Abstract

The most desirable benefit that patients will hope for in relation to the cost of pharmaceutical products are outcome reach and evaluation of improvements based of quality of life (QOL).  As established  and believed by most people, life is priceless.  For most consumers, any pharmaceutical product that lacks the potency to improve QOL or attain an outcome reach is viewed as an act of product failure or lack of a quality product design. Hence, based on consumers perception survey on the pharmaceutical industry, 94% believed that pharmaceutical companies are “too aggressive” in promoting the off-label use of prescription drug, and 62% believed that drug companies undermines clinical trial data just to get market approval from the regulatory agency (Walden U, 2013). Nonetheless, several historical factors that contributed to the demand for greater transparency in research, pricing, and marketing of medical products include but not limited to product recalls, conflict of interests, and ghost-writing to mention but a few.

Perception and Transparency

One of the historical factors which have contributed to the demand for greater transparency in research, pricing, and marketing of medical products is product recalls. The general rule of thumb for the cost associated with product error or correcting a product defect is 1-10-100 rule (Whitmore, 2004). The defect cost-factor that is associated to a product defect prevention is 1. The defect cost-factor associated to a product defect before the product reaches consumers is 10 while the defect cost-factor associated to a product defect after it reaches consumers is 100.  Therefore, the idea of maintaining a transparent standard within the pharmaceutical industry, regulatory agency and the public is essential.  A transparent environment will minimize not only the cost-factor associated with the 100 factorial rule of a product defect but also will keep products safer, and may minimize death incidents associated with bad product or product defect. In 2001, the FDA reported that 42% of medication errors were due to human errors (design issues, characteristics of uses etc.) (Whitmore, 2004). In addition, the institute of medicine reported that 44,000 to 98,000 people die each year from medical errors in the US. When this is put into perspective, the consequences of death related to medical product in relation to other risk out there is staggering. The aforementioned death rate is greater than the number of people who die yearly from motor accident, breast cancer and AIDS.  Indicating that as much as medical industries are improving advancement in extending lives or improving QOL with medicinal products, medicinal products that were meant to cure or use for palliative treatments kills more people than motor accidents and some diseases. This is in itself a “disease” that should be addressed.

Applying human factor errors in design of a product may allow easy integration, clinical utility, market needs, user needs and cost effectiveness into product design (Whitmore, 2004).  More effort is needed to support the post-marketing surveillance of a medicinal product by establishing systems that encourage product development transparency such as the FDA transparent initiatives of 2009 (phase I, phase II and phase III initiatives) and the FDA amendment Act (FDAAA) of 2007 that will inform medical professional, regulatory agency and users alike of potential medical danger with a product (FDA, 2012).

Conflict of interest within the pharmaceutical industry is of great concern. There is great concern that sometimes pharmaceutical companies will cover up, or downgrade relevant information or coerce principal investigators or physicians just to obtain market approval or influence their prescription preference respectively (Wechsler, 2009). For instance, Vioxx, Xigris, and Plavix are some good examples. Based on the potential danger, harm and threat that conflict of interest poses on medicinal product development, the co-operate integrity agreements (CIAs) require complete disclosure of payments, gifts, travel etc. made to medical professionals by pharmaceutical companies. In addition, under the Sunshine Act proposed in 2009, pharmaceutical companies are required to report any payment that is more than $100 made to medical professionals (Wechsler, 2009). More importantly, in 2009 the office of inspector general (OIG) requires principal investigators to disclose financial interests before a clinical trial begins as oppose to the old disclosure system during NDA filing period (Wechsler, 2009). Any payment that is made to a PI that is greater than $10000 must be reported. According to the investigation conducted among psychiatrists, it was discovered that there were millions of dollars made to psychiatrists that were not reported (Wechsler, 2009). As much as conflict of interest in medical practices demanded transparency and lack of undue influence, it is also a privacy issue for medical practitioners to whom the court supported their position that releasing of physician-level medicare claims to consumer violates their privacy right (Wechsler, 2009). In contrast, when it comes to pharmaceutical companies claim for the right to access physician’s prescribing information for marketing purposes, the appeal court in 2008 ruled that consumer’s right and prescriber’s right overrides the commercial speech right of data mining companies (Wechsler, 2009).

Furthermore, ghost-writing is a disservice to scientific innovation and public knowledge information. The society cannot ignore the fact that pharmaceutical giant like Wyeth was caught in 2005 on the ghost-writing allegation on their Premarin hormone product, when other scientific evidence suggested that similar hormone could increase the risk of breast cancer. Similarly, in 6 major medical journal, 40 articles published in 2008 were ghost-articles. Adding more insults to the injury is when JAMA indicated that about 7% of all articles published in JAMA and Plos medicine, and about 11% articles in the NEJM were ghost-articles, then it became obvious that the scientific community has a bigger ghost-writing problem than was anticipated (Singer, & Wilson, 2009). When such antagonistic practices which demises the essence of research and development, and most dangerously misinformation of the public are becoming a common practice, the government must take a swift action to resolve the life threatening situation. Senator Charles Grassley of Iowa—a member of the Senate Finance Committee is taking a leading role in the health overhaul effort and ghost-writing issue. In addition, the anti-Kickback Statute was enacted to prevent such influence and fraudulent act. “The federal Anti-Kickback Statute (“Anti-Kickback Statute”) is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business (American Health Lawyers Association, 2011). The government and the public must enforce the use of principles, ethics and common reasoning to bridge the disparity and double standard associated with violation of the laws and common rational principles of life. In this regard,  a pen-triggered crime should have similar public outcry and media attention as other crimes.  With a transparent system in medical product development, the industry will be better off and may regain more public trust.

References

American Health Lawyers Association. (2011). Anti-Kickback statute . Retrieved from http://www.healthlawyers.org/hlresources/Health%20Law%20Wiki/Anti-Kickback %20Statute.aspx.

Food and Drug Administration. (2012). FDA transparency initiative. Retrieved from http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm.

Singer, N., & Wilson, D. (2009). Medical editors push for ghost-writing crackdown. The New York Times. Retrieved from http://www.nytimes.com/2009/09/18/business / 18ghost.html? scp=3&sq=medical%20journal%20ghost%20writer&st=cse.

Walden University. (2013). Perception and transparency. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tab_tab_group_id=_2_1&url= %2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id %3D_2099284_1%26url%3D.

Wechsler, J. (2009). Safety & transparency shape drug development. Applied Clinical Trials, 18(7), 24-26. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search. ebscohost. com/login.aspx?direct=true&db=a9h&AN=43533893&site=ehost- live&scope=site.

Whitmore, E. (2004). Development of FDA-regulated medical products: Prescription drugs, biologics, and medical devices. Milwaukee, WI: ASQ Quality Press.