GlaxoSmithKline Ventolin recall hits 1.1M units as drugmaker retrieves half-million more


http://www.fiercepharma.com/manufacturing/gsk-ventolin-recall-hits-1-1m-units-as-drugmaker-retrieves-half-million-more

GlaxoSmithKline has added three more lots of its Ventolin inhalers to its recent recall, bringing the total to more than 1.1 million units.

According to a recent FDA Enforcement Report, the drugmaker this month voluntarily recalled the three lots, amounting to 562,883 of the inhalers used by patients with asthma or COPD to prevent bronchospasms. The class II recall again is because the company discovered an elevated number of units that were out of spec for leak rate.

The company in March had recalled three lots amounting to 593,088 inhalers. This brings the total to 1,155,971 units, which a GSK spokesperson pointed out amounts to about 4%  of total US annual Ventolin volume. The inhalers were made at GSK’s plant in Zebulon, North Carolina.

GSK in late 2015 recalled nearly 130,000 Ventolin inhalers over a similar issue.

In an email Thursday, the GSK spokesperson said the extended voluntary recall “is due to product complaints relating to overly inflated overwraps or pouches”. He said that could could indicate leaking, which may result in the inhaler delivering fewer doses than anticipated on the dose counter. The company again pointed out the recall is not to the consumer level, meaning patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level, so products are being removed from those channels.

“GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this extended voluntary recall may cause,” he said.

Ventolin continues to be a strong-selling product for GSK, which is adding capacity to its production line for the product. While GSK’s top-selling respiratory drug Advair turned in fading sales in 2016, Ventolin had a 23% jump to about $527 million, as a competitor struggled with supplies of a competing COPD drug.

In February, the U.K.-based company informed local authorities it intended to build a $137 million, four-story facility at its site in Scotland for the production of salbutamol, the API in Ventolin.

How FDA Avoided Finding Adult Antidepressant Suicidality (Dr Peter Breggin- Mad In America)


https://www.madinamerica.com/2017/05/how-fda-avoided-finding-adult-antidepressant-suicidality/

How FDA Avoided Finding Adult Antidepressant Suicidality

Peter Breggin, MD

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Doctors often tell patients that antidepressants can only cause suicidal behavior in children and not in adults. Many publications also make the same claim. The false claim is based on the FDA-approved Black Box Warning for antidepressants that warns about an increased rate of suicidality in children, youth and young adults taking antidepressants, but not in adults over age 24. The Black Box Warning specifically summarizes, “Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.”

The studies that the FDA relied upon for adults over age 24 were dismally flawed and untrustworthy compared to the ones used for children. According to the FDA at the 2006 hearings:

Due to the large number of subjects in the adult analysis, almost 100,000 patients, the adjudication process was left as the responsibility of the sponsors [the drug companies] and was not overseen or otherwise verified by the FDA. This is in contrast to the pediatric suicidality analysis in which the FDA was actively involved in the adjudication (p. 14).”

In addition, the FDA also announced at the 2006 hearings on antidepressant-induced adult suicidality that it did not require a uniform method of analysis by each drug company and an independent evaluator as required with the pediatric sample.

Thus, the FDA was comparing somewhat good apples (the pediatric studies) to rotten apples (the adult studies), while making them seem comparable. The child studies showed that antidepressants can cause suicidality — the adult studies (after age 24) showed nothing other than FDA collusion with the self-serving drug companies. As I have described in my books and scientific articles, drug companies routinely manipulate their data on suicide to avoid any causal connection to their drug (see for example my 2006 paper about GSK and Paxil).

In the case of Eli Lilly, here are two memos by employee Claude Bouchey (pages 2 & 3 of document) written to the hierarchy of the company in which he expresses guilt and shame about changing official investigator reports of Prozac-induced suicide attempt to misleading terms like “overdose” or “depression.”

Ironically, the FDA controlled and monitored the original pediatric studies precisely because the drug companies on their own failed to find any risk of antidepressant-induced suicidality in any age group. Why would the FDA assume these same self-serving drug companies, left on their own again, would spontaneously begin for the first time to conduct honest studies on the capacity of their products to cause adult suicidality?

Furthermore, even in the rotten-apple adult studies, despite the drug company’s manipulations, Paxil (paroxetine) turned out to be causally associated with increased suicidality in depressed adults in an internal FDA review of the data. As a result, in 2006 the FDA then forced the maker of Paxil, GlaxoSmithKline (GSK), to write a “Dear Doctor” letter to all healthcare providers confirming the Paxil/suicidality causal link in adults.

In April 2006, the FDA also made the drug company put a warning in its Full Prescribing Information (label or package insert) about the risk of Paxil causing suicidality in adults with depression; but GSK convinced them to drop it in subsequent years. The warning appeared in the Physician’s Desk Reference (PDR) only once in 2007.

