Do you think the situation is bad now? A year ago, pharmaceutical companies applied to the FDA for approval to use direct-to-consumer advertising to promote the off-label use of drugs for unapproved indications. First, I would require manufacturers to describe the expected level of benefit. This may be a statement of placebo-corrected effect on the primary endpoint of the pivotal study that led to approval. Second, I would require manufacturers to tell the public how much the drug costs. This should be the list price, not the discounted price (which companies don`t disclose anyway). CHILDS: But Lou says they decide to study TV commercials so they can give pharmaceutical companies clear advice on what the ads might say. So they make a series of fake TV ads to see how consumers would react. Do other medications have different side effects for my condition? And the drug advertising landscape can change even more. Dr. Sarpatwari says pharmaceutical companies may soon be able to promote drug applications that have not been reviewed by the FDA, called off-label applications.
While some off-label drug uses have been well studied and have been part of medical routine for years, many other off-label uses have not. And while consumers believe the drug is credible, they may ignore many of these side effects that could cause serious harm. When so much information is compressed into a short drug advertisement, it is unlikely that most consumers will absorb everything and adequately weigh the benefits and risks of a particular drug. I know we`re all focused on the war in Europe – as we should be – but I thought I`d take a week to fill Andy Rooney and complain about the TV commercials. Specifically, I`d like to talk about the television ad that really sticks to me more than anyone else: pharmaceutical advertising. CHILDS: Drug companies don`t just spend a lot of money on advertising and then pass the costs on to consumers. It`s more subtle. It`s more us. When we see an advertisement for a branded drug, the advertisement makes us appreciate that brand name. And if we enjoy something, we`ll pay more for it — or at least ask our insurance company to pay more for it.
What really happens is that pharmaceutical companies create demand for their product by flooding consumers with advertisements convincing them that they need treatment. Since the Food and Drug Administration changed its policies in 1997 to allow pharmaceutical companies to advertise on air, many doctors have argued that there is a growing movement of patients looking for unnecessary drugs. This puts pressure on physicians to prescribe medications to their patients that they believe are not in the best interest of the patient. Help-seeking ads describe a constellation of symptoms and encourage the public to seek advice or help from their doctor. These ads usually include the name and phone number of a pharmaceutical company, which you can call for more information. For example, a help-seeking ad might list several symptoms for a particular disorder for which the pharmaceutical company has a drug it wants to promote. Then, the ad suggests that if the person suffers from these symptoms, they should ask their doctor for more information without giving the name of the drug. Typically, ads asking for help are not regulated by the FDA, but by the FTC, as they must not contain or recommend a particular drug. However, in the event that a seeker for help announcement suggests a particular drug, the FDA monitors the ad as an advertisement for product claims. All members of the patient care team, including nursing, paramedic and interprofessional team, have a role to play in ensuring proper oversight of medication prescribing and medication.
Patients talk to nurses and pharmacists when they request a drug renewal. These team members are in an excellent position to assess potential side effects and/or the effectiveness of the drug and report them to the prescribing physician to help decide whether or not a drug should be continued or if dosage adjustments may be beneficial. Prescribing physicians could be even scarier than uninformed patients – after all, patients are not the ones who spend nearly a decade becoming healthcare professionals. Reviews of the DTCM show that patients tend to be more familiar with the benefits of a drug than with its risks, which is bad enough. The worst part is that patients tend to believe that pills are really the solution to all problems, which can lead to a prescription even when doctors try to discourage their patients. In fact, while there is lip service to lifestyle factors, no drug advertising claims that a condition could be solved by lifestyle changes alone. CHILDS: In 1997, pharmaceutical companies spent $300 million on television advertising. In `98, it was twice as high – 600 million. And in 2000, we were in the billions — $1.57 billion for television advertising about drugs.
Pharmaceutical companies will also argue that rising drug costs help support research and development of new drugs. They explain that the process is very expensive and time-consuming, and that for every successful drug, there are many drugs that fail. There is a grain of truth in this argument and the development of new drugs is indeed a noble and necessary undertaking, but it does not tell the whole story. Drug advertising, as you know, did not begin until 1997, when restrictions were eased and new drugs appeared in television commercials. For its part, the FDA notes that no federal law has ever banned drug advertising, justifying its increasingly lax regulation. GONZALEZ: But people like Liz Mensch, who received the first drug commercial on television, they say, listen; If a doctor feels intimidated into prescribing medication to someone, that is a problematic doctor. They should be the gatekeepers. The FDA`s stated goals in 1906 (it was not known as the FDA until 1930) were much the same as they are today: “[The organization] protects public health by ensuring the safety, efficacy, and safety of a wide range of products, including prescription drugs.” Can direct-to-consumer advertising of prescription drugs be prohibited? Apparently, it is legally difficult. The courts have held that product advertising is a form of commercial freedom of expression protected by the principle that a manufacturer has the right to market its products.
UNKNOWN PERSON #1: You should ask your doctor or pharmacist for calls. They will tell you that Motrin 400 milligram tablets and 400 milligram tablets are different brand names for the same ibuprofen drug. The Food and Drug Administration (FDA) is responsible for DTCA prescription drugs, while the Federal Trade Committee oversees over-the-counter drug notifications. Although the FDA monitors all prescription drug advertisements, drug ads do not need to be approved for compliance before being made public.  In the case of advertising to clinicians, it has been well documented that advertising drugs to medical providers influences prescribing patterns and behaviours. A systematic review of fifty-eight studies showed a negative impact of drug selection by suppliers with greater exposure to pharmaceutical company information.  These negative influences included “higher prescribing frequency, higher costs and lower prescription quality.”  In 1997, the FDA liberalized its guidelines for broadcast advertising by allowing for the “adequate provision” of information about side effects and benefits of drugs by directing consumers to another source of information, such as a toll-free telephone number or website.  This made advertising in broadcast media more viable for pharmaceutical companies, as they didn`t have to spend as much time listing all the side effects during advertising.
Since then, spending on DTCA has increased significantly.   This relaxation does not apply to prescription-only print advertising, which must nevertheless contain all adverse effects. Print drug advertising must include a “brief summary” to summarize all side effects of a drug based on prescribing information. These summaries do not have to include information unrelated to the risks of a drug, such as: mechanism of action, etc. There are no restrictions on advertising product claims of drugs with known potential serious side effects. CHILDS: How do these ads affect the cost of drugs, and has all of this led the United States to prescribe more drugs? It`s after the break. Look, I get it. Some ads are just plain disgusting, especially for supplements for everything from memory to testosterone.
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