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Talk to Your Doctor: Direct-to-Consumer Advertising of Prescription Drugs, Part 3

August 13, 2010

By Ishmeal Bradley

 Faculty Peer Reviewed

In the first two parts of this article, we explored the historical and legal contexts of direct-to-consumer (DTC) advertising, the effects of these ads on prescribing behavior, and the economic incentives to advertise. In this final installment, we will examine what patients and physicians really think about these ads and offer one possible way to minimize the potentially harmful effects of DTC advertising.

 Perceptions about DTC Advertising

 Patient perceptions about DTC advertising are dynamic and have become less favorable over time. The FDA carried out a series of surveys in 1999 and 2002 to determine what patients thought about consumer advertising.[1 ] In both years, the agency interviewed more than 900 patients. Overwhelmingly, in both surveys the most common source of DTC advertising was television (>90%). Over the course of three years, patients’ attitudes about DTC became less positive. The percentage of patients who said that they liked seeing prescription drug advertisements fell from 52% in 1999 to 32% in 2002. Also, the percentage of patients who thought that advertisements helped them to make better decisions about their health fell from 47% to 32%. And finally, when asked if advertisements helped them to have better discussions with their doctors, 62% of patients agreed in 1999 compared to 43% in 2002. The lobbying group, Pharmaceutical Research and Manufacturers of America (PhRMA), claims that its ads are beneficial because they help patients to make better healthcare decisions.[2] However, given these survey results, this does not appear to be true.

 The FDA results are not unique. Another survey study from Colorado in 2004 also examined patients’ and physicians’ opinions about DTC advertising. In their study, only 29% of patients felt that DTC advertising was a positive trend in healthcare.[3] Furthermore, only a fraction of consumers (28.6%) felt that DTC ads made them better informed about their health. Of note, these patient surveys were conducted during and immediately after the Vioxx scandal. A more recent survey is needed to see if these attitudes have held up over time.

 Physicians had more mixed views about DTC advertising. Whereas 29% of patients thought DTC ads were a positive trend, only 9.8% of physicians agreed. Despite this negative opinion, data from the FDA physician survey in 2002 showed that physicians actually thought that DTC ads improved the clinical encounter. Half of the surveyed physicians (53%) felt that these ads allowed them to have better discussions with their patients. Also, 73% thought that patients who had seen these ads asked more thoughtful questions, and 45% felt that the time they spent with their patients was used more effectively as opposed to 35% who disagreed. The discrepancy between patient and physician perceptions about the utility of these ads demonstrates that there is a fundamental gap between what patients want and what they actually receive in the clinical encounter. Given the mixed results from these survey studies, it remains unclear how much impact, if any, these advertisements actually have on the doctor-patient relationship and effective clinical decision-making.

 “Advertising is Information”: Pros and Cons of DTC Advertising

 DTC advertising is inherently controversial, with business interests on one side and consumer groups and physicians cautiously on the other. DTC ads do make patients more aware of available treatments and may indeed improve communication between patients and doctors. On the other hand, though, these ads do cause an increase in prescription writing that may or may not be beneficial, do not fully illustrate the risks alongside the benefits, and may confuse patients about what are acceptable standards of care.

 On the eve of the FDA’s remarkable reversal to allow broadcast DTC ads in 1997, Nancy Buc, a spokeswoman for Wyeth-Ayerst Laboratories (makers of Zosyn, Protonix, and Ativan) was quoted as saying, “Advertising is information.”[4] Is this information educational and valuable? PhRMA agrees. In their 2008 press release on the matter, the organization contended that without the “active dissemination of information about medicines to both physicians and consumers,” the gap between necessary care and the care that patients actually received would widen.2

 So what information are consumers getting from these ads? According to the FDA surveys, not much. When consumers were asked if advertisements provided enough information about risks, only 31% agreed in 1999 and 32% in 2002. Regarding information about benefits, a selling point that one would think would be over-emphasized, only a minority of consumers agreed that DTC ads gave enough (39% in 1999 and 41% in 2002). The paucity of substantive information about drug indications, side effects, duration of treatment, or alternative non-medical therapies is glossed over with images of celebrities, cartoons, and ex-presidents all encouraging us to “talk to our doctors.”

