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Book Review Deadly Medicines and Organised Crime by Gøtzsche

The Danish medical researcher Dr. Peter C. Gøtzsche uses examples and scientific studies to show how the pharma industry has corrupted our health care system.

Collage book "Deadly Medicine" by Prof. Gøtzsche with text statement on the right.© CC-by-sa 2.0, Catalina Sparleanu, PhD, Foundation Diet and Health Switzerland

Conclusion

From a world company we received the demand for not using 4864 different names. They are mainly prescription drugs, etc. Including "I" for the active ingredient in the body that inhibits diabetes. We now use "shortcuts" and have deleted some passages and numerous helpful links. The original contribution can only be viewed by members (membership is possible at the top left of our pages, EE June 2019).

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In a precise and in-depth manner, professor Peter Christian Gøtzsche describes the many manipulations (also intrigue) of the pharmaceutical industry. It is a story of deception, concealment of negative studies, bribery, intimidation, and threats directed at critics (criticism).

The goal of the major players in this industry is to make their already huge profits even larger.

The book does not contain a critique of capitalism. It is easy to read and comes across a bit like a crime thriller. However, in our book review, we only have room to present the facts, which are somewhat drier to read. We were only able to include a few of the many examples from the book.

The author suggests a number of solutions, which he summarizes in Chapter 21. Keywords here are independent medical testing bodies and regulatory authorities, rejection of money and benefits the industry provides to those who play a role in the healthcare industry including physicians, hospitals, universities, institutes, self-help groups, newspapers, journalists, and politics, and preventing conflicts of interests where experts are involved.

The book is definitely a must-read for all medical professionals who still believe that the pharmaceutical industry acts in the best interest of patients and not simply for their own benefit. It is a question whether or not this book should also be recommended to laypeople without prior knowledge.

After reading this book or our book review, no one should simply stop taking their medications. Instead, they should consult their physician and give him or her this book review to read. You can just send them the link. There are many essential medications.

In contrast to the information in this book, you should know that we owe the successes we have had with achieving a higher life expectancy to the pharmaceutical industry. This scathing but objective critique doesn’t have the task of conveying this fact. This book review includes confirmation that Gøtzsche is right on the mark.

Video image: "A pharmaceutical insider unpacks - ZDF".© CC-by-sa 2.0, Uwe Dolata, ZDF
Video: Ein Pharma-Insider packt aus (A pharma-insider reveals the shocking truth), 3:28 min. YouTube channel DieAndereWahrheit (The other truth).

ZDF, a German public-service television broadcaster in Germany, is known for its reliable and unbiased reports. This is further evidence that the book discussed here depicts the situation as it is — without exaggerating.

1. Summary

What is the subject of this book? It deals with the methods employed by pharmaceutical companies and their managers. Their goal is usually to increase their profits, no matter what the price. Using the tricks provided by the author, they could offer good, effective medications that have very few side effects and are reasonably priced. But if a company wants to be successful today, this can’t be their goal. Society would have to first change.

The author dedicated the book to the many honest people who work in the pharmaceutical industry who are as outraged as he is about the criminal dealings of their superiors and the consequences that these have on patients and the economy.

To some extent, the companies in the food industry act similarly, as we saw in the book review of Salt Sugar Fat (book written by Michael Moss). Moss received a Pulitzer Prize for his book.

How people act when money and/or prestige are at stake

Both books, Salt Sugar Fat and Deadly Medicines and Organised Crime actually only show how people act when money and/or prestige are at stake.

In our schools, we are failing to teach ethics and the meaning of ethics. In-depth study, specifically applied ethics (see domains included), philosophy, and further education should be offered for young adults — as required subjects for both genders. Otherwise, society doesn’t have the chance to change, and it must change. There is no doubt about that. This is similar to when we take a country that doesn’t understand democracy and try to introduce just this or even a direct democratic system as we have in our Western countries.

See also the entry on business ethics on Wikipedia. On the German entry for the topic, we read Central values here are humanitas, solidarity, and responsibility.

