The Fines Imposed on the Drug Companies: Obviously Ineffective

In recent years the USA have seen some of the biggest fines for multinational corporations in US history. It were the big multinational pharmaceutical companies which received those extremely high fines resulting from US court settlements.

See for this the Wikipedia article titled “List of largest pharmaceutical settlements“.

This list is headed by a billion fine imposed on GlaxoSmithKline (headquartered in Brentford, London) and by a 2.3 billion fine imposed on Pfizer (headquartered in New York City).

See also an article published on October 2, 2010 titled “Side Effects May Include Lawsuits” in “The New York Times“.

As investigative reporter Duff Wilson explains in this article, “for decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases. (…).

Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers SquibbEli LillyPfizerAstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing”.

Well, the astonishing fact about all this is that though those were the highest fines ever imposed to multinational companies in US history, they even then are obviously ineffective.

See for this an article published on December 20, 2013 in “Medscape” titled “Fines for Drug Companies Ineffective?

As Marcia Frellick states in this article, “a study of a recent escalation of fines paid by multinational drug companies to US federal and state governments shows that neither the amount of the penalties nor the measures to stop illegal practices are working, according to a report published online December 18 in BMJ. However, some experts think the problem lies, in part, with a complicated legal environment.

In the current study, Sidney Wolfe, MD, founder and senior adviser to the Health Research Group at Public Citizen in Washington, DC, reviewed all civil and criminal penalties paid to the US federal and state governments by pharmaceutical companies from January 1991 to July 2012 and found that they totaled $30.2 billion“. (…).

Dr. Wolfe’s analysis shows that from 2002, GSK and Pfizer were repeatedly fined, with penalties in the billions, for practices including fraudulent drug pricing, illegal off-label marketing of drugs, and paying kickbacks to healthcare professionals to encourage them to promote and prescribe drugs.

During this time, Dr. Wolfe notes, both companies signed several corporate integrity agreements, which are designed to prevent these offenses. The Office of the Inspector General negotiates such agreements with companies as part of the settlement of federal investigations. The terms include requiring companies to hire compliance officers or committees, develop written policies, and establish employee training programs.

On the basis of an analysis of the fines, Dr. Wolfe concludes, “There is a pathological lack of corporate integrity in many drug companies.”

If the usual judicial measures for such cases and even the highest fines imposed on multinational corporations in the history of the USA obviously are not able to stop the fraudulent and criminal business practises of those big pharmaceutical companies like GlaxoSmithKline and Pfizer, the lawmakers in the USA should start to think about other possible methods and actions to stop those multinational corporations to go on violating the laws of the United States.

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Fire in the Blood (2013)

I just watched “Fire in the Blood, a documentary directed by Dylan Mohan Gray released in 2013 .

This documentary, which was shot across four continents, depicts the countless deaths brought about in AfricaAsia and India due to intentional obstruction of low-cost antiretroviral drugs used for treatment of HIV/AIDS from reaching the mostly poor people in those continents, spearheaded by the big pharmaceutical companies (Big Pharma) which hold the patents for those medications.

The documentary shows how the battle against this intentional obstruction with the goal to protect and maximize their profits in developing and Third-World countries, was fought and at least for the moment won.

The intentional obstruction by the big pharmaceutical companies is estimated to have resulted in ten- to twelve million unnecessary deaths.

Dylan Mohan Gray first came to know of this issue in 2004, after he read an article in The Economist about the battle between Big Pharma and the HIV/AIDS treatment activists over the access to low-cost antiretroviral drugs for Africa. He decided to make this documentary three years later.

The film was shot from March 2008 to the end of 2010. The editing was completed in 2012.

Fire in the Blood” features interviews with former US President Bill Clinton, intellectual property activist James Love, global health reporter Donald McNeilJr. of The New York Times, HIV/AIDS treatment activist Zackie Achmat, pioneering generic drugmaker Yusuf Hamied, former Pfizer executive-turned-whistleblower Peter Rost, leading African AIDS physician Peter MugyenyiNobel Prize-laureates Desmond Tutu and Joseph Stiglitz (economist and professor at Columbia University and former senior vice president and chief economist of the World Bank).  

The film is narrated by William Hurt, who lent his voice to this documentary on a pro bono basis because he felt the story and subject matter were so important.

