The Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical industry trade organization, stated the following in its Dec. 2008 "PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines,” available at www.phrma.org:
"An important benefit of direct to consumer (DTC) advertising is that it fosters an informed conversation about health, disease and treatments between patients and their health care practitioners.
A strong empirical record demonstrates that DTC communications about prescription medicines serve the public health by:
Increasing awareness about diseases;
Educating patients about treatment options;
Motivating patients to contact their physicians and engage in a dialogue about health concerns;
Increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated; and
Encouraging compliance with prescription drug treatment regimens...
PhRMA members want patients and consumers to talk to their physicians about the medicines that may help them and to fully understand the known risks regarding these medicines. We know that DTC communications, particularly DTC television advertising, can be a powerful tool for reaching and educating millions of people."
The American Advertising Federation, a national advertising trade association, stated the following in its Sep. 2008 position statement "DTC Prescription Drug Advertising," available at www.aaf.org:
"The AAF supports the right of pharmaceutical companies to advertise prescription drugs directly to consumers, provided all claims are substantiated and appropriate disclosures are included in the advertising. Proposed moratoriums on pharmaceutical advertising would violate the First Amendment protection for commercial speech. Barring information from advertising will cause more harm to consumers who are not encouraged by an ad to see a doctor about an illness. Surveys show that these ads prompted more than 39 million to ask their doctor about a particular health condition. Advertising is an important source of information about pharmaceuticals."
The US Food and Drug Administration (FDA) provided the following testimony, in a statement delivered by Rachel E. Behrman, MD, during the Sep. 29, 2005 US Senate Special Committee on Aging titled "The Impact of Direct to Consumer Drug Advertising on Senior's Health and Health Care Costs," available at www.aging.senate.gov:
"Consistent with the First Amendment, FDA may only regulate prescription drug advertising that is false or misleading. To that end, FDA regulations specify, among other things, that prescription drug advertisements cannot omit material facts, and must present a 'fair balance' between benefit and risk information...
The Agency believes that, if done properly, prescription drug advertising can provide consumers with important information about new prescriptions and new indications for existing prescription drugs, as well as information about symptoms of treatable illnesses and other conditions. Done properly, prescription drug advertising can assist consumers in taking a pro-active role in improving their health."
Alan F. Holmer, JD, Director of Inspire Pharmaceuticals Inc., stated the following in his 1999 article "Direct to Consumer Prescription Drug Advertising Builds Bridges Between Patients and Physicians," published in the Journal of the American Medical Association:
"Direct-to-consumer (DTC) advertising is an excellent way to meet the growing demand for medical information, empowering consumers by educating them about health conditions and possible treatments. By so doing, it can play an important role in improving public health...
Direct-to-consumer advertising that encourages millions of Americans to consult their physicians can help to improve public health because a number of leading diseases are under diagnosed and under-treated...
Direct-to-consumer advertising is a highly effective way to communicate the availability of treatments to the public. In 1992, the first DTC consumer television advertisement for a nicotine patch aired during the Super Bowl. According to the American Association of Advertising Agencies (AAAA), the public response was so great that, within weeks, demand for the patches exceeded the supply. The product had been available for months, but people who might have been interested in quitting smoking were simply not aware of it.
Advertising promoted widespread awareness overnight, prompted patient-physician conversations, and may have helped many people to stop smoking.
Pharmaceutical companies have both a right and a responsibility to inform people about their products under the supervision of the FDA, which regulates prescription drug advertising. Companies are committed to responsible advertising that enhances the patient-physician relationship and encourages the appropriate use of prescription drugs under a physician's supervision. While such advertising prompts more people to seek professional help, it does not dictate the outcome of the physician visit or the kind of help patients eventually receive.
Direct-to-consumer advertising merely motivates patients to learn more about medical conditions and treatment options and to consult their physicians."
Daniel Carlat, MD, Practicing Psychiatrist, stated the following in his Oct. 29, 2007 article "What's Wrong with DTC Ads?," available at carlatpsychiatry.blogspot.com:
"I have certainly received an excessive dose of DTC ads... And, yes, I get that DTC's encourage consumers to ask their doctors to prescribe the newest and most expensive meds.