When we compare theory and practice with political entanglement, we can only come to the conclusion that the well-intentioned and good recommendations the author makes aren’t realistic as they aren’t far-reaching enough. The majority doesn’t have the will to change the situation. And they are far from being able to delve into this topic or see the problem and its implications in the long term.

Book back of "Deadly Medicine and Organized Crime."© CC-by-sa 2.0, Ernst Erb, Foundation Diet Health Switzerland
You can enlarge all of the images by clicking on them and in this case then read the text.

See this Wikipedia entry on CONSORT (Consolidated Standards Of Reporting Trials). The CONSORT Group, based at The Ottawa Hospital Research Institute (OHRI) in Canada and at additional locations, is trying to introduce guidelines for publishing randomized treatment studies that could dramatically increase their reliability.

Clip on YouTube about ZDF heute show. Interview with a lobbyist of ProGenerika.© CC-by-sa 2.0, Martin Sonneborn, ZDF
Video: Martin Sonneborn interviews a spokesperson for the lobby association ProGenerika. (German only, 3:42 min, uploaded by QVCinsider, ZDF’s heute-show (satirical television program) on May 14, 2010)

You can hear more about how cheap medications from China or India really have the same quality as medications produced in Europe.

It’s quite funny, the point being that the pharmaceutical industry wants us to buy their more expensive medications, but it doesn’t add anything that isn’t already included in this book.

Forewords and statements

Dr. Gerd Gigerenzer, psychologist and director of the Max Planck Institute for Human Development, praised the book as being a true eye-opener.

Dr. Peter Sawicki, diabetologist, agrees with the author that:

the pharmaceutical industry is endangering our health with the ways that they strive to make profits, regulatory authorities that work inefficiently, and legislative bodies that fail to pass effective laws to protect the people.

Dr. Sawicki is the former head of the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wissenschaftlichkeit im Gesundheitswesen, IQWIG). Politicians released him from service in 2010.

Dr. Wolfgang Becker-Brüser, also a Pharm. D. and editor of Arznei-Telegramm (German medical journal) doesn’t see the provocative title to be an exaggeration. The sponsor of Arnzei-Telegramm, an ad-free journal, is A.T.I. Arzneimittelinformation Berlin GmbH.

Best-seller author Dr. Frank Wittig considers Gøtzsche to be the most high-profile pursuer of the pharma mafia in the world. Dr. Wittig is also an author and wrote the books "Die Weisse Mafia" (The white mafia, Feb. 2013), which was a "Spiegel" (influential German magazine) best seller, and "Krank durch Früherkennung" (Sick by early detection, Sept. 2015). See the interview with him conducted by Thieme Verlag with the title Mafiöse Machenschaften (Mafia-style manipulations, in German only) and an interview conducted by SWR1 (German radio station) about his latest book published by Riva Verlag on senseless early detection methods for breast and prostate cancer.

In his foreword, Dr. Richard Smith praises the way Gøtzsche systematically uncovers the methods used by pharma companies and their warehouses.

These include, bribery, deception, concealment of study results, use of medications that don’t meet the requirements of regulatory authorities, threats, and the pursuit of informants.

Dr. Smith worked for the British Medical Journal (BMJ) for a total of 25 years and was the editor for 13.

Wikipedia on Dr. Smith: He sits on the Board of Directors of the Public Library of Science, an open access publisher of scientific and medical research. He was editor in chief of the open-access Cases Journal, which aimed to create a database of medical case reports. And he was also head of UnitedHealth Europe, a division of UnitedHealth.

See also "The Constant Gardener" by John le Carré (2001) and the film adaption with the same name by Fernando Meirelles (2005).

Smith quotes the former vice-president of Pfitzer as saying:

It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry (p. 13).

In a second foreword, Dr. Drummond Rennie, a former editor for the Journal of the American Medical Association, affirms the author’s unparalleled position that are result of his unique scientific abilities, research, integrity, truthfulness, and courage (p. x). As Rennie has also had decades of experience with the pharmaceutical industry and knows Dr. Gøtzsche well, he trusts him to have his facts right (p. x). The title of his forward is Evidence-based outrage.

