As Healthcare Reform develops and shape regulations within the healthcare industry, unethical practices and conflicts of interest in the pharmaceutical industry affirm the need for transparency and improved traditions. Conflict of interest from a legal standpoint is “a conflict between the private interests and the official or professional responsibilities of a person in a position of trust.” (Merriam-Webster’s Dictionary of Law, 2010) From a business perspective, conflict of interest is defined as a “situation that has the potential to undermine the impartiality of a person because of the possibility of a clash between the person’s self-interest and professional-interest or personal-interest.” (BusinessDictionary.com)
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With the number of physicians operating private practices in the United States, the clinical drug trial kickbacks have become common practice and the ravenous patterns have been explicitly revealed. The frequency of such behaviors and exposure of financial gain are enough to further strengthen the necessity for health care reform. Each unscrupulous circumstance that is exposed brings about further insight to the widespread unethical conduct of the pharmaceutical industry. There is an abundance of scenarios and examples depicting behaviors as well as emergent methods to circumvent such conflicts of interest. Additionally, laws and processes are in place to further develop and establish parameters around acceptable and unacceptable practices for both pharmaceutical manufacturers and physicians alike. With the objective to deter, eliminate and expose conflicts of interest, various projects, acts and charitable trusts have been developed and comprised of committees of citizens, organizations, and donors who vigorously advocate patient safety through improved changes in the manufacturing and marketing of prescription drugs.
So how does conflict of interest play a role in clinical drug trials? When discussing conflict of interest as it relates to clinical drug trials the scenario is usually one in which a researcher has a monetary rapport and research money, with the company that manufacturers the drug being studied. There is nothing fundamentally erroneous with these types of conflicts of interest, they are practically everywhere within drug trials because most of the trials are financed by the drug companies that produce the drugs being studied.
In an article written by John H. Montgomery related to the examination of conflicts of interest, research was done by Dr. Roy H. Perlis on the outcome of drug trials and the relationship that the author or industry has to that outcome. Research shows that 397 trials were reviewed and of those, 162 random trials yielded positive results that were funded by the manufacturer of the drug being studied. These results give indication that conflict of interest is common and associated to the outcome of the trials. This is just one of many examples of how common conflicts of interest arise in the healthcare industry. Another study conducted “looked at randomized controlled trials of NSAIDs (non-steroidal anti-inflammatory drugs) between 1987 and 1990” (Bodenheimer). This study found that relatively all of the trials in the three-year span were sponsored by the drug producer. The research also discovered that the drug being compared to the manufactured drug was equivalent in efficiency and in some cases was even better than the manufactured drug in every trial. The study also reported that “the manufacturer-associated drug was safer than the comparison drug in 86% of the trials” (Bodenheimer). Remember, these trials were funded by the drug companies sponsoring the trials.
How can conflicts of interest be avoided? First, when a patient is registered in a drug trial, full disclosure of any financial relationships with the drug manufacturer should be given. This builds trust with the patient and also fulfills the patient’s right to know this information so they can make the decision as to whether or not they want to participate in the study. Second, disclosure statements should be offered to the participant and ought to be clear and simple; this will often entice the patient to ask questions. Finally, research planners should be sufficiently familiar with any conflicts of interest with the investigator or the institution so that patient’s questions can be answered appropriately and correctly. Disclosure may not always be what most patients are looking for but the aforementioned suggestions could help satisfy the patient and trust the research process. The investigator cannot be the only responsible party though patients must also do their homework before they participate in a clinical trial.
The issue of whether or not conflict of interest is unacceptable when drug companies perform their own clinical drug trials is becoming an increasingly hot topic in the industry today. In an article written in BMJ magazine by Goldacre this topic is discussed. Goldacre talks about the NSAIDs study mentioned above and how impossible the results of that trial were. He notes that an organized evaluation found 30 studies that investigated whether or not industry support is connected with results that are beneficial for the sponsor. The result: “studies sponsored by drug companies were more than four times as likely to have outcomes favoring the funder, compared with studies with other sponsors” (Goldacre).
How can this partiality be allowed to take place? Perhaps it is the way the trials are planned. For instance, in some studies the opponent drug is given at an insufficient amount which raises the side effects of the drug. This in turn makes the supporter’s drug look more appealing. Another known issue is that there is no standard for communicating results of drug trials. The industry has the ability to print whatever they would like to report. More often than not, the negative results from clinical drug trials remain unavailable. The most alarming concern about the clinical drug trial process is that data is not only used once, in some cases data was published within the results of 14 other trials. It is inevitable that issues like this will exist in the industry when there is no formal standard by which clinical drug trials must adhere to.