 Perhaps the biggest criticism of DTC advertising is that the bulk of these ads air within a year of FDA approval. The approval process, based on small studies involving only hundreds of patients over weeks to months, may not detect infrequent adverse events. However, clinical trials conducted over longer time frames with larger groups of patients are not feasible and are prohibitively expensive. As a result, the FDA relies on post-marketing surveillance to ensure that a drug that was considered safe actually is. Scott Lassman, senior assistant general counsel of PhRMA said that “when a drug is approved, the FDA has already made an assessment that it is safe.”[5]

 One only has to look at the Vioxx scandal to see how wrong that statement is. When the FDA approved Vioxx in May 1999, Merck heralded the drug as a godsend for patients with osteoarthritis. Within a year, the $161 million marketing campaign began. However, early in 2000, the results of the VIGOR study (VIoxx GI Outcomes Research) were published, which showed an increase in cardiovascular events associated with Vioxx. Later, in 2001, the APPROVe study (Adenomatous Polyp PRevention On Vioxx) also showed a similar increase in patients taking Vioxx for more than eighteen months. Amidst these two trials were allegations that Merck had intentionally withheld poor outcomes data from the FDA to make the drug appear safer than it really was. In September 2004, Merck voluntarily withdrew the drug. Shortly thereafter, the lawsuits began.

 The Future of DTC Advertising: A Way Out?

 Direct-to-consumer advertising is here to stay and will most likely only increase in the coming years. Advertising has been afforded First Amendment protection under the doctrine of commercial free speech, and there are few in the public or in Congress who are willing to challenge that. Attempts by individual members of Congress, notably Rep. Henry Waxman and Senators Edward Kennedy and Michael Enzi, to give the FDA more regulatory power, have so far been unsuccessful. One potential solution would be a moratorium on advertising for the first few years that a drug is on the market. This would allow time for post-marketing data collection on adverse events before the drug is widely advertised to the public. There is support for this idea, both in the federal government and in industry. However, whereas the FDA would prefer a two-year limit, individual pharmaceutical companies are asking for only six months to one year.

 The bottom line: drug companies are businesses. They make a product that impacts the health of the consumer and they can charge a premium for that product. We should not expect drug companies to be altruistic in their motives or in their advertising. As a medical profession, we should be wary of exaggerated claims and should place the same amount of scrutiny on ads for prescription drug as we would on any other advertisements. Also, as physicians, we should not be hesitant or annoyed to discuss these ads when patients bring up the topic in our offices. They may have genuine concerns and questions about their health that we should honor. Yes, prescription drug ads are far from perfect, but they can serve a purpose in the larger context of patient education if they are indeed fair, balanced, and honest. Hopefully, DTC advertising will make consumers not just more informed, but better informed.

Dr. Bradley is a Section Editor, Clinical Correlations

Peer reviewed by  Scott Sherman, MD, MPH Associate Professor of Medicine and Psychiatry at NYU Langone Medical Center

 References:

[1]  Food and Drug Administration. “Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research Results.” Final Report November 19, 2004. Available at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm109593.htm. Accessed July 22, 2009.

[2]   Pharmaceutical Research and Manufacturers of America. “Pharmaceutical Marketing in Perspective: Its Value and Role as One of Many Factors Informing Prescribing.” July 2008. Available at http://www.phrma.org/files/PhRMA%20Marketing%20Brochure%20Influences%20on%20Prescribing%20FINAL.pdf. Accessed July 22, 2009.

 [3]   Robinson, Andrew R. et al. “Direct-to-Consumer Pharmaceutical Advertising: Physician and Public Opinion and Potential Effects on the Physician-Patient Relationship.” Arch Int Med 2004;164:427-432.

[4]   Zuger, Abigail. “Drug Companies’ Sales Pitch: ‘Ask Your Doctor.’” New York Times. August 5, 1997.

[5]  Weintraub, Arlene. “Putting Drug Ads Back in the Bottle.” BusinessWeek. August 13, 2007.

 

Talk to Your Doctor: Direct-to-Consumer Advertising of Prescription Drugs, Part 2

August 6, 2010

By Ishmeal Bradley

Faculty Peer Reviewed

 In the first installment, we looked at the history behind consumer advertising of prescription drugs. We also explored the concept of commercial free speech and why this form of advertising is legal. To fully appreciate the controversy about direct-to-consumer (DTC) advertising, we must now examine the commercial effects of these ad campaigns. Do these ads really increase prescription volume and drug costs? Are both physicians and patients affected by the commercials they see on television? In this installment, we will delve into the economics and commercial impact of DTC advertising.

