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DIRECT TO CONSUMER ADVERTISING: WHO THOUGHT THIS WAS A GOOD IDEA?Feb 1, 2005 In our March/April 2002 Newsletter we discussed the ongoing debate surrounding the controversial methods being used by pharmaceutical manufacturers to market prescription drugs. Recent high profile drug withdrawals and potential scandals have only intensified that debate, and no element of marketing is more controversial than direct-to-consumer advertising (DTCA).
While some experts maintain that DTCA actually strengthens our health care system, others are equally certain that DTCA has caused many of the problems that plague the drug industry (over-medicating, over-pricing, and exaggerated and often misleading advertising claims). There are even those who strongly urge that DTCA “must be banned as part of FDA reform.” (http://www.newstarget.com/z003204.html)
We believe that any perceived benefits from DTCA are far outweighed by the problems it has caused and the burden it has placed on the FDA to regulate the content and accuracy of thousands of TV, radio, print, and online advertisements.
The Evolution of DTCA
Before DTCA, pharmaceutical advertisements appeared in professional publications, promotional materials, and samples intended for physicians, pharmacists, and hospital administrators. Patients were never intended as the primary target for any form of prescription drug advertising. Thus, the commercial success (or failure) of a drug depended on its effectiveness and safety record not on slick marketing campaigns.
Today, however, the rules of the game have changed dramatically. Stiff global competition, expiring patents, generic drugs, sky rocketing research and development costs, and substantial damage awards and settlements have made marketing more important than science when it comes to turning a profit. Moreover, a commercially successful “blockbuster” drug can mean billions of dollars in annual profits to a company. This has served as justification for bloated advertising budgets, withholding negative information, and ad campaigns that very often become deceptive and misleading. Today, drug advertising has become an industry unto itself, and inadequately tested and hastily marketed drugs permeate the market and expose the public to great risk. How did this all come about?
The first advertising specifically intended to target the consumer appeared in the early 1980s. From that time until the mid-1990s, the bulk of DTCA appeared in magazines and newspapers. In 1997, however, the FDA issued a draft guidance (finalized 1n 1999) that permitted the expansion of DTCA into electronic and broadcast mediums. Today, DTCA is regarded as a “catchall” phrase covering all information provided by drug companies directly or indirectly to consumers. This would include traditional print advertising (newspapers and magazines), television, radio, and internet ads, and brochures, newsletters, and samples distributed by physicians and pharmacists.
In 1989 DTCA spending totaled $12 million. By 1992 that figure had jumped to $156 million. When TV and radio ads were added to the mix, spending began to take off, reaching $844 million in 1997 and $1.58 billion in 1999. The figure then soared to $2.38 billion in 2001 and is now in the vicinity of $3 billion. (Between 1999 and 2003 alone, Pfizer spent about $406.3 million on DTCA advertising for Celebrex while, during the same period, Merck spent approximately $459.8 million on DTCA for Vioxx.)
All of this spending is not without reward, however. A recent study by researchers at Harvard University and the Massachusetts Institute of Technology analyzed the effect of DTCA advertising on consumer spending for prescription drugs. The study found that a 10% increase in advertising of drugs within a therapeutic drug class resulted in a 1% increase in sales of the drugs in that class. When these findings were applied to the 25 largest drug classes in 2000, it was found that every $1.00 spent on DTCA yielded $4.20 in drug sales. DTCA was thus responsible for 12% of the increase in prescription drug sales or an additional $2.6 billion in 2000 alone.
Another study conducted (between 1999 and 2000) by the National Institute for Health Care Management (NIHCM) found that DTCA resulted in significant increases in retail spending. In fact, the study found that the 50 most heavily advertised drugs were responsible for 47.8% of the increase in retail spending on prescription drugs between 1999 and 2000 (some $9.95 billion) while increases in sales of some 9,850 other drugs on the retail market accounted for 52.2% of the one-year rise in retail pharmaceutical spending (about $10.86 billion). Other significant findings were:
* Retail sales for the 50 most heavily advertised drugs rose an aggregate 32% compared to 13.6% for all other drugs combined.
* The number of prescriptions for the 50 most heavily advertised drugs rose 24.6% compared to an increase of only 4.3% for all other drugs combined.
