a lesser-redacted version of FAERS report 10213469, pursuant to 21 CFR 20.81, since the agency had publicly released a summary of the case narrative of a duplicate report.

I figured that the FDA would now have to cough up the report.

The next day, on April 14th, Shire submitted a New Drug Application (NDA) for a chewable formulation of Vyvanse, as if following a script written long before the Pediatric Advisory Committee meeting. The company wrote in its press release that the Vyvanse chewable tablets are intended for patients “who may have difficulty swallowing or opening a capsule,” which is likely targeting very young children.

A day later, on April 15th, the Assistant U.S. attorney sent me an email, indicating that rather than provide me a lesser-redacted version of FAERS report 10213469, the FDA had instead decided to remove the case summary detailing the homicide from its drug safety review on its website.   Just like that, Uncle Sam had covered up the homicide of a 3-month-old infant girl, by an amphetamine-addled child, as if the baby had never existed. Now you see the homicide, now you don’t.

Apparently, we can’t have a story made public about a 10-year-old girl on Vyvanse who forced the ADHD drug down a baby girl’s throat before suffocating her to death. That would be bad for business. Especially even as Vyvanse chewable tablets are being approved for the market.

There is one more part to this story of homicide linked to ADHD drugs. Earlier, after I had filed my FOIA lawsuit concerning the FAERS homicide cases, the FDA approved Adzenys XR-ODT, the first orally disintegrating amphetamine tablet approved for kids with ADHD.  Without fanfare, a homicidal ideation warning was added to the label of Adzenys XR-ODT: “Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed.”

Adzenys XR-ODT was approved as a bioequivalent of Adderall XR, another Shire-manufactured amphetamine drug that was formerly the most prescribed drug for ADHD prior to Vyvanse. Oddly, at this writing, Adderall XR does not have a homicidal ideation warning on its label, whereas its bioequivalent Adzenys XR-ODT does. I’ve emailed the FDA Division of Drug Information for an explanation of the inconsistent homicidal ideation label warnings for these bioequivalent drugs, and was told that a Subject Matter Expert (SME) had to be consulted before the agency could respond. Of similar interest, a homicidal ideation warning was added to the Vyvanse label as well.

Case 7979016

This case involves a 16-year-old male from Canada taking Prozac, who experienced the reported drug reaction of “homicide.”  The FDA initially released a completely redacted version of this report, claiming in effect that public disclosure of any information whatsoever would constitute an unwarranted invasion of personal privacy. Once I reminded the FDA of 21 CFR 20.81, the agency produced a lesser-redacted version. This time, the FDA did not redact age, gender, nationality, drug name, or drug reactions disclosed in the FAERS data files, yet persisted with the redaction of the entire case narrative.

As it so happens, I had requested FAERS 7979016 twice, so the FDA produced yet another version of the report. This time, much of the case narrative could be read, and it contained a bombshell:

The reporting psychiatrist assessed the homicide, self-injurious behavior, manic symptoms, and worsening of his condition as related to fluoxetine, it drove him over the edge and it contributed to his actions.

Under the pretext of a phony privacy claim, the FDA had, in its previous redactions,  deliberately kept hidden a psychiatrist’s damaging causality assessment linking a popular antidepressant to homicide.

Case 8464514

This case involves a 35-year-old female from Australia, who took the antidepressant nortriptyline and killed her daughter. In one version of the report, the FDA as I subsequently learned, had completely redacted the following narrative:

My husband was drinking. I took small doses of valerian for a month and had weird dreams and premonitions. When I took nortriptyline, I immediately wanted to kill myself, talked myself out of it. I’d never had thoughts like that before. My husband was angry, shouting. I walked outside a lot, with palpitations, trouble breathing, and became more depressed. My smoking went up to 25 a day, no alcohol. I didn’t sleep for two nights, dreamt, then slept maybe three hours, felt awful. I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it. I felt like a zombie. I believed I had to help my daughter, that a bad spirit possessed her. I picked up a knife and stabbed her and woke up. I was not myself. I was looking on from the outside, controlled by dark forces. She said, “Mum, what are you doing here?” I realized what I’d done. I asked my husband to kill me. He called the police. I felt better in the police cells without the pills, but the pills started again, and thoughts of killing myself returned.