The documentary received numerous awards:

Grand Jury Prize, World Documentary (Nominated) — Sundance Film Festival, January 2013

One World Media Award (UK), Documentary (Shortlisted), February 2013

Winner—Justice Matters Award—27th Washington DC International Film Festival, April 2013

Winner—DOXA Feature Documentary Award (main prize) — 2013 DOXA Documentary Film Festival, Vancouver, May 2013

Grierson Awards (Grierson British Documentary Awards), Best Cinema Documentary (Shortlisted), July 2013

Winner—Friedrich-Ebert-Stiftung Prize for Political Film, Filmfest Hamburg, October 2013

Winner—Dadasaheb Phalke Chitranagari Award for Best Debut Film for a Director, Mumbai International Film Festival, February 2014

Fire in the Blood” is without doubt a must-see-documentary.  And the battle for the right of the developing and Third-World countries to produce and to buy low-cost-medication has only been won temporarily.

Especially the so called TRIPS-Agreement was one of the main causes for this bitter fight over the access to low-cost antiretroviral drugs for developing and Third-World countries.

See for this also the webpage titled “TRIPS and Big Pharma” in the website of the “International People´s Health University“.

And the TRIPS-Agreement is still being a main reason for constant battles over this issue.

See for this also the article of September 8, 2012 titled “Drugs and emerging markets: Tripped up” in The Economist.

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Generation RX (2008) – 2

So this seems to be somewhat weird to me: If some youngster buys some “Crystal Meth” (methamphetamine) from some drug dealer, at least the dealer sure will go to jail if the police gets him. And if the youngster who buys that stuff is caught by the police he also might get into serious legal troubles.

But if you get a diagnosis of attention deficit hyperactivity disorder (ADHD) which is quite common today you not only can get those amphetamines (also methamphetamine)   legally but the psychiatrists and the pharmaceutical companies even encourage you to take those drugs?

This diagnosis attention deficit hyperactivity disorder (ADHD)  was not usual when I was a school boy in the 1970s and 1980s. And even if some school boys had troubles like that (at that time in Germany we called such kids a “Zappelphilipp“, because they usually were often not able to sit still on their chairs) they usually didn´t get any pharmacological treatment at that time.

The psychiatrists probably will say now that this is the nature of medical progress that you have treatments today that were not usual some over thirty years ago.

But first this medication named “Ritalin” (Methylphenidate) is in fact just an old and well known powerful and efficiency increasing stimulant that was first synthesized in 1944 and was identified as a stimulant in 1954.

And in the end “Ritalin” (Methylphenidate) is just another variant of amphetamine that was first synthesized in 1887 at the University of Berlin.

The German journalist and author Hans-Christian Dany has published in 2008 a rewarding book about the long history of the use of amphetamines in the different areas of society.

See for this my blog article (written in German): “Hans-Christian Dany: `Speed´ (2008)“.

And second nobody in my youth would have seriously considered to give to children such powerful drugs like amphetamines and methamphetamines only because they were not behaving properly or performing well at school.

Of course also in the case of Ritalin the risk of substance abuse is high.

See for example the webpage “Ritalin” on the website of the “Center of Substance Abuse Research” (CESAR) of the University of Maryland at College Park.

“Ritalin comes in 5, 10, and 20 mg water-soluble tablets intended for oral ingestion. Those who misuse Ritalin increase the amphetamine-like effects by crushing the tablets into a powder and snorting it or dissolving it in water for intravenous injection.

As a Schedule II substance, Ritalin has a high potential for abuse. When injected it may produce feelings of euphoria. Early reports of abuse in Sweden led to the removal of Ritalin from the Swedish market in 1968.The dramatic increase in prescriptions in the United States over the past decade has increased the potential for diversion from medical use. The DEA has collected reports indicating that adolescents who are prescribed Ritalin may give or sell it to their classmates who crush and snort the tablets. Ritalin is also diverted through “Attention Deficit Scams” in which a parent or other adult takes a child they claim has ADHD to a number of doctors to obtain prescriptions for Ritalin. The adult then keeps the drug for his or her own use or to sell or trade for other drugs.

