Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Donald Trump. Show all posts
Showing posts with label Donald Trump. Show all posts

Thursday, November 16, 2017

Business as Usual Means Bad News for Consumers


As an advocate for drug safety, I sometimes feel as if I'm pissing in the wind. Today is one of those times. (For American readers, the Cambridge Dictionary describes pissing in the wind as "trying to do something when there is no hope of succeeding.")

This week President Trump nominated Alex Azar as the next Secretary of the Department of Health and Human Services (HHS). Azar is former senior vice president of corporate affairs and communication for US pharmaceutical giant Eli Lilly. This US announcement comes on the heels of similar incestuous behavior by the UK government which recently announced Andrew Witty, former head of GlaxoSmithKline, has been selected to head its new pathway, 'Accelerated Access Review' (AAR). Days later, GSK's website highlighted another kick in the teeth for British drug consumers: Patrick Vallance, who is currently GSK's president of research and development, will become the UK government's new Chief Scientific Adviser.

What a sick few weeks for health consumers. Three top executives from Big Pharma land positions that are supposed to better protect health consumers by ensuring scientific information is accurate, and drugs are safe and effective. These three appointments should prompt Britain and US residents to take notice and be on full DEFCON alert. I'm certain families across the globe who have lost loved ones to Prozac and Paxil won't be jumping for joy at this week's announcements, and I imagine their dead relatives are turning in their graves.

Lilly & GSK are two companies that have frequently been sued by consumers who were harmed by their dangerous products. Further, both companies have engaged in abhorrent and illegal tactics to peddle their pills. Some of these unscrupulous behaviors include paying doctors to prescribe, bribing government officials, and fraudulently marketing drugs for unapproved uses. But apparently, this type of leadership is rewarded by governments that prefer corporate collusion to consumer care.

GSK and Lilly have paid billions in fines and lawsuits because their illegal activities caused the suffering and deaths of countless innocent men, women, and children. In 2009, Lilly was fined $1.42 billion to resolve a government investigation regarding off-label promotion of the antipsychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law."

Similarly, in 2012, GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs and its failure to report safety data. This is the largest healthcare fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug was not approved for children. GSK also pled guilty to failing to disclose safety information to the FDA about the diabetes drug Avandia. These pharmaceutical companies don't mind paying a couple of billion dollars here and there for criminal violations because shady criminal behavior reaps more sales profits than does subsequent fines. This unethical behavior is just part of pharma's business plan.

Back to Those Incestuous Appointments

Alex Azar has had previous connections to the US government. He was deputy secretary of Health and Human Services under George W. Bush and served as the chief operating officer for two years. In that role, Azar oversaw such agencies as the Food and Drug Administration (FDA), the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. In May 2007, Azar became senior vice president of corporate affairs and communication for Lilly. This revolving door employment agency is standard US practice. Corporate execs leave the industry for cushy jobs in government, then they leave government for industry and lobbying jobs, etc.

This incestuous fox guarding the hen house is commonplace and will continue to put consumers at great risk. It was US President George W. Bush who named Eli Lilly President and CEO, Sidney Taurel, as a Homeland Security Advisory Council member in 2002. Further, soon after the Homeland Security Act was signed in 2002, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute. On November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that incredibly will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.” (Thimerosal is a mercury-based preservative that is used in vaccines. It was developed by Lilly in the 1920s and by the 1990s its use was widespread)

In 2003, Bush appointed Taurel to the President’s Export Council. The same year, “60 Minutes II” aired a segment on Lillygate and Prozac. Lilly's patent for Prozac had run out so they began marketing a new drug, Prozac Weekly. According to 60 Minutes II, Lilly sales reps gained access to “confidential” patient information records and mailed out free samples of Prozac Weekly. Regulations, proposed under Bill Clinton and later implemented under George Bush, contained a provision that allowed healthcare providers the right to sell a person’s confidential medical information to marketing firms and drug companies.

Bush was later rewarded for his job placements and overseeing provisions when he left the White House. He went straight to Eli Lilly headquarters where he served as an Eli Lilly Board of Director.

You scratch my back, I'll scratch yours, huh?

Assuming he's confirmed, Azar will oversee 11 agencies including the FDA, Center for Disease Control (CDC), National Institutes of Health (NIH), Administration for Children and Families (ACF) and Centers for Medicare & Medicaid Services (CMS).

When Patrick Vallance of GSK takes over the role of UK Government Chief Scientific Adviser, he will oversee science and technology-related activities and recommend policies to the Prime Minister and  Cabinet. He will also sit as chair of the UK’s Scientific Advisory Group for Emergencies.