Meanwhile, there are many studies showing that antidepressants do cause suicidality and suicide in adults.

Next time you hear someone say that the FDA studies only showed increased suicidality in children and young adults as opposed to adults, remember that the adult studies, unlike the pediatric studies, were not controlled, monitored or validated by the FDA. This is one more example of the extremes the FDA will go to in order to protect drug companies and their often lethal products.

It was bad enough to find out that antidepressants cause suicidality in children. The drug companies and their minions complained mightily. The FDA and the drug companies were not going to allow a repetition of sufficiently unbiased studies that might conclude that adults are also vulnerable to antidepressant-induced suicide.

Theresa May And GSK: Is This Why GSK Get Away With Decades Of Unethical Corporate Behavior?


Seems to me, it all boils down to economics.

When you have the prime minister of the UK, effectively bolstering the status of a company like GSK (a huge asset to the UK economy) perhaps that also helps the company to believe it can operate above the law, morals and ethics?

Does Theresa care about Seroxat ?

Does she even know anything about it?

Does she know about GSK’s decades of unethical behavior? Or Greg Thorpe’s Department of Justice Complaint? (the details of which would make your hair stand on end).

These are recent speeches from UK prime minister Theresa May at GSK’s Maidenhead factory.

1492787336988.jpg--Theresa+May+GSK+speech+sack

 

 

13 Ways That GSK Hid The Seroxat/Paxil Suicide Signal…


Seroxat/Paxil/Aropax (Paroxetine) : The Anti-Depressant that makes you want to kill yourself!..

 


https://davidhealy.org/change-in-chicago-whose-problem/

Change in Chicago: Whose Problem?

May, 24, 2017 | Reply

Stewart Dolin’s Doctor Says (about Paxil) : ““I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”…


And why would he?

Why would anybody trust GSK? Would you trust a felon?

The Dolin trial opened a can of worms about Paxil/Seroxat, suicidality and akathisia which GSK would rather remained tightly in the can. It’s too late now though, the worms are already out…

See Dr. David Healy’s excellent new post about wider implications of the Stewart Dolin Paxil induced suicide trial.


“……The regulatory history of Paxil and the other SSRI’s was almost Byzantine.   For years they carried no warnings of a risk for suicide.  In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents.  A number of medical experts felt the warning should apply with equal urgency to adults.

However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new.  This was the “24 and under” label attached to both brand-name and generic Paxil in 2010.  This suited GSK just fine.  The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.

More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product.  In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide.  The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty…..”


https://davidhealy.org/change-in-chicago-dr-welby-on-the-witness-stand/

Change in Chicago:  Dr. Welby on the Witness Stand

May, 15, 2017 | 8 Comments

Chris Cornell’s Wife Issues Statement, Blames Anxiety Medicine for Suicide


Interesting article about the death of Soundgarden lead singer, Chris Cornell. I loved Soundgarden when I was a teenager. RIP Chris,

http://www.rollingstone.com/music/news/chris-cornells-wife-issues-statement-w483179

 

Statement, Blames Anxiety Medicine for Suicide

“When we spoke after the show, I noticed he was slurring his words,” Vicky Cornell says. “He was different”

Vicky Cornell, the wife of Soundgarden singer Chris Cornell, issued a statement Friday morning where she remembered her late husband, who died Thursday morning at the age of 52, and speculated whether his suicide was the result of taking too much of his anxiety medication.

“Chris’s death is a loss that escapes words and has created an emptiness in my heart that will never be filled. As everyone who knew him commented, Chris was a devoted father and husband. He was my best friend,” Vicky wrote.

“His world revolved around his family first and, of course, his music second. He flew home for Mother’s Day to spend time with our family. He flew out mid-day Wednesday, the day of the show, after spending time with the children. When we spoke before the show, we discussed plans for a vacation over Memorial Day and other things we wanted to do.”

However, following Soundgarden’s concert Wednesday night, Vicky noticed a change in her husband’s demeanor when they talked on the phone after the show.

“When we spoke after the show, I noticed he was slurring his words; he was different. When he told me he may have taken an extra Ativan or two, I contacted security and asked that they check on him,” she continued. “What happened is inexplicable and I am hopeful that further medical reports will provide additional details. I know that he loved our children and he would not hurt them by intentionally taking his own life.”

An attorney for the Cornell family, Kirk Pasich, reiterated Vicky’s belief that an extra dosage of Ativan, an anxiety medication often employed by recovering addicts, altered Chris Cornell’s mental faculties after the Detroit show. Pasich added that the Cornell family is “disturbed at inferences that Chris knowingly and intentionally took his life.”