Though there is no standard set the FDA has published guidelines that the industry must follow regarding financial disclosure in drug trials. The FDA Guidance for Industry on Financial Disclosure by Clinical Investigators requires that anyone submitting an application to market a drug, product or device disclose any financial relationship or compensation received by all investigators involved in the trial being set up. The FDA specifies requirements about what information is required to be reported and lists actions that the agency will take if these requirements are not followed. The FDA should not be the only one addressing conflicts of interest in clinical drug trials though. Physicians should be attentive when participating in the trials or when treating a patient that is currently or is eligible to participate in one.
Physicians participating in drug trials or enlisting patients for trials should be aware of the following guidelines:
Physicians should only consent to participate in trials that are within their range of capability and practice and they should be appropriately trained in performing research.
Physicians should be knowledgeable of ethics and should only participate in trials that they are convinced have been evaluated by a review board, the participants in the study are not at risk of being harmed, and that government policies are followed during the course of the study.
If a physician is treating patients that are enrolled in a study or are eligible to participate in a study, they will need to make sure the patient understands that they treat them under both pretenses but as both physician and investigator.
Physicians should make certain that procedure include stipulations that will support the participant’s health care should difficulty arise as a result of the trial.
“The nature and source of funding and financial incentives offered to the investigators must be disclosed to a potential participant as part of the informed consent process” (Managing Conflicts of Interest in the Conduct of Clinical Trials).
The physician should make certain that there is no impediment in the publication of the results of the study by the sponsor of the trial.
Conflict of interest is a growing concern in the health care industry today. The issues are reported on the news and in publications more and more frequently. Bringing attention to the matter and raising awareness will aid in the development and improvement of ethics in clinical drug trials.
An example of one of the reformation objectives would be eliminating the behavior of a physician who treats a patient suffering from dementia and later bills Medicare; however, this same physician does not report the adverse impact on the patient, because the physician has been promised adequate compensation for evading details and touting benefits of the drug. The patient filed a malpractice suit against the physician. The attorney during discovery learned that the plaintiff was enrolled in a study and did not meet the criteria to be included in the study. It was also discovered that the medical assistant did not have any experience or training in coordinating studies and were paid a fee for each person enrolled. The study was not in compliance or conducted in conjunction with the FDA statutes and regulations. The IRB which once approved the Protocol and Informed Consent halted the study eight months earlier. An additional $5,000 per month was paid to the physician for consulting services. These same payments were paid to the physician under the Clinical Trial Agreement creating a duplication of services. Medicare was billed by the physician as well for the same items and services which including the drug that for formally paid out by the sponsor in which the physician has previously been reimbursed. The Plaintiff signed the informed consent alone without any counseling even though the sponsor knew the subject was diagnosed as suffering from dementia.
Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and the chief of pediatric psychopharmacology at Harvard’s Massachusetts General Hospital poses a prime situation of drug payments going to physicians. Children as young as two years old are now being diagnosed with having bipolar disorder thanks largely to Dr. Biederman. Many of the children were treated with combinations of powerful drugs known as cocktails that were never approved by the Food and Drug Administration (FDA). The FDA must approve any children below the age of ten for any purpose in a drug study trial. Physicians may legally use only drugs that have been previously approved for a particular purpose or diagnosis, for any other purpose there must be upheld published scientific evidence before administering drugs. That was not the case for Biederman. His studies advocated the drugs that treated childhood bipolar disorder and was summarized by an article in The New York Times. Biederman was paid $1.6 million in consulting and speaking fees from 2000 and 2007 including drugs that he advocated for childhood bipolar disorder. Similar amounts were paid two of his colleagues. The president of the Massachusetts General Hospital and the chairman of its physician organization apologized and express sympathy to its beneficiaries after the conflicts of interest were revealed.
Chair of Stanford’s psychiatry department and president-elect of the American Psychiatric Association Dr. Alan F. Schatzberg is another example of drug payments to physicians. Schatzberg controlled and co-founded Corcept Therapeutics in which he owned more than $6 million worth of stock. The company tested the drug Mifepristone, otherwise known as RU-486 the abortion drug as well as the drug used for the treatment of psychotic depression. Schatzberg, principal investigator on a National Institute of Mental Health grant that included research coauthored three papers on the subject of mifepriston. Schatzberg was later replaced as principal investigator to avoid a conflict of interest of misunderstanding.