2. Book review

Professor Peter C. Gøtzsche writes that the major epidemics are under control in the majority of the countries in the world — and he criticizes the fact that many poor people still die of AIDS or malaria because they can’t afford the expensive medications. Instead we have two new epidemics: tobacco and medications.

In the United States and Europe drugs are the third leading cause of death after heart disease and cancer (p. 1).

He compares the tobacco industry with the pharmaceutical industry. Although there have long been studies about the addictive nature and the harm that both active and passive smoking cause, these were not published and their existence was kept confidential. The tobacco firm Philip Morris even conducted some of the studies itself.

This is corruption

When reputable researchers prove that a product is dangerous, a number of studies appear out of nowhere that show the opposite and make people feel insecure. And this allows the industry to buy themselves time — both the tobacco — and the pharmaceutical industries. This is corruption. (p. 2).

Redaction comment

There are various types of addiction including substance dependence, which is a group of psychological and behavioral disorders (syndrome) caused by repeated consumption of psychoactive drugs. This can include strong, periodic, or lasting desire for a certain substance, a progressive neglect of responsibilities or activities, loss of control, and compulsive consumption of the substance. In medical terms, this is called addiction.

Society often tolerates certain types of addiction such as nicotine dependence, video game addictions, gambling addictions, caffeine dependence (coffee addictions), and alcohol dependence (alcoholism). See also information about the dangers of passive smoking.

Very few people know that caffeine can have toxic effects when more than 1 g per day is consumed. 1 g of caffeine is found in 10 liters of standard soft drinks or about 11 cans (250 mL each) of energy drinks. Wikipedia shows the addiction potential of a number of substances (German only). "The substances with the highest physical addiction potential are heroin and nicotine."

In the United States, TV commercials urge viewers to take pills, tablets, or capsules as a way to get their life back under control. The characters in Aldous Huxley’s novel from 1932 Brave New World can take somadrugs as tablets every day ... (p. 2).

According to the author, the people in Denmark take so many drugs that it equals an average of 1.4 daily adult doses per person.

Why do people do this? The author believes that the main reason is that the pharmaceutical companies aren’t selling drugs to people, but instead lies about drugs.

This book is not about the successes the pharmaceutical industry has had against infections, some types of cancer, and hormone deficiencies such as Type 1 diabetes; instead it is about the failures of the system and the reasons for this. The author writes:

The research literature on drugs is systematically distorted through trials with flawed designs and analyses, selective publication of trials and data, suppression of unwelcome results, and ghostwritten papers.

Ghostwriters are paid to remain anonymous, and the articles are then published under the names of well-known professors even though they often contribute nothing to the text (p. 3).

2.1. Confessions from an insider

The author begins by reporting on his first experiences with preventative medicines.

Some types of vitamins increases overall mortality

When he was eight years old, he remembers his mom telling him that he should take two vitamins every day.

In the 1950s, people still believed in the great benefits of taking multivitamins. It was not until 2008 that a study found that taking some types of vitamins increases overall mortality.

See Bjelakovic G, Nikolova G. et al.: "Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases." (Cochrane Database Syst Rev.)

Enterovioform (Clioquinol) for diarrhea leads to nerve damage, paralysis, and eye disorders.

His second experience was with Enterovioform (Clioquinol), which his grandfather gave them to take in case they got diarrhea while on vacation in Italy. This was quite senseless as the drug is only effective against diarrhea caused by protozoans (amoebae and "Giardia") or Shigella bacteria (Shigella), but these were definitely not a problem in Italy.

However, when used for a longer period of time, this drug can cause everything from nerve damage to paralysis of the legs and serious eye disorders. The company Ciba (a division of Novartis) knew this for some time. Even though 10'000 people in Japan had developed SMON by 1970 and the company paid 490 million dollars in damages to them, it didn’t take the drug off the market until 1985. SMON is the acronym for subacute myelo-optic neuropathy.

Upon completing a degree in chemistry and biology, the author applied for a position as a drug representative at Astra (today AstraZeneca). There he learned how to persuade physicians to use the company’s product rather than the products of its competitors.

"Miracle drugs"

In the 1960s, corticosteroids were introduced to the market as the new miracle cure for Rheumatoid arthritis. It wasn’t until later that the serious adverse effects (e.g., bone fractures) of corticosteroids were discovered.

At the time, Astra had just introduced the drug Globacillin, a "p." that was supposedly more effective against acute sinusitis than other drugs on the market. However, the supposed proof for this provided to him by the company was incorrect. The position wasn’t good for the author’s self-esteem, especially after he read the book Death of a Salesman (1949) by Arthur Miller (1915–2005).

Zinc lozenges were another “miracle drug” introduced at the time. They were approved for the treatment of venous and ischaemic leg ulcers. Although the studies conducted by the company were supposedly very impressive, a Cochrane review later showed the lozenges to have no beneficial effect.

After eight months, he became a product manager. In this position, he was responsible for the sales of the asthma spray "Brican.." ("terbutali.." and inhalers). The goal was to get doctors to prescribe their patients constant treatment with the spray. And asthma death rates increased accordingly.

Asthma

The epidemiologist Dr. Neil Pearce from New Zealand (London School of Hygiene & Tropical Medicine (LSHTM) and previously president of the International Epidemiological Association (IEA)) wrote:

a most disturbing account of the powers of the drug industry and its paid allies among doctors in relation to asthma (p. 11).

Today, doctors no longer recommend the regular inhalation of short-acting beta-antagonists (Beta2-adrenergic agonist). And the asthma death rate has decreased accordingly.

The drug industry also tried to get doctors to prescribe "terbutali.." for chronic bronchitis. However, it wasn’t approved for this as no relevant studies had been conducted. And they also wanted to sell it as a cough medicine — but it was not approved for this purpose either.

Pearce N. "Adverse Reactions: The Fenoterol Story". Auckland University Press. 2007. Why wasn’t this book published earlier? Because the author wasn’t able to find a medical journal that would print it in spite of threats from Boehringer Ingelheim!

Picture of a YouTube video, titled: "10 Lies That Advertising Sold You".© CC-by-sa 2.0, Alltime10s
YouTube video about marketing persuasion techniques: Top 10 Lies That Advertising Has Sold You (7:13 min.).

During his time at Astra-Syntex, where he was responsible for clinical studies and registration applications for new drugs and indications, the author studied medicine.

NSAIDs

The most important drug for this company was naproxen ("Napros.."), a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammations without cortisone and prescribed, for example, for “joint wear.”

NSARs are a dime a dozen. A new drug should actually be better than the previous, cheaper versions, but the company wasn’t interested in a comparative study. Those responsible already knew that their drug wasn’t better, only more expensive.

In a study conducted in cooperation with orthopedic surgeons, Peter C. Gøtzsche determined that naproxen did not have an anti-inflammatory effect, as the company had claimed.

The principal investigator divided the patients with ankle distortions into two groups. One group received crutches and the other did not (mobilization). The swelling (edema) disappeared more quickly in the patients who were mobilized. Naproxen had no impact.

As NSARs have been shown to have a number of side effects on the stomach, heart, and kidneys, in many cases they could be replaced by less dangerous and perhaps cheaper pain relievers.

The company advised physicians to prescribe a double dose instead of the standard dose but failed to mention that the effects did not improve and the harm, in the form of side effects, doubled.

Other companies also used aggressive methods to try to sell their NSAR as the best on the market.

  • Pfizer stated that "piroxic.." ("Felde..") was more effective than aspirin, even though it was shown to be dangerous for older people in particular as the slower excretion causes it to accumulate in the body and to cause an increased incidence of stomach bleeding.
  • Eli Lilly even went so far as to falsely claim that its drug benoxaprofen (Opren, Oraflex) was capable of preventing the advance of joint damage. It did not inform the authorities that the drug caused severe liver defects.
  • The supposedly good gastrointestinal tolerance of the coxibs ("celecox..", "etoricox..", "rofecox..", "lumiracox..", and "parecox..") was accompanied by serious cardiac side effects (selective COX-2 inhibitors).

In his doctoral thesis Bias in Double-Blind Trials, Peter C. Gøtzsche showed that many studies are designed to come out in favor of the sponsoring company’s drug and against the control drug (sponsors).

2.2. Organised Crime, the Business Model of Big Pharma

The pharmaceutical industry doesn’t speak about the advantages and disadvantages of its drugs, but instead of their efficacy and safety. When doctors prescribe medications and patients take them, both parties are convinced that the pharmaceutical industry has done thorough testing and the drug regulatory authorities have carefully scrutinised them (p. 53).

Pharmaceutical companies try to create the impression that they do so, but not even the majority of the employees believe their bosses are honest.

Examples of settlements

In 2012 Pfizer paid $60 million to stop a US federal investigation into bribery in Europe and Asia. Pfifzer was accused of hiding money paid out as costs for training, freight, and other regular expenses.

From the 1970s up to the end of the 1990s, a cartel of vitamin producers (Vitamin Inc.) led by Hoffmann-La Roche worked together to artificially keep the prices of vitamins high. After the conspiracy was uncovered, some managers were imprisoned for a short period of time, and some companies paid fines in amounts up to $500 million and £523 million. But that is only a small percentage of the profits that the companies made with their price manipulations.

Between the two world wars, Roche and other drug companies supplied the black market in the United States with opium, "morphi..", and heroin. For more information, see Corporate Crime in the Pharmaceutical Industry by John Braithwaite, publisher Routledge & Kegan Paul, London, 1984.

At the beginning of the 1970s, Roche was ordered to pay fines for obstructing the sale of the tranquilizers "Vali.." and "Libri..". After reports were published which clearly showed that tranquilizers are addictive, it took 27 years before drug regulators acknowledged this fact.

Quote from the author:

I believe that the fact that some drugs affecting the brain are legal and others are illegal is irrelevant from an ethical perspective, if we try to understand what the drug industry is doing to the population (p. 25).

Image of a YouTube video, title: "The Pharma-Kartell - How to Betray Patients - ZDF".© CC-by-sa 2.0, Christian Esser, ZDF
Video: Das Pharma-Kartell - Wie Patienten betrogen werden (The pharma cartel—how patients are deceived), 44:17 min, from the program ZDF Frontal 21 - political show on the German television channel ZDF, clearly explains how the pharmaceutical industry uses certain steps and strategies to achieve its goals. Uploaded by DieAndereWahrheit.

The Hall of Shame for Big Pharma

Although the British Medical Journal (BMJ) and the New York Times publish articles almost weekly about the misconduct of drug companies, the companies dismiss these by stating that they are isolated cases.

In order to determine if this was indeed the case, in 2012 the author searched the Web (Google search combining the names of the top 10 drug companies with the word “fraud”). He then chose the most prominent case to describe in more detail:

Pfizer, Novartis, and Sanofi-Aventis

Pfizer agreed to pay $2.3 billion in 2009 because it was found that the company had marketed four drugs illegally. The company signed a Corporate Integrity Agreement, committing to good behavior for the next five years. Most likely it paid as little attention to this agreement as it had to the previous three similar agreements. One of these drugs was the antibiotic "Zyvo." (active ingredient: "linezol.."), which caused a number of deaths because the company falsely claimed that it was more effective against serious infections than the standard drug "vancomyc..". They claimed this because "Zyvo." cost eight times more than "vancomyc..".

Novartis agreed to pay $423 million in 2010 for illegally marketing the epilepsy drug "Trilept.." ("oxcarbazep...") for unauthorized use (pain and psychiatric issues). However, the company did the same with five other drugs.

Sanofi-Aventis agreed to pay $95 million in 2009 for fraud. The firm deliberately misquoted the prices, underpaying rebates to Medicaid and overcharging some public health agencies for the medications (p. 27).

Sanofi-Aventis knew about cases of fraud in a study on its antibiotic "Ket.." ("Telithromy..."), but the drug was still approved by the FDA. However, it wasn’t very long thereafter that the first death as a result of liver failure occurred. The drug is still sold in the United States, but there is a warning on the package and also a 26-page information brochure included.

GlaxoSmithKline, AstraZeneca and Roche

GlaxoSmithKline (GSK) paid $3 billion as part of the largest healthcare fraud settlement in the US for illegally marketing drugs for off-label uses. This included marketing the antidepressant "Wellbutr.." ("Bupropi..") for weight loss and the diabetes drug "Avand.." ("rosiglitazo..") for its supposedly positive effect on the circulatory system. The drug was later taken off the market because it was shown to have caused heart failure.

AstraZeneca agreed to pay $520 million for fraud. The firm had recommended its antipsychotic drug "Seroqu.." ("quetiapi..") to children, the elderly, and others for off-label uses. These included aggression, anxiety, dementia, Alzheimer’s disease, attention-deficit hyperactivity disorder (ADHD), depression, and sleep disorders.

Roche was not even brought to court for what was the biggest theft in history (p. 28). Based on independent studies, the firm claimed that "Tamif.." ("oselta....") significantly descreased hospital admissions caused by influenza and secondary complications.

In 2009, Roche managed to convince the governments in the United States and many European countries to purchase "Tamif.." in the amount of several billions of dollars to prevent an influenza epidemic.

Neither "Tamif.." nor "Relen.." ("zanamiv.."), the drug from rival company GlaxoSmithKline, are more effective than a placebo.

An official at the Food and Drug Administration (FDA) had been assigned the application for "oselta....", but as a result of pressure from Roche, this was taken away from him.

Even though "Tamif.." wasn’t effective, it did have some unpleasant side effects: hallucinations and weird accidents.

Johnson & Johnson, Merk, Eli Lilly and Abbott

Johnson & Johnson paid a fine of $1.1 billion in 2012 because it had downplayed the risks of the antipsychotic drug "Risperd.." ("risperido.."). J&J and its subsidiary Janssen had claimed that it had fewer side effects than other drugs in the same group and it was then prescribed to children and the elderly.

Merck, the largest pharmaceutical company, paid $670 million over Medicaid fraud in 2007 because it failed to pay the appropriate rebates to Medicaid and other government healthcare programmes (p. 31).

Eli Lilly paid $1.4 billion for illegal marketing in 2009 because it sold its antipsychotic drug "Zypre.." ("olanzapi..") for several off-label uses (including dementia, Alzheimer’s disease, and depression, particular in children and the elderly) and minimized the side effects (e.g., heart failure, pneumonia, considerable weight gain, and diabetes. See the film "Der Diabetesmythos" (The diabetes myth).

Abbott paid $1.5 billion for fraud in 2012 because it sold its epilepsy drug "Depako.." (Valproate) for uses not approved by the FDA.

More cases

We could naturally continue to list out many more cases:

Sanofi-Aventis knew about cases of fraud in a study on its antibiotic "Ket.." ("Telithromy..."), but the drug was still approved by the FDA. However, it wasn’t very long thereafter that the first death as a result of liver failure occurred. The drug is still sold in the United States, but there is a warning on the package and also a 26-page information brochure included.

And AstraZeneca , for example, paid millions as a payoff after pleading guilty to charges that it encouraged physicians to illegally request Medicare reimbursements for its drug against prostate cancer, "Zolad" ("Goserel.."), and bribed doctors to buy it (p. 33).

Johnson & Johnson bribed hospital administrators and physicians in a number of countries so that they would use its products.

It is illegal to push generic drugs out of the market when the patent runs out (p. 34). Glaxo filed law suits without cause against its generics competitor as a way to keep a certain generic drug off the market. In the United States, a company can legally do this to keep a competitor’s product off the market for 30 months.

For decades, Bristol-Myers Squibb blocked the market entry of cheap cancer drugs by paying a generic manufacturer (generic drug) and providing false information.

Lundbeck paid large sums of money to generic producers of Cipramil ("citalopr..") as a way to delay the market entry of the drug.

The firm Purdue Pharma falsely claimed that its opioid "OxyCont.." ("oxycodo..) was less addictive than other opiates.

In 2004–05, the Health Committee in the British House of Commons examined the drug industry in detail and found that its influence was enormous and out of control. They found an industry that buys influence over doctors, charities, patient groups, journalists and politicians, and whose regulation is sometimes weak or ambiguous (p. 37).

In the United States, the pharmaceutical companies violate the law three times more than other industries.

The report showed that it would be good to limit the industry’s influence, also good for the industry because then they could again concentrate on developing new drugs instead of spending money on corrupt deals. But the British government did nothing; after all, the pharmaceutical industry is the third most profitable industry in the country (p. 37).

Pharma industry falls into the category of “organised crime"

As proof that the pharma industry falls into the category of organised crime, the author describes the Racketeer Influenced and Corrupt Organizations Act (RICO, act against racketeering), which was created to fight against the mafia and similar organizations.

The list of offences that constitute racketeering include extortion, fraud, federal drug offences, bribery, embezzlement, obstruction of justice, obstruction of law enforcement, tampering with witnesses, and political corruption (p. 38).

In the United States, the pharmaceutical companies violate the law three times more than other industries. The number of settlements and fines for misconduct has increased dramatically over the last few years and decades. The pharmaceutical industry’s claims that these accusations are old and that it has changed its practices radically are therefore simply not true.

2.3. Very few patients benefit from the drugs they take

In this chapter, the authors explains the importance of double-blind trials. With this type of study, neither the patients nor the doctors know who receives the medication and who receives the placebo. The assessment of the effectiveness changes depending on who and what percent of the investigators and test subjects aren’t “blind.”

Active placebos

The author also explains that the patients who receive the placebo often know this because they don’t experience any side effects.

For a while, “active” placebos were used. These produce side effects similar to that of the active drug, for example, dryness in the mouth.

However, active placebos are no longer used because they are not in the best interest of the pharmaceutical industry. This is because they show a smaller difference between the effectiveness of the drug and placebo.

But with clever mathematical calculations and repeat studies, the results can be inflated. Because there is certainly a study out there that will yield the right results.

The Number Needed to Treat (NNT) is a practical method used to determine how many people will be helped by a certain treatment. Using the example of statins, the author explains that an NNT is not provided for healthy patients with high cholesterol because they do not benefit from the treatment. However, they do experience a diminished quality of life because of muscle pain and weakness.

2.4. Clinical trials, a broken social contract with patients

As the pharmaceutical industry has had a monopoly on clinical trials conducted on its own products and only published the information that is to its benefit, this social contract has been broken over and over again.

The industry doesn’t only hide negative studies, it also intimidates people who have discovered harmful effects of its medications.

It covers up study aims if the desired result is not achieved and it designs studies so that the results can hardly be refuted.

Our governments have not succeeded in regulating the powerful pharmaceutical companies or in protecting scientific objectivity and academic curiousity (p. 52) against commercial interests.

Misleading results, data massage and fishing expeditions

In the first half of the twentieth century, drugs were hardly tested before they were put on the market.

However, this did change to some extent after the "thalidomi.." disaster in 1961–62. The drug was recommended by the manufacturer Grünenthal GmbH for several indications including pregnancy-induced nausea. After this disaster, extensive animal experiments and efficacy trials were finally introduced. However, a large number of drugs that had not been tested remained on the market.

It is particularly problematic that the only requirement for the approval of a drug is that the pharmaceutical industry can show it has a statistically significant effect in two placebo-controlled trials.

However, there are numerous ways in which a drug company can manipulate its clinical trials to ensure that the results become useful for its salespeople, no matter what an honest approach to science would have shown. The manipulations are so common and serious that one of my colleagues said that we should see published reports of industry trials as nothing else than advertisements for its drugs. To which I dryly remarked that industry trials do not even live up to EU requirements for advertising. (p. 53)

In the case of three major cardiovascular trials conducted by independent researchers, it was shown that the results were misleading and in each case in favor of the sponsor’s drug.

The names of the drugs, trials, and sponsors were as follows: "prasugr.." in the TRITON trial for Daiichi Sanyko and Eli Lilly; ticagrelor in the PLATO trial for AstraZenca, whereby for these two the number of heart attacks for the comparator was doubled, and "rosiglitazo.." in the RECORD trial for GlaxoSmithKline.

In the RECORD trial, the number of heart attacks supposedly decreased from 24 to 8. However, to achieve this result, the pharmaceutical company had to slightly change the definition of a heart attack.