 The Economic Motive behind Pharmaceutical Advertising

 Prescription drugs are a big business in America. There will always be sick patients and doctors ready to treat them. This inevitability has not been lost on the pharmaceutical industry. Like any other business, drug manufacturers seek to minimize costs and maximize profits. One proven way to ensure that your product is more likely to be bought is through advertising. By sidestepping healthcare professionals and advertising directly to consumers, though, some critics argue that drug companies are creating demand for prescription drugs that may not be appropriate. Regardless of whether the increased prescription writing is appropriate, one cannot deny the fact that advertising works. Shannon Brownlee, senior fellow at the New America Foundation, in her book Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer, quoted a statistic that shockingly showed that every dollar the pharmaceutical industry spends on advertising generates $4.20 in increased sales.1

 One only has to look at marketing and sales data to see how profitable advertising can be. In 2000, the top ten most heavily advertised drugs (including blockbusters like Vioxx, Paxil, and Claritin) cost $926 million to promote to consumers. In a market where there were 9,880 other drugs also advertised, these ten drugs took up 37% of the advertising dollars. The drug companies were handsomely rewarded for their investment in ads; sales of these ten drugs alone topped $16 billion.2

 Effects of DTC Advertising

 The central question behind the DTC ad controversy is what effects (if any) do these ads have on physician prescribing behavior and drug costs? As noted above, advertising plays a tremendous role in increasing the number of prescriptions written. But is this increase appropriate?

 Regarding the growth in prescriptions, Pharmaceutical Research and Manufacturers of America (PhRMA), the industry lobby, argues that a positive effect of DTC advertising is that more patients are seeking medical care and are consequently being screened for common conditions.3 Although this argument has an element of truth, it does not match reality. Yes, better primary care and preventive screening will catch more patients with hypertension, depression, diabetes, and dyslipidemia. And yes, these newly diagnosed patients will require medications, sometimes indefinitely. PhRMA would have more credibility, though, if the DTC ads actually focused on medications used to manage chronic diseases, especially with hopes of reducing long term complications. When the top twenty advertised drugs in 2005 include Cialis ($110 million), Lamisil ($110 million), and Lunesta ($224 million), it becomes clear that drug companies are spending considerable resources to promote lifestyle drugs rather than public health.

 One considerable concern about DTC advertising is its potential effects on prescribing behavior. To better study this, Kravitz et al. performed a randomized control trial to see if patients’ requests for an advertised antidepressant, Paxil, affected which antidepressant, if any, the physician prescribed.4 In their study, they used standardized patients exhibiting symptoms of either major depression or adjustment disorder. These SPs presented to primary care physicians in New York and California. To determine if a patient’s request for a specific advertised medication effected which antidepressant the physician prescribed, the SPs were told to either ask for Paxil by name, ask for a general antidepressant, or neither. Paxil was chosen because, at the time of the data collection, it was heavily advertised ($92 million spent in 2000), priced higher than fluoxetine (which had become generic at that time), and was on the formulary of the large health insurance plans in these two states. Focusing on the major depression group, of those that asked for Paxil by name, 27% received it, while 25% received another antidepressant (and 47% received nothing). By comparison, of those that asked for any antidepressant, only 1% received Paxil and 74% received another drug.

 Their results showed that for those patients with symptoms of major depressive disorder and who asked for Paxil, they were more likely to receive it (OR-2.72). They also showed that even those patients who made only a general request were more likely to be started on treatment with any antidepressant, not just Paxil (OR-7.99).  The study authors did not examine whether Paxil was a legitimate first-line agent to use, but their results highlight the fact that patient requests do increase prescriptions for that particular drug, even when there are other (potentially cheaper) options available.

 Admittedly, the pressure to prescribe an advertised medication that a patient asks for by name can be great. Physicians may feel compelled to comply with the patient’s wishes. In an FDA survey published in 2004, the agency posed this question to both primary care physicians and specialists: “To what extent did the patient’s expectation influence your decision to prescribe or not prescribe?” For the primary care physicians, only a third felt that the patient’s expectations had no influence over them at all (34%). However, a majority thought that there was some pressure (a little bit to somewhat) to prescribe (52%). On the other hand, the specialty physicians felt that they were less influenced by patient requests (51% for no influence and 49% for some degree of influence); they also felt less pressured than the primary care physicians (58% felt no pressure to prescribe at all).5

 The Kravitz study gives more credence to the idea that DTC advertising increases prescription volume. Who ultimately pays for this advertising? The costs of drug marketing—along with research and development costs—are passed on to consumers. PhRMA counters, however, the popular belief that DTC advertising significantly increases drug costs.

 The rise in prescription drug costs and spending is multifactorial.6 As the American population ages, the prevalence of chronic conditions also increases. Treating chronic diseases, like depression, hypertension, and diabetes, is costly in the long term. Also, as professional organizations like the American Diabetes Association or the American College of Cardiology recommend tighter glycemic control or more stringent post-myocardial infarction goals, more medications will have to be prescribed to adhere to these ever-changing guidelines. Finally, as newer, more efficacious medications come to the market, the shift towards these better drugs will unfortunately increase the amount of healthcare dollars spent on prescription drugs. Better disease management, although good for the patient, will result in higher drug spending, be it through more prescriptions written per patient or price increases for individual drugs.

