The saga of the class of drugs known as COX-2 inhibitors has provided an ongoing glimpse into a number of aspects of the multi-billion dollar pharmaceutical industry. These so-called super aspirins, were seen by critics as over-priced painkillers that worked no better than older, safer, and far less expensive drugs. Supporters viewed them as safe and effective drugs that were easier on the stomach than other pain medications.
The three main COX-2s (Celebrex, Vioxx, and Bextra) quickly reached blockbuster status and produced billions of dollars in annual sales for Pfizer (Celebrex and Bextra) and Merck (Vioxx). Massive direct-to-consumer (DTC) marketing campaigns, featuring everything from celebrity spokespersons to classic rock and roll music, kept the drugs in the public eye on a 24/7 basis.
Between January 2003 and June 2004 alone, Merck & Co. spent almost $123.9 million dollars in DTC advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems.
Attractive actors and celebrities, like Olympic figure skating champion Dorothy Hammil, pitched the drug in carefully orchestrated commercials set to The Rascals 1968 hit Beautiful Morning.
The ad-driven popularity of the drugs, and the enormous cash flow that it created, were more than adequate to stave off challenges from consumer groups, scientists, and even FDA whistleblowers who charged that all COX-2 inhibitors were dangerous in that they significantly increased the risk of heart attacks. Even proof of manipulation of clinical study data, withholding negative information, and a complete failure of the FDA drug monitoring system were not enough to bring down these drugs.
The house of cards collapsed, however, when a study designed to gain FDA approval for even wider use of Vioxx ended abruptly in September 2004 when the cardiovascular risk posed by the drug could no longer be ignored. Vioxx was pulled from the market at that time and, despite a favorable vote by an advisory panel in February 2005, has never returned. Bextra, which had other problems in addition to the heart-risk possibility, was also pulled from the market in 2005.
Litigation that had begun while Vioxx and Bextra were on the market increased dramatically once they were pulled. Today, almost 12,000 individual personal injury and wrongful death cases are pending with respect to Vioxx and there are class-actions by private insurers and individual states to recover billions of dollars in drug-reimbursement costs from the manufacturers.
Considering the one-time popularity of these drugs, the favorable FDA panel vote, and the fact that, with Vioxx and Bextra taken off the market, Celebrex was the only game in town, one would have expected sales of the only remaining COX-2 inhibitor to go through the roof. That did not happen, however. To the contrary, Celebrex sales plummeted.
To many experts (financial analysts, marketing consultants, doctors, and attorneys), the key factor in dropping Celebrex sales from $3.3 billion in 2004 to $1.7 billion in 2005 was the suspension of advertising and not the Vioxx litigation or the revelations concerning the COX-2 link to an increased risk of heart attack.
DTC advertising is now the most powerful tool in the pharmaceutical industrys arsenal in terms of generating revenue. This fact has prompted a growing concern among consumer advocates, scientists, and even legislators that the notion of marketing prescription drugs directly to the public is simply not a very good idea. Direct-to-consumer advertising was also brought up by Senator John Edwards during the vice-presidential debate as a severe problem in the medical field.
For the past several years, there has been an ongoing debate over 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)
Many 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.
Before DTCA, pharmaceutical advertisements appeared only 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. In 2004, Pfizer spent another $117 million on Celebrex ads.)
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 he 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 M
anagement (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:
1. Retail sales for the 50 most heavily advertised drugs rose an aggregate 32% compared to 13.6% for all other drugs combined. 2. 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. 3. The 50 most heavily advertised drugs (in 2000) had combined sales of $41.3 billion (31.3% of total prescription drug sales). 4. 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 brands of Dell computers. In 2000, Merck spent $160 million on advertising for Vioxx alone. 5. Each of the top seven most heavily advertised drugs beat Nike's ad budget of $78.2 million. 6. Each of the top 15 drugs exceeded Campbell's soups advertising expenditure of $58 million. 7. DTCA accounted for 32% of all drug promotional spending (not counting the cost of samples).
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. Some of those problems include:
1. Repeated findings by the FDA that many ads are deceptive, inaccurate, misleading, and otherwise in violation of federal law. 2. 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. 3. DTCA takes valuable assets away from research and development. 4. DTCA drives up the retail price of drugs. 5. DTCA results in over medicating the public. 6. DTCA results in expensive drugs being taken by patients who would be better off taking safer and cheaper alternatives already on the market. 7. DTCA leads people taking drugs they do not need in the first place. 8. 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. 9. 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. 10. Warnings are confined to extremely small type at the bottom of the page or TV screen and rapidly spoken segments of commercials. 11. DTCA capitalizes on the widely held but erroneous belief among consumers that newer is better. 12. DTCA ultimately places marketing above science.
