MEDICAL FRAUD In this abstract, I will explain the specifics of my research and a detailed outline of my paper. Understanding the topic of medical fraud and off labeling is important, especially for consumers who participate in the use of prescription drugs. It is imperative to understand what your doctor is prescribing and knowing the specific uses of said drug. Off labeling may occur and recognizing this fact will only benefit a wise consumer and make them aware of the risks of using a drug that was prescribed for a uses not on the label.
This topic is especially important during the time of new Healthcare reform. Although it seems like we should be able to trust our doctors and believe what they tell us and the drugs they approve for us to use, we have the responsibility to check their credibility and research the drugs on our own. When we don’t look for specifics about pharmaceutical drugs, we are at risk of being hurt with side effects.
Because the doctors are allowed to prescribe an approved drug for anything, as long as the FDA clears it, we can be fooled into believing it was made for a specific ailment. Also, the doctors are not required to tell the specifics of a drug, we can only be responsible for knowing that ourselves. The problem this topic addresses is the reality that major pharmaceutical companies are committing fraud to fool consumers. Recognizing that what they are participating in is fraud shed’s a light on what we should be questioning.
It also includes understanding the role of the FDA and how effective their laws are. Witnessing crack downs on major companies on behalf of the consumer, and the penalties administered, makes us believe that our government, in some ways, is looking out for our best interest. I believe bringing this fraud into the light is the start of a change. The more consumers hear about big cases, like that of Pfizer, the more they can begin to question. The purpose of this paper is to talk about the awareness while explaining the facts.
The methods of approach used to address this topic are clarifying what off labeling is and a brief history of medical fraud and quackery, describing the Food and Drug Administration and their roles in eliminating fraud in major pharmaceutical companies, and citing the case of Pfizer to show a specific example of what off labeling fraud looks like. I have come up with several key findings in my research of off labeling and medical fraud. First, medical fraud is something that can be committed in all levels of the medical/ healthcare industry.
While doctors, at a lower level, may have the ability to prescribe drugs off label, they are still not being completely truthful when doing so. Keeping information from the consumer doesn’t seem to be an attribute one would be pleased to discover in the doctors they want to trust. On a much larger level, pharmaceutical companies commit fraud when they try and push the marketing of a drug they know can be used to different uses than what was approved by the FDA. This in fact is illegal, but knowing that fact, they still seem to see that the reward could be greater than the risk.
The conclusions that stem from my findings in this paper, are like I previously stated; the importance of being aware of what prescriptions are given and the specifics about a drug, the benefits of knowing what the FDA does and how it effects us daily, and how to recognize fraud in the major pharmaceutical companies and what can and is being done to stop and prevent such actions. Medical fraud has been around as long as medicine has existed. It was not until early in the twentieth century that there was much difference between the practices of mainstream medicine and quacks.
Medicine made from unknown natural oils and such were passed off to have healing attributes while containing nothing of the sort. People are inclined to spend their money on anything they believe will make their quality of life better, and anyone who claims to know how to cure a health ailment becomes a medical expert. Today it has become easier to commit medical fraud because the Internet is making it easier to promote worthless products to an even larger audience and sophisticated marketing ploys are easier to pull off.
However, the psychology and operating method of using people’s fears and unrealistic expectations to make a buck selling worthless medical treatments or devices has not changed. One form of medical fraud is known as off labeling. A drug is used off label when the doctor prescribes that drug for a medical use other than the one that received Food and Drug Administration approval. Off label prescribing is a commonly used and accepted medical practice. These drugs do have FDA approval but for a different use. (Lawrence, 2008) Off labeling has its risk and its benefits.
Although in recent healthcare history, off labeling has been getting a bad reputation, it remains to be a beneficial thing for a lot of consumers. The truth that off labeling is completely legal shouldn’t be forgotten. Caleb Alexander, who is a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center, asserts “Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and … doctors are free to prescribe a drug for any reason they think is medically appropriate” (SLHG, 2009).
Off label prescribing isn’t necessarily bad. It can be beneficial, especially when patients have exhausted all other approved options, as may be the case with rare diseases or cancer. While a patient can surely benefit from the off labeling of a prescription drug, few are aware that they are receiving an off labeled drug. While it would seem to be illegal to keep medical information from a patient, doctors are not required to tell a patient that a drug is being used off label. (Findlaw, 2009) A big example of what off labeling would be Aspirin, though not as seemingly harmful as other drugs could be.
While aspirin has been a common pain reliever for more than 100 years, in 1988 doctors began recommending its use in preventing heart attacks. Many drugs are found to remedy ailments other than those they were originally intended to treat, and as prescription drug use has soared, patients are increasingly taking them for off label purposes. (Findlaw, 2009) With all of the off label drug use comes a lot of controversy as well. While it’s understood that prescribing a drug for off label use is not considered illegal, the debate lies within whether the benefits outweigh the risk. So what can be risky about off labeling?