 Advertising, as expected, does play a profound role in increasing prescription volume, especially for newer medications. Drug manufacturers would hardly waste the money on multimillion dollar campaigns if this were not true. Furthermore, physicians, as stalwart as they may try to be, are not immune to the effects of advertising. The data do show that physicians are more likely to prescribe a medication (even though it may not be the one advertised) than not if a patient requests one. This is not necessarily bad. In the Kravitz study, those symptomatic patients that asked for any antidepressant were much more likely to receive adequate depression care than those that asked for nothing at all. As PhRMA points out, better medical care may actually be more costly and the increase in prescription drug costs may not be due solely to advertising. Regardless of the actual numbers, PhRMA still must counteract the public’s often negative perceptions about DTC advertising. In the final installment, we will examine how the public and physicians feel about advertising, the Vioxx debacle and its impact on the industry, and propose a potential solution to this controversy.

Dr. Bradley is a Section Editor, Clinical Correlations

Peer reviewed by  Scott Sherman, MD, MPH Associate Professor of Medicine and Psychiatry at NYU Langone Medical Center

References:

1. Weintraub, Arlene. “More Frequent Dose of Dollars for Drug Ads.” BusinessWeek. August 15, 2007.

 2. National Institute for Health Care Management. “Prescription Drugs and Mass Media Advertising, 2000.” Available at http://nihcm.org/~nihcmor/pdf/DTCbrief2001.pdf. Accessed August 18, 2009.

 3. Pharmaceutical Research and Manufacturers of America. “Pharmaceutical Marketing in Perspective: Its Value and Role as One of Many Factors Informing Prescribing.” July 2008. Available at http://www.phrma.org/files/PhRMA%20Marketing%20Brochure%20Influences%20on%20Prescribing%20FINAL.pdf. Accessed July 22, 2009.

 4. Kravitz, Richard L. et al. “Influence of Patients’ Requests for Direct-to-Consumer Advertised Antidepressants: A Randomized Controlled Trial.” JAMA 2005;293:1995-2002.

 5. Food and Drug Administration. “Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research Results.” Final Report November 19, 2004. Available at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm109593.htm. Accessed July 22, 2009.

 6. Dubois, Robert W. et al. “Explaining Drug Spending Trends: Does Perception Match Reality?” Health Affairs 2000;19,2:231-9.

Image courtesy of Wikimedia Commons.

Talk to Your Doctor: Direct-to-Consumer Advertising of Prescription Drugs, Part 1

July 30, 2010

By Ishmeal Bradley, MD

Faculty Peer Reviewed

 Advertising is everywhere. That should come as no surprise to anyone who has lived in modern America. It is impossible to turn on the television, ride the subway, or even sort through the daily mail without coming across an ad for a new car, a soft drink, or the latest digital toy. These advertisements have only one goal: to entice you to buy their products. This is harmless enough when these ads refer to shoes, peanut butter, or shampoo. But what about drugs, especially prescription medications? Pharmaceutical companies and their hired advertising firms are increasingly marketing their wares directly to consumers and bypassing healthcare providers. Are drug companies really doing the public a service by disseminating this type of information? Can the motive to increase prescription volume (and profits) be reconciled with this goal of consumer education? Is this form of advertising really in the public’s best interest?

 To better explore direct-to-consumer (DTC) advertising in this three-part series, we must first examine the roots of commercial advertising of drugs, the role of the FDA in regulating advertising, and the legal protections surrounding commercial free speech. With that historical and legal context, we will then look at the economics and effects of DTC advertising. Finally, we will conclude with perceptions (both patient and physician) about DTC advertising and propose a possible solution to the controversy.

 Historical Trends in Direct-To-Consumer Advertising

 The stunning imagery of “the purple pill”, the bumblebee encouraging us to ask our doctors about Nasonex, or the “Viva Viagra” commercials, are relative newcomers to the public sphere. Not until 1997 did the FDA permit broadcast advertisements for prescription drugs. Currently, only two countries in the world, the United States and New Zealand, allow this type of advertising. Early print advertisements dating back to the 18th century were only for over-the-counter medications. These ads made inflated claims that their products could cure everything from alcoholism and obesity to dyspepsia. Unfortunately, before the early 1900s, there was little governmental oversight over drug safety or efficacy. By the turn of the 20th century, a glut of new products flooded the American pharmaceutical market, many with dubious claims of effectiveness. Congress, wanting to ensure that drugs on the market were safe for consumer use, passed the Food, Drug, and Cosmetic Act in 1938 which gave the FDA the authority to mandate that drug companies prove their products safe before marketing them. Congress later amended the original law in 1962 to grant the FDA additional authority to regulate advertisements of prescription drugs and to further require that pharmaceutical companies prove that their products were not only just safe, but also efficacious.1

 During this time, pharmaceutical companies, while complying with federal regulations, advertised their products only to healthcare professionals. OTC medications were still advertised to the public, but advertising prescription medications over the heads of physicians was thought socially unconscionable. This changed in 1981 when Merck published the first DTC ad for a prescription medication, Pneumovax, in Reader’s Digest. Following Merck’s lead, several other companies began to print consumer-directed ads. Then in 1983 the first televised DTC ad, for Boots Pharmaceutical’s Rufen (prescription strength ibuprofen), aired. Given concerns about the possible negative—but  unproven—effects of DTC advertising of prescription medications, the FDA imposed a moratorium on advertisements later that year to further study the issue. After two years, the FDA suspended the moratorium in 1985. Although the agency felt that “direct to the public prescription advertising was not in the public interest”, it lifted the moratorium due to concerns over commercial free speech; it also believed that current guidelines regulating advertising were sufficient enough to protect consumers.2 Furthermore, the agency explicitly warned that these DTC ads “should be held to the same standards as those directed to physicians.”3

 For the next twelve years, advertisements were primarily focused in print media. This was because of the “brief summary” requirement. The FDA required all prescription drug ads to disclose a brief summary which included all the warnings, precautions, contraindications, and adverse events of a particular drug. This was difficult to accomplish in a one-minute television or radio ad, essentially barring broadcast advertisements.4 Under pressure from the pharmaceutical lobby, the FDA conducted a series of public hearings in 1995 to reconsider its restrictions on DTC advertising. Then in August 1997 the FDA released a new set of guidelines entitled “Guidance for Industry: Consumer-Directed Broadcast Advertisements.” This statement, publicized more as a reinterpretation of current regulations, drastically changed the way that pharmaceutical companies were allowed to advertise. To make broadcast advertising easier, the new statement no longer mandated the lengthy brief summary and replaced it with the “adequate provision” clause. Adequate provision meant that since advertisements no longer had to present all the risks and precautions, they must provide consumers with alternative means of acquiring this information by referring them to a toll-free telephone number, a website address, a concurrently running print advertisement, or referral to a healthcare provider.4 Also, broadcast advertisements had to comply with a new “major statement” clause which required that only the major risks and most common adverse effects be disclosed. With these new rules, pharmaceutical companies could easily saturate the airwaves with ads, as long as the ads counseled patients to “talk to your doctor.”

 There are three types of DTC advertisements, only one of which is subject to regulation.5 The first are the so-called “help-seeking” advertisements. These advertisements describe a disease or condition, but they do not discuss specific treatments. Instead, they encourage the consumer to discuss the condition with their doctor. The second type are “reminder” advertisements. In these ads, the drugmaker can mention a particular medication, but cannot give information on the drug’s indication or make claims about efficacy.4 These first two types of ads are not required to disclose any risk information because they do not discuss benefits.

 The third type, the one from which the controversy stems, are the “product-claim” ads. These discuss both the drug and the condition for which is supposed to be used. The FDA requires drugmakers to include a “fair balance” of risks and benefits, and that the ads contain both the major statement and adequate provision according to the 1997 guidelines.4

Since the relaxation of advertising rules in 1997, there has been tremendous growth in the amount of money spent on DTC ads, both print and broadcast. In 1996, pharmaceutical companies spent $11.4 billion on all promotional spending (most of which was spent on advertising to healthcare professionals and free samples). Of this, 14.2%, or $985 million, was spent on DTC ads. By 2005, total promotional spending had nearly tripled to $29.9 billion, while the amount spent on DTC ads quadrupled to $4.2 billion.6 Indeed, by the year 2000, Merck was spending more money advertising its soon-to-be defunct painkiller, Vioxx ($160 million), than Budweiser ($146 million), Pepsi ($125 million), or Nike ($78 million).7 Those ads paid off; drug sales for Vioxx topped $1.5 billion that year.

 Role of the FDA

 Although Congress has afforded regulatory power to the FDA, the agency has faced serious challenges to its ability to ensure that DTC advertisements are accurate and reasonable. One hurdle that hampers the FDA is the lack of manpower . For example, the number of promotional pieces submitted to the FDA for review has ballooned from 32,000 in 1999 to nearly 53,000 in 2004.8 Despite this growth in the volume of consumer ads, staffing at the FDA’s Division of Drug Marketing, Advertising and Communications has been relatively stagnant. In 2002 when drug companies spent $2.9 billion on advertising, there were only three staff members to review these ads. By 2004 there were four staff members, even though spending on ads had increased to $4.5 billion.6 Furthermore, with the ever-increasing number of ads produced, the FDA has not been able to keep up with pre-market review. The percentage of broadcast advertisements that underwent FDA review before airing fell from 64% in 1999 to 32% by 2004.6

 Also, in this decade, there has been a change in the culture of the FDA. Under the conservative leadership of Secretary Tommy Thompson in 2002, the Department of Health and Human Services began requiring that all regulatory letters to industry about advertising violations first be approved by the FDA’s Office of Chief Counsel.6 This review process greatly increased the amount of time it took for warning letters to reach offending advertisers, so much so that by the time the letters were released, the ads were already off the air.