The most shocking case of drug payments to physician is that of Dr. Charles B. Nemeroff. Nemeroff, chair of Emory University’s department of psychiatry along with Schatzberg, both served as coeditors of the influential Textbook of Psychopharmacology. Nemeroff served as principal investigator of the National Institute of Mental Health grant that was worth $3.95 million over five years. Emory University received $1.35 million which was used as overhead to study several drugs administered by GlaxoSmithKline. Emory University had to comply with government regulators along with the university to disclose income received from GlaxoSmithKline. Emory had to report any payments over $10,000 per year per the National Institutes of Health. This was done to ensure and eliminate the conflict of interest.
Emory University compared records with GlaxoSmithKline and Nemeroff failed to disclose approximately $500,000 of speaking and consulting fees promoting the company’s drugs. Emory conducted its own investigation in June 2004 and multiple violations of policies were founded on behalf Nemeroff. Nemeroff responded by issuing a memorandum at Emory stating he has been in compliance however GlaxoSmithKline reported paying Nemeroff a salary of $171,031. Nemeroff reported only $9,999 to Emory. He under reported by one dollar in which $10,000 is the threshold for reporting per the National Institutes of Health.
As a result of Health Care Reform which was passed in 2010 and initiated by President Barack Obama’s administration, the Pew Prescription Project is an initiative of the Pew Charitable Trust promoting consumer safety through health care reform in the approval of manufacturing and marketing of prescription drugs. These initiatives will encourage or force evidence-based prescribing. The Pew Prescription Project conducts nonpartisan research through rigorous federal oversight in relation to drug safety. The purpose is to better illuminate problems and potential solutions in the area of prescription drugs.
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The Pew Prescription Act current goal includes the passage of the Physicians Payments Sunshine Act and the Independence Drug Education and Outreach Act. This includes improvements to current federal laws and regulations while improving FDA oversights and drug manufacturing. The advancement of evidence-based prescribing practices and ensuring clinical safety of drugs for children is another goal.
The Physician Payments Sunshine Act has been passed within the current health care reform legislation. The provisions require drug and device companies to publicly report any gifts and payments that are made to doctors. The information must be posted on their web sites and reported to the US Department of Human Services. Companies can be fined starting at $10,000 up to $100,000. Many of the provisions must be fully operational starting in 2013.
The government believes patients deserve and have the right to know if their doctors are receiving money from drug companies. “Congress has added much needed transparency to the financial relationships between the pharmaceutical industry and physicians.
The reporting requirements in the health care legislation will better protect patients and will help restore trust in our health care system. This new legislation will enhance the safety of consumers by increasing transparency while in no way restricting business or limiting innovation.” (Jewett)
Though pharmaceutical marketing strategies has taken a new “enlightened” turn in the world of advertising, previous tactics of physicians actually promoting through accompanying pharmaceutical sales representatives has resulted in essential stimulated scrutiny. Less face-to-face interaction between pharmaceutical sales representatives and physicians is underway to aid in eliminating the engagement as well as the hint of unethical proposals and initiatives. Rewarding physicians with branded-name gifts, meals, apparel, etc., did in fact strengthen the marketing concept and played a significant impact on the positive profitability of many pharmaceutical companies. However, the proof is in the patient. Other marketing techniques have included persuasive testimonials from respected physicians claiming to have realized improvements in their patients’ prognoses. Further marketing techniques consist of published promotional reporting from trusted colleagues where the tracking of physicians’ likes and dislikes are captured and substantiate biographical purchasing data.