* The 50 most heavily advertised drugs (in 2000) had combined sales of $41.3 billion (31.3% of total prescription drug sales).
* In 2000, $125 million was spent to advertise Pepsi Cola, $146 million on Budweiser beer, $169 million on GM’s Saturn, $160 million on the top models of Dell computers. In 2000, Merck spent $160 million on advertising for Vioxx alone.
* Each of the top seven most heavily advertised drugs beat Nike’s ad budget of $78.2 million.
* Each of the top 15 drugs exceeded Campbell’s soup’s advertising expenditure of $58 million.
* DTCA accounted for 32% of all drug promotional spending (not counting the cost of samples).
The Dangers of Direct-to-Consumer Advertising
While, in a perfect world, the benefits of DTCA touted by some experts would be understandable and even warranted, serious problems plague the system thereby making any such praise undeserved. We will discuss a number of those problems but a list would include:
* Repeated findings by the FDA that many ads are deceptive, inaccurate, misleading, and otherwise in violation of federal law.
* The FDA is forced to expend an ever-increasing portion of its budget and manpower on policing advertising instead of more carefully investigating new drug applications and adverse reaction reports.
* DTCA takes valuable assets away from research and development.
* DTCA drives up the retail price of drugs.
* DTCA results in over medicating the public.
* DTCA results in expensive drugs being taken by patients who would be better off taking safer and cheaper alternatives already on the market.
* DTCA leads people taking drugs they do not need in the first place.
* DTCA eliminates the “learned intermediary” (physician) from the decision making process in many cases and, in others, doctors are placed in the awkward position of having to prescribe a drug or lose a patient.
* DTCA uses celebrities, athletes, and even retired news anchors (who have no medical or pharmaceutical training) to vouch for the safety and effectiveness of prescription drugs.
* DTCA uses music which is (or was) popular with the target audience in order to subconsciously influence choice.
* Warnings are confined to extremely small type at the bottom of the page or TV screen and rapidly spoken segments of commercials.
* DTCA capitalizes on the widely held but erroneous belief among consumers that “newer is better.”
* DTCA ultimately places marketing above science.
The problem with the majority of prescription drug advertisements is that they are just too slick. Critical information such as side effects or other hazards is often omitted or not explained in sufficient detail. Some advertisements do not even specify what condition the drug is designed to treat. People supposedly suffering from extremely serious medical problems are often shown smiling and laughing or engaging in activities that make the drug appear to be far more effective than it really is.
The FDA often issues stern warnings to drug companies about misleading or deceptive statements or unproven claims of superiority. These warnings, however, are usually not made public. In fact, they are even sometimes ignored by the offending company or not acted upon for months or years. Recently, pharmaceutical giants such as Merck, Pfizer, and GlaxoSmithKline have received warning letters from the FDA regarding the use of false or misleading advertisements and promotional materials. Merck, the manufacturer of Vioxx, the Cox-2 inhibitor that was pulled from the market in September of 2004, was warned as far back as September 2001that their promotional activities and materials were “false” and “lacking in fair balance.” In addition, Merck’s promotional campaign minimized the now-known serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.
Pfizer also received a warning letter (January 2005) identifying five promotional pieces for the Cox-2 inhibitors Bextra and Celebrex which, according to the FDA’s letter: “omit material facts, including the indication and risk information; fail to make adequate provision for the dissemination of the FDA-approved product labeling; and make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims.” The FDA claims that the ads in question, such as the one featuring a woman playing the long version of a song on the guitar and a 27-minute long infomercial featuring “regular people” talking about their arthritis pain, are misleading because of their overstatement of effectiveness as well as the omission of risk information.
GlaxoSmithKline was likewise warned about misleading advertisements for its hypertension drug called Coreg. Thus, rather than demonstrate a commitment to truthful advertising, pharmaceutical companies are likely to attempt to get away with whatever they can in terms of misleading the public. This untrustworthiness forces the FDA to divert valuable resources (money and manpower) from investigating new drug applications and adverse events related to existing drugs. (This would be like telling the referee at the Super Bowl that he will also be responsible for making sure the vendors at the stadium are not overcharging fans for hot dogs during the game.)
