It's a start

My daughter, Meredyth Warren from Long Beach, California, the pharmacist's assistant who is in college to be a pharmacist and doesn't believe in Natural Medicine wrote this:

Fatal Drug Advertising:
The Lessons of Vioxx

In 2000, pharmaceutical giant Merck spent $160 million on DTC (direct-to-consumer) advertising for its newly approved prescription arthritis drug Vioxx. That figure tops the expenditures of Pepsi and Budweiser each that year to promote their top products (National Institute for Healthcare Management 5). This advertising blitz started just months after the FDA (Food and Drug Administration) had approved Vioxx (Abramson 23). Advertising works. By the end of 2000, Vioxx sales reached $1.5 billion (National Institute for Healthcare Management 2). In the ensuing few years, troubling evidence regarding the severe and potentially fatal side-effects of Vioxx began to emerge, including studies showing that Vioxx might double the chances of heart attacks and or strokes (Abramson 35). Merck continued to advertise Vioxx to everyone, even after being reprimanded more than once by the FDA for not including a fair representation of this important information in their ads (Abramson 32). Merck eventually discontinued sales of Vioxx voluntarily in 2004(Burke 1753). This action came too late for many consumers. As noted by healthcare ethicist Leonard J. Weber, by the time that Vioxx was pulled, there were already millions of people taking it at serious risk to their health (2). While the exact number of patients adversely affected by Vioxx is still unknown, in a study of drugs belonging to the same family as Vioxx (known as COX-2 inhibitors) it was concluded by Dr. Campen, et al. that the drug Vioxx alone could have been responsible for over 100,000 serious heart attacks and strokes in the few years it was on the market (479). If the FDA continues to allow drug companies to advertise their prescription products to consumers, it is obvious that changes in policy are necessary in order to protect the public. The Vioxx debacle clearly shows the glaring inadequacies in the current FDA regulations of DTC prescription drug advertising.
Once a drug has been approved by the FDA, no waiting period currently exists to prevent that drug from being marketed to consumers immediately. This proved to be especially problematic in the case of Vioxx. In an article this year for Clinical Pharmacology & Therapeutics, authors Bell and Kravitz conclude that DTC advertising can be most dangerous when it involves newly approved drugs that have not had time enough on the market to prove themselves. Often, the risks of a new drug aren’t apparent until it has been given to enough people to evaluate its dangers (361). They go on to propose that a newly approved prescription drug should be given 2 years to prove itself as both effective and safe before it is marketed to consumers. This waiting period would allow physicians some time to become more familiar with the drug and its limitations when compared to other therapies that are already available (361). Mass marketing of Vioxx before its risks and limitations could be assessed, caused unnecessary injury and death. As Dr. John Abramson points out, Vioxx was prescribed to far too many people. The drug should have been limited to arthritic patients on steroids, who had no history of cardiovascular disease, and who had exhibited adverse stomach problems while taking NSAIDs (non-steroidal anti-inflammatory drugs) such as Naproxen (36). This is a far cry from what actually happened in the Vioxx case. Patients were asking for Vioxx, and being prescribed it, for any type of ache and pain imaginable. The pharmaceutical industry may complain that a two year moratorium on DTC after the drug is approved is an unfair burden, but as Drs. Bell and Kravitz point out, a waiting period may be advantageous for the drug industry as well. “A [2 year] moratorium reduces the inherent financial liabilities that accompany the mass adoption of understudied new drugs“(361). Merck may just agree in light of the ongoing court battles it faces because of Vioxx. As Todd Zwillich reports in an article for The Lancet, Merck has reserved $675 million to fight lawsuits resulting from Vioxx that could lead eventually to losses in the billions of dollars (1673).
DTC marketing of prescription drugs began a decade ago, when the FDA relaxed its restrictions (Nelson 25). At that time, the FDA thought that the restrictions in place would be sufficient to protect the public. The FDA would have the power of regulatory letters to admonish companies running misleading ads, and force them to pull such ads from the airwaves. However, in a report by the GAO (U.S. Government Accountability Office), it was noted that the FDA’s method of admonishing drug companies for false or misleading advertising fell far short of what was necessary to protect the public (2). The letters, which are meant to force companies to comply with regulations, can do nothing more than force the company to pull the ad that violates FDA regulations. The GAO found that it took the FDA an average of 8 months to issue such a letter. This was too late in most cases to stop the ad in question. The letters also couldn’t prevent the same company from running similar and just as misleading ads in the future (7). Vioxx is a good example of how little power the FDA‘s regulatory letters have. According to Dr. John Abramson, the FDA sent two regulatory letters to Merck regarding their Vioxx ads. The first letter was issued in 2000 and accused Merck of putting out ads that misrepresented Vioxx, namely that Merck’s ads didn’t give sufficient weight to evidence that the drug could have potentially dangerous cardiovascular side effects. The second, in 2001, came after a press release entitled “Merck Confirms Cardiovascular Safety Profile of Vioxx”. The FDA was particularly upset with Merck for putting out this press release considering that they had already warned the company the previous year about their misleading ads (36). Merck‘s response was to continue to aggressively push Vioxx on unsuspecting consumers even in the face of repeated admonishments by the FDA, and with the knowledge that their product could possibly cause undue harm. The FDA needs better tools at its disposal to deal with DTC ads that mislead consumers. The FDA should have the ability adequately deal with drug companies that refuse to follow the law. Instead of issuing hollow warnings, a drug company in violation of FDA rules could be warned once, then be imposed monetary fines if they continued to run false or misleading advertisements for their products.
Since the FDA changed its guidelines in 1997, DTC advertising has exploded. According to the GAO, over $4 billion was spent in 2005 by drug companies in DTC advertising alone (5). Consumers are being bombarded daily by radio and television ads that encourage them to “ask their Doctor” if a particular drug is “right for them”. There is no question that these ads work. What can be questioned, however, is whether there are sufficient safeguards in place to protect the public from undue harm resulting from the drugs that these ads are touting. The drug companies may cry foul if told that they cannot advertise their newly approved drugs to everyone with a television or radio, but the lessons of Vioxx should not be ignored. No drug should be considered safe enough to be advertised to the masses until it has been on the market long enough to assess its true risks. Then, once DTC advertising of a new drug starts, the FDA needs to act swiftly and strongly to curtail misleading ads so as to assure the safety of the American public.

K.
I asked her to lambast Gardasil next.