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 need 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 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.