 Coupled with the declining real power of the FDA, is a general misconception by the public of the FDA’s role in regulation. According to one study, 50% of consumers thought that DTC ads had to be pre-approved by the government; 43% believed that only drugs that were completely safe could be advertised; and 21% thought that only extremely effective drugs could be advertised to the public.9 These misguided beliefs and the diminishing ability of the agency to wield regulatory authority over the pharmaceutical industry can create a false sense of security in the objectivity and truthfulness of drug advertisements.

 Commercial Free Speech and First Amendment Rights

 Legislatures, both state and federal, have also weighed in on the legality of direct-to-consumer advertising of prescription drugs. Two high-profile cases in the 1970s brought the idea of “commercial free speech” into the judicial vernacular. In the 1976 case of Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, the Supreme Court ruled that state laws could not block pharmacies from advertising prescription drug prices.10 When Justice Harry Blackmun, writing for the majority, declared that “the free flow of commercial information is indispensable,” he extended First Amendment protection to commercial advertising. The decision was not unanimous, though. Then- Associate Justice William Rehnquist, the lone dissenter, protested the notion that advertising was worthy of the same free speech protections afforded to political and social rhetoric. In his dissenting opinion, he wrote that “there are sufficient dangers attending [the] widespread use [of pharmaceuticals] that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste.”1

 To determine whether limits on commercial free speech are acceptable, the Supreme Court established the “Central Hudson Test.” These guidelines were based on the 1980 case, Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, wherein the state of New York wanted to prevent utility companies from broadcasting ads encouraging consumers to use more electricity. The Central Hudson Test has three main criteria for determining whether a restriction on commercial free speech is permissible: is the speech misleading (if so, then the speech can be banned); does banning the speech advance a government interest (if not, then the government has no role in attempting to regulate the speech); and can that interest be advanced through less restrictive means (if so, then the less restrictive means should be undertaken). One could argue that a ban on prescription drug advertising may indeed serve a government interest, that of protecting consumers from potentially misleading ads, but neither industry nor consumer groups have brought forth a case, for fear of losing an incredibly murky constitutional battle. This did not stop U.S. Representative Henry Waxman (D-Calif.), however, from trying to attach a rider to a drug safety bill in 2007 that would have banned DTC ads for drugs that had been on the market for less than three years.11 The bill passed without his amendment.

 Insights from the Medical Profession

 The American Medical Association issued its own statement on DTC advertising in 1999.12 The AMA currently asks physicians to remain vigilant for advertisements that promise unfounded benefits and for those that do not comply with FDA standards. Furthermore, the AMA cautions physicians not to be biased against advertised drugs and to not feel pressured to prescribe these drugs against their better judgment. Instead, it urges doctors to foster a relationship with the patient that encourages an open dialogue about effective, individualized medical treatment.

 Direct-to-consumer prescription drug advertising has grown tremendously in the last decade. Furthermore, with the help of the Supreme Court, DTC advertising is protected under the doctrine of commercial free speech. The FDA, with its limited staff and resources, faces the enormous challenge of trying to police these advertisements to make sure that misleading information does not reach the public. If current trends continue, the growth in DTC advertising will only increase. What effects, if any, does advertising have on drugs costs and physician prescribing behavior? In the next installment, we will examine this question and the economic motives behind advertising. Can advertising really be as bad as we think it is?

Dr. Bradley is a Section Editor, Clinical Correlations

Peer reviewed by  Scott Sherman, MD, MPH Associate Professor of Medicine and Psychiatry at NYU Langone Medical Center

References:

1. Kesselheim, Aaron S. and Jerry Avorn. “Pharmaceutical Promotion to Physicians and First Amendment Rights.” N Engl J Med 2008;358:1727-32.

 2. Woloshin, Steven et al. “Direct-to-Consumer Advertisements for Prescription Drugs: What Are Americans Being Sold?” Lancet 2001;358:1141-46.

 3. Gellad, Ziad F. and Kenneth W. Lyles. “Direct-to-Consumer Advertising of Pharmaceuticals.” Am J Med 2007;120:475-80.

 4. Ostrove, Nancy M. “Testimony on Prescription Drug Promotion before the Senate Committee on Commerce, Science, and Transportation, Subcommittee on Consumer Affairs, Foreign Commerce, and Tourism.” (Date July 24, 2001). Text available at http://www.fda.gov/NewsEvents/Testimony/ucm115206.htm. Accessed July 18, 2009.

