|
_______________________________________________________________
Economic Incentives for Drug Companies Lead to
Aggressive Marketing of Defective & Ineffective Medications
and Need for FDA Regulations, Checks on Drug Marketing, and Defective Drug Lawsuits
(Texas Lawyer Jason S. Coomer)
The
Pharmaceutical industry or "Big Pharma" has become extremely
rich and powerful over the last decade as the industry has changed the way
drugs are regulated and marketed in the United States and
throughout the World. It is estimated that the drug
industry will have drug sales
of over $300 Billion in the United States in 2010 and
over $750 Billion Worldwide. These revenues are over
twice what they were 10 years ago.
The
main reasons for this rapid growth are that the drug
industry has been able to put their own people in top
positions in the United States Food and Drug Administration to change regulations to relax the drug
approval process, been able to help push through Medicare D
(a major giveaway to the drug companies that increased government purchasing of drugs
& limited competition), and been
more aggressively marketing their drugs including off-label
marketing regardless of
dangers or effectiveness of the drug.
This article
is intended to help explain the economic incentives that are
encouraging the pharmaceutical industry to aggressively push
drugs for approved and off label uses regardless of the
effectiveness or potential dangerous side effects of the
drugs as well as
explain why additional safe guards are needed to help
protect consumers from dangerous drugs and to curtail the
drug industry's aggressive pursuit of profits regardless of
the potential dangers or effectiveness of specific drugs.
Significant Investments in Research and Development
Create Economic Incentives for Pharmaceutical Companies to
Aggressively Market Drugs Regardless of Effectiveness or
Potential Dangers
Because of
the significant cost of researching and developing a drug,
pharmaceutical companies have tremendous investments in
making sure that a drug is profitable regardless of the
effectiveness or potential dangers of a drug.
Pharmaceutical professionals that have spent years and
significant resources developing a new drug often cannot
afford to risk their careers and company's
profitability by having a drug's approval delayed, a drug
taken off the market, or a drug sent back for further
research. These precautions though often safer for
consumers could allow another drug company or pharmaceutical
professional to develop a similar drug and steal the
potential
market or cause potential profits to be delayed. Thus, the significant investment that a drug
company has in a particular drug combined with fierce
competition and the need for short term profitability create
a strong economic incentive for a drug company to
aggressively push patenting, approval, and marketing of a
drug regardless of its effectiveness or potential dangerous
side effects.
Further,
once a drug is approved for a specific use there is also
tremendous economic pressure to start marketing and pushing
a drug for off label uses to increase the drug's
profitability regardless of effectiveness or potential
dangers. Even in cases where one drug company has been
warned by the FDA not to market a drug for off label uses,
other companies have purchased the drug and found it more
profitable at least in the short term to market the drug and
later pay any fines and/or lawsuits (Yasmin
and Yaz example).
These
economic incentives have led to increased emphasis on
marketing and promotions rather than more research and
development. In fact,
studies have shown that the drug industry is now spending
more on marketing and promotions than it is on research and
development of new drugs. This startling fact is
contrary to the drug industry's argument that most of their
large revenues are needed for research and development of
new drugs and suggests that new regulations are needed for
drug marketing as many drug companies have found it more
profitable to aggressively market drugs rather than to
develop new drugs and/or make sure their product is safe and
effective.
Economic
Incentives Have Created More Aggressive Marketing
Departments that Push Drugs Through Advertising and Doctors
Regardless of Effectiveness or Dangerous Side Effects
Drug company
spending on sales and marketing has increased significantly
over the past decade. This increased focus on
aggressive marketing has led to increased sales of drugs and
profits for the pharmaceutical industry, but has also caused
a large increase in off label use of drugs as well as the
use of drugs that can cause significant health problems or
death.
In pushing their drugs to consumers,
some pharmaceutical marketing departments have
turned many doctors and health care providers into drug pushers through incentive
based marketing, kick back programs, and propaganda given to the doctors to
encourage off label use of drugs and a push towards the use
of more drugs and more expensive drugs regardless of
necessity or effectiveness. The marketing departments have also in some instances
taken control of the FDA to hide negative information about
potential dangers of some drugs. These actions allowed the drug
companies to sell more drugs even when they had information
that the drugs were dangerous and could cause death or
serious injuries.
