SPY : Scandals in Pharmaceutical industrY

A new happiness pill arrived and this time it was simple, legal and safe. After the Valium generation, here comes the Prozac generation.

Prozac is the registered trademarked name for fluoxetine hydrochloride, which was first documented in 1974 by scientists from Eli Lilly Company.

According to an article from the New-York Times, in 1988, a year after the Food and Drug Administration (FDA) approved Prozac, 2 469 000 prescriptions for it were dispensed in America and by 2002, that number had risen to 33 320 000.

However 40 years ago, depression was hardly anywhere, and studies suggest that in America, depression more than double from 1991 to 2001. Is it a coincidence if Eli Lilly supported a huge National campaign that alerted GPs and the public to the danger of depression?

Eventually in 2007, 20 years after the Prozac’s launch the World Health Organization considers that depression is set to become second only to heart disease as the world’s leading disability in 2020.

Prozac is now entered in the collective consciousness as a concept not just as a drug. Books were written about it as “Prozac nation”, Elizabeth Wurtzel’s bestselling memoire in 1994, that became a movie in 2001, or songs (Vanilla Ice’s “Prozac”).

Maybe it was too good to be true but since it was launched in the USA, the Guardian in 1999 considers that 200 cases have come to court in the US. As Prozac was prescribed by GP on the whole population rather than selected patient, some disturbing violent behaviors appeared.

The fist case to come to litigation concerned Joseph Wesbecker (see picture at the left), a Louisville printer who has been prescribed Prozac because of his depression. Few month after, in September 1989, Joseph Wesbecker went to his work with automatic weapons, killed eight and injured 16 of his colleagues before committing suicide. Eli Lilly won the case by 9-3. The defense was: “blame the disease not the drug”.

Lot of other cases came to court but there were all dropped or Lilly settled out of court, sometimes for millions of dollars. Indeed in 1999, Prozac was providing to the company with more than 25 per cent of its revenue, so it was primordial to hide this kind of adverse events.

Until 1993, when the Forsyths,, decided to get a hearing after their parents’ death and internal document belonging to Lilly were produced to court…

Antidepressants: a never-ending controversy

If you feel sad or depressed don’t worry there are some pills of happiness! This is the story of the antidepressants, one of the most commercially drug.

It all beguines in the 1960’s with the word’s first wonder drug the benzodiazepines, also named “benzos”. In the mid-1930s in Cracow in Poland, the Dr Leo Sterbach worked in the compound and when he came to the USA, he resumed work on these compounds in the Chemical Research Department of Hoffman-La Roche, USA, in Nutley New Jersey. The drug first appeared to be inactive but eventually, in 1963 the diazepam marketed as Valium was introduced, followed by Mogadon or Librium.(http://www.benzo.org.uk/amisc/lader.pdf)

Within a decade they had become the most commonly used treatment for anxiety and stress conditions in the States and Britain.

It appears that two studies carried out in the early 1960s established the potential of the benzodiazepines to induce a physical dependence state when the drug was given in high dose for several weeks. ([i], [ii]).

But the benzos were considered much more safer compared with their predecessors, the barbiturates. So little notice were taken against those adverse events.

In the 7O’s, some clinicians noticed a dependence to the drug for long-term users a normal dose ([iii]), and the authorities still didn’t make a move.

Eventually, at the end of the 80’s guidelines being issued by the U.K. Committee on Safety of Medicines and the Royal College of Psychiatrists restrict benzodiazepines to short-term use, stress the need to establish a definite indication, and warn against abrupt withdrawal.

In similar vein, in the U.S.A., Schweizer, Case, & Rickels (1989) have averred “we have unpublished data which demonstrate that many patients, once they have been withdrawn from their maintenance benzodiazepines, show more improvement on clinical measures of anxiety and depression than they did during their chronically medicated state.”

Widely known to be addictive and to cause a range of serious side effects, benzos became less popular in the 1980s and 1990s owing largely to the rise of SSRI (selective serotonin reuptake inhibitors) such as Prozac and the British drug Seroxat, known as Paxil in the US, which were widely considered to be safer and nonaddictive. 

So one drug replaces an other one. And the story repeats.

According to the NCHS (National Center for Health Statistics) in the USA, about one in ten Americans over 12 and over take anti-depressant medication.(http://www.cdc.gov/nchs/data/databriefs/db76.htm).

People buy drug to be cured, but instead of that, their states are worse than before. Here are some stories:

A doctor in United States prescribes Risperdal for a psychiatric illness for which the drug is not approved by the health authorities and this had many side effects: the man is now wheelchair with diabetes and Parkinson. There are evidences that Risperdal can cause diabetes, Parkinson. It can also cause serious complications in adolescent boys (Gynecomastia: breast development), See the link http://www.rxlist.com/risperdal-drug.htm

Avandia which used to be the world’s best selling diabetes drug for years, is now linked to over 100,000 heart attacks in the United States. “The maker of controversial diabetes drug Avandia knew for around a decade that the medication increased risks of heart problems in patients but covered up that fact from the public”, according to a Senate Finance Committee probe. See the link http://www.cbsnews.com/stories/2010/07/13/health/main6673320.shtml

“Pharmaceutical fraud is one of our top three threats.” Said Sharon Ornsby, a member of the FBI financial crimes unit, in an interview on Al Jazeera television.

Glen Demott was a top Pfizer representative selling the drug Bextra while earning 100,000 dollars per year. He claims he was trained to lie to physicians, “they were training us to say things to physicians that weren’t accurate. Bextra was not approved to be used for acute pain and we were out there trying to get standing orders for acute pain.” See the link http://www.reuters.com/article/2009/09/02/idUS196265+02-Sep-2009+PRN20090902

Much case involved drug industry in pervasive fraud, corruption and huge kickbacks which were paid to doctors to prescribe drug even if there were no indication for the disease.

Which decision can one make? Take medicines without knowing if we shall get better or less, or stay without making anything and risking not to seize a chance of cure??...