The DEA has received anecdotal reports of college students using Ritalin to help them study, especially for all-night study sessions and cramming for exams, in addition to using it as a “party drug”. One survey of students at a public liberal arts college found that over 50% of survey participants knew other students who had used Ritalin for fun, 16% had used it themselves, and nearly 13% reported their own use included snorting the drug”.

See for this also the article titled “Teens Abusing And Selling Ritalin for High” (2/25/2003) in ABC News.

This phenomenon that Ritalin was used by teens also for getting high obviously was known already more than ten years ago. Some of those teens are flying high when taking Ritalin, no doubt about it.

Ozzy OsbourneFlying High Again (album: Diary of a Madman, 1981)

Lyrics Flying High Again

See also the article “Recreational ritalin as ‘risky’ as methamphetamine” in One News (13/11/2013)

For a critical and intelligent evaluation of this current dubious “mass drugging” of children with Ritalin see also the article of Alan Sroufe titled “Ritalin Gone Wrong” in “The New York Times” (1/28/2012).

I can really recommend to you to watch this documentary “Generation RX“.

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Generation RX (2008) – 1

Two days ago I watched an intelligent documentary titled “Generation RX” made by Kevin P. Miller.

For decades, scores of doctors, government officials, journalists, and others
have praised the benefits of psychiatric medicines for children without presenting the often massive side effects and dangers that are included if you give to children powerful psychiatric drugs like antipsychotics, antidepressants and amphetamines (Methylphenidate – known often also under the brand name Ritalin).

By using the expertise of professionals from the fields of medicine, ethics, journalism, and academia, “Generation RX” investigates the collusion between drug companies and their regulatory watchdogs at the FDA

Generation RX” is a film about families who confronted the desastrous consequences of giving their children psychiatric medications:  A practise advocated by leading psychiatrists that often have very close financial ties to the big pharmaceutical companies.

This documentary shows how millions of children in the USA have been caught in the vortex of mind-bending drugs at the earliest stages of their growth and development. It also shows that these children were hooked on pharmaceutical drugs for commercial rather than for scientific reasons.

In the WWW can be found a press kit (PDF) for this documentary that was offered at the M.U.C.K.-Film-Festival (Movies of Uncommon Knowledge) in Toronto (Canada).

I published myself in March 2012 a blog article (in German) titled “Teenscreen in Amerika” about the so called TeenScreen program. 

The “TeenScreen National Center for Mental Health Checkups at Columbia University” was an supposedly evidence-based, national mental health and suicide risk screening initiative for middle- and high-school age adolescents.

On November 15, 2012, according to its website, the program was terminated.

But with terminating this dubious program of course the underlying problem in the USA (and more and more also in Europe) of giving psychiatric drugs to children was not eliminated too.

Children are an extremely profitable market for “Big Pharma“. The patients get hooked on those drugs on a very early age, which means that the pharmaceutical companies can make a lot of money with those patients during a whole life span (in the developed countries the average life span is currently around 80 years).

So it´s no wonder that the pharmaceutical companies are aiming with their cynical market strategies also at this group of very lucrative future patients.

The parents of those kids often enough might not be aware that these psychiatric drugs can have very severe side effects. And the younger those kids are the more dangerous and harmful can be those side effects, because your body, brain and your personality is still in a stadium of development.

The most astonishing phenomenon for me is that powerful and efficiency increasing stimulants like the amphetamines and methamphetamines (Methylphenidate – known often also under the brand name Ritalin) are given now to children.

Amphetamine was first synthesized in 1887 by Romanian chemist Lazăr Edeleanu who synthesized amphetamine at the University of Berlin.

Its stimulant effects remained unknown until 1927, when it was independently resynthesized by Gordon Alles and reported to have sympathomimetic properties.

Amphetamine had no pharmacological use until 1934, when Smith, Kline and French began selling it as an inhaler under the trade name Benzedrine as a decongestant.

During World War II, amphetamines and methamphetamines were used extensively by both the Allied and Axis forces for their stimulant and performance-enhancing effects. Especially pilots used this drug during World War II on both sides.

The Germans used Pervitine, an methamphetamine that was first synthesized in 1938 by a chemist of the pharmaceutical company Temmler of Berlin. It was commercialized by Temmler as a psychiatric drug and used by the German soldiers during World War II.

See for this the article of May 30, 2013 titled “WWII Drug: The German Granddaddy of Crystal Meth” in “Spiegel Online International”.