Because of the large profits
that have been made or can be made by the drug companies,
many pharmaceutical executives have been willing to risk
large fines for illegal and deceptive practices including
off-label marketing, misleading advertisements, and hiding
known dangers of drugs because they know that the profits
will be larger than the potential fines. Pfizer
has paid a total of $2.75 billion in off-label penalties
since 2004 which is a little more than 1 percent of the
company’s revenue of $245 billion from 2004 to 2008. (Pfizer
Broke the Law by Promoting Drugs for Unapproved Uses)
Off-Label Drug Marketing and Off-Label
Pharmaceutical Marketing Medicare Fraud Lawsuits
Off-label marketing is the practice of
pharmaceutical marketing professionals creating financial
incentives and pressuring doctors to prescribe
pharmaceuticals for unapproved uses. In the United
States, the Food and Drug Administration Center for Drug
Evaluation and Research (CDER) reviews a company's New Drug
Application (NDA) for data from clinical trials to see if
the results support the drug for a specific use or
indication. If satisfied that the drug is safe and
effective, the drug's manufacturer and the FDA agree on
specific language describing dosage, route of
administration, and other information to be included on the
drug's label and package
insert.
The Federal Food Drug and Cosmetic Act (”FDCA”),
provides a specific regulation process for the approval of
new drugs and new drug formulations intended to be marketed
for use in interstate commerce. Under the FDCA, a new drug
product cannot be marketed unless the FDA approves the
product and determines that it is safe and effective for its
intended use. When the FDA approves a drug, it approves the
drug only for the particular use for which it was tested,
but after the drug is approved for a particular use, the
FDCA does not regulate how the drug may be prescribed by
doctors. Thus, a drug that has been tested and approved by
the FDA for one use only can also be prescribed by a
physician for another use, known as off-label. Though
physicians may prescribe drugs for off-label usage, the FDA
prohibits drug manufacturers from marketing or promoting a
drug for a use that the FDA has not approved.
In the past ten years some pharmaceutical
marketing departments have found it extremely profitable to
market their drug for non-FDA approved uses. The FDA's
inability to regulate physicians allowed the drug company
marketing departments and drug representatives to set up
elaborate schemes to encourage physicians to prescribe drugs
for off-label uses including misleading doctors as to the
efficacy of a drug for a particular treatment and forms of
kickbacks including vacations, conferences, initial free
samples, hiring physician's families.
These marketing schemes have been very
successful in increasing pharmaceutical profits, but have
led to
False Claims Act Off-Label Marketing Lawsuits by the
United States Department of Justice and
False Claims Act Lawyers. These Off-Label
Marketing False Claims Act Lawsuits have led to
Billions of Dollars in Civil and Criminal fines against
large drug companies. However, because of the
extremely large profits that have been and can be made by
off-label marketing, there is an economic incentive to
continue the practice.
Recent Letter from the
FDA Expresses Outrage at Wrongful and Criminal Actions of
some Top FDA Officials During the Bush Administration that
Changed Regulatory Procedures and Rubber Stamped Ineffective
and Dangerous Drugs
Recent
allegations have been made that the United States Food and Drug Administration
(FDA)
under the Bush administration in many instances ignored
science and did not protect consumers from known dangers
from pharmaceutical drugs. A
letter dated April 2, 2009 from the Department of Health and
Human Services FDA, confirms that top FDA Officials were
suppressing science and information that could have hurt
profits for the pharmaceutical companies. These FDA
officials, FDA attorneys, and lawyers from the
pharmaceutical companies, were working together in an effort
to use false data and suppressed data to not only sell more
dangerous drugs and medical devices to consumers, but also
were attempting to block consumers that were severely
injured or families that lost a loved one from defectively
dangerous drugs from seeking any recourse through the
justice system.
Fortunately,
brave whistleblowers including FDA physicians and scientists, public advocacy
groups, and the press were able to
shine a light on some of the serious wrongdoing done by top
FDA officials resulting in the letter. The letter
expressed the outrage of many FDA professionals and other
whistleblowers that are trying to root out FDA managers that
failed to protect consumers from dangerous drugs.
It appears
that the FDA is in the process of rooting out industry
insiders that have valued their careers and/or helping drug
companies make more money over the health and safety of
American consumers. However, the fact that corrupt
officials loyal to the drug industry were able to hijack the
FDA is troubling. These outrageous actions have led to
a call for new regulations and prohibitions against a
revolving door policy between the FDA and the drug industry.
