DEADLY MEDICINE AND ORGANIZED CRIME

By Peter Gøtzsche
A book report by David G. Schwartz, M.D.

Dr. Gøtzsche makes some astonishing claims that the global pharmaceutical industry
can be compared to the mob. Is this hyperbole or reality? He is not alone in his outrage.
Marcia Angell, M.D., former editor of the New England Journal of Medicine, and
Richard Smith, M.D., former editor of the British Medical Journal have written books
about the corruption and have expressed dismay at the enormity of the problem. Rennie
Drummond, M.D., deputy Editor of JAMA, has repeatedly written indignant editorials
about unethical behavior by researchers and their sponsors. I have read plenty of
editorials in JAMA about the conflict of interest physicians have with financial ties to the
pharmaceutical companies, and about the lack of credibility in published research and
treatment guidelines due to the corruption in research. They all seem to end on a
hopeless note, that we don’t know how to solve the problem. I would say, “Just cut the
financial ties!” I have written articles also on the lack of credibility of medical “science.”

What are the author’s qualifications to make such a statement? He is a Danish

physician specializing in Internal Medicine with a master’s degree in biology and
chemistry, and professor of Clinical Research and Design Analysis at University of
Copenhagen. He co-founded the Cochrane Collaboration in 1993, is founder and head of
the Nordic Cochrane Center. He is a member of several groups that publish guidelines
about research protocols, systematic reviews and meta-analyses, and good reporting of
research. The Cochrane Collaboration is an independent, nonprofit, non-governmental
organization with 31,000 volunteers in more than 120 countries, whose purpose is to
organize medical research information systematically to promote principals of evidence-
based medicine. He has published 70 papers in the 5 major medical journals and has
written several books, including Rational Diagnosis, Evidence Based Clinical Decision
Making.

Although his literary style sometimes uses superlatives and a little hyperbole, and
although the narrative does not always flow smoothly, translating from Danish to
English, his facts are well documented, and he speaks out of accomplishments that have
authenticity and integrity. He is a true whistle-blower, having worked inside the industry
as pharmaceutical representative and product manager, before he acquired his medical
degree.

In the introduction on page 1, he says, “In the United States and Europe, drugs are the
3rd leading cause of death after heart disease and cancer.” (I have to add that to determine
ranking in cause of death is difficult, especially what is primary and what is secondary.
A drug may have prevented death from cancer, but later the drug caused death. What is
the real cause? Tobacco caused a case of fatal heart disease. What caused the death,
heart disease or tobacco?) He states that there are 2 major human-made epidemics, both
highly lethal: tobacco and prescription drugs. In Big Pharma, in common with the
tobacco industry, “the morally repugnant disregard for human lives is the
norm…Tobacco executives know they are peddling death and so do drug company
executives.”

He states that this book is not about the well-known benefits of drugs, which he
acknowledges are many. It focuses on a system that needs radical reform.

The epidemic easily could be brought under control, but the politicians, heavily
lobbied by the industry, do nothing about it. The research literature is distorted by
scientific misconduct through trials with flawed designs and analysis, selective
publication of trials and data, and ghostwritten papers. The influential doctors chosen to
“author” the papers contribute little to the ghostwritten manuscripts. Although polls
show that drug companies rank near the bottom in esteem along with tobacco and oil
companies, people still have confidence in the drugs their doctors prescribe, not
recognizing their doctors have little knowledge about the drugs that has not been
carefully crafted by the drug industry.

“The NSAID area is a horror story filled with extravagant claims, bending of the rules,
regulatory inaction…” (p. 20) Regulatory agencies favored industry’s desires even
though statements from industry scientists were illogical, inconsistent, and wrong.
Several drugs that were easily approved by the FDA were later withdrawn from the
market because of their toxicity: benoxaprofen, indoprofen, rofecoxib, ketorolac,
tolmetin, zomegirac, suprofen, and valdecoxib, marketed with claims such as “superior
tolerance,” “proven gastrointestinal safety,” “least possible side effect profile,” “excellent
gastrointestinal tolerance.” Studies showing ineffectiveness and toxic effects were not
allowed to be published. Drug sales reps would show doctors the studies but present
them showing the drugs being effective and safer than other drugs. The FDA violated its
own rules by allowing approval without proper studies. Boeringer Ingelheim harassed
the journal Lancet not to publish a study demonstrating an epidemic of asthma deaths
mirroring the sales curve for fenoterol, its asthma drug. The company sent several
lengthy faxes every day. It tried to get the Department of Health to interfere with the
publication and to give the company a copy so the company could come up with other
results before the data went to print.