The FDA–and this is almost hard to believe–had redacted signs or symptoms of medication-induced suicidal ideation (“When I took nortriptyline, I immediately wanted to kill myself. I’d never had thoughts like that before” and “I asked my husband to kill me”); parasomnia or hallucinations (“I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it”); delusions (“I believed I had to help my daughter, that a bad spirit possessed her); automatism: (“I felt like a zombie”); homicide, somnambulism, and parasomnia (“I picked up a knife and stabbed her and woke up”); dissociation (“I was not myself”); depersonalization (“I was looking on from the outside”); paranoia (“controlled by dark forces”); as well as positive dechallenge (“I felt better in the police cells without the pills”); and positive rechallenge – considered the gold standard with regard to causality (“but the pills started again and thoughts of killing myself returned.”)

The FDA then provided another version of the report to me, this time with bits and pieces of the above testimonial unredacted, yet with much of the passage still missing. However, this version contained another gem:

Ranbaxy medical reviewers comment: The case is deemed serious. Medical Reviewer considered the case to be possibly related to suspect drug due to its temporal association as per WHO UMC system for standardized causality assessment.

The FDA understood that there was likely a causal link to homicide. This was the finding that the FDA did not want to make public.

Case 6179785

This case report describes a 47-year-old male prescribed Prozac (fluoxetine), lithium, temazepam, and trazodone who committed homicide. The FDA redacted the type of place he entered, as well as whom or what he shot, but did reveal that the subject ultimately shot himself.  Only the report cited a BMJ article  entitled “FDA to review ‘missing’ drug company documents,” which contained the following passage:

The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings.

This is a well-known case, dating back to 1989, which has been the subject of a book, The Power to Harm, by John Cornwall. The survivors and relatives of the dead sued Eli Lilly, the manufacturer of Prozac. The jury ruled in favor of Eli Lilly, which–as this was the first such case to be tried in court over whether an SSRI could stir homicidal actions–proved to be a boon to the company. Its drug had been cleared, and Lilly’s stock price soared. However, as Cornwall later revealed, Eli Lilly had made a secret deal with the plaintiffs during the trial, paying them a huge sum of money to deliberately lose the case.

So here it is twenty-five years later, and the FDA, in its case report of this fluoxetine-related homicide, which was the subject of a book, redacted some of the pertinent information. And this leads to the obvious question: has the FDA attempted to hide, from the public, links between psychotropic medications and mass shootings? More on that subject in a future post.

Now the FDA Wants Some Case Reports Back

Besides antidepressants and homicide, the three preceding FAERS reports and many others like them share two additional commonalities: 1) The cases were widely publicized in news and scholarly publications; and 2) The FDA now wants the versions that spilled some of the narrative details back from me. Much like the FDA removed the evidence of a 3-month-old girl murdered by a ten-year-old on Vyvanse from its Vyvanse pediatric safety review, the FDA, in its efforts to get these documents back, apparently wants to conceal the details about other homicides linked to psychotropics.

It is doubtful that the legislators who passed the Freedom of Information Act intended for government redactors to be censoring media reports and scholarly publications.

Last week, consumer advocacy group Public Citizen also sued the FDA, alleging the agency has arbitrarily and capriciously redacted public information from the curricula vitae of advisory committee members, thus obscuring their ties to pharmaceutical companies. It seems as though the FDA views the redaction process as thwarting the intentions of the FOIA act, and keeping secret information that might damage commercial interests.

I’ll end with a prediction: more homicidal ideation warnings are coming to psychotropic drug labels. Pharmaceutical companies will need to protect themselves from failure-to-warn lawsuits, and the FDA will no longer stand in their way from doing so, like when they wouldn’t allow Wyeth to place a suicidal ideation warning on Effexor. Tellingly, a homicidal ideation warning was also added to the Effexor label in the premarketing evaluation adverse events section, i.e.,  the company received reports of homicidal ideation before the drug was even approved.

More reports linking psychotropic drugs to homicides can be found here.