Prescribing under the influence is a term used as a result of the drug reps intoxicating the physicians, residents and interns with breakfast, lunch, pens, and other pharmaceutical logo branded apparel, etc. The general idea is for the pharmaceutical sales representatives to be granted another opportunity to educate physicians about the targeted drugs, which is part of substantiating marketing strategies. The pharmaceutical reps take advantage of the physicians’ empty stomachs with an offer of free lunch or breakfast and prey on their wandering eyes with the fancy pens, notebooks, calendars and other items that coerce physicians to agree to their objectives in increasing sales. However, when a physician is questioned about the effectiveness of this type of marketing they often respond, “It doesn’t influence me at all. They’re not going to buy my soul with a laser pointer.” (Morreim)
Many studies support that this kind of advertising has proven vital to the steady increase in pharmaceutical sales. So, perhaps physicians need to reexamine just how much they are persuaded by the irresistible allure of free fresh baked cookies or the tiny thin tubes that hold inks that we all know as a pen. Often a doctor is not going to prescribe medication that they barely know anything about; it’s the responsibility of the drug representative to educate the physicians on the name of the drug and drug facts so that they can then feel comfortable prescribing it to their patients. Drug representatives have basically been buying physicians’ time with whatever little inexpensive knick knack and kick-back it may take to get the name of the drug into the physician’s brain and onto his prescription pad. What’s even worse is that most physicians will not give the drug representatives the time of day without some type of bribe or induction that is surprisingly not considered a kickback (in terms of legalities).
A letter in the Journal of American Medical Association attests to just how intoxicating the advertising of the drug reps can be. The story describes a patient who came into the emergency room for an insect bite. The patient was originally seen by an intern who wanted to prescribe an inexpensive antibiotic, however the decision to prescribe the inexpensive antibiotic was overruled due to the fact that another resident recommended prescribing an new antibiotic that cost $183 per day. This incident was investigated by the attending physician who supervised the house officers and found out that this particular intern had recently wined and dined the day before by a drug rep from the manufacturer of the new expensive antibiotic prescribed. This type of behavior validates the enormous impact that marketing has on gifts of persuasion.
In a story posted in the New York Times magazine, titled “Dr. Drug Rep.” a well respected physician Dr. Joseph Carlat shares his experience in being solicited by Wyeth Pharmaceutical Company to be a spokesperson for their drug Effexor XR, which is used for treating depression. They made him an enticing offer, and told him that all he would have to do is speak with his fellow colleagues about the features and benefits of the drug. Wyeth would provide all the information and materials that he needed to educate the other physicians about the drug and in return Dr. Carlat would be paid $500 for a one-hour training session or $750 if he had to drive for an hour.
Dr. Carlat thought this would be easy enough. He was reputable; he had a busy private psychiatry practice specializing in psychopharmacology. He was quite familiar with drug Effexor and had read different studies pertaining to its effectiveness. The drug Effexor was being promoted by Wyeth as a dual reuptake inhibitor meaning that it increased both serotonin and norepinephrine, another neurotransmitter. The theory promoted by Wyeth was that two neurotransmitters were better than one, and that Effexor was more powerful and effective than S.S.R.I.’s. (Carlat) Because he had already prescribed Effexor to several patients and it seemed to work, Dr. Carlat did not feel like there was anything unethical about him talking to other doctors about the drug.
Dr. Carlat subsequently attended a full, expense paid physicians’ conference in Boston. When he began socializing at the conference there were other physicians functioning as spokespersons for other drugs and pharmaceutical companies. One physician that stood out was Dr. Michael Thase, the researcher who single-handedly put Effexor on the map. Thase presented evidence from clinical trials of Effexor being more effective than any other antidepressant. He rebutted criticisms of him being a paid consultant of Wyeth quite convincingly which was important. He explained to the attendees that he had requested and received complete information, both advantagess and disadvantages of the research data and not just the advantages. “This was a significant point, because companies sometimes withhold negative data from publication in medical journals. For example, in 2004, GlaxoSmithKline was sued by Eliot Spitzer, who was then the New York attorney general, for suppressing relevant data that hinted Paxil caused suicidal thoughts in children. The company settled the case and agreed to make clinical-trial results public. (Carlat)
“Was I swallowing the message whole? Certainly not. I knew that this was hardly impartial medical education, and that we were being fed a marketing line. But when you are treated like the anointed, wined and dined in Manhattan and placed among the leaders of the field, you inevitably put some of your critical faculties on hold. I was truly impressed with Effexor’s remission numbers, and like any physician, I was hopeful that something new and different had been introduced to my quiver of therapeutic options. At the end of the last lecture, we were all handed envelopes as we left the conference room. Inside were checks for $750. It was time to enjoy ourselves in the city.” (Carlat)
However, after a year of pharmaceutical “detailing” Dr. Carlat became disturbed concerning feedback that Effexor caused hypertensions in a small but significant percentage of patients. For that reason, amongst other ethical reasons, Carlat decided to sever ties with Wyeth. Looking back on the year he spent speaking for Wyeth, he asked himself, “Did I contribute to faulty medical decision making? Did my advice lead doctors to make inappropriate drug choices, and did their patients suffer needlessly?” He admitted that there was a huge financial incentive for physicians to partner with pharmaceutical companies. (Carlat) Although he still allows drug reps to visit his office because it helps him stay abreast of the growing trends, he keeps the visits short and does not accept their offers and invitations.