Doctors emphasize that off label prescribing has its place in medical practice, but they also admit that using a drug off label can raise the risk of lawsuits should a patient have unwanted or bad side effects. In The Journal of Law, Medicine & Ethics, Joel Frader, MD states that “Off-label prescribing can expose patients to risky and ineffective treatments”(Vucci, 2009). In his further opinion, Frader emphasizes that although some off-label therapies can be beneficial and even lifesaving for some patients, in most cases, there is little or no scientific evidence to prove they work (Vucci, 2009).
As stated previously, the Food and Drug Administration is the federal agency that regulates pharmaceutical products. The Food and Drug Administration is the oldest United States federal government consumer protection agency and falls under the umbrella of the United States Department of Health and Human Services. (SLHG, 2009) The Center for Drug Evaluation and Research is a branch of the FDA responsible for approving drug labeling and enforcing manufacturing standards for new drugs, generic drugs and over the counter drugs.
When the Food and Drug Administration approves a drug, it does so after evaluating the benefits and risks from a particular drug. The drugs are tested and evaluated under various health conditions, before being approved. A drug may be useful for other purposes that have not been approved by the FDA. However, in these cases, the agency has not evaluated the risks of the drug, verses the benefits. Therefore, patients who take the drug may be exposed to side effects and dangerous reactions, because the drug has not been evaluated and approved for this condition.
Although, as stated previously, the practice of off labeling prescription drugs is not illegal, the marketing of a drug for uses not approved by the FDA is! The evaluation of alternative uses of drugs is more times than not, not done, increasing the risk of injury or problems, but this doesn’t seem to stop pharmaceutical companies from continuing to push doctors and physicians to prescribe drugs for conditions not approved by the FDA. The more the number of conditions a particular drug can be prescribed for, the higher profits. Over the past few years, several companies have been punished for their aggressive promotion of unapproved drugs.
A major example of this is when Pfizer, the world’s largest drug company, marketed and pushed the use of several different drugs, uses of which were not approved. Pfizer is in control of several different units, whom are responsible for manufacturing and marketing drugs. One of Pfizer’s units Warner-Lambert, had been pushing doctors to prescribe an epilepsy drug called Neurontin. The New York-based Pfizer unit agreed to pay $430 million in criminal fines and civil penalties, and the company assured Pfizer and its units would stop promoting drugs for unauthorized purposes.
This was only the beginning. (Vucci, 2009) After this incident, another Pfizer unit, Pharmacia & Upjohn, made history when they were fined civil and criminal penalties amounting to $2. 3 billion. This amount was the record for civil penalties over off label marketing of drugs. The penalties that were announced by the Justice Department included $1. 2 billion in criminal fines and a criminal forfeiture of $105 million. Pfizer was also responsible to pay $1 billion to compensate federal healthcare programs, like Medicare and Medicaid. Evans, 2010) The total penalties are the largest paid by a drug maker for violations of federal rules. The allegations against Pfizer are that the company promoted four prescription drugs for purposes not approved by the FDA. The four drugs include the painkiller Bextra, the anti psychotic Geoden, antibiotic Zyvox and anti epileptic Lyrica (Vucci, 2009). Pfizer representatives created fake doctor requests for medical information in order to be able to send unsolicited information to physicians about unapproved uses of these drugs.
According to New York attorney general Andrew Cuomo, the company aggressively marketed these four drugs for off label uses. Doctors were sent on exotic holidays, and were wooed with gifts to persuade them into prescribing the drugs for purposes not approved by the FDA, for patients covered by federal healthcare programs like Medicare (Evans, 2010). While Pfizer thought they would get away with promoting and marketing these drugs, bribing and persuading the doctors into prescribing the drugs, and hiding their activities from the FDA, they eventually were caught and punished.
The question of whether the Justice Department’s aggressive legal tactics will stop drug makers from pushing their products to doctors for uses that have not been FDA approved is still to be answered. With the Pfizer settlement, federal authorities tried to send a strong message to the pharmaceutical players and we will see whether if that can be enough to put an end to this form of medical fraud. References Evans, D. (n. d. ). Pfizer Broke the Law by Promoting Drugs for Unapproved Uses – Bloomberg. com. Bloomberg. com. Retrieved April 2, 2010, from http://www. bloomberg. com/apps/news? id=20601202&sid=a4yV1nYxCGoA FindLaw&, t. B. (n. d. ). FindLaw’s Common Law: Pfizer’s ‘Off-Label’ Marketing of Bextra Draws Record Breaking Fines. FindLaw’s Common Law. Retrieved April 2, 2010, from http://commonlaw. findlaw. com/2009/09/pfizers-offlabel-marketing-of-bextra-draws-record-breaking-fines. html Just what does the FDA do, anyway? | Seattle/LocalHealthGuide. (n. d. ). Seattle Local Health Guide. Retrieved April 2, 2010, from http://localhealthguideonline. com/just-what-does-the-fda-do-anyway/ Lawrence, D. (n. d. ). Off-Labeling: A Major Pharmaceutical Issue – Levick
Cite this Understanding the Topic of Medical Fraud
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