Many see the problem with the majority of prescription drug advertisements as being 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.
As a result, 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 was warned as far back as September 2001 that its promotional activities and materials with respect to Vioxx 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 and warned of by reputable medical experts.
On September 17, 2001, the FDA issued an 8-page WARNING LETTER to Merck concerning its false and misleading promotional campaign. The FDA found:
You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MI's) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).
The FDA demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses and found after a review of several of Merck's promotional conference calls and sales pitches that the promotions by Merck are false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. The FDA also required Merck to send letters about the deception to the medical community.
The letter dealt with so many improper and deceptive practices that it is difficult to imagine Merck, a leader in the field of prescription pharmaceuticals, had not formulated a plan to intentionally deceive the public, prescribing physicians, and the FDA itself as to the dangers posed by Vioxx. The FDA found:
1. False advertising in misrepresenting the safety profile for Vioxx;
2. Minimization of the potentially serious cardiovascular findings found in a prior study;
3. Failure to disclose the fact that Merck's explanation for the cardiovascular incident discrepancy in a prior study was only hypothetical and not demonstrated by substantial evidence;
4. Failure to disclose that another explanation for the increased cardiovascular incident rate in the Vioxx group was that Vioxx may have pro-thrombotic properties;
5. Improper minimization of the Vioxx/Coumadin (warfarin) drug interaction;
6. The omission of important risk information;
7. Unsubstantiated superiority claims against other NSAIDs;
8. Promotion of Vioxx for unapproved uses;
9. Promotion of an unapproved dosing regimen; and
10. Misrepresenting Vioxx's safety profile by minimizing the potentially serious risk of significant bleeding that can result from using Vioxx and warfarin concomitantly.
The FDA concluded that Merck's minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns. Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx's safety profile.
Pfizer also received a warning letter (January 2005) identifying five promotional pieces for the 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 claimed 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 viewed as 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 other important agency functions.
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 would be a one time fall in profits, but then they would 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 voice overs, 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 videos 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 scared 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.
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.
Although one would like to believe that a doctor will only be guided by his medical training when deciding whether to prescribe a drug, many consumer advocates believe 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.
Some possible solutions to the DTCA problem have been proposed. One would be to make 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.
Many advocate increased disclosure and posting of clinical trial results. The American Medical Association has asked federal officials to create a national database where drug companies would be required to post trial results. 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.
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 U.S. 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 di
sclosure 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 industries relentless campaign of misinformation the hollow arguments that are put forward to protect profits short term- will in the end backfire.
This claim appears to have been proven by the recent Vioxx disaster. In a different context, Bausch & Lomb is suffering from the effects of a poor response to a developing crisis with respect to one of its eye solutions. Experts agree that, 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.
A well written and informative article from NewsTarget.com (February 9, 2005) 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 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 be 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.
While consumer advocates believe stricter rules and regulations are needed, the FDA is currently looking at a proposal which would allow drug manufacturers to simplify magazine and newspaper ads which are currently required to include a list of detailed information about risks and benefits. Critics of DTCA believe removing such information would be a step in the wrong direction.
Thus, as Pfizer brings its freeze on DTCA with respect to Celebrex to an end, the role of that marketing tool in generating massive amounts of income could not be clearer.
Pfizer is willing to advertise Celebrex again, even with dire warnings that, Important Information: Celebrex may increase the chance of a heart attack or stroke that can lead to death, because the company knows people will then begin to ask their doctors for the drug once more despite the risk. That can only translate into increased sales of a drug that has potentially deadly side effects.
Warnings have never convinced consumers to avoid a dangerous product completely. All you need to do is consider the most extreme example; cigarettes. In that case, the tobacco companies actually advertise against smoking and, still, smoking (and death from smoking) abounds.
While Celebrex remains an FDA-approved drug, the worlds biggest pharmaceutical company, Pfizer, has more than enough money to resurrect Celebrex through creative marketing. The results of Pfizer's ad campaign will no doubt give critics of DTCA more ammunition in their fight to put an end to a system they believe is the triumph of marketing over science.