But banning them doesn't make sense. Why? For one, it's one of the only arenas where drug companies advertise their products with full disclosure. Everybody knows it's an expensive ad paid for by the company. There's no pseudo-legitimate journal or medical education company pretending to be a scientific article, when in reality it's a paid advertisement.
Second, they do serve an educational function for consumers, if biased. There are a lot of guys out there urinating very frequently who would not consider this a potentially treatable issue if they hadn't seen those irksome Flomax commercials, the ones featuring the sports-crazed baby boomers who get to hang out in their kayaks longer without having to run into the woods--all because they're taking their Flomax. Sure, viewers are going to run to their doctors and ask for Flomax my name, but it's up to the docs to decide which drug is best. And meanwhile, some men will find out they have early prostate cancer (rather than benign prostatic hyperplasia) and might get their lives saved in the bargain.
Richard E. Ralston, MA, Executive Director of Americans for Free Choice in Medicine, stated the following in his June 2005 article "Prescription Drug Advertising is Good for All of Us," available at www.capmag.com:
"Critics of the pharmaceutical industry demonstrate willful ignorance of the basic principles of economics and marketing. They say firms that develop breakthrough drugs after investing billions of dollars in research are not to be commended but persecuted—because they won't keep quiet about them. Those who attack drug advertising are just looking for an excuse to impose government regulation and price controls. They pretend ignorance of marketing because they want to destroy individual choice and free markets, and replace them with government micro-management of all aspects of health care. They are also conveniently ignorant of other principles, such as 'freedom of speech.'
Effective advertising of new drugs provides obvious benefits. Most importantly, it informs those with medical conditions about new treatments (including those who may have given up on getting relief). It may motivate them to discuss the condition with a physician for the first time, creating an opportunity for the physician to undertake testing and make a correct diagnosis. The physician may prescribe another medication better suited to the patient's needs. Or, the physician's knowledge of the condition's serious consequences may alter the treatment course instead of just addressing the symptoms reported by the patient."
Bob Ehrlich, MBA, Chief Executive Officer of DTC Perspectives, Inc., stated the following in his Feb. 19, 2010 article "A World Without DTC?," available at www.dtcperspectives.com:
"Critics constantly call for a ban on DTC. The most common claim is that DTC raises treatment cost because advertised branded drugs are often not better than generics, lifestyle changes, or other non-prescription remedies. They also say DTC creates imagined disease categories which cause people to demand expensive treatments for questionable conditions. They argue the DTC drugs overstate benefits without properly giving the risks. Critics bemoan the fact that the doctor-patient relationship is harmed by patient initiated discussions and demand for a drug. None of the above is borne out by the facts but the arguments continue to have traction in Congress.
Ok. Let's assume enough Congressmen agree and enact a ban that The Supreme Court says is constitutional. DTC is now banned. Is the health care system better off?...
The best solution is to let information flow for DTC and other items with viable alternatives. There are plenty of sources of information on drugs, many of which are critical of branded drugs and offer alternatives. Government is free to publish clinical results that can refute claims of brands. Managed care can play one branded drug against another to get a great price. Doctors can decide if the branded drug really is better for their patients. Patients can check the Internet or ask friends if the drug works well. Putting the DTC information genie back in the bottle seems a bad alternative after 13 years of mass DTC availability."
The Coalition for Healthcare Communication, a health care industry trade organization, stated the following in their Nov. 24, 2009 statement "Coalition Speaks Out on New DTC Research Analysis," available at www.cohealth.org:
"DTC plays a critical role in informing patients about their treatment choices, and as the starting point in a dialogue between physician and patient in defining a treatment path. The Coalition supports responsible, effective communication on treatment benefits and risks that improve physician-patient dialogue and foster better care. Limiting FDA-vetted healthcare information impedes access to fair-balance information and stunts two-way dialogue between a patient and their doctor critical to improving medical treatment and quality-of-life."