Witty's new title is self-explanatory. He will head a new UK government initiative known as 'Accelerated Access Review' (AAR) where his role is to get new drugs and devices on the market quickly.

If you want to know more about how Lilly operates, I highly recommend John Cornwell's book, "The Power to Harm: Mind, Medicine, and Murder on Trial." It's a jaw-dropping insight regarding how far Lilly went to cover up the deadly ADRs caused by their lucrative drug, Prozac. If you want to know how GSK operate, well, there are more than 2,000 posts about GSK's shenanigans on my blog alone.

Unreported Terror & Risk

These appointments are scary and put citizens at greater risk of being harmed by unsafe, ineffective drugs, many of which should never have been approved. In both the UK and the US, we see frequent media reports about terrorist threats and acts, but we almost never hear news about pharma created deaths. When was the last time you heard a news report or read an article highlighting that prescription drugs are the fourth leading cause of death? In America, I chalk this up to the lucrative drug advertisements that essentially pay for TV news production. In the UK we don't have drug ads, but we still have pharma money negatively influencing government policy and political appointments.

Hiring CEO's of criminal corporations to protect citizens is wrong. But these types of crimes pay. If you don't like the status quo, you can petition your respective government and share your disgust. I'm sure they'll be happy to send you a form letter response within 30 days...

So, back to pissing in the wind: It's understandable I'm disgusted by this week's news. It's easy to throw up my hands when hearing such outrageous appointments. But sometimes those who've lost a loved one to pharma help me persevere. As one mom whose child died from pharma products recently said, "To the world, my child was just one person, but to me, she was the world. If my advocacy saves even one child, I have saved someone else's world."


In other news involving incestuous revolving doors, the FDA has now approved a new "digital pill." The pill contains a sensor that digitally tracks whether or not patients have ingested their medication. And what pill has this sensor been embedded into? ~ aripiprazole, (Abilify) a drug used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia.

On top of this, the commissioner of the FDA, Scott Gottlieb, is opposing a natural plant, Kratom, (mitragyna speciosa) that could help people effectively treat an addiction caused by opioids.

More on the aripiprazole and kratom scandals next week.

Bob Fiddaman












Sunday, August 13, 2017

Donald Trump - The Role of Psychiatry





I'm not into politics, particularly American politics. I've often laughed at the whole election process over there. Obscene amounts of money thrown at huge campaigns, even rock stars get in on the act in efforts to persuade their fans who to vote for. Here in the UK it's very low key. On the odd occasion, we may see a minor scuffle outside a polling station on a damp and dreary Thursday ~ It's nothing compared to the firework displays and live bands performing for our American counterparts.

So, if I'm not into politics why am I using my free time on a Sunday to write a blog about Donald Trump?

Well, I'm finding him very interesting. I can't weigh him up though. I know he has a disdain for journalists and I know he tweets a lot. His tweets are causing concern for many as are his speeches, so much so that a number of mental health professionals are claiming that Trump’s speeches and actions make him incapable of serving safely as president. They claim that Trump is showing 'grave emotional instability.'

In a letter to the New York Times, no less than 35 health care professionals, led by Lance Dodes, M.D., claim that:
(Donald Trump's) actions demonstrate an inability to tolerate views different from his own, leading to rage reactions. His words and behavior suggest a profound inability to empathize. Individuals with these traits distort reality to suit their psychological state.
Let's take a look at this closer by using the Merck Manual of personality disorders.

According to the 35 health care professionals, Trump is showing:

- grave emotional instability - Another term for this, I guess, could be 'emotionally detached.'
- profound inability to empathize -

Schizotypal personality disorder
People with schizotypal personality disorder are emotionally detached. In addition, they have odd ways of thinking, perceiving, and communicating similar to those of people with schizophrenia. Odd ways of thinking may include magical thinking and paranoid ideas. In magical thinking, people believe that their thoughts or actions can control something or someone. For example, people may believe that they can harm others by thinking angry thoughts. People with paranoid ideas tend to be suspicious and mistrustful and wrongfully think other people have hostile motives or intend to harm them. Schizotypal personality disorder may be treated with antipsychotic drugs.

Fair to say that Trump, if the 35 professionals assessment of him is correct, would meet the criteria for someone having Schizotypal personality disorder.