Andrew ThibaultAndrew Thibault is an extremely curious, inconvenient parent.  He is Co-Founder of Parents Against Pharmaceutical Abuse (PAPA), a parent movement opposed to over-diagnosis and over-medication of children.  A frequent guest of The Justice Hour on South Florida’s Health Talk Radio, he has also been quoted and his research has appeared in the Orlando Sentinel, Tampa Tribune, Tampa Bay Times, and Christian Science Monitor.

In 1991, Jeffrey Lieberman (On The FDA Panel) Officially Cleared Paxil Of Any Link To Suicide (ABC News- 2003)


So Jeffrey, what do you think now then? Do you think Paxil (Seroxat) causes suicide? or not?

It says in this ABC News article from 2003 that you were part of the 1991 FDA panel that cleared Paxil of any links to suicide? Were you receiving any funding, or money from speaking engagements etc, from GSK at this time, Jeffrey? Would you care to enlighten us on this- and also what are your views on Paxil now? Do you still think it’s safe? and also are you still receiving money/payment from GSK or any other drug companies? Where can we find full disclosures pertaining to this?

It seems that also- according to a NY Times Article about dodgy Paxil CR drugs coming out of a GSK plant in Puerto Rico- in 2005,  you were – at least- aware that Paxil had a quick and severe withdrawal syndrome, maybe you could relay that information to people when you are on your next talk show, blithering about your new book? Wouldn’t that be in patients’ interests?

(GSK spokeswoman) “Ms. Pekarek said the problems with the pills were unlikely ever to hurt patients. Patients who took an inert half of Paxil CR would be no worse off than if they had simply skipped a day’s dose – something that happens often, she said.”

“But Dr. Jeffrey Lieberman, a professor of psychiatry at Columbia University, said Paxil was the wrong drug to skip for a day. Paxil remains in the bloodstream far shorter than Prozac.”

You also said that: “In 1991, we said there wasn’t sufficient evidence to support a link,” said Jeffrey Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina and a member of the panel. “Now there is evidence, at least in children, and I wouldn’t rule out that it’s in adults, too.”

So what is your opinion now Jeffrey? do you rule out (or in) the link between Paxil and suicide? And furthermore, why do you compare anti-depressants to Insulin when you know that these drugs cause severe withdrawals, and you also know they are definitely dangerous in kids, and say they might be in adults? (I can assure you they are just as dangerous in any age group Jeffrey).

Despite your earlier views that Paxil, and SSRI’s in general, might cause suicide in adults based on the evidence that they definitely can in children, in 2004 on an article about the effectiveness of antidepressant use in kids you said:

“Dr. Jeffrey Lieberman, a professor of psychiatry at the University of North Carolina, said he found the report persuasive. “What the report said is that the risks of not treating patients with severe depressive illness is outweighed by the risk of treating them with SSRIs,” Lieberman said.”

Critics pointed to some weaknesses in the latest report. The task force did not have access to some data that British drug regulators used to reach with opposite conclusions. And it did not undertake a sophisticated and difficult “meta-analysis” in which data from many studies are pooled for examination. Other researchers are conducting such an analysis.

In addition, critics of these medicines noted that nine of the 10 task force members have significant financial ties to the drug industry, although such ties are common among prominent researchers. The task force said no industry money financed the report.

So which is it Jeffrey, either these drugs are safe, effective, and efficacious or they are not? either they can cause suicide, in adults and kids, or they can’t? what is your opinion now Jeffrey, in light of all the evidence in 2015? Maybe you should read the hundreds of blog posts and links about Paxil (Seroxat) on my blog and you just might begin to see the stark reality of the dangers of these drugs you’ve been involved with these past decades…

One final thing, in your recent interview on ABC news, you down-played the fact that anti-depressants were over prescribed, and you made no mention of either your own links to drug companies, or the range of data now indicating that SSRI’s have been harming people for decades- yet in 2004, while commenting on the black box warnings on all antidepressants  you said

“Dr. Jeffrey Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina, said that the agency’s action suggested that antidepressants had become too popular and physicians too casual about dispensing them.

“I think the effect of these warnings will be to have physicians become a bit more conservative in using these drugs,” Dr. Lieberman said. “They’ll start limiting their use of them just to patients who are clearly depressed with clinically significant symptoms as opposed to those who have very mild symptoms.”