Product Liability
Litigation, Dangerous Drug Lawsuits, and Seeking
Compensation for & Protecting Consumers
Medications can be extremely beneficial, but when
they are used incorrectly, marketed for the wrong purpose,
or dangerous side effects are hidden; defective drugs can cause serious
problems and catastrophic damages. In our
modern society, the pharmaceutical companies have become
extremely rich and powerful. Arguably this pooling of resources
into the pharmaceutical companies allows these large
corporations to spend billions of dollars on developing new
drugs, but also on aggressive marketing and lobbying.
Therefore, checks are needed on how the drug industry uses
their massive resources and power including limits on drug
marketing, lobbying, and their influence on FDA regulations.
Further, it
is important that consumers that have lost a loved one or
have been seriously injured by a drug which is known to be
unsafe have recourse in the United States justice system.
Like the Pinto cases from the 1970s, large companies
that determine that it is more profitable to aggressively
market
unsafe and dangerous drugs and pay any fine than it is to develop
new and better drugs need to be made to answer for the
damages that they cause. Allowing consumers to seek
recourse from drug companies that have caused devastating
health problems and death is an important check on the
aggressive pharmaceutical marketing of drugs including off-label marketing that is currently occurring.
Defective drug lawsuits fall into
product liability law.
Product Liability
Lawsuits that stem from defective medications can be
extremely complicated and expensive to develop. Many
of these defective medication lawsuits have aspects of medicine,
science, evidence, and law to investigate, examine, and
prove. To successful pursue defective and dangerous
drug litigation, it is common to hire multiple
experts to prove that a medication is defective and that
it caused harm to a particular person or particular group of
people. For this reason
many defective medication lawsuits require severe
catastrophic damages
and/or multiple injured parties to be viable.
Even when a
dangerous medication has caused catastrophic damages to many
people and families, it can be quite
a fight to prove that a medication is defective.
Fighting through industry produced research and discovering
hidden adverse research can be difficult.
This is because the product's manufacturer has typically
invested a significant amount of money in designing the
product, manufacturing the product, and marketing the
product. For some dangerous drugs billions of dollars have
been invested in designing, manufacturing, marketing, and
distributing the defective drug. As such, everyone in the
production and distribution lines have a stake in disproving
that the medication is defective or dangerous.
Defective Drug Litigation, Bad Drug Lawsuits, and
other Drug Product Liability Lawsuits (Texas
Defective Drug Lawyer)
These highly
profitable, but aggressive, misleading, and sometimes illegal
marketing practices have brought crack downs by the United
States Department of Justice, the Food and Drug
Administration, and Product Liability Defective Drug
Lawyers. For more information on some types of defective drug litigation
that are now pending please feel free to click on the
following links: Chantix
Suicide
Lawsuits, Reglan
Tardive Dyskinesia Lawsuits,
Defective Birth Control
(Yaz, Yasmine, & Ocella)
Lawsuits, Avandia Lawsuits, Vioxx
Lawsuits, Ketek Lawsuits,
Gadolinium Contrast Dye
Lawsuits, Trasylol Lawsuits, Zyprexa
Lawsuits, Antidepressant (SSRI) drug Lawsuits, and
other defective
drug and medication
Lawsuits.
Reglan GERD Tardive Dyskinesia Lawsuits (Tardive
Dyskinesia Neuroleptic Medication Lawsuits)
Reglan is a neuroleptic medication used
to treat gastrointestinal problems that have had many cases
of Tardive Dyskinesia reported in response to it. Reglan is
supposed to increase the stomach and small intestine
contractions to help the passage of food. As every
medication, Reglan has side effects associated to it and
some of them are very serious. In February 1996, the FDA
warned that Reglan causes an increased risk of Parkinsonism.
Reglan is a dopamine antagonist that
increases lower esophageal sphincter pressure and improves
gastrointestinal emptying. The FDA approved Reglan, which is
manufactured by Baxter Healthcare Corporation, for
short-term treatment (between 4 and 12 weeks) of these
conditions only after conservative methods of treatment have
failed. However, it is common that patients are prescribed
Reglan for longer than 12 weeks, which is against FDA
recommendations.