But wait, there's more from the Merck Manual:

Antisocial personality disorder
Many people with antisocial personality disorder become frustrated easily and tolerate frustration poorly. As a result, they act impulsively and irresponsibly, sometimes committing criminal acts. In these cases, they act without considering the negative consequences of their behavior and the problems or harm they cause others. There are no medications specifically approved by the Food and Drug Administration to treat antisocial personality disorder. Doctors may prescribe medications for conditions sometimes associated with antisocial personality disorder, such as anxiety or depression, or for symptoms of aggression

Furthermore:

Narcissistic personality disorder
This type is characterized by an inflated view of self-worth (called grandiosity). People with this disorder expect to be treated with deference and may exploit others because they think their superiority justifies it. Their relationships are characterized by a need for admiration, and they often think that others are jealous of or envy them. These people are sensitive to the reactions of others but only as far as the reactions relate to themselves. They are extremely sensitive to failure, defeat, and negative reactions from others, including criticism. Such reactions from others can trigger sudden rages or depression (including suicidal thoughts or actions). There are no medications specifically used to treat narcissistic personality disorder. However, if you have symptoms of depression, anxiety or other conditions, medications such as antidepressants or anti-anxiety drugs may be helpful.

Moving across to the Diagnostic Statistical Manual of Mental Disorders, we see Trump also meets the criteria (If the 35 health care professionals are to be believed) for:

Obsessive-Compulsive Personality Disorder
Empathy: Difficulty understanding and appreciating the ideas, feelings, or behaviors of others. In most cases, medication for this disorder is not indicated unless the individuals is also suffering from another psychiatric disorder. However, newer medications such as Prozac, an SSRI, have been approved for the treatment of obsessive-compulsive disorder and may provide some relief to individuals with the related personality disorder.

In fact, according to the 35 health care professionals, Trump also meets the criteria for Avoidant Personality Disorder and Borderline Personality Disorder, both can be treated with psychiatric medications.

So, my question to these 35 health care professionals is simple, however, I don't expect an answer.

If Trump was your patient would you prescribe him any of the medications listed above and let him continue in office?

I highly suspect the answer would be a defiant 'No' - not because they don't want him to continue in office, not because they believe that Trump is beyond repair either. Neither of these health care professionals would prescribe any psychiatric drug to Trump because of this one Tweet:


Why would any psychiatrist or doctor prescribe an antipsychotic or SSRI to someone who throws out a gauntlet like this?

Which brings me nicely to the recent Panorama programme, 'A Prescription For Murder.'

James Holmes, despite telling his psychiatrist he had murderous thoughts, was prescribed the SSRI sertraline, known better by its brand name of Zoloft in the US and Lustral in the UK. Holmes, after taking sertraline for 6 weeks carried out those murderous thoughts regardless. Much was said in the defence of SSRIs prior to and after the airing of the Panorama programme. Those same critics who chastised Panorama are now in a wonderful position. Why not let them decide if a psychiatric drug, which they believe does not induce murderous thoughts, should be administered to President Donald J. Trump?

If they are so cocksure that the benefits of these types of medications outweigh the serious risks they can pose then I'm sure they will pull out their prescription pads and write him a prescription for some medication.

Given what we know about these meds, and what we have been saying for many years about these meds, this is one occasion where psychiatry can prove us all wrong.

I double-dare you all.

Bob Fiddaman



Wednesday, June 07, 2017

Trump Nominates King & Spalding Attorney






Who is Christopher A. Wray?

Well, he's a litigation partner in King & Spalding's Washington DC and Atlanta office.

And who, I hear you ask, are King & Spalding?

Well, they're the law firm who just got spanked in Chicago. They defended GlaxoSmithKline, arguing that their antidepressant, Paxil, did not cause the suicide of Stewart Dolin.

The jury saw through the weak defence and found Glaxo liable.

Prior to joining the firm, Wray served from 2003 to 2005 as the Assistant Attorney General in charge of the U.S. Department of Justice’s (DOJ) Criminal Division, the same department who, in 2012, slammed down a $3 billion fine after GlaxoSmithKline pleaded guilty to a whole host of federal crimes.

So, what duties does one who becomes director at the FBI have to carry out?

Well, he's basically responsible for its day-to-day operations.

The FBI has jurisdiction over violations of more than 200 categories of federal crimes.

So nice to know that one of King & Spalding's biggest and wealthiest clients, GlaxoSmithKline, may now have someone to oversee any future criminal behaviour of theirs.

This shit just writes itself.

Nice move, Don.


Bob Fiddaman





Please contact me if you would like a guest post considered for publication on my blog.