So, 11 years ago, you thought that the drugs were possibly dangerous in adults, definitely dangerous in kids, and vastly over prescribed, yet you have been in the media recently claiming that SSRI’s are no different that taking insulin for diabetes, and that “Robert Whitaker is a menace to society” and furthermore you downplay the fact that anti-depressants are even more over-prescribed today than they ever were, by comparing them with the over-prescription of anti-biotics. Why do you have so many vastly opposing views? What do you really think? It seems to me- that similar to a politician- you sway your views with whichever way the tide of public opinion is swaying- on any given day in any given era… hardly expert or reliable is it?

It seems to me Dr. Lieberman, that your opinion is about as credible as a snake oil salesman.. but boy have you made a lot of money out of the ‘mental health industry’ haven’t you?… good luck with the new book… I’m sure you’ll sell stack loads… I have to say though, I’d rather invest in good quality toilet roll… suffice to say, I won’t be reading it..

ps.. you’re speech from 2014.

“Time to Re-Engage With Pharma?”

….is hypocritical, disturbing, ill-conceived and basically downright appalling…

It seems you have never stopped personally and professionally engaging with Pharma Jeffrey- perhaps that’s part of the reason why you are so utterly biased and conflicted?


(NaturalNews) In a recent message to subscribers, American Psychiatric Association President Jeffrey Lieberman urged members to support big pharma.

He did this while openly admitting that the pharmaceutical industry makes a practice of advertising unethically, paying off doctors, and suppressing critical scientific data as to the dangers of their drugs.

With calm and poise, President Lieberman reminded APA members that we need big pharma and they need us. In fact, he suggests we’d be lost without them.

What would we do without pharmaceuticals? Who would support scientific research? How would psychiatrists stay in business? Dr. Jeffrey Lieberman is asking these questions as if the answer obviously favors supporting and sustaining a criminal industry.

It would seem that, according to Lieberman, humanity would be lost and all medical advancement would come to a screeching halt if not for the scoundrels who run big pharma.

http://www.abc.net.au/worldtoday/content/2003/s920461.htm

Concerns over the prescription of anti-depressants to adolescents

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The World Today – Friday, 8 August , 2003  12:30:24

Reporter: Tanya Nolan

ELEANOR HALL: Now to concerns about the prescription of anti-depressants to adolescents, with the American Food and Drug Administration considering whether tighter restrictions should be placed on their use.

After examining new evidence suggesting young people taking the anti-depressant Paxil have a higher risk of suicide, the FDA is due to decide next week whether the drug, should be prescribed to people under the age of 18.

And the prediction is that the Administration will follow the recent decision by British health authorities to declare that the drug in fact must not be prescribed to young people.

And in Australia, the Australian Therapeutic Goods Administration already cautions against the prescription of anti-depressants to children, but it has strengthened its position in the last two months, as Tanya Nolan reports.

TANYA NOLAN: It was the clinical trial conducted by GlaxoSmithKline into its own drug Paxil, or Aropax as it’s known here in Australia, that sparked huge public debate in the UK and recently prompted health authorities there to declare that the drug must not be prescribed to people aged under 18.

The company found that a higher risk of self-harm and suicidal thoughts, in at least two per cent of the study group and that there was a similar risk of dependency on the drug. The American Food and Drug Administration has been reviewing that evidence and is considering following Britain’s lead.

Professor Jeffrey Lieberman was on the original FDA panel, which formally cleared Paxil of any link to suicide, back in 1991.

JEFFREY LIEBERMAN: Uh, the view now is that this a signal that there may be the potential risk of activating such behaviours in people who are treated with this medication and particularly in young people – adolescents or children.

TANYA NOLAN: So, is that evidence in any way conclusive that there is a link or a causal effect of the prescription of those drugs.

JEFFREY LIEBERMAN: No, no. The evidence at this point is purely associational. Further evaluation needs to be done to determine whether it’s causal.

TANYA NOLAN: Although the evidence is in no way definitive and the FDA, in fact, cautions against young people stopping their medication without professional advice, Professor Lieberman believes there is every likelihood the adverse effects identified in Paxil could be found in other anti-depressants.