This is problematic because prolonged use
of Reglan can cause Tardive Dyskinesia, a serious and often
irreversible movement disorder. Infants who are given Reglan
appear to be at an even greater risk for this serious drug
side effect.
The symptoms a person can experience from
Tardive Dyskinesia can vary from mild barely noticeable
facial ticks and involuntary movements to severe problems.
Severe cases of Tardive Dyskinesia can have a significant
impact on a person's life disabling them from normal
functioning. Severe facial ticks and involuntary body
movements can be extremely embarrassing and can cause a person to
withdraw from social interactions.
For more
information on Reglan and Tardive Dyskinesia, please go to
the following Reglan
Tardive Dyskinesia GERD Lawsuit Webpage.
Chantix Suicide Lawsuits (Chantix Suicide
Litigation)
Chantix
is a stop smoking aid or smoking cessation medication that
has been linked to mood and behavior changes in people that
use the drug. These behavior changes include suicidal
behavior and suicidal idealation. These changes are
especially problematic when Chantix is used in combination
with alcohol.
Health care professionals, patients,
patients' families, and caregivers should be alert to and
monitor for changes in mood and behavior in patients treated
with Chantix. Symptoms may include anxiety, nervousness,
tension, depressed mood, unusual behaviors and thinking
about or attempting suicide. In most cases, neuropsychiatric
symptoms developed during Chantix treatment, but in others,
symptoms developed following withdrawal of varenicline
therapy.
-
Patients should immediately report
changes in mood and behavior to their doctor.
-
Vivid, unusual, or strange dreams may
occur while taking Chantix.
-
Patients taking Chantix may
experience impairment of the ability to drive or operate
heavy machinery.
FDA will continue to update health care
professionals with new information from FDA's continuing
review or if new information is received on Chantix and
serious neuropsychiatric symptoms.
For more
information on Chantix Suicide and Attempted Suicide
Lawsuits, please go to the following
Chantix Lawsuit
Webpage.
Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs)
Birth Defect Lawsuits
Some medications that have been linked to
birth defects include Selective Serotonin Reuptake Inhibitor
Antidepressants (SSRIs). Women that have taken SSRIs
after the 20th week of pregnancy have a 6-fold
increased risk of developing persistent pulmonary
hypertension, a life-threatening lung disorder.
Infants with persistent pulmonary hypertension have
abnormal blood flow through the heart and lungs and do not
get enough oxygen to their bodies and may become very sick
or die. For more information on Selective Serotonin
Reuptake Inhibitor Antidepressant Birth Defect Claims,
please go to our
SSRI Birth Defect Claim Information Page.
The SSRIs antidepressants that have been
linked to persistent pulmonary hypertension (PPHN) include
Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac
sold by Eli Lilly; Celexa and Lexapro by Forest
Laboratories, Effexor marketed by Wyeth, Luvox by Solvay,
and the generic makers of these drugs include Barr
Pharmaceuticals, Ranbaxy Labs and Genpharm.
Infants born with PPHN often require
mechanical assistance to breath and even worse about 10% to
20% of the infants do not survive even when they receive
treatment. The PPHN babies that do survive often experience
developmental delays, brain abnormalities and hearing loss,
experts say.
For more
information on PPHN, PPH and SSRI Birth Defect Lawsuits,
please go to the following
SSRI Antidepressant PPHN Birth Defect Lawsuit Webpage.
Birth Control Medication Lawsuits
(Yaz, Yasmin, and Ocella Birth Control Drug Lawsuits)
YAZ,
Ocella, and Yasmin are oral contraceptives that produced
over $1 Billion in sales in the United States and $1.8
Billion worldwide in 2008. These birth control pills are
oral contraceptives that have been heavily marketed by Bayer
HealthCare Pharmaceuticals, Inc., however, the FDA has found
that past marketing campaigns were misleading as it
minimized the potential health risks that have been
associated with these oral contraceptives. These health
risks include sudden death, cardiovascular problems, blood
clots, heart attacks, stokes, and gallbladder disease
YAZ and Yasmin are combined oral
contraceptive (COC) pills that contain ethinylestradiol (EE)
and drospirenone (DRSP). These birth control medications
are manufactured by Bayer HealthCare Pharmaceuticals, Inc.,
while Ocella is the generic equivalent of Yasmin that is
manufactured by Barr Laboratories. Each of these birth
control medications contain ethinyl estradiol and the new
"fourth generation" progestin drospirenone (DRSP).