See also the article of May 6, 2005 titled “The Nazi Death Machine: Hitler´s Drugged Soldiers” in “Spiegel Online International”.

As the addictive properties of amphetamines became known, governments began to place strict controls on the sale of those drugs. 

For example, during the early 1970s in the United States, amphetamine became a schedule II controlled substance under the Controlled Substances Act. 

In spite of strict government controls, amphetamine  (= commonly also known under the slang term “speed“) has been used legally or illicitly by people from a variety of backgrounds, including authors, musicians, mathematicians and athletes.

Billy IdolSpeed (1994)

Lyrics Speed

Wikipedia: Speed (1994 film)

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Some other Documentaries and Television Reports about the Cynical Marketing Tactics of “Big Pharma”

Another interesting and rewarding documentary on the cynical marketing tactics of drug companies is “Money Talks: Profits Before Patient Safety” directed by John Ennis and Kathleen Slattery-Moschkau. This documentary was released in 2006.

Money Talks: Profits Before Patient Safety” explores the ethical and societal implications of the fraudulent schemes and practices of the pharmaceutical industry.

This documentary features interviews with investigative journalists, medical professionals, former pharmaceutical sales representatives, and others. These experts talk frankly about the pharmaceutical influence as it relates to consumers, physicians, research, the FDA and Capitol Hill.

There is a website in the WWW that includes a lot additional information about this documentary “Money Talks: Profits Before Patient Safety“.

A really good and straight television report on the fraudulent schemes and practises of the pharmaceutical companies titled “Drug Money” was presented in August 2010 in the current affairs programme “People & Power” of Al Jazeera English.

I saw another documentary about the same subject (the pharmaceutical companies and their cynical marketing tactics) released by Gary Null in 2006 titled “Prescription for Disaster“.

But I didn´t really like this documentary, because it was not only criticizing the pharmaceutical companies for their ruthless marketing tactics, but is was also advocating so called alternative medicine and nutritional additives (dietary supplements like vitamins) as a therapy for dangerous illnesses like cancer.

I don´t really believe in this all this alternative medicine stuff, though some of those alternative medical techniques like for example chiropractic can sometimes be useful as an additional therapeutical method to standard academic medicine.

I believe in evidence based academic and scientific medicine. And a healthy life style sure is very important preserving one´s health (healthy food, sports, no or little alcohol, no smoking, of course no drugs too, etc.) but I don´t believe that dietary supplements are necessary if you are eating enough healthy food on a daily and regular basis.

Gary Null (born 1945) has made a lot of movies about health and health care related subjects (see the list with his movies in the Internet Movie Database) but this guy might be a quack.

Stephen Barrett´s Quackwatch includes 13 files about or mentioning Gary Null.

So I don´t recommend this documentary, though some of the facts that are presented here are in accordance with the facts serious critics of the pharmaceutical companies are presenting too.

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Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs (2006)

Yesterday night I watched an interesting and rewarding documentary about the schemes and dubious practices of “Big Pharma” in the USA titled “Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs

This documentary was produced and edited in 2006 by Ronit Ridberg in cooperation with the “Media Education Foundation“.

Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs” pulls back the curtain on the multi-billion dollar pharmaceutical industry to expose how illnesses are used, manipulated, and in some instances created, for capital gain.

Focusing on the pharmaceutical industry‘s often fraudulent marketing practices, media scholars and health professionals help viewers understand the ways in which direct-to-consumer advertising (mainly television ads) glamorizes and normalizes the use of prescription medication and works in tandem with promotion to doctors. Combined, these industry practices shape how both patients and doctors understand and relate to disease and treatment.

This documentary features interviews with Dr. Marcia Angell (Dept. of Social Medicine, Harvard Medical School; Former Editor New England Journal of Medicine), Dr. Bob Goodman (Columbia University Medical Center; Founder of “No Free Lunch), Gene Carbona (Former Pharmaceutical Industry Insider and Current Executive Director of Sales, The Medical Letter), Katharine Greider (Journalist; Author,The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers), Dr. Elizabeth Preston (Dept. of Communication, Westfield State College), and Dr. Larry Sasich (Public Citizen Health Research Group). 

A transcript of this documentary can be found online (PDF) in the WWW.

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