JEFFREY LIEBERMAN: It is known that Serotonin is a neurochemical, a neurotransmitter that is involved in regulating emotion and aggression and hostility. And it’s possible since these drugs act on serotonin that they could induce or somehow activate such behaviours.

However, if this is the case, it would not be specific to any single SRI (serotonin reuptake inhibitor), but would be the case for all of the drugs that act by the same pharmacologic mechanism of action.

TANYA NOLAN: Up to 80 per cent of teenagers on anti-depressants are prescribed Arapax, here in Australia. The Therapeutic Goods Administration has long warned against the use of anti-depressants by young people, and in recent months, has toughened it stance to state that Arapax should not be prescribed to anyone under 18.

GlaxoSmithKline has changed the labelling of its product to include the new warning. However, makers of the other most commonly prescribed anti-depressants say there’s no evidence to suggest any similar risk of suicide amongst young people taking their products. And those prescribing the medicines tend to agree.

Doctor Louise Newman is Chair of the Faculty of Adolescent Psychiatry with the Royal College of Psychiatrists, and she says the profession is becoming more adept at diagnosing depression in adolescents and the risks and benefits of medication are carefully weighed up.

LOUISE NEWMAN: There’s evidence that anti-depressants are actually very helpful for that type of depression, so we certainly don’t want to be withholding anti-depressants.

TANYA NOLAN: But Dr Newman says any decision by the FDA will be an important one for Australian psychiatrists.

LOUISE NEWMAN: I think that we obviously need to be guided by the FDA in terms of their monitoring of side effects of all sorts with these sorts of medications. We’re certainly very supportive of that and if there is a ruling that a particular drug shouldn’t be used, then obviously, that would be a very important finding.

I think it’s important to recognise that there is a whole range of these drugs. The evidence isn’t clearly there at the moment as to which ones are likely to be more effective. Currently, it’s probably fair to say they all seem to be equally effective in the treatment of depression.

But there needs to be an ongoing monitoring of side effect profiles and increasing research looking at the safe use of these drugs, particularly in younger populations.

ELEANOR HALL: Dr Louise Newman from the Royal College of Psychiatrists, with Tanya Nolan.

GSK recalls vaccine made at troubled plant in Canada


http://www.fiercepharmamanufacturing.com/story/gsk-recalls-vaccine-made-troubled-plant-canada/2015-04-20

GSK recalls vaccine made at troubled plant in Canada

Potency issue unrelated to issues in FDA warning letter
 GlaxoSmithKline ($GSK) is recalling 1.7 million doses of its quadrivalent flu vaccine that was manufactured at a plant that ran into a series of manufacturing issues last year including an FDA warning letter. The company says there are questions about whether the vaccine is retaining its potency.

“As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine,” the drugmaker said in a letter to distributors and healthcare providers issued last week. “The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern.”

In an emailed statement, GSK spokeswoman Anna Padula said the voluntary recall to U.S. customers was “for all remaining doses of FluLaval Quadrivalent Thimerosal-Free (Influenza) Vaccine, in the Pre-Filled Syringe, which were provided to the U.S. market for the 2014/15 flu season.” According to the Associated Press, it was unknown how many of the 1.7 million units were still on the market since 99% of it was distributed in 2014, before the potency began to wane.

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In a follow-up telephone interview, Padula said the problem that led to the recall was not tied to the issues raised last year by the FDA in the warning letter to the plant in Quebec City where the vaccine is manufactured. She said the Canadian plant does all of the manufacturing of the vaccine except the fill and finish work, which is done at a plant in Belgium. She said it was “premature to comment on the potential root causes,” and whether they were tied to the manufacturing or the fill/finish work, “because we are still investigating.”

The company had to actually reduce the amount of vaccine it shipped last year after a series of manufacturing problems at the Quebec City plant. The FDA issued a warning letter in June in which it raised concerns about bacterial contamination, questioning the quality of the new FluLaval vaccine and its intermediates. The agency pointed out that there have been problems with the purified water at the plant for years, including alerts because of organisms, including Ralstonia pickettii and Achromobacter xylosoxidans, both of which have been implicated in product contamination that dates back to 2011.