DTCA has been blamed for COX-2 inhibitors like Vioxx, Celebrex, and Bextra being greatly over-prescribed for years especially to patients who never needed them in the first place. These drugs were originally touted as being easier on the stomach than other painkillers. This led to countless prescriptions being written to people for that reason alone. Studies have shown, however, that the vast majority of people taking COX-2 inhibitors would have tolerated older, cheaper, and safer painkillers without any significant gastrointestinal problems. We also now know that these drugs are no easier on the stomach and have even been shown to cause abdominal bleeding in certain cases.
Over-medicating is a very serious problem and it is occurring more and more frequently with respect to the most advertised drugs such as those for pain, high cholesterol, gastrointestinal disorders, depression, and disorders that cause embarrassment (incontinence, herpes, yeast and fungal infections, and erectile dysfunction).
In addition, the fact that COX-2 inhibitors cost between 10 and 15 times more than cheaper, safer, and equally effective painkillers such as naproxen, ibuprofen, and aspirin was never conveyed in any of the DTCA. This is a common occurrence in DTCA of designer drugs and one that greatly increases the cost of healthcare. Of course as healthcare expenditures rise, so does the cost of health insurance and government programs that subsidize health benefits to senior citizens and those of limited means.
In her book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, Dr. Marcia Angell, a senior lecturer at Harvard Medical School, explains that the pharmaceutical giants are “price-gouging” Americans. According to Dr. Angell: “Many people, particularly senior citizens, simply cannot afford prescription drugs anymore.” She says that a solution would be for drug companies to “ease up on price increases, since there is a growing public resistance, as well as resistance from employers and state governments.” Dr. Peter Rost, a senior executive at Pfizer, argues that “if price controls came in, at first there’d be a one time fall in profits, but then they’d start climbing again and life would go on.”
Two in three Americans now believe that drug prices are “unreasonably high.” Right now, however, the drug companies are doing everything they can to avoid lowering costs such as refusing to legalize drug importation from Canada and trying to hook more and more people on what Angell calls “lifestyle drugs.” Certainly, spending billions of dollars on DTCA is not helping.
While many DTC advertisements feature unknown actors or voiceovers, a significant number of ads rely upon celebrities, athletes, and famous musical recordings to entice the public. Prominent broadcast journalists such as Walter Cronkite and Aaron Brown were used to blur the line between journalism and advertising. These reputable news anchors, who were paid handsomely for their appearances, hosted video “news breaks” produced by a Florida company called WJMK. These ads appeared on local public television stations between regular programs. Another company called Healthology hires journalists to appear in video Web casts for the same purpose. Critics argue that this kind of DTCA misleads viewers by “packaging promotional material to look like news.”
Morley Safer of CBS appeared in hundreds of promotional videos before deciding that the work did not meet the standards of CBS news. Although all of the news anchors involved maintain that they appeared in the videos or Web casts to advertise drugs for educational purposes only, the true purpose of these videos is to promote the drugs for retail purposes.
Dr. Steven Haimowitz, the president of Heathology said that the drug companies did not write or edit the video’s script. He claims the Web casts are “fair and balanced” and are “editorial in nature.” This type of DTCA takes advantage of the relationship between the viewer and a trusted broadcast journalist.
Pharmaceutical advertising has always been regarded by many as nothing more than "an attempt to get somebody to buy something." Clearly, there is nothing sacred about pharmaceutical ads that would make them more reliable or accurate than any other type of advertising. In fact, DTCA advertising suffers from the very same shortcomings as advertising in general which Canadian economist Stephen Leacock characterizes as "the science of arresting the human intelligence long enough to get money from it". It is simply not right to advertise powerful prescription drugs, with potentially serious or fatal side effects, as if they were different types of shampoo, toothpaste, SUVs, or beer.
As discussed above, DTCA leads to over-medicating when consumers become convinced that the answer to their medical or psychological problems can be found in a pill. Many people on cholesterol lowering drugs would benefit more from a healthy diet and exercise. Most people taking COX-2 inhibitors would be much better off taking older, safer, and far less expensive alternative medications. Lifestyle changes and therapy may be more effective for certain people than the anti-depressants or social anxiety drugs they are taking. DTCA, however, will never tell any of these people this simple fact.