Drospirenone is known for increasing the risk for
hyperkalemia and these DRSP oral contraceptives have been
associated with adverse health effects such as Death, Deep
Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes,
Heart Attacks, Gallbladder Disease, and other health
problems.
For more information on Yaz, Ocella, and
Yasmin Lawsuits, please go to the following
Yaz, Ocella, and Yasmin Lawsuit Webpage.
Neurontin FDA Actions and Warnings (Gabapentin
and Antiepileptic Drug Suicide Lawsuits)
In December 2008, the U.S. Food and Drug
Administration announced it will require the manufacturers
of antiepileptic drugs to add to these products' prescribing
information, or labeling, a warning that their use increases
risk of suicidal thoughts and behaviors (suicidality). The
action includes all antiepileptic drugs including those used
to treat psychiatric disorders, migraine headaches and other
conditions, as well as epilepsy.
The FDA is also requiring the
manufacturers to submit for each of these products a Risk
Evaluation and Mitigation Strategy, including a Medication
Guide for patients. Medication Guides are
manufacturer-developed handouts that are given to patients,
their families and caregivers when a medicine is dispensed.
The guides will contain FDA-approved information about the
risks of suicidal thoughts and behaviors associated with the
class of antiepileptic medications.
"Patients being treated with
antiepileptic drugs for any indication should be monitored
for the emergence or worsening of depression, suicidal
thoughts or behavior, or any unusual changes in mood or
behavior," said Russell Katz, M.D., director of the Division
of Neurology Products in the FDA's Center for Drug
Evaluation and Research. " Patients who are currently taking
an antiepileptic medicine should not make any treatment
changes without talking to their health care professional."
The FDA today also disseminated
information to the public about the risks associated with
antiepileptic medications by issuing a public health
advisory and an information alert to health care
professionals. Health care professionals should notify
patients, their families, and caregivers of the potential
for an increase in the risk of suicidal thoughts or
behaviors so that patients may be closely observed.
Gabapentin (brand name
Neurontin) has been aggressively marketed for many off-label
uses including to relieve pain, migraine headaches,
neuropathic pain, nystagmus, Complex Regional Pain Syndrome,
mood-stabilizing treatment for bipolar disorder,
menopausal hot flashes, and idiopathic subjective
tinnitus. This off-label marketing for Neurontin is a
serious problem in that the FDA has issued a warning of an
increased risk of suicidal thoughts and behaviors in
patients taking Neurotin.
It is estimated that over 90 percent of
Pfizer's revenue from Neurontin which is in the billions of
dollars is from off-label use. Pfizer has paid a total of
$2.75 billion in off-label penalties since 2004 which is a
little more than 1 percent of the company’s revenue of $245
billion from 2004 to 2008. (Pfizer
Broke the Law by Promoting Drugs for Unapproved Uses)
For more information on Neurontin and
Antiepileptic Drug Suicide Lawsuits, please go to the following
Neurontin, Off Label Marketing, and Antiepileptic Drug
Suicide Lawsuit Webpage.
Defective Medication Lawsuits, Bad Drug Lawsuits,
and other Drug Product Liability Lawsuits (Texas Dangerous
Defective Drug Lawyer)
Dangerous
drug lawsuits, defective drug lawsuits, and other defective
drug product liability lawsuits are becoming more common as
drug companies and the pharmaceutical industry continue to
produce, market, and sell drugs that they know cause
devastating health problems.
Texas defective medication and dangerous
drug lawyer, Jason S. Coomer, helps
individuals and their families that have been injured or damaged
by defective medications and dangerous drugs.
Because of the size, complexity, and expense of most product
liability claims, Jason Coomer commonly works with other
defective medication
lawyers across the United States as well as around the
World to prosecute product liability lawsuits. He has worked with
San Antonio defective medication
Lawyers, Boston dangerous drug Lawyers, Houston
defective medication Lawyers, Atlanta defective product Lawyers, and
several other defective product lawyers.
If you have a question about a defective product and need a
defective medication
Lawyer or a dangerous drug to advise you,
contact Austin Texas defective drug lawyer Jason Coomer.
|
