The MHRA has two ex Glaxo Smith Kline (GSK) directors on its board, Ian Hudson and Gerald Heddell.
So how does the MHRA treat GSK in the UK?
In the USA in July 2012, GSK pleaded guilty to federal criminal charges and paid a $3 billion fine. This was the largest health-care fraud in U.S. history, and included pricing fraud.
Paxil – killed 1,026
22 died while on Paxil in the clinical trials. https://fiddaman.blogspot.co.uk/2017/04/dolin-vs-gsk-jury-shown-list-of-dead-in.html#.WdDPjIprxMY
The company admitted that for five years, ending in 2003, it illegally promoted Paxil to treat depression in patients under the age of 18, even though the FDA never approved the drug for pediatric use.
GSK published a misleading medical journal article that stated a clinical trial of Paxil showed it was effective treating depression in young patients
The company also hid the data from two other studies that showed Paxil was ineffective in pediatric patients. In addition, the company sponsored dinner, lunch and spa programs to promote the use of Paxil in children, and paid a speaker to talk to an audience of doctors whose meals and spa treatments were provided free by GlaxoSmithKline.
In 2004, the FDA required a black box warning that antidepressants may increase the risk of suicide in patients under 18.
Antidepressant Paxil was created at the former SmithKline Beecham in 1992, and it became the fifth-most prescribed antidepressant in the U.S. by 2007. From the late 1990s to the mid 2000s, Paxil generated $11.6 billion in sales.
As of September 2017, 78,781 have side effects from Paxil, and it killed 1,026 according to the FDA.
Serious side effects included the risk of suicidal thoughts in children and the risk of birth defects if taken while pregnant. These risks led to thousands of lawsuits against GSK. In April 2017, a Chicago jury ordered GSK to pay $3 million to the widow of a corporate attorney who killed himself by stepping in front of a train in 2010 after taking a generic form of Paxil that had not been made by GSK. The jury held GSK responsible because the drugs were identical and carried the same labeling.
GSK also admitted it illegally promoted Wellbutrin for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, when it was approved only for major depressive disorder. The company paid millions of dollars for representatives to speak at and attend meetings, sometimes at lavish resorts, where the off-label uses were promoted. It paid television personality Dr. Drew Pinsky $275,000 to talk for two months about antidepressants and sex, touting Wellbutrin as being better for the sex drive than other drugs.
Avandia – 100,000 deaths
From 2001 to 2007, GSK failed to inform the FDA of post-marketing studies and data as it related to Avandia’s cardiovascular safety.
Since 2007, Avandia has had to carry a black box warning relating to an increased risk of congestive heart failure and heart attacks. Ultimately, the FDA said patients who were not already using Avandia should not start taking the drug.
A related civil settlement with the U.S. Justice Department also resolved allegations of improper marketing of Advair and anti-nausea drug Zofran.
Two years after the U.S. prosecution concluded, GSK was convicted in China of bribery and made to pay almost $500 million.
This all came on the heels of the 2010 settlement of a whistleblower lawsuit in which GSK payed $750 million to resolve allegations it sold contaminated products, including Paxil and Avandia, made at its since-closed plant in Puerto Rico.
Type 2 diabetes drug Avandia has been on the market since 1999. It part of a class of drugs, including Rezulin and Actos, known as thiazolidinediones. Rezulin, the first of the class, caused liver damage and was recalled in 2000. Avandia filled the gap in the marketplace and by 2006 became the top selling diabetes drug in the world with $3 billion in sales. But after the drug was linked to thousands of strokes, heart attacks and heart failures, the FDA severely restricted the use of the drug in 2010. Toward the end of 2013, the FDA dropped the restrictions, but more than 50,000 lawsuits were filed against GSK, which paid more than $460 million to resolve the claims.
The FDA estimates Avandia caused up to 100,000 heart attacks with studies finding the drug increases the risk as much as 43 percent. GSK set aside $6.4 billion for Avandia litigation and settlements. As of February 2017, the company had agreed to settle a substantial number of pending cases in U.S. federal and state courts.
Glaxo Wellcome began selling Zofram (ondansetron) in 1991 to treat or prevent nausea and vomiting in cancer patients. But doctors prescribed the drug to prevent morning sickness in pregnant patients, and it was later found to be associated with the risk of birth defects. Families who claimed their children suffered birth defects when their mothers took the drug filed hundreds of lawsuits against GSK. As of February 2017, the company was named as a defendant in 312 such suits in the U.S. Most of them are part of multidistrict litigation in the District of Massachusetts.
MHRA prosecutions? – None.
The rest of the world made GSK pay $4,173 billion, for killing 100,000 and the dishonesty, and GSK set aside $6.4 Billion for Avandia settlements.
So what did ex GSK men Ian Hudson and Gerald Heddell do at the MHRA in the UK?
They merely carried out an expensive enquiry into Paxil.
GSK got no fines, no arrests, no raids, absolutely nothing at all. Under the MHRA, they got away with murder – they knew scores of thousands were dying from Avandia, and the MHRA allowed them to keep on selling it.
Ian Hudson and Gerald Heddell have deadly a conflict of interest that has killed much more than 100,000 people in the UK, by denying people inexpensive treatments that work, and by licensing drugs that kill..
Partially abridged from Elaine Silvestrini on Drugwatch.com