Parker Waichman LLP Injury Alerts
Marketing Drugs in the 21st Century: The Pharmaceutical Companies' Double Barrel Assault on the PublicMar 1, 2002 For decades, the release of a new prescription drug onto the market was a rather low-key affair. Publicly, the event was usually marked by little more than a news item. Serious media coverage was reserved for major breakthroughs.
Advertisements, if any, appeared in medical publications and were directed towards physicians who, it was presumed, could separate the facts from the "hype". Patients rarely saw these ads. Samples would be disseminated to physicians and hospitals with the hope that they would begin the use and then prescribe the drug. Small promotional "gifts" to physicians (pens, paperweights and the like) hardly insured the commercial success of any drug. Moreover, there was no direct contact between the pharmaceutical companies and those who might ultimately use their products. In fact, drugs were usually forced to succeed or fail based upon their ability to work as promised while not exhibiting any disastrous side effects.
Today, however, the rules of the game have changed dramatically. Stiff global competition, the emergence of generic drugs, the sky rocketing costs of research and development, and massive damage awards and settlements resulting form drugs that have caused widespread catastrophic injuries, have led pharmaceutical companies to rely on Madison Avenue and questionable marketing practices, rather than the safety and effectiveness of their products, to reap billions of dollars in profits. Often, these unconscionably large profits have come from inadequately tested and hastily marketed drugs that have caused untold suffering and death before being pulled off the market by the FDA.
We hope the following will help our readers understand the magnitude of the campaign that has been launched against them by the pharmaceutical industry.
I. Direct-to-Consumer Advertising:
One of the most controversial marketing approaches ever used by any industry is the direct-to-consumer (DTC) advertising campaign with which pharmaceutical manufacturers are now bombarding the public. Advertisements for every conceivable type of prescription drug are now commonplace on television and radio as well as in print on billboards, trains, buses, taxicabs and almost every newspaper and magazine. Pitchmen (and women) range from famous politicians (Bob Dole for Viagra) to athletes and coaches (Dan Reeves for Zocor) to entertainers (Robert Klein for Combivent) to "everyday people" suffering from everything from herpes to acid reflux.
While many of these ads are done in "a responsible and ethical manner", others are used "primarily as a mechanism to drive sales". In testimony before the Senate Commerce Subcommittee on Consumer Affairs, Dr. Michael Shaw, Executive Director of EthicAd, stated that this "disparity can mislead the consumer. Consumers have no way to differentiate between educational programs promoting their own welfare and programs designed just to promote the welfare of the sponsor." In fact, Dr. Shaw even went so far as to state that the DTC advertising makes drug manufacturers "health care information providers just like doctors or hospitals." As a result, "they have the responsibility to given them [the public] all the facts". (EthicAd has spent a year developing the EthicAd DTC standards with the assistance of the pharmaceutical industry, consumer groups, health care organizations and the regulatory community, in the hope that such standards will serve as "a good starting point".)
In the lead article of Worst Pills, Best Pills News for March, 2002, (reprinted from the New England Journal of Medicine 2002; 346: 524-526), its Editor, Dr. Sidney Wolfe, notes that while "increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is represented as educational." Dr. Wolfe acknowledges other articles that raise several questions about DTC advertising such as:
1. Is DTC advertising educational or emotional?
2. How often is it misleading?
3. Is FDA enforcement of advertising regulations adequate?
4. What can be done to neutralize the effect of DTC advertising?
5. Can DTC advertising, whose aim is to sell a product, ever provide the type of information consumers need?
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, DTC advertising suffers from the very same shortcomings as advertising. In fact, DTC 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".
Although Dr. Wolfe strongly recommends that the FDA "crack down harder on misleading ads", he notes that as DTC advertising has sky rocketed, there has been a "significant decrease in the number of actions taken by the FDA to enforce advertising regulations." Dr. Wolfe sees this as the direct result of a "grossly understaffed" Division of Drug Marketing, Advertising, and Communications within the FDA and the fact that the FDA lacks the authority "to impose civil monetary penalties on companies even when the repeatedly violate the law."
Although the pharmaceutical industry claims that DTC advertising is an excellent way to educate consumers, many physicians argue that their patients receive unbalanced information that misleads them "into believing that drugs are better than they actually are.
Finally, what may be the best indication that DTC advertising is paying big dividends to the pharmaceutical industry is the fact that sales of the 50 most heavily advertised drugs accounted for 48% of the $20.8 Billion increase in retail prescription drug spending between 1999 and 2000. Those same 50 drugs also accounted for about $41.3 Billion or 31% of the entire amount Americans spent on all prescription drugs in 2000. Thus, the $2.5 Billion spent on DTC advertising in 200 amounted to a brilliant investment by the drug industry. (Consider that Merck spent $160.8 Million promoting Vioxx in 2000. In return, Merck made $1.5 Billion from the sale of Vioxx alone in 2000. In 1999, Vioxx sales were only $417 million. The 360% rise in sales was primarily attributable to the DTC ad blitz. Pfizer and Pharmacia which co-market Celebrex spent $78.3 Million on DTC ads for that drug which enjoyed sales of $2.6 Billion in 2000, an increase of 78% over 1999.
Nancy Chockley, President of the National Institute for Health Care Management Research and Education Foundation (NIHCM) stated that DTC advertising is "clearly becoming an important influence." Steven Findlay, NIHCM's Director of Research Studies states "DTC advertising does have a more than subtle effect of steering millions of patients to ask for drug X rather than another one." Significantly, however, the drug industry's leading trade organization has denied that there is any direct relationship between DTC advertising and the dramatic sales increases for prescription drugs. We leave it to our readers to draw their own conclusion.