The American College of Physicians, a national membership organization of physicians, provided the following testimony, in a statement delivered by Donna Sweet, MD, during the Sep. 29, 2005 US Senate Special Committee on Aging titled "The Impact of Direct to Consumer Drug Advertising on Senior's Health and Health Care Costs," available at www.aging.senate.gov:
"Since 1998, ACP has been opposed to the practice of DTC advertising, which often leaves our patients confused and misinformed about medications. It undermines the patient-physician relationship and impedes the practice of medicine by challenging the individual physician’s medical judgment...
The power of media broadcast is huge. Pharmaceutical companies and ad agencies know that. That is why DTC advertising is done. But it does put an adversarial element into the physician-patient relationship...
Consider the toenail ad, my personal favorite. While I am trying to tell a senior that it is not life-threatening; that there really aren’t little creatures with horns, legs, and arms under their toenails, living in sofas and chairs; that the drug is quite expensive; and that the risks of toxicity are significant and that it may not work, I lose valuable time that could have been directed at the underlying reason they have those toenails—their diabetes, their vascular disease, their cholesterol, their overall health...
ACP would prefer to see Congress ban DTC advertising because it does not constitute appropriate patient education."
Robert M. Centor, MD, Director of the Division of General Internal Medicine at the University of Alabama at Birmingham, stated the following in his June 12, 2005 editorial "Take Drug Ads off the Air," published in USA Today:
"Direct-to-consumer drug advertising works very well - for pharmaceutical company profits, but not for the public health...
Some argue that the First Amendment protects direct-to-consumer drug advertising. However, restrictions on commercial speech exist when the outcome of the speech can be harmful to the public. The Federal Communications Commission no longer allows tobacco ads to appear on TV. Following the same logic, prescription-drug ads should be taken off the air.
Drug advertising results in more costly prescriptions. Few inexpensive drugs are advertised on TV. The commercials don't educate patients. Rather, they create a demand for a product based on an effective commercial rather than the patient's medical need...
Direct-to-consumer ads should be banned. Doctors and patients have much to gain. Only the pharmaceutical industry has anything to lose."
Kurt C. Stange, MD, PhD, Professor of Family Medicine, Epidemiology & Biostatistics, Oncology and Sociology at Case Western Reserve University, stated the following in his 2007 editorial "Time to Ban Direct-to-Consumer Prescription Drug Marketing," available at www.anfammed.org:
"It is time to ban direct-to-consumer (DTC) advertising of prescription drugs. The current US system of pharmaceutical company self-monitoring and Food and Drug Administration oversight is not working...
[S]ources show an emerging public health tragedy that is happening so surreptitiously that we are blind to the magnitude of the encroaching effect on the quality of health care and the health of Americans.
The use of broad media coverage to encourage prescription drug use is a shotgun where an individualized, personalized approach is needed. These ads present biased appeals to the masses to influence decisions about drugs...
DTC ads manipulate the patient’s agenda and steal precious time away from an evidence-based primary care clinician agenda that is attempting to promote healthy behavior, screen for early-stage treatable disease, and address mental health...
[A]ction is needed if the insidious, pervasive, detrimental, and misconstrued effects of DTC ads are to be stemmed in the United States and New Zealand, as they have been in the rest of the developed world...
Only a ban will work. The impossibility of regulating complex overt and covert multichannel messages with both rational and emotional appeals, the power imbalance between the public good and the commercial imperative, the difficulty of anticipating ads’ unintended consequences, and the availability of less-biased sources of information and motivation all argue for totally proscribing DTC ads."
Jerry Avorn, MD, Professor of Medicine at Harvard Medical School, stated the following in his comment to the Aug. 4, 2009 article "Should Prescription Drugs Ads Be Reined In?" published in the New York Times:
"Just as every other industrialized nation has figured out how to provide health care to all their citizens and how to get drug makers to negotiate the prices of their products, each of those countries (with the exception of New Zealand) also bans direct-to-consumer advertising for prescription drugs...
All those other countries have it right, and we don’t. Doctors spend precious minutes of ever-shorter office visits explaining to patients why their cholesterol drug is every bit as good as the one they saw on television, or why feeling sad at the death of a loved one doesn’t require an antidepressant. Hawking medications to the public encourages rapid adoption of new products that may be no better — or even worse — than older, unadvertised generic drugs...
