Prescription drugs - Research Paper Example

? Advertising Prescription Drugs Direct-to- Consumers Direct to Consumer advertising of prescription drugs on Television is permitted in theUS but not in the European Union or other advanced economies. There are arguments both in favor of such advertising and against it. The patient’s right to information and his active participation in the diagnosis and treatment of his disease are the clear positive arguments in favor of such advertising. The main argument against such advertising is the risk of self medication with prescription drugs without clear awareness of the harmful side effects. The large numbers of emergency room admissions from prescription drug abuse in the US are a compelling argument against DTC advertising. There is the need for pharma companies to show a higher degree of restraint in such DTC advertising, keeping in mind that the messages are viewed by people with varying levels of understanding of possible side effects from improper use of prescription drugs. Key words: Prescription Drugs, DTC advertising 1. Introduction The US is the only country in the world (apart from New Zealand) that permits Television advertisements for prescription drugs. The US Federal Drugs Administration (FDA) relaxed its requirements for information content needed in such advertising in 1997. The pharma industry’s spending on DTC (direct-to-customer) advertisements has grown rapidly since the FDA rule change and reached a peak of over $ 6 billion in 2006 and 2007 before falling off due to the global economic crisis. The spending in 2012 was still a high $ 3.47 billion (Mack, 2013). The European Union does not permit DTC advertising by pharma companies. This was reaffirmed in December 2010 when 22 of the 27 EU countries voted against the proposal despite lobbying by the pharma industry. Instead, the new ad regulations have become even tougher with the focus “on the rights of the patient to get the information he needs and not on the rights of pharma companies to spread information” (Golby, 2010). This paper examines the arguments in favor and against DTC advertising prescription drugs. 2. The benefits of DTC advertising PhRMA, the pharma industry association, in its 2008 guidelines for DTC advertising lists the benefits of DTC advertising as increased patient awareness about disease and the treatment options. The ads motivate patients to contact their doctors and engage in a dialogue about health concerns and increases likelihood of receiving care for conditions that get under-diagnosed or under treated. The advertisements also help patients to continue taking the prescribed medication (PhRMA, 2008). The beneficial effects of DTC advertising based on surveys of patients and doctors are shown in the chart below (Shaw, 2008). The chart shows that 95% of the benefit is from patient awareness and better discussion the doctor can have with the patient. The question clearly is whether these benefits outweigh potential negative effects of DTC advertising. 3. Top pharma companies advertising budgets in 2012 The table below shows the 2012 advertising budgets of the top 10 global pharma companies. The tabulation has been made from data published on 26 February 2013 in FiercePharma.com (Palmer, 2013) Pharma Ad Spend 2012 ( in $ million)             TV Magazine Other Total  Products     Pfizer 342.7 240 39.6 622.3 Celebrex- pain drug, Viagra, Lyrica - pain drug Eli Lilly 367.3 43.4 22.7 433.4 Cymbalta for pain, Cymbalta for depression, Cialis Abbott 264 35 2.7 301.7 Humira for arthritis, AndroGel, Humira for Crohn's disease Merck 133.7 87.8 64 285.5 Shingles awareness, Nasonex, Zostavax Amgen 164 52.1 13.2 229.3 Enbrel for arthritis, Prolia, Enbrel for psoriasis Astra Zeneca 156.5 41 11.8 209.3 Nexium - stomach , Symbicort, Crestor - cholesterol Allergan 85.9 107.2 0.23 193.3 Restasis, Botox for wrinkles, Botox for migbraine Boehringer 119.6 54.7 0.36 174.7 Spiriva, Pradaxa Glaxo SmithKline 70.3 84.8 15.5 170.6 Advair Diskus - respiratory , Lovaza - cholesterol , Jalyn Otsuka 73.9 41.2 0 115.1 Ability - antidepressant The data shows that TV advertising budgets are significantly higher than magazine advertisements for most companies. In the last column which shows the major products advertised, there is only one company, Merck, which has spent money on Shingles awareness. All other companies have used TV advertising to sell well established products for treatment of ailments already well known to patients and medical care professionals such as pain relief, arthritis and cholesterol. 