If the main trial doesn’t yield any positive results, researchers always have the option of focusing on subgroup analyses.

The practice of going through data until something is found randomly is referred to as data massage or fishing expeditions.

One of these fishing expeditions led to the recommendation that patients with spinal cord injury be prescribed high-dose steroids. Fourteen years and thousands of deaths later, it was discovered that in the trial with 31 patients one of the patients who had been treated with cortisone instead of the placebo had died.

As long as studies are designed by firms and the data can only be published with their approval, we shouldn’t wonder that our drugs are getting more expensive but not better.

The Fortune 500 (500 companies with the most revenue) report for 2012 found that the profits of the ten pharmaceutical companies with the most revenue exceeded the sum profits of 490 other companies.

The extensive CRASH trial published in The Lancet on the effects of steroids on 10'000 people with serious brain injuries showed that steroids are very dangerous. For every 31 patients treated with steroids rather than placebo, there was one additional death. Thousands of patients with spinal cord or brain injuries have died because they were given steroids and the fishing expedition in the New England Journal of Medicine is to blame for many of these deaths (p. 61).

Another interesting link: Why we can’t trust clinical guidelines.

2.5. Conflicts of interest at medical journals

Medical journals are finding it increasingly difficult to find authors who are independent from the pharmaceutical industry. They also have difficulties rejecting “pro-industry” articles because they then lose out on the profits for lucrative reprints and advertisements paid for by the industry.

This fact was also confirmed by the former editor of the British Medical Journal.

New England Journal of Medicine (NEJM)

According to Gøtzsche, the New England Journal of Medicine (NEJM) is the pharmaceutical industry’s preferred journal and the journal with the highest impact factor.

As an example of why he is not a fan of this journal, he describes an article about a drug from Pfizer for treating invasive fungal infections. Two trials were conducted:

In one of the trials, "voriconazo.." was significantly inferior to the comparator drug, liposomal "amphoteri..." B, according to the prespecified analysis plan, which staff at the FDA pointed out in a subsequent letter, but the paper concluded that "voriconazo.." was a suitable alternative. More patients died in the "voriconazo.." group and a claimed significant reduction in ‘breakthrough’ fungal infections in favour of "voriconazo.." disappeared when we included infections that had arbitrarily been excluded from analysis. The abstract described manipulated results ... (p. 66).

The other trial used "amphoteri..." B deoxycholate as a comparator, but handicapped the drug by not requiring pre-medication to reduce infusion-related toxicity or substitution with electrolytes and fluid to reduce nephrotoxicity, although the planned duration of treatment was 84 days.

The new drug "voriconazo..", which was under investigation was given as treatment for serious fungal infections (mycosis) for an average of 77 days, whereas the comparator drug was only given for an average of 10 days.

This precludes a meaningful comparison. The last sentence in the abstract was: In patients with invasive aspergillosis, initial therapy with "voriconazo.." led to better responses and improved survival and resulted in fewer severe side effects than the standard approach of initial therapy with "amphoteri..." B. A trial that is seriously flawed by design doesn’t allow any such a conclusion” (p. 66).

By publishing such terribly flawed trial reports the New England Journal of Medicine not only earns a lot of money from selling reprints, the editors also boost the journal’s impact factor, especially because companies usually orchestrate a large number of ghostwritten, secondary publications that cite the trial reports (p. 66).

The author shows how a number of various types of studies have resulted in misleading results and describes one study in particular that was published in the NEJM. This study recommended that all patients with smoker’s lung be prescribed "fluticaso.." (cortisone or glucocorticoid), but the recommendation was made based on an inappropriate analysis.

According to the author, the British Medical Journal (BMJ) is a journal that is very dependent on pharmaceutical companies.

2.6. The corruptive influence of easy money

Speaking from his own experience, the author explains how corruption can begin. About 20 years ago, he took part in a planning meeting with clinical investigators and a certain company. In the evening, the head of the division for clinical trials gave him an envelope that contained cash.

If you don’t send the money back, you have signalled that you might be willing to think you are even more valuable for the company the next time (p. 70).

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