II. The Not-So-Subtle Seduction of the Medical Establishment
No prescription drug can be even modestly successful without the cooperation of tens of thousands of physicians. In the end, pharmaceutical companies must rely on individual physicians to write and re-write the hundreds of thousands or millions of prescriptions required to make a drug profitable. How is it that one of the world's largest industries can base its very survival on unpredictable acts of individuals over whom it has no apparent control. The answer is quite simples. The pharmaceutical companies do, in fact, control much of the medical profession in the very same way Pavlov controlled his dogs.
Promotional gifts have always been associated with American business. Every type of industry has always given away log-laden trinkets such as pens, key chains, calendars, paperweights, letter openings, coffee mugs, flash lights and, of course, free samples. The goal of such "generosity" is no secret. It is designed to remind potential customers of a particular product t or company name as often as possible. While this practice can sometimes be "tacky", it is harmless enough when associated with most products and services. Unfortunately, when it comes to the pharmaceutical industry, the gifts involved can be quite lavish and the goal can be much more subliminal.
Traditionally, pharmaceutical companies would promote goodwill and name recognition by the widespread distribution of trivial gifts to physicians and hospitals. Along with promotional information and free samples of its products, a drug company would hand out pens, pads, paperweights and the like through it sales representatives.
Although these marketing techniques were unquestionably designed to aid in the sale of pharmaceutical products in some tangible, if not measurable, way, there never seemed to be any manipulative or coercive aspect to the practice.
In the early 1980's, however, changes in the pharmaceutical industry apparently convinced drug manufacturers that they needed to have more control over the physicians who determined which drugs were prescribed to the public. Higher research and development costs, greater financial risks from litigation and unsuccessful products, increased competition, and the enormous profit potential for "breakthrough" type drugs for HIV/AIDS, cancer, diabetes, obesity and other contemporary medical problems seem to have made drug companies less willing to leave the most critical aspect of the pharmaceutical marketing cycle to chance. Thus, the industry as a whole began to bombard the medical profession with an array of lavish gifts and funding. This has raised serious questions as to conflicts of interest, medical ethics, manipulation and other potential abuses which strongly suggest prescriptions are now very often written as a direct result of the quality of the gifts associated with the drug, rather than the quality of the drug associated with the gifts.
The following is only a partial list of the kind of gifts and funding given out to members of the medical profession:
1. Paid vacations.
2. Airlines travel miles awarded on the basis of prescriptions written.
3. Complimentary meals and entertainment at Continuing Medical Education (CME) courses.
4. Consultation fees.
5. Financial support of CME-accredited activities.
6. Sponsorship of psuedo-CME courses. (These are not accredited and usually little more than thinly veiled advertising campaigns)
7. Meals of all types ranging from buffets offered to hospital residents, to lunches and dinners at the finest restaurants for physicians and their families.
8. Funding for travel or lodging
10. Sponsorship of events for physicians and their families at them parks including meals, entertainment and the use of the facilities.
In January of 2000, the Journal of the American Medical Association presented an excellent Commentary by Dr. Robert M. Tenery and Review by Dr. Ashley Wazana on this subject. (JAMA, Vol. 283 No. 3). We highly recommend both pieces, which are extensively annotated, to our readers who wish to read more about these controversial issues.
We also highly recommend David D. Kirkpatrick's article entitled "Selling Happiness" in the May 15, 2000 issue of New York Magazine. Mr. Kirkpatrick has certainly done his homework and everyone taking a relatively new prescription drug of any kind would be well served by reading this captivating expose of an industry practice that uses "free gifts, dinners, propaganda and research funds" to "capture the minds of doctors". There can bee little doubt, if any, that an industry that commands an army of 68,000 sales representatives and spends $9 Billion dollars on marketing to its target audience ($12,000 for each doctor in the U.S.), wants (and gets) much more than just name recognition. In fact, many suspect that the degree to which many doctors now fund themselves influenced by this highly questionable practice borders on the unethical.
Dr. Robert Goodman, a New York internist, fed up with this entire matter, has launched the "No Free Lunch" campaign. His t-shirts, coffee mugs and pens read "NO FREE LUNCH : JUST SAY NO TO DRUG REPS". He even has a website, www.nofreelunch.org which includes "facts and research about the influence of drug companies of medicine." Dr. Goodman openly admits, "What really annoyed me was physicians' willingness to be bribed."
Finally, we note that for the past 10 years, the pharmaceutical manufacturers have been compiling information on the prescribing patterns of the nation's health care professionals. As a result of buying all of the available information from pharmacies, the AMA, and the federal government, the drug industry has succeeded in compiling "prescriber profiles" for just about every health care professional who write prescriptions. These profiles allow drug companies to target specific doctors or geographical areas with promotional campaigns for specific drugs or categories of drugs.
Although the pharmaceutical industry "has the best market research system of any industry in the world" according to Mickey C. Smith, a professor of pharmaceutical marketing at the University of Mississippi, many health privacy experts like Lawrence O. Gostin of the Georgetown University Law Center, regard such practices as "a fundamental violation" of a physician's right to privacy.
Recently, an article by Dr. Ashley Wazana, in the Journal of the American Medical Association, analyzed 29 studies on the effects of gifts to doctors. Dr. Wazana's analysis concluded that doctors are "influence able".
Thus, the one-two punch of DTC advertising and gifts to health care professionals has succeeded in generating ever-increasing revenues for the drug industry. With such results, it is highly unlikely that the drug companies will choose to police themselves in either area. Clearly, the FDA, AMA and the federal government must formulate, promulgate and enforce standards and rules regarding both. In the end, however, it is up to each health care professional to guard against being unduly influenced and each consumer to resist being flimflammed by an industry that has demonstrated it is capable of doing both when the price is right.