Drug Ads on Television - How Did It Happen?

Drug Ads on Television - How Did It Happen?

Most of us often wish for easy solutions to our problems. If we see that our clothes are getting tight, what is wrong with wishing for a harmless pill that will allow us to lose weight without changing our eating habits? When we watch television, we see example after example of happy people who have lost 20, 40 or even 100 pounds by taking this or that pill. However, most of us have learned that these pills don't really work. Yet, they are on television for a reason—they sell enough products to pay for the costs and make a profit for the company promoting them. Hope springs eternal in most of us. We hope that this solution will be different. Maybe this is why the diet pills keep selling on television. Maybe this one will work.

This attitude of consumers is also why the drug companies spent lots of money lobbying to get the Federal Drug Administration (“FDA”) to modify its rules regarding television advertising of prescription drugs. They knew that they could sell more and more of their drugs—even if they weren't needed and might actually do harm. Sales, nothing else, was important. For years their lobbying efforts were unsuccessful. In fact, many of us remember when we could watch television with our children and not be asked to explain “erectile dysfunction” or “herpes” and then explain what the advertised drug does. This changed in August of 1997.

DIRECT TO CONSUMER Direct to consumer advertising (“DTC”) is the name given to advertising prescription drugs in magazines, newspapers and television. Prior to 1997, the FDA rules said, “Advertisements promoting the medical use of prescription drugs must contain a "brief summary" of all important information about the advertised drug, including its side effects, contraindications and effectiveness. In addition, advertisements broadcast over radio, TV or through telephone communications systems must include a "major statement" prominently disclosing all of the major risks associated with the drug.” Prior to August of 1997, print advertisements for prescription drugs were able to meet the "brief summary" requirement by including the risk-related sections of drug labeling together with the advertising copy.

As the drug companies looked wistfully at the enormous marketing potential of television, they saw that there was no way to provide the required information about the drug in 30 second or one minute television ads. Did Congress act? No, the FDA made the August 1997 rule change quietly and without consulting Congress or really anyone else. Their change allowed the drug companies to “...include information about any major risks, as well as instructions for how consumers can easily obtain more detailed information about the drug's approved uses and risks.” FDA Lead Deputy Commissioner Michael J. Friedman, M.D was one of the driving forces behind this change long sought by the drug companies. Dr. Friedman said in 1997, "Today's action can help promote greater consumer awareness about prescription drugs.

By describing realistic standards for television advertising of prescription drugs, we hope to end the uncertainty which has plagued both consumers and industry about the use of this medium. The FDA is committed to making sure that accurate and complete information is available to consumers." In the 1997 rule revision, the FDA “...presumes that the broadcast ad is truthful, not misleading, and contains information about the major health risks associated with the drug. In lieu of providing a "brief summary," the advertiser would have to provide a mechanism to ensure that consumers can easily obtain full product labeling.”

In other words it is enough to quickly list some of the side effects along with a toll-free phone number or web address or advise the listener to speak with a physician. In her book, Our Daily Meds, Melody Peterson states, “Dr. Friedman soon left the agency. In 1998, President Clinton nominated Dr. Jane Henney to be the next commissioner of the FDA, and Dr. Friedman resigned the next year to become a senior vice president at Searle, a subsidiary of Monsanto, which had just introduced a new pain pill.” It is significant that the United States and New Zealand are the only two industrial nations that allow the drug companies to advertise on television in this fashion.

RESULT According to the Government Accounting Office (report no. GAO-07-54, December 14, 2006): “In the past decade, drug companies have quadrupled expenditures on ads aimed at consumers. Spending on direct-to-consumer advertising increased by 296.4% from 1997 to 2005, during which time spending on promotion to physicians increased by 86.0% and spending on pharmaceutical research and development increased by 103.3%.” In an article entitled, Direct-to-Consumer Advertising of Prescription Drugs published in the August of 2007 issue of Journal Watch, Dr. Allan S. Brett, MD summarized the findings of his study of DTC advertising of prescription drugs on television. Dr. Brett concluded that: Total spending on DTC advertising in the U.S. increased from about $1 billion in 1996 to $4 billion in 2005; DTC advertising represented about 14% of drug company promotional expenditures in 2005.

The five single drugs with the highest expenditures for DTC advertising were Nexium, Lunesta, Vytorin, Crestor, and Advair. From 2002 to 2006, DTC advertising was the target of one third to one half of letters sent by the FDA to drug companies regarding violations in regulations on drug promotion. Most citations were for DTC advertising that minimized risks or exaggerated effectiveness. The level of FDA staffing dedicated to review of DTC advertising has not kept pace with the recent increase in DTC advertising. DTC has led to the manipulation of information in ways that subtly overstate the drug’s benefits, indications, and target populations. All of us intuitively know that television commercials always show the most ideal situation. The people presented tell us about how all of their problems were solved by taking a drug.

They imply that now their lives are what we dream our lives could be. But you ask, is this not the same thing that the companies selling diet pills do? Yes, but except in rare cases, taking these diet drugs doesn't create other serious health problems or cost society millions of dollars. Vioxx was popularized mainly by the image of Dorothy Hamill lacing up her skates and gliding over the ice despite her osteoarthritis, all because of Vioxx. Merck had to take Vioxx off the market because even while the commercials were running, they were receiving alarming reports that the millions of patients who responded to the ad and demanded their doctors prescibe Vioxx were risking stroke or serious heart problems.

CONCLUSION Few things better illustrate the extent that the FDA has come under the control of the drug companies than the DTC changes in 1997. While some of the drug company spokespeople have stated that anyone attacking their misleading television advertisements are attacking free speech, this is a silly argument. It is unlikely that any court would refuse to uphold an action by the FDA that required a complete statement of the risks of these dangerous drugs. It would not prohibit television advertising but allow it, only if the drug companies met the same requirements of pre-August 1997 law.

What can we do? We can contact our U.S. Representative and two U.S. Senators and demand that the rules in effect prior to August of 1997 be required for DTC advertising. It is only if enough of us make our feelings known and demand change that we will see a change. At Novus Medical Detox Center we take pride in helping people safely and more comfortably withdraw from some of these drugs promoted shamelessly by the drug companies.

We help people with OxyContin addiction, Vicodin addiction, Percocet addiction, and methadone addiction and help them withdraw from any unneeded antidepressants and benzodiazepines. If you know anyone that wants to take the first step toward freedom from these dangerous drugs, please tell them about Novus.

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