GSK’s efforts to fix some of the issues did not resolve them, leading GSK to resort to a manufacturing process it had used in the past. But then it had to temporarily suspend production to investigate “irregular results” in quality-control monitoring. It also reported getting an “invalid test result on one component of the trivalent vaccine,” which required retesting. The issues led it to reduce the amount of vaccine that it could ship from the plant.

This past season’s flu vaccines posted one of the worst efficacy rates in recent memory. That had been blamed on the fact that the viral strains the vaccines contained did not closely match the ones that ended up circulating.

– here’s the recall letter
– here’s the AP story

GSK’s Zofran Drug And Birth Defects..


http://www.lawyersandsettlements.com/articles/zofran-birth-defects/zofran-glaxosmithkline-llc-gsk-us-20540.html#.VRduKEbIto5

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?

March 27, 2015, 08:00:00AM. By

Pittsburgh, PA: Twenty-three years is a long time. And yet, that’s the timespan a Zofran lawsuit alleges that Zofran manufacturer GlaxoSmithKline (GSK) has been in possession of evidence suggesting a risk of birth defects associated with the use of Zofran in pregnancy.

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?Various studies have offered conflicting views on Zofran, and other generic versions of ondansetron (Zofran). And there is little doubt about ondansetron’s capacity for curbing nausea – an often debilitating byproduct of pregnancy. For some women, morning sickness can be so extreme that only medication can prevent the sometimes constant vomiting, dehydration and weight loss that severe morning sickness can foster.

And yet, ondansetron was never approved by the US Food and Drug Administration (FDA) for use as a treatment for morning sickness. Zofran manufacturer GSK makes that very point, noting in a Canadian media report last June that “the safety of ondansetron for use in human pregnancy has not been established…[GSK] monitors and reports all adverse event reports…” (The Toronto Star, 6/25/14).

But is GSK talking from both sides of its mouth? That’s the way it appears, as GSK was previously accused of promoting Zofran off-label for morning sickness, or so it is alleged. The US Department of Justice asserted that GSK had not only promoted Zofran and other drugs off-label, but that the company provided kickbacks to doctors in exchange for prescribing Zofran for morning sickness. Court documents, according to The Toronto Star, alleged that GSK disseminated false and misleading information about the safety and effectiveness of Zofran.

In 2012, GSK settled with the US Department of Justice for $3 billion. As part of the settlement, GSK was not required to admit to any wrongdoing. That latter bit is a frequent feature of government settlements: the ability to escape a finding of wrongdoing in exchange for a massive payment.

One of the more recent Zofran lawsuits, filed by plaintiff Cheri Flynn in Pennsylvania, mirrors allegations contained in the US Department of Justice lawsuit: that GSK knowingly marketed Zofran to pregnant women without sharing information about the potential for Zofran birth defects – information the lawsuit alleges GSK has had in its possession since 1992, if not before.

“GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects,” the Flynn lawsuit states, “but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in [pregnant] women.”

Drug manufacturers do not have the legal, ethical or medical authority to market a drug off-label. Ondansetron was originally approved by the FDA for treatment of nausea in cancer patients following chemotherapy. It was never indicated for pregnant women, although doctors have always had the authority to prescribe off-label should they feel it would benefit the patient. And yet, The Toronto Star last June suggested that doctors in Canada are prescribing ondansetron off-label without having all the facts.

One wonders if the same thing is happening in the US.

“Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance,” the Flynn lawsuit contends. “When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

The Zofran lawsuit is Cheri Flynn v. GlaxoSmithKline LLC, Case No. 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania. The lawsuit alleges that Flynn’s two children suffered congenital heart defects and other birth defects following fetal exposure to Zofran.

http://www.wkrg.com/story/28277705/zofran-lawsuit-alleges-gsk-failed-to-disclose-zofran-dangers

Zofran Lawsuit Alleges GSK Failed to Disclose Zofran Dangers

Posted: Mar 06, 2015 8:06 AM GMT

This article was originally distributed via PRWeb. PRWeb, WorldNow and this Site make no warranties or representations in connection therewith.

Zofran lawyers at the Onder Law Firm have expanded their website to provide information about the allegations made in a new Zofran lawsuit filed in Pennsylvania.

St. Louis, MO (PRWEB) March 06, 2015

A new Zofran lawsuit has been filed in U.S. District Court in Pennsylvania, according to attorneys handling Zofran lawsuit claims alleging birth defects.* The lawsuit alleges that the plaintiffs two children suffered congenital heart defects and other birth defects after fetal exposure to Zofran, according to court documents.

This Zofran lawsuit alleges that the defendant, pharmaceutical company GlaxoSmithKline (GSK) was aware of evidence supporting a link between Zofran use during pregnancy and the increased incidence of congenital heart defects and other birth defects, according to court documents:

Since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy.* According to court documents, the lawsuit cites numerous pieces of evidence in support of this statement, saying GSK was aware of the following:

  • Zofran readily crosses human placental barriers during pregnancy.*
  • Animal studies conducted on Zofran indicate that Zofran cannot be used safely or effectively in pregnant women.*
  • Since 1992, GSK has received hundreds of reports of major birth defects associated with prenatal Zofran exposure.*

According to court documents, the plaintiff alleges that GSK knowingly marketed Zofran to pregnant women, without issuing a birth defects warning, despite evidence suggesting this was not a safe application of the drug: GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.*

The FDA has never approved Zofran as safe for pregnant women, yet women are still being prescribed Zofran during pregnancy, believing the drug is safe, according to court documents: “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”*

A few women have now stepped forward to file Zofran lawsuits. As more families learn about the allegations of birth defects from Zofran, we anticipate hearing from others interested in filing Zofran lawsuits, said Jim Onder of the Onder Law Firm.

The Onder Law Firm, nationally-renowned as a leading family safety and consumer liability law firm, provides legal representation for families seeking to file Zofran lawsuits for allegations of birth defects. Zofran attorneys representing clients nationwide offer Zofran lawsuit news and updates at their website. The firm provides no-cost, no-obligation case evaluation for mothers and families whose babies wer born with a birth defect following prenatal exposure to Zofran. Individuals who fit this description may contact a lawyer to discuss whether they have grounds for a Zofran lawsuit. The firms Zofran lawyers believe persons who meet this description may be entitled to real compensation. For more information, visit the Zofran lawsuit website.

The Onder Law Firm welcomes Zofran case inquiries from law firms in regards to handling them or working as co-counsel.

About The Onder Law Firm
Onder, Shelton, OLeary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The pharmaceutical and medical device litigators at The Onder Law Firm have represented thousands of Americans in lawsuits against multinational conglomerates from products liability for manufacture of defective or dangerous products to deceptive advertising practices. Other firms throughout the nation often seek its experience and expertise on complex litigation. It is also a recognized leader in products liability cases such as window blind cord strangulation. The Onder Law Firm offers information on Zofran lawsuits at http://www.247LawsuitNews.com.

*Cheri Flynn vs. GlaxoSmithKline LLC, Case 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania

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FDA orders GlaxoSmithKline to review manufacturing worldwide


Britain’s biggest drugmaker warned by US watchdog over flu vaccine production at Canadian subsidiary
GlaxoSmithKline sold 26m doses of flu vaccines in the US last year, generating £150m in sales. Photograph: Photofusion/Rex Features

The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval.

It is another serious blow to Britain’s biggest drugmaker, already reeling from corruption allegations in Poland, Iraq, Jordan, Lebanon and China, and facing a criminal investigation by the UK’s Serious Fraud Office into its sales practices. It also recently paid out £63m to settle US marketing allegations. Earlier this week GSK had to apologise for the pitch adopted by a marketing firm working for the FTSE 100 company to recruit unpaid interns for clinical trials in the UK.

In a warning letter to the British company, the FDA cited “deviations from current good manufacturing practice” in the manufacture of FluLaval at GSK’s Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the US.

The US watchdog said when it inspected the site in Sainte-Foy, Quebec, in April it found that the plant had failed to take appropriate steps to prevent microbiological contamination of drug products purporting to be sterile. It also found that controls for the purified water system at the site, which employs 600 people, were inadequate to prevent contamination.

The FDA said it “expects ID Biomedical and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements”.