 5. Food and Drug Administration. “Keeping Watch Over Direct-to-Consumer Ads.” 2008. Available at http://www.fda.gov/consumer/updates/dtc_advertising093008. Accessed July 14, 2009.

 6. Donahue, Julie M, Marisa Cevasco, and Meredith B. Rosenthal. “A Decade of Direct-to-Consumer Advertising of Prescription Drugs.” N Eng J Med 2007;357:673-81.

 7. Rosenthal, M, ER Berndt, JM Donahue, et al. “Promotion of Prescription Drugs to Consumers.” N Eng J Med 2002;346:498-505.

 8. Behrman, Rachel E. “Testimony on Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Health Care Costs before the Senate Special Committee on Aging.” (Date September 29, 2005). Text available at http://www.fda.gov/NewsEvents/Testimony/ucm112706.htm. Accessed July 18, 2009.

 9. Bell, Robert A., Richard L. Kravitz, and Michael S. Wilkes. “Direct-to-Consumer Prescription Drug Advertising and the Public.” J Gen Int Med 1999;14:651-7.

 10. Shuchman, Miriam. “Drug Risks and Free Speech – Can Congress Ban Consumer Drug Ads?” N Eng J Med 2007;356:2236-39.

 11. Weintraub, Arlene. “Putting Drug Ads Back in the Bottle.” BusinessWeek. August 13, 2007.

 12. American Medical Association. “Opinion 5.015 – Direct-to-Consumer Advertisements for Prescription Drugs.” AMA Code of Medical Ethics 1999. Available at http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion5015.shtml. Accessed July 14, 2009.

 Image courtesy of Wikimedia Commons

Clinical Correlations Reaches 1000 Articles Published!!

May 1, 2014

By: Neil Shapiro, MD Editor in Chief, Clinical Correlations

It’s so hard to fathom that Clinical Correlations, now in its 8th year, has reached yet another very significant milestone – 1000 articles published. Now this may not rate up there with McDonald’s over 300 billion served, but nonetheless I believe it is a milestone truly worth celebrating. Our website had its origin as a simple internal medicine residency program “blog” back in 2006, a year best remembered for the Human Genome Project publishing the last chromosome sequence in Nature and Pluto losing its status as a planet. From our humble origins until now, our goal has always been to highlight the fascinating aspects of internal medicine. Remarkably, through the years, we have stayed true to our course. Clinical Correlations continues to strive to be a potpourri of the field of internal medicine – highlighting anything and everything that could stir your curiosity. Over the years we have formalized our processes, instituted peer review and as a consequence, probably became a bit stuffier. However we pursued this stuffiness in the hope of ensuring the quality of the pieces we publish would be top notch and unassailable.

Three years ago I wrote about my hopes and aspirations for Clinical Correlations, and while I’ve wracked my brain trying to come up with something equally pithy yet more eloquent, I don’t think I can top my previous musings:

“We want to inspire you to say ‘wow, that’s fascinating, let me go read a little further about that.’ Our field of internal medicine is captivating – every aspect, every direction we look, and every now and then we need to stop and remind ourselves of this fact. That’s what Clinical Correlations tries to do…turn the noise off for a few moments and try to answer a difficult question, clarify a complicated disease, or just reflect on what makes us want to be physicians in the first place.”

I do want to recognize our current inner circle of editors – namely Michael Tanner our executive editor who has been by my side since the early days and Matthew Vorsanger and Brian Greet our current Associate Editors. This year we have worked hard to build a strong foundation for the years to come. There have been so many other people who have come along for the ride; the ever-changing cast of literally hundreds of students, residents, faculty peer reviewers, and editorial board members. There are too many to thank, and lest I insult anyone by leaving them off a list, I will avoid naming more names. You all know who you are and I deeply thank you for your contributions and commitment to Clinical Correlations.

In celebration, myself, Michael Tanner, Matthew Vorsanger and Brian Greet have put together a list of our top 10 all-time favorite Clinical Correlations articles…this was no easy task and unfortunately there are many wonderful pieces that did not make the list. I encourage you to visit our site map and peruse our archives. I’m sure you will find more than a few articles to add to your reading list.