2. The US regulations relating to DTC advertising A prescription drug is defined as one where a medical professional must supervise its use because patients are not able to use the drug safely on their own. Pharma advertisements are classified by the FDA under different categories and each type of advertisement requires a different level of disclosure of risks and benefits associated with it (FDA, 2012). One category is a “Product Claim Advertisement” which names a drug and discusses its benefits and risks. Each advertisement must include not only the brand name of the drug but also its generic name, at least one FDA approved use of the drug and the most significant risks of the drug. For advertisements in the print media, the FDA requires a brief summary which includes all the risks listed in the FDA’s approved prescribing information. For advertisements in the broadcast media, there is only the requirement to disclose the major risks and the inclusion of a toll-free number, a website or the phone number of a healthcare provider or a print advertisement where further information could be obtained (FDA, 2012). Another category is “Reminder Advertisements” which can name a drug but not its uses. Since the drug’s benefits are not shown, no risks need to be disclosed. A third category is called “Help Seeking Advertisements” that can describe diseases and symptoms but cannot recommend a drug for treatment. It can however show the name of the pharma company and include a help line number to get further information (FDA, 2012). 3. Examples of pharma companies’ misleading DTC advertising In the period immediately after the above rules came into force, the FDA was very active in monitoring pharma advertising and sent out 142 warning letters in 1997 about dubious marketing claims. That number fell off to 21 in 2006 but FDA has again tightened its scrutiny since 2009 with public warnings to major pharma companies. Eli Lilly was warned for a print ad misrepresenting a depression and pain drug, Abbott Laboratories for broadcast of an interview where Magic Johnson claiming greater effectiveness of an HIV drug and GlaxoSmithKline for marketing a migraine medication without disclosure of life-threatening side effects. Pfizer was another major pharma company over its advertisements to promote a cholesterol lowering drug (Ruiz, 2010). The Pharma Industry Association (PhRMA) guidelines amplify the FDA rules and require that pharma companies work with health care professionals on new drugs or a new therapeutic application of an existing drug before any DTC campaign is launched. This is to help prepare the health care person to answer questions and provide advice when patients approach them after seeing an ad. All new DTC television ads are required to be submitted to FDA for approval before they are broadcast. Ads that use actors should disclose the fact. If a doctor appearing in an ad is being paid for his appearance, the fact needs to be disclosed (PhRMA, 2008). 4. The negative outcomes of DTC advertising 4.1 Self- medication with prescription drugs The most important concern with DTC advertising is that it can promote potentially dangerous self medication. Over $ 23 billion of over-the-counter (OTC) medicines were sold in the US in 2010 and were used to0 treat many commonly occurring ailments including the common cold, headaches, body pain, allergies, heartburn and stomach aches and upsets. This self medication is beneficial to the patient and saves $ 102 billion annually for the US healthcare system (Booz, 2012). With DTC advertising, brand names of prescription drugs for treatment of ailments become as commonly known as the names of analgesics or cough medication and increase the probability of prescription drugs being used for self medication. A related problem is that several types of medical insurance policies exclude coverage for OTC medication which prompts the use of medication prescribed for one family member being used by others. A recent report said that over 35% of people in US have used the internet for information of a medical condition, their own or that of a family member. The pharma industry can therefore rightly argue that DTC advertising does not increase the risk of self medication. 4.2 Prescription drug abuse Improper use of prescription drugs often starts with self medication and degenerates into abuse as shown in the chart below. A report from the US Office of National Drug Control Policy says that one-third of people aged 12 or over who used drugs for the first time in 2009 started by using a prescription drug non-medically. Young people wrongly believe that prescription medication is safer than illicit drugs. Painkillers are the most commonly abused prescription drugs and opioid analgesics have caused more deaths than heroin or cocaine (NDCP, 2010). In 2009, there were a total of 1.2 million hospital emergency room visits related to non-medical use of pharmaceuticals or dietary supplements. Over 50 % of these visits related to opiate / opioid analgesics and another 30% related to medication used for anxiety and sleep disorders (NIH, 2011). A 2010 study by the University of Michigan on the use of illicit drugs by 12th graders in the US showed widespread use prescription drugs, often taken from family medicine cabinets based on messages from DTC advertising. 