Health professionals count on reliable, accurate, information on how to carefully use

toxic drugs (All drugs have their dangers.) to benefit patients as safely as possible. The
Pharmaceutical Research and Manufacturers of America (PhRMA) Code on interactions
with health care professionals: “Ethical relationships with health care professionals are
critical to our mission of helping patients.” How similar to: “our goal is to be the world’s
most successful, respected, and socially responsible consumer ware producer,” an
advertisement for Philip Morris. An internal survey of Pfizer employees: 30% did not
agree with the statement: “Senior management demonstrates honest ethical behavior.”

The author found evidence of fraud by the 10 largest drug companies, 2007-2012, all
in the USA. The most common offenses were illegal marketing, misrepresentation of
research results, hiding data on harms, and Medicare and Medicaid fraud. Patients and
doctors commonly think that these companies are not allowed to falsify drug information
because they would be held legally accountable with penalties enough to deter fraud. Not
so. Rarely does anyone go to prison, and if so, only a few months. They nearly always
settle without admitting guilt, or pay a fine, small change in comparison to their total
profits, just a cost of doing business. (Sound reminiscent of the big banks’
“prosecutions”?).

Pfizer agreed to pay $2.3 billion in 2009 to settle for charges of bribery and fraud.
Pfizer agreed to good behavior for the next 5 years, similar agreements having been made
3 times prior, while continuing to violate the agreements all the while.

In 2012, Pfizer agreed to pay $60 million to settle a US Federal investigation into
bribing doctors, hospital administrators, and drug regulator in several countries in Europe
and Asia.

Similar scenarios transpired with others:

Novartis $423 million in 2010
Sanofi-Aventis $95 million in 2009
GlaxoSmithKline $3 billion in 2011 (obstruction of justice, lying to investigators,
illegal marketing, concealing safety data, fraud, kickbacks.)
AstraZeneca $520 million in 2010
Roche defrauded the world, withholding evidence of Tamiflu’s very limited
effectiveness for the 2009 influnza epidemic, convinced the WHO to authorize
stockpiling Tamiflu, costing billions of Euro’s.
Johnson & Johnson $1.1 billion 2012, concealed risks of Risperdal, marketed
unapproved use in children and the elderly. Alex Gorsky, Vice President of Marketing,
was charged with participation in and first hand knowledge of fraud, and was rewarded
by being promoted to CEO. (Like the mob, the greater the crime, the greater the
advancement)
Merck $670 million 2007, illegal kickbacks to doctors, Medicaid fraud.
Eli Lilly $1.4 billion 2009, illegal marketing, unapproved use of Zyprexa in children
and the elderly, with substantial harms to patients. Fired whistle-blowers.
Abbot $1.5 billion 2012 Medicaid fraud, unapproved use of Depakote to the elderly,
concealment of adverse effects, kickbacks to doctors.
Perdue Pharma paid $635 million in fines in 2007 for claiming that oxycontin was
less addictive than other opiates and lying to doctors and patients about the risks. The
drug has killed large numbers of people. In Denmark the drug was aggressively pushed
to doctors until the hospital banned the drug altogether from its pharmacy.

It seems to be the standard practice at the FDA to exert internal pressures on its
scientists to alter their conclusions in favor of a drug, even while the company is under
criminal investigation regarding that drug. Sanofi-Aventis marked the antibiotic Ketek as
safe, asserted by a study that the FDA knew was fraudulent, and not until 27 cases of
liver damage and 4 deaths occurred, did the FDA re-label it as hepatotoxic with a black
box warning.