A Doctor’s Dilemma
Although one would like to believe that a doctor will only be guided by his medical training when deciding whether to prescribe a drug, that is not always the case. Doctors are often faced with patients who literally demand to be given a certain drug based on nothing more than a slick TV ad. The doctor is then faced with a decision that has little, if anything, to do with medicine.
A doctor must decide if possibly losing a patient is more important than compromising his or her ethical standards. He or she must also be willing to spend the time to convince patients that the drugs they want may not be necessary or even the safest choices. Surveys have shown, however, that doctors too can be prone to believing that “newer is better.”
Full Disclosure as a Solution
One way to attack the problems caused by DTCA is by making databases with complete and accurate drug information available to medical professionals and consumers alike. While many are in favor of such an approach, there are those who are against the release of medical data which they regard as classified to anyone outside of the pharmaceutical industry or the FDA.
GlaxoSmithKline has been an advocate of increased disclosure and has already begun posting the results of clinical trials of its drugs including 65 tests about a new diabetes medication. The company said that its database will include all tests on drugs sold by the company that were conducted since the year 2000. While this initiative is admirable, it only came after the settlement of a lawsuit filed by the New York State Attorney General regarding misleading information presented to doctors about the drug Paxil.
The American Medical Association has asked federal officials to create a national database where drug companies would be required to post trial results. Merck has openly supported the idea of a government-run database. Such a resource would allow people to see any single drug trial, whether positive or negative, in the context of other tests relating to the same drug. If the International Committee of Medical Journal Editors should approve such a database, any pharmaceutical companies not wanting to participate could still publish their research in less-prominent medical journals.
The National Institutes of Health (NIH) is also seeking more disclosure. The NIH will soon be issuing rules making scholarly articles produced by scientists getting NIH grants available to the public for free. The published work should be available within one year of publication on a government website.
The United States is not the only country attempting to provide disclosure of medical results to consumer. After several drug-safety scandals, Britain’s health minister said that British regulators will now begin collecting and publishing online patient reports of drug side effects.
Having more disclosure would allow doctors and patients alike to make more informed decisions about prescription drugs. It would certainly offer a reliable way to check the accuracy and completeness of claims made in DTCA or sales pitches to medical professionals.
In an expose on the pharmaceutical industry included in the November 2004 edition of the AARP Bulletin, Dr. Rost says that the pharmaceutical industry’s “relentless campaign of misinformation the hollow arguments that are put forward to protect profits short term will in the end backfire.” This is most certainly the truth. As we have seen with the recent Vioxx disaster, in the end it is not in the best interests of a pharmaceutical company to cover up negative data about a drug.
The important thing is to determine, with the help of a physician and truthful information from the drug companies, what the correct medical decision is for the patient. Consumers should not be making these decisions. Unfortunately, this is exactly what DTCA seeks to do as one of its goals.
We close this Newsletter with the following quote from NewsTarget.com (February 9, 2005) which states the case against DTCA as clearly as possible.
“The next thing that should be done in reforming the FDA is to reverse some of the dangerous and poorly made decisions put in place by the FDA over the last few years. The most obvious of these is the legalization of direct-to-consumer advertising by drug companies. This decision was made in 1997 and it allowed drug companies to place ads on television, in magazines, newspapers, billboards and other media with the purported goal of "educating" consumers about prescription drugs. And yet the very premise is laughable. No reasonable person could possibly believe that drug companies should advertising prescription drugs to patients who don't have medical qualifications to even understand if they should use those drugs in the first place. The idea of pushing these drugs to patients so that they go to their doctors and request them by name is medically reckless. It has no medical basis whatsoever. It is clearly just a ploy that was approved by the FDA to financially benefit the drug companies at the expense of public health.
It is this direct-to-consumer advertising, in fact, that is largely responsible for the over-medication of people with dangerous drugs such as Vioxx. This direct-to-consumer advertising continues today, and it is adding to the problem by creating an over-medicated nation where patients think they have to make a list of advertised drugs, then go to their doctor and request them by name. Many times, patients don't even have any idea what these drugs do -- they just see these images of happy, healthy people on television who have been hired to play roles in these drug advertisements, and the patients of course think they want to feel that way too, so they go to their doctor and request these drugs.
The whole system is absurd.”