Introduction
A rise in direct-to-consumer advertising has been observed in the recent past. This increased favorable and adverse effects on patients who make their own healthcare decisions (U.S. Food and Drug Administration, 2013). It is this adverse effect of direct-to-consumer advertising that the essay is based upon, with the aim of digging deep into finding out why the ethics governing the industry has continuously been ignored. Additionally, the paper explores the cause of the ineffectiveness of the agency charged with maintaining quality standards, ethics, and good practice. Critics point out that the rules are too relaxed, though a number of arguments that oppose or favor direct-to-consumer pharmaceutical advertisement (DTCPA) are fairly balanced (Iizuka and Jin, 2005).
Industry Arguments
Though proponents of DTCPA argue that they provide health information to patients, there are several risks associated with DTCPA. This has caused several patient deaths in the United States (Donohue et al, 2007). On average, viewers watch nine drug advertisements every day, summing up to sixteen hours a year, which exceeds the amount of time they spend with physicians. Interestingly, the conveyed information has never been conclusive, hence the patients’ inability to understand the risks. Many of these advertisements are on television, which most of the time has a mismatch between verbal message and visual imagery when presenting risky information, for example, a person is seen chatting happily while they narrate side effects. This has brought confusion to the consumers hence reducing their ability to understand risks (Donohue and Berndt, 2004).
Economists argue that, direct-to-consumer advertisement has contributed to the growth of both pharmaceutical and media industries, for example from the year 1980 to the year 1997, the amount spent on DTCPA had increased from 12 million dollars to 1.2 billion dollars, which represents over 3000 percent increase in revenue to the media industry (Parekh et al, 2011). An increase has also been witnessed in internet marketing which is lucrative with a 5:1 return on investment. This has led to massive employment opportunities in the industry. However, an examination of the available data shows that from 1996 to 2008, the percentage of money used to promote new drugs directly to medical professionals versus total sales had been greatly reduced while those spent on direct-to-consumer advertisements have increased immensely (Parekh et al, 2011). This disturbing trend obviously indicates that there is a higher return on DTC advertised drugs and suggests why there is laxity in the industry.
Although the increase may be of help to the economic development, its adverse effect to consumers is equally great. It has encouraged drug overutilization in medicating natural conditions, hence overmedicated society. Over 74 per cent of health providers agree that patients always ask an advertised drug that is appropriate; this has the strained relationship between physicians and the patients (Parekh et al, 2011). Food and Drug Administration agency has been largely accused of laxity in implementation of the legal and ethical reviews, which has led to a reduced number of warning letters that has been issued as well as delays that led to those letters being sent after the end of advert campaign (FDA, 2002). In 2002, health secretary issued a directive that all adverts be approved by food and drug administration (FDA) Office of chief counsel before they are released. The result of this was that the employees of FDA were not able to review all the drafts on time, leading to a reduced number of regulatory letters sent in the year 2002 than in 2001 (28 verses 68). Surprisingly, the problems cited in the same period increased from 15% to 33.3% (Food and Drug Administration, 2012).
Another indication of FDA’s loss of grip on direct-to-consumer advertising is that while the use of such advertisements has substantially increased, the number of staff dedicated to the work has remained constant (Donohue et al, 2007).Though the increase in spending on this form of advertisement has been witnessed, the number of workers assigned to reviewing them has not grown proportionally. From the year 2002 to 2004, FDA employed only one additional staff, while expenditure on this form of advertisement increased by 45 per cent from 2.9 billion dollars in 2002 to 4.1 billion in 2004 (Food and Drug Administration, 2012). However, the risk benefit analysis of this form of advertisement has not been done conclusively, medical practitioners attest to the fact that the number of patients dying due to misdiagnosis and overdose has gradually increased. This can be due to insufficient control of this type of advertisement by FDA (Food and Drug Administration, 2012).
Conclusion
Although the spending on DTCA has been criticized, it has significantly increased in the recent years, with many calling for the suspension of such advertising of new drugs, which would see a drastic departure from the current practices (Donohue et al, 2007). As much as the pharmacist and the health providers have a divergent opinion on this issue, the FDA should ensure that they reduce the risks of irresponsible direct-to-customer advertisement. The following are the proposed ways in which FDA can reduce the risks. Advertisement of new products should be suspended for at least two years, to allow enough time for post marketing safety surveillance (Institute of medicine, 2012). A pre-test to consumers should be conducted on larger samples and diligently, to prove the FDA that the advert is compliant with the regulation. Internet users have increased in recent years, and there is the need for strict regulations. Online advertisement should be enforced to improve the patient’s comprehension and proper use of medications. Price tag should also be included with the advertisement to avoid exploitation of consumers by the pharmacists. In addition, a positive advice to consumers to visit a physician before buying the drug advertised, a comprehensive medical examination should be encouraged. Product-specific advertisements should be banned because they increase unnecessary expectations on the performance of the drug by the consumer, which later leads to disappointments.
The pharmaceutical companies should similarly be encouraged to assume corporate social responsibilities. To minimize negative impacts of DTCA, the information should be up to date, non-misleading and reflecting the balance between benefits and risks. Additionally, consumers are advised to discuss their medication with healthcare providers, as they are a better source of information in relation to the suitable medication. It is in the best interest for the healthcare providers to understand that patients seek information from a number of channels concerning the new therapies, and discuss the therapies with them.
References List
Donohue, J. M. and Berndt, E. R. (2004). Direct-to consumer advertising and the choice of antidepressant. Journal of Public Policy Marketing 12: 23:115-27.
Donohue, J. M., Cevasco, M. and Rosenthal, M. B. (2007) A Decade of Direct-to-Consumer Advertising of Prescription Drugs. The New England Journal of medicine. 357:673-81.
Food And Drug Administration (FDA). 2012. Division of drug marketing, advertising and communication. Washington, DC: General Accounting Office.
Food and Drug Administration (FDA). (2002). Oversight of direct-to-consumer advertising has limitations. Washington, DC: General Accounting Office.
Iizuk, T. and Jin, G. Z. (2005). The effect of prescription drug advertising on doctor visits. Journal of Economic Management Strategy 2005;14:70127.
Parekh, A., Marcus, R., Roberts, M., & Dennis, W, R.,(2011). Risk and benefits of direct to consumer advertising on patient- provider relationship. International society for pharmaco-economics and outcomes. Web.