The letter piles further pressure on GSK’s boss, Sir Andrew Witty, whopledged a major overhaul of the company two years ago after a £1.9bn US fine for mis-selling drugs. At the same time, he has been behind industry leading measures on data transparency, clinical trials and access to medicines. The company also claims that Witty has transformed sales and manufacturing practices. GSK said on Tuesday that it was working with the FDA and making progress addressing the concerns. “We are committed to working with the agency to fully resolve all outstanding issues,” the drugmaker added.

“Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”

Pending FDA approvals, GSK now expects to provide between 28m and 33m doses of flu vaccine to the US health authorities for next winter. It had planned to supply 36m doses, 23m of which would be made in the Sainte-Foy site in Quebec. GSK is also working with the Canadian health authorities to meet its supply commitments for 2014-15.

GSK sold 26m doses of flu vaccines (Fluarix and FluLaval) in the US last year, which generated £150m in sales. While it is still working to determine the impact the FDA concerns will have on supply, it expects to increase output this year. Its sites in Dresden in Germany and Rixensart in Belgium, which make Fluarix, are not affected by the warning letter.

Vaccines is one of GSK’s key growth areas. The company won plaudits within the industry when it unveiled a complex asset swap with Switzerland’s Novartis in April. GSK beefed up its vaccines business with the acquisition of Novartis’s vaccines divisions for up to $7.1bn and offloaded its portfolio of cancer drugs.

GSK points out that it had six new medicines approved by the FDA last year, nearly a fifth of all approvals and the highest number of any drugmaker.

In early June, GSK settled allegations by 44 US states and the District of Columbia going back 14 years that it promoted its big-selling medicines Advair, Paxil and Wellbutrin for unapproved uses. The £1.9bn Federal fine from the FDA for mis-selling drugs also related to anti-depressents Paxil and Wellbutrin as well as Avandia, once the world’s most popular type-2 diabetes drug, until it was found to have potential serious side effects, including heart attacks.

GSK And Catch 22 (Wendy Dolan Sues For Husband Stewart’s Generic Paroxetine Induced Suicide)


http://wp.rxisk.org/gsk-and-catch-22/

GSK and Catch 22

June 5, 2014 • Leave a comment

Editorial: This post by Johanna Ryan notes a significant legal development for anyone taking a generic drug.  Its also a testament to the ability of  motivated women to make a difference to the landscape.

We’re posting this interview with Wendy Dolin to draw attention to a victory – a possible break in the terrible legal Catch-22 faced by people in the United States who suffer harm after taking a generic drug.

Wendy will now be able to sue GSK for the suicide of her husband, Stewart Dolin, after six days on generic paroxetine or Paxil (Seroxat in the UK).   Under a theory endorsed by the Supreme Court in 2011, she could not sue Mylan, the generic drugmaker.   That’s because the law requires them to use the same information label, and the same chemical formula, as GSK developed for Paxil.   Yet she also couldn’t sue GSK, which developed the drug and wrote the label, because the six pills her husband swallowed were not made by GSK.   In February, however, a federal judge ruled that Wendy Dolin could indeed sue GSK for negligence.

Wendy Dolin has founded MISSD (The Medication-Induced Suicide Education Foundation in Memory of Stewart Dolin) to start a conversation in her community and beyond about the problem that took her husband’s life.   The takes on the issue full and squarely of the link between antidepressants and suicide in adults.  The risk of suicidal acts in 45-65 year olds from FDA data is the same as that in 18-25 year olds.  The mystery is trying to work out what was done to the data to try and hide and the risk to adults.  The data Pfizer sent to FDA for adults was totally different to the data they sent regulators in Europe and to the data the company itself published some years later.  See Where were the adults?

This interview, first aired May 27th on Chicago’s Channel 5 evening news, is part of that effort.  The video is here

And yesterday, June 4th, the 7th Circuit denied GSK’s writ questioning Judge Zagel’s ruling in this case.  GSK had argued that Judge Zagel’s decision was “patently wrong” and he – Judge Zagel – should be ordered to enter judgment in favor of GSK.

Watch this spot.  This could be legal history in the making.

– See more at: http://wp.rxisk.org/gsk-and-catch-22/#sthash.uTX3uVBG.dpuf