So without further ado, in alphabetical order:

The Top 10 All Time Favorite Clinical Correlations Articles

1. Are We Too Hesitant to Anticoagulate Elderly Patients with Atrial Fibrillation? A Risk-Benefit Analysis – By: Sunny Shah

2. Decoding the apoL1 kidney – By: Areeba Sadiq

3. Fast Hearts and Funny Currents: Is Tachcardia Part of the Problem in Heart Failure Part 1 and 2 – By: Santosh Vardhana

4. Fractional Excretion of Sodium (FENa): Diagnostic Godsend or Gimmick – By: Jon-Emile Kenny?

5. In Search of a Competitive Advantage: A Primer for the Clinician Treating the Anabolic Steroid User – By: David Rosenthal and Robert Gianotti

6. Is a VBG as good as an ABG? – By: Sunnie Kim

7. Kayexalate: What is it and Does it Work? – By: Todd Cutler

8. Obesity 2.0: More than Just the Extra Weight – By: Aviva Regev

9. Reflections on Hurricane Sandy – By: Jessica Taff

10. Talk to your Doctor: Direct to Consumer Advertising parts 1,2,3 – By: Ishmeal Bradley, Part 1, Part 2, Part 3

And since choosing 10 out of 1000 articles was just too onerous, here are another 10 that also deserve to share a bit of the limelight.

1. Corticosteroids and prophylaxis: What Complications Should you Try to Prevent in Patients on Chronic Corticosteroids? – By: Robert Fakheri

2. Did Abraham Lincoln Have Marfan’s Syndrome? – By: Anna Krigel

3. Does Heyde Syndrome (The Association Between Aortic Stenosis and Intestinal Angiodysplasia) Exist? – By: Lara Dunn

4. Does Running cause Knee Osteoarthritis? – By: Karin Katz

5. Does the BCG Vaccine really Work? – By: Mitchell Kim

6. How Do You Diagnose Polymyalgia Rheumatica? – By: Eve Wadsworth

7. Primary Care for the Transgender Population – By: Ishita Aggarwal

8. Should Patients with Nephrotic Syndrome Receive Anticoagulation? – By: Jennifer Mulliken

9. The DLO: Does FFP correct INR? – By: Nicole Lamparello

10. The Hangover: Pathophysiology and Treatment of an Alcohol Induced Hangover – By: Anthony Tolisano

Reaching the first 1000 articles has been an awesome ride…here’s to the next 1000 and beyond…

 

Happy New Year…and Happy 4th Birthday to Us!

January 1, 2011

File:Times Square ball.jpgFour years and still going strong.  It’s hard to believe.  If you told me when we first launched Clinical Correlations that we would have posted over 700 articles tackling a potpourri of internal medicine, average 1000 hits/day with readers from all over the world, I would have laughed at the ridiculousness of the thought.  But here we are four years later and I am so proud of all we have accomplished.  I’m frequently asked  about our motivation-and to be honest, I never give the same answer twice.  We’re not hoping to make money, we’re not looking to compete with the New England Journal of Medicine and we’re not trying to be the go to news site.  I realize however that we do have a goal; to be as thought provoking as possible.  We want to inspire you to say wow, that’s fascinating, let me go read a little further about that.  Our field of internal medicine is captivating-every aspect, every direction we look, and every now and then we need to stop and remind ourselves of this fact.  That’s what Clinical Correaltions tries to do…turn the noise off for a few moments and try to  answer a difficult question, clarify a complicated disease, or just reflect on what makes us want to be physicians in the first place.

So, in wishing you a Happy New Year it’s only appropriate to give you a chance to take a few moments to recall the most engaging posts from Clinical Correlations in 2010.   Of course I would also like to send a very special thank you to all our contributors-our new managing editor Anita Smitherman, our editors, writers, peer reviewers, copy editors and most of all our readers.

Why do we do this?  The answer I now know is to inspire you…Here’s to a safe, happy and healthy New Year for all.

-Neil Shapiro, MD  Editor-in-Chief, Clinical Correlations

The Top 10 Articles in Chronological Order

1. Evolution and Medicine: Why Do We Age? By: Mark D. Schwartz, MD and Julia Hyland Bruno, MD

2. Mystery Quiz By: Vivian Hayashi, MD and Robert Smith, MD and Mystery Quiz, The Answer

3. Appropriateness for Revascularizaion in Stable Angina By: Ramin Shayegan Hastings MD, Jonathan Willner MD, and Steven Sedlis MD

4. Talk to Your Doctor: Direct to Consumer Advertising of Prescription Drugs Parts I, II, III By: Ishmeal Bradley, MD

5. Cannabinoid Hyperemesis: High on the Differential for Intractable Vomiting By:  Sarah A. Buckley and Nicholas M. Mark

6. Myths and Realities: Heart and Wine: By: Aditya Matoo

7. Tales of Survival Snapshots of Bellevue at night By: Christopher Tully, MD

8. Creatine Kinase: How much is too much? By: Jon-Emile Kenny, MD

9. Proton Pump Inhibitors  2.0 By: Mary Whitman, MD

10. Kayexelate: What is it and does it work? By: Todd Cutler, MD