4.3 Counterfeit Prescription Drugs A 2011 study by Brian Liang and Timothy Mackey published in the Journal of Medical Internet Research found that all 10 of the largest pharma companies in the world were marketing their drugs through social media such as Face book and Twitter and that over 90% of these drugs were also marketed on the same media by illegal on-line drug sellers. Social media is widely used by young people and is also accessible from countries where DTC advertising is banned. On-line sales from illicit sources could happen even for prescription drugs subject to recall or bans after discovery of new medical issues (Liang and MacKey, 2011). The FDA has just received a go-ahead to study DTC advertising in the social media and the impact not only on patients and doctors but also on nurses and physician attendants who play an important role especially with poorer or immigrant patients (Gaffney, 2013). Counterfeit drugs are generally thought to be a problem in the third world countries of Asia or Africa. In 2012, the FDA issued warnings three times about Avastin, a tumor-fighting drug including a version imported from Turkey. In 2008, at least 149 deaths and many more cases of severe allergic reactions were reported due to blood thinner imported from China. The counterfeit drugs problem in the US is estimated to be only about 1-2% of all drug sales but with over 4 billion prescriptions filled each year, the risks remain high especially when the patient is looking to save money (Bowman, 2013). 4.4 DTC increases drug costs and rules out generic alternatives The US expenditure on retail prescription drugs in 2010 was $ 259 billion, the largest per capita spending in the world and the growth rates are much higher than population growth or inflation. Prices of major drugs in the US are close to twice that in other advanced economies. DTC advertising in the US inhibits health care providers from prescribing generic or lower cost alternatives. The chart on the right shows that most major prescription drugs in the US do have generic alternatives that are lower in price. Some family physicians point out that even the most effective pharmaceutical may not be right for every patient. Physicians need to consider medical history, individual risk factors, life style issues and even insurance status before writing a prescription. Nearly all ads are based on emotional appeal and do not provide adequate details of the causes of the medical condition, or the lifestyle changes that may be an alternative to medication. Nearly one-third of DTC advertising in 2005 was for sleep disorders and another major part was for allergies. Neither of these would rank amongst the top 10 ailments for the American public. These show that the objective of the advertising is not patient education as the pharma industry claims but for increased sales (Kessler and Levy, 2006). 5. Summary and Conclusions The very fact that the European Union does not permit Television advertising of prescription drugs while the US does so is evidence that there are strong arguments both in favor and against the concept. A number of proposals have been made from time to time for pharma companies to regulate these advertisements to limit possible negative consequences. One of them has been for the industry association PhRMA to conduct disease awareness advertising funded by the pharma companies where they point out that alternate drugs are available for treatment and that the health care provider should be consulted. There is also the call for the companies to avoid misleading images in TV advertising such as instant relief from pain or allergies or an arthritis patient being able to run up stairs and so on. There is also a call for not advertising new drug formulations for a period of 3 to 6 months after introduction to gain experience from actual use in patients under physician care. In this age of widespread information availability through the internet, any restriction on advertising through one medium such as Television is bound to be non-productive. * * * * References: 1. Booz, (2012). “The value of OTC medicine to the United States”, Booz & Co, January 2012. Retrieved from http://www.yourhealthathand,org. 2. Bowman, L., (2013). “Fake prescription drugs on the rise in US”, Standard-Examiner, 20 Feb 2013. Retrieved from http://www.standard.net. 3. FDA, (2012). “Basics of Drug Ads”, FDA, 13 Sept 2012. Retrieved from http:www.fda.gov. 4. Gaffney, A., (2013). “FDA gets go-ahead for Study of DTC Advertising and Social Media”, Regulatory Focus, 18 April 2013. Retrieved from http://www.raps.org. 5. Golby, M., (2010). “Pharma Advertising and the EU”, PharmiWeb.com, 2 Dec 2010. Retrieved from http:// www.pharmiwebcom. 6. Kessler, D.A. and Levy, D.A., (2006). “Direct-to-Consumer Advertising: Is it too late to manage the risks?” Annals of Family Medicine, 23 Oct 2006. Retrieved from http://www.annfammed.org. 7. Liang, B.A. and MacKey, T.K., (2011). “Prevalence and Global Health implications of Social Media in Direct to Consumer Drug advertising”, Journal of Medical Internet Research, 2011; 13(3):e64. Retrieved from http://www.jmir.org. 8. Mack, J., (2013). Pharma Marketing, 2 April 2013. Retrieved from http:// www.pharmamkting.in. 9. NDCP, (2010). “Prescription Drug Abuse”, Office of National Drug Control Policy, 2010. Retrieved from http://www.whitehouse.gov. 10. NIH, (2011). “Drug Related Hospital Emergency Room Visits”, National Institute on Drug Abuse, May 2011. Retrieved from http://www.drugabuse.gov. 11. Palmer, E., (2013). “Top 10 Pharma Advertising Budgets”, FiercePharma, 26 Feb 2013. Retrieved from http://www.fiercepharma.com 12. PhRMA, (2008). “PhRMA Guiding Principles: Direct to Customer Advertisements about Prescription Medicines”, PhRMA, December, 2008. Retrieved from http://www.phrma.org 13. Ruiz, R., (2010). “Ten Misleading Drug Ads”, Forbes, 2 Feb 2010. Retrieved from http://www.forbes.com. 14. Shaw, A., (2008). “Direct-to-Customer advertising of pharmaceuticals”, ProQuest, March 2008. Retrieved from http://www.csa.com. Read More