Who says this type of marketing isn’t effective? Do other physicians really think they are invincible from the powers of persuasion? How many doctors actually engage in this type of marketing for drug companies? What role do ethics play in the decision to speak or not to speak on behalf of the insurance company?
The truth is that previously many physicians engaged in this type of pharmaceutical “detailing”. While the median physician salary of 140,000 annually may be representative of a good salary, the additional $30,000 in supplemental income is quite alluring. In addition, to the monetary earnings earning respect based on reputation is important among colleagues. At least 25% of U.S. doctors are still receiving drug money for lecturing to physicians or assisting drug companies in other ways. Many physicians engage in this type of career appendage and perhaps go in with the purest of intentions; nonetheless, ethics are being violated when the physicians are not relaying accurate and appropriate information about the new medications that they are pushing, and much of the information that they are giving is provided to them from the pharmaceutical companies.
PhRMA, Pharmaceutical Research and Medical Practices of America are part of an ongoing effort to ensure that pharmaceutical marketing organizations practice with the highest ethical standards. In January 2009, the voluntary PhRMA Code on Interactions with Healthcare Professionals took effect and its focus was developed to keep representatives from drug companies and healthcare professionals centered on patient care. It is committed to making sure that drug representatives are provided with the most current, accurate, and reliable information to assist in their decision making on drug selection. Amongst its changes, “prohibits distribution of no-educational items (Such as pens, mugs and other “reminder” objects typically adorned with a company or product logo). It prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals. It includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations, and industry codes and practice. Companies are also asked to periodically access whether or not the representatives are abiding by the codes.” (PhRMA) CEO’s and Compliance Officers will have a process in place patterned after the Sarbanes – Oxley compliance, other changes to the code reflects PhRMa’s support of transparency in relation to healthcare professionals.
There is necessary education offered to interested parties regarding marketing techniques and physicians’ outlooks on pharmaceutical products, diagnoses and expected and proven outcomes. Since Pharmaceutical products must be marketed differently than other healtcare industry products for sale and there are distinct diversions for implementing successful marketing. The potential user or patient, must be granted a prescription from the prescribing physician. Proper use of the pharmaceutical is key which provides favorable or unfavorable outcomes. Within the public health sector, determinations on accessible drugs may very well be taken based on politics, which undoubtedly broadens the scope of advertising and marketing strategies in this field, replacing advertising by appealing via petitions through lobbyism. Various marketing schemes play into different levels of interests such as financial, scientific gain or even personal. Academic conferences and medical journals provide varying mediums for exposure.
Ethical pharmaceutical trials developed arguments depends on knowledge, outcomes and concrete unbiased facts. This type of knowledge requires transparency, a level of transparency being sought after throughout the healthcare industry as a whole. The pharmaceutical industry requires skilled marketing experts to ensure that all aspects of reaching targeted audiences effectively are exceeded, not just met. Those regulations developed by the Pharmaceutical Research and Manufacturers of America and nofreelunch.org, which are not law, were developed to promote transparency. A doctor as a pharmaceutical representative shares his personal story about lecturing on a particular drug. There are ethical guidelines developed specifically for the healthcare industry that includes the pharmaceutical industry. AdvaMed’s Code of Ethics, in particular, is a model for appropriate ethical behaviors within the healthcare industry that outlines specific recommendations for the drug industry. AdvaMed addresses parameters covering educational grants, modest meals and hospitality, faculty expenses, and advertisements. In presenting the issues of unethical behaviors, it is imperative to understand the prevalence based on historical and current behaviors in society and the ever-evolving methods developed to discourage physician kickbacks in the pharmaceutical industry.
Though AdvaMed’s Code of Ethics regulations do not mandate their guidelines be adhered to, health care organizations are strongly urged to utilize and enforce their codes can assist in eliminating and curtailing unethical behaviors that lead to lawsuits that actually develop in to Case Studies. As long as viable codes of ethics are followed, fear of transparency can be removed. Acceptably ethical behaviors will indeed help aid in the inevitable reformation efforts that this nation continues to experience.
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