The author cites 12 other cases from 201 to 2007, of settlements for criminal activity.
 Doctors are complicit in the crimes by accepting kickbacks, bribes, and other acts of
corruption, but they don’t get prosecuted. Both legal and illegal marketing has lead to
massive over-treatment of the population and a lot of harm to patients and unnecessary
health care costs.

In 2004-2005 the Health Committee in the British House of Commons found that the
influence of the drug industry was enormous and out of control and needed to be reduced,
but the British government did nothing in response, because the British drug industry is
the third most profitable activity. The Department of Health defended the industry: “The
stakeholder relationship between government and industry brings many gains and many
innovative medicines…with huge impacts on health outcomes.” With governments in
denial, is it no wonder that crime flourishes?

The U.S. Organized Crime Control Act of 1970 defined racketeering to include
extortion, fraud, federal drug offenses, bribery, embezzlement, obstruction of justice,
obstruction of law enforcement, tampering with witnesses, and political corruption. Big
Pharma does much of this all of the time and fulfills the criteria of organized crime.

A previous global vice president of marketing for Pfizer, turned whistle blower, states:
“It is scary how many similarities there are between this industry and the mob. The mob
makes obscene amounts of money, as does the 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…The difference is, all these
people in the drug industry look upon themselves – well, I’d say 99% anyway – look
upon themselves as law-abiding citizens, not as citizens who would ever rob a
bank…however, when they get together as a group and manage these corporations,
something seems to happen…to otherwise good citizens when they are a part of a
corporation. It’s almost like when you have war atrocities: people do things they don’t
think they’re capable of. When you’re in a group, people can do things they otherwise
wouldn’t, because the group can validate what you’re doing is OK.”

The situation has not been improving. On the contrary, these crimes are actually
increasing. Three fourths of the 165 settlements comprising $20 billion in penalties
during a 20-year period from 1991-2010 occurred in the last 5 years of that period.

When doctors harm patients by accident, lack of knowledge, or negligence, they harm
only one patient at a time. The actions of senior executives in the drug industry have
potential to harm millions of people, so their ethical standards should be higher than
those of doctors.

Big Pharma in the U.S. beat out all other industries in terms of crimes, more than 3
times as many serious law violations as other companies, even after adjusting for
company size. It has a worse record than other companies for international bribery and
corruption and criminal negligence.
 The author states on page 39, “Almost every type of person who can affect the
interests of the industry has been bribed: doctors, hospital administrators, cabinet
ministers, health inspectors, customs officers, tax assessors, drug registration officials,
factory inspectors, pricing officials, and political parties.”

To the question of whether this is due to a lone “bad apple” now and then, the author
states, ”What we are seeing is organized crime in an industry that is completely rotten.”

In describing threats to whistle blowers, (page 237) “Intimidation, instigation of fear,

threats of firing or legal proceedings, actual firing and litigation, unfounded accusation of
scientific misconduct, and other attempts at defamation and destruction of research
careers. The maneuvers are often carried out by the industry’s lawyers, and private
detectives may be involved.”

He lists in detail various deaths from various drugs: anti-arrhythmic drugs 50,000
deaths per year in the U.S., rofecoxib 120,000 deaths worldwide by 2004, celecoxib
75,000 deaths worldwide, NSAIDs 20,000 deaths every year in the U.S., olanzapine
200,00 deaths worldwide by 2007.

The author lists several myths, one of which is that drugs are expensive because of
discovery and development costs. Prices reflect mainly what society is willing to pay and
how good companies are at keeping competition at bay. Innovation? As profits have
skyrocketed, fewer innovative drugs have come to market. Mostly “me-too” drugs have
been introduced. Breakthroughs? A U.S. Congressional report of 2000 said, “of the 21
most important drugs introduced between 1965 and 1992, 15 were developed using
knowledge and techniques from federally funded research.”

Dr. Gøtzsche calls for a “revolution” to remedy this problem:

Use fewer drugs more rationally.
Changing the for-profit mode
Not allowing the industry to conduct trials
Fewer use of placebos. New “me-too” drugs need to be compared with current
available drugs.
Drug regulatory agencies need to be evidence-based.
All clinical data publicly available
Eliminate user fees for drug agencies
More truthful labeling of drugs
No drug marketing. “Marketing of drugs is similarly harmful, as marketing of
tobacco, and it should be therefore banned to the extent that tobacco is.”
Doctors should not attend educational meetings sponsored by the drug industry,
should not accept donations from the industry, and should not accept visits from drug
sales people.
Medical journals should not publish drug ads.
Journalism educators should not accept funding from health care and drug industries.

He has recommendations for patients:

 Withdraw membership if your patient organization accepts industry favors.
Ask your doctor whether her or she receives money or other benefits from the
industry, or sees pharmaceutical reps, and if so, find another doctor.
Avoid taking drugs unless absolutely necessary, which they seldom are.
Avoid taking new drugs the first 7 years they are on the market.
Remind yourself constantly that we cannot believe a word of what drug companies tell
us.

In my opinion, to make many of the changes Dr. Gøtzsche recommends requires some
global political will. This may not happen as long as the ideology of the unrestricted
“free market” is a prevailing force in the world. Adam Smith never said that capitalism
should be unregulated. For the common good, with restrictions, capitalism can be
beneficial. This global organized crime’s reach extends not only to the drug industry, but
also the petrochemical, armaments, biotech, and food industries, as well as the big banks.
The standards of common decency, fairness, justice, and social responsibility that we
expect in personal and community relations appears to go out the window regarding
global corporations, according to this philosophy of the so-called “free market.” This
permissive attitude to allow the global demonic forces of selfishness, greed, and “might
makes right” to prevail, allows a small number of people to threaten to destroy human life
and habitat. It corrupts the major political parties and media conglomerates, and allows
corporations to usurp national sovereignties through “free trade” agreements that increase
the clout of the pharmaceutical industries and the polluters. The drug industry in my
view is part of this larger crime network. Is there still time to curtail this monstrosity
before it becomes too powerful to control?

What may be required is massive grassroots political action that is not co-opted by any
major political parties. It doesn’t help if we stay home election day. Silence is consent.
“When good people do nothing, evil prevails.” Voting for a write-in is usually an option,
or “none of the above” sends a message. We can write and email our legislators. We can
do massive demonstrations, strikes, boycotts, class action litigation, and massive non-
violent civil disobedience if necessary. The best disobedience to undermine the control
by the drug industry is to stay healthy!

We can “just say no to drugs” unless life and limb are in immanent danger. There is a
place for drugs in infections, acute severe illnesses, injuries, and severe painful chronic
illness, especially near the end of life. Some vaccines can protect against deadly
infections. Drugs can be used carefully and judiciously with the help of a qualified health
care practitioner who understands the dangers of and the dependency-forming nature of
drugs. The vast majority of drug use does not fall into this area, especially over-the-
counter drugs.

Dropping the “pill for every ill” habit and the “better living through chemistry”
attitude will go a long way toward breaking our dependency on drugs. Tieraona Low
Dog’s book, Healthy at Home, reviewed in one of my previous articles, gives excellent
guidelines for when to do home remedies and when to seek medical care. We can
prevent or reverse much chronic illness with sleep, exercise, stress management,
counseling, bodywork, social support, positive attitude, spiritual connection, the right
foods, nutritional supplements, and herbs.

I have tried to point out what I see as the “elephant in the living room,” which I think
many people would rather not look at or may simply underestimate the size of the
problem and its dangers, and I do not think I am being unduly alarmist. This is a major
world problem that is not being addressed. I also do not intend to instill pessimism,
because we do actually have the power to raise awareness of this issue, and to bring back
fairness, decency, and ethical behavior on a large scale if we act together. There is a
growing awareness in people throughout the globe across many political parties, people
who have a vision of a better world, have a high spiritual consciousness, and have the
power to act as a force for good. We are not alone.