“Without the results of toxicology tests, we do not know what was going on with Chris — or if any substances contributed to his demise,” Pasich said. “Chris, a recovering addict, had a prescription for Ativan and may have taken more Ativan than recommended dosages. The family believes that if Chris took his life, he did not know what he was doing, and that drugs or other substances may have affected his actions.”

Pasich added that side effects of Ativan include “paranoid or suicidal thoughts, slurred speech and impaired judgment”; Vicky Cornell noted her husband’s slurred speech following the Detroit concert in her statement.

She added, “The outpouring of love and support from his fans, friends and family means so much more to us than anyone can know. Thank you for that, and for understanding how difficult this is for us.”

Hours after Cornell’s death at a Detroit hotel, a medical examiner’s report confirmed that the singer had died by suicide.

Chris Cornell, lead singer for Soundgarden, has died at age 52. Watch here.

Professor John Reed: “Psychiatry sold its soul to the pharmaceutical industry”..


Just wanted to highlight James Moore‘s excellent Podcast series about psychiatric drug withdrawal and related issues.

Check them out on Youtube, below is an interview with Prof. John Reed and his views on psychiatric drugs and the pharmaceutical industry.

Another Seroxat Horror Story..


For the full story see link:

http://vox.gi/cms/local/10831-psychology-vs-psychiatry-what-can-happen-if-the-system-fails.html

“… This sense of inundation and doom moved me to see a GP. It is to be noted that this GP did not even refer me to the mental health team, but rather took it up himself to prescribe a drug called Seroxat. As we tend to do, I put my trust in a medical professional, and took the drug. After a couple of months, I went back and told this same GP that I felt like I was losing touch with reality because I was finding it increasingly hard to focus or control my behaviour, so he doubled the dose.

The result was my first psychotic episode that saw me run away, spend 24 hours walking around Gatwick Airport booking flights and not getting on them, and eventually being escorted out of the departure lounge. I was taken to see a psychiatrist in London who mistakenly diagnosed me with bipolar disorder based on those symptoms he was seeing.

Those were not symptoms of “ME”; they were a horrific side effect of Seroxat. Had I just been taken off that drug at this point, this is where the story would end. I was taken off it, but it was replaced with Lithium and Lamictal, drugs to treat bipolar disorder. As hard as it is to believe, I then spent about ten years continuing to have psychotic episodes and mood swings, which were taken by psychiatrists to be further evidence of my diagnosis, and having doses not only increased but, as the years went by and still having pschotic episodes, the drugs changed for others to find the ones that would work.

None worked. Why? Because the drugs were the problem; the drugs themselves, in my case, were triggering the psychotic episodes the whole time. I spent ten years, however, convinced I had bipolar disorder because the psychiatrists said so, and believed I must have such a severe case that, despite drugs, I was still having episodes. It was not until four years ago, having lost my 20s to chaos, that I became totally desperate and pleaded at a local psychiatrist to help me because I was at the end of my rope. The initial point of my visit was to say if the drugs aren’t working then please just take me off them. Little did I know that this is what I should have done years earlier. Had she taken this course of action, because ultimately it was up to me whether or not I took those drugs, the end result would have been the same and a shock: I am way better now without them. But this psychiatrist actually spent about two hours looking over my entire case history and asked me the only question no other psychiatrist had thought to ask me the entire time: “Had you ever had a psychotic episode before being put on any of these drugs?” And of course the answer was no…..”

Why Is Greg Thorpe The Only GSK Whistle-Blower Willing To Speak The Truth About GSK’s 3 Billion Quid Pro Quo (Sham-Fine) With The US Department Of Justice?…


Greg Thorpe originally blew the whistle on GSK’s fraudulent activity- and it was as a direct result of Greg’s actions- that GSK were fined 3 Billion in 2012 by the department of Justice. Greg regularly leaves comments on this blog, and they are always extremely interesting, particularly in relation to the department of Justice- GSK fine -debacle.

I call this scandal a debacle because I have long thought that GSK’s fine of 3 billion, and the corporate integrity agreement etc, was merely a little slap on the wrist for GSK. People died because of GSK’s various unethical shenanigans; crimes committed by GSK over many years: many patients were harmed, maimed or killed. GSK should have had its license to trade revoked, instead the department of Justice fined them 3 months profits and allowed to them continue on -business as usual. The executives all sailed off into the sunset, dripping with even more wealth and money than they had previously earned – golden parachutes all-round for the GSK top brass-despite being party to the biggest health care fraud of the 21st century.

Astounding isn’t it?

I’ve always felt that the whole thing stank to high heaven, and furthermore, I have always wondered, why is Greg the only whistle-blower willing to tell the truth about this sham fine?

There were, apparently, another 5 whistle-blowers- why do they not speak out about the quid pro quo? Why do they not criticize Eric Holder and the revolving door? Why do they not speak out about this grave travesty of justice to consumers and patients? Why do they not speak about this slap on the wrist for GSK? Why do they not tell the public that far from being a success for patients, this fine was merely a sleight of hand and a smokescreen?- as GSK were allowed to continue on- as evident by their China-Bribe scandal in 214, to commit more bribery and fraud in different countries, further afield.

Why do they not inform the public about the real scandals of this debacle?

Thankfully, we have people like Greg, he’s not afraid to speak out- here is his latest comment-

https://truthman30.wordpress.com/2017/05/12/interesting-comment-by-whistle-blower-greg-thorpe-about-gsks-lamictal-scandal/#comments

May 13, 2017 – 3:58 pm High Plains Drifter

There are hundreds if not thousands in the DOJ that are to say the least, are not interested in real justice or the truth. They are not in lockstep with Jeff Sessions to say the least. They regularly monitor this site. Truthman knows this. I hate to coin a phrase, but this swamp cannot be fully drained.

I have been threatened and put myself at risk with everything I say…they violated my constitutional rights by putting a gag order on me for 9 1/2 years…so GSK could continue to reap off label marketing profits and worst of all patients and physicians were kept in the dark. The law I filed under, the False Claims Act has no provision for this conduct, for such a length of time. They are allowed to seal the case only to investigate whether it has merit. I was interviewed under oath by the FBI…3 months after I filed. every government agency was present who had a stake in the case…DEA, HHS, FDA, DOD, IRS, CIA, VA ,DOJ, FBI and others…Shortly after that, I was informed through Counsel that DOJ had dozens of people on the case, and a entire floor at DOJ working on the case. I assume this was true. The False Claims Act seal is to only be extended after they decide to take the case, usually 6 months, for good cause. Obviously it became apparent after 9 years that the seal only remained in place so DOJ could secretly, without public knowledge cut a deal with GSK or go to trial. During this long, long period of time, I was never told that they had joined my complaint until the 11th hour AFTER the settlement was reached. They used this tactic to threaten me with non joining and tossing me out for 9 years plus. During this time, patients continued to receive prescriptions on the 9 drugs I reported …physicians were kept in the dark. In short, the carnage continued…I consistently objected but to no avail. The lead prosecutor told me after I demanded that this go to trial that they “would bankrupt the company, and nobody would get anything”…at the time I thought the statement may have merit, although I now know it was sheer B.S. It would be hard to bankrupt a company with a market cap approaching 200 billion dollars or more.. So I kept my mouth shut while people died, and that haunts me to this day. It included my mother who developed congestive heart failure while kept on Avandia, for diabetes. I did not know GSK had hidden data showing it caused CHF, until it was too late. Hundreds of thousands of patients suffered the same effect, and this was going on with all the drugs reported…but did the DOJ care. Hell no they kept all of this important data sealed from patients and physicians. Why ?

The only reason I know now was to negotiate a sweetheart deal for GSK under a former attorney for the company….ERIC HOLDER. Holder was supposed to have recused himself. I have no evidence that he did. I BELIEVE after he gave GSK the quid pro quo for his law firm, Covington Burling….IN A FINE THAT AMOUNTED TO 3 MONTHS OF COMPANY PROFIT..that he had his hand on the trigger. Supporting this is the fact that he returned to Covington Burling to what has been reported as a “hero’s welcome and a huge raise”.They were even nice enough to give him his old office back, supposedly saved for his return. Holder committed many acts as Attorney General which warrant investigation …but none of this caliber.
GSK lost 3 billion dollars…one month of profit. Nobody was prosecuted .
Nine and one half YEARS is a long time…especially to rob the taxpayers who fund these illegal prescriptions of 40-50 billion dollars, at least. This would not even be what the punishment calls for under the statute. People should be in prison and maybe the company should be bankrupt…they continued the crimes all over the world after the settlement, while under 3 corporate integrity agreements, which called for the so called “death penalty” meaning no Federal program Medicare, Medicaid, VA, etc could use ANY GSK drug..

Why? It defies anything I can come up with except massive criminal fraud and corruption at the highest levels of government. This is a huge story, what I saw and heard over ten years makes me literally sick…yet Nobody seemingly will say anything…the other , second to file whistleblowers, were a joke…copied my complaint, took their money and hid . Mere accomplices to the crimes in my opinion.

Do I fear retaliation for what I say…hell yes I do, but someone has to speak up on this.

I am hopeful someone in the DOJ will come forward, everyone cannot be corrupt or cowardly and I hope we will see under a new administration, something done.
As to the post about Jeff Sessions.. the answer is I don’t know what he can or will do. All I know is my son was in second grade when this began , now he is about to graduate from college. This hasn’t been easy for my family or me and I’m not sure if the swamp can ever be drained. I know a lot more, but someone in the DOJ has inside information…I hope they come forward. The lead investigator, Sara Bloom …would be a good start.