[T]his advertising promotes only the most expensive products, it drives prescription costs up and also encourages the 'medicalization' of American life — the sense that pills are needed for most everyday problems that people notice, and many that they don’t."
Gary Ruskin, MPP, Executive Director and Co-Founder of Commercial Alert, authored the following statement, endorsed by 226 US medical school professors(243 KB) , and delivered it at the Nov. 2, 2005 "US Food and Drug Administration Hearings on Direct-to-Consumer Prescription Drug Advertising," available at www.commercialalert.org:
"Direct-to-consumer marketing of prescription drugs should be prohibited…
This advertising does not promote public health. It increases the cost of drugs and the number of unnecessary prescriptions, which is expensive to taxpayers, and can be harmful or deadly to patients…
Prescription drug advertising pressures health professionals to prescribe particular medications, and often the ones that may be less effective and more expensive and dangerous. This intrudes in the relationship between medical professionals and patients, and disrupts the therapeutic process. It takes up valuable time to explain to patients why they may have been misled by the drug advertisements they have seen.
Prescription drug advertising is not educational. It is inherently misleading because it features emotive imagery and omits crucial information about drugs and their proper use, as well as about side effects and contraindications that can be found on the full FDA-approved label. Drug companies have an inherent and irredeemable financial conflict-of-interest which drives them to exaggerate the positive and minimize the negative qualities of their own products."
Andrew Weil, MD, Founder and Director of the Arizona Center for Integrative Medicine, stated the following in his Aug. 1, 2009 article "Should You Get Your Drug Information from an Actor?," available at www.huffingtonpost.com:
"A major component of today's high-tech medical treatment is the reckless overuse of pharmaceutical drugs. An estimated 50 percent of Americans take at least one prescribed medication every day; in 2007, drug sales accounted for an astonishing $315 billion in revenue. When I was growing up, far fewer Americans took prescription drugs...
Direct-to-consumer (DTC) pharmaceutical marketing... is a major engine behind this unfortunate change. American television, radio, internet and print are saturated with ads for every imaginable drug, typically ending with an entreaty to 'ask your doctor.' In 2004, American drug companies spent 24.4% of their sales revenue on promotion, versus just 13.4% for research and development...
Drug ads strengthen our belief in pharmaceutical drugs as the cures for all of our problems. In fact, the consequences of poor lifestyle choices cannot be undone with pills...
Because heavily advertised drugs have such vast profit potential, political and financial interests collude to speed them to market before they have received sufficient scientific scrutiny...
The free market works well in many ways, but it has failed us here. Whether it is done independently or as part of an omnibus health care reform initiative, we need to make the same decision that the rest of the developed world has made: that is, ban direct-to-consumer advertising of prescription pharmaceutical products."
Peter Lurie, MD, MPH, Former Deputy Director of the Health Research Group at Public Citizen, provided the following testimony during the Sep. 29, 2005 US Senate Special Committee on Aging titled "The Impact of Direct to Consumer Drug Advertising on Senior's Health and Health Care Costs," available at www.aging.senate.gov:
"Like all interventions in health care, DTC advertising should be evaluated by comparing risks and benefits in the context of available or potentially available alternatives. On balance, we believe that the clearly demonstrated adverse effects of DTC advertising outweigh the still undemonstrated effects that might be beneficial. Where there is any hint of a beneficial effect, we find that there are better ways of accomplishing it...
[D]irect-to-consumer advertisements bear little relationship to public health needs. New and expensive drugs, those for diseases that are bothersome and incurable, are the ones that we see advertised. Only 14 percent of sales for the top 50 DTC-advertised drugs are for acute conditions, and only one of the top 50 DTC-advertised drugs was an antibiotic, presumably because people are quickly cured and there is no need for a refill...
[T]he price of health care is being driven up. Patients are being induced to request new, more expensive medications instead of equally effective, older generic ones."
, and delivered it at the Nov. 2, 2005 "US Food and Drug Administration Hearings on Direct-to-Consumer Prescription Drug